National Toxicology Program

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TDMS Study 05025-01 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/04/94   
EXP: 05025                     ETHYLENE GLYCOL                 TIME: 06:15:40   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 00920A   
CONT: N01CP9565102                                             CAS: 107-21-1    
PATHOLOGIST: D. FARNELL                      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: 09/04/94  
EXP: 05025                     ETHYLENE GLYCOL                 TIME: 06:15:40  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 00920A  
CONT: N01CP9565102                                             CAS: 107-21-1   
PATHOLOGIST: D. FARNELL                      S. EUSTIS                         

                                  ETHYLENE GLYCOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 6    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      54    120   123   126   136   145   186   213   350   386                 |
 |      415   469   538   585   595   598   602   602   630   637                 |
 |      649   654   667   682   709                                               |
 |  CENSORED DEATHS                                                               |
 |      465   465   465   465   465   465                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.625%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 6    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      98    175   346   394   514   514   578   599   599   601                 |
 |      601   624   627   641   654   654   667   682   693   697                 |
 |      697   709                                                                 |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   463   463   463                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 6    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      31    32    42    46    93    121   383   384   384   384                 |
 |      513   517   584   598   607   620   622   633   654   667                 |
 |      697   705                                                                 |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   463   463   463                                         |
 |                                                                                |
 ==================================================================================

                                  ETHYLENE GLYCOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 31     CENSORED DEATHS 6    TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      60    91    98    101   126   127   144   145   149   150                 |
 |      154   161   168   215   241   317   386   498   519   590                 |
 |      595   597   654   667   681   681   682   697   709   709                 |
 |      722                                                                       |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   463   463   463                                         |
 |                                                                                |
 ==================================================================================

                                  ETHYLENE GLYCOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   731 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |    98.3  90.0  86.7  85.0  81.7  79.8  77.9  68.4  60.8  55.1      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.625%     |   100.0  96.7  96.7  95.0  93.3  93.3  89.6  80.3  70.9  59.7      |
 |           |                                                                    |
 |           |                                                                    |
 |1.25%      |    93.3  90.0  90.0  90.0  83.3  83.3  79.5  75.8  66.3  60.6      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5%       |    98.3  78.3  75.0  73.3  71.7  71.7  67.8  62.0  60.0  44.5      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATD     0.625%       1.25%        2.5%     |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       55.1%        59.7%        60.6%        44.5%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.136      P=0.455N     P=0.706N     P=0.306  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       434.8        562.0        423.5        381.7    |
 |NATURAL DEATHS (C)      |       (45.4)       (35.5)       (53.0)       (45.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       581.0        642.2        591.5        523.8    |
 |(STANDARD ERROR)        |       (26.6)       (18.2)       (27.3)       (31.7)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                  ETHYLENE GLYCOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 10   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      472   518   520   536   546   574   578   581   605   606                 |
 |      655   665   665   696   696   697   698                                   |
 |  CENSORED DEATHS                                                               |
 |      465   465   465   465   465   465   465   465   465   465                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 20     CENSORED DEATHS 10   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      472   476   533   535   539   543   554   561   577   594                 |
 |      612   633   644   663   679   688   696   696   718   725                 |
 |  CENSORED DEATHS                                                               |
 |      464   464   464   464   464   464   464   464   464   464                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 9    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      98    367   490   500   511   535   538   548   579   612                 |
 |      634   638   639   644   665   665   681   691   700   708                 |
 |      730                                                                       |
 |  CENSORED DEATHS                                                               |
 |      464   464   464   464   464   464   464   464   464                       |
 |                                                                                |
 ==================================================================================

                                  ETHYLENE GLYCOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 10   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      391   457   469   500   541   634   639   659   665   665                 |
 |      665   682   708                                                           |
 |  CENSORED DEATHS                                                               |
 |      464   464   464   464   464   464   464   464   464   464                 |
 |                                                                                |
 ==================================================================================

                                  ETHYLENE GLYCOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   731 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  82.0  74.0  66.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |1.25%      |   100.0 100.0 100.0 100.0 100.0  96.0  88.0  80.0  72.0  60.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5%       |   100.0  98.3  98.3  98.3  96.7  96.7  86.8  82.9  69.0  59.2      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |   100.0 100.0 100.0 100.0  98.3  94.7  90.6  90.6  78.5  74.5      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATD     1.25%        2.5%         5.0%     |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       66.0%        60.0%        59.2%        74.5%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.371N     P=0.649      P=0.554      P=0.514N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       606.4        606.9        579.7        590.4    |
 |NATURAL DEATHS (C)      |       (17.8)       (17.8)       (31.1)       (29.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       651.4        645.1        638.0        656.0    |
 |(STANDARD ERROR)        |       (13.8)       (14.0)       (16.9)       (14.7)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                          ETHYLENE GLYCOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.625%           = 2
                                                        1.25%            = 3
                                                        2.5%             = 4

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

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

      |
      |
  100 + 1     3  14    2
      |       33 14   42    1       2                          2
      |        33      4 4                                     2       2
      |         3      3 4  1411                                       2                 2
P  90 +                     34 1      1                              3                   2         2
E     |                        44     1   1                    1                                   2   2
R     |                                                        1      1
C     |                         44                                   31   1       1      3
E  80 +                          44                                               1      3   1      3  2   2
N     |                           4       4    4                                             1      1  3   2 2
T     |                                        4           4                                        1 113 3  2 2
      |                                                    4          4                4
S  70 +                                                                                4   4              3 3  2  2 2
U     |                                                                                    4          41   11  3  3 22
R     |                                                                                               44    1 1   3  22
V     |                                                                                                4      11      232
I  60 +                                                                                                        1  1 1  32   2
V     |                                                                                                           4 1   1
A     |                                                                                                                 1   1
L     |                                                                                                             4 4
   50 +                                                                                                               4 4
      |                                                                                                                 4 4
      |                                                                                                                   4 4
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 32 obs hidden.

                                                          ETHYLENE GLYCOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        1.25%            = 2
                                                        2.5%             = 3
                                                        5.0%             = 4

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

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

      |
      |
  100 + 1              3                                              4            1
      |                3                                          3   4          4
      |                                                                            1     1
      |                                                           3              442 3   1 1 2
   95 +                                                                           4  3 3
      |                                                                                    1 1
      |                                                                                33    11
      |                                                                                 3    34             4
   90 +                                                                                      21   1
      |                                                                                                     44
P     |                                                                                       2 2 11
E     |                                                                                      3 322           4   4
R  85 +                                                                                        3   3
C     |                                                                                          2 1    1
E     |                                                                                            2  2  3
N     |                                                                                                  3  3
T  80 +                                                                                               2 12     1
      |                                                                                                     33   4  4
S     |                                                                                                  2  2  1 1
U     |                                                                                                     22      4   4
R  75 +                                                                                                                 4   4
V     |                                                                                                      2   1    1
I     |                                                                                                      3   2 2
V     |
A  70 +                                                                                                            2 2
L     |                                                                                                          3  3
      |                                                                                                             322
      |                                                                                                               1     1
   65 +                                                                                                              33
      |                                                                                                               2 32
      |                                                                                                                  22
      |                                                                                                                 3   3
   60 +                                                                                                                   2 2
      |                                                                                                                     3
      |
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 14 obs hidden.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.