National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/5344

TDMS Study 96007-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                    TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                 DATE: 09/29/03       
EXPERIMENT: 96007 TEST: 04                                                                                     TIME: 12:11:17       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007B       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: TEFDIOXINMIX    
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#4/RATS                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                    TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                 DATE: 09/29/03       
EXPERIMENT: 96007 TEST: 04                                                                                     TIME: 12:11:17       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007B       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: TEFDIOXINMIX    
                                                                                                                                   
               TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = TERT.MIXCONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 37     CENSORED DEATHS 0    TERMINAL 16        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      176   218   276   387   416   435   444   454   456   484                 |                                                 
 |      500   508   526   540   568   575   587   625   625   626                 |                                                 
 |      627   631   645   655   658   666   668   668   669   682                 |                                                 
 |      682   693   702   715   721   723   727                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = TERT.MIXTEQ=10                                 |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 23        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      227   350   362   416   455   456   498   540   546   548                 |                                                 
 |      562   563   563   626   627   627   627   631   652   659                 |                                                 
 |      668   668   669   669   683   689   702   702   718   721                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = TERT.MIXTEQ=22                                 |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 28     CENSORED DEATHS 1    TERMINAL 24        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      203   263   322   456   526   529   540   548   592   609                 |                                                 
 |      616   617   621   639   652   659   659   666   669   669                 |                                                 
 |      683   699   702   702   702   703   709   723                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      46                                                                        |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
               TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = TERT.MIXTEQ=46                                 |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 29     CENSORED DEATHS 1    TERMINAL 23        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      276   315   322   333   469   490   505   521   521   542                 |                                                 
 |      548   585   616   619   626   626   668   668   668   669                 |                                                 
 |      669   669   669   669   682   682   682   697   702                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      465                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = TERT.MIXTEQ=100                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 43     CENSORED DEATHS 2    TERMINAL 8         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      2     287   312   339   387   409   434   434   497   498                 |                                                 
 |      526   542   546   548   548   562   563   575   589   592                 |                                                 
 |      598   598   617   623   631   633   634   639   658   666                 |                                                 
 |      674   674   674   682   682   688   689   689   715   718                 |                                                 
 |      721   728   728                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      392   399                                                                 |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
               TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                                                                 
                       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)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |TERT.MIXCON|ROL100.0  98.1  96.2  94.3  90.6  81.1  73.6  67.9  52.8  30.2      |                                                 
 |T          |                                                                    |                                                 
 |           |                                                                    |                                                 
 |TERT.MIXTEQ|10 100.0 100.0  98.1  94.3  92.5  88.7  84.9  75.5  62.3  43.4      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |TERT.MIXTEQ|22 100.0 100.0  96.2  94.2  94.2  92.3  86.5  82.7  67.3  46.2      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |TERT.MIXTEQ|46 100.0 100.0 100.0  92.5  92.5  90.5  80.9  77.0  69.3  44.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |TERT.MIXTEQ|100 98.1  98.1  98.1  92.5  88.6  84.7  76.8  57.1  43.3  15.8      |                                                 
 |T          |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
                                                                                                                                   
               TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ===============================================================================================================================    
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |    
 |                                                                                                                             |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |                                                                           DOSE                                              |    
 |                                                                                                                             |    
 |                                TERT.MIXCONTROL    TERT.MIXTEQ=10     TERT.MIXTEQ=22     TERT.MIXTEQ=46     TERT.MIXTEQ=100  |    
 |                                T                                                                           T                |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |SURVIVAL AT END OF STUDY|       30.2%              43.4%              46.2%              44.3%              15.8%            |    
 |(KAPLAN-MEIER)          |                                                                                                    |    
 |                        |                                                                                                    |    
 |SIGNIFICANCE (B)        |       P=0.012            P=0.195N           P=0.080N           P=0.160N           P=0.165          |    
 |(LIFE TABLE)            |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN DAY OF             |       566.4              580.8              595.6              576.1              570.9            |    
 |NATURAL DEATHS (C)      |       (23.4)             (22.5)             (25.6)             (23.7)             (22.2)           |    
 |(STANDARD ERROR)        |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN LIFE SPAN (D)      |       615.5              645.1              645.7              640.4              588.2            |    
 |(STANDARD ERROR)        |       (19.3)             (16.2)             (19.9)             (16.9)             (20.3)           |    
 |                        |                                                                                                    |    
 ===============================================================================================================================    
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                        TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE)                                        
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        TERT.MIXCONTROL  = 1                                                        
                                                        TERT.MIXTEQ=10   = 2                                                        
                                                        TERT.MIXTEQ=22   = 3                                                        
                                                        TERT.MIXTEQ=46   = 4                                                        
                                                        TERT.MIXTEQ=100  = 5                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 15                           1  3   2       4                                                                               
      |  5                           1  3  12     3 45    4    2                                                                    
      |                                    1      3 15    43 452 2    1   2      3                                                  
      |                                                      45       1   1     234         3                                       
   90 +                                                               5  51  1  224  4                                              
      |                                                                  5  511 12   4 24  43 23                                    
      |                                                                     5   11    5        3      3                             
      |                                                                          1   155   4  22      3 3                           
   80 +                                                                              1 11   5 42 2  4   333                         
      |                                                                                 1   1       4    4                          
P     |                                                                                     1 15 2       432 3                      
E     |                                                                                       1   11      44 3 3                    
R  70 +                                                                                        5 5 11      4   3 34                 
C     |                                                                                          5 51      12    33                 
E     |                                                                                            5  5     2  2 2                  
N     |                                                                                                          22 3               
T  60 +                                                                                               55   11       3 3             
      |                                                                                                5  5 1 11      33            
S     |                                                                                                           2 2               
U     |                                                                                                   5 5  1  1 22              
R  50 +                                                                                                              2 23           
V     |                                                                                                     55      4 42323         
I     |                                                                                                      5 5  1 1 44  3 3       
V     |                                                                                                        5  5511   2  2       
A  40 +                                                                                                              1 1            
L     |                                                                                                                1 1          
      |                                                                                                            55    11         
      |                                                                                                             55              
   30 +                                                                                                                   1 1       
      |                                                                                                                             
      |                                                                                                              5   5          
      |                                                                                                                             
   20 +                                                                                                                  55         
      |                                                                                                                             
      |                                                                                                                   5 5       
      |                                                                                                                             
   10 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 39 obs hidden.                                                                                                                
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