National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/5941

TDMS Study 96007-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:32:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           FINAL #3/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(PECDF)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 05                                                                                     TIME: 11:32:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007F       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 57117-31-4      
                                                                                                                                   
                    TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 NG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 25        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      289   310   321   377   500   500   513   536   554   588                 |                                                 
 |      603   610   619   619   651   651   652   659   675   678                 |                                                 
 |      678   678   678   699   715   715   720   727                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 6 NG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 30     CENSORED DEATHS 1    TERMINAL 22        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      289   321   393   420   432   451   467   498   503   516                 |                                                 
 |      526   530   547   587   600   624   635   645   647   651                 |                                                 
 |      651   651   665   667   668   687   689   693   706   707                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      296                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 20 NG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 27     CENSORED DEATHS 2    TERMINAL 24        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      116   196   219   246   297   393   420   451   497   517                 |                                                 
 |      561   570   584   586   587   587   605   619   629   636                 |                                                 
 |      638   668   675   675   677   689   701                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      300   301                                                                 |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                    TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 44 NG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 27     CENSORED DEATHS 1    TERMINAL 25        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      302   410   429   470   470   470   489   499   525   525                 |                                                 
 |      525   548   561   570   570   573   589   599   603   616                 |                                                 
 |      624   645   645   668   675   675   716                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      472                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 92 NG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 33     CENSORED DEATHS 0    TERMINAL 20        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      113   241   267   315   321   337   348   353   382   420                 |                                                 
 |      451   454   500   500   513   555   561   580   619   642                 |                                                 
 |      651   662   667   668   675   675   675   681   707   717                 |                                                 
 |      721   721   726                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 200     NG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 23        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      78    326   329   398   412   442   442   443   451   498                 |                                                 
 |      498   498   513   513   549   570   570   577   586   597                 |                                                 
 |      603   608   624   624   659   668   689   706   706   716                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                    TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 200 NG/ KG STOP                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 35     CENSORED DEATHS 0    TERMINAL 15        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      215   240   276   370   384   413   451   451   476   491                 |                                                 
 |      495   500   500   503   512   525   547   605   610   610                 |                                                 
 |      619   619   625   638   651   667   680   689   692   699                 |                                                 
 |      701   715   715   716   716                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                    TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 NG/KG    |   100.0 100.0 100.0  94.3  92.5  92.5  84.9  79.2  66.0  47.2      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |6 NG/KG    |   100.0 100.0 100.0  96.2  92.3  86.6  77.0  71.2  55.8  42.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |20 NG/KG   |   100.0  98.1  92.5  90.6  86.6  84.7  80.7  66.9  59.1  47.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |44 NG/KG   |   100.0 100.0 100.0  98.1  96.2  88.7  79.0  63.6  55.9  48.2      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |92 NG/KG   |   100.0  98.1  94.3  84.9  81.1  77.4  71.7  66.0  58.5  37.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |200        |    98.1  98.1  98.1  94.3  90.6  83.0  73.6  60.4  52.8  43.4      |                                                 
 |NG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |200        |   100.0 100.0  96.0  94.0  88.0  82.0  68.0  64.0  50.0  30.0      |                                                 
 |NG/ KG STOP|                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                    TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
 ===============================================================================================================================    
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |    
 |                                                                                                                             |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |                                                                        DOSE                                                 |    
 |                                                                                                                             |    
 |                                0 NG/KG      6 NG/KG      20 NG/KG     44 NG/KG     92 NG/KG     200          200            |    
 |                                                                                                 NG/KG        NG/ KG STOP    |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |SURVIVAL AT END OF STUDY|       47.2%        42.3%        47.3%        48.2%        37.7%        43.4%        30.0%          |    
 |(KAPLAN-MEIER)          |                                                                                                    |    
 |                        |                                                                                                    |    
 |SIGNIFICANCE (B)        |       P=0.089      P=0.531      P=0.765      P=0.823      P=0.272      P=0.470      P=0.057        |    
 |(LIFE TABLE)            |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN DAY OF             |       589.8        568.9        520.0        555.2        527.8        529.8        551.9          |    
 |NATURAL DEATHS (C)      |       (24.4)       (21.5)       (32.7)       (18.1)       (29.6)       (25.2)       (23.7)         |    
 |(STANDARD ERROR)        |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN LIFE SPAN (D)      |       655.0        629.8        605.9        635.2        603.4        615.8        604.7          |    
 |(STANDARD ERROR)        |       (15.9)       (17.4)       (23.3)       (15.3)       (22.7)       (19.6)       (20.2)         |    
 |                        |                                                                                                    |    
 ===============================================================================================================================    
                                                                                                                                    
       (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(PECDF)                                             
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 NG/KG          = 1                                                        
                                                        6 NG/KG          = 2                                                        
                                                        20 NG/KG         = 3                                                        
                                                        44 NG/KG         = 4                                                        
                                                        92 NG/KG         = 5                                                        
                                                        200     NG/KG    = 6                                                        
                                                        200 NG/ KG STOP  = 7                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1            6     3              7           1 4                                                                           
      |              6     3           3  7    5      1 4 126            4                                                          
      |                                3   3   53  57     116     71   2 42 4      4                                                
      |                                         3      3  55      71 7 6 62 2          1                                            
   90 +                                                3   5  5      7 3 6  2 6 2                                                   
      |                                                       555      3 73     2 24 4 1 1   1                                      
P     |                                                         5    5        6 3  7  34   4 1  1                                   
E     |                                                              5    5     6  7  32 2      1   1                               
R  80 +                                                                   5     5        2 42  4 33 1   11                          
C     |                                                                         5     75 6  2  2 43 3    11                         
E     |                                                                                        2 44 2                               
N     |                                                                                5 5     65 6 2  2  1   1                     
T  70 +                                                                                  7 7    554 3 423  22 11                    
      |                                                                                    7   7 565  443 3 2 21 1                  
S     |                                                                                        7   56  44733 5   1 1                
U     |                                                                                                644 3355                     
R  60 +                                                                                                  774334  53                 
V     |                                                                                                 6  6  2  231  1             
I     |                                                                                                   76 74  224  1  1          
V     |                                                                                                      77  62  2              
A  50 +                                                                                                       7   6353 3 11         
L     |                                                                                                           7 5  3 41         
      |                                                                                                             72 2 5          
      |                                                                                                              772 62         
   40 +                                                                                                               77 55         
      |                                                                                                                7 75         
      |                                                                                                                             
      |                                                                                                                             
   30 +                                                                                                                  77         
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 89 obs hidden.                                                                                                                
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