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TDMS Study 96007-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                         TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 08:48:54       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007G       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 1746-01-6       
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                                                           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 (TCDD)                      DATE: 09/30/03       
EXPERIMENT: 96007 TEST: 03                                                                                     TIME: 08:48:54       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007G       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 1746-01-6       
                                                                                                                                   
                    TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 NG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 25        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      169   185   351   361   366   469   474   487   492   512                 |                                                 
 |      526   533   548   610   631   645   646   646   647   648                 |                                                 
 |      666   668   675   694   697   701   717   722                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 3 NG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 54     UNCENSORED DEATHS 33     CENSORED DEATHS 0    TERMINAL 21        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      200   241   264   264   341   361   394   448   449   462                 |                                                 
 |      485   490   492   526   548   556   556   556   556   557                 |                                                 
 |      557   578   578   604   604   607   613   620   647   648                 |                                                 
 |      681   718   729                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 10 NG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 25     CENSORED DEATHS 5    TERMINAL 23        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      240   344   348   429   550   578   578   578   578   578                 |                                                 
 |      604   613   614   626   635   645   650   659   659   676                 |                                                 
 |      697   717   718   720   728                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      47    54    177   236   724                                               |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                    TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 22 NG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 34     CENSORED DEATHS 0    TERMINAL 19        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      53    197   338   373   380   389   406   416   417   453                 |                                                 
 |      462   485   522   533   545   557   561   578   578   578                 |                                                 
 |      592   601   607   615   626   626   626   641   645   675                 |                                                 
 |      680   690   708   708                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 46 NG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 31     CENSORED DEATHS 0    TERMINAL 22        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      141   185   317   341   396   444   474   486   486   518                 |                                                 
 |      557   578   589   590   599   621   642   645   657   659                 |                                                 
 |      672   673   673   675   677   683   694   701   701   708                 |                                                 
 |      720                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 100     NG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 32     CENSORED DEATHS 0    TERMINAL 21        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      396   474   546   561   581   598   599   604   610   610                 |                                                 
 |      612   614   638   638   641   641   642   647   648   652                 |                                                 
 |      655   667   668   673   680   693   701   716   717   721                 |                                                 
 |      722   723                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                    TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 100 NG/ KG/STOP                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 21        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      215   345   394   410   474   484   520   537   578   578                 |                                                 
 |      578   584   604   614   629   641   643   645   645   653                 |                                                 
 |      656   673   702   702   718   724   726   726   729                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                    TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       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)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 NG/KG    |   100.0  98.1  96.2  92.5  90.6  86.8  77.4  75.5  62.3  47.2      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |3 NG/KG    |   100.0 100.0  92.6  88.9  87.0  79.6  74.1  53.7  44.4  38.9      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |10 NG/KG   |   100.0 100.0  98.0  93.9  93.9  91.8  91.8  77.6  61.2  48.9      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |22 NG/KG   |    98.1  98.1  96.2  94.3  83.0  77.4  71.7  58.5  45.3  35.8      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |46 NG/KG   |   100.0  98.1  96.2  92.5  90.6  86.8  81.1  71.7  62.3  41.5      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |100        |   100.0 100.0 100.0 100.0  98.1  96.2  96.2  84.9  60.4  39.6      |                                                 
 |NG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |100        |   100.0 100.0  98.0  96.0  92.0  88.0  84.0  74.0  58.0  42.0      |                                                 
 |NG/ KG/STOP|                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                    TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
 ===============================================================================================================================    
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |    
 |                                                                                                                             |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |                                                                        DOSE                                                 |    
 |                                                                                                                             |    
 |                                0 NG/KG      3 NG/KG      10 NG/KG     22 NG/KG     46 NG/KG     100          100            |    
 |                                                                                                 NG/KG        NG/ KG/STOP    |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |SURVIVAL AT END OF STUDY|       47.2%        38.9%        48.9%        35.8%        41.5%        39.6%        42.0%          |    
 |(KAPLAN-MEIER)          |                                                                                                    |    
 |                        |                                                                                                    |    
 |SIGNIFICANCE (B)        |       P=0.736N     P=0.289      P=0.840N     P=0.184      P=0.728      P=0.807      P=0.860        |    
 |(LIFE TABLE)            |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN DAY OF             |       553.1        513.0        590.5        525.3        564.6        634.0        590.6          |    
 |NATURAL DEATHS (C)      |       (28.9)       (23.8)       (25.1)       (25.2)       (27.6)       (12.5)       (23.5)         |    
 |(STANDARD ERROR)        |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN LIFE SPAN (D)      |       637.0        597.8        619.1        599.1        633.7        672.4        649.6          |    
 |(STANDARD ERROR)        |       (19.5)       (20.5)       (24.7)       (21.1)       (19.7)       (10.0)       (16.8)         |    
 |                        |                                                                                                    |    
 ===============================================================================================================================    
                                                                                                                                    
       (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 (TCDD)                                             
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 NG/KG          = 1                                                        
                                                        3 NG/KG          = 2                                                        
                                                        10 NG/KG         = 3                                                        
                                                        22 NG/KG         = 4                                                        
                                                        46 NG/KG         = 5                                                        
                                                        100     NG/KG    = 6                                                        
                                                        100 NG/ KG/STOP  = 7                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1        4             5    1   2 7    3                       6                                                            
      |          4             5    1 1 2 7    2  2            3       6           6                                                
      |                               1 4                  5  4311 4   7 7  3      6          6  6                                  
      |                                           2           2  114 4 5 7  3      7           3 6 6                                
   90 +                                                       2  21  442      5   17 7         3   3   6                            
      |                                                               424 4   2   11 1     7           66                           
P     |                                                                       2 2    11    7 7     7    66                          
E     |                                                                   4     22   21  1                                          
R  80 +                                                                         44   4   1  11  5  3    3                           
C     |                                                                              22    4 1 1   57 5 33   6                      
E     |                                                                               2    424 1    7   71                          
N     |                                                                                      4422     55 1531 1                     
T  70 +                                                                                         44        57353                     
      |                                                                                          4 4         55                     
S     |                                                                                                      735 3                  
U     |                                                                                            4  4       17 51                 
R  60 +                                                                                         2  2  44       6 353  3             
V     |                                                                                            2   424     7  11  1  3          
I     |                                                                                                  4 4       66  7            
V     |                                                                                                 22         55611 7          
A  50 +                                                                                                  224 4      5651 11 3       
L     |                                                                                                   2  42           1 1       
      |                                                                                                       2    42  55 7 7       
      |                                                                                                            424  526 5       
   40 +                                                                                                              4  426 2       
      |                                                                                                                             
      |                                                                                                                 4   4       
      |                                                                                                                             
   30 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 101 obs hidden.