National Toxicology Program

National Toxicology Program
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TDMS Study 96021-01 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 02/12/04       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 13:53:36       
TEST TYPE:  CHRONIC                                                                                            PAGE:       1        
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25018 Dosing Accident                                                                        
                                       25023 Missing                                                                                
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25026 Other                                                                                  
                                       25021 Terminal Sacrifice                                                                     
                                       25007 Wrong Sex                                                                              
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 UG/KG                                                                       
                                       INCLUDE 002    10 UG/KG                                                                      
                                       INCLUDE 003    100     UG/KG                                                                 
                                       INCLUDE 004    300     UG/KG                                                                 
                                       INCLUDE 005    1000    UG/KG                                                                 
                                       INCLUDE 006    3000    UG/KG                                                                 
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                    DATE: 02/12/04       
EXPERIMENT: 96021 TEST: 01                                                                                     TIME: 13:53:36       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: NO1-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: C96021       
PATHOLOGIST: SELLS, DONALD                                                                                     CAS: 35065-27-1      
                                                                                                                                   
                   TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 UG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 24        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      211   399   410   418   437   442   502   507   551   555                 |                                                 
 |      555   557   571   590   603   608   613   613   613   621                 |                                                 
 |      641   644   656   664   672   696   696   701   701                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 10 UG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 54     UNCENSORED DEATHS 38     CENSORED DEATHS 0    TERMINAL 16        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      250   250   261   261   310   310   331   352   352   360                 |                                                 
 |      393   405   438   479   479   479   502   506   507   527                 |                                                 
 |      528   545   557   590   600   613   616   622   624   624                 |                                                 
 |      624   637   647   663   675   696   701   701                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 100     UG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 28        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      418   429   429   443   501   501   514   514   514   522                 |                                                 
 |      527   530   530   553   591   636   656   674   674   683                 |                                                 
 |      696   700   701   701   701                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                   TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 300     UG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 31     CENSORED DEATHS 1    TERMINAL 21        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      222   263   269   322   360   443   452   457   486   507                 |                                                 
 |      526   528   530   555   555   568   610   613   621   624                 |                                                 
 |      647   647   656   675   675   675   691   691   693   703                 |                                                 
 |      703                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      59                                                                        |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 1000    UG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 33     CENSORED DEATHS 0    TERMINAL 20        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      341   360   383   452   467   479   497   502   510   514                 |                                                 
 |      529   541   555   579   590   613   617   621   621   625                 |                                                 
 |      636   639   647   647   649   675   696   696   702   706                 |                                                 
 |      715   715   729                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 3000    UG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 51     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 21        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      79    360   387   387   393   432   438   442   443   452                 |                                                 
 |      479   486   501   505   509   514   514   548   557   583                 |                                                 
 |      586   591   612   613   621   641   668   672   675   723                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                   TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                                                                    
                       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 UG/KG    |   100.0 100.0  98.1  98.1  92.5  88.7  84.9  71.7  54.7  45.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |10 UG/KG   |   100.0 100.0  92.6  81.5  77.8  70.4  59.3  53.7  37.0  29.6      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |100        |   100.0 100.0 100.0 100.0  98.1  92.5  75.5  71.7  67.9  52.8      |                                                 
 |UG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |300        |   100.0 100.0  94.2  90.4  90.4  84.6  75.0  69.2  55.8  40.4      |                                                 
 |UG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1000       |   100.0 100.0 100.0  96.2  94.3  88.7  77.4  71.7  52.8  37.7      |                                                 
 |UG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |3000       |    98.0  98.0  98.0  96.1  90.2  78.4  66.7  56.9  49.0  41.2      |                                                 
 |UG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                   TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153)                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
 ===============================================================================================================================    
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |    
 |                                                                                                                             |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |                                                                          DOSE                                               |    
 |                                                                                                                             |    
 |                                0 UG/KG         10 UG/KG        100             300             1000            3000         |    
 |                                                                UG/KG           UG/KG           UG/KG           UG/KG        |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |SURVIVAL AT END OF STUDY|       45.3%           29.6%           52.8%           40.4%           37.7%           41.2%        |    
 |(KAPLAN-MEIER)          |                                                                                                    |    
 |                        |                                                                                                    |    
 |SIGNIFICANCE (B)        |       P=0.701         P=0.051         P=0.518N        P=0.715         P=0.658         P=0.469      |    
 |(LIFE TABLE)            |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN DAY OF             |       567.1           500.4           573.5           547.3           583.3           513.7        |    
 |NATURAL DEATHS (C)      |       (21.2)          (23.2)          (19.8)          (25.3)          (18.6)          (23.3)       |    
 |(STANDARD ERROR)        |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN LIFE SPAN (D)      |       641.3           568.7           656.7           610.9           639.0           603.2        |    
 |(STANDARD ERROR)        |       (16.1)          (21.8)          (14.3)          (22.0)          (15.2)          (20.4)       |    
 |                        |                                                                                                    |    
 ===============================================================================================================================    
                                                                                                                                    
       (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 (PCB 153)                                            
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 UG/KG          = 1                                                        
                                                        10 UG/KG         = 2                                                        
                                                        100     UG/KG    = 3                                                        
                                                        300     UG/KG    = 4                                                        
                                                        1000    UG/KG    = 5                                                        
                                                        3000    UG/KG    = 6                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1            6                    14    2             5           3                                                         
      |              6                    14    2 2           5  5     1  3 3                                                       
      |                                           44       4     5   561 11 3 3 5                                                   
      |                                           2       24     4    66  1  13 5 5    3                                            
   90 +                                                   2  2   4     6    611   5 5                                               
      |                                                      2  2           661 44  5 5113                                          
P     |                                                                          4   4 51      1                                    
E     |                                                         22     2      6 6    4  43 3   11                                   
R  80 +                                                                22       6   6   45 33 5                                     
C     |                                                                 2    2      66 6      5 1 1                                 
E     |                                                                      2      2  66   3  34 15  1                             
N     |                                                                                        3   5  1 15  3                       
T  70 +                                                                             2  266      4 4     115 3  3                    
      |                                                                                226     6               3   3                
S     |                                                                                 2   2  66        115       33               
U     |                                                                                         6   6     14514     3 3             
R  60 +                                                                                     2 2 2   6 6     55                      
V     |                                                                                         2     2  6   141 1    33            
I     |                                                                                               22       4 114                
V     |                                                                                                2 26   5   15  13    3       
A  50 +                                                                                                  22  6    64 411            
L     |                                                                                                   22          55            
      |                                                                                                           66 4 1    1       
      |                                                                                                    22      6   5 56         
   40 +                                                                                                     2 2  2     4 56 4       
      |                                                                                                          2 2        5       
      |                                                                                                            2  2             
      |                                                                                                               22            
   30 +                                                                                                                2    2       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 59 obs hidden.                                                                                                                
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