National Toxicology Program

National Toxicology Program
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TDMS Study 96007-01 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                    DATE: 09/23/03       
EXPERIMENT: 96007 TEST: 01                                                                                     TIME: 12:38:03       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007D       
PATHOLOGIST: MISSING                                                                                           CAS: 57465-28-8      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                        FINAL#2; REVISION #1                                                        
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 NG/KG                                                                       
                                       INCLUDE 003    30 NG/KG                                                                      
                                       INCLUDE 004    100     NG/KG                                                                 
                                       INCLUDE 005    175     NG/KG                                                                 
                                       INCLUDE 006    300     NG/KG                                                                 
                                       INCLUDE 007    550     NG/KG                                                                 
                                       INCLUDE 008    1000    NG/KG                                                                 
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                        TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                    DATE: 09/23/03       
EXPERIMENT: 96007 TEST: 01                                                                                     TIME: 12:38:03       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-75411                              ROUTE: GAVAGE                                                  NTP C#: 96007D       
PATHOLOGIST: MISSING                                                                                           CAS: 57465-28-8      
                                                                                                                                   
                   TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 NG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 35     CENSORED DEATHS 3    TERMINAL 15        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      176   201   201   309   321   343   354   391   400   405                 |                                                 
 |      496   496   519   531   541   546   547   554   574   583                 |                                                 
 |      592   600   603   607   611   618   650   652   660   660                 |                                                 
 |      660   671   688   705   709                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      126   222   644                                                           |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 30 NG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 55     UNCENSORED DEATHS 27     CENSORED DEATHS 3    TERMINAL 25        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      82    202   223   253   328   350   434   448   498   516                 |                                                 
 |      524   546   572   574   580   607   630   630   652   652                 |                                                 
 |      652   671   681   700   720   720   722                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      356   356   356                                                           |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 100     NG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 27     CENSORED DEATHS 0    TERMINAL 26        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      188   236   300   328   376   428   498   509   531   533                 |                                                 
 |      541   554   555   586   602   621   651   651   651   652                 |                                                 
 |      653   653   659   678   688   709   709                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                   TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 175     NG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 30     CENSORED DEATHS 1    TERMINAL 22        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      385   405   436   448   454   481   487   496   500   530                 |                                                 
 |      546   559   573   574   576   592   595   600   604   607                 |                                                 
 |      611   658   658   658   658   659   660   660   660   720                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      124                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 300     NG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 36     CENSORED DEATHS 1    TERMINAL 16        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      40    247   301   328   331   403   454   531   531   541                 |                                                 
 |      546   554   554   599   607   607   607   618   618   630                 |                                                 
 |      642   645   658   658   659   659   662   665   680   688                 |                                                 
 |      688   709   715   719   722   722                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      163                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 550     NG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 23        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      185   320   327   440   498   535   554   573   574   588                 |                                                 
 |      614   618   618   618   628   637   651   651   667   678                 |                                                 
 |      678   699   700   702   712   714   714   720   722   722                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                   TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 1000    NG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 53     UNCENSORED DEATHS 46     CENSORED DEATHS 0    TERMINAL 7         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      72    188   243   244   258   309   394   484   523   525                 |                                                 
 |      530   531   547   555   562   574   588   588   603   603                 |                                                 
 |      603   607   607   607   607   611   614   618   621   621                 |                                                 
 |      621   630   642   650   650   660   663   663   681   688                 |                                                 
 |      694   694   700   700   704   720                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                   TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   727 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 NG/KG    |   100.0  98.1  94.2  86.4  80.5  80.5  70.7  55.0  38.9  30.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |30 NG/KG   |    98.2  98.2  92.7  89.1  89.1  85.2  79.4  71.7  60.0  48.4      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |100        |   100.0 100.0  96.2  92.5  90.6  88.7  79.2  71.7  56.6  49.1      |                                                 
 |NG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |175        |   100.0 100.0 100.0 100.0  96.2  88.5  80.8  63.5  44.2  42.3      |                                                 
 |NG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |300        |    98.1  98.1  96.2  90.4  88.5  86.6  80.8  73.1  46.2  30.8      |                                                 
 |NG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |550        |   100.0 100.0  98.1  94.3  94.3  92.5  88.7  81.1  66.0  43.4      |                                                 
 |NG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1000       |    98.1  98.1  90.6  88.7  86.8  84.9  77.4  60.4  28.3  13.2      |                                                 
 |NG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                   TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
 ===============================================================================================================================    
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |    
 |                                                                                                                             |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |                                                                        DOSE                                                 |    
 |                                                                                                                             |    
 |                                0 NG/KG      30 NG/KG     100          175          300          550          1000           |    
 |                                                          NG/KG        NG/KG        NG/KG        NG/KG        NG/KG          |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |SURVIVAL AT END OF STUDY|       30.7%        48.4%        49.1%        42.3%        30.8%        43.4%        13.2%          |    
 |(KAPLAN-MEIER)          |                                                                                                    |    
 |                        |                                                                                                    |    
 |SIGNIFICANCE (B)        |       P=0.004      P=0.070N     P=0.057N     P=0.223N     P=0.589N     P=0.048N     P=0.219        |    
 |(LIFE TABLE)            |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN DAY OF             |       519.3        524.7        545.9        568.3        570.5        601.9        560.8          |    
 |NATURAL DEATHS (C)      |       (25.6)       (34.3)       (28.3)       (16.2)       (25.8)       (24.1)       (22.2)         |    
 |(STANDARD ERROR)        |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN LIFE SPAN (D)      |       567.4        607.5        634.8        625.8        610.1        656.2        582.8          |    
 |(STANDARD ERROR)        |       (23.8)       (22.9)       (19.0)       (17.1)       (21.9)       (16.1)       (20.7)         |    
 |                        |                                                                                                    |    
 ===============================================================================================================================    
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                           TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126)                                            
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 NG/KG          = 1                                                        
                                                        30 NG/KG         = 2                                                        
                                                        100     NG/KG    = 3                                                        
                                                        175     NG/KG    = 4                                                        
                                                        300     NG/KG    = 5                                                        
                                                        550     NG/KG    = 6                                                        
                                                        1000    NG/KG    = 7                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1      5    72               13                              4                                                              
      |        5    72               13 1  2 3  5          6         4  4                                                           
      |                               7 1  2 3 752     3  163           4    44                                                     
      |                                        7 2        1125     3         64 4      6                                            
   90 +                                          7        712512   3    5   2   4   4  6     6                                      
      |                                                   7   1 1     175   2 2 5   44433   56  6 6                                 
      |                                                               1 1     2      7423  73                                       
      |                                                                                2 2 2335   6 6                               
   80 +                                                                 1             1    2432 3   6    66                         
      |                                                                               1    17 274 2                                 
P     |                                                                                    11  73   3  5                            
E     |                                                                                     1 1 77223  32 366                       
R  70 +                                                                                           747 4 2 326 3                     
C     |                                                                                       111     445 5                         
E     |                                                                                         1 1 7  44  2  32  66                
N     |                                                                                           1 1   4455 5                      
T  60 +                                                                                             1 11 4   552  26  6             
      |                                                                                                11     53 3232 66            
S     |                                                                                                        5 5 3232662          
U     |                                                                                                 11     4 4   3  3           
R  50 +                                                                                                  11   1         322         
V     |                                                                                                       11         62         
I     |                                                                                                        1 1  55   4          
V     |                                                                                                   77             44         
A  40 +                                                                                                    7 7   11  5  5           
L     |                                                                                                      77   1  1  55          
      |                                                                                                       7  7   1 1 55         
      |                                                                                                                11           
   30 +                                                                                                                 1 1         
      |                                                                                                          7  77              
      |                                                                                                              77             
      |                                                                                                                             
   20 +                                                                                                                             
      |                                                                                                               77            
      |                                                                                                                7 7          
      |                                                                                                                  77         
   10 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 87 obs hidden.                                                                                                                
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