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TDMS Study 05203-08 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  O-NITROTOLUENE                                    DATE: 11/16/00       
EXPERIMENT: 05203 TEST: 08                                                                                     TIME: 09:36:35       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55393                              ROUTE: DOSED FEED                                              NTP C#: 62340D       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 88-72-2         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                     RATS, FINAL#1; CORE STUDY                                                      
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 PPM                                                                         
                                       INCLUDE 002    0 PPM                                                                         
                                       INCLUDE 003    625 PPM                                                                       
                                       INCLUDE 004    625 PPM                                                                       
                                       INCLUDE 005    1250 PPM                                                                      
                                       INCLUDE 006    1250 PPM                                                                      
                                       INCLUDE 007    2000 PPM                                                                      
                                       INCLUDE 008    2000 PPM                                                                      
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  O-NITROTOLUENE                                    DATE: 11/16/00       
EXPERIMENT: 05203 TEST: 08                                                                                     TIME: 09:36:35       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: DOSED FEED                                              NTP C#: 62340D       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 88-72-2         
                                                                                                                                   
                                  O-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 PPM                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      441   533   533   537   555   586   631   640   644   649                 |                                                 
 |      663   673   674   691   705   705   707   714   720   722                 |                                                 
 |      727                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 625 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 42     CENSORED DEATHS 0    TERMINAL 18        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      378   428   465   471   499   529   534   555   559   567                 |                                                 
 |      567   569   569   589   600   603   615   615   616   616                 |                                                 
 |      616   621   621   632   636   636   639   641   650   656                 |                                                 
 |      656   658   684   684   691   707   707   713   714   726                 |                                                 
 |      726   727                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1250 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 54     CENSORED DEATHS 3    TERMINAL 3         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      384   391   432   483   483   483   502   502   512   515                 |                                                 
 |      519   519   523   527   531   564   567   569   576   581                 |                                                 
 |      581   589   597   597   597   603   615   616   616   621                 |                                                 
 |      628   632   636   636   637   637   652   656   656   658                 |                                                 
 |      658   673   676   685   685   685   691   691   691   706                 |                                                 
 |      714   714   714   714                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      298   299   299                                                           |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  O-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 2000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 60     CENSORED DEATHS 0    TERMINAL 0         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      359   391   391   396   404   404   414   419   419   419                 |                                                 
 |      421   432   439   439   463   464   471   471   471   474                 |                                                 
 |      479   483   483   495   495   502   509   509   509   512                 |                                                 
 |      512   512   512   519   523   527   531   534   534   538                 |                                                 
 |      540   544   544   544   544   562   567   567   569   576                 |                                                 
 |      581   586   589   589   603   608   632   637   655   656                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  O-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 PPM      |   100.0 100.0 100.0 100.0 100.0  98.3  93.3  90.0  81.7  65.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |625 PPM    |   100.0 100.0 100.0 100.0  98.3  93.3  88.3  73.3  46.7  30.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1250 PPM   |   100.0 100.0 100.0 100.0  96.5  89.5  73.7  54.4  28.1   5.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2000 PPM   |   100.0 100.0 100.0  98.3  81.7  61.7  25.0   8.3   0.0   0.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 PPM        625 PPM      1250 PPM     2000 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       65.0%        30.0%         5.3%         0.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P<0.001      P<0.001      P<0.001      P<0.001  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       640.5        611.5        598.5        507.9    |                                                 
 |NATURAL DEATHS (C)      |       (17.5)       (12.7)       (11.4)       ( 9.2)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       698.0        646.8        590.1        507.9    |                                                 
 |(STANDARD ERROR)        |       ( 8.1)       (11.3)       (14.0)       ( 9.2)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                  O-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 PPM                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 47        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      401   453   620   620   674   691   700   706   707   719                 |                                                 
 |      719   722   726                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 625 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 47        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      429   495   505   531   582   669   682   684   695   702                 |                                                 
 |      705   708   716                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1250 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      370   432   523   525   569   586   597   636   656   672                 |                                                 
 |      685   698   706   706   707   707   708   708   709   709                 |                                                 
 |      709                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  O-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 2000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 27     CENSORED DEATHS 0    TERMINAL 33        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      464   488   569   586   603   632   636   636   639   663                 |                                                 
 |      663   665   676   685   685   687   691   698   702   706                 |                                                 
 |      708   708   708   708   708   709   722                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  O-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 PPM      |   100.0 100.0 100.0 100.0  98.3  96.7  96.7  96.7  93.3  78.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |625 PPM    |   100.0 100.0 100.0 100.0 100.0  98.3  93.3  91.7  91.7  78.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1250 PPM   |   100.0 100.0 100.0 100.0  98.3  96.7  93.3  88.3  85.0  65.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2000 PPM   |   100.0 100.0 100.0 100.0 100.0  98.3  96.7  91.7  80.0  55.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 PPM        625 PPM      1250 PPM     2000 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       78.3%        78.3%        65.0%        55.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.002      P=1.000      P=0.128      P=0.009  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       650.6        623.3        634.2        657.2    |                                                 
 |NATURAL DEATHS (C)      |       (29.3)       (27.9)       (21.8)       (12.7)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       712.0        706.1        695.8        696.7    |                                                 
 |(STANDARD ERROR)        |       ( 7.5)       ( 8.2)       ( 9.5)       ( 7.3)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                                           O-NITROTOLUENE                                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 PPM            = 1                                                        
                                                        625 PPM          = 2                                                        
                                                        1250 PPM         = 3                                                        
                                                        2000 PPM         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
  100 + 1                                                        4 2 3       1                                                      
      |                                                          4 2 33     21    2          1                                      
      |                                                               44    3     223                                               
      |                                                                44          2   2    21  1   1                               
   90 +                                                                 4 4         3  3    22      1       1                       
      |                                                                                      2  2           11                      
      |                                                                                3 3      22           11                     
      |                                                                   444            3 3     22           1  1 1                
   80 +                                                                     44                                                      
      |                                                                      4    4        33     2   22           1 1 1            
      |                                                                                                22                           
      |                                                                           44        3    3      22             11           
P  70 +                                                                                          33                     11          
E     |                                                                            44             33                     11         
R     |                                                                                                  22               1 1       
C     |                                                                             4 4            3  33  2 2                       
E  60 +                                                                                                                             
N     |                                                                               444                   22                      
T     |                                                                                                333                          
      |                                                                                 44                   222                    
S  50 +                                                                                                  33                         
U     |                                                                                                   33   2    2               
R     |                                                                                  4 4               33                       
V     |                                                                                    44                       22 2            
I  40 +                                                                                                                             
V     |                                                                                     44              3  3       22           
A     |                                                                                                                 2 2         
L     |                                                                                      44                                     
   30 +                                                                                                                   2 2       
      |                                                                                                        3   3                
      |                                                                                       4  4                 33               
      |                                                                                                                             
   20 +                                                                                          44                 33              
      |                                                                                           44                                
      |                                                                                            44                3 3            
      |                                                                                             4 4                33           
   10 +                                                                                               4 4                           
      |                                                                                                 4   4                       
      |                                                                                                                 3   3       
      |                                                                                                     4  4                    
    0 +                                                                                                        4                    
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 18 obs hidden.                                                                                                                
                                                                                                                                   
                                                           O-NITROTOLUENE                                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 PPM            = 1                                                        
                                                        625 PPM          = 2                                                        
                                                        1250 PPM         = 3                                                        
                                                        2000 PPM         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                         3     1   2     4                                                 
      |                                                           3     1   2   1 4  42                                             
      |                                                                                                                             
      |                                                                     3   1    42 2  3      4       1                         
   95 +                                                                                 2   2     4 4                               
      |                                                                                    32     3 2   4 1        1                
      |                                                                                                                             
      |                                                                                           3 2   4   4     21 1              
   90 +                                                                                             3  3          2 211             
      |                                                                                                3    3         11            
P     |                                                                                                                             
E     |                                                                                                     34 3    2 2             
R  85 +                                                                                                      4 3 43   21 1          
C     |                                                                                                           3 3               
E     |                                                                                                                             
N     |                                                                                                             3 32211         
T  80 +                                                                                                          4 4  3322          
      |                                                                                                            44    21 1       
S     |                                                                                                                             
U     |                                                                                                                             
R  75 +                                                                                                             44              
V     |                                                                                                                33           
I     |                                                                                                                             
V     |                                                                                                              44             
A  70 +                                                                                                               44            
L     |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                44           
   65 +                                                                                                                 3   3       
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   60 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                 4 4         
   55 +                                                                                                                   4 4       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 9 obs hidden.                                                                                                                 

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