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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: 09:40:51       
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; CONTROL + 2000 & 5000PPM STOP GROUPS                                         
                                                                                                                                    
                                                                                                                                    
               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 009    2000 PPM(STOP)                                                                
                                       INCLUDE 010    5000 PPM(STOP)                                                                
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  O-NITROTOLUENE                                    DATE: 11/16/00       
EXPERIMENT: 05203 TEST: 08                                                                                     TIME: 09:40:51       
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 = 2000 PPM(STOP)                                 |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 49     CENSORED DEATHS 0    TERMINAL 11        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      260   275   370   419   420   470   499   502   523   523                 |                                                 
 |      531   534   537   555   567   569   569   569   576   579                 |                                                 
 |      579   579   589   589   592   595   595   603   615   621                 |                                                 
 |      621   637   649   656   658   658   658   670   673   677                 |                                                 
 |      684   685   702   703   708   708   710   716   716                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 5000 PPM(STOP)                                 |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 60     CENSORED DEATHS 0    TERMINAL 0         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      299   299   316   359   359   359   359   362   384   384                 |                                                 
 |      384   384   391   391   391   401   412   417   419   419                 |                                                 
 |      432   439   453   464   464   464   471   485   485   499                 |                                                 
 |      501   502   502   502   502   505   512   512   540   540                 |                                                 
 |      540   544   547   555   555   555   567   567   567   569                 |                                                 
 |      579   581   595   597   597   603   621   632   636   691                 |                                                 
 |  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      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2000       |   100.0 100.0  98.3  96.7  91.7  90.0  78.3  53.3  38.3  18.3      |                                                 
 |PPM(STOP)  |                                                                    |                                                 
 |           |                                                                    |                                                 
 |5000       |   100.0 100.0 100.0  86.7  66.7  51.7  30.0   6.7   1.7   0.0      |                                                 
 |PPM(STOP)  |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                    DOSE                        |                                                 
 |                                                                                |                                                 
 |                                0 PPM            2000             5000          |                                                 
 |                                                 PPM(STOP)        PPM(STOP)     |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       65.0%            18.3%             0.0%         |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P<0.001          P<0.001          P<0.001       |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       640.5            585.6            482.7         |                                                 
 |NATURAL DEATHS (C)      |       (17.5)           (15.0)           (12.0)        |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       698.0            611.9            482.7         |                                                 
 |(STANDARD ERROR)        |       ( 8.1)           (14.2)           (12.0)        |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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                                                        
                                                        2000 PPM(STOP)   = 2                                                        
                                                        5000 PPM(STOP)   = 3                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                         2    3                     1                                                      
      |                                           2 2  3   3      2          1               1                                      
      |                                                    3     32       2                                                         
      |                                                                   2        2         1  1   1                               
   90 +                                                                            2   2            1       1                       
      |                                                          3   3                 2   2                11                      
      |                                                                                                      11                     
      |                                                                                    222                1  1 1                
   80 +                                                              33                                                             
      |                                                                                      2  22                 1 1 1            
      |                                                               3 3                        22                                 
      |                                                                 333                                            11           
P  70 +                                                                                           22                    11          
E     |                                                                   3 3                                            11         
R     |                                                                     33                                            1 1       
C     |                                                                      3  3 3                2  2                             
E  60 +                                                                                                                             
N     |                                                                           33                                                
T     |                                                                            3 3                2 2                           
      |                                                                              3 3                222                         
S  50 +                                                                                                                             
U     |                                                                                                   2 2 2                     
R     |                                                                                                       22                    
V     |                                                                                33                                           
I  40 +                                                                                 33                                          
V     |                                                                                  3    3                2  22                
A     |                                                                                                                             
L     |                                                                                                            22               
   30 +                                                                                       33                    2  2            
      |                                                                                        33                      22           
      |                                                                                                                             
      |                                                                                         33                      22          
   20 +                                                                                                                             
      |                                                                                          333                     2  2       
      |                                                                                                                             
      |                                                                                            3  33                            
   10 +                                                                                                                             
      |                                                                                                33 3                         
      |                                                                                                   3 3                       
      |                                                                                                     3        3              
    0 +                                                                                                              3              
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 16 obs hidden.