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TDMS Study 05205-07 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  P-NITROTOLUENE                                    DATE: 01/04/01       
EXPERIMENT: 05205 TEST: 07                                                                                     TIME: 08:04:48       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55393                              ROUTE: DOSED FEED                                              NTP C#: 62537D       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 99-99-0         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            Final#2/Rats                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  P-NITROTOLUENE                                    DATE: 01/04/01       
EXPERIMENT: 05205 TEST: 07                                                                                     TIME: 08:04:48       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: DOSED FEED                                              NTP C#: 62537D       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 99-99-0         
                                                                                                                                   
                                  P-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0       PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      378   504   591   592   609   627   637   639   639   679                 |                                                 
 |      681   687   695   704   713   722   722   726   726                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1250    PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      490   515   516   581   592   592   611   627   631   659                 |                                                 
 |      668   724                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 2500    PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      523   621   627   659   668   676   679   679   704   724                 |                                                 
 |      724   724                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  P-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 5000    PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      496   497   591   595   617   676   682   685   693   707                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  P-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  98.0  98.0  96.0  92.0  82.0  62.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1250    PPM|   100.0 100.0 100.0 100.0 100.0 100.0  94.0  88.0  80.0  76.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2500    PPM|   100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  92.0  76.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |5000    PPM|   100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0  90.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0       PPM  1250    PPM  2500    PPM  5000    P|M                                                
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       62.0%        76.0%        76.0%        80.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.096N     P=0.269N     P=0.174N     P=0.096N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       645.8        600.5        667.3        623.9    |                                                 
 |NATURAL DEATHS (C)      |       (20.1)       (19.9)       (16.5)       (24.9)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       697.4        698.2        714.2        708.0    |                                                 
 |(STANDARD ERROR)        |       ( 9.5)       ( 9.1)       ( 5.4)       ( 7.7)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                  P-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0       PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      380   497   504   574   591   655   676   693   695   708                 |                                                 
 |      712                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1250    PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      387   528   577   629   639   639   659   675   701   702                 |                                                 
 |      724   724   728                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 2500    PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      387   633   639   655   675   676   676   676   679   687                 |                                                 
 |      721                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  P-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 5000    PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 0    TERMINAL 41        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      532   617   639   672   676   690   722   725   728                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  P-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  98.0  98.0  94.0  90.0  88.0  78.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1250    PPM|   100.0 100.0 100.0 100.0  98.0  98.0  96.0  94.0  86.0  74.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2500    PPM|   100.0 100.0 100.0 100.0  98.0  98.0  98.0  98.0  92.0  78.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |5000    PPM|   100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  94.0  82.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0       PPM  1250    PPM  2500    PPM  5000    P|M                                                
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       78.0%        74.0%        78.0%        82.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.507N     P=0.851      P=1.000N     P=0.725N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       607.7        639.4        645.8        666.8    |                                                 
 |NATURAL DEATHS (C)      |       (32.9)       (26.8)       (26.9)       (21.2)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       702.3        705.7        710.7        717.8    |                                                 
 |(STANDARD ERROR)        |       (10.0)       ( 8.8)       ( 7.5)       ( 5.0)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                           P-NITROTOLUENE                                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0       PPM      = 1                                                        
                                                        1250    PPM      = 2                                                        
                                                        2500    PPM      = 3                                                        
                                                        5000    PPM      = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                          1                 24    3                                        
      |                                                                                                                             
      |                                                            1                 2 1 2 3              3                         
      |                                                                               41              1   33                        
   95 +                                                                                                                             
      |                                                                                  2         2       3     3                  
      |                                                                                            2  1 1 4      33                 
      |                                                                                                                             
P  90 +                                                                                                 1 41      33                
E     |                                                                                                                             
R     |                                                                                               2  2 11      44               
C     |                                                                                                  2 211                      
E  85 +                                                                                                                             
N     |                                                                                                    22      344 3            
T     |                                                                                                     21   2 1 4 3  3         
      |                                                                                                                             
S  80 +                                                                                                          2211  4    4       
U     |                                                                                                                             
R     |                                                                                                           2 11    2         
V     |                                                                                                              11   2 2       
I  75 +                                                                                                                             
V     |                                                                                                               11            
A     |                                                                                                                11           
L     |                                                                                                                             
   70 +                                                                                                                 1 1         
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   65 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                   1 1       
      |                                                                                                                             
   60 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 10 obs hidden.                                                                                                                
                                                                                                                                   
                                                           P-NITROTOLUENE                                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0       PPM      = 1                                                        
                                                        1250    PPM      = 2                                                        
                                                        2500    PPM      = 3                                                        
                                                        5000    PPM      = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                            12                     4                                       
      |                                                                                                                             
      |                                                              12               1     2             4 3                       
      |                                                                               11    2      2      4 33                      
P  95 +                                                                                                                             
E     |                                                                                1          12       2 3 3  4                 
R     |                                                                                           1   1    2 2 3  43                
C     |                                                                                                                             
E  90 +                                                                                               1        1   4 4              
N     |                                                                                                                             
T     |                                                                                                      2 1 2 1 4    4         
      |                                                                                                          2 1 1              
S  85 +                                                                                                                             
U     |                                                                                                            2 112            
R     |                                                                                                            3 31 1 4 4       
V     |                                                                                                                             
I  80 +                                                                                                              3 2 32         
V     |                                                                                                                             
A     |                                                                                                                 13  1       
L     |                                                                                                                             
   75 +                                                                                                                             
      |                                                                                                                   2 2       
      |                                                                                                                             
      |                                                                                                                             
   70 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 11 obs hidden.