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TDMS Study 90004-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                            PROPYLENE GLYCOL MONO-T-BUTYL ETHER                         DATE: 01/02/02       
EXPERIMENT: 90004 TEST: 06                                                                                     TIME: 09:24:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55392                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C90004       
PATHOLOGIST: MISSING                                                                                           CAS: 57018-52-7      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             FINAL/MICE                                                             
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                            PROPYLENE GLYCOL MONO-T-BUTYL ETHER                         DATE: 01/02/02       
EXPERIMENT: 90004 TEST: 06                                                                                     TIME: 09:24:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-55392                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C90004       
PATHOLOGIST: MISSING                                                                                           CAS: 57018-52-7      
                                                                                                                                   
                        PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                                         
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      281   610   622   630   634   641   668   669   669   671                 |                                                 
 |      693   708   711   714   722                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 75 PPM                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      137   137   466   568   611   627   630   663   705   712                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 300 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      451   463   531   562   564   596   606   641   642   702                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                        PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                                         
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1200 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      325   526   527   560   599   600   632   637   642   643                 |                                                 
 |      672   705   711                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                        PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                                         
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       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)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0 100.0 100.0  98.0  98.0  98.0  98.0  98.0  88.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |75 PPM     |   100.0  96.0  96.0  96.0  96.0  94.0  94.0  92.0  84.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |300 PPM    |   100.0 100.0 100.0 100.0 100.0  96.0  94.0  88.0  82.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1200 PPM   |   100.0 100.0 100.0  98.0  98.0  98.0  94.0  88.0  80.0  74.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                CONTROL      75 PPM       300 PPM      1200 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       70.0%        80.0%        80.0%        74.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.927      P=0.430N     P=0.462N     P=0.931N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       642.9        525.6        575.8        598.4    |                                                 
 |NATURAL DEATHS (C)      |       (27.4)       (68.4)       (25.1)       (28.0)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       703.2        688.3        698.4        695.0    |                                                 
 |(STANDARD ERROR)        |       ( 9.8)       (17.5)       (10.0)       (10.8)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                        PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                                         
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      588   624   638   653   680   680   683   691   701   705                 |                                                 
 |      725                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 75 PPM                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 1    TERMINAL 36        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      533   586   602   630   643   669   680   686   694   695                 |                                                 
 |      705   725   730                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      616                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 300 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 42        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      600   641   655   656   658   669   711   717                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                        PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                                         
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1200 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 1    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      440   501   519   585   632   666   681   694   722   722                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      6                                                                         |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                        PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                                         
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   731 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  92.0  78.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |75 PPM     |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  94.0  89.9  73.6      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |300 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  90.0  84.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1200 PPM   |   100.0 100.0 100.0 100.0 100.0  98.0  93.9  91.8  89.8  79.6      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                CONTROL      75 PPM       300 PPM      1200 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       78.0%        73.6%        84.0%        79.6%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.878N     P=0.749      P=0.612N     P=1.000N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       669.8        659.8        663.4        616.2    |                                                 
 |NATURAL DEATHS (C)      |       (12.1)       (16.2)       (13.3)       (31.6)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       717.5        710.2        720.2        693.5    |                                                 
 |(STANDARD ERROR)        |       ( 4.4)       ( 6.3)       ( 4.1)       (16.6)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                 
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        CONTROL          = 1                                                        
                                                        75 PPM           = 2                                                        
                                                        300 PPM          = 3                                                        
                                                        1200 PPM         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                     2                      1      4                   3                                                   
      |                                                                                                                             
      |                                              1      4                   3 3         4            1                          
      |                                                                                                                             
   96 +                       2                                                   2         3            11                         
      |                                                                                                                             
      |                                                                           2         3   432       11                        
      |                                                                                                                             
P  92 +                                                                                         4 2    4 2 11                       
E     |                                                                                                                             
R     |                                                                                          3     3 2 211                      
C     |                                                                                                                             
E  88 +                                                                                                33   41    1                 
N     |                                                                                                                             
T     |                                                                                                 3  2 3   2                  
      |                                                                                                                             
S  84 +                                                                                                     44   2     2            
U     |                                                                                                                             
R     |                                                                                                      3         22           
V     |                                                                                                                             
I  80 +                                                                                                      4    1  1 32   2       
V     |                                                                                                                             
A     |                                                                                                           4  1 41           
L     |                                                                                                                             
   76 +                                                                                                                44           
      |                                                                                                                             
      |                                                                                                                 4   4       
      |                                                                                                                             
   72 +                                                                                                                 1 1         
      |                                                                                                                             
      |                                                                                                                   1 1       
      |                                                                                                                             
   68 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 9 obs hidden.                                                                                                                 
                                                                                                                                   
                                                PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                 
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        CONTROL          = 1                                                        
                                                        75 PPM           = 2                                                        
                                                        300 PPM          = 3                                                        
                                                        1200 PPM         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                                    4               2      1  3                            
      |                                                                                                                             
      |                                                                      4         4     2      1  3   1 3                      
      |                                                                                4   4        2  2   1 1 3                    
P  95 +                                                                                                                             
E     |                                                                                    4        4  2   2 1 1                    
R     |                                                                                                    2 2 1    1               
C     |                                                                                             4       4                       
E  90 +                                                                                                     42 3  2                 
N     |                                                                                                                             
T     |                                                                                                           2 2   3           
      |                                                                                                             114 33          
S  85 +                                                                                                                             
U     |                                                                                                             2121 34 3       
R     |                                                                                                                             
V     |                                                                                                                             
I  80 +                                                                                                               21  1 4       
V     |                                                                                                                             
A     |                                                                                                                2  1 1       
L     |                                                                                                                             
   75 +                                                                                                                   2 2       
      |                                                                                                                     2       
      |                                                                                                                             
      |                                                                                                                             
   70 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 15 obs hidden.