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TDMS Study 90004-07 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                            PROPYLENE GLYCOL MONO-T-BUTYL ETHER                         DATE: 11/14/01       
EXPERIMENT: 90004 TEST: 07                                                                                     TIME: 10:00:42       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55392                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C90004       
PATHOLOGIST: RENNE, ROGER                                                                                      CAS: 57018-52-7      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1/RATS                                                            
                                                                                                                                    
                                                                                                                                    
               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: 11/14/01       
EXPERIMENT: 90004 TEST: 07                                                                                     TIME: 10:00:42       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55392                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C90004       
PATHOLOGIST: RENNE, ROGER                                                                                      CAS: 57018-52-7      
                                                                                                                                   
                        PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                                         
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      296   409   458   465   539   604   625   630   631   639                 |                                                 
 |      642   642   646   655   655   656   668   681   684   712                 |                                                 
 |      712   718   723                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 75 PPM                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      464   509   509   513   569   591   621   642   642   642                 |                                                 
 |      648   656   666   675   689   697   705   709   713   719                 |                                                 
 |      726                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 300 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 34     CENSORED DEATHS 0    TERMINAL 16        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      9     361   431   509   509   537   550   550   561   565                 |                                                 
 |      565   590   593   605   611   619   621   634   642   646                 |                                                 
 |      646   652   656   656   670   681   684   690   696   697                 |                                                 
 |      709   716   718   722                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                        PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                                         
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1200 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      254   509   518   537   550   582   598   612   616   631                 |                                                 
 |      635   635   639   648   648   655   656   662   663   666                 |                                                 
 |      681   683   684   696   698   716   724   725                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                        PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                                         
                       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)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0 100.0 100.0  98.0  96.0  92.0  90.0  88.0  68.0  54.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |75 PPM     |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  88.0  76.0  58.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |300 PPM    |    98.0  98.0  98.0  96.0  96.0  94.0  88.0  72.0  52.0  32.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1200 PPM   |   100.0 100.0  98.0  98.0  98.0  98.0  92.0  86.0  62.0  44.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                CONTROL      75 PPM       300 PPM      1200 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       54.0%        58.0%        32.0%        44.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.358      P=0.727N     P=0.031      P=0.435  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       612.6        633.6        597.1        625.8    |                                                 
 |NATURAL DEATHS (C)      |       (22.6)       (17.2)       (22.8)       (17.6)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       675.5        688.9        639.3        671.2    |                                                 
 |(STANDARD ERROR)        |       (13.2)       ( 9.8)       (17.7)       (12.2)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                        PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                                         
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 730 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      171   284   380   415   537   558   587   593   625   642                 |                                                 
 |      670   684   687   702   708   715   718                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 75 PPM                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      410   621   642   642   656   656   660   676   681   683                 |                                                 
 |      684   708   722   725   726   726                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 300 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      471   507   509   523   528   559   576   593   610   617                 |                                                 
 |      634   637   646   646   670   682   692   698   698   709                 |                                                 
 |      712   712                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                        PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                                         
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 730 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1200 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      283   519   550   555   586   617   642   669   675   684                 |                                                 
 |      684   717   722   726                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                        PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                                         
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 730 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0  98.0  98.0  96.0  92.0  92.0  90.0  84.0  80.0  66.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |75 PPM     |   100.0 100.0 100.0 100.0  98.0  98.0  98.0  98.0  86.0  68.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |300 PPM    |   100.0 100.0 100.0 100.0 100.0  98.0  90.0  84.0  72.0  56.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1200 PPM   |   100.0 100.0 100.0  98.0  98.0  98.0  96.0  90.0  86.0  72.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                CONTROL      75 PPM       300 PPM      1200 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       66.0%        68.0%        56.0%        72.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.515N     P=0.801N     P=0.419      P=0.602N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       569.2        663.6        619.5        616.4    |                                                 
 |NATURAL DEATHS (C)      |       (39.6)       (18.9)       (16.3)       (31.4)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       675.3        708.8        681.4        698.2    |                                                 
 |(STANDARD ERROR)        |       (17.1)       ( 7.4)       (10.5)       (11.2)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                                PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                 
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        CONTROL          = 1                                                        
                                                        75 PPM           = 2                                                        
                                                        300 PPM          = 3                                                        
                                                        1200 PPM         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1 3                                      4     1                          2                                                 
      |   3                                      4     1         3       1        2     2                                           
      |                                                          3       1  3    11     22   4                                      
      |                                                                           1      2   1 4  2                                 
   90 +                                                                                 3    1 4  2 4 2 1                           
      |                                                                                      3 3    4 241 21                        
P     |                                                                                        3 3     4 42112                      
E     |                                                                                                  4  11                      
R  80 +                                                                                                      22                     
C     |                                                                                          3    3       22                    
E     |                                                                                               3 3   4111  22                
N     |                                                                                                 33         2 2              
T  70 +                                                                                                  33   44     22             
      |                                                                                                        1  1   22            
S     |                                                                                                   3 33 4 41 1  22           
U     |                                                                                                      33  44 1   12          
R  60 +                                                                                                           4 4    22         
V     |                                                                                                       33        112 2       
I     |                                                                                                             4 4  11 1       
V     |                                                                                                        3  3                 
A  50 +                                                                                                           3 3 4  4          
L     |                                                                                                                  44         
      |                                                                                                             333   4 4       
      |                                                                                                                             
   40 +                                                                                                               3 3           
      |                                                                                                                 33          
      |                                                                                                                  33         
      |                                                                                                                   3 3       
   30 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 23 obs hidden.                                                                                                                
                                                                                                                                   
                                                PROPYLENE GLYCOL MONO-T-BUTYL ETHER                                                 
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        CONTROL          = 1                                                        
                                                        75 PPM           = 2                                                        
                                                        300 PPM          = 3                                                        
                                                        1200 PPM         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                           1                4                   2         3                                                
      |                                                                                                                             
      |                             1                1                   2         3    3  4              2                         
      |                                              1               1                     4   4          2  2                      
   95 +                                                                                                                             
      |                                                              1    1             3  3   44                                   
      |                                                                   1                331  4   4        2 2                    
      |                                                                                                                             
   90 +                                                                                     31  1   4     4                         
      |                                                                                                                             
P     |                                                                                         1  31     4  4 2 2                  
E     |                                                                                            31 1      4   242                
R  85 +                                                                                                                             
C     |                                                                                               1  3 1      422               
E     |                                                                                                  331 1     44               
N     |                                                                                                                             
T  80 +                                                                                                   3 31    1                 
      |                                                                                                                             
S     |                                                                                                           1 1   24          
U     |                                                                                                     3 3     11  242         
R  75 +                                                                                                                             
V     |                                                                                                              1 1            
I     |                                                                                                       3   3    11 4 4       
V     |                                                                                                                             
A  70 +                                                                                                           3 3   11          
L     |                                                                                                                             
      |                                                                                                             33    2 2       
      |                                                                                                              33  1  1       
   65 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                               3 3           
      |                                                                                                                             
   60 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                 3   3       
   55 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 12 obs hidden.