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TDMS Study 88031-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                     DIPROPYLENE GLYCOL                                  DATE: 02/04/02       
EXPERIMENT: 88031 TEST: 05                                                                                     TIME: 10:32:00       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55388                              ROUTE: DOSED WATER                                             NTP C#: C88031       
PATHOLOGIST: MISSING                                                                                           CAS: 25265-71-8      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                              FINAL#3                                                               
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                     DIPROPYLENE GLYCOL                                  DATE: 02/04/02       
EXPERIMENT: 88031 TEST: 05                                                                                     TIME: 10:32:00       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55388                              ROUTE: DOSED WATER                                             NTP C#: C88031       
PATHOLOGIST: MISSING                                                                                           CAS: 25265-71-8      
                                                                                                                                   
                                DIPROPYLENE GLYCOL                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 27     CENSORED DEATHS 0    TERMINAL 23        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      261   323   376   511   564   564   565   568   569   582                 |                                                 
 |      584   636   645   653   653   654   667   673   676   679                 |                                                 
 |      687   697   697   698   698   717   718                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 0.25%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      417   456   505   528   550   554   558   564   586   614                 |                                                 
 |      649   649   661   680   684   698   709   711   716   717                 |                                                 
 |      721   726   728                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      340   543   562   564   583   584   586   598   617   619                 |                                                 
 |      623   627   627   647   649   649   674   682   698   712                 |                                                 
 |      718   725   726                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                DIPROPYLENE GLYCOL                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 4.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 50     CENSORED DEATHS 0    TERMINAL 0         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      398   408   431   438   449   483   484   484   484   502                 |                                                 
 |      507   525   529   532   543   554   561   564   564   564                 |                                                 
 |      565   574   578   584   586   589   596   598   598   610                 |                                                 
 |      610   613   613   614   614   617   619   624   627   627                 |                                                 
 |      627   629   631   640   645   647   653   673   682   690                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                DIPROPYLENE GLYCOL                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0.0%       |   100.0 100.0  98.0  96.0  94.0  94.0  92.0  78.0  68.0  46.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.25%      |   100.0 100.0 100.0 100.0  98.0  96.0  92.0  82.0  74.0  54.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.0%       |   100.0 100.0 100.0  98.0  98.0  98.0  96.0  84.0  68.0  54.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |4.0%       |   100.0 100.0 100.0 100.0  96.0  82.0  70.0  42.0   6.0   0.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0.0%         0.25%        1.0%         4.0%     |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       46.0%        54.0%        54.0%         0.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P<0.001      P=0.437N     P=0.507N     P<0.001  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       604.3        625.3        624.0        571.5    |                                                 
 |NATURAL DEATHS (C)      |       (22.7)       (19.5)       (17.2)       (10.1)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       661.6        681.3        680.7        571.5    |                                                 
 |(STANDARD ERROR)        |       (15.1)       (11.5)       (10.8)       (10.1)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                DIPROPYLENE GLYCOL                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      247   413   527   540   542   543   596   624   626   626                 |                                                 
 |      659   696   697   697   697   697   702   709   724   728                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 0.25%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      417   425   435   542   585   585   585   622   624   626                 |                                                 
 |      634   641   668   680   683   717   717   721   725                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      295   597   598   600   604   627   638   665   667   681                 |                                                 
 |      717   725                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                DIPROPYLENE GLYCOL                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 4.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 1    TERMINAL 31        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      533   542   564   577   582   597   597   626   626   652                 |                                                 
 |      659   668   681   694   694   711   718   725                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      536                                                                       |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                DIPROPYLENE GLYCOL                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0.0%       |   100.0 100.0  98.0  98.0  96.0  96.0  88.0  86.0  78.0  60.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.25%      |   100.0 100.0 100.0 100.0  96.0  94.0  92.0  86.0  76.0  62.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.0%       |   100.0 100.0 100.0  98.0  98.0  98.0  98.0  90.0  84.0  76.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |4.0%       |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  85.7  77.6  63.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0.0%         0.25%        1.0%         4.0%     |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       60.0%        62.0%        76.0%        63.3%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=1.000N     P=1.000N     P=0.134N     P=0.889N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       614.5        612.2        617.8        635.9    |                                                 
 |NATURAL DEATHS (C)      |       (27.0)       (22.5)       (32.1)       (14.6)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       683.2        684.6        702.3        691.6    |                                                 
 |(STANDARD ERROR)        |       (13.3)       (11.7)       (10.1)       ( 8.8)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                         DIPROPYLENE GLYCOL                                                         
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0.0%             = 1                                                        
                                                        0.25%            = 2                                                        
                                                        1.0%             = 3                                                        
                                                        4.0%             = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  112 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
      | 1                                         1         1 3        4 42      2            3                                     
   96 +                                                     1      1     4  44   2      1   2 3  3                                  
      |                                                                      4  4   4   1   2  221  3                               
P     |                                                                             44          211 3  3                            
E     |                                                                              4 4         21 1  3 23                         
R  80 +                                                                                44  4        1    2331 2                     
C     |                                                                                    44              31 11 2  2               
E     |                                                                                     4 4 4                   2 2             
N     |                                                                                         44            31  113 2 2           
T  64 +                                                                                                             3 3 22          
      |                                                                                          44                1 11 322         
S     |                                                                                           444                     2 2       
U     |                                                                                             4 4               1  1          
R  48 +                                                                                               44                 1  1       
V     |                                                                                                4 4                          
I     |                                                                                                                             
V     |                                                                                                                             
A  32 +                                                                                                  44                         
L     |                                                                                                   44                        
      |                                                                                                                             
      |                                                                                                                             
   16 +                                                                                                    444                      
      |                                                                                                      44                     
      |                                                                                                       44   4                
      |                                                                                                            444              
    0 +                                                                                                              4              
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 38 obs hidden.                                                                                                                
                                                                                                                                   
                                                         DIPROPYLENE GLYCOL                                                         
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0.0%             = 1                                                        
                                                        0.25%            = 2                                                        
                                                        1.0%             = 3                                                        
                                                        4.0%             = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                       1      3                  2                  4                                      
      |                                                                                                                             
      |                                         1      3                 122                 44        3                            
      |                                                                  1 2 2              1 4  4                                  
   95 +                                                                                                                             
      |                                                                      2              1 1  4 4                                
      |                                                                                       2    42  33                           
      |                                                                                                                             
P  90 +                                                                                             4  43  3                        
E     |                                                                                                                             
R     |                                                                                       1        1   3 3                      
C     |                                                                                             2  1  21 3   3                  
E  85 +                                                                                                                             
N     |                                                                                                   22     33                 
T     |                                                                                                           3 3               
      |                                                                                                    4   4                    
S  80 +                                                                                                    12  4 1  3    3          
U     |                                                                                                                             
R     |                                                                                                     22   14   1  33         
V     |                                                                                                      2    2       3 3       
I  75 +                                                                                                           4 4               
V     |                                                                                                           2 2 4             
A     |                                                                                                                             
L     |                                                                                                                             
   70 +                                                                                                             2 4 42          
      |                                                                                                                             
      |                                                                                                               1144          
      |                                                                                                                11           
   65 +                                                                                                                  44         
      |                                                                                                                 121 4       
      |                                                                                                                   2 2       
      |                                                                                                                             
   60 +                                                                                                                   1 1       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 13 obs hidden.