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TDMS Study 88031-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                     DIPROPYLENE GLYCOL                                  DATE: 05/15/01       
EXPERIMENT: 88031 TEST: 06                                                                                     TIME: 09:47:03       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55388                              ROUTE: DOSED WATER                                             NTP C#: C88031       
PATHOLOGIST: RYAN, MICHAEL                                                                                     CAS: 25265-71-8      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            Final#1/Mice                                                            
                                                                                                                                    
                                                                                                                                    
               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: 05/15/01       
EXPERIMENT: 88031 TEST: 06                                                                                     TIME: 09:47:03       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55388                              ROUTE: DOSED WATER                                             NTP C#: C88031       
PATHOLOGIST: RYAN, MICHAEL                                                                                     CAS: 25265-71-8      
                                                                                                                                   
                                DIPROPYLENE GLYCOL                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      416   546   556   575   592   603   629   666   708   724                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      224   405   405   491   501   561   588   619   661   686                 |                                                 
 |      710                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 2.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      494   518   542   575   616   640   645   645   661   666                 |                                                 
 |      672   676   706   708   727                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                DIPROPYLENE GLYCOL                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 4.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 1    TERMINAL 34        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      416   416   451   464   513   515   533   582   610   661                 |                                                 
 |      661   668   688   708   710                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      366                                                                       |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                DIPROPYLENE GLYCOL                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0.0%       |   100.0 100.0 100.0 100.0  98.0  98.0  98.0  88.0  86.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.0%       |   100.0 100.0  98.0  98.0  94.0  94.0  90.0  86.0  82.0  78.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2.0%       |   100.0 100.0 100.0 100.0 100.0 100.0  94.0  92.0  82.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |4.0%       |   100.0 100.0 100.0 100.0  95.9  91.8  85.7  83.7  77.6  69.4      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0.0%         1.0%         2.0%         4.0%     |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       80.0%        78.0%        70.0%        69.4%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.204      P=0.921      P=0.382      P=0.292  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       601.5        531.9        632.7        573.1    |                                                 
 |NATURAL DEATHS (C)      |       (28.2)       (44.0)       (18.2)       (27.7)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       703.5        685.6        700.1        675.0    |                                                 
 |(STANDARD ERROR)        |       ( 9.1)       (14.9)       ( 8.3)       (14.4)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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 MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      193   497   570   599   621   641   651   683   693   699                 |                                                 
 |      704   721   725                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      494   543   561   585   641   643   671   687   689   693                 |                                                 
 |      711   726                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 2.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      340   406   484   515   543   576   576   599   654   654                 |                                                 
 |      693   708                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                DIPROPYLENE GLYCOL                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 4.0%                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 4    TERMINAL 33        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      20    228   395   452   501   501   504   542   565   647                 |                                                 
 |      654   687   698                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      542   542   542   542                                                     |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                DIPROPYLENE GLYCOL                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0.0%       |   100.0 100.0  98.0  98.0  98.0  98.0  96.0  92.0  86.0  74.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.0%       |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0  88.0  76.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2.0%       |   100.0 100.0 100.0  98.0  96.0  94.0  90.0  84.0  80.0  76.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |4.0%       |    98.0  98.0  96.0  96.0  94.0  92.0  84.0  81.8  77.4  72.9      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0.0%         1.0%         2.0%         4.0%     |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       74.0%        76.0%        76.0%        72.9%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.702      P=0.989N     P=1.000N     P=0.873  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       615.2        637.0        562.3        491.8    |                                                 
 |NATURAL DEATHS (C)      |       (39.7)       (21.4)       (32.5)       (53.3)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       698.7        706.2        688.2        651.7    |                                                 
 |(STANDARD ERROR)        |       (12.3)       ( 7.5)       (12.6)       (20.4)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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                                                        
                                                        1.0%             = 2                                                        
                                                        2.0%             = 3                                                        
                                                        4.0%             = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                  2                              1           3                                             
      |                                                                                                                             
      |                                    2                            2 1           3  3    1                                     
      |                                                                   4     4        3    1 1                                   
   95 +                                                                                                                             
      |                                                                 2       4 4   2       3 1  1                                
P     |                                                                               22           1  1  3                          
E     |                                                                           4      4                                          
R  90 +                                                                                2         2    1 13   3                      
C     |                                                                                                                             
E     |                                                                                  4   4   2  2   1  1 33                     
N     |                                                                                      4      2     21      1                 
T  85 +                                                                                                                             
      |                                                                                             4    42   3  21     1           
S     |                                                                                                          23 2   1 1         
U     |                                                                                                  4       4                  
R  80 +                                                                                                             2   2 1 1       
V     |                                                                                                                             
I     |                                                                                                          433    2   2       
V     |                                                                                                            3   3            
A  75 +                                                                                                           4  4              
L     |                                                                                                              4 33           
      |                                                                                                                 3 3         
      |                                                                                                                             
   70 +                                                                                                                 4 3 3       
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   65 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 13 obs hidden.                                                                                                                
                                                                                                                                   
                                                         DIPROPYLENE GLYCOL                                                         
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0.0%             = 1                                                        
                                                        1.0%             = 2                                                        
                                                        2.0%             = 3                                                        
                                                        4.0%             = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1  4                           1                      3                       2                                             
      |                                                                                                                             
      |    4                           1    4                 3         3             1       2                                     
      |                                     4                          43            31       2  21                                 
P  95 +                                                                                                                             
E     |                                                                4        4    3   3       21 2  1                            
R     |                                                                         4      4 3    3     2  1  1  2                      
C     |                                                                                                                             
E  90 +                                                                                       3    3      1  1                      
N     |                                                                                                                             
T     |                                                                                                      11   2                 
      |                                                                                4      4    3   3      1   2 12              
S  85 +                                                                                                                             
U     |                                                                                       4  4     3       3    11              
R     |                                                                                                              11             
V     |                                                                                          4            4                     
I  80 +                                                                                                       43     2112           
V     |                                                                                                                             
A     |                                                                                                        4     3 1212         
L     |                                                                                                                 311         
   75 +                                                                                                              44             
      |                                                                                                                   1         
      |                                                                                                               4   4         
      |                                                                                                                             
   70 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 11 obs hidden.