Share This:
https://ntp.niehs.nih.gov/go/6833

TDMS Study 97006-01 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                  METHYL ISOBUTYL KETONE                                DATE: 05/11/04       
EXPERIMENT: 97006 TEST: 01                                                                                     TIME: 09:02:41       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05452                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C97006       
PATHOLOGIST: RENNE, ROGER                                                                                      CAS: 108-10-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1/RATS                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                  METHYL ISOBUTYL KETONE                                DATE: 05/11/04       
EXPERIMENT: 97006 TEST: 01                                                                                     TIME: 09:02:41       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-05452                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C97006       
PATHOLOGIST: RENNE, ROGER                                                                                      CAS: 108-10-1        
                                                                                                                                   
                              METHYL ISOBUTYL KETONE                                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 726 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      468   492   505   554   588   592   624   629   671   679                 |                                                 
 |      679   687   687   701   702   702   713   723                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 450 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 1    TERMINAL 28        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      338   405   420   471   551   595   602   609   618   621                 |                                                 
 |      637   654   658   659   664   674   677   685   705   720                 |                                                 
 |      721                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      621                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 900 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 25        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      57    205   539   540   544   567   580   619   633   637                 |                                                 
 |      637   660   667   670   677   688   695   695   695   702                 |                                                 
 |      702   707   707   713   721                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                              METHYL ISOBUTYL KETONE                                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 726 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1800 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 31     CENSORED DEATHS 0    TERMINAL 19        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      498   544   567   595   604   609   621   622   623   636                 |                                                 
 |      638   638   639   645   645   649   652   653   659   665                 |                                                 
 |      674   677   681   693   694   694   702   705   706   712                 |                                                 
 |      719                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                              METHYL ISOBUTYL KETONE                                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 726 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   726 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  98.0  94.0  88.0  84.0  64.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |450 PPM    |   100.0 100.0 100.0  98.0  94.0  92.0  92.0  86.0  69.7  57.4      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |900 PPM    |    98.0  98.0  96.0  96.0  96.0  96.0  90.0  86.0  76.0  50.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1800 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  90.0  60.0  38.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                CONTROL      450 PPM      900 PPM      1800 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       64.0%        57.4%        50.0%        38.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.010      P=0.512      P=0.221      P=0.015  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       633.1        604.0        610.3        647.1    |                                                 
 |NATURAL DEATHS (C)      |       (19.3)       (23.5)       (31.3)       ( 9.1)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       692.6        672.7        668.1        677.1    |                                                 
 |(STANDARD ERROR)        |       ( 9.3)       (13.0)       (17.6)       ( 7.8)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                              METHYL ISOBUTYL KETONE                                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      370   454   523   576   583   606   616   643   650   685                 |                                                 
 |      696   707   709   714   716                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 450 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      356   455   537   539   562   569   594   595   665   693                 |                                                 
 |      707   707   712   718   721   722                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 900 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      489   509   513   546   581   582   590   614   616   621                 |                                                 
 |      636   637   642   642   643   653   653   674   677   684                 |                                                 
 |      702   714   726   726                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                              METHYL ISOBUTYL KETONE                                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1800 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      364   398   454   489   499   506   548   637   651   667                 |                                                 
 |      681   681   691   692   695   695   723   726                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                              METHYL ISOBUTYL KETONE                                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   727 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0 100.0 100.0 100.0  98.0  96.0  94.0  90.0  82.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |450 PPM    |   100.0 100.0 100.0  98.0  98.0  96.0  92.0  84.0  82.0  68.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |900 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  94.0  86.0  66.0  52.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1800 PPM   |   100.0 100.0 100.0  98.0  96.0  94.0  88.0  86.0  82.0  64.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                CONTROL      450 PPM      900 PPM      1800 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       70.0%        68.0%        52.0%        64.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.439      P=0.993      P=0.093      P=0.621  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       616.5        615.8        627.9        599.8    |                                                 
 |NATURAL DEATHS (C)      |       (26.5)       (27.3)       (13.5)       (28.0)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       693.9        691.4        679.4        681.2    |                                                 
 |(STANDARD ERROR)        |       (10.6)       (11.3)       ( 9.6)       (13.2)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                                       METHYL ISOBUTYL KETONE                                                       
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        CONTROL          = 1                                                        
                                                        450 PPM          = 2                                                        
                                                        900 PPM          = 3                                                        
                                                        1800 PPM         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1         3                                           2                   1    4                                            
      |           3                      3                    2         2         1   14      4                                     
      |                                  3                              2 2        2  1 1    33 14    4                             
      |                                                                            2           21   1 4 4                           
   90 +                                                                                       32 3  1 1                             
      |                                                                                          3 3  124 41                        
P     |                                                                                            3   22 213     1                 
E     |                                                                                                   4 4     11                
R  80 +                                                                                                   2 24                      
C     |                                                                                                     2  2 3 1 1              
E     |                                                                                                      442 23  1 1            
N     |                                                                                                           33                
T  70 +                                                                                                          2 2 3              
      |                                                                                                       44     3311           
S     |                                                                                                        4 4 22   1 1         
U     |                                                                                                             2 32 2          
R  60 +                                                                                                          4 4                
V     |                                                                                                                  22         
I     |                                                                                                            444 33           
V     |                                                                                                              44 33          
A  50 +                                                                                                                  33         
L     |                                                                                                               44            
      |                                                                                                                             
      |                                                                                                                44           
   40 +                                                                                                                 44          
      |                                                                                                                  44         
      |                                                                                                                             
      |                                                                                                                             
   30 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 21 obs hidden.                                                                                                                
                                                                                                                                   
                                                       METHYL ISOBUTYL KETONE                                                       
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        CONTROL          = 1                                                        
                                                        450 PPM          = 2                                                        
                                                        900 PPM          = 3                                                        
                                                        1800 PPM         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
  100 + 1                                                       241                  3                                              
      |                                                                                                                             
      |                                                         241    4        1    3  3                                           
      |                                                                4        1       33 1 2                                      
   95 +                                                                                                                             
      |                                                                         4    4   3 1  3    1                                
      |                                                                              4 4     23  2 11                               
      |                                                                                                                             
   90 +                                                                                44        2231   1                           
      |                                                                                                                             
      |                                                                                 4      4  2 3 2 11                          
      |                                                                                        4      3  1  41                      
P  85 +                                                                                                                             
E     |                                                                                               2     411  2                  
R     |                                                                                                  33   1  24 12              
C     |                                                                                                                             
E  80 +                                                                                                   3 3     4 1212            
N     |                                                                                                                             
T     |                                                                                                               11            
      |                                                                                                     33      44 11           
S  75 +                                                                                                                             
U     |                                                                                                                 22          
R     |                                                                                                              44 11          
V     |                                                                                                                             
I  70 +                                                                                                      3 3         11         
V     |                                                                                                                             
A     |                                                                                                               4   2         
L     |                                                                                                        3   3                
   65 +                                                                                                                             
      |                                                                                                                   4         
      |                                                                                                            33               
      |                                                                                                                             
   60 +                                                                                                             3  3            
      |                                                                                                                             
      |                                                                                                                33           
      |                                                                                                                 3 3         
   55 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                   3         
      |                                                                                                                             
   50 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 18 obs hidden.