National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/6853

TDMS Study 97006-02 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                  METHYL ISOBUTYL KETONE                                DATE: 04/29/04       
EXPERIMENT: 97006 TEST: 02                                                                                     TIME: 07:53:07       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05452                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C97006       
PATHOLOGIST: GRUMBEIN, SONDRA                                                                                  CAS: 108-10-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            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 Northwest                                  METHYL ISOBUTYL KETONE                                DATE: 04/29/04       
EXPERIMENT: 97006 TEST: 02                                                                                     TIME: 07:53:07       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-05452                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C97006       
PATHOLOGIST: GRUMBEIN, SONDRA                                                                                  CAS: 108-10-1        
                                                                                                                                   
                              METHYL ISOBUTYL KETONE                                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      482   598   612   614   618   622   666   676   678   704                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 450 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 42        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      493   565   582   661   670   680   704   724                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 900 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      26    412   471   480   501   519   520   520   554   602                 |                                                 
 |      639   659   698   701   717                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                              METHYL ISOBUTYL KETONE                                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1800 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      441   513   551   593   601   607   617   637   656   678                 |                                                 
 |      710   717   725                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                              METHYL ISOBUTYL KETONE                                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  96.0  88.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |450 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  94.0  92.0  84.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |900 PPM    |    98.0  98.0  98.0  98.0  96.0  92.0  84.0  80.0  76.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1800 PPM   |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  90.0  82.0  74.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                CONTROL      450 PPM      900 PPM      1800 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       80.0%        84.0%        70.0%        74.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.322      P=0.759N     P=0.286      P=0.609  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       627.0        634.9        534.6        618.9    |                                                 
 |NATURAL DEATHS (C)      |       (19.7)       (28.2)       (43.7)       (23.1)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       708.6        713.9        670.7        700.4    |                                                 
 |(STANDARD ERROR)        |       ( 6.9)       ( 6.5)       (18.1)       ( 9.0)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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 MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      177   368   537   578   586   632   653   681   684   691                 |                                                 
 |      697   706   715   715   724                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 450 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 1    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      515   598   620   628   638   662   683   687   702   710                 |                                                 
 |      715   715                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      21                                                                        |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 900 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      75    530   551   567   648   648   673   684   695   696                 |                                                 
 |      701                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                              METHYL ISOBUTYL KETONE                                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1800 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      329   435   535   617   643   687   705   714   715   719                 |                                                 
 |      722   724                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                              METHYL ISOBUTYL KETONE                                                                                
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   731 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0  98.0  98.0  98.0  96.0  96.0  94.0  90.0  86.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |450 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  95.9  87.8  75.5      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |900 PPM    |    98.0  98.0  98.0  98.0  98.0  98.0  96.0  92.0  88.0  78.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1800 PPM   |   100.0 100.0 100.0  98.0  98.0  96.0  94.0  94.0  90.0  76.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                CONTROL      450 PPM      900 PPM      1800 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       70.0%        75.5%        78.0%        76.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.567N     P=0.659N     P=0.527N     P=0.590N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       609.6        656.1        588.0        628.8    |                                                 
 |NATURAL DEATHS (C)      |       (39.3)       (17.3)       (54.6)       (37.6)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       694.6        698.8        699.5        706.5    |                                                 
 |(STANDARD ERROR)        |       (14.0)       (15.1)       (14.3)       (10.7)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1   3                                                                4      1 2                                             
      |                                                                                                                             
      |     3                                                            3   4      1 2  4       2     1                            
      |                                                                                                                             
   96 +                                                                  3         3     4     4 2  2  1 1                          
      |                                                                                                                             
      |                                                                            33          4    2 4          2                  
      |                                                                                                                             
P  92 +                                                                             3  3              44 11      22                 
E     |                                                                                                                             
R     |                                                                                3   3           44         2 2               
C     |                                                                                                                             
E  88 +                                                                                                 4 1       1 2  2            
N     |                                                                                                                             
T     |                                                                                                   4 4     11   2  2         
      |                                                                                                                             
S  84 +                                                                                    3    3           4  4          2 2       
U     |                                                                                                                             
R     |                                                                                         3      3       4   1   1            
V     |                                                                                                                             
I  80 +                                                                                                3     3     4   14   1       
V     |                                                                                                                             
A     |                                                                                                      3   3      44          
L     |                                                                                                                             
   76 +                                                                                                          3    3  44         
      |                                                                                                                             
      |                                                                                                               33  4 4       
      |                                                                                                                             
   72 +                                                                                                                3 3          
      |                                                                                                                             
      |                                                                                                                  3  3       
      |                                                                                                                             
   68 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 5 obs hidden.                                                                                                                 
                                                                                                                                   
                                                       METHYL ISOBUTYL KETONE                                                       
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        CONTROL          = 1                                                        
                                                        450 PPM          = 2                                                        
                                                        900 PPM          = 3                                                        
                                                        1800 PPM         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1           3                1                      4                            2                                          
      |                                                                                                                             
      |             3                1                      4     1          4           2  3          2                            
      |                                                           1          4              31 3       2  2                         
P  95 +                                                                                                                             
E     |                                                                                      1 3 3 1      22                        
R     |                                                                                          3 11     4  43                     
C     |                                                                                                    2 2                      
E  90 +                                                                                             1       12   2   4              
N     |                                                                                                                             
T     |                                                                                                     1 31 2 324 4            
      |                                                                                                        1   312 44           
S  85 +                                                                                                                             
U     |                                                                                                             323244          
R     |                                                                                                             11              
V     |                                                                                                                22           
I  80 +                                                                                                              113224         
V     |                                                                                                                             
A     |                                                                                                               11    3       
L     |                                                                                                                1 14 4       
   75 +                                                                                                                  2  2       
      |                                                                                                                             
      |                                                                                                                  11         
      |                                                                                                                             
   70 +                                                                                                                   1 1       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 12 obs hidden.                                                                                                                
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.