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TDMS Study 93026-07 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                         DECALIN                                        DATE: 08/24/01       
EXPERIMENT: 93026 TEST: 07                                                                                     TIME: 11:38:52       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55392                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C93026       
PATHOLOGIST: RENNE, ROGER                                                                                      CAS: 91-17-8         
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                                                              FINAL#1                                                               
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                         DECALIN                                        DATE: 08/24/01       
EXPERIMENT: 93026 TEST: 07                                                                                     TIME: 11:38:52       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55392                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C93026       
PATHOLOGIST: RENNE, ROGER                                                                                      CAS: 91-17-8         
                                                                                                                                   
                                      DECALIN                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 733 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      387   421   561   561   572   577   581   589   614   628                 |                                                 
 |      638   638   658   666   680   680   688   694   694   700                 |                                                 
 |      706   728                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 25 PPM                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 27     CENSORED DEATHS 0    TERMINAL 23        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      315   509   525   532   538   561   567   581   581   589                 |                                                 
 |      592   638   638   644   652   670   673   681   688   694                 |                                                 
 |      701   708   708   721   722   722   725                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 50 PPM                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 49     UNCENSORED DEATHS 26     CENSORED DEATHS 0    TERMINAL 23        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      574   596   602   605   610   617   617   638   652   658                 |                                                 
 |      665   666   671   680   680   680   688   694   694   699                 |                                                 
 |      708   715   715   716   718   722                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      DECALIN                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 733 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 100 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 20        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      379   419   506   529   561   567   600   613   615   617                 |                                                 
 |      617   634   634   638   649   652   669   673   679   687                 |                                                 
 |      687   687   688   688   705   708   715   716   722   722                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 400 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 20     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      433   694   706   708   708   716                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      DECALIN                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 733 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0 100.0 100.0 100.0  96.0  96.0  96.0  84.0  74.0  56.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |25 PPM     |   100.0 100.0 100.0  98.0  98.0  98.0  90.0  78.0  70.0  46.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |50 PPM     |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  91.8  77.6  46.9      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |100 PPM    |   100.0 100.0 100.0 100.0  96.0  96.0  92.0  86.0  68.0  40.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |400 PPM    |   100.0 100.0 100.0 100.0 100.0  95.0  95.0  95.0  95.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      DECALIN                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 733 DAYS                                                                         
 ===============================================================================================================================    
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |    
 |                                                                                                                             |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |                                                                           DOSE                                              |    
 |                                                                                                                             |    
 |                                CONTROL            25 PPM             50 PPM             100 PPM            400 PPM          |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |SURVIVAL AT END OF STUDY|       56.0%              46.0%              46.9%              40.0%              70.0%            |    
 |(KAPLAN-MEIER)          |                                                                                                    |    
 |                        |                                                                                                    |    
 |SIGNIFICANCE (B)        |       P=0.169N           P=0.453            P=0.686            P=0.192            P=0.266N         |    
 |(LIFE TABLE)            |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN DAY OF             |       621.0              625.0              664.6              632.5              660.8            |    
 |NATURAL DEATHS (C)      |       (18.6)             (17.9)             ( 8.7)             (15.5)             (45.7)           |    
 |(STANDARD ERROR)        |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN LIFE SPAN (D)      |       683.7              674.7              696.7              672.7              711.4            |    
 |(STANDARD ERROR)        |       (11.3)             (12.3)             ( 6.7)             (11.6)             (14.9)           |    
 |                        |                                                                                                    |    
 ===============================================================================================================================    
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                      DECALIN                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 734 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      359   525   561   573   609   639   652   652   666   666                 |                                                 
 |      666   680   688   705   716   716   717   722                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 25 PPM                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      499   533   613   635   638   656   663   706   708   708                 |                                                 
 |      722   722   722   728   728                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 100 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 1    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      349   617   665   665   666   679   680   688   694   722                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      113                                                                       |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      DECALIN                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 734 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 400 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      478   492   538   538   561   566   580   589   590   590                 |                                                 
 |      602   618   634   644   644   694   699   700   702   706                 |                                                 
 |      708   708                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      DECALIN                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 734 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   734 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0 100.0 100.0  98.0  98.0  98.0  96.0  92.0  84.0  64.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |25 PPM     |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  96.0  86.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |100 PPM    |   100.0 100.0 100.0  98.0  98.0  98.0  98.0  98.0  91.8  79.6      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |400 PPM    |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  78.0  70.0  56.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                CONTROL      25 PPM       100 PPM      400 PPM  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       64.0%        70.0%        79.6%        56.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.076      P=0.554N     P=0.124N     P=0.391  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       639.6        665.4        642.5        617.3    |                                                 
 |NATURAL DEATHS (C)      |       (21.3)       (18.6)       (33.7)       (15.4)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       700.0        713.4        703.3        682.7    |                                                 
 |(STANDARD ERROR)        |       ( 9.9)       ( 7.1)       (14.6)       (10.6)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                              DECALIN                                                               
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        CONTROL          = 1                                                        
                                                        25 PPM           = 2                                                        
                                                        50 PPM           = 3                                                        
                                                        100 PPM          = 4                                                        
                                                        400 PPM          = 5                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                 2          41     5                     3                                 
      |                                                   2          41   41            2         3    3                            
      |                                                                   415           2  22    1     33             5             
      |                                                                                     22   11     33                          
P  90 +                                                                                      2   211     33           55            
E     |                                                                                          4     4                            
R     |                                                                                          2 1  14 13  3         55           
C     |                                                                                            2  2  141 3 3                    
E  80 +                                                                                                    1 1 3 3                  
N     |                                                                                               2   4 42   33                 
T     |                                                                                                     41 1  1     55          
      |                                                                                                      242  1 1               
S  70 +                                                                                                       42  2      5  5       
U     |                                                                                                        4  2211              
R     |                                                                                                           42211             
V     |                                                                                                            4 22             
I  60 +                                                                                                               113           
V     |                                                                                                                1231         
A     |                                                                                                                 221 1       
L     |                                                                                                              4 4 22         
   50 +                                                                                                                4433         
      |                                                                                                                 443 3       
      |                                                                                                                  42 2       
      |                                                                                                                             
   40 +                                                                                                                   4 4       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 35 obs hidden.                                                                                                                
                                                                                                                                   
                                                              DECALIN                                                               
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        CONTROL          = 1                                                        
                                                        25 PPM           = 2                                                        
                                                        100 PPM          = 3                                                        
                                                        400 PPM          = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                      3 1                  4  2                                            
      |                                                                                                                             
      |                                                        3 1                  4 42   1 2            3                         
      |                                                                               4    1 2   1       23      3                  
   95 +                                                                                                                             
      |                                                                                          11      2  2                       
      |                                                                                      4   41     1   22                      
      |                                                                                                          33                 
   90 +                                                                                                 1    1 2  33                
      |                                                                                                                             
P     |                                                                                          4 4         1 1 2 33               
E     |                                                                                            4  4          2  33 2            
R  85 +                                                                                                                             
C     |                                                                                                        1  1  3322           
E     |                                                                                                                             
N     |                                                                                                               3   3         
T  80 +                                                                                               44                2 2 3       
      |                                                                                                                             
S     |                                                                                                4  4       1 1               
U     |                                                                                                   4 4       11              
R  75 +                                                                                                                             
V     |                                                                                                     44       1 1            
I     |                                                                                                                1 1          
V     |                                                                                                                             
A  70 +                                                                                                      4        4   2 2       
L     |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                  11         
   65 +                                                                                                                             
      |                                                                                                               44  1 1       
      |                                                                                                                             
      |                                                                                                                             
   60 +                                                                                                                44           
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                 4   4       
   55 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 7 obs hidden.