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TDMS Study 96017-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID)                  DATE: 05/19/04       
EXPERIMENT: 96017 TEST: 06                                                                                     TIME: 09:31:13       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85420                              ROUTE: DOSED WATER                                             NTP C#: C96017       
PATHOLOGIST: HEATH, JAMES                                                                                      CAS: 631-64-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID)                  DATE: 05/19/04       
EXPERIMENT: 96017 TEST: 06                                                                                     TIME: 09:31:13       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85420                              ROUTE: DOSED WATER                                             NTP C#: C96017       
PATHOLOGIST: HEATH, JAMES                                                                                      CAS: 631-64-1        
                                                                                                                                   
                WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID)                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/L                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 49     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 31        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      435   451   458   482   514   596   601   626   631   632                 |                                                 
 |      655   662   669   703   710   710   715   717                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 50 MG/L                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      297   562   573   582   596   659   659   684   690   691                 |                                                 
 |      717   721                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 500 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      367   431   521   573   576   596   604   625   626   631                 |                                                 
 |      653   654   691   699   708   714                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID)                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 1000    MG/L                                   |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      469   476   489   558   563   597   623   627   637   652                 |                                                 
 |      659   659   689   691   692   694   702   706   707                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID)                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/L     |   100.0 100.0 100.0 100.0 100.0  91.8  89.8  85.7  75.5  63.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |50 MG/L    |   100.0 100.0 100.0  98.0  98.0  98.0  98.0  90.0  86.0  76.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |500 MG/L   |   100.0 100.0 100.0 100.0  98.0  96.0  94.0  86.0  76.0  68.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1000       |   100.0 100.0 100.0 100.0 100.0  96.0  94.0  88.0  76.0  62.0      |                                                 
 |MG/L       |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/L       50 MG/L      500 MG/L     1000     |                                                 
 |                                                                       MG/L     |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       63.3%        76.0%        68.0%        62.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.428      P=0.221N     P=0.813N     P=1.000  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       609.3        619.3        604.3        625.8    |                                                 
 |NATURAL DEATHS (C)      |       (23.2)       (33.6)       (24.2)       (18.3)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       685.0        702.7        689.1        689.8    |                                                 
 |(STANDARD ERROR)        |       (11.8)       (10.3)       (11.2)       ( 9.9)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID)                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/L                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      474   517   555   563   591   621   653   658   710   714                 |                                                 
 |      720   723                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 50 MG/L                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      383   487   490   584   601   615   659   682   694   697                 |                                                 
 |      706   710   715   721   724                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 500 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      479   507   553   573   617   618   622   629   634   643                 |                                                 
 |      659   668   680   692   701   712   718   724                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID)                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 1000    MG/L                                   |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      279   430   593   596   629   636   659   671   676   682                 |                                                 
 |      682   688   702   715   717   719   721   721                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID)                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/L     |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  90.0  84.0  76.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |50 MG/L    |   100.0 100.0 100.0 100.0  98.0  98.0  94.0  90.0  86.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |500 MG/L   |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  92.0  78.0  64.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1000       |   100.0 100.0 100.0  98.0  98.0  96.0  96.0  92.0  86.0  64.0      |                                                 
 |MG/L       |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/L       50 MG/L      500 MG/L     1000     |                                                 
 |                                                                       MG/L     |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       76.0%        70.0%        64.0%        64.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.276      P=0.658      P=0.273      P=0.309  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       624.9        631.2        634.9        639.8    |                                                 
 |NATURAL DEATHS (C)      |       (24.6)       (27.0)       (16.6)       (26.9)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       704.0        699.7        695.1        696.9    |                                                 
 |(STANDARD ERROR)        |       ( 8.5)       (10.2)       ( 8.7)       (11.3)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                         WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID)                                         
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/L           = 1                                                        
                                                        50 MG/L          = 2                                                        
                                                        500 MG/L         = 3                                                        
                                                        1000    MG/L     = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                              2          3          1    4                                                 
      |                                                                                                                             
      |                                                2          3         31  1 44             2                                  
      |                                                                     3   11 4 4     3     22                                 
   95 +                                                                                                                             
      |                                                                          1  14     3    4 2 2                               
      |                                                                                         44332  2                            
      |                                                                             1    1                                          
P  90 +                                                                                  1       4 3   1         2                  
E     |                                                                                                                             
R     |                                                                                                33 4                         
C     |                                                                                                13 41     2  2               
E  85 +                                                                                                                             
N     |                                                                                                    11       22              
T     |                                                                                                    33  4                    
      |                                                                                                                             
S  80 +                                                                                                     1  1 4   2   2          
U     |                                                                                                                             
R     |                                                                                                        1 1                  
V     |                                                                                                        3 4   3   2  2       
I  75 +                                                                                                          11                 
V     |                                                                                                           1  331            
A     |                                                                                                               3 3           
L     |                                                                                                                11           
   70 +                                                                                                              44             
      |                                                                                                                             
      |                                                                                                               4411  3       
      |                                                                                                                             
   65 +                                                                                                                             
      |                                                                                                                  1  1       
      |                                                                                                                4    4       
      |                                                                                                                             
   60 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 18 obs hidden.                                                                                                                
                                                                                                                                   
                                         WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID)                                         
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/L           = 1                                                        
                                                        50 MG/L          = 2                                                        
                                                        500 MG/L         = 3                                                        
                                                        1000    MG/L     = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                           4                2             13                                               
      |                                                                                                                             
      |                                             4                2      4      132  31                                          
      |                                                                                                                             
   96 +                                                                     4           31     31     4                             
      |                                                                                                                             
      |                                                                              2         3113 2 44                            
      |                                                                                                                             
   92 +                                                                                          13 2 12  34                        
      |                                                                                                                             
P     |                                                                                               12 2144                       
E     |                                                                                                                             
R  88 +                                                                                                  21 4  1 2                  
C     |                                                                                                                             
E     |                                                                                                   33     24 2               
N     |                                                                                                                             
T  84 +                                                                                                    33  1  442 2 1           
      |                                                                                                                             
S     |                                                                                                     33     44               
U     |                                                                                                                             
R  80 +                                                                                                      3   3    2211          
V     |                                                                                                                             
I     |                                                                                                          33 44 2211         
V     |                                                                                                                             
A  76 +                                                                                                           3 34 4221 1       
L     |                                                                                                                             
      |                                                                                                             33 4 4          
      |                                                                                                                             
   72 +                                                                                                              3 3 22         
      |                                                                                                                             
      |                                                                                                                33 2 2       
      |                                                                                                                             
   68 +                                                                                                                 33          
      |                                                                                                                             
      |                                                                                                                  33         
      |                                                                                                                             
   64 +                                                                                                                  43 3       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 7 obs hidden.