National Toxicology Program

National Toxicology Program
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TDMS Study 96010-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                  WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE)                   DATE: 05/27/03       
EXPERIMENT: 96010 TEST: 03                                                                                     TIME: 13:32:44       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85420                              ROUTE: DOSED WATER                                             NTP C#: 96010A       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 7775-09-9       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1/RATS                                                            
                                                                                                                                    
                                                                                                                                    
               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 (SODIUM CHLORATE)                   DATE: 05/27/03       
EXPERIMENT: 96010 TEST: 03                                                                                     TIME: 13:32:44       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85420                              ROUTE: DOSED WATER                                             NTP C#: 96010A       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 7775-09-9       
                                                                                                                                   
                  WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/L                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 1    TERMINAL 36        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      381   469   503   511   545   574   630   636   636   695                 |                                                 
 |      699   705   706                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      423                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 125 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      542   555   562   574   582   605   614   619   638   652                 |                                                 
 |      660   663   668   672   693   695   699   703   714   714                 |                                                 
 |      714   721   726                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1000MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      209   475   561   566   576   605   607   626   647   660                 |                                                 
 |      667   673   675   695   698   703   703   714   721                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 2000MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      443   465   482   545   562   590   639   644   651   651                 |                                                 
 |      671   672   678   681   699   699   701   703   703   710                 |                                                 
 |      718   720                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       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  98.0  96.0  89.8  87.8  81.7  73.5      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |125 MG/L   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  88.0  76.0  54.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1000MG/L   |   100.0 100.0  98.0  98.0  98.0  96.0  96.0  88.0  80.0  62.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2000MG/L   |   100.0 100.0 100.0 100.0 100.0  94.0  92.0  88.0  80.0  56.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/L       125 MG/L     1000MG/L     2000MG/L |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       73.5%        54.0%        62.0%        56.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.412      P=0.108      P=0.353      P=0.146  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       591.5        651.5        620.1        637.6    |                                                 
 |NATURAL DEATHS (C)      |       (28.8)       (12.3)       (27.2)       (18.2)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       687.1        693.4        687.6        688.8    |                                                 
 |(STANDARD ERROR)        |       (12.5)       ( 7.9)       (12.7)       (10.2)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                  WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/L                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      423   462   511   555   566   594   595   623   644   661                 |                                                 
 |      717   718   727                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 125 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      365   423   433   511   541   563   623   626   636   639                 |                                                 
 |      644   657   714   727                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1000MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      401   511   514   547   573   587   587   615   615   626                 |                                                 
 |      636   636   651   699   699   703   703                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 2000MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 0    TERMINAL 41        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      475   542   635   636   644   668   670   693   703                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       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  98.0  96.0  94.0  86.0  80.0  74.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |125 MG/L   |   100.0 100.0 100.0  98.0  96.0  94.0  90.0  88.0  76.0  72.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1000MG/L   |   100.0 100.0 100.0 100.0  98.0  98.0  94.0  86.0  74.0  66.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2000MG/L   |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  96.0  90.0  82.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/L       125 MG/L     1000MG/L     2000MG/L |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       74.0%        72.0%        66.0%        82.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.368N     P=0.945      P=0.498      P=0.426N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       599.7        578.7        606.1        629.6    |                                                 
 |NATURAL DEATHS (C)      |       (26.7)       (29.6)       (19.7)       (24.8)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       695.4        686.9        687.2        711.1    |                                                 
 |(STANDARD ERROR)        |       (10.5)       (12.6)       (10.6)       ( 6.9)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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 (SODIUM CHLORATE)                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/L           = 1                                                        
                                                        125 MG/L         = 2                                                        
                                                        1000MG/L         = 3                                                        
                                                        2000MG/L         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  104 +                                                                                                                             
      |                                                                                                                             
      | 1                                3                           1        4               2                                     
      |                                  3                           1        4   13          2 2                                   
   96 +                                                                           134  1        22                                  
      |                                                                             4  11     4  22                                 
P     |                                                                                 1     1  3232                               
E     |                                                                                       1  4132 4 2                           
R  88 +                                                                                           1   4 22 1 4                      
C     |                                                                                                 32211                       
E     |                                                                                                   23 23                     
N     |                                                                                                     1232 3    1             
T  80 +                                                                                                       42 23                 
      |                                                                                                           33  11            
S     |                                                                                                          224                
U     |                                                                                                            34 31    1       
R  72 +                                                                                                           2 424             
V     |                                                                                                              223            
I     |                                                                                                               44            
V     |                                                                                                               223           
A  64 +                                                                                                                223          
L     |                                                                                                                443  3       
      |                                                                                                                 44          
      |                                                                                                                 22          
   56 +                                                                                                                  22 4       
      |                                                                                                                   2 2       
      |                                                                                                                             
      |                                                                                                                             
   48 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 20 obs hidden.                                                                                                                
                                                                                                                                   
                                          WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE)                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/L           = 1                                                        
                                                        125 MG/L         = 2                                                        
                                                        1000MG/L         = 3                                                        
                                                        2000MG/L         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                         2     3  1       4                                                
      |                                                                                                                             
      |                                                           2     3  1     1 4    3     4                                     
      |                                                                    22    1      13    4             4                       
   95 +                                                                                                                             
      |                                                                     2           13     31                                   
P     |                                                                                 2     23113         44                      
E     |                                                                                                                             
R  90 +                                                                                       2  13 3 1      4    4                 
C     |                                                                                                                             
E     |                                                                                          2        2                         
N     |                                                                                             3 1  312      4  4              
T  85 +                                                                                                                             
      |                                                                                                   1221       4 4            
S     |                                                                                                  3 321   1     4    4       
U     |                                                                                                                             
R  80 +                                                                                                    33    1       1          
V     |                                                                                                                             
I     |                                                                                                      2 2                    
V     |                                                                                                     3 32        211         
A  75 +                                                                                                                             
L     |                                                                                                       3       3 2 1 1       
      |                                                                                                                   2 2       
      |                                                                                                                             
   70 +                                                                                                               33            
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                3    3       
   65 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 10 obs hidden.                                                                                                                

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