National Toxicology Program

National Toxicology Program
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TDMS Study 93005-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: NCTR                                                    MALACHITE GREEN                                   DATE: 06/18/03       
EXPERIMENT: 93005 TEST: 03                                                                                     TIME: 14:28:35       
TEST TYPE:  CHRONIC                                                                                            PAGE:       1        
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93005       
PATHOLOGIST: MELLICK, PAUL                                                                                     CAS: 569-64-2        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: NCTR                                                    MALACHITE GREEN                                   DATE: 06/18/03       
EXPERIMENT: 93005 TEST: 03                                                                                     TIME: 14:28:35       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93005       
PATHOLOGIST: MELLICK, PAUL                                                                                     CAS: 569-64-2        
                                                                                                                                   
                                  MALACHITE GREEN                                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 PPM                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 29        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      401   443   526   529   533   535   552   589   606   626                 |                                                 
 |      626   631   641   641   647   667   704   711   722                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 100 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 23        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      443   485   494   512   539   540   556   574   577   591                 |                                                 
 |      596   598   600   610   613   624   641   648   686   687                 |                                                 
 |      707   708   718   718   722                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 300 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 32        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      484   508   603   619   626   627   652   659   659   666                 |                                                 
 |      673   692   697   697   715   719                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  MALACHITE GREEN                                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 600 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 25        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      111   323   378   443   454   508   546   562   570   581                 |                                                 
 |      589   605   619   620   630   633   634   654   670   685                 |                                                 
 |      694   697   699                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  MALACHITE GREEN                                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 PPM      |   100.0 100.0 100.0 100.0  97.9  95.8  87.5  83.3  68.8  60.4      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |100 PPM    |   100.0 100.0 100.0 100.0 100.0  95.8  87.5  72.9  62.5  47.9      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |300 PPM    |   100.0 100.0 100.0 100.0 100.0  97.9  95.8  93.7  81.2  66.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |600 PPM    |   100.0  97.9  97.9  95.8  93.8  89.6  87.5  75.0  62.5  52.1      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 PPM        100 PPM      300 PPM      600 PPM  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       60.4%        47.9%        66.7%        52.1%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.804      P=0.312      P=0.500N     P=0.452  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       596.3        607.5        643.5        561.1    |                                                 
 |NATURAL DEATHS (C)      |       (19.9)       (15.9)       (16.8)       (29.4)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       675.9        665.2        699.8        648.0    |                                                 
 |(STANDARD ERROR)        |       (12.2)       (12.0)       ( 8.0)       (18.5)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                          MALACHITE GREEN                                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 PPM            = 1                                                        
                                                        100 PPM          = 2                                                        
                                                        300 PPM          = 3                                                        
                                                        600 PPM          = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
         |                                                                                                                          
         |                                                                                                                          
  100.00 +1                 4                                             1     2      3                                            
         |                  4                                 4           1     1      2  3                                         
         |                                                    4      4          1      22 3   1           3                         
         |                                                           4          4       2  2              3 3                       
   91.67 +                                                                      4 4        2  11            33                      
         |                                                                        4       4    22                                   
P        |                                                                                4    1212          3   3                  
E        |                                                                                      41242   1        3 3                
R  83.33 +                                                                                         422  1 1                         
C        |                                                                                          42  2 1  1     33               
E        |                                                                                           4  22          33              
N        |                                                                                              4 4  11      3 3            
T  75.00 +                                                                                                4 4 11       33           
         |                                                                                               2 2                        
S        |                                                                                                  44 11       3  3        
U        |                                                                                                 2 24 1   1               
R  66.67 +                                                                                                   2 2    1    1 33       
V        |                                                                                                    4224       11         
I        |                                                                                                      24  4 2   1 1       
V        |                                                                                                          4 22    1       
A  58.33 +                                                                                                            4242          
L        |                                                                                                               22         
         |                                                                                                                22        
         |                                                                                                              4   4       
   50.00 +                                                                                                                 22       
         |                                                                                                                  2       
         |                                                                                                                          
         |                                                                                                                          
   41.67 +                                                                                                                          
         |                                                                                                                          
         -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
          0         10         20         30         40         50         60         70         80         90         100       110
                                                                                                                                    
                                                                     WEEK                                                           
                                                                                                                                    
NOTE: 12 obs hidden.                                                                                                                
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