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TDMS Study 88133-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                           TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA)                        DATE: 07/12/02       
EXPERIMENT: 88133 TEST: 06                                                                                     TIME: 08:53:21       
TEST TYPE:  SUBCHRON 26-WEEK                                                                                   PAGE:       1        
CONT: NO1-ES-65406                              ROUTE: SKIN APPLICATION                                        NTP C#: 88133B       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 15625-89-5      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                              Final#2                                                               
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 MG/KG                                                                       
                                       INCLUDE 002    0 MG/KG                                                                       
                                       INCLUDE 003    0.75    MG/KG                                                                 
                                       INCLUDE 004    0.75    MG/KG                                                                 
                                       INCLUDE 005    1.5     MG/KG                                                                 
                                       INCLUDE 006    1.5     MG/KG                                                                 
                                       INCLUDE 007    3 MG/KG                                                                       
                                       INCLUDE 008    3 MG/KG                                                                       
                                       INCLUDE 009    6 MG/KG                                                                       
                                       INCLUDE 010    6 MG/KG                                                                       
                                       INCLUDE 011    12 MG/KG                                                                      
                                       INCLUDE 012    12 MG/KG                                                                      
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                           TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA)                        DATE: 07/12/02       
EXPERIMENT: 88133 TEST: 06                                                                                     TIME: 08:53:21       
TEST TYPE:  SUBCHRON 26-WEEK                                                                                                        
CONT: NO1-ES-65406                              ROUTE: SKIN APPLICATION                                        NTP C#: 88133B       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 15625-89-5      
                                                                                                                                   
                      TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA)                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 192 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      101                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 0.75    MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 0    TERMINAL 15        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |     NONE                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 1.5     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 12        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      74    95    157                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                      TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA)                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 192 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 3 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      132                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 6 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 13        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      92    180                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 12 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 11        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      161   161   182   191                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                      TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA)                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 192 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 20    40    60    80   100   120   140   160   180   192 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0  93.3  93.3  93.3  93.3  93.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.75       |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.5        |   100.0 100.0 100.0  93.3  86.7  86.7  86.7  86.7  80.0  80.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |3 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0  93.3  93.3  93.3  93.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |6 MG/KG    |   100.0 100.0 100.0 100.0  93.3  93.3  93.3  93.3  93.3  86.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |12 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  86.7  73.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                      TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA)                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 192 DAYS                                                                         
 ===============================================================================================================================    
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |    
 |                                                                                                                             |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |                                                                          DOSE                                               |    
 |                                                                                                                             |    
 |                                0 MG/KG         0.75            1.5             3 MG/KG         6 MG/KG         12 MG/KG     |    
 |                                                MG/KG           MG/KG                                                        |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |SURVIVAL AT END OF STUDY|       93.3%          100.0%           80.0%           93.3%           86.7%           73.3%        |    
 |(KAPLAN-MEIER)          |                                                                                                    |    
 |                        |                                                                                                    |    
 |SIGNIFICANCE (B)        |       P=0.111         P=1.000N        P=0.567         P=1.000N        P=0.984         P=0.357      |    
 |(LIFE TABLE)            |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN DAY OF             |       101.0              .            108.7           132.0           136.0           173.8        |    
 |NATURAL DEATHS (C)      |       (  . )          (  . )          (24.9)          (  . )          (44.0)          ( 7.6)       |    
 |(STANDARD ERROR)        |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN LIFE SPAN (D)      |       185.9           192.0           175.3           188.0           184.5           187.1        |    
 |(STANDARD ERROR)        |       ( 6.1)          ( 0.0)          ( 9.9)          ( 4.0)          ( 6.7)          ( 2.8)       |    
 |                        |                                                                                                    |    
 ===============================================================================================================================    
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                      TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA)                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 193 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 0    TERMINAL 15        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |     NONE                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 0.75    MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      183                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 1.5     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 12        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      63    63    122                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                      TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA)                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 193 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 3 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      124                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 6 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      162                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 12 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 12        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      118   176   189                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                      TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA)                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 193 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 20    40    60    80   100   120   140   160   180   193 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.75       |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.5        |   100.0 100.0 100.0  86.7  86.7  86.7  80.0  80.0  80.0  80.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |3 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0  93.3  93.3  93.3  93.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |6 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3  93.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |12 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  93.3  93.3  93.3  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                      TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA)                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 193 DAYS                                                                         
 ===============================================================================================================================    
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |    
 |                                                                                                                             |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |                                                                          DOSE                                               |    
 |                                                                                                                             |    
 |                                0 MG/KG         0.75            1.5             3 MG/KG         6 MG/KG         12 MG/KG     |    
 |                                                MG/KG           MG/KG                                                        |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |SURVIVAL AT END OF STUDY|      100.0%           93.3%           80.0%           93.3%           93.3%           80.0%        |    
 |(KAPLAN-MEIER)          |                                                                                                    |    
 |                        |                                                                                                    |    
 |SIGNIFICANCE (B)        |       P=0.305         P=1.000         P=0.226         P=1.000         P=1.000         P=0.224      |    
 |(LIFE TABLE)            |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN DAY OF             |          .            183.0            82.7           124.0           162.0           161.0        |    
 |NATURAL DEATHS (C)      |       (  . )          (  . )          (19.7)          (  . )          (  . )          (21.8)       |    
 |(STANDARD ERROR)        |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN LIFE SPAN (D)      |       193.0           192.3           170.9           188.4           190.9           186.6        |    
 |(STANDARD ERROR)        |       ( 0.0)          ( 0.7)          (12.3)          ( 4.6)          ( 2.1)          ( 5.0)       |    
 |                        |                                                                                                    |    
 ===============================================================================================================================    
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                               TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA)                                               
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        0.75    MG/KG    = 2                                                        
                                                        1.5     MG/KG    = 3                                                        
                                                        3 MG/KG          = 4                                                        
                                                        6 MG/KG          = 5                                                        
                                                        12 MG/KG         = 6                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
           |                                                                                                                        
           |                                                                                                                        
  P 100.00 +  1                                           3           5   1               4               6                   2     
  E        |                                                                                                                        
  R        |                                                                                                                        
  C        |                                                                                                                        
  E  93.33 +                                              3           3   1               4                           5       1     
  N        |                                                                                                                        
  T        |                                                                                                                        
           |                                                                                                                        
  S  86.67 +                                                          3                                   3           5       5     
  U        |                                                                                                                        
  R        |                                                                                                                        
  V        |                                                                                                                        
  I  80.00 +                                                                                              3           6       3     
  V        |                                                                                                                        
  A        |                                                                                                                        
  L        |                                                                                                                        
     73.33 +                                                                                                                  6     
           |                                                                                                                        
           ---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+--   
              0   1   2   3   4   5   6   7   8   9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28     
                                                                                                                                    
                                                                    WEEK                                                            
                                                                                                                                    
NOTE: 10 obs hidden.                                                                                                                
                                                                                                                                   
                                               TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA)                                               
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        0.75    MG/KG    = 2                                                        
                                                        1.5     MG/KG    = 3                                                        
                                                        3 MG/KG          = 4                                                        
                                                        6 MG/KG          = 5                                                        
                                                        12 MG/KG         = 6                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
  P        |                                                                                                                        
  E        |                                                                                                                        
  R 100.00 +  1                                   3                               6   4                       5           2   1     
  C        |                                                                                                                        
  E        |                                                                                                                        
  N        |                                                                                                                        
  T  93.33 +                                                                      6   4                       5       6   2   2     
           |                                                                                                                        
  S        |                                                                                                                        
  U        |                                                                                                                        
  R  86.67 +                                      3                                   3                               6   6         
  V        |                                                                                                                        
  I        |                                                                                                                        
  V        |                                                                                                                        
  A  80.00 +                                                                          3                                   6   3     
  L        |                                                                                                                        
           ---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+--   
              0   1   2   3   4   5   6   7   8   9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28     
                                                                                                                                    
                                                                    WEEK                                                            
                                                                                                                                    
NOTE: 8 obs hidden.