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TDMS Study 05069-07 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: TSI Mason Research                      1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)                    DATE: 04/03/96       
EXPERIMENT: 05069 TEST: 07                                                                                     TIME: 03:33:54       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-95256                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 60902D       
PATHOLOGIST: DR. VOELKER                                                                                       CAS: 147-47-7        
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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: TSI Mason Research                      1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)                    DATE: 04/03/96      
EXPERIMENT: 05069 TEST: 07                                                                                     TIME: 03:33:54      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-95256                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 60902D      
PATHOLOGIST: DR. VOELKER                                                                                       CAS: 147-47-7       
                  1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 10   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      6     592   603   612   626   638   639   679   695   701                 |
 |      709                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 3.6     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 12     CENSORED DEATHS 11   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      22    357   400   540   560   588   616   626   640   708                 |
 |      710   724                                                                 |
 |  CENSORED DEATHS                                                               |
 |      207   456   456   456   456   456   456   456   456   456                 |
 |      456                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 6.0     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 10   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      385   553   571   592   603   618   661   661   669                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================
                  1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 10.0    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 10   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      464   490   515   536   581   582   623   660   676   686                 |
 |      691   722   728                                                           |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================
                  1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |    98.3  98.3  98.3  98.3  98.3  98.3  98.3  94.3  86.3  78.3      |
 |           |                                                                    |
 |           |                                                                    |
 |3.6        |    98.3  98.3  98.3  96.6  94.9  94.9  92.9  88.8  82.6  76.4      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |6.0        |   100.0 100.0 100.0 100.0  98.3  98.3  98.3  90.3  84.3  82.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |10.0       |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  88.0  84.0  74.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      3.6          6.0          10.0     |
 |                                             MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       78.3%        76.4%        82.3%        74.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.800      P=0.894      P=0.852N     P=0.763  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       590.9        540.9        590.3        611.8    |
 |NATURAL DEATHS (C)      |       (59.8)       (57.6)       (29.1)       (25.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       658.2        637.2        662.7        658.1    |
 |(STANDARD ERROR)        |       (17.2)       (19.7)       (14.2)       (14.3)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                  1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 16     CENSORED DEATHS 10   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      388   502   567   630   665   672   675   684   708   709                 |
 |      711   713   714   714   721   729                                         |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   455   455   455   455   455                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 3.6     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 10   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      448   490   560   581   593   659   684   698   699   724                 |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   455   455   455   455   455                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 6.0     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 10   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      394   446   490   504   628   694   709   717   726   735                 |
 |  CENSORED DEATHS                                                               |
 |      28    455   455   455   455   455   455   455   455   455                 |
 |                                                                                |
 ==================================================================================
                  1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 10.0    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 10   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      493   537   603   638   642   670   684   687   718   719                 |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   455   455   455   455   455                 |
 |                                                                                |
 ==================================================================================
                  1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 736 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   736 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0 100.0  98.3  98.3  96.3  94.3  90.3  68.2      |
 |           |                                                                    |
 |           |                                                                    |
 |3.6        |   100.0 100.0 100.0 100.0 100.0  98.3  96.3  90.3  88.3  80.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |6.0        |   100.0 100.0 100.0 100.0  98.3  96.6  92.6  92.6  90.6  80.5      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |10.0       |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  94.0  90.0  80.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      3.6          6.0          10.0     |
 |                                             MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       68.2%        80.3%        80.5%        80.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.215N     P=0.302N     P=0.265N     P=0.281N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       656.4        613.6        604.3        639.1    |
 |NATURAL DEATHS (C)      |       (23.6)       (29.9)       (41.7)       (23.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       667.9        668.8        660.1        673.0    |
 |(STANDARD ERROR)        |       (14.5)       (14.5)       (18.4)       (14.0)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                           1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        3.6     MG/KG    = 2
                                                        6.0     MG/KG    = 3
                                                        10.0    MG/KG    = 4

------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------

                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.

      |
      |
  100 + 11  2                                                        3            4
      |  1  2                                                   2    3                         3      1
      |                                                                           4  4
      |                                                         2       2            4   4     3  3   1 1
P  95 +                                                                 2                     2
E     |                                                                                  4   4    3   3 11
R     |                                                                                      42 2  4  3 31 1
C     |                                                                                         2   2
E  90 +                                                                                            44   3 31 1
N     |                                                                                             2    23      3
T     |                                                                                             4     4
      |                                                                                                  242 1   4 1
S  85 +                                                                                                    2 2
U     |                                                                                                          331  1
R     |                                                                                                      2    344 112   3
V     |
I  80 +                                                                                                             44 11
V     |                                                                                                                 1 2 1
A     |                                                                                                              4    4
L     |                                                                                                                   2 2
   75 +
      |                                                                                                                   4 4
      |
      |
   70 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 6 obs hidden.
                                           1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        3.6     MG/KG    = 2
                                                        6.0     MG/KG    = 3
                                                        10.0    MG/KG    = 4

----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------

                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.

      |
      |
  100 + 1                                                             13      2       4
      |                                                               13      2      2 1
      |                                                                               4      4
      |                                                                       3      2 1     4  21      4
   95 +                                                                              3 3
      |                                                                                         21 2    4  1 4
P     |                                                                                3           2  2    1     1
E     |
R  90 +                                                                                               2    3 4   11   3
C     |                                                                                                          2112 3 3
E     |                                                                                                           4 4
N     |                                                                                                            1142 33
T  85 +                                                                                                                  33
      |                                                                                                             14  14
S     |                                                                                                               2   2 3
U     |
R  80 +                                                                                                                  42 32
V     |
I     |
V     |
A  75 +
L     |
      |                                                                                                                 11
      |
   70 +                                                                                                                  1  1
      |                                                                                                                     11
      |
      |
   65 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 13 obs hidden.