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TDMS Study 05130-02 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Microbiological Assoc.                                    DATE: 09/17/94   
EXP: 05130                  C. I. DIRECT BLUE 218              TIME: 00:05:11   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60877B   
CONT: NO1-ES-5096                                              CAS: 10401-500   
PATHOLOGIST: L. BRENNECKE                                                       
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Microbiological Assoc.                                    DATE: 09/17/94  
EXP: 05130                  C. I. DIRECT BLUE 218              TIME: 00:05:11  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60877B  
CONT: NO1-ES-5096                                              CAS: 10401-500  
PATHOLOGIST: L. BRENNECKE                                                      

                               C. I. DIRECT BLUE 218


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 737 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 5      CENSORED DEATHS 11   TERMINAL 44        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      388   519   613   667   676                                               |
 |  CENSORED DEATHS                                                               |
 |      24    87    455   455   455   455   455   456   456   456                 |
 |      456                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1000 PPMLOW                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 4      CENSORED DEATHS 10   TERMINAL 46        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      455   653   659   689                                                     |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 3000 PP  ID                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 8      CENSORED DEATHS 10   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      511   622   646   650   655   686   702   704                             |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                               C. I. DIRECT BLUE 218


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 737 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 10000PPMHIGH                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 5      CENSORED DEATHS 10   TERMINAL 45        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      568   576   660   675   716                                               |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                               C. I. DIRECT BLUE 218


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 737 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   737 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0  98.3  98.3  96.2  96.2  94.2  90.1      |
 |           |                                                                    |
 |           |                                                                    |
 |1000 PPMLOW|   100.0 100.0 100.0 100.0 100.0  98.3  98.3  98.3  94.3  92.3      |
 |           |                                                                    |
 |           |                                                                    |
 |3000 PP  ID|   100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  90.0  84.0      |
 |           |                                                                    |
 |           |                                                                    |
 |10000PPMHIG|   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  94.0  90.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      1000 PPMLOW  3000 PP  ID  10000PPMH|GH
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       90.1%        92.3%        84.0%        90.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000      P=0.949N     P=0.602      P=1.000N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       572.6        614.0        647.0        639.0    |
 |NATURAL DEATHS (C)      |       (53.9)       (53.6)       (22.0)       (28.9)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       658.4        681.9        678.1        681.9    |
 |(STANDARD ERROR)        |       (20.4)       (14.1)       (13.8)       (13.8)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                               C. I. DIRECT BLUE 218


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 739 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 12     CENSORED DEATHS 11   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      88    184   368   518   580   613   617   627   644   688                 |
 |      701   728                                                                 |
 |  CENSORED DEATHS                                                               |
 |      43    455   455   455   455   455   456   456   456   456                 |
 |      456                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1000 PPMLOW                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 10   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      522   554   590   639   639   648   648   669   679   693                 |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 3000 PP  ID                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 3      CENSORED DEATHS 11   TERMINAL 46        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      532   676   704                                                           |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   456   456   456   456   456                 |
 |      470                                                                       |
 |                                                                                |
 ==================================================================================

                               C. I. DIRECT BLUE 218


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 739 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 10000PPMHIGH                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 12   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      108   427   504   541   567   689   694   700   715   721                 |
 |  CENSORED DEATHS                                                               |
 |      38    455   455   455   455   455   456   456   456   456                 |
 |      456   539                                                                 |
 |                                                                                |
 ==================================================================================

                               C. I. DIRECT BLUE 218


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 739 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   739 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |    98.3  98.3  96.6  96.6  94.9  94.9  92.9  90.8  82.5  76.3      |
 |           |                                                                    |
 |           |                                                                    |
 |1000 PPMLOW|   100.0 100.0 100.0 100.0 100.0 100.0  98.0  94.0  86.0  80.0      |
 |           |                                                                    |
 |           |                                                                    |
 |3000 PP  ID|   100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  98.0  93.9      |
 |           |                                                                    |
 |           |                                                                    |
 |10000PPMHIG|   100.0  98.3  98.3  98.3  98.3  96.6  92.5  90.4  90.4  79.8      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      1000 PPMLOW  3000 PP  ID  10000PPMH|GH
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       76.3%        80.0%        93.9%        79.8%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000N     P=0.695N     P=0.022N     P=0.792N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       529.7        628.1        637.3        566.6    |
 |NATURAL DEATHS (C)      |       (59.9)       (17.5)       (53.3)       (60.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       638.3        673.3        682.2        648.0    |
 |(STANDARD ERROR)        |       (21.8)       (14.0)       (14.4)       (20.3)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                       C. I. DIRECT BLUE 218
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        1000 PPMLOW      = 2
                                                        3000 PP  ID      = 3
                                                        10000PPMHIGH     = 4

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

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

      |
      |
  100 + 1                                                             1         2       3         4
      |
      |
      |                                                               1         2          1                   2
   98 +                                                                                 3         44      3
      |
      |
      |                                                                                                        2 2
P  96 +                                                                                    1       4     13   3  4
E     |
R     |
C     |                                                                                                          2   2
E  94 +                                                                                                  1       414
N     |
T     |
      |                                                                                                              2       2
S  92 +                                                                                                       33  11     4
U     |
R     |
V     |
I  90 +                                                                                                        3   13    4   1
V     |
A     |
L     |
   88 +                                                                                                             3  3
      |
      |
      |
   86 +
      |
      |
      |
   84 +                                                                                                                3     3
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 5 obs hidden.

                                                       C. I. DIRECT BLUE 218
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        1000 PPMLOW      = 2
                                                        3000 PP  ID      = 3
                                                        10000PPMHIGH     = 4

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

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

        |
  100.0 +1             1   4                                                                23
        |
        |
        |              1   4           1                                    4               23   2                  3
   97.5 +
        |                              1                           1        4           4
        |                                                                                        2     2
        |                                                                                                           3   3
   95.0 +                                                          1                      1
        |                                                                               4      4
        |                                                                                              2      2         3     3
        |                                                                                 1         1
P  92.5 +                                                                                      4  4
E       |
R       |
C       |                                                                                         4 1     1           4
E  90.0 +                                                                                                     22
N       |
T       |                                                                                                 11
        |                                                                                                             44
S  87.5 +
U       |                                                                                                  11
R       |                                                                                                      2   2
V       |
I  85.0 +
V       |                                                                                                   1 1
A       |                                                                                                          22  4  4
L       |
   82.5 +                                                                                                     1       1
        |                                                                                                           2 2
        |
        |                                                                                                             1 1
   80.0 +                                                                                                             2   4   2
        |
        |
        |                                                                                                               1  1
   77.5 +
        |
        |                                                                                                                  1  1
        |
   75.0 +
        |
        -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-
         0         10         20         30         40         50         60         70         80         90         100        110

                                                                    WEEK

NOTE: 4 obs hidden.