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TDMS Study 05169-01 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: HLA, VA                                                   DATE: 09/18/94   
EXP: 05169                   C. I. DIRECT BLUE 15              TIME: 03:51:08   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED WATER                 NTP C#: 61290    
CONT: NO1ES9565503                                             CAS: 2429-74-5   
PATHOLOGIST: B. ULLAND                       S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: HLA, VA                                                   DATE: 09/18/94  
EXP: 05169                   C. I. DIRECT BLUE 15              TIME: 03:51:08  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED WATER                 NTP C#: 61290   
CONT: NO1ES9565503                                             CAS: 2429-74-5  
PATHOLOGIST: B. ULLAND                       S. EUSTIS                         

                               C. I. DIRECT BLUE 15


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 680 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 13     CENSORED DEATHS 20   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      333   357   445   495   501   558   565   589   637   642                 |
 |      659   659   663                                                           |
 |  CENSORED DEATHS                                                               |
 |      276   276   276   276   276   276   276   276   276   276                 |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.063                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 45     UNCENSORED DEATHS 27     CENSORED DEATHS 10   TERMINAL 8         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      293   316   421   435   512   513   544   566   578   578                 |
 |      579   583   591   592   614   619   620   624   626   632                 |
 |      646   646   646   646   646   660   668                                   |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.125                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 54     CENSORED DEATHS 10   TERMINAL 11        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      323   372   402   451   460   472   502   505   505   506                 |
 |      530   534   559   570   572   574   575   577   579   583                 |
 |      585   595   605   606   611   617   619   623   626   626                 |
 |      628   629   630   632   632   632   633   633   637   638                 |
 |      640   640   641   646   646   646   646   646   646   670                 |
 |      670   672   673   679                                                     |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 ==================================================================================

                               C. I. DIRECT BLUE 15


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 680 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.25                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 46     CENSORED DEATHS 22   TERMINAL 2         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      243   317   372   372   372   408   449   452   460   460                 |
 |      463   465   479   495   495   502   505   506   506   520                 |
 |      521   535   539   543   547   551   556   561   565   565                 |
 |      568   570   579   583   592   600   612   613   621   624                 |
 |      645   646   646   646   656   659                                         |
 |  CENSORED DEATHS                                                               |
 |      85    85    276   276   276   276   276   276   276   276                 |
 |      276   276   458   458   458   458   458   458   458   458                 |
 |      458   458                                                                 |
 |                                                                                |
 ==================================================================================

                               C. I. DIRECT BLUE 15


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 680 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   680 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0  96.7  96.7  95.0  91.0  84.9  74.8  74.8      |
 |           |                                                                    |
 |           |                                                                    |
 |0.063      |   100.0 100.0 100.0  95.6  93.3  91.1  82.3  61.7  26.5  23.5      |
 |           |                                                                    |
 |           |                                                                    |
 |0.125      |   100.0 100.0 100.0  98.7  96.0  91.6  82.3  65.2  24.8  17.1      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25       |   100.0 100.0  98.5  96.8  89.9  75.6  51.9  25.9   4.3   4.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.063        0.125        0.25     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       74.8%        23.5%        17.1%         4.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P<0.001      P<0.001      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       546.4        570.1        587.9        525.7    |
 |NATURAL DEATHS (C)      |       (31.5)       (19.0)       (10.7)       (13.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       565.8        564.8        584.1        472.2    |
 |(STANDARD ERROR)        |       (18.2)       (15.5)       (10.3)       (16.4)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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 15


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 682 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 10     CENSORED DEATHS 20   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      292   500   502   550   624   659   664   666   669   676                 |
 |  CENSORED DEATHS                                                               |
 |      276   276   276   276   276   276   276   276   276   276                 |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.063                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 45     UNCENSORED DEATHS 22     CENSORED DEATHS 10   TERMINAL 13        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      463   465   495   506   506   506   529   535   540   558                 |
 |      565   568   576   579   622   635   635   646   647   647                 |
 |      647   653                                                                 |
 |  CENSORED DEATHS                                                               |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.125                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 43     CENSORED DEATHS 10   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      253   368   372   372   408   432   432   449   460   479                 |
 |      495   524   527   529   555   559   583   589   592   598                 |
 |      616   620   625   625   626   630   630   633   633   638                 |
 |      640   640   645   646   646   654   659   659   659   666                 |
 |      673   680   680                                                           |
 |  CENSORED DEATHS                                                               |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                               C. I. DIRECT BLUE 15


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 682 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.25                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 46     CENSORED DEATHS 20   TERMINAL 4         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      296   316   339   359   372   402   408   408   453   463                 |
 |      466   474   484   486   495   495   502   502   513   513                 |
 |      527   534   547   564   578   581   585   585   585   592                 |
 |      592   600   600   607   613   619   620   623   624   624                 |
 |      635   645   646   646   646   646                                         |
 |  CENSORED DEATHS                                                               |
 |      276   276   276   276   276   276   276   276   276   276                 |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                               C. I. DIRECT BLUE 15


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 682 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   682 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0  98.3  98.3  98.3  94.3  92.3  86.3  80.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.063      |   100.0 100.0 100.0 100.0 100.0  94.3  74.3  60.0  37.1  37.1      |
 |           |                                                                    |
 |           |                                                                    |
 |0.125      |   100.0 100.0  98.7  98.7  93.3  86.2  79.9  70.5  40.7  34.5      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25       |   100.0 100.0 100.0  93.3  86.7  76.7  58.0  35.2   8.3   8.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.063        0.125        0.25     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       80.3%        37.1%        34.5%         8.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P<0.001      P<0.001      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       580.2        569.2        567.4        530.7    |
 |NATURAL DEATHS (C)      |       (38.9)       (13.6)       (16.1)       (14.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       577.6        577.3        586.6        492.7    |
 |(STANDARD ERROR)        |       (18.3)       (13.7)       (12.3)       (15.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


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

                                                        C. I. DIRECT BLUE 15
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.063            = 2
                                                        0.125            = 3
                                                        0.25             = 4

------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------

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

      |
  100 +  1                                         4       2     3 1
      |                                            4       2    23 1  1   3    3      1
      |                                                         2              3  2   133     1
      |                                                                   4     4 2  2  3  3  11
   90 +                                                                         4    2 4       1 32      11
      |                                                                                44                 1    1
      |                                                                                          32 33 2       1      1
      |                                                                                 44           3 2 32           11
   80 +                                                                                                  323 2         1   1
      |                                                                                  4  4
      |                                                                                     4 4            3 3             1   1
      |                                                                                       44             33
P  70 +                                                                                        4 4           22
E     |                                                                                                       22 3
R     |
C     |                                                                                          4 4           2 3 23
E  60 +                                                                                                            22
N     |                                                                                            4 4              33
T     |                                                                                              4 4
      |                                                                                                44           22
S  50 +                                                                                                              33
U     |                                                                                                 44           22
R     |                                                                                                  44           2  2
V     |
I  40 +                                                                                                   44          33
V     |
A     |                                                                                                    4 4         3 3
L     |                                                                                                      44
   30 +                                                                                                       44         2 2
      |                                                                                                        44          22
      |                                                                                                         4  4     3  3
      |                                                                                                            44       2  2
   20 +                                                                                                             44      33
      |                                                                                                              4   4   3 3
      |
      |
   10 +
      |                                                                                                                  444
      |                                                                                                                    4   4
      |
    0 +
      |
      ---+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+--
         0          10          20          30          40          50          60          70          80          90          100

                                                                   WEEK

NOTE: 20 obs hidden.

                                                        C. I. DIRECT BLUE 15
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.063            = 2
                                                        0.125            = 3
                                                        0.25             = 4

----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------

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

      |
  100 +  1                                           3     1 4                           2
      |                                              3     1 4  4   4    33                    1
      |                                                             4  4  3     3        2    21        1
      |                                                                4  4    43  3          2  2      1            1
   90 +                                                                        44  3   33                            1     1
      |                                                                         4      43   3                              11
      |                                                                                4 4  3 3    3
      |                                                                                          2 32                       11
   80 +                                                                                  4 4 4      22   3                   1 1
      |                                                                                              2 2 3    3
      |                                                                                      44        2 2    33
      |                                                                                                  22    33
P  70 +                                                                                       44                3  33
E     |                                                                                        4  4       22        33
R     |                                                                                                    2 2
C     |                                                                                           4 4
E  60 +                                                                                             44       2      233
N     |                                                                                              4  4           2 23
T     |                                                                                                 4 4  4
      |                                                                                                               23 2
S  50 +                                                                                                      44
U     |                                                                                                                  33
R     |                                                                                                                   33
V     |                                                                                                       44
I  40 +                                                                                                        44        22333
V     |                                                                                                                   2  3 2
A     |                                                                                                         44             3
L     |                                                                                                          4 4
   30 +                                                                                                            44
      |
      |                                                                                                             44
      |
   20 +                                                                                                              44
      |                                                                                                               4  4
      |
      |
   10 +
      |                                                                                                                  4     4
      |
      |
    0 +
      |
      ---+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+--
         0          10          20          30          40          50          60          70          80          90          100

                                                                   WEEK

NOTE: 17 obs hidden.

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