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TDMS Study 05130-03 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: 01:47:33   
TEST: 03              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60877B   
CONT: N01-ES-5096                                              CAS: 10401-500   
PATHOLOGIST: L. BRENNECKE                    Hailey, Rick                       
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


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: 01:47:33  
TEST: 03              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60877B  
CONT: N01-ES-5096                                              CAS: 10401-500  
PATHOLOGIST: L. BRENNECKE                    Hailey, Rick                      

                               C. I. DIRECT BLUE 218


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 20     CENSORED DEATHS 10   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      273   438   506   539   548   570   572   572   581   607                 |
 |      614   618   629   630   673   673   679   682   693   715                 |
 |  CENSORED DEATHS                                                               |
 |      460   460   460   460   460   460   460   460   460   460                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 10   TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      369   601   614   617   618   621   631   637   637   641                 |
 |      646   651   651   660   670   671   671   673   685   713                 |
 |      713   714   715   721   726                                               |
 |  CENSORED DEATHS                                                               |
 |      460   460   460   460   460   460   460   460   460   460                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 3000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 10   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      356   533   537   581   621   632   649   670   671   674                 |
 |      677   677   680   686   692   692   694   700   709   714                 |
 |      725                                                                       |
 |  CENSORED DEATHS                                                               |
 |      460   460   460   460   460   460   460   460   460   460                 |
 |                                                                                |
 ==================================================================================

                               C. I. DIRECT BLUE 218


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 10000PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 27     CENSORED DEATHS 9    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      305   447   450   460   506   506   531   532   566   580                 |
 |      583   601   610   614   646   646   668   680   680   684                 |
 |      692   699   702   702   706   722   722                                   |
 |  CENSORED DEATHS                                                               |
 |      460   460   460   460   460   460   460   460   460                       |
 |                                                                                |
 ==================================================================================

                               C. I. DIRECT BLUE 218


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       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 PPM      |   100.0 100.0 100.0  98.3  98.3  96.7  92.6  82.6  72.5  60.4      |
 |           |                                                                    |
 |           |                                                                    |
 |1000 PPM   |   100.0 100.0 100.0 100.0  98.3  98.3  98.3  96.3  72.2  50.2      |
 |           |                                                                    |
 |           |                                                                    |
 |3000 PPM   |   100.0 100.0 100.0  98.3  98.3  98.3  94.3  92.3  86.3  58.2      |
 |           |                                                                    |
 |           |                                                                    |
 |10000PPM   |   100.0 100.0 100.0  98.3  98.3  93.3  85.4  77.4  69.5  47.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        1000 PPM     3000 PPM     10000PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       60.4%        50.2%        58.2%        47.7%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.285      P=0.670      P=1.000N     P=0.314  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       590.6        650.6        646.2        601.5    |
 |NATURAL DEATHS (C)      |       (22.8)       (13.9)       (18.6)       (20.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       638.0        651.5        655.2        631.3    |
 |(STANDARD ERROR)        |       (15.1)       (13.4)       (13.9)       (15.1)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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 RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 16     CENSORED DEATHS 9    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      270   428   449   460   499   532   532   642   659   666                 |
 |      666   671   671   673   684   714                                         |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   461   461   461                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 9    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      340   419   452   477   494   504   523   572   621   624                 |
 |      649   652   659   659   670   681   684   684   699   713                 |
 |      721   726                                                                 |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   461   461   461                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 3000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 10   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      317   428   506   532   533   540   583   587   610   617                 |
 |      629   639   652   660   669   674   688   706   726                       |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   461   461   461   461                 |
 |                                                                                |
 ==================================================================================

                               C. I. DIRECT BLUE 218


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 10000PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 10   TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      85    176   226   296   484   502   502   554   555   560                 |
 |      572   595   618   637   639   649   658   658   658   660                 |
 |      663   665   674   702   719                                               |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   461   461   461   461                 |
 |                                                                                |
 ==================================================================================

                               C. I. DIRECT BLUE 218


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       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 PPM      |   100.0 100.0  98.3  98.3  98.3  93.3  87.4  87.4  83.4  69.5      |
 |           |                                                                    |
 |           |                                                                    |
 |1000 PPM   |   100.0 100.0 100.0  98.3  96.7  93.0  87.1  85.1  73.2  57.4      |
 |           |                                                                    |
 |           |                                                                    |
 |3000 PPM   |   100.0 100.0 100.0  98.3  98.3  96.7  88.6  84.6  72.5  62.4      |
 |           |                                                                    |
 |           |                                                                    |
 |10000PPM   |    98.3  96.7  95.0  93.3  93.3  91.3  87.2  77.1  56.8  50.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        1000 PPM     3000 PPM     10000PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       69.5%        57.4%        62.4%        50.7%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.086      P=0.326      P=0.615      P=0.069  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       576.0        601.0        594.5        548.3    |
 |NATURAL DEATHS (C)      |       (31.7)       (23.6)       (23.3)       (34.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       648.0        641.9        641.8        609.0    |
 |(STANDARD ERROR)        |       (15.7)       (15.1)       (14.9)       (19.7)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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
                                                        0 PPM            = 1
                                                        1000 PPM         = 2
                                                        3000 PPM         = 3
                                                        10000PPM         = 4

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

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

      |
      |
  100 + 1                                          1    4       3 2
      |                                            1    4       3 2          14 4       1    3         2 2
      |                                                                         44      1    1     3     22
      |                                                                          4      4    1 1   3      3
P  90 +                                                                                 4   4  1  1       3 3
E     |                                                                                                   2 2 3   3
R     |                                                                                     4    411
C     |                                                                                          4 14   1   22    33
E  80 +                                                                                             4  411   22
N     |                                                                                                4 111       33
T     |                                                                                                       2  2
      |                                                                                                  4 1  4  22133
S  70 +                                                                                                       4   4
U     |                                                                                                           41133
R     |                                                                                                           22113 3
V     |                                                                                                             21  21
I  60 +                                                                                                              44 313 1
V     |                                                                                                               44  3 3
A     |                                                                                                                 22
L     |                                                                                                                4 22
   50 +                                                                                                                   2 2
      |                                                                                                                   4 4
      |
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 19 obs hidden.

                                                       C. I. DIRECT BLUE 218
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        1000 PPM         = 2
                                                        3000 PPM         = 3
                                                        10000PPM         = 4

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

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

      |
  100 + 1             4                            1       3  2
      |               4              4             1       3  2           2 1
      |
      |                              4      4                             2 1   1       3
   95 +                                     4          4                        11  2   3   3
      |                                                4                         1   4 1
      |                                                                             2 2     33
      |                                                                              421    133
   90 +
      |                                                                                2   2  3     3
      |                                                                                4   21   4 2          1
      |
P  85 +                                                                                           2 3    32  1   1
E     |                                                                                                   22     11
R     |                                                                                                  33
C     |                                                                                         4 4        2  2
E  80 +                                                                                                   33
N     |                                                                                           4   4    3 322
T     |                                                                                               4   4    2 2
      |                                                                                                      3 3
S  75 +                                                                                                   4 4  3 311
U     |                                                                                                          2211
R     |                                                                                                     44   33
V     |                                                                                                      44   2 1   1
I  70 +                                                                                                           33    1   1
V     |                                                                                                       44   3 3
A     |
L     |                                                                                                              3 3
   65 +                                                                                                             2 23  3
      |                                                                                                               2 2
      |                                                                                                        4 4        3 3
      |                                                                                                                 22
   60 +                                                                                                                  22
      |
      |                                                                                                                   2 2
      |                                                                                                          4 4
   55 +                                                                                                            4   4
      |
      |                                                                                                                4 4
      |                                                                                                                  4  4
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 10 obs hidden.