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TDMS Study 05021-04 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/03/94   
EXP: 05021                    CI PIGMENT RED 23                TIME: 23:16:43   
TEST: 04              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60377    
CONT: N01ES9565102                                             CAS: 6471-49-4   
PATHOLOGIST: S. EUSTIS                       J. SEALY                           
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/03/94  
EXP: 05021                    CI PIGMENT RED 23                TIME: 23:16:43  
TEST: 04              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60377   
CONT: N01ES9565102                                             CAS: 6471-49-4  
PATHOLOGIST: S. EUSTIS                       J. SEALY                          

                                 CI PIGMENT RED 23


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 723 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 9    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      27    140   364   418   455   463   511   518   536   604                 |
 |      610   618   644   644   644   644   647   647   687   694                 |
 |      711   722                                                                 |
 |  CENSORED DEATHS                                                               |
 |      361   463   463   463   464   464   464   464   464                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 36     CENSORED DEATHS 7    TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      35    73    79    85    87    115   122   125   168   189                 |
 |      258   327   380   388   421   422   436   472   515   524                 |
 |      581   598   603   617   644   647   648   673   687   719                 |
 |      721   721   721   722   722   722                                         |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   464   464   464   464                                   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 8    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      87    87    87    207   339   393   452   505   520   529                 |
 |      583   585   590   603   617   618   622   647   647   648                 |
 |      648   687   719   721   721                                               |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   463   463   463   464   464                             |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 23


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 723 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 9    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      151   408   469   542   559   571   596   603   606   638                 |
 |      647   648   648   648   672   672   672   672   672   673                 |
 |      700                                                                       |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   464   464   464   464   464   464                       |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 23


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 723 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   723 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |    98.3  96.7  96.7  95.0  93.3  89.9  83.9  81.9  65.9  57.9      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |1.0%       |    91.7  85.0  81.7  80.0  73.3  69.7  65.7  59.7  51.8  33.8      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5%       |    95.0  95.0  93.3  91.7  90.0  88.3  82.4  74.6  60.9  53.0      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |   100.0  98.3  98.3  98.3  96.7  94.7  92.7  84.8  73.0  59.2      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATD     1.0%         2.5%         5.0%     |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       57.9%        33.8%        53.0%        59.2%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.177N     P=0.010      P=0.678      P=0.819N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       543.1        443.5        514.5        593.7    |
 |NATURAL DEATHS (C)      |       (38.1)       (40.7)       (40.3)       (27.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       616.4        525.1        601.5        638.8    |
 |(STANDARD ERROR)        |       (19.7)       (29.2)       (22.0)       (15.4)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                 CI PIGMENT RED 23


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 723 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 10   TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      501   559   585   603   610   616   618   634   655   655                 |
 |      661   673   687   694   710                                               |
 |  CENSORED DEATHS                                                               |
 |      465   465   465   465   465   466   466   466   466   466                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 11   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      77    80    420   445   487   516   571   613   619   647                 |
 |      665   683   703   710   722                                               |
 |  CENSORED DEATHS                                                               |
 |      465   465   465   465   465   465   465   466   466   466                 |
 |      469                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 14     CENSORED DEATHS 10   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      452   472   516   521   585   606   631   645   661   667                 |
 |      707   710   721   721                                                     |
 |  CENSORED DEATHS                                                               |
 |      465   465   465   465   465   466   466   466   466   470                 |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 23


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 723 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 14     CENSORED DEATHS 11   TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      297   515   553   583   585   588   599   618   627   633                 |
 |      645   652   658   667                                                     |
 |  CENSORED DEATHS                                                               |
 |      13    465   465   465   466   466   466   466   466   466                 |
 |      466                                                                       |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 23


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 723 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   723 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  92.0  78.0  70.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |1.0%       |    96.7  96.7  96.7  96.7  95.0  93.3  89.2  87.1  78.8  70.5      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5%       |   100.0 100.0 100.0 100.0 100.0  96.3  92.3  90.3  82.3  72.2      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |   100.0 100.0 100.0  98.3  98.3  98.3  96.3  86.0  73.7  71.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATD     1.0%         2.5%         5.0%     |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       70.0%        70.5%        72.2%        71.7%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.966N     P=1.000      P=0.972N     P=1.000  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       630.7        530.5        615.4        587.1    |
 |NATURAL DEATHS (C)      |       (14.3)       (53.5)       (24.9)       (25.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       657.0        627.7        655.0        636.6    |
 |(STANDARD ERROR)        |       (12.7)       (19.5)       (13.6)       (17.6)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                         CI PIGMENT RED 23
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        1.0%             = 2
                                                        2.5%             = 3
                                                        5.0%             = 4

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

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

      |
      |
  100 + 1   1 2       3         4
      |     1 2     22        1 4                                1       4        4
      |              22                  3                       1        1       4           4
      |               2    2             3                    3        3  1     1 1           4 4
   90 +                    22                                          3        3 1     1       4 4    4
      |                     2     2                                             3       11 3           44
P     |                           2   2                                                  1 331          1
E     |                               2          2          2                               3       3   11   4
R  80 +                                                     2        2                                   11  44
C     |                                                              22    2                        3 3 3 1  1
E     |                                                                                                 3 3
N     |                                                                    2 2     2                          4   4
T  70 +                                                                            2     2                   11
      |                                                                                  2 2              3   3
S     |                                                                                    2       2          1      11
U     |                                                                                            2   22         44  1 1
R  60 +                                                                                                 2 2   3    4 34 131
V     |                                                                                                   2  2            1
I     |                                                                                                      22
V     |                                                                                                       2    2     33
A  50 +                                                                                                            2 2
L     |                                                                                                              2   2
      |
      |
   40 +                                                                                                                  22
      |
      |                                                                                                                   2
      |
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 23 obs hidden.

                                                         CI PIGMENT RED 23
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        1.0%             = 2
                                                        2.5%             = 3
                                                        5.0%             = 4

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

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

      |
      |
  100 + 1           2                                  4                        3      1
      |             22                                 4                        3  3     4
      |                                                                                1        1
      |              2                                                    2        3     3     41   1
P  95 +                                                                   2   2
E     |                                                                       2      2   3 3   4    1   1
R     |                                                                                    3        3   11
C     |                                                                              2   2
E  90 +                                                                                             3   3
N     |                                                                                  2        2     3   3
T     |                                                                                           2 4  4 11
      |                                                                                                4  1 1 3
S  85 +                                                                                                  22
U     |                                                                                                   441 31 3
R     |                                                                                                   244 2  33
V     |                                                                                                       2  2
I  80 +                                                                                                     4 41 13    3
V     |                                                                                                          2  2  33
A     |                                                                                                       44 1 1
L     |                                                                                                            121 233
   75 +                                                                                                                22
      |                                                                                                        4  4  11
      |                                                                                                               1 132
      |                                                                                                           4       4
   70 +                                                                                                                 1 1
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 11 obs hidden.