National Toxicology Program

National Toxicology Program
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TDMS Study 05019-03 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Southern Research Inst                                    DATE: 09/03/94   
EXP: 05019                     CI PIGMENT RED 3                TIME: 14:50:25   
TEST: 03              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60366    
CONT: NOIES9565102                                             CAS: 2425-85-6   
PATHOLOGIST: H. GILES                        S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


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TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Southern Research Inst                                    DATE: 09/03/94  
EXP: 05019                     CI PIGMENT RED 3                TIME: 14:50:25  
TEST: 03              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 60366   
CONT: NOIES9565102                                             CAS: 2425-85-6  
PATHOLOGIST: H. GILES                        S. EUSTIS                         

                                 CI PIGMENT RED 3


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 10   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      534   553   587   610   611   637   644   653   658   658                 |
 |      660   663   666   666   666   681   690   700   700   706                 |
 |      716   721                                                                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.6%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 9    TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      398   420   581   605   610   616   624   651   660   694                 |
 |      696                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   457   457   457   457                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 23     CENSORED DEATHS 9    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      452   529   540   575   576   576   578   598   610   641                 |
 |      682   682   687   690   695   707   708   708   710   710                 |
 |      714   718   722                                                           |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   457   457   457   457                       |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 3


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 31     CENSORED DEATHS 9    TERMINAL 20        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      451   486   567   577   581   605   612   612   624   626                 |
 |      643   655   658   658   666   678   679   680   681   682                 |
 |      690   690   694   708   710   710   716   718   718   723                 |
 |      723                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   457   457   457   457   457                       |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 3


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  94.0  76.0  56.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.6%       |   100.0 100.0 100.0 100.0  96.7  96.7  96.7  92.7  82.9  78.9      |
 |           |                                                                    |
 |           |                                                                    |
 |1.25%      |   100.0 100.0 100.0 100.0 100.0  98.3  94.4  84.6  80.6  55.1      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5%       |   100.0 100.0 100.0 100.0 100.0  98.3  96.4  88.5  72.8  39.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATD     0.6%         1.25%        2.5%     |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       56.0%        78.9%        55.1%        39.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.013      P=0.047N     P=1.000      P=0.167  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       653.6        595.9        643.8        652.3    |
 |NATURAL DEATHS (C)      |       (10.5)       (29.9)       (16.0)       (12.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       656.0        663.7        655.5        648.5    |
 |(STANDARD ERROR)        |       (13.0)       (14.1)       (13.4)       (13.0)   |
 |                        |                                                       |
 ==================================================================================
                                    


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

                                 CI PIGMENT RED 3


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATD CONTROL                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 18     CENSORED DEATHS 10   TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      158   409   532   604   622   626   666   686   687   687                 |
 |      687   690   690   694   710   716   723   723                             |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.6%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 10   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      390   457   508   518   587   612   639   665   694                       |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   458   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 10   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      429   491   567   597   611   653   658   680   682   694                 |
 |      708                                                                       |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 3


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 10   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      427   477   519   553   574   611   682   687   711   723                 |
 |  CENSORED DEATHS                                                               |
 |      458   458   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                                 CI PIGMENT RED 3


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATD   |   100.0  98.3  98.3  98.3  96.7  96.7  94.7  92.6  88.6  64.4      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.6%       |   100.0 100.0 100.0 100.0  98.3  96.7  92.6  90.6  84.6  82.6      |
 |           |                                                                    |
 |           |                                                                    |
 |1.25%      |   100.0 100.0 100.0 100.0 100.0  98.3  96.3  92.3  86.3  78.3      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5%       |   100.0 100.0 100.0 100.0 100.0  96.3  94.3  90.3  88.3  80.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATD     0.6%         1.25%        2.5%     |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       64.4%        82.6%        78.3%        80.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.217N     P=0.105N     P=0.234N     P=0.145N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       628.3        563.3        615.5        596.4    |
 |NATURAL DEATHS (C)      |       (33.3)       (33.9)       (26.9)       (32.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       653.7        659.0        663.1        661.9    |
 |(STANDARD ERROR)        |       (16.1)       (14.7)       (14.0)       (14.4)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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 3
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.6%             = 2
                                                        1.25%            = 3
                                                        2.5%             = 4

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

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

      |
      |
  100 + 1                                                              2        3            1
      |                                                                2  2     3    4      3131 4 2
      |                                                                                       31 4 21   21
      |                                                                                                 22
P  90 +                                                                                            4    41 21
E     |                                                                                            3   344 2112
R     |                                                                                                3 3 4 121 2
C     |                                                                                                  3   3   2    2
E  80 +                                                                                                    4 3 1 1  3 2     2
N     |                                                                                                      4 4    33
T     |                                                                                                          11
      |                                                                                                        4  4  33
S  70 +                                                                                                           141 333
U     |                                                                                                            411
R     |                                                                                                              11
V     |                                                                                                               11
I  60 +                                                                                                             44 131
V     |                                                                                                              44  33
A     |                                                                                                               4 413 1
L     |
   50 +                                                                                                                 44
      |
      |
      |                                                                                                                  44
   40 +                                                                                                                   4 4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 19 obs hidden.

                                                          CI PIGMENT RED 3
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATD CONTROL = 1
                                                        0.6%             = 2
                                                        1.25%            = 3
                                                        2.5%             = 4

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

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

      |
      |
  100 + 1                        1                                    2    43
      |                          1                                    2  1 43    2  4 3
      |
      |                                                                  1       2  4 3 2  41    3
   95 +                                                                                 22  1           1
      |                                                                                    4   4 3     3
      |                                                                                  2     4  4 2  3131
      |                                                                                             2    211
P  90 +                                                                                           4      3     3
E     |                                                                                                  2 1 2    1 4
R     |
C     |                                                                                                      2 3 21 14
E  85 +                                                                                                          2  112
N     |                                                                                                              4  4
T     |                                                                                                             3 2 4 4 2
      |
S  80 +                                                                                                               3 3 4 4
U     |                                                                                                                 3   3
R     |
V     |
I  75 +                                                                                                              11
V     |
A     |                                                                                                               1 1
L     |
   70 +                                                                                                                 11
      |                                                                                                                  11
      |
      |
   65 +                                                                                                                   1 1
      |
      |
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.

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