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TDMS Study 05163-01 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: HLA, VA                                                   DATE: 09/17/94   
EXP: 05163                    C. I. ACID RED 114               TIME: 22:06:13   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED WATER                 NTP C#: 61096    
CONT: NO1ES9565503                                             CAS: 6459-94-5   
PATHOLOGIST: G. PARKER                       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: 09/17/94  
EXP: 05163                    C. I. ACID RED 114               TIME: 22:06:13  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED WATER                 NTP C#: 61096   
CONT: NO1ES9565503                                             CAS: 6459-94-5  
PATHOLOGIST: G. PARKER                       S. EUSTIS                         

                                C. I. ACID RED 114


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 732 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 26     CENSORED DEATHS 20   TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      131   355   454   458   475   529   564   569   590   607                 |
 |      607   636   641   650   651   671   680   682   687   696                 |
 |      701   706   711   715   715   729                                         |
 |  CENSORED DEATHS                                                               |
 |      277   277   277   277   277   277   277   277   277   277                 |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.007                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 45     UNCENSORED DEATHS 20     CENSORED DEATHS 10   TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      352   447   465   524   530   530   545   631   641   649                 |
 |      651   652   658   666   694   694   694   701   705   724                 |
 |  CENSORED DEATHS                                                               |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.015                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 39     CENSORED DEATHS 10   TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      325   403   455   499   530   565   567   593   594   599                 |
 |      614   638   641   641   641   641   641   654   654   657                 |
 |      663   666   669   672   673   677   681   687   691   691                 |
 |      693   693   694   694   694   705   711   714   715                       |
 |  CENSORED DEATHS                                                               |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                                C. I. ACID RED 114


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 732 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.03                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 49     CENSORED DEATHS 20   TERMINAL 1         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      298   377   383   412   456   470   473   501   511   512                 |
 |      524   524   530   530   530   531   531   531   538   545                 |
 |      556   581   582   614   617   622   625   634   638   638                 |
 |      649   651   658   661   663   663   663   663   677   693                 |
 |      693   694   694   694   704   711   711   723   724                       |
 |  CENSORED DEATHS                                                               |
 |      277   277   277   277   277   277   277   277   277   277                 |
 |      459   459   459   459   459   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                                C. I. ACID RED 114


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 732 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   732 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0  98.6  98.6  96.9  96.9  91.5  89.5  83.4  71.2  48.8      |
 |           |                                                                    |
 |           |                                                                    |
 |0.007      |   100.0 100.0 100.0  97.8  97.8  92.7  81.1  81.1  63.7  43.4      |
 |           |                                                                    |
 |           |                                                                    |
 |0.015      |   100.0 100.0 100.0  98.7  97.3  96.0  92.9  85.2  68.1  40.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.03       |   100.0 100.0 100.0  98.3  93.3  87.6  61.1  55.0  24.4   2.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.007        0.015        0.03     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       48.8%        43.4%        40.3%         2.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.730      P=0.507      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       600.4        607.7        631.7        587.8    |
 |NATURAL DEATHS (C)      |       (26.7)       (23.0)       (13.9)       (14.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       579.1        616.1        643.4        527.1    |
 |(STANDARD ERROR)        |       (20.8)       (18.1)       (12.3)       (17.0)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                C. I. ACID RED 114


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 14     CENSORED DEATHS 20   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      431   505   524   533   547   562   587   589   641   663                 |
 |      683   711   715   715                                                     |
 |  CENSORED DEATHS                                                               |
 |      277   277   277   277   277   277   277   277   277   277                 |
 |      460   460   460   460   460   460   460   460   460   460                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.015                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 45     UNCENSORED DEATHS 22     CENSORED DEATHS 10   TERMINAL 13        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      411   411   462   500   523   538   567   582   607   614                 |
 |      638   638   641   658   658   662   663   665   677   708                 |
 |      715   726                                                                 |
 |  CENSORED DEATHS                                                               |
 |      460   460   460   460   460   460   460   460   460   460                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.03                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 58     CENSORED DEATHS 11   TERMINAL 6         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      87    285   344   400   403   448   454   477   487   491                 |
 |      494   496   515   517   521   523   530   531   532   538                 |
 |      545   545   554   567   575   579   581   582   587   588                 |
 |      592   592   592   592   599   609   614   617   631   637                 |
 |      638   641   641   648   649   656   658   676   677   680                 |
 |      693   693   694   709   715   715   715   715                             |
 |  CENSORED DEATHS                                                               |
 |      53    460   460   460   460   460   460   460   460   460                 |
 |      460                                                                       |
 |                                                                                |
 ==================================================================================

                                C. I. ACID RED 114


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.06                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 50     CENSORED DEATHS 20   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      186   229   258   276   339   344   349   351   355   355                 |
 |      372   379   383   384   384   392   400   403   403   411                 |
 |      411   411   411   412   413   413   413   421   433   433                 |
 |      433   454   456   458   473   475   477   486   488   501                 |
 |      501   501   545   551   551   578   582   599   603   614                 |
 |  CENSORED DEATHS                                                               |
 |      277   277   277   277   277   277   277   277   277   277                 |
 |      460   460   460   460   460   460   460   460   460   460                 |
 |                                                                                |
 ==================================================================================

                                C. I. ACID RED 114


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  98.3  92.3  84.3  80.3  72.2      |
 |           |                                                                    |
 |           |                                                                    |
 |0.015      |   100.0 100.0 100.0 100.0  95.6  92.7  84.0  78.2  49.2  37.6      |
 |           |                                                                    |
 |           |                                                                    |
 |0.03       |    98.6  98.6  98.6  95.9  93.2  89.0  66.7  46.1  27.0   9.5      |
 |           |                                                                    |
 |           |                                                                    |
 |0.06       |   100.0 100.0  95.7  84.2  53.9  35.6  19.2   2.7   0.0   0.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.015        0.03         0.06     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       72.2%        37.6%         9.5%         0.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.002      P<0.001      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       600.4        602.9        570.1        429.0    |
 |NATURAL DEATHS (C)      |       (23.9)       (19.8)       (15.0)       (13.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       602.3        608.7        561.5        411.7    |
 |(STANDARD ERROR)        |       (20.2)       (17.5)       (15.2)       (11.5)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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. ACID RED 114
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.007            = 2
                                                        0.015            = 3
                                                        0.03             = 4

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

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

      |
  100 + 1                    1                         4    3   2
      |                      1                         4    3   1  4 4  3     2 1
      |                                                              4   4    2 112    3    3
      |                                                                  4       121       21    3
   90 +                                                                                    21    1    3
      |                                                                            4   4         11   33
      |                                                                                44   2 2   1   13 3
      |                                                                                 44 4          1 13   3
   80 +                                                                                       2         1   1
      |                                                                                    44               11
      |                                                                                                      113
      |
P  70 +                                                                                                       12 31 1
E     |                                                                                                          33
R     |                                                                                     44                      11
C     |                                                                                      44                2  23 11
E  60 +                                                                                       4 4  4              233311
N     |                                                                                            44                  11
T     |                                                                                             4    4              11
      |                                                                                                  44           22
S  50 +                                                                                                   44         33  1  1
U     |                                                                                                    44         32  2
R     |                                                                                                     44         33
V     |                                                                                                                 332 2
I  40 +                                                                                                      44          3  3
V     |                                                                                                       44
A     |                                                                                                        4 4
L     |
   30 +
      |
      |                                                                                                          4 4
      |                                                                                                            4 4
   20 +
      |                                                                                                              44
      |
      |                                                                                                               44
   10 +                                                                                                                44
      |
      |                                                                                                                 4 4
      |                                                                                                                   4 4
    0 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 33 obs hidden.

                                                         C. I. ACID RED 114
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.015            = 2
                                                        0.03             = 3
                                                        0.06             = 4

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

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

      |
  100 + 1             3               4                                  2  1
      |               3               4     4    4   3         3            1           1  1
      |                                          4  4         43        32       2         1 1
      |                                                       44        3     3 32     2     1 1
   90 +                                                        44               3   33 2   2   1 1
      |                                                                              33    2 2   1  1 1
      |                                                         4  4                         2   2    1      1
      |                                                            4 4                3  3                   1   1
   80 +                                                                                  3 3     2  2            1  1
      |                                                                                             2   2           1   11
      |                                                              44 4                  33           22
      |                                                                                     33           2   2           1  1
P  70 +                                                                 44                   33
E     |                                                                                       3 3
R     |                                                                                         33
C     |                                                                                          3 3         2 2
E  60 +                                                                                            33
N     |                                                                                                        2 2
T     |                                                                  4 44                       3 3
      |
S  50 +                                                                     4   4                                2 2
U     |                                                                         44                    33           2    2
R     |                                                                          4 4                   333
V     |                                                                                                  33 3           22
I  40 +                                                                                                                  22
V     |                                                                            44                       33            2 2
A     |                                                                             44
L     |                                                                                                      33
   30 +                                                                              4 4                      33
      |                                                                                                        3   3
      |                                                                                                            33
      |                                                                                4      4                     33
   20 +                                                                                       44                     33
      |                                                                                                               3 3
      |                                                                                                                 33
      |                                                                                        4   4
   10 +                                                                                            44                    3  3
      |                                                                                             4  4
      |                                                                                                44
      |                                                                                                 44
    0 +                                                                                                  4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 15 obs hidden.