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TDMS Study 05166-01 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: HLA, VA                                                   DATE: 09/18/94   
EXP: 05166          3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE      TIME: 01:07:11   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED WATER                 NTP C#: 99990    
CONT: NO1ES9565503                                             CAS: 612-82-8    
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: 09/18/94  
EXP: 05166          3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE      TIME: 01:07:11  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED WATER                 NTP C#: 99990   
CONT: NO1ES9565503                                             CAS: 612-82-8   
PATHOLOGIST: G. PARKER                       S. EUSTIS                         

                       3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 419 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 0      CENSORED DEATHS 10   TERMINAL 60        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |     NONE                                                                       |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   275   275   275   275   275                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.003                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 45     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      250   359   391   405                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.007                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 24     CENSORED DEATHS 1    TERMINAL 50        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      215   229   285   285   285   295   307   341   343   355                 |
 |      372   378   379   379   384   384   391   393   404   405                 |
 |      405   406   406   406                                                     |
 |  CENSORED DEATHS                                                               |
 |      12                                                                        |
 |                                                                                |
 ==================================================================================

                       3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 419 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.015                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 60     CENSORED DEATHS 10   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      209   211   211   226   229   238   254   264   264   265                 |
 |      268   280   280   280   280   281   290   296   296   303                 |
 |      305   306   308   308   309   309   310   312   324   324                 |
 |      324   328   333   338   338   338   338   338   338   338                 |
 |      343   343   344   348   349   350   350   352   352   352                 |
 |      352   352   352   352   372   372   372   379   383   384                 |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   275   275   275   275   275                 |
 |                                                                                |
 ==================================================================================

                       3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 419 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   419 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.003      |   100.0 100.0  97.8  95.6  91.1  91.1  91.1  91.1  91.1  91.1      |
 |           |                                                                    |
 |           |                                                                    |
 |0.007      |   100.0 100.0  97.3  86.5  67.6  67.6  67.6  67.6  67.6  67.6      |
 |           |                                                                    |
 |           |                                                                    |
 |0.015      |   100.0 100.0  84.3  10.3   0.0   0.0   0.0   0.0   0.0   0.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.003        0.007        0.015    |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|      100.0%        91.1%        67.6%         0.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.059      P<0.001      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |          .         351.3        351.3        314.1    |
 |NATURAL DEATHS (C)      |       (  . )       (35.1)       (11.9)       ( 5.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       398.4        413.0        391.9        308.5    |
 |(STANDARD ERROR)        |       ( 6.1)       ( 4.0)       ( 7.3)       ( 5.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


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

                       3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 421 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 1      CENSORED DEATHS 10   TERMINAL 59        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      390                                                                       |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   275   275   275   275   275                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.003                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 45     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      357   384   391   391   391   393                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.007                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 75     UNCENSORED DEATHS 43     CENSORED DEATHS 0    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      142   184   229   268   309   310   315   315   315   320                 |
 |      327   338   338   338   338   338   355   363   364   365                 |
 |      369   369   370   378   379   383   384   388   390   390                 |
 |      391   391   391   405   405   405   406   406   406   406                 |
 |      406   409   419                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                       3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 421 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.015                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 50     CENSORED DEATHS 10   TERMINAL 10        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      142   229   247   251   254   264   264   265   280   285                 |
 |      285   295   296   296   315   315   335   335   336   338                 |
 |      338   338   341   341   343   343   343   355   355   364                 |
 |      370   370   377   378   383   383   384   384   390   391                 |
 |      391   391   391   391   405   405   405   406   406   406                 |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   275   275   275   275   275                 |
 |                                                                                |
 ==================================================================================

                       3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 421 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   421 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0  98.3  98.3  98.3  98.3  98.3  98.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.003      |   100.0 100.0 100.0  97.8  86.7  86.7  86.7  86.7  86.7  86.7      |
 |           |                                                                    |
 |           |                                                                    |
 |0.007      |   100.0  98.7  94.7  73.3  42.7  42.7  42.7  42.7  42.7  42.7      |
 |           |                                                                    |
 |           |                                                                    |
 |0.015      |   100.0  98.6  88.6  51.1  17.0  17.0  17.0  17.0  17.0  17.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL      0.003        0.007        0.015    |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       98.3%        86.7%        42.7%        17.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.049      P<0.001      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       390.0        384.5        353.9        337.9    |
 |NATURAL DEATHS (C)      |       (  . )       ( 5.6)       ( 9.1)       ( 8.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       399.7        416.1        382.5        340.8    |
 |(STANDARD ERROR)        |       ( 6.1)       ( 2.0)       ( 6.5)       ( 7.5)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.003            = 2
                                                        0.007            = 3
                                                        0.015            = 4

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

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

      |
  100 +  1                                                           4 3         2                                               1
      |                                                              4 3   3     2         3                     2
      |                                                                4   4                                     2       2
      |                                                                    4 4     4       3   3 3                       2   2
   90 +                                                                            4 4           3         3                 2   2
      |                                                                                                    3   3     3
      |                                                                              4 4 4                           3 3
      |
   80 +
      |                                                                                  4 4                           3 3 3
      |                                                                                    4 4 4                           3 3
      |
P  70 +                                                                                        4 4
E     |                                                                                                                      3   3
R     |
C     |                                                                                          4 4
E  60 +
N     |
T     |                                                                                            4   4
      |
S  50 +
U     |                                                                                                4 4 4
R     |
V     |
I  40 +
V     |
A     |
L     |
   30 +                                                                                                    4 4
      |
      |
      |                                                                                                      4 4
   20 +
      |
      |
      |
   10 +                                                                                                        4     4
      |
      |                                                                                                              4 4
      |
    0 +                                                                                                                4
      |
      ---+---------+---------+---------+---------+---------+---------+---------+---------+---------+---------+---------+---------+--
         0         5        10        15        20        25        30        35        40        45        50        55        60

                                                                   WEEK

NOTE: 12 obs hidden.

                                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.003            = 2
                                                        0.007            = 3
                                                        0.015            = 4

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

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

             |
             |
         100 +  1                                  3                                                 2       1
             |                                     3         3         3    4                        2      21        1
             |                                                         3    4 4  3         3                22
             |                                                                44
          90 +                                                                                               2 2
             |                                                                 4   44      3 33                2      2
             |                                                                                3   3
             |                                                                      4   4
          80 +
             |                                                                          4  4      3  3 3
       P     |                                                                             4    4      33
       E     |
       R  70 +                                                                                  4 4     3 3
       C     |                                                                                            3 3
       E     |                                                                                              33
       N     |
       T  60 +
             |
       S     |                                                                                    4  4       3   3
       U     |                                                                                       4 4
       R  50 +                                                                                         44
       V     |                                                                                          4 4
       I     |                                                                                            4 4    33 3
       V     |                                                                                                      3 3
       A  40 +
       L     |                                                                                              44
             |
             |
          30 +
             |                                                                                               4   4
             |
             |
          20 +
             |                                                                                                   4    4
             |
             |
          10 +
             |
             ---+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+--
                0    3    6    9   12   15   18   21   24   27   30   33   36   39   42   45   48   51   54   57   60   63

                                                                   WEEK

NOTE: 13 obs hidden.

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