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TR 392 Rat Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 05/07/97       
EXPERIMENT: 05089 TEST: 01                                                                                     TIME: 16:06:18       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-45037                              ROUTE: DOSED WATER                                             NTP C#: C91004       
PATHOLOGIST: D. FARNELL                                                                                        CAS: 10599903        
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               REASONS FOR REMOVAL:    25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       EXCLUDE 017    0.0275%                                                                       
                                       EXCLUDE 018    0.0275% 3 SSAC                                                                
                                       EXCLUDE 019    0.0275%                                                                       
                                       EXCLUDE 020    0.0275% 3 SSAC                                                                
                                       EXCLUDE 021    0.0140%                                                                       
                                       EXCLUDE 022    0.0140% 3 SSAC                                                                
                                       EXCLUDE 023    0.0140%                                                                       
                                       EXCLUDE 024    0.0140% 3 SSAC                                                                
                                       EXCLUDE 025    0.00700%                                                                      
                                       EXCLUDE 026    0.00700% 3 SSAC                                                               
                                       EXCLUDE 027    0.00700%                                                                      
                                       EXCLUDE 028    0.00700% 3 SSAC                                                               
                                       EXCLUDE 029    SENTINEL                                                                      
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Southern Research Inst                                    CHLORAMINE                                      DATE: 05/07/97      
EXPERIMENT: 05089 TEST: 01                                                                                     TIME: 16:06:18      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-45037                              ROUTE: DOSED WATER                                             NTP C#: C91004      
PATHOLOGIST: D. FARNELL                                                                                        CAS: 10599903       
                                    CHLORAMINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 51     UNCENSORED DEATHS 37     CENSORED DEATHS 0    TERMINAL 14        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      315   361   446   451   465   513   516   537   539   541                 |
 |      569   570   578   591   598   598   605   606   618   618                 |
 |      626   638   652   659   667   674   674   675   687   694                 |
 |      695   697   710   710   715   726   726                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.00500%                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      473   579   581   601   605   613   614   618   625   627                 |
 |      645   653   654   654   661   662   667   668   668   675                 |
 |      676   676   695   701   701   701   715   718                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0100%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 51     UNCENSORED DEATHS 37     CENSORED DEATHS 0    TERMINAL 14        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      429   447   519   530   533   549   562   566   583   586                 |
 |      590   590   591   591   596   605   614   618   625   631                 |
 |      639   656   666   668   669   674   675   675   690   696                 |
 |      698   701   702   703   710   719   719                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    CHLORAMINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.0200%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 34     CENSORED DEATHS 0    TERMINAL 16        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      495   524   530   543   577   587   591   591   591   619                 |
 |      620   622   632   636   654   656   656   661   661   661                 |
 |      664   666   667   668   675   680   697   698   701   712                 |
 |      712   718   718   719                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    CHLORAMINE

                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0  96.1  96.1  90.2  80.4  66.7  52.9  27.5      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.00500%   |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  90.0  68.0  44.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0100%    |   100.0 100.0 100.0 100.0 100.0  96.1  90.2  68.6  56.9  27.5      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0200%    |   100.0 100.0 100.0 100.0 100.0 100.0  92.0  82.0  58.0  32.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      0.00500%     0.0100%      0.0200%  |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       27.5%        44.0%        27.5%        32.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.870N     P=0.049N     P=0.984N     P=0.433N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       601.6        647.4        622.0        641.2    |
 |NATURAL DEATHS (C)      |       (16.5)       ( 9.8)       (12.0)       (10.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       636.6        683.3        651.4        669.3    |
 |(STANDARD ERROR)        |       (14.4)       ( 7.9)       (11.0)       ( 9.1)   |
 |                        |                                                       |
 ==================================================================================
                                    

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

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      472   508   531   569   578   620   639   650   666   666                 |
 |      667   668   668   673   675   702   703   712   721                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.00500%                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      299   348   452   540   570   576   622   626   626   641                 |
 |      652   656   662   695   698   702   703   714   719   719                 |
 |      719   726                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.0100%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      200   456   465   509   560   584   590   605   619   620                 |
 |      628   667   668   676   697   698   698   704   719   719                 |
 |      726                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    CHLORAMINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.0200%                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 0    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      465   508   508   519   589   589   591   592   618   620                 |
 |      621   662   669   687   687   687   687   690   690   694                 |
 |      703   704   712   719   722   725                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                    CHLORAMINE

                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0  98.0  94.0  90.0  84.0  62.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.00500%   |   100.0 100.0 100.0  96.0  96.0  94.0  92.0  88.0  74.0  56.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0100%    |   100.0 100.0  98.0  98.0  98.0  94.0  92.0  84.0  78.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.0200%    |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  84.0  76.0  48.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      0.00500%     0.0100%      0.0200%  |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       62.0%        56.0%        58.0%        48.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.232      P=0.683      P=0.792      P=0.272  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       636.2        621.1        609.9        640.7    |
 |NATURAL DEATHS (C)      |       (16.4)       (25.3)       (27.0)       (14.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       693.7        681.5        679.0        683.1    |
 |(STANDARD ERROR)        |       ( 8.9)       (13.4)       (14.0)       ( 9.9)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                             CHLORAMINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        0.00500%         = 2
                                                        0.0100%          = 3
                                                        0.0200%          = 4

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

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

      |
      |
  100 + 1                                                 1                 3      2  4
      |                                                   1      1          3 3    2  4    4       2
      |                                                          1            1 1          33 4    2   2
      |                                                                         1 1         334    4   22
   90 +                                                                           1      1   3 3   44   22
      |                                                                                  1   1 3 3  4 4
      |                                                                                          3  3    222
      |                                                                                      11       4   4
P  80 +                                                                                       1   1 3 3    2  2
E     |                                                                                           11          22
R     |                                                                                            1  1   4 4
C     |                                                                                               11    4  2 2
E  70 +                                                                                                33
N     |                                                                                                1133      22
T     |                                                                                                 1 13   4 4
      |                                                                                                    33     22
S  60 +                                                                                                   1131 3
U     |                                                                                                      1 1 43
R     |                                                                                                        1 1 2  22
V     |                                                                                                          114
I  50 +                                                                                                           114
V     |                                                                                                             4 42 2
A     |                                                                                                            1 144 2  2
L     |                                                                                                              1144
   40 +                                                                                                               33
      |                                                                                                               1 14
      |
      |                                                                                                                3111 4
   30 +
      |                                                                                                                  31 1
      |
      |
   20 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 37 obs hidden.
                                                             CHLORAMINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        0.00500%         = 2
                                                        0.0100%          = 3
                                                        0.0200%          = 4

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

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

      |
      |
  100 + 1                               3              2                          41
      |                                 3              2       2                 341    1
      |                                                        2                233     1  41 2   1
      |                                                                                 3  4  2 3 11  4
P  90 +                                                                                         3 213     1
E     |                                                                                            23 3   1  1
R     |                                                                                               3 3 22 11   1
C     |                                                                                                    2 2
E  80 +                                                                                                   33 2 2
N     |                                                                                                   43     43
T     |                                                                                                        2 211 42
      |                                                                                                            3  3
S  70 +                                                                                                            1  21
U     |
R     |                                                                                                               3111
V     |                                                                                                              44  1  1
I  60 +                                                                                                               44 33
V     |                                                                                                                  22 3
A     |                                                                                                                4442 2
L     |                                                                                                                  44
   50 +
      |                                                                                                                   4 4
      |
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 34 obs hidden.

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