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TDMS Study 05102-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                    BENZETHONIUM CHLORIDE                                DATE: 05/19/95       
EXPERIMENT: 05102 TEST: 05                                                                                     TIME: 18:22:52       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75177                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61494B       
PATHOLOGIST: R. PERSING                      S. EUSTIS                                                         CAS: 121-54-0        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Columbus                                    BENZETHONIUM CHLORIDE                                DATE: 05/19/95      
EXPERIMENT: 05102 TEST: 05                                                                                     TIME: 18:22:52      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-75177                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 61494B      
PATHOLOGIST: R. PERSING                      S. EUSTIS                                                         CAS: 121-54-0       

                               BENZETHONIUM CHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0MG/KG                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 37     CENSORED DEATHS 8    TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      406   437   513   533   549   551   556   564   583   585                 |
 |      592   603   606   606   606   612   632   634   635   647                 |
 |      647   648   650   653   653   655   659   679   689   691                 |
 |      691   709   709   714   716   716   726                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456                             |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = .15MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 41     CENSORED DEATHS 8    TERMINAL 11        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      264   379   457   461   479   499   541   542   556   556                 |
 |      564   576   578   579   591   593   606   610   612   612                 |
 |      616   620   621   623   626   632   638   639   659   659                 |
 |      668   670   671   675   691   698   698   710   712   722                 |
 |      723                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456                             |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 45     CENSORED DEATHS 6    TERMINAL 9         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      199   367   416   437   483   500   505   511   523   526                 |
 |      537   556   575   587   589   599   601   613   613   621                 |
 |      626   632   632   635   635   643   648   649   655   658                 |
 |      658   662   663   664   666   671   676   682   683   696                 |
 |      698   707   712   718   727                                               |
 |  CENSORED DEATHS                                                               |
 |      25    456   456   456   456   456                                         |
 |                                                                                |
 ==================================================================================

                               BENZETHONIUM CHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1.5MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 40     CENSORED DEATHS 4    TERMINAL 16        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      170   291   364   396   408   425   465   533   537   549                 |
 |      551   556   557   562   594   605   609   613   613   619                 |
 |      626   635   639   639   643   644   649   655   659   660                 |
 |      662   675   679   683   691   692   710   710   722   722                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456                                                     |
 |                                                                                |
 ==================================================================================

                               BENZETHONIUM CHLORIDE


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0MG/KG     |   100.0 100.0 100.0 100.0  98.3  96.7  92.8  77.3  48.3  29.0      |
 |           |                                                                    |
 |           |                                                                    |
 |.15MG/KG   |   100.0 100.0  98.3  98.3  96.7  90.9  85.1  69.6  42.5  21.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5MG/KG   |   100.0 100.0  98.3  98.3  94.9  91.4  80.2  69.0  37.3  16.8      |
 |           |                                                                    |
 |           |                                                                    |
 |1.5MG/KG   |   100.0  98.3  98.3  95.0  90.0  88.2  84.6  72.0  45.0  28.8      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       29.0%        21.3%        16.8%        28.8%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.892N     P=0.286      P=0.129      P=0.802  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       623.1        600.6        601.2        585.3    |
 |NATURAL DEATHS (C)      |       (12.3)       (14.7)       (15.4)       (19.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       627.3        604.9        598.7        615.0    |
 |(STANDARD ERROR)        |       (12.9)       (14.1)       (17.3)       (16.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                               BENZETHONIUM CHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0MG/KG                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 27     CENSORED DEATHS 9    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      176   485   515   519   526   554   572   595   603   610                 |
 |      612   633   642   642   644   645   648   649   667   696                 |
 |      709   718   719   720   722   724   724                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = .15MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 20     CENSORED DEATHS 7    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      366   393   456   519   530   538   551   582   602   612                 |
 |      612   633   638   659   677   680   684   696   710   727                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456                                   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 9    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      297   465   492   533   549   565   578   579   579   581                 |
 |      606   610   632   668   678   679   685   686   694   698                 |
 |      704   708   712   720   725                                               |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 ==================================================================================

                               BENZETHONIUM CHLORIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1.5MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 29     CENSORED DEATHS 7    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      303   322   358   486   525   533   537   562   576   587                 |
 |      587   594   603   613   619   632   634   634   636   640                 |
 |      647   658   667   668   677   680   699   700   723                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456                                   |
 |                                                                                |
 ==================================================================================

                               BENZETHONIUM CHLORIDE


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0MG/KG     |   100.0  98.3  98.3  98.3  98.3  96.4  90.5  82.6  64.9  47.2      |
 |           |                                                                    |
 |           |                                                                    |
 |.15MG/KG   |   100.0 100.0 100.0 100.0  96.7  95.0  89.3  83.6  74.1  62.7      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5MG/KG   |   100.0 100.0 100.0  98.3  98.3  96.4  92.4  80.6  74.7  51.1      |
 |           |                                                                    |
 |           |                                                                    |
 |1.5MG/KG   |   100.0 100.0 100.0  95.0  95.0  95.0  87.4  76.0  58.9  45.6      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0MG/KG       .15MG/KG     0.5MG/KG     1.5MG/KG |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       47.2%        62.7%        51.1%        45.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.256      P=0.232N     P=0.854N     P=0.728  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       617.4        593.3        616.9        589.7    |
 |NATURAL DEATHS (C)      |       (21.8)       (22.9)       (20.0)       (19.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       637.8        651.9        641.4        629.8    |
 |(STANDARD ERROR)        |       (15.4)       (14.4)       (14.7)       (15.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                       BENZETHONIUM CHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0MG/KG           = 1
                                                        .15MG/KG         = 2
                                                        0.5MG/KG         = 3
                                                        1.5MG/KG         = 4

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

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

      |
      |
  100 + 1                           4   3         2                     1
      |                             4   3         2   4          43  2  1 3  1   2       1
      |                                                          4     4  3  3           1   1
      |                                                                4 4 4 3   2  2  3     1 1
   90 +                                                                    4      4 2  23     211
      |                                                                           4          4  11
      |                                                                                 3  3342421  1
      |                                                                                     33
   80 +                                                                                      3 422 21 1 1
      |                                                                                         34 33
P     |                                                                                          4  3 3 4
E     |                                                                                            2  2311
R  70 +                                                                                               2321  1
C     |                                                                                                 224
E     |                                                                                                  3341 1
N     |                                                                                                   333
T  60 +                                                                                                  22 44
      |
S     |                                                                                                   223311
U     |                                                                                                    22334
R  50 +                                                                                                     22 1 1
V     |                                                                                                      233 1 1 1
I     |                                                                                                          4 4
V     |                                                                                                        3 2244
A  40 +                                                                                                             41  1
L     |                                                                                                          322
      |                                                                                                            2 2  11
      |                                                                                                           33322 4 4
   30 +                                                                                                               2 211 1
      |                                                                                                             3 3
      |                                                                                                               332 2
      |                                                                                                                33 2 2
   20 +                                                                                                                 33
      |                                                                                                                  33 3
      |
      |
   10 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 47 obs hidden.

                                                       BENZETHONIUM CHLORIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0MG/KG           = 1
                                                        .15MG/KG         = 2
                                                        0.5MG/KG         = 3
                                                        1.5MG/KG         = 4

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

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

      |
      |
  100 + 1                            1                 34         2
      |                              1                 34  4     42    2         23  13  1
      |                                                          4               2   43  1 1 3
      |                                                                              4     113 3
P  90 +                                                                                    412 213
E     |                                                                                      4 213132 1
R     |                                                                                          4 42 121
C     |                                                                                            44  211
E  80 +                                                                                            34 4 32  2
N     |                                                                                               4 31  11
T     |                                                                                                 444 32   232
      |                                                                                                   4 4     322
S  70 +                                                                                                      11    33
U     |                                                                                                             2 2 2
R     |                                                                                                     441   1 3 3 2 2
V     |                                                                                                      44   1   1   2 2
I  60 +                                                                                                       44  4   1311
V     |
A     |                                                                                                           44    33
L     |                                                                                                            44 4  11
   50 +                                                                                                                   3 3
      |                                                                                                               4   1 1
      |                                                                                                                   4 4
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 38 obs hidden.