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TDMS Study 05069-08 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: TSI Mason Research                      1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)                    DATE: 04/03/96       
EXPERIMENT: 05069 TEST: 08                                                                                     TIME: 04:42:11       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-95256                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 60902D       
PATHOLOGIST: K. MURTHY                       VOELKER, FRANK                                                    CAS: 147-47-7        
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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: TSI Mason Research                      1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)                    DATE: 04/03/96      
EXPERIMENT: 05069 TEST: 08                                                                                     TIME: 04:42:11      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-95256                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 60902D      
PATHOLOGIST: K. MURTHY                       VOELKER, FRANK                                                    CAS: 147-47-7       
                  1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 45     CENSORED DEATHS 10   TERMINAL 5         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      393   428   435   492   498   507   513   521   522   527                 |
 |      542   557   563   564   603   610   613   616   618   620                 |
 |      624   625   630   631   637   649   650   650   652   652                 |
 |      652   653   656   662   667   668   668   675   679   683                 |
 |      687   689   691   709   722                                               |
 |  CENSORED DEATHS                                                               |
 |      462   462   462   462   462   462   462   462   462   462                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 36 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 48     CENSORED DEATHS 10   TERMINAL 2         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      471   504   554   563   568   571   580   592   592   594                 |
 |      598   600   601   603   603   609   610   613   613   619                 |
 |      625   626   627   630   639   640   641   641   645   647                 |
 |      649   649   650   650   651   653   653   660   660   663                 |
 |      675   693   702   704   716   718   725   728                             |
 |  CENSORED DEATHS                                                               |
 |      462   462   462   462   462   462   462   462   462   462                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 60 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 59     UNCENSORED DEATHS 45     CENSORED DEATHS 10   TERMINAL 4         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      381   455   459   522   526   550   553   568   570   570                 |
 |      570   575   575   585   590   603   612   613   616   617                 |
 |      619   620   621   622   628   629   630   643   644   646                 |
 |      647   651   653   653   655   661   665   667   668   675                 |
 |      680   692   693   697   703                                               |
 |  CENSORED DEATHS                                                               |
 |      462   462   462   462   462   462   462   462   462   462                 |
 |                                                                                |
 ==================================================================================
                  1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 100     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 49     CENSORED DEATHS 10   TERMINAL 1         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      339   378   445   487   519   530   536   542   543   546                 |
 |      550   555   560   564   565   596   596   599   599   601                 |
 |      601   602   603   609   612   614   618   618   619   622                 |
 |      624   628   630   630   633   635   648   651   653   654                 |
 |      654   662   668   673   691   693   697   719   723                       |
 |  CENSORED DEATHS                                                               |
 |      462   462   462   462   462   462   462   462   462   462                 |
 |                                                                                |
 ==================================================================================
                  1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)

                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0 100.0  98.3  95.0  78.8  70.7  32.3  10.1      |
 |           |                                                                    |
 |           |                                                                    |
 |36 MG/KG   |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  70.0  20.0   4.0      |
 |           |                                                                    |
 |           |                                                                    |
 |60 MG/KG   |   100.0 100.0 100.0 100.0  98.3  94.9  90.8  68.1  24.8   8.3      |
 |           |                                                                    |
 |           |                                                                    |
 |100        |   100.0 100.0 100.0  98.3  96.7  95.0  82.9  54.6  16.2   2.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      36 MG/KG     60 MG/KG     100      |
 |                                                                       MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       10.1%         4.0%         8.3%         2.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.046      P=0.598      P=0.694      P=0.068  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       606.7        629.5        610.5        598.7    |
 |NATURAL DEATHS (C)      |       (11.8)       ( 7.5)       (10.0)       (10.9)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       592.8        604.9        593.4        578.1    |
 |(STANDARD ERROR)        |       (12.4)       (10.5)       (11.5)       (11.4)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                  1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 31     CENSORED DEATHS 10   TERMINAL 19        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      272   427   498   500   527   554   563   568   576   581                 |
 |      591   604   606   621   625   646   654   663   679   696                 |
 |      698   702   704   716   719   721   722   723   729   734                 |
 |      735                                                                       |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   461   461   461   461                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 36 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 29     CENSORED DEATHS 10   TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      292   454   485   487   492   505   524   554   557   608                 |
 |      622   635   638   647   649   655   667   672   673   687                 |
 |      688   688   692   713   714   714   719   725   734                       |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   461   461   461   461                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 60 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 28     CENSORED DEATHS 10   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      447   457   492   492   540   551   560   588   602   607                 |
 |      609   619   626   659   663   664   668   689   690   691                 |
 |      694   697   698   709   712   727   730   734                             |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   461   461   461   461                 |
 |                                                                                |
 ==================================================================================
                  1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 100     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 28     CENSORED DEATHS 10   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      336   410   448   484   540   579   581   583   598   602                 |
 |      626   627   632   641   644   646   655   675   676   685                 |
 |      688   701   704   708   708   714   716   722                             |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   461   461   461   461                 |
 |                                                                                |
 ==================================================================================
                  1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 736 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   736 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0  98.3  98.3  96.7  90.6  76.5  64.4  38.3      |
 |           |                                                                    |
 |           |                                                                    |
 |36 MG/KG   |   100.0 100.0 100.0  98.3  98.3  94.7  86.6  82.6  68.5  42.3      |
 |           |                                                                    |
 |           |                                                                    |
 |60 MG/KG   |   100.0 100.0 100.0 100.0 100.0  96.7  90.6  82.6  68.5  44.3      |
 |           |                                                                    |
 |           |                                                                    |
 |100        |   100.0 100.0 100.0  98.3  96.7  93.0  91.0  80.9  66.7  44.5      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      36 MG/KG     60 MG/KG     100      |
 |                                                                       MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       38.3%        42.3%        44.3%        44.5%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.690N     P=0.911N     P=0.711N     P=0.765N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       624.3        616.9        629.1        618.9    |
 |NATURAL DEATHS (C)      |       (18.9)       (19.5)       (16.1)       (18.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       632.5        632.6        640.3        635.5    |
 |(STANDARD ERROR)        |       (15.3)       (15.4)       (14.3)       (15.0)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                           1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        36 MG/KG         = 2
                                                        60 MG/KG         = 3
                                                        100     MG/KG    = 4

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

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

      |
  100 + 1                                                     4      3 1           2
      |                                                       4    4 3 1    114 33 2   2
      |                                                                      14  3   412   3    22
      |                                                                              411   33    22
   90 +                                                                                111 434 3
      |                                                                                  1 1 443  22
      |                                                                                            2  2
      |                                                                                    11
   80 +                                                                                     1 141     22
      |                                                                                         1133
      |                                                                                         44 33  22
      |                                                                                          1  3 3 1
P  70 +                                                                                          4    3411
E     |                                                                                                 22
R     |                                                                                                  11
C     |                                                                                                  22
E  60 +                                                                                                   11
N     |                                                                                                44
T     |                                                                                                    11
      |                                                                                                 4432 2
S  50 +                                                                                                     1 1
U     |                                                                                                  44
R     |                                                                                                    3 211
V     |                                                                                                      33
I  40 +                                                                                                   44
V     |
A     |                                                                                                       31 1
L     |                                                                                                    44    11
   30 +                                                                                                       22 3
      |                                                                                                     4 4   11
      |                                                                                                       42 23
      |                                                                                                            11
   20 +                                                                                                          23211
      |                                                                                                        4 4 232
      |                                                                                                          444 1 21
      |                                                                                                            4 332121
   10 +                                                                                                               33  1 1
      |                                                                                                              443 22 3
      |                                                                                                               4  42 2
      |                                                                                                                   4 4
    0 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 39 obs hidden.
                                           1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE_(MONOMER)
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        36 MG/KG         = 2
                                                        60 MG/KG         = 3
                                                        100     MG/KG    = 4

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

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

      |
      |
  100 + 1                                          1  2      4                3
      |                                            1  2      4           4 1  3 23   231
      |                                                                       4      4
      |                                                                              221    1 3
   90 +                                                                               2 2   1 331  4
      |                                                                                 2  2   311143
P     |                                                                                           113  3
E     |                                                                                         2      32
R  80 +                                                                                            1  142 24
C     |                                                                                               1 1 2322
E     |                                                                                                 1 13422  3
N     |                                                                                                   11
T  70 +                                                                                                    1 412
      |                                                                                                       11 124 3
S     |                                                                                                          121
U     |                                                                                                            1421
R  60 +                                                                                                             433
V     |                                                                                                              411
I     |                                                                                                              23121
V     |
A  50 +                                                                                                                 3 3
L     |                                                                                                                 211 3
      |                                                                                                                   1 13
      |                                                                                                                     22
   40 +
      |                                                                                                                     11
      |
      |
   30 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 59 obs hidden.