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TDMS Study 05106-03 Pathology Tables


NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Hazelton, MD                                           DIETHYLPHTHALATE                                   DATE: 05/19/95       
EXPERIMENT: 05106 TEST: 03                                                                                     TIME: 21:47:31       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-45036                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 60048B       
PATHOLOGIST: R. CARDY                        S. EUSTIS                                                         CAS: 84-66-2         
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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: Hazelton, MD                                           DIETHYLPHTHALATE                                   DATE: 05/19/95      
EXPERIMENT: 05106 TEST: 03                                                                                     TIME: 21:47:31      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-45036                              ROUTE: DERMAL,SOLUTION                                         NTP C#: 60048B      
PATHOLOGIST: R. CARDY                        S. EUSTIS                                                         CAS: 84-66-2        

                                 DIETHYLPHTHALATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0 MICROLITERS                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 7      CENSORED DEATHS 10   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      431   536   558   620   635   690   716                                   |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   450   450   451   451   451   451   451                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 7.5 MICROLITERS                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 7      CENSORED DEATHS 12   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      378   397   576   590   590   680   727                                   |
 |  CENSORED DEATHS                                                               |
 |      29    165   450   450   450   450   450   451   451   451                 |
 |      451   451                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 15 MICROLITERS                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 4      CENSORED DEATHS 10   TERMINAL 46        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      633   663   695   714                                                     |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   450   450   450   450   451   451   451                 |
 |                                                                                |
 ==================================================================================

                                 DIETHYLPHTHALATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 30 MICROLITERS                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 7      CENSORED DEATHS 10   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      512   556   577   644   675   698   707                                   |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   451   451   451   451   451   451   451                 |
 |                                                                                |
 ==================================================================================

                                 DIETHYLPHTHALATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0          |   100.0 100.0 100.0 100.0 100.0  98.3  96.3  94.3  90.3  86.3      |
 |MICROLITERS|                                                                    |
 |           |                                                                    |
 |7.5        |   100.0 100.0 100.0 100.0  96.6  96.6  96.6  90.3  90.3  86.1      |
 |MICROLITERS|                                                                    |
 |           |                                                                    |
 |15         |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0      |
 |MICROLITERS|                                                                    |
 |           |                                                                    |
 |30         |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  94.0  92.0  86.0      |
 |MICROLITERS|                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0            7.5          15           30       |
 |                                MICROLITERS  MICROLITERS  MICROLITERS  MICROLITE|S
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       86.3%        86.1%        92.0%        86.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.980N     P=1.000      P=0.486N     P=1.000N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       598.0        562.6        676.3        624.1    |
 |NATURAL DEATHS (C)      |       (37.0)       (49.8)       (17.8)       (28.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       668.0        642.8        679.8        671.1    |
 |(STANDARD ERROR)        |       (14.4)       (20.1)       (13.5)       (13.9)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                 DIETHYLPHTHALATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0 MICROLITERS                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 10   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      193   591   620   662   663   665   675   724   727                       |
 |  CENSORED DEATHS                                                               |
 |      450   450   450   450   450   450   450   450   451   451                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 7.5 MICROLITERS                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 9    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      273   365   481   484   509   560   563   597   668   675                 |
 |      678   682   718                                                           |
 |  CENSORED DEATHS                                                               |
 |      450   450   451   451   451   451   451   451   451                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 15 MICROLITERS                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 12     CENSORED DEATHS 11   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      393   521   568   583   586   632   644   653   661   673                 |
 |      675   708                                                                 |
 |  CENSORED DEATHS                                                               |
 |      193   450   450   450   450   450   451   451   451   451                 |
 |      451                                                                       |
 |                                                                                |
 ==================================================================================

                                 DIETHYLPHTHALATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 30 MICROLITERS                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 11   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      456   521   633   636   645   645   648   691   693   693                 |
 |      712   712   725                                                           |
 |  CENSORED DEATHS                                                               |
 |      247   450   450   450   450   450   451   451   451   451                 |
 |      451                                                                       |
 |                                                                                |
 ==================================================================================

                                 DIETHYLPHTHALATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0          |   100.0 100.0  98.3  98.3  98.3  98.3  98.3  96.3  88.3  82.3      |
 |MICROLITERS|                                                                    |
 |           |                                                                    |
 |7.5        |   100.0 100.0 100.0  96.7  96.7  92.7  90.7  84.8  84.8  75.0      |
 |MICROLITERS|                                                                    |
 |           |                                                                    |
 |15         |   100.0 100.0 100.0 100.0  98.3  98.3  96.3  90.1  81.9  75.8      |
 |MICROLITERS|                                                                    |
 |           |                                                                    |
 |30         |   100.0 100.0 100.0 100.0 100.0  98.0  95.9  95.9  85.7  73.5      |
 |MICROLITERS|                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0            7.5          15           30       |
 |                                MICROLITERS  MICROLITERS  MICROLITERS  MICROLITE|S
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       82.3%        75.0%        75.8%        73.5%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.507      P=0.439      P=0.514      P=0.433  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       613.3        557.9        608.1        646.9    |
 |NATURAL DEATHS (C)      |       (54.5)       (37.1)       (24.9)       (21.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       665.9        650.8        650.1        657.4    |
 |(STANDARD ERROR)        |       (15.7)       (16.2)       (16.4)       (15.6)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                          DIETHYLPHTHALATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MICROLITERS    = 1
                                                        7.5 MICROLITERS  = 2
                                                        15 MICROLITERS   = 3
                                                        30 MICROLITERS   = 4

------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------

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

      |
      |
  100 + 1                                                          2        1            4                  3
      |
      |
      |                                                            2   2    1                1
   98 +                                                                                  4      4           3    3
      |
P     |
E     |                                                                2                     1  1  2
R  96 +                                                                                         4  4             3    3
C     |
E     |
N     |                                                                                         1  2  2   1
T  94 +                                                                                            4         4        3 3
      |
S     |
U     |                                                                                                   1 1
R  92 +                                                                                                      4     4    3   3
V     |
I     |
V     |                                                                                               2     1       21
A  90 +                                                                                                            4  4
L     |
      |
      |                                                                                                              1   1
   88 +                                                                                                             2 44  2
      |
      |
      |                                                                                                                  1  1
   86 +                                                                                                                4  2 2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 4 obs hidden.

                                                          DIETHYLPHTHALATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MICROLITERS    = 1
                                                        7.5 MICROLITERS  = 2
                                                        15 MICROLITERS   = 3
                                                        30 MICROLITERS   = 4

----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------

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

      |
      |
  100 + 1                              1           2                   3         4
      |                                1           2              2    3                   3          1
      |                                                                          4         4
      |                                                           2                 2      3      3   1   1 4
P  95 +                                                                             22
E     |                                                                                           3 3     1      1
R     |                                                                              2  2
C     |                                                                                 2       2           4 4
E  90 +                                                                                             3       3
N     |                                                                                         22               1 1
T     |                                                                                                     33
      |                                                                                          2     2     343   1 4    1
S  85 +                                                                                                2          2
U     |                                                                                                        3 3
R     |                                                                                                          322      1 1
V     |
I  80 +                                                                                                              4  4
V     |                                                                                                            22
A     |                                                                                                            32   32
L     |                                                                                                                 3   3
   75 +                                                                                                                 424 2
      |                                                                                                                   4 4
      |
      |
   70 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 5 obs hidden.