National Toxicology Program

National Toxicology Program
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TDMS Study 05085-01 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Battelle Columbus                                         DATE: 09/11/94   
EXP: 05085                    MANGANESE SULFATE                TIME: 02:32:54   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 61143B   
CONT: N01-ES-45041                                             CAS: 7785-87-7   
PATHOLOGIST: J. TOFT                                                            
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
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REMOVAL DATE RANGE:                                                             


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INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Battelle Columbus                                         DATE: 09/11/94  
EXP: 05085                    MANGANESE SULFATE                TIME: 02:32:54  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 61143B  
CONT: N01-ES-45041                                             CAS: 7785-87-7  
PATHOLOGIST: J. TOFT                                                           

                                 MANGANESE SULFATE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 27     CENSORED DEATHS 18   TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      95    269   456   495   526   547   562   571   578   590                 |
 |      603   603   610   612   621   627   642   655   670   673                 |
 |      673   677   690   691   695   701   726                                   |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   276   276   276   437   437                 |
 |      437   437   437   437   437   437   437   437                             |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1500 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 34     CENSORED DEATHS 19   TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      124   333   346   451   466   532   578   590   613   613                 |
 |      613   635   642   652   658   659   666   666   670   674                 |
 |      677   682   683   684   690   694   694   698   711   717                 |
 |      723   726   726   726                                                     |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   276   276   276   276   276                 |
 |      437   437   437   437   437   437   437   437   437                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 29     CENSORED DEATHS 19   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      380   417   481   499   509   519   528   528   557   582                 |
 |      606   613   618   621   631   635   654   659   663   684                 |
 |      690   698   701   703   711   714   715   727   728                       |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   276   276   276   276   276                 |
 |      437   437   437   437   437   437   437   437   437                       |
 |                                                                                |
 ==================================================================================

                                 MANGANESE SULFATE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 15000  PPM                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 45     CENSORED DEATHS 18   TERMINAL 7         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      268   275   354   498   498   527   557   568   618   626                 |
 |      631   631   632   632   632   638   638   652   655   660                 |
 |      660   661   661   663   670   673   677   684   687   687                 |
 |      690   691   698   701   707   711   713   713   715   715                 |
 |      715   719   726   726   727                                               |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   276   276   276   276   276   276                 |
 |      437   437   437   437   437   437   437   437                             |
 |                                                                                |
 ==================================================================================

                                 MANGANESE SULFATE


                       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 PPM      |   100.0  98.6  97.1  97.1  97.1  95.2  91.3  77.7  66.1  48.6      |
 |           |                                                                    |
 |           |                                                                    |
 |1500 PPM   |   100.0  98.6  98.6  95.2  95.2  91.3  89.3  85.3  69.4  33.7      |
 |           |                                                                    |
 |           |                                                                    |
 |5000 PPM   |   100.0 100.0 100.0 100.0  96.7  94.7  84.8  80.9  63.1  43.4      |
 |           |                                                                    |
 |           |                                                                    |
 |15000  PPM |   100.0 100.0  98.6  95.5  95.5  95.5  89.6  85.7  54.6  13.6      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        1500 PPM     5000 PPM     15000  PP|
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       48.6%        33.7%        43.4%        13.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.004      P=0.381      P=0.872      P=0.006  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       587.3        618.0        612.8        635.1    |
 |NATURAL DEATHS (C)      |       (26.2)       (22.7)       (17.9)       (16.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       580.8        572.8        578.5        570.5    |
 |(STANDARD ERROR)        |       (20.3)       (20.9)       (19.8)       (19.8)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                 MANGANESE SULFATE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 13     CENSORED DEATHS 20   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      547   585   599   620   624   638   642   675   690   694                 |
 |      694   699   728                                                           |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   275   276   276   276   276                 |
 |      437   437   437   437   437   437   437   437   437   437                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1500 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 13     CENSORED DEATHS 20   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      396   451   491   540   543   548   557   568   609   667                 |
 |      673   718   718                                                           |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   275   276   276   276   276   276                 |
 |      437   437   437   437   437   437   437   437   437   437                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 8      CENSORED DEATHS 20   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      78    528   571   599   609   663   666   684                             |
 |  CENSORED DEATHS                                                               |
 |      45    275   275   275   275   275   276   276   276   276                 |
 |      276   437   437   437   437   437   437   437   437   437                 |
 |                                                                                |
 ==================================================================================

                                 MANGANESE SULFATE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 15000   PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 68     UNCENSORED DEATHS 12     CENSORED DEATHS 20   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      495   527   642   663   680   684   694   701   701   701                 |
 |      715   723                                                                 |
 |  CENSORED DEATHS                                                               |
 |      275   275   275   275   276   276   276   276   276   276                 |
 |      437   437   437   437   437   437   437   437   437   437                 |
 |                                                                                |
 ==================================================================================

                                 MANGANESE SULFATE


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  94.0  86.0  74.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1500 PPM   |   100.0 100.0 100.0 100.0  98.3  96.3  90.3  84.3  82.3  74.3      |
 |           |                                                                    |
 |           |                                                                    |
 |5000 PPM   |    98.6  98.6  98.6  98.6  98.6  98.6  96.5  92.5  88.5  84.5      |
 |           |                                                                    |
 |           |                                                                    |
 |15000   PPM|   100.0 100.0 100.0 100.0 100.0 100.0  95.8  95.8  91.7  75.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        1500 PPM     5000 PPM     15000   P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       74.0%        74.3%        84.5%        75.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.914N     P=1.000      P=0.378N     P=0.984N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       648.8        575.3        549.8        660.5    |
 |NATURAL DEATHS (C)      |       (14.7)       (27.5)       (69.9)       (21.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       607.6        594.0        596.4        607.3    |
 |(STANDARD ERROR)        |       (20.3)       (20.6)       (23.2)       (21.0)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                         MANGANESE SULFATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        1500 PPM         = 2
                                                        5000 PPM         = 3
                                                        15000  PPM       = 4

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

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

      |
      |
  100 + 1              1    2                      4                 3
      |                1    2                      14        2 24    3    3      1  3
      |                                                        24               21  3 13
      |                                                                         2 2   133   1  1
   90 +                                                                                 3  32  141 2
      |                                                                                         4112  2
      |                                                                                     3   3 11  2  244
      |                                                                                         3  13 1 1  44
   80 +                                                                                             3   32  2
      |                                                                                                 113 22
P     |                                                                                                  11  2 2
E     |                                                                                                   1134 2 2
R  70 +                                                                                                    131 3 22
C     |                                                                                                      1 1 3
E     |                                                                                                        1 411
N     |                                                                                                          3223
T  60 +                                                                                                            2233
      |                                                                                                            1 133
S     |                                                                                                          44  11
U     |                                                                                                           4422113
R  50 +                                                                                                                1331
V     |                                                                                                            444   31 1
I     |                                                                                                               2 2
V     |                                                                                                                 222 3
A  40 +                                                                                                              44
L     |                                                                                                               44
      |
      |                                                                                                                44 2 2
   30 +
      |                                                                                                                 44
      |
      |
   20 +                                                                                                                  44
      |
      |
      |                                                                                                                   4 4
   10 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 40 obs hidden.

                                                         MANGANESE SULFATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        1500 PPM         = 2
                                                        5000 PPM         = 3
                                                        15000   PPM      = 4

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

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

      |
      |
  100 + 1            3                                                 2              4        1
      |              3                                                 2        2           3
      |                                                                               4     4  1    1
      |                                                                         2     2     3     3 1  1     4
P  95 +                                                                                           3    3
E     |                                                                               2       2        1  1  4   4
R     |                                                                                                33 11
C     |                                                                                                          4  4
E  90 +                                                                                       22        3  1 1   3
N     |                                                                                        22                33
T     |                                                                                                             4 4
      |                                                                                         2 2          1    313
S  85 +                                                                                                             3 44    3
U     |                                                                                           2     2          1 1
R     |                                                                                                 2         2  11
V     |
I  80 +                                                                                                           22
V     |                                                                                                            2   4 2
A     |                                                                                                                  44
L     |                                                                                                               1   1
   75 +                                                                                                                   4 4
      |                                                                                                                  21 1
      |
      |
   70 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 6 obs hidden.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.