National Toxicology Program

National Toxicology Program
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TDMS Study 05085-02 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Battelle Columbus                                         DATE: 09/11/94   
EXP: 05085                    MANGANESE SULFATE                TIME: 05:12:19   
TEST: 02              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: R. PERSING                                                         
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Battelle Columbus                                         DATE: 09/11/94  
EXP: 05085                    MANGANESE SULFATE                TIME: 05:12:19  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 61143B  
CONT: N01-ES-45041                                             CAS: 7785-87-7  
PATHOLOGIST: R. PERSING                                                        

                                 MANGANESE SULFATE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0PPM                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 4      CENSORED DEATHS 20   TERMINAL 46        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      466   687   709   725                                                     |
 |  CENSORED DEATHS                                                               |
 |      276   276   276   276   276   276   276   277   277   277                 |
 |      452   452   452   452   452   452   453   453   453   453                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1500 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 6      CENSORED DEATHS 20   TERMINAL 44        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      580   617   647   679   701   708                                         |
 |  CENSORED DEATHS                                                               |
 |      276   276   276   276   277   277   277   277   277   277                 |
 |      452   452   452   452   452   453   453   453   453   453                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 5      CENSORED DEATHS 19   TERMINAL 46        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      251   417   592   702   727                                               |
 |  CENSORED DEATHS                                                               |
 |      276   276   276   276   276   277   277   277   277   277                 |
 |      452   452   452   453   453   453   453   453   453                       |
 |                                                                                |
 ==================================================================================

                                 MANGANESE SULFATE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 15000  PPM                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 4      CENSORED DEATHS 20   TERMINAL 46        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      140   634   645   645                                                     |
 |  CENSORED DEATHS                                                               |
 |      276   276   276   276   277   277   277   277   277   452                 |
 |      452   452   452   452   452   453   453   453   453   453                 |
 |                                                                                |
 ==================================================================================

                                 MANGANESE SULFATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0PPM       |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  98.0  98.0  92.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1500 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  94.0  88.0      |
 |           |                                                                    |
 |           |                                                                    |
 |5000 PPM   |   100.0 100.0  98.6  98.6  96.9  96.9  96.9  94.9  94.9  91.0      |
 |           |                                                                    |
 |           |                                                                    |
 |15000  PPM |   100.0  98.6  98.6  98.6  98.6  98.6  98.6  98.6  92.5  92.5      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0PPM         1500 PPM     5000 PPM     15000  PP|
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       92.0%        88.0%        91.0%        92.5%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.920N     P=0.708      P=0.992      P=1.000  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       646.8        655.3        537.8        516.0    |
 |NATURAL DEATHS (C)      |       (60.8)       (20.5)       (90.2)       ( 125)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       620.1        618.6        615.2        615.2    |
 |(STANDARD ERROR)        |       (20.6)       (20.4)       (21.2)       (21.1)   |
 |                        |                                                       |
 ==================================================================================
                                    


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

                                 MANGANESE SULFATE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0PPM                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 8      CENSORED DEATHS 20   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      323   397   537   607   620   696   708   720                             |
 |  CENSORED DEATHS                                                               |
 |      276   276   276   276   276   276   276   276   277   277                 |
 |      277   452   452   452   453   453   453   453   453   453                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1500 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 4      CENSORED DEATHS 20   TERMINAL 46        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      679   701   712   720                                                     |
 |  CENSORED DEATHS                                                               |
 |      276   276   276   276   276   277   277   277   277   277                 |
 |      452   452   452   452   453   453   453   453   453   453                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 12     CENSORED DEATHS 20   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      107   409   488   554   607   610   693   696   702   704                 |
 |      723   725                                                                 |
 |  CENSORED DEATHS                                                               |
 |      19    276   276   276   277   277   277   277   277   277                 |
 |      277   452   452   452   452   453   453   453   453   453                 |
 |                                                                                |
 ==================================================================================

                                 MANGANESE SULFATE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 15000  PPM                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 9      CENSORED DEATHS 19   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      447   473   488   631   676   689   696   709   726                       |
 |  CENSORED DEATHS                                                               |
 |      276   276   276   276   277   277   277   277   277   277                 |
 |      452   452   452   452   452   452   453   453   453                       |
 |                                                                                |
 ==================================================================================

                                 MANGANESE SULFATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0PPM       |   100.0 100.0 100.0  98.3  96.6  96.6  94.6  94.6  90.6  84.5      |
 |           |                                                                    |
 |           |                                                                    |
 |1500 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  92.0      |
 |           |                                                                    |
 |           |                                                                    |
 |5000 PPM   |   100.0  98.6  98.6  98.6  96.9  96.9  94.8  92.8  88.8  76.7      |
 |           |                                                                    |
 |           |                                                                    |
 |15000  PPM |   100.0 100.0 100.0 100.0 100.0  96.4  94.4  94.4  92.4  82.6      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0PPM         1500 PPM     5000 PPM     15000  PP|
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       84.5%        92.0%        76.7%        82.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.563      P=0.318N     P=0.456      P=1.000  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       576.0        703.0        584.8        615.0    |
 |NATURAL DEATHS (C)      |       (52.3)       ( 8.9)       (52.3)       (37.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       604.8        623.4        594.0        614.1    |
 |(STANDARD ERROR)        |       (21.4)       (20.5)       (23.1)       (20.5)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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
                                                        0PPM             = 1
                                                        1500 PPM         = 2
                                                        5000 PPM         = 3
                                                        15000  PPM       = 4

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

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

      |
      |
  100 + 1                     4                 3                                 1                2
      |
      |
      |                       4                 3                         3                                 4
P  98 +                                                                           1                2      2          1
E     |
R     |                                                                   3                           3
C     |                                                                                                     4 4
E  96 +                                                                                                   2   2      1  1
N     |
T     |                                                                                               3                3
      |
S  94 +                                                                                                       2    2    1 1
U     |
R     |                                                                                                                3  3
V     |                                                                                                       4             4
I  92 +                                                                                                            2   2  1 1
V     |
A     |                                                                                                                   3 3
L     |
   90 +                                                                                                                22
      |
      |
      |
   88 +                                                                                                                 2   2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 3 obs hidden.

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

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

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

        |
  100.0 +1                 3                                 1                 4                                    2
        |
        |                  3                                              3
        |                                                    1          1      4    4                               2   2
   97.5 +
        |                                                               1 3           3       1
        |                                                                           4 4                                 22
        |
   95.0 +                                                                             3          3
        |                                                                             4       1          1   4
        |                                                                                                                22
        |                                                                                        3       3
P  92.5 +                                                                                                1 1 4      4
E       |                                                                                                                 2  2
R       |
C       |                                                                                                331        4 41
E  90.0 +
N       |
T       |                                                                                                 3           31 1
        |
S  87.5 +
U       |                                                                                                             33
R       |                                                                                                              4 11
V       |
I  85.0 +                                                                                                              33
V       |                                                                                                                414 1
A       |
L       |
   82.5 +                                                                                                                  4 4
        |
        |
        |                                                                                                               3  3
   80.0 +
        |
        |
        |
   77.5 +
        |                                                                                                                  3 3
        |
        |
   75.0 +
        |
        -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-
         0         10         20         30         40         50         60         70         80         90         100        110

                                                                    WEEK

NOTE: 6 obs hidden.
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