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TDMS Study 88050-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

LAB: Battelle Columbus                                     METHACRYLONITRILE                                   DATE: 02/24/00       

EXPERIMENT: 88050 TEST: 05                                                                                     TIME: 14:26:23       

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        

CONT: NO1-ES-55388                              ROUTE: GAVAGE                                                  NTP C#: 88050B       

PATHOLOGIST: YARRINGTON, JOHN                                                                                  CAS: 126-98-7        

------------------------------------------------------------------------------------------------------------------------------------

                                                                                                                                    

                                                    FINAL#1 2 YEAR CHRONIC RATS                                                     

                                                                                                                                    


               REASONS FOR REMOVAL:    ALL                                                                                          

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

               REMOVAL DATE RANGE:     ALL                                                                                          

                                                                                                                                    

               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    

LAB: Battelle Columbus                                     METHACRYLONITRILE                                   DATE: 02/24/00      

EXPERIMENT: 88050 TEST: 05                                                                                     TIME: 14:26:23      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

CONT: NO1-ES-55388                              ROUTE: GAVAGE                                                  NTP C#: 88050B      

PATHOLOGIST: YARRINGTON, JOHN                                                                                  CAS: 126-98-7       
                                 METHACRYLONITRILE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE RATS

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

 ==================================================================================

 |                                DOSE = 0 MG/KG                                  |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 25        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      38    439   453   474   493   549   563   579   584   607                 |

 |      617   629   639   657   668   674   674   691   697   701                 |

 |      708   710   716   724   724                                               |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                DOSE = 3 MG/KG                                  |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      400   474   536   589   592   641   645   674   681   683                 |

 |      696   697   697   697   710   716                                         |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                DOSE = 10 MG/KG                                 |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      276   464   464   474   480   617   642   662   687   688                 |

 |      689   691   712   722   722                                               |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                 METHACRYLONITRILE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE RATS

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

 ==================================================================================

 |                                DOSE = 30 MG/KG                                 |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 1    TERMINAL 31        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      351   456   466   530   533   603   618   624   645   657                 |

 |      662   680   681   699   708   710   722   726                             |

 |  CENSORED DEATHS                                                               |

 |      530                                                                       |

 |                                                                                |

 ==================================================================================
                                 METHACRYLONITRILE


                       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    |    98.0  98.0  98.0  98.0  98.0  92.0  90.0  82.0  72.0  50.0      |

 |           |                                                                    |

 |           |                                                                    |

 |3 MG/KG    |   100.0 100.0 100.0 100.0  98.0  96.0  94.0  90.0  86.0  68.0      |

 |           |                                                                    |

 |           |                                                                    |

 |10 MG/KG   |   100.0 100.0 100.0  98.0  98.0  90.0  90.0  90.0  84.0  70.0      |

 |           |                                                                    |

 |           |                                                                    |

 |30 MG/KG   |   100.0 100.0 100.0  98.0  98.0  94.0  90.0  87.9  77.7  63.4      |

 |           |                                                                    |

 |           |                                                                    |

 ==================================================================================

 ==================================================================================

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                                  DOSE                          |

 |                                                                                |

 |                                0 MG/KG      3 MG/KG      10 MG/KG     30 MG/KG |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |SURVIVAL AT END OF STUDY|       50.0%        68.0%        70.0%        63.4%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.592N     P=0.084N     P=0.062N     P=0.234N |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       600.3        633.0        599.3        615.1    |

 |NATURAL DEATHS (C)      |       (29.2)       (23.1)       (34.6)       (25.1)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       664.7        698.3        690.1        684.0    |

 |(STANDARD ERROR)        |       (17.1)       ( 9.7)       (13.2)       (12.2)   |

 |                        |                                                       |

 ==================================================================================

                                    


       (A)  FIRST TERMINAL SACRIFICE

       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.

            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS

            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".

       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE

       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                 METHACRYLONITRILE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 731 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

 ==================================================================================

 |                                DOSE = 0 MG/KG                                  |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 1    TERMINAL 38        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      438   514   589   616   641   679   690   716   718   719                 |

 |      728                                                                       |

 |  CENSORED DEATHS                                                               |

 |      674                                                                       |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                DOSE = 3 MG/KG                                  |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 1    TERMINAL 33        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      441   505   527   540   575   599   609   617   679   679                 |

 |      686   690   697   715   721   721                                         |

 |  CENSORED DEATHS                                                               |

 |      328                                                                       |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                DOSE = 10 MG/KG                                 |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 1    TERMINAL 34        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      256   325   434   470   470   562   603   651   661   686                 |

 |      690   696   704   711   724                                               |

 |  CENSORED DEATHS                                                               |

 |      508                                                                       |

 |                                                                                |

 ==================================================================================
                                 METHACRYLONITRILE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 731 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

 ==================================================================================

 |                                DOSE = 30 MG/KG                                 |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      246   499   500   527   549   553   589   595   641   682                 |

 |      693   697   707   730                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                 METHACRYLONITRILE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 731 DAYS


 ==================================================================================

 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |    DOSE                               TIME (DAYS)                              |

 |                 90   180   270   365   425   485   545   605   665   731 (A)   |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |           |                                                                    |

 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  94.0  90.0  77.7      |

 |           |                                                                    |

 |           |                                                                    |

 |3 MG/KG    |   100.0 100.0 100.0 100.0 100.0  98.0  91.8  87.8  83.7  67.3      |

 |           |                                                                    |

 |           |                                                                    |

 |10 MG/KG   |   100.0 100.0  98.0  96.0  96.0  90.0  90.0  85.9  81.8  69.5      |

 |           |                                                                    |

 |           |                                                                    |

 |30 MG/KG   |   100.0 100.0  98.0  98.0  98.0  98.0  92.0  84.0  82.0  72.0      |

 |           |                                                                    |

 |           |                                                                    |

 ==================================================================================

 ==================================================================================

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                                  DOSE                          |

 |                                                                                |

 |                                0 MG/KG      3 MG/KG      10 MG/KG     30 MG/KG |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |SURVIVAL AT END OF STUDY|       77.7%        67.3%        69.5%        72.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.878      P=0.312      P=0.408      P=0.577  |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       640.7        625.1        576.2        586.3    |

 |NATURAL DEATHS (C)      |       (28.6)       (21.8)       (38.9)       (33.8)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       710.0        689.0        680.1        690.5    |

 |(STANDARD ERROR)        |       ( 8.1)       (12.3)       (15.6)       (13.1)   |

 |                        |                                                       |

 ==================================================================================

                                    


       (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)
                                                         METHACRYLONITRILE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 MG/KG          = 1

                                                        3 MG/KG          = 2

                                                        10 MG/KG         = 3

                                                        30 MG/KG         = 4



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



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



      |

  100 + 1      1                                    3           4       2

      |

      |        1                                    3           4       2    1   432

      |                                                                      1  1442         2

   95 +

      |                                                                         1 31        42        2

      |                                                                            13 1     44

      |

   90 +                                                                             3 1      4 1      2 4 3  2

      |

      |                                                                                        1 1      4 3  22

      |                                                                                          1 1      44 32  3 2

P  85 +

E     |                                                                                            11      4  4  3 223

R     |                                                                                             1   1

C     |                                                                                                       44

E  80 +                                                                                                 1 1    4 4  2 2

N     |

T     |                                                                                                   11     4  4

      |                                                                                                    1 1       3  3

S  75 +

U     |                                                                                                      1 1    4 4 3 3

R     |                                                                                                        1  1   2 2

V     |                                                                                                               4 4

I  70 +                                                                                                           11    223 3

V     |

A     |                                                                                                                 424 2

L     |                                                                                                            1 1

   65 +

      |                                                                                                              11   4 4

      |                                                                                                               11

      |

   60 +                                                                                                                11

      |

      |

      |                                                                                                                 11

   55 +

      |                                                                                                                  11

      |

      |

   50 +                                                                                                                   1 1

      |

      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--

        0         10         20         30         40         50         60         70         80         90         100        110



                                                                   WEEK



NOTE: 8 obs hidden.
                                                         METHACRYLONITRILE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 MG/KG          = 1

                                                        3 MG/KG          = 2

                                                        10 MG/KG         = 3

                                                        30 MG/KG         = 4



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



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



      |

      |

  100 + 1                                       43                           1

      |

      |                                         43          3                1         421

      |                                                     3               3           21  2         1

   95 +

      |                                                                     3      3   4    2 2       1  1

P     |                                                                                     4  4         1   1

E     |                                                                                       2    2

R  90 +                                                                            3             3 2   2     1     1

C     |

E     |                                                                                        4 3    422          1 1

N     |                                                                                                 2 2   3      1   1

T  85 +

      |                                                                                               4   2  43  3 2

S     |                                                                                                      4      4

U     |                                                                                                          3  3

R  80 +                                                                                                            223   11

V     |

I     |                                                                                                             223   1 1

V     |                                                                                                               33

A  75 +                                                                                                              22

L     |                                                                                                               2332  4

      |                                                                                                                     4

      |                                                                                                                 3 3

   70 +                                                                                                                   3 3

      |

      |                                                                                                                  2  2

      |

   65 +

      |

      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--

        0         10         20         30         40         50         60         70         80         90         100        110



                                                                   WEEK



NOTE: 17 obs hidden.