TDMS Study 97006-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Northwest METHYL ISOBUTYL KETONE DATE: 05/11/04 EXPERIMENT: 97006 TEST: 01 TIME: 09:02:41 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-05452 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C97006 PATHOLOGIST: RENNE, ROGER CAS: 108-10-1 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#1/RATS REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Northwest METHYL ISOBUTYL KETONE DATE: 05/11/04 EXPERIMENT: 97006 TEST: 01 TIME: 09:02:41 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05452 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C97006 PATHOLOGIST: RENNE, ROGER CAS: 108-10-1 METHYL ISOBUTYL KETONE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 0 TERMINAL 32 | | | | UNCENSORED DEATHS | | 468 492 505 554 588 592 624 629 671 679 | | 679 687 687 701 702 702 713 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 450 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 21 CENSORED DEATHS 1 TERMINAL 28 | | | | UNCENSORED DEATHS | | 338 405 420 471 551 595 602 609 618 621 | | 637 654 658 659 664 674 677 685 705 720 | | 721 | | CENSORED DEATHS | | 621 | | | |--------------------------------------------------------------------------------| | DOSE = 900 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 25 CENSORED DEATHS 0 TERMINAL 25 | | | | UNCENSORED DEATHS | | 57 205 539 540 544 567 580 619 633 637 | | 637 660 667 670 677 688 695 695 695 702 | | 702 707 707 713 721 | | CENSORED DEATHS | | NONE | | | ================================================================================== METHYL ISOBUTYL KETONE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1800 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 31 CENSORED DEATHS 0 TERMINAL 19 | | | | UNCENSORED DEATHS | | 498 544 567 595 604 609 621 622 623 636 | | 638 638 639 645 645 649 652 653 659 665 | | 674 677 681 693 694 694 702 705 706 712 | | 719 | | CENSORED DEATHS | | NONE | | | ================================================================================== METHYL ISOBUTYL KETONE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 726 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 726 (A) | | | |--------------------------------------------------------------------------------| | | | |CONTROL | 100.0 100.0 100.0 100.0 100.0 98.0 94.0 88.0 84.0 64.0 | | | | | | | |450 PPM | 100.0 100.0 100.0 98.0 94.0 92.0 92.0 86.0 69.7 57.4 | | | | | | | |900 PPM | 98.0 98.0 96.0 96.0 96.0 96.0 90.0 86.0 76.0 50.0 | | | | | | | |1800 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 90.0 60.0 38.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 450 PPM 900 PPM 1800 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 64.0% 57.4% 50.0% 38.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.010 P=0.512 P=0.221 P=0.015 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 633.1 604.0 610.3 647.1 | |NATURAL DEATHS (C) | (19.3) (23.5) (31.3) ( 9.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 692.6 672.7 668.1 677.1 | |(STANDARD ERROR) | ( 9.3) (13.0) (17.6) ( 7.8) | | | | ================================================================================== (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) METHYL ISOBUTYL KETONE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 727 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 370 454 523 576 583 606 616 643 650 685 | | 696 707 709 714 716 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 450 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 356 455 537 539 562 569 594 595 665 693 | | 707 707 712 718 721 722 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 900 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 24 CENSORED DEATHS 0 TERMINAL 26 | | | | UNCENSORED DEATHS | | 489 509 513 546 581 582 590 614 616 621 | | 636 637 642 642 643 653 653 674 677 684 | | 702 714 726 726 | | CENSORED DEATHS | | NONE | | | ================================================================================== METHYL ISOBUTYL KETONE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 727 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1800 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 0 TERMINAL 32 | | | | UNCENSORED DEATHS | | 364 398 454 489 499 506 548 637 651 667 | | 681 681 691 692 695 695 723 726 | | CENSORED DEATHS | | NONE | | | ================================================================================== METHYL ISOBUTYL KETONE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 727 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 727 (A) | | | |--------------------------------------------------------------------------------| | | | |CONTROL | 100.0 100.0 100.0 100.0 98.0 96.0 94.0 90.0 82.0 70.0 | | | | | | | |450 PPM | 100.0 100.0 100.0 98.0 98.0 96.0 92.0 84.0 82.0 68.0 | | | | | | | |900 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 94.0 86.0 66.0 52.0 | | | | | | | |1800 PPM | 100.0 100.0 100.0 98.0 96.0 94.0 88.0 86.0 82.0 64.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 450 PPM 900 PPM 1800 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 70.0% 68.0% 52.0% 64.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.439 P=0.993 P=0.093 P=0.621 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 616.5 615.8 627.9 599.8 | |NATURAL DEATHS (C) | (26.5) (27.3) (13.5) (28.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 693.9 691.4 679.4 681.2 | |(STANDARD ERROR) | (10.6) (11.3) ( 9.6) (13.2) | | | | ================================================================================== (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) METHYL ISOBUTYL KETONE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 450 PPM = 2 900 PPM = 3 1800 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 2 1 4 | 3 3 2 2 1 14 4 | 3 2 2 2 1 1 33 14 4 | 2 21 1 4 4 90 + 32 3 1 1 | 3 3 124 41 P | 3 22 213 1 E | 4 4 11 R 80 + 2 24 C | 2 2 3 1 1 E | 442 23 1 1 N | 33 T 70 + 2 2 3 | 44 3311 S | 4 4 22 1 1 U | 2 32 2 R 60 + 4 4 V | 22 I | 444 33 V | 44 33 A 50 + 33 L | 44 | | 44 40 + 44 | 44 | | 30 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 21 obs hidden. METHYL ISOBUTYL KETONE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 450 PPM = 2 900 PPM = 3 1800 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 241 3 | | 241 4 1 3 3 | 4 1 33 1 2 95 + | 4 4 3 1 3 1 | 4 4 23 2 11 | 90 + 44 2231 1 | | 4 4 2 3 2 11 | 4 3 1 41 P 85 + E | 2 411 2 R | 33 1 24 12 C | E 80 + 3 3 4 1212 N | T | 11 | 33 44 11 S 75 + U | 22 R | 44 11 V | I 70 + 3 3 11 V | A | 4 2 L | 3 3 65 + | 4 | 33 | 60 + 3 3 | | 33 | 3 3 55 + | | 3 | 50 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 18 obs hidden.