TDMS Study 96007-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) DATE: 09/23/03 EXPERIMENT: 96007 TEST: 01 TIME: 12:38:03 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-75411 ROUTE: GAVAGE NTP C#: 96007D PATHOLOGIST: MISSING CAS: 57465-28-8 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#2; REVISION #1 REASONS FOR REMOVAL: 25022 Accidently Killed 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 0 NG/KG INCLUDE 003 30 NG/KG INCLUDE 004 100 NG/KG INCLUDE 005 175 NG/KG INCLUDE 006 300 NG/KG INCLUDE 007 550 NG/KG INCLUDE 008 1000 NG/KG NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) DATE: 09/23/03 EXPERIMENT: 96007 TEST: 01 TIME: 12:38:03 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-75411 ROUTE: GAVAGE NTP C#: 96007D PATHOLOGIST: MISSING CAS: 57465-28-8 TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 727 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 NG/KG | | --------------------- | | | | TOTAL 53 UNCENSORED DEATHS 35 CENSORED DEATHS 3 TERMINAL 15 | | | | UNCENSORED DEATHS | | 176 201 201 309 321 343 354 391 400 405 | | 496 496 519 531 541 546 547 554 574 583 | | 592 600 603 607 611 618 650 652 660 660 | | 660 671 688 705 709 | | CENSORED DEATHS | | 126 222 644 | | | |--------------------------------------------------------------------------------| | DOSE = 30 NG/KG | | --------------------- | | | | TOTAL 55 UNCENSORED DEATHS 27 CENSORED DEATHS 3 TERMINAL 25 | | | | UNCENSORED DEATHS | | 82 202 223 253 328 350 434 448 498 516 | | 524 546 572 574 580 607 630 630 652 652 | | 652 671 681 700 720 720 722 | | CENSORED DEATHS | | 356 356 356 | | | |--------------------------------------------------------------------------------| | DOSE = 100 NG/KG | | ---------------------------- | | | | TOTAL 53 UNCENSORED DEATHS 27 CENSORED DEATHS 0 TERMINAL 26 | | | | UNCENSORED DEATHS | | 188 236 300 328 376 428 498 509 531 533 | | 541 554 555 586 602 621 651 651 651 652 | | 653 653 659 678 688 709 709 | | CENSORED DEATHS | | NONE | | | ================================================================================== TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 727 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 175 NG/KG | | ---------------------------- | | | | TOTAL 53 UNCENSORED DEATHS 30 CENSORED DEATHS 1 TERMINAL 22 | | | | UNCENSORED DEATHS | | 385 405 436 448 454 481 487 496 500 530 | | 546 559 573 574 576 592 595 600 604 607 | | 611 658 658 658 658 659 660 660 660 720 | | CENSORED DEATHS | | 124 | | | |--------------------------------------------------------------------------------| | DOSE = 300 NG/KG | | ---------------------------- | | | | TOTAL 53 UNCENSORED DEATHS 36 CENSORED DEATHS 1 TERMINAL 16 | | | | UNCENSORED DEATHS | | 40 247 301 328 331 403 454 531 531 541 | | 546 554 554 599 607 607 607 618 618 630 | | 642 645 658 658 659 659 662 665 680 688 | | 688 709 715 719 722 722 | | CENSORED DEATHS | | 163 | | | |--------------------------------------------------------------------------------| | DOSE = 550 NG/KG | | ---------------------------- | | | | TOTAL 53 UNCENSORED DEATHS 30 CENSORED DEATHS 0 TERMINAL 23 | | | | UNCENSORED DEATHS | | 185 320 327 440 498 535 554 573 574 588 | | 614 618 618 618 628 637 651 651 667 678 | | 678 699 700 702 712 714 714 720 722 722 | | CENSORED DEATHS | | NONE | | | ================================================================================== TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 727 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1000 NG/KG | | ---------------------------- | | | | TOTAL 53 UNCENSORED DEATHS 46 CENSORED DEATHS 0 TERMINAL 7 | | | | UNCENSORED DEATHS | | 72 188 243 244 258 309 394 484 523 525 | | 530 531 547 555 562 574 588 588 603 603 | | 603 607 607 607 607 611 614 618 621 621 | | 621 630 642 650 650 660 663 663 681 688 | | 694 694 700 700 704 720 | | CENSORED DEATHS | | NONE | | | ================================================================================== TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) 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) | | | |--------------------------------------------------------------------------------| | | | |0 NG/KG | 100.0 98.1 94.2 86.4 80.5 80.5 70.7 55.0 38.9 30.7 | | | | | | | |30 NG/KG | 98.2 98.2 92.7 89.1 89.1 85.2 79.4 71.7 60.0 48.4 | | | | | | | |100 | 100.0 100.0 96.2 92.5 90.6 88.7 79.2 71.7 56.6 49.1 | |NG/KG | | | | | |175 | 100.0 100.0 100.0 100.0 96.2 88.5 80.8 63.5 44.2 42.3 | |NG/KG | | | | | |300 | 98.1 98.1 96.2 90.4 88.5 86.6 80.8 73.1 46.2 30.8 | |NG/KG | | | | | |550 | 100.0 100.0 98.1 94.3 94.3 92.5 88.7 81.1 66.0 43.4 | |NG/KG | | | | | |1000 | 98.1 98.1 90.6 88.7 86.8 84.9 77.4 60.4 28.3 13.2 | |NG/KG | | | | | ================================================================================== TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 727 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 NG/KG 30 NG/KG 100 175 300 550 1000 | | NG/KG NG/KG NG/KG NG/KG NG/KG | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 30.7% 48.4% 49.1% 42.3% 30.8% 43.4% 13.2% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.004 P=0.070N P=0.057N P=0.223N P=0.589N P=0.048N P=0.219 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 519.3 524.7 545.9 568.3 570.5 601.9 560.8 | |NATURAL DEATHS (C) | (25.6) (34.3) (28.3) (16.2) (25.8) (24.1) (22.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 567.4 607.5 634.8 625.8 610.1 656.2 582.8 | |(STANDARD ERROR) | (23.8) (22.9) (19.0) (17.1) (21.9) (16.1) (20.7) | | | | =============================================================================================================================== (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) TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) KAPLAN-MEIER SURVIVAL CURVES 0 NG/KG = 1 30 NG/KG = 2 100 NG/KG = 3 175 NG/KG = 4 300 NG/KG = 5 550 NG/KG = 6 1000 NG/KG = 7 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 5 72 13 4 | 5 72 13 1 2 3 5 6 4 4 | 7 1 2 3 752 3 163 4 44 | 7 2 1125 3 64 4 6 90 + 7 712512 3 5 2 4 4 6 6 | 7 1 1 175 2 2 5 44433 56 6 6 | 1 1 2 7423 73 | 2 2 2335 6 6 80 + 1 1 2432 3 6 66 | 1 17 274 2 P | 11 73 3 5 E | 1 1 77223 32 366 R 70 + 747 4 2 326 3 C | 111 445 5 E | 1 1 7 44 2 32 66 N | 1 1 4455 5 T 60 + 1 11 4 552 26 6 | 11 53 3232 66 S | 5 5 3232662 U | 11 4 4 3 3 R 50 + 11 1 322 V | 11 62 I | 1 1 55 4 V | 77 44 A 40 + 7 7 11 5 5 L | 77 1 1 55 | 7 7 1 1 55 | 11 30 + 1 1 | 7 77 | 77 | 20 + | 77 | 7 7 | 77 10 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 87 obs hidden.