TDMS Study 05094-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Southern Research Inst BUTYL BENZYL PHTHALATE DATE: 04/03/96
EXPERIMENT: 05094 TEST: 02 TIME: 07:26:55
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85222 ROUTE: DOSED FEED NTP C#: 54375C
PATHOLOGIST: DR J. E. HEATH CAS: 85-68-7
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Southern Research Inst BUTYL BENZYL PHTHALATE DATE: 04/03/96
EXPERIMENT: 05094 TEST: 02 TIME: 07:26:55
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85222 ROUTE: DOSED FEED NTP C#: 54375C
PATHOLOGIST: DR J. E. HEATH CAS: 85-68-7
BUTYL BENZYL PHTHALATE
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = UNTREATDCONTROL |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 22 CENSORED DEATHS 10 TERMINAL 28 |
| |
| UNCENSORED DEATHS |
| 255 261 438 477 479 541 544 557 562 576 |
| 593 607 611 614 631 631 644 662 677 717 |
| 718 718 |
| CENSORED DEATHS |
| 458 458 458 458 458 458 458 458 458 458 |
| |
|--------------------------------------------------------------------------------|
| DOSE = CONTROL FEED RTD |
| ---------------------------- |
| |
| TOTAL 59 UNCENSORED DEATHS 16 CENSORED DEATHS 10 TERMINAL 33 |
| |
| UNCENSORED DEATHS |
| 339 422 451 479 499 584 607 639 649 654 |
| 669 678 702 719 722 722 |
| CENSORED DEATHS |
| 458 458 458 458 458 458 458 458 458 458 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 0.3% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 30 CENSORED DEATHS 10 TERMINAL 20 |
| |
| UNCENSORED DEATHS |
| 303 450 477 499 499 519 541 544 550 565 |
| 569 584 586 601 607 607 607 611 626 627 |
| 644 645 649 678 694 698 708 708 723 723 |
| CENSORED DEATHS |
| 458 458 458 458 458 458 458 458 458 458 |
| |
==================================================================================
BUTYL BENZYL PHTHALATE
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0.6% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 28 CENSORED DEATHS 10 TERMINAL 22 |
| |
| UNCENSORED DEATHS |
| 400 494 542 542 569 574 592 611 614 628 |
| 651 655 670 674 681 681 683 684 697 697 |
| 701 702 702 703 708 717 722 723 |
| CENSORED DEATHS |
| 458 458 458 458 458 458 458 458 458 458 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 1.2% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 28 CENSORED DEATHS 10 TERMINAL 22 |
| |
| UNCENSORED DEATHS |
| 180 297 464 466 477 550 593 614 634 639 |
| 639 654 662 663 668 674 674 675 684 698 |
| 698 703 709 709 716 716 716 718 |
| CENSORED DEATHS |
| 458 458 458 458 458 458 458 458 458 458 |
| |
==================================================================================
BUTYL BENZYL PHTHALATE
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) |
| |
|--------------------------------------------------------------------------------|
| | |
|UNTREATDCON|ROL100.0 100.0 96.7 96.7 96.7 91.0 86.9 78.8 64.7 56.6 |
|U | |
| | |
|CONTROL | 100.0 100.0 100.0 98.3 96.6 92.9 90.8 88.7 80.5 68.1 |
|FEED RTD | |
| | |
|0.3% | 100.0 100.0 100.0 98.3 98.3 94.7 84.6 72.5 54.4 40.3 |
| | |
| | |
|0.6% | 100.0 100.0 100.0 100.0 98.3 98.3 92.3 86.3 76.3 44.1 |
| | |
| | |
|1.2% | 100.0 98.3 98.3 96.7 96.7 90.6 90.6 86.6 72.5 44.3 |
| | |
| | |
==================================================================================
BUTYL BENZYL PHTHALATE
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
===============================================================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|-----------------------------------------------------------------------------------------------------------------------------|
| DOSE |
| |
| UNTREATDCONTROL CONTROL 0.3% 0.6% 1.2% |
| U FEED RTD |
|-----------------------------------------------------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 56.6% 68.1% 40.3% 44.1% 44.3% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.140 ----- P=0.185 P=0.570 P=0.520 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 568.8 595.9 594.7 643.5 617.5 |
|NATURAL DEATHS (C) | (26.9) (30.2) (16.9) (14.9) (24.8) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 625.1 647.0 616.7 643.9 631.8 |
|(STANDARD ERROR) | (16.7) (15.7) (14.7) (13.8) (16.6) |
| | |
===============================================================================================================================
(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)
BUTYL BENZYL PHTHALATE
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 736 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = UNTREATDCONTROL |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 25 CENSORED DEATHS 10 TERMINAL 25 |
| |
| UNCENSORED DEATHS |
| 39 368 512 570 587 598 668 670 681 684 |
| 691 702 702 703 711 713 716 717 717 717 |
| 719 725 725 725 726 |
| CENSORED DEATHS |
| 459 459 459 459 459 459 459 459 459 459 |
| |
|--------------------------------------------------------------------------------|
| DOSE = CONTROL FEED RTD |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 9 CENSORED DEATHS 10 TERMINAL 41 |
| |
| UNCENSORED DEATHS |
| 225 491 551 586 721 722 722 731 733 |
| CENSORED DEATHS |
| 459 459 459 459 459 459 459 459 459 459 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 0.6% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 21 CENSORED DEATHS 10 TERMINAL 29 |
| |
| UNCENSORED DEATHS |
| 247 405 424 529 593 606 606 611 618 663 |
| 682 689 701 703 718 722 725 725 725 725 |
| 726 |
| CENSORED DEATHS |
| 459 459 459 459 459 459 459 459 459 459 |
| |
==================================================================================
BUTYL BENZYL PHTHALATE
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 736 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 1.2% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 21 CENSORED DEATHS 10 TERMINAL 29 |
| |
| UNCENSORED DEATHS |
| 285 479 509 544 544 551 572 607 646 647 |
| 647 666 670 703 722 724 725 725 726 726 |
| 733 |
| CENSORED DEATHS |
| 459 459 459 459 459 459 459 459 459 459 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 2.4% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 21 CENSORED DEATHS 10 TERMINAL 29 |
| |
| UNCENSORED DEATHS |
| 404 452 452 452 487 487 551 592 607 607 |
| 611 681 684 684 684 703 703 703 717 722 |
| 725 |
| CENSORED DEATHS |
| 459 459 459 459 459 459 459 459 459 459 |
| |
==================================================================================
BUTYL BENZYL PHTHALATE
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 736 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 736 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|UNTREATDCON|ROL 98.3 98.3 98.3 98.3 96.7 96.7 94.7 88.6 88.6 50.3 |
|U | |
| | |
|CONTROL | 100.0 100.0 98.3 98.3 98.3 98.3 96.3 92.3 92.3 82.3 |
|FEED RTD | |
| | |
|0.6% | 100.0 100.0 98.3 98.3 95.0 95.0 93.0 91.0 80.9 58.6 |
| | |
| | |
|1.2% | 100.0 100.0 100.0 98.3 98.3 96.3 90.3 86.3 78.3 58.2 |
| | |
| | |
|2.4% | 100.0 100.0 100.0 100.0 98.3 93.3 89.3 85.2 79.1 58.8 |
| | |
| | |
==================================================================================
BUTYL BENZYL PHTHALATE
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 736 DAYS
===============================================================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|-----------------------------------------------------------------------------------------------------------------------------|
| DOSE |
| |
| UNTREATDCONTROL CONTROL 0.6% 1.2% 2.4% |
| U FEED RTD |
|-----------------------------------------------------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 50.3% 82.3% 58.6% 58.2% 58.8% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.245 ----- P=0.567N P=0.596N P=0.759N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 643.4 609.1 625.9 626.2 605.1 |
|NATURAL DEATHS (C) | (30.3) (57.0) (28.1) (24.6) (23.7) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 651.3 670.8 651.3 651.4 644.0 |
|(STANDARD ERROR) | (17.6) (15.9) (16.1) (15.5) (15.5) |
| | |
===============================================================================================================================
(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)
BUTYL BENZYL PHTHALATE
KAPLAN-MEIER SURVIVAL CURVES
UNTREATDCONTROL = 1
CONTROL FEED RTD = 2
0.3% = 3
0.6% = 4
1.2% = 5
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 5 1 3 2 4
| 5 11 53 2 4 2 1 2 5 3 4 4
| 1 2 1 3
| 5 2 2 4 4
P 90 + 1 2 3 15 2
E | 3 151 4 2 4 24 2
R | 3311 5 522
C | 3 1 1 4 45522
E 80 + 331 1 1 4 42 2
N | 3 3 11 544 522 2
T | 3 3 44 2 2
| 331 1 5544 22
S 70 + 55
U | 33 11 1 2 2
R | 3 3 1 14 4
V | 15 5 1
I 60 + 3 3 44
V | 33 5551 1
A | 3 3
L | 3 3445
50 + 44
| 3 344
| 353 4
|
40 + 3 3
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 35 obs hidden.
BUTYL BENZYL PHTHALATE
KAPLAN-MEIER SURVIVAL CURVES
UNTREATDCONTROL = 1
CONTROL FEED RTD = 2
0.6% = 3
1.2% = 4
2.4% = 5
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
100 + 1 1 2 3 4 5
| 1 2 3 4 1 3 5 4 2
|
| 1 3 3 4 2 41 2
95 + 3 1 3 1
| 5 5 4 42 2
| 3 1 1 3 2
| 1 313
90 + 44 22
| 5 4 4 1 1
| 5 5 33
| 4 4 2 2
P 85 + 5 533 1 1
E | 4 4
R | 3 3 22
C | 55 3 3
E 80 + 11
N | 5 4 4 31 1
T |
| 3 3
S 75 +
U | 4 4
R | 1134
V | 5 5 33
I 70 +
V | 11
A |
L |
65 + 5 5
|
| 55
|
60 + 4 4
| 11 43
|
|
55 +
|
|
|
50 + 1 1
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 15 obs hidden.