TDMS Study 55312-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus COCONUT OIL ACID DIETHANOLAMINE CONDENSATE DATE: 09/18/97 EXPERIMENT: 55312 TEST: 04 TIME: 08:25:34 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55312B PATHOLOGIST: SINGER, A. CAS: 68603-42-9 ------------------------------------------------------------------------------------------------------------------------------------ 2 YEAR CHRONIC REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus COCONUT OIL ACID DIETHANOLAMINE CONDENSATE DATE: 09/18/97 EXPERIMENT: 55312 TEST: 04 TIME: 08:25:34 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55312B PATHOLOGIST: SINGER, A. CAS: 68603-42-9 COCONUT OIL ACID DIETHANOLAMINE CONDENSATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 727 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 9 CENSORED DEATHS 0 TERMINAL 41 | | | | UNCENSORED DEATHS | | 420 490 584 612 618 645 664 673 700 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 100 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 37 | | | | UNCENSORED DEATHS | | 304 356 454 507 576 617 645 652 653 653 | | 692 696 711 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 200 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 401 456 505 555 595 597 630 662 667 692 | | 692 710 713 722 | | CENSORED DEATHS | | NONE | | | ================================================================================== COCONUT OIL ACID DIETHANOLAMINE CONDENSATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE 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 MG/KG | 100.0 100.0 100.0 100.0 98.0 98.0 96.0 94.0 86.0 82.0 | | | | | | | |100 | 100.0 100.0 100.0 96.0 96.0 94.0 92.0 90.0 80.0 74.0 | |MG/KG | | | | | |200 | 100.0 100.0 100.0 100.0 98.0 96.0 94.0 88.0 84.0 72.0 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 100 200 | | MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 82.0% 74.0% 72.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.318 P=0.456 P=0.356 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 600.7 578.2 614.1 | |NATURAL DEATHS (C) | (30.4) (36.9) (27.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 704.3 688.3 695.4 | |(STANDARD ERROR) | ( 8.7) (13.2) (10.4) | | | | ================================================================================== (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) COCONUT OIL ACID DIETHANOLAMINE CONDENSATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 429 479 506 568 589 617 664 679 681 687 | | 701 702 713 719 726 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 100 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 473 553 561 567 584 611 616 618 629 644 | | 649 678 680 691 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 200 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 24 CENSORED DEATHS 0 TERMINAL 26 | | | | UNCENSORED DEATHS | | 98 366 422 506 552 564 567 580 610 610 | | 621 630 632 649 653 653 661 665 672 701 | | 702 711 722 728 | | CENSORED DEATHS | | NONE | | | ================================================================================== COCONUT OIL ACID DIETHANOLAMINE CONDENSATE 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) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 100.0 100.0 96.0 94.0 90.0 86.0 70.0 | | | | | | | |100 | 100.0 100.0 100.0 100.0 100.0 98.0 98.0 90.0 78.0 72.0 | |MG/KG | | | | | |200 | 100.0 98.0 98.0 98.0 94.0 94.0 92.0 84.0 64.0 52.0 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 100 200 | | MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 70.0% 72.0% 52.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.056 P=1.000N P=0.070 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 630.7 611.0 594.8 | |NATURAL DEATHS (C) | (24.7) (15.9) (28.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 699.5 696.0 664.6 | |(STANDARD ERROR) | ( 9.7) ( 8.7) (16.5) | | | | ================================================================================== (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) COCONUT OIL ACID DIETHANOLAMINE CONDENSATE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 100 MG/KG = 2 200 MG/KG = 3 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 3 1 | | 2 2 3 1 3 1 | 96 + 2 23 1 3 1 | P | 2 2 3 1 1 E | R 92 + 2 3 2 3 11 C | E | 2 33 1 1 N | T 88 + 3 23 1 1 | S | 3 22 1 1 U | R 84 + 331 1 V | I | 3 31 1 V | A 80 + 2 2 L | | 22 3 | 76 + 2 2 | | 2 2 | 72 + 3 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 9 obs hidden. COCONUT OIL ACID DIETHANOLAMINE CONDENSATE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 100 MG/KG = 2 200 MG/KG = 3 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 1 2 | | 3 3 1 21 2 | 3 3 1 1 2 2 95 + | 3 1 1 | 3 3 21 2 1 | 90 + 3 3 2 1 21 | | 1 1 | 3 3 22 1 1 P 85 + E | 3 322 11 R | 2 2 11 C | E 80 + 33 22 1 1 N | T | 33 2 2 | 33 22 11 S 75 + U | 3 3 22 11 R | 33 2 11 2 V | I 70 + 1 1 V | A | 3 3 L | 65 + | 33 | 3 3 | 60 + | | 33 | 3 3 55 + | | 3 3 | 50 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 3 obs hidden.