TDMS Study 96021-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) DATE: 06/05/03
EXPERIMENT: 96021 TEST: 01 TIME: 10:40:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96021
PATHOLOGIST: SELLS, DONALD CAS: 35065-27-1
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14 WEEK SSAC FINAL#1
REASONS FOR REMOVAL: 25017 Scheduled Sacrifice
REMOVAL DATE RANGE: 112398 112498
TREATMENT GROUPS: INCLUDE 001 0 UG/KG
INCLUDE 002 10 UG/KG
INCLUDE 003 100 UG/KG
INCLUDE 004 300 UG/KG
INCLUDE 005 1000 UG/KG
INCLUDE 006 3000 UG/KG
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) DATE: 06/05/03
EXPERIMENT: 96021 TEST: 01 TIME: 10:40:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96021
PATHOLOGIST: SELLS, DONALD CAS: 35065-27-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TOXIC EQUIVALENCY FACTOR EVALUATION (
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Liver: Hepatocyte Hypertrophy
===============================================================
Date: 06/05/03 EXPERIMENT: 96021 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 9/10 (90%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 10/10.00 10/10.00 9/9.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 10/10 (100%) 10/10 (100%) 10/10 (100%) 9/10 (90%) 10/10 (100%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.701 (e) (e) P=0.500N (e) (e) |
|POLY 3 | P=0.712 (e) (e) P=0.490N (e) (e) |
|POLY 1.5 | P=0.707 (e) (e) P=0.485N (e) (e) |
|POLY 6 | P=0.723 (e) (e) P=0.503N (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.703 (e) (e) P=0.500N (e) (e) |
|ORDER RESTRICTED | P=0.508N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.01 0/0.01 0/0.01 0/0.01 9/9.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 92 (I) 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/05/03 EXPERIMENT: 96021 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 0/0.00 0/0.00 0/0.00 0/0.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|INT SACRIFICE 1 (c)| 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (I) --- --- --- --- 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 3/10 (30%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 2/2.01 3/3.01 1/1.01 1/1.01 0/0.01 4/4.01 |
|POLY-3 PERCENT (g) | 99.7% 99.8% 99.3% 99.3% 0.0% 99.9% |
|INT SACRIFICE 1 (c)| 2/10 (20%) 3/10 (30%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 4/10 (40%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (I) 92 (I) 92 (I) 92 (I) --- 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.150 P=0.500 P=0.500N P=0.500N P=0.234N P=0.317 |
|POLY 3 | P=0.100 P=0.354 P=0.300N P=0.300N P=0.067N P=0.203 |
|POLY 1.5 | P=0.102 P=0.357 P=0.305N P=0.305N P=0.070N P=0.206 |
|POLY 6 | P=0.100 P=0.355 P=0.300N P=0.300N P=0.067N P=0.204 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.148 P=0.500 P=0.500N P=0.500N P=0.237N P=0.314 |
|ORDER RESTRICTED | P=0.178 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/05/03 EXPERIMENT: 96021 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 5/5.00 0/0.00 0/0.00 0/0.00 0/0.00 2/2.01 |
|POLY-3 PERCENT (g) | 99.9% 0.0% 0.0% 0.0% 0.0% 99.7% |
|INT SACRIFICE 1 (c)| 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (I) --- --- --- --- 92 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.143N P=1.000N P=1.000 P=1.000 P=1.000N P=0.180N |
|POLY 3 | (e) (e) (e) (e) (e) P=0.099N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.101N |
|POLY 6 | (e) (e) (e) (e) (e) P=0.099N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.137N P=1.000 P=1.000 P=1.000 P=1.000 P=0.175N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).