TDMS Study 05211-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst EMODIN DATE: 03/26/99
EXPERIMENT: 05211 TEST: 05 TIME: 08:45:14
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-85216 ROUTE: DOSED FEED NTP C#: C62408
PATHOLOGIST: HEATH, JAMES CAS: 518-82-1
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27 WEEK SSAC
REASONS FOR REMOVAL: 25017 Scheduled Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst EMODIN DATE: 03/26/99
EXPERIMENT: 05211 TEST: 05 TIME: 08:45:14
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-85216 ROUTE: DOSED FEED NTP C#: C62408
PATHOLOGIST: HEATH, JAMES CAS: 518-82-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF EMODIN
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Kidney: Renal Tubule Hyaline Droplet
===============================================================
Female Rats
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Organ Morphology
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Hyaline Droplet
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Date: 03/26/99 EXPERIMENT: 05211 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/10 (90%) 9/10 (90%) 10/10 (100%) 8/10 (80%) |1/10 (10%) 2/10 (20%) 1/10 (10%) 3/10 (30%) |
|POLY-3 ADJUSTED (b)| 99.9% 99.9% 100.0% 99.8% |94.4% 97.4% 94.4% 98.5% |
|INT SACRIFICE 1 (c)| 9/10 (90%) 9/10 (90%) 10/10 (100%) 8/10 (80%) |1/10 (10%) 2/10 (20%) 1/10 (10%) 3/10 (30%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 185 (I) 185 (I) 185 (I) 185 (I) |187 (I) 187 (I) 187 (I) 187 (I) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.327N P=0.766 P=0.500 P=0.500N |P=0.231 P=0.500 P=0.766 P=0.293 |
|POLY 3 | P=0.297N P=0.738 P=0.478 P=0.463N |P=0.159 P=0.300 P=0.530 P=0.153 |
|POLY 1.5 | P=0.300N P=0.740 P=0.480 P=0.466N |P=0.166 P=0.316 P=0.549 P=0.163 |
|POLY 6 | P=0.297N P=0.738 P=0.478 P=0.463N |P=0.158 P=0.299 P=0.528 P=0.152 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.325N P=0.763N P=0.500 P=0.500N |P=0.228 P=0.500 P=0.763N P=0.291 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%)|6/10 (60%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 ADJUSTED (b)| 0.0% 100.0% 100.0% 100.0% |99.6% 100.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%)|6/10 (60%) 10/10 (100%) 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%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 185 (I) 185 (I) 185 (I) |187 (I) 187 (I) 187 (I) 187 (I) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.068 P=0.051 P=0.051 P=0.051 |
|POLY 3 | P=1.000N P=1.000N P=1.000N P=1.000N |P=0.040 * P=0.022 * P=0.022 * P=0.022 * |
|POLY 1.5 | P=1.000N P=1.000N P=1.000N P=1.000N |P=0.040 * P=0.023 * P=0.023 * P=0.023 * |
|POLY 6 | P=1.000N P=1.000N P=1.000N P=1.000N |P=0.040 * P=0.022 * P=0.022 * P=0.022 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.066 P=0.043 * P=0.043 * P=0.043 * |
|=================================================================================================================================|
Date: 03/26/99 EXPERIMENT: 05211 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - EMODIN
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%)|10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 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%) 10/10 (100%)|10/10 (100%) 10/10 (100%) 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%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 185 (I) 185 (I) 185 (I) 185 (I) |187 (I) 187 (I) 187 (I) 187 (I) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 280 830 2500 |0 280 830 2500 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |2/10 (20%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 94.6% 0.0% |97.4% 0.0% 94.4% 94.4% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |2/10 (20%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 185 (I) --- |187 (I) --- 187 (I) 187 (I) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.784N (e) P=0.500 (e) |P=0.617N P=0.234N P=0.500N P=0.500N |
|POLY 3 | P=0.472N (e) P=0.160 (e) |P=0.460N P=0.067N P=0.300N P=0.300N |
|POLY 1.5 | P=0.498N (e) P=0.183 (e) |P=0.471N P=0.077N P=0.316N P=0.316N |
|POLY 6 | P=0.470N (e) P=0.159 (e) |P=0.458N P=0.067N P=0.299N P=0.299N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.787N (e) P=0.500 (e) |P=0.619N P=0.237N P=0.500N P=0.500N |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(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.
(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).