TDMS Study 05196-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: TSI Mason Research SODIUM SELENITE DATE: 10/19/04
EXPERIMENT: 05196 TEST: 04 TIME: 07:25:34
TEST TYPE: SUBCHRON 90-DAY PAGE: 1
CONT: N01-ES-75146 ROUTE: DOSED WATER NTP C#: C04308
PATHOLOGIST: F. VOELKER M. GOAD CAS: 10102-18-8
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REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 PPM
INCLUDE 002 0 PPM
INCLUDE 003 2 PPM
INCLUDE 004 2 PPM
INCLUDE 005 4 PPM
INCLUDE 006 4 PPM
INCLUDE 007 8 PPM
INCLUDE 008 8 PPM
INCLUDE 009 16 PPM
INCLUDE 010 16 PPM
INCLUDE 011 32 PPM
INCLUDE 012 32 PPM
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: TSI Mason Research SODIUM SELENITE DATE: 10/19/04
EXPERIMENT: 05196 TEST: 04 TIME: 07:25:34
TEST TYPE: SUBCHRON 90-DAY
CONT: N01-ES-75146 ROUTE: DOSED WATER NTP C#: C04308
PATHOLOGIST: F. VOELKER M. GOAD CAS: 10102-18-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF SODIUM SELENITE
===============================================================
Male Mice
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Organ Morphology
----- ----------
Lung Adrenal Gland Medulla
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Date: 10/19/04 EXPERIMENT: 05196 TEST: 04 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.642 P=1.000N P=1.000N P=1.000N P=1.000N P=0.766 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.760 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.760 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.760 |
|LOGISTIC REGRESSION| P=0.642 (e) (e) (e) (e) P=0.766 |
|COCH-ARM / FISHERS | P=0.645 P=1.000 P=1.000 P=1.000 P=1.000 P=0.763N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 5/10.00 0/0.00 1/1.00 0/0.00 0/0.00 4/10.00 |
|POLY-3 PERCENT (g) | 50.0% 0.0% 100.0% 0.0% 0.0% 40.0% |
|TERMINAL (d) | 5/10 (50%) 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|FIRST INCIDENCE | 92 (T) --- 92 (T) --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.350N P=1.000N P=0.536 P=1.000N P=1.000N P=0.500N |
|POLY 3 | (e) (e) P=0.536 (e) (e) P=0.500N |
|POLY 1.5 | (e) (e) P=0.536 (e) (e) P=0.500N |
|POLY 6 | (e) (e) P=0.536 (e) (e) P=0.500N |
|LOGISTIC REGRESSION| P=0.350N (e) P=0.536 (e) (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.347N P=1.000 P=0.545 P=1.000 P=1.000 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 04 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Adrenal Gland Medulla |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 5/10.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 0.0% 50.0% |
|TERMINAL (d) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.048 * P=1.000N P=1.000N P=1.000N P=1.000N P=0.077 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.061 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.061 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.061 |
|LOGISTIC REGRESSION| P=0.048 * (e) (e) (e) (e) P=0.077 |
|COCH-ARM / FISHERS | P=0.044 * P=1.000 P=1.000 P=1.000 P=1.000 P=0.070 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Adrenal Gland Medulla |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) |
|POLY-3 RATE (b) | 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 3/10.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 0.0% 30.0% |
|TERMINAL (d) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.207 P=1.000N P=1.000N P=1.000N P=1.000N P=0.293 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.292 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.292 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.292 |
|LOGISTIC REGRESSION| P=0.207 (e) (e) (e) (e) P=0.293 |
|COCH-ARM / FISHERS | P=0.201 P=1.000 P=1.000 P=1.000 P=1.000 P=0.291 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 04 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Salivary Glands |
| Stomach Forestomach |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|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 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Salivary Glands |
| Stomach Forestomach |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 2/10.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.607 P=1.000N P=1.000N P=1.000N P=1.000N P=0.707 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.702 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.702 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.702 |
|LOGISTIC REGRESSION| P=0.607 (e) (e) (e) (e) P=0.707 |
|COCH-ARM / FISHERS | P=0.610 P=1.000 P=1.000 P=1.000 P=1.000 P=0.709N |
|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).