TDMS Study 05206-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus CUPRIC SULFATE DATE: 10/15/04
EXPERIMENT: 05206 TEST: 06 TIME: 08:27:45
TEST TYPE: SUBCHRON 90-DAY PAGE: 1
CONT: NO1ES75169 ROUTE: DOSED FEED NTP C#: 62191B
PATHOLOGIST: M. RYAN CAS: 7758-99-8
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REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus CUPRIC SULFATE DATE: 10/15/04
EXPERIMENT: 05206 TEST: 06 TIME: 08:27:45
TEST TYPE: SUBCHRON 90-DAY
CONT: NO1ES75169 ROUTE: DOSED FEED NTP C#: 62191B
PATHOLOGIST: M. RYAN CAS: 7758-99-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF CUPRIC SULFATE
===============================================================
Male Mice
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Organ Morphology
----- ----------
Adrenal Gland Cortex Hyperplasia
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Hyperplasia
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Date: 10/15/04 EXPERIMENT: 05206 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CUPRIC SULFATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM 16,000 |
| | PPM |
|=================================================================================================================================|
| |
|Adrenal Gland Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 6/10 (60%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 2/10.00 6/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 20.0% 60.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 6/10 (60%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- 92 (T) 92 (T) 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.234 P=0.009 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.227 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.227 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.227 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.234 P=0.009 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.237 P=0.005 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM 16,000 |
| | PPM |
|=================================================================================================================================|
| |
|Adrenal Gland Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 5/10 (50%) 8/10 (80%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/10.00 5/10.00 8/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 50.0% 80.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 5/10 (50%) 8/10 (80%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- 92 (T) 92 (T) 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.022 * P<0.001 ** P<0.001 ** |
|POLY 3 | (e) (e) (e) P=0.008 ** P<0.001 ** P<0.001N** |
|POLY 1.5 | (e) (e) (e) P=0.008 ** P<0.001 ** P<0.001N** |
|POLY 6 | (e) (e) (e) P=0.008 ** P<0.001 ** P<0.001N** |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.022 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.016 * P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05206 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - CUPRIC SULFATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM 16,000 |
| | PPM |
|=================================================================================================================================|
| |
|Urinary Bladder: Adrenal Gland Medulla |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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 PPM 1000 PPM 2000 PPM 4000 PPM 8000 PPM 16,000 |
| | PPM |
|=================================================================================================================================|
| |
|Urinary Bladder: Adrenal Gland Medulla |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 3/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.064N P=1.000N P=1.000N P=1.000N P=1.000N P=0.111N |
|POLY 3 | (e) (e) (e) (e) (e) P=0.095N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.095N |
|POLY 6 | (e) (e) (e) (e) (e) P=0.095N |
|LOGISTIC REGRESSION| P=0.064N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.059N P=1.000 P=1.000 P=1.000 P=1.000 P=0.105N |
|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).