TDMS Study 89029-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: I. I. T. Research Inst MAGNETIC FIELDS (EMF) DATE: 10/25/04
EXPERIMENT: 89029 TEST: 01 TIME: 11:32:02
TEST TYPE: SUBCHRON 8-WEEK PAGE: 1
CONT: N01-ES-25351 ROUTE: MAGNETIC FIELDS NTP C#: C89029
PATHOLOGIST: BRENNECKE, L. CAS: ELECTROMAG
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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: I. I. T. Research Inst MAGNETIC FIELDS (EMF) DATE: 10/25/04
EXPERIMENT: 89029 TEST: 01 TIME: 11:32:02
TEST TYPE: SUBCHRON 8-WEEK
CONT: N01-ES-25351 ROUTE: MAGNETIC FIELDS NTP C#: C89029
PATHOLOGIST: BRENNECKE, L. CAS: ELECTROMAG
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF MAGNETIC FIELDS (EMF)
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Lung Hemorrhage
Pancreas: Acinus Atrophy
===============================================================
Date: 10/25/04 EXPERIMENT: 89029 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - MAGNETIC FIELDS (EMF)
Terminal Sacrifice at 9 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 |
| | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS |
|=================================================================================================================================|
| |
|Harderian Gland |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 3/20 (15%) |1/10 (10%) 1/10 (10%) 0/10 (0%) 1/20 (5%) |
|POLY-3 RATE (b) | 1/10.00 0/10.00 0/10.00 3/20.00 |1/10.00 1/10.00 0/9.57 1/20.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 15.0% |10.0% 10.0% 0.0% 5.0% |
|TERMINAL (d) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 3/20 (15%) |1/10 (10%) 1/10 (10%) 0/9 (0%) 1/20 (5%) |
|FIRST INCIDENCE | 58 (T) --- --- 58 (T) |59 (T) 59 (T) --- 59 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.175 P=0.500N P=0.500N P=0.574 |P=0.533N P=0.766 P=0.521N P=0.600N |
|POLY 3 | P=0.175 P=0.500N P=0.500N P=0.573 |P=0.532N P=0.760 P=0.509N P=0.599N |
|POLY 1.5 | P=0.175 P=0.500N P=0.500N P=0.573 |P=0.535N P=0.760 P=0.505N P=0.599N |
|POLY 6 | P=0.175 P=0.500N P=0.500N P=0.573 |P=0.527N P=0.760 P=0.514N P=0.599N |
|LOGISTIC REGRESSION| P=0.175 (e) (e) P=0.574 |P=0.533N P=0.766 (e) P=0.600N |
|COCH-ARM / FISHERS | P=0.172 P=0.500N P=0.500N P=0.593 |P=0.541N P=0.763N P=0.500N P=0.563N |
|ORDER RESTRICTED | P=0.218 (e) (e) (e) |P=0.389N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 |
| | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/10 (70%) 4/10 (40%) 5/10 (50%) 13/20 (65%) |1/10 (10%) 0/10 (0%) 0/10 (0%) 2/20 (10%) |
|POLY-3 RATE (b) | 7/10.00 4/10.00 5/10.00 13/20.00 |1/10.00 0/10.00 0/9.57 2/20.00 |
|POLY-3 PERCENT (g) | 70.0% 40.0% 50.0% 65.0% |10.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 7/10 (70%) 4/10 (40%) 5/10 (50%) 13/20 (65%) |1/10 (10%) 0/10 (0%) 0/9 (0%) 2/20 (10%) |
|FIRST INCIDENCE | 58 (T) 58 (T) 58 (T) 58 (T) |59 (T) --- --- 59 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.304 P=0.190N P=0.328N P=0.554N |P=0.369 P=0.500N P=0.521N P=0.737 |
|POLY 3 | P=0.305 P=0.186N P=0.329N P=0.553N |P=0.366 P=0.500N P=0.509N P=0.734 |
|POLY 1.5 | P=0.305 P=0.186N P=0.329N P=0.553N |P=0.364 P=0.500N P=0.505N P=0.734 |
|POLY 6 | P=0.305 P=0.186N P=0.329N P=0.553N |P=0.367 P=0.500N P=0.514N P=0.734 |
|LOGISTIC REGRESSION| P=0.304 P=0.190N P=0.328N P=0.554N |P=0.369 (e) (e) P=0.737 |
|COCH-ARM / FISHERS | P=0.302 P=0.185N P=0.325N P=0.560N |P=0.360 P=0.500N P=0.500N P=0.719N |
|ORDER RESTRICTED | P=0.356N (e) (e) (e) |P=0.386 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/25/04 EXPERIMENT: 89029 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - MAGNETIC FIELDS (EMF)
Terminal Sacrifice at 9 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 |
| | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 2/20 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/20.00 |0/10.00 0/10.00 0/9.57 2/20.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) |0/10 (0%) 0/10 (0%) 0/9 (0%) 2/20 (10%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 59 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.138 (e) (e) P=0.400 |
|POLY 3 | (e) (e) (e) (e) |P=0.134 (e) (e) P=0.400 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.133 (e) (e) P=0.400 |
|POLY 6 | (e) (e) (e) (e) |P=0.134 (e) (e) P=0.400 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.400 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.131 (e) (e) P=0.437 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.151 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 |
| | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/20 (15%) |3/10 (30%) 0/10 (0%) 1/10 (10%) 0/20 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 1/10.00 3/20.00 |3/10.00 0/10.00 1/9.57 0/20.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.0% 15.0% |30.0% 0.0% 10.5% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/20 (15%) |3/10 (30%) 0/10 (0%) 1/9 (11%) 0/20 (0%) |
|FIRST INCIDENCE | --- --- 58 (T) 58 (T) |59 (T) --- 59 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123 (e) P=0.500 P=0.263 |P=0.095N P=0.111N P=0.333N P=0.028N* |
|POLY 3 | P=0.123 (e) P=0.500 P=0.261 |P=0.080N P=0.095N P=0.308N P=0.017N* |
|POLY 1.5 | P=0.123 (e) P=0.500 P=0.261 |P=0.081N P=0.095N P=0.301N P=0.017N* |
|POLY 6 | P=0.123 (e) P=0.500 P=0.261 |P=0.078N P=0.095N P=0.318N P=0.017N* |
|LOGISTIC REGRESSION| (e) (e) P=0.500 P=0.263 |P=0.095N (e) P=0.333N (e) |
|COCH-ARM / FISHERS | P=0.121 (e) P=0.500 P=0.281 |P=0.095N P=0.105N P=0.291N P=0.030N* |
|ORDER RESTRICTED | P=0.126 (e) (e) (e) |P=0.002N** (e) (e) (e) |
|=================================================================================================================================|
Date: 10/25/04 EXPERIMENT: 89029 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - MAGNETIC FIELDS (EMF)
Terminal Sacrifice at 9 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 |
| | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/10 (0%) 1/10 (10%) 2/10 (20%) 2/20 (10%) |
|POLY-3 RATE (b) | |0/10.00 1/10.00 2/9.57 2/20.00 |
|POLY-3 PERCENT (g) | |0.0% 10.0% 20.9% 10.0% |
|TERMINAL (d) | |0/10 (0%) 1/10 (10%) 2/9 (22%) 2/20 (10%) |
|FIRST INCIDENCE | |--- 59 (T) 59 (T) 59 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.589 P=0.500 P=0.210 P=0.400 |
|POLY 3 | |P=0.577 P=0.500 P=0.216 P=0.400 |
|POLY 1.5 | |P=0.578 P=0.500 P=0.220 P=0.400 |
|POLY 6 | |P=0.576 P=0.500 P=0.210 P=0.400 |
|LOGISTIC REGRESSION| |(e) P=0.500 P=0.210 P=0.400 |
|COCH-ARM / FISHERS | |P=0.581 P=0.500 P=0.237 P=0.437 |
|ORDER RESTRICTED | |P=0.204 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 |
| | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) |2/10 (20%) 0/10 (0%) 0/10 (0%) 1/20 (5%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/20.00 |2/10.00 0/10.00 0/9.57 1/20.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |20.0% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) |2/10 (20%) 0/10 (0%) 0/9 (0%) 1/20 (5%) |
|FIRST INCIDENCE | --- --- --- --- |59 (T) --- --- 59 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.532N P=0.234N P=0.257N P=0.263N |
|POLY 3 | (e) (e) (e) (e) |P=0.532N P=0.227N P=0.237N P=0.261N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.536N P=0.227N P=0.232N P=0.261N |
|POLY 6 | (e) (e) (e) (e) |P=0.527N P=0.227N P=0.243N P=0.261N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.532N (e) (e) P=0.263N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.540N P=0.237N P=0.237N P=0.251N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.044N* (e) (e) (e) |
|=================================================================================================================================|
Date: 10/25/04 EXPERIMENT: 89029 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - MAGNETIC FIELDS (EMF)
Terminal Sacrifice at 9 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 |
| | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/20 (5%) |1/10 (10%) 0/10 (0%) 2/10 (20%) 2/20 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 1/20.00 |1/10.00 0/10.00 2/9.57 2/20.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.0% |10.0% 0.0% 20.9% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/20 (5%) |1/10 (10%) 0/10 (0%) 2/9 (22%) 2/20 (10%) |
|FIRST INCIDENCE | --- --- --- 58 (T) |59 (T) --- 59 (T) 59 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.365 (e) (e) P=0.638 |P=0.590 P=0.500N P=0.461 P=0.737 |
|POLY 3 | P=0.367 (e) (e) P=0.637 |P=0.578 P=0.500N P=0.484 P=0.734 |
|POLY 1.5 | P=0.367 (e) (e) P=0.637 |P=0.579 P=0.500N P=0.491 P=0.734 |
|POLY 6 | P=0.367 (e) (e) P=0.637 |P=0.577 P=0.500N P=0.475 P=0.734 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.638 |P=0.590 (e) P=0.461 P=0.737 |
|COCH-ARM / FISHERS | P=0.364 (e) (e) P=0.667 |P=0.582 P=0.500N P=0.500 P=0.719N |
|ORDER RESTRICTED | P=0.296 (e) (e) (e) |P=0.380 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 |
| | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS |
|=================================================================================================================================|
| |
|Thymus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 2/10 (20%) 5/20 (25%) |2/10 (20%) 2/10 (20%) 1/10 (10%) 2/20 (10%) |
|POLY-3 RATE (b) | 1/10.00 1/10.00 2/10.00 5/20.00 |2/10.00 2/10.00 1/10.00 2/20.00 |
|POLY-3 PERCENT (g) | 10.0% 10.0% 20.0% 25.0% |20.0% 20.0% 10.0% 10.0% |
|TERMINAL (d) | 1/10 (10%) 1/10 (10%) 2/10 (20%) 5/20 (25%) |2/10 (20%) 2/10 (20%) 0/9 (0%) 2/20 (10%) |
|FIRST INCIDENCE | 58 (T) 58 (T) 58 (T) 58 (T) |59 (T) 59 (T) 49 59 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.207 P=0.766 P=0.500 P=0.317 |P=0.333N P=0.707 P=0.525N P=0.426N |
|POLY 3 | P=0.210 P=0.760 P=0.500 P=0.317 |P=0.341N P=0.702 P=0.500N P=0.427N |
|POLY 1.5 | P=0.210 P=0.760 P=0.500 P=0.317 |P=0.341N P=0.702 P=0.500N P=0.427N |
|POLY 6 | P=0.210 P=0.760 P=0.500 P=0.317 |P=0.341N P=0.702 P=0.500N P=0.427N |
|LOGISTIC REGRESSION| P=0.207 P=0.766 P=0.500 P=0.317 |P=0.333N P=0.707 (e) P=0.426N |
|COCH-ARM / FISHERS | P=0.204 P=0.763N P=0.500 P=0.326 |P=0.337N P=0.709N P=0.500N P=0.407N |
|ORDER RESTRICTED | P=0.261 (e) (e) (e) |P=0.377N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/25/04 EXPERIMENT: 89029 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - MAGNETIC FIELDS (EMF)
Terminal Sacrifice at 9 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 |
| | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/10 (10%) 1/10 (10%) 2/10 (20%) 7/20 (35%) |
|POLY-3 RATE (b) | |1/10.00 1/10.00 2/10.00 7/20.00 |
|POLY-3 PERCENT (g) | |10.0% 10.0% 20.0% 35.0% |
|TERMINAL (d) | |1/10 (10%) 1/10 (10%) 1/9 (11%) 7/20 (35%) |
|FIRST INCIDENCE | |59 (T) 59 (T) 49 59 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.067 P=0.766 P=0.475 P=0.158 |
|POLY 3 | |P=0.056 P=0.760 P=0.500 P=0.153 |
|POLY 1.5 | |P=0.056 P=0.760 P=0.500 P=0.153 |
|POLY 6 | |P=0.056 P=0.760 P=0.500 P=0.153 |
|LOGISTIC REGRESSION| |P=0.067 P=0.766 (e) P=0.158 |
|COCH-ARM / FISHERS | |P=0.056 P=0.763N P=0.500 P=0.154 |
|ORDER RESTRICTED | |P=0.095 (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).