TDMS Study 05195-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: TSI Mason Research SODIUM SELENATE DATE: 10/19/04
EXPERIMENT: 05195 TEST: 03 TIME: 06:59:52
TEST TYPE: SUBCHRON 90-DAY PAGE: 1
CONT: N01ES75146 ROUTE: DOSED WATER NTP C#: C62113
PATHOLOGIST: F. VOELKER S. EUSTIS M. CAS: 13410-01-0
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 PPM
INCLUDE 002 0 PPM
INCLUDE 003 3.75 PPM
INCLUDE 004 3.75 PPM
INCLUDE 005 7.5 PPM
INCLUDE 006 7.5 PPM
INCLUDE 007 15 PPM
INCLUDE 008 15 PPM
INCLUDE 009 30 PPM
INCLUDE 010 30 PPM
INCLUDE 011 60 PPM
INCLUDE 012 60 PPM
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: TSI Mason Research SODIUM SELENATE DATE: 10/19/04
EXPERIMENT: 05195 TEST: 03 TIME: 06:59:52
TEST TYPE: SUBCHRON 90-DAY
CONT: N01ES75146 ROUTE: DOSED WATER NTP C#: C62113
PATHOLOGIST: F. VOELKER S. EUSTIS M. CAS: 13410-01-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF SODIUM SELENATE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia
Vacuolization Cytoplasmic
Bone Marrow: Femoral Depletion Cellular
Pigmentation Hemosiderin
Bone: Distal, Femur, Metaphysis Atrophy
Epididymis: Lumen Degeneration
Heart Cardiomyopathy
Kidney Mineralization Focal
Kidney: Papilla Degeneration
Kidney: Renal Tubule Dilatation Focal
Liver Hematopoietic Cell Proliferation Focal
Hepatodiaphragmatic Nodule
Necrosis Focal
Lymph Node, Mandibular: Lymphocyte Depletion Cellular
Lymph Node, Mesenteric: Lymphocyte Depletion Cellular
Pancreas Atrophy
Preputial Gland Atrophy
Salivary Glands Atrophy
Seminal Vesicle Atrophy
Spleen: Lymphocyte Depletion Cellular
Stomach, Forestomach: Mucosa Erosion Focal
Stomach, Glandular: Mucosa Hemorrhage Focal
Testes: Germinal Epithelium Degeneration
Thymus Depletion Lymphoid
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Bone Marrow: Femoral Depletion Cellular
Pigmentation Hemosiderin
Bone: Distal, Femur, Metaphysis Atrophy
Clitoral Gland Atrophy
Kidney Mineralization Focal
Kidney: Papilla Degeneration
Liver Hematopoietic Cell Proliferation Focal
Hepatodiaphragmatic Nodule
Inflammation Focal
Necrosis Focal
Lymph Node, Mandibular: Lymphocyte Depletion Cellular
Lymph Node, Mesenteric Hyperplasia Lymphoid
Lymph Node, Mesenteric: Lymphocyte Depletion Cellular
Mammary Gland Atrophy
Ovary Cyst
Ovary: Interstitium Atrophy
Pancreas Atrophy
Salivary Glands Atrophy
Spleen: Lymphocyte Depletion Cellular
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: TSI Mason Research SODIUM SELENATE DATE: 10/19/04
EXPERIMENT: 05195 TEST: 03 TIME: 06:59:52
TEST TYPE: SUBCHRON 90-DAY
CONT: N01ES75146 ROUTE: DOSED WATER NTP C#: C62113
PATHOLOGIST: F. VOELKER S. EUSTIS M. CAS: 13410-01-0
Stomach, Glandular: Mucosa Hemorrhage Focal
Thymus Depletion Lymphoid
Uterus: Endometrium Atrophy
===============================================================
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 2/3.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 63.6% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** (e) (e) (e) (e) P=0.136 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.059 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.091 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.046 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.089 (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 0/0.51 |
|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%) 0/10 (0%) 0/0 (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) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/10 (80%) 0/10 (0%) |
|POLY-3 RATE (b) | 10/10.00 0/0.00 0/0.00 0/0.00 8/10.00 0/1.22 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 80.0% 0.0% |
|TERMINAL (d) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/10 (80%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.234N (e) (e) (e) P=0.234N P=1.000N |
|POLY 3 | (e) (e) (e) (e) P=0.227N P=0.017N* |
|POLY 1.5 | (e) (e) (e) (e) P=0.227N P<0.001N** |
|POLY 6 | (e) (e) (e) (e) P=0.227N P=0.782N |
|LOGISTIC REGRESSION| P=0.234N (e) (e) (e) P=0.234N (e) |
|COCH-ARM / FISHERS | P<0.001N** (e) (e) (e) P=0.237N P<0.001N** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 0/0.51 |
|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%) 0/10 (0%) 0/0 (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) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow: Femoral |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 9/10 (90%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/10.00 9/10.00 9/9.10 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 90.0% 98.9% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 9/10 (90%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 92 (T) 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P<0.001 ** P=0.494 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow: Femoral |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/10.00 3/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 30.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 92 (T) 92 (T) 23 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.111 P<0.001 ** P<0.001 ** |
|POLY 3 | (e) (e) (e) P=0.095 P<0.001 ** P<0.001 ** |
|POLY 1.5 | (e) (e) (e) P=0.095 P<0.001 ** P<0.001 ** |
|POLY 6 | (e) (e) (e) P=0.095 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.111 P<0.001 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.105 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow: Femoral |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/10.00 0/10.00 5/5.95 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 84.1% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.006 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.992 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.016 * |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow: Femoral |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/10.00 0/10.00 0/10.00 3/3.32 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 90.5% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 35 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.014 * |
|POLY 3 | (e) (e) (e) (e) (e) P=0.004 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.010 * |
|POLY 6 | (e) (e) (e) (e) (e) P=0.003 ** |
|LOGISTIC REGRESSION| P=0.622 (e) (e) (e) (e) P=0.976 |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) (e) (e) P=0.105 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone: Distal, Femur, Metaphysis |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 3/10 (30%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/10.00 3/10.00 9/9.10 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 30.0% 98.9% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 3/10 (30%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 92 (T) 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.111 P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) P=0.095 P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) P=0.095 P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) P=0.095 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.031 * (e) (e) (e) P=0.111 P=0.494 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.105 P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone: Distal, Femur, Metaphysis |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/10.00 0/10.00 9/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 90.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 92 (T) 23 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P<0.001 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 0/1 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/1.00 0/1.00 0/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 0/1 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 23 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Epididymis: Lumen |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 9/9.10 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 98.9% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.265 (e) (e) (e) (e) P=0.494 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Epididymis: Lumen |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) 0/10 (0%) |
|POLY-3 RATE (b) | 5/10.00 0/0.00 0/0.00 0/0.00 3/10.00 0/1.22 |
|POLY-3 PERCENT (g) | 50.0% 0.0% 0.0% 0.0% 30.0% 0.0% |
|TERMINAL (d) | 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.328N P=1.000 P=1.000N P=1.000N P=0.328N P=1.000N |
|POLY 3 | (e) (e) (e) (e) P=0.329N P=0.483N |
|POLY 1.5 | (e) (e) (e) (e) P=0.329N P=0.237N |
|POLY 6 | (e) (e) (e) (e) P=0.329N P=0.612N |
|LOGISTIC REGRESSION| P=0.328N (e) (e) (e) P=0.328N (e) |
|COCH-ARM / FISHERS | P=0.011N* P=1.000 P=1.000 P=1.000 P=0.325N P=0.016N* |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 0/0.51 |
|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%) 0/10 (0%) 0/0 (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) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/3.00 0/6.00 0/10.00 1/2.17 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 46.2% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/3 (0%) 0/6 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 35 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.033 * (e) (e) (e) (e) P=0.318 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.280 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.335 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.254 |
|LOGISTIC REGRESSION| P=0.995 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.199 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/10 (90%) 0/1 (0%) 0/5 (0%) 0/8 (0%) 4/10 (40%) 4/10 (40%) |
|POLY-3 RATE (b) | 9/10.00 0/1.00 0/5.00 0/8.00 4/10.00 4/4.27 |
|POLY-3 PERCENT (g) | 90.0% 0.0% 0.0% 0.0% 40.0% 93.6% |
|TERMINAL (d) | 9/10 (90%) 0/1 (0%) 0/5 (0%) 0/8 (0%) 4/10 (40%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) 24 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.010 * P=0.205N P=0.003N** P<0.001N** P=0.034N* P<0.001 ** |
|POLY 3 | P=0.444N P=0.146N P<0.001N** P<0.001N** P=0.018N* P=0.761 |
|POLY 1.5 | P=0.454N P=0.146N P<0.001N** P<0.001N** P=0.018N* P=0.516N |
|POLY 6 | P=0.433N P=0.146N P<0.001N** P<0.001N** P=0.018N* P=0.658 |
|LOGISTIC REGRESSION| P=0.149N (e) (e) (e) P=0.034N* P=0.999 |
|COCH-ARM / FISHERS | P=0.312N P=0.182N P=0.002N** P<0.001N** P=0.029N* P=0.029N* |
|ORDER RESTRICTED | P=0.009N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Papilla |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 3/3 (100%) 6/6 (100%) 6/10 (60%) 7/10 (70%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 3/3.00 6/6.00 6/10.00 7/7.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% 100.0% 60.0% 98.2% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 3/3 (100%) 6/6 (100%) 6/10 (60%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 92 (T) 92 (T) 92 (T) 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.003 ** P<0.001 ** P=0.009 ** P<0.001 ** |
|POLY 3 | (e) (e) P=0.003 ** P<0.001N** P<0.001 ** P<0.001 ** |
|POLY 1.5 | (e) (e) P=0.003 ** P<0.001N** P<0.001 ** P<0.001 ** |
|POLY 6 | (e) (e) P=0.003 ** P<0.001N** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.008 ** (e) P=0.003 ** P<0.001 ** P=0.009 ** P=0.073 |
|COCH-ARM / FISHERS | P=0.037 * (e) P=0.003 ** P<0.001 ** P=0.005 ** P=0.002 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Papilla |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 1/1 (100%) 5/5 (100%) 8/8 (100%) 7/10 (70%) 6/10 (60%) |
|POLY-3 RATE (b) | 1/10.00 1/1.00 5/5.00 8/8.00 7/10.00 6/6.17 |
|POLY-3 PERCENT (g) | 10.0% 100.0% 100.0% 100.0% 70.0% 97.2% |
|TERMINAL (d) | 1/10 (10%) 1/1 (100%) 5/5 (100%) 8/8 (100%) 7/10 (70%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 23 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.205 P=0.003 ** P<0.001 ** P=0.013 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.146 P<0.001 ** P<0.001 ** P=0.003 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.146 P<0.001 ** P<0.001 ** P=0.003 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.146 P<0.001 ** P<0.001 ** P=0.003 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.031 * P=0.205 P=0.003 ** P<0.001 ** P=0.013 * P=0.989 |
|COCH-ARM / FISHERS | P=0.281 P=0.182 P=0.002 ** P<0.001 ** P=0.010 * P=0.029 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/0 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | 1/10.00 0/0.00 0/3.00 0/6.00 1/10.00 2/2.63 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 10.0% 76.2% |
|TERMINAL (d) | 1/10 (10%) 0/0 (0%) 0/3 (0%) 0/6 (0%) 1/10 (10%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) 35 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=1.000 P=0.739N P=0.602N P=0.766 P=0.010 * |
|POLY 3 | (e) (e) P=0.732N P=0.600N P=0.760 P=0.147 |
|POLY 1.5 | (e) (e) P=0.732N P=0.600N P=0.760 P=0.222 |
|POLY 6 | (e) (e) P=0.732N P=0.600N P=0.760 P=0.123 |
|LOGISTIC REGRESSION| P=0.274 (e) (e) (e) P=0.766 P=0.437 |
|COCH-ARM / FISHERS | P=0.235 P=1.000 P=0.769N P=0.625N P=0.763N P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/5 (0%) 0/8 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/1.00 0/5.00 0/8.00 0/10.00 0/0.51 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/1 (0%) 0/5 (0%) 0/8 (0%) 0/10 (0%) 0/0 (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) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/10 (40%) 2/6 (33%) 4/8 (50%) 2/10 (20%) 4/10 (40%) 0/10 (0%) |
|POLY-3 RATE (b) | 4/10.00 2/6.00 4/8.00 2/10.00 4/10.00 0/1.22 |
|POLY-3 PERCENT (g) | 40.0% 33.3% 50.0% 20.0% 40.0% 0.0% |
|TERMINAL (d) | 4/10 (40%) 2/6 (33%) 4/8 (50%) 2/10 (20%) 4/10 (40%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.598N P=0.602N P=0.521 P=0.317N P=0.672 P=1.000N |
|POLY 3 | P=0.486N P=0.599N P=0.520 P=0.318N P=0.667 P=0.525N |
|POLY 1.5 | P=0.352N P=0.599N P=0.520 P=0.318N P=0.667 P=0.317N |
|POLY 6 | P=0.514N P=0.599N P=0.520 P=0.318N P=0.667 P=0.626N |
|LOGISTIC REGRESSION| P=0.598N P=0.602N P=0.521 P=0.317N P=0.672 (e) |
|COCH-ARM / FISHERS | P=0.030N* P=0.608N P=0.520 P=0.314N P=0.675N P=0.043N* |
|ORDER RESTRICTED | P=0.634N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/10 (70%) 5/8 (63%) 3/7 (43%) 2/10 (20%) 3/10 (30%) 0/10 (0%) |
|POLY-3 RATE (b) | 7/10.00 5/8.00 3/7.00 2/10.00 3/10.00 0/0.51 |
|POLY-3 PERCENT (g) | 70.0% 62.5% 42.9% 20.0% 30.0% 0.0% |
|TERMINAL (d) | 7/10 (70%) 5/8 (63%) 3/7 (43%) 2/10 (20%) 3/10 (30%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.052N P=0.565N P=0.274N P=0.040N* P=0.095N P=1.000N |
|POLY 3 | P=0.018N* P=0.563N P=0.273N P=0.024N* P=0.082N P=0.561N |
|POLY 1.5 | P=0.014N* P=0.563N P=0.273N P=0.024N* P=0.082N P=0.201N |
|POLY 6 | P=0.018N* P=0.563N P=0.273N P=0.024N* P=0.082N P=0.672N |
|LOGISTIC REGRESSION| P=0.052N P=0.565N P=0.274N P=0.040N* P=0.095N (e) |
|COCH-ARM / FISHERS | P<0.001N** P=0.563N P=0.268N P=0.035N* P=0.089N P=0.002N** |
|ORDER RESTRICTED | P=0.693N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 3/6 (50%) 3/8 (38%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/10.00 3/6.00 3/8.00 0/10.00 1/10.00 0/1.22 |
|POLY-3 PERCENT (g) | 20.0% 50.0% 37.5% 0.0% 10.0% 0.0% |
|TERMINAL (d) | 2/10 (20%) 3/6 (50%) 3/8 (38%) 0/10 (0%) 1/10 (10%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) --- 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.156N P=0.250 P=0.387 P=0.234N P=0.500N P=1.000N |
|POLY 3 | P=0.069N P=0.246 P=0.389 P=0.227N P=0.500N P=0.630N |
|POLY 1.5 | P=0.061N P=0.246 P=0.389 P=0.227N P=0.500N P=0.515N |
|POLY 6 | P=0.070N P=0.246 P=0.389 P=0.227N P=0.500N P=0.681N |
|LOGISTIC REGRESSION| P=0.156N P=0.250 P=0.387 (e) P=0.500N (e) |
|COCH-ARM / FISHERS | P=0.028N* P=0.242 P=0.382 P=0.237N P=0.500N P=0.237N |
|ORDER RESTRICTED | P=0.631N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 3/8 (38%) 5/7 (71%) 1/10 (10%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 3/8.00 5/7.00 1/10.00 1/10.00 0/0.51 |
|POLY-3 PERCENT (g) | 0.0% 37.5% 71.4% 10.0% 10.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 3/8 (38%) 5/7 (71%) 1/10 (10%) 1/10 (10%) 0/0 (0%) |
|FIRST INCIDENCE | --- 92 (T) 92 (T) 92 (T) 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.379N P=0.074 P=0.005 ** P=0.500 P=0.500 (e) |
|POLY 3 | P=0.234N P=0.053 P<0.001 ** P=0.500 P=0.500 (e) |
|POLY 1.5 | P=0.198N P=0.053 P<0.001 ** P=0.500 P=0.500 (e) |
|POLY 6 | P=0.237N P=0.053 P<0.001 ** P=0.500 P=0.500 (e) |
|LOGISTIC REGRESSION| (e) P=0.074 P=0.005 ** P=0.500 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.054N P=0.069 P=0.003 ** P=0.500 P=0.500 (e) |
|ORDER RESTRICTED | P=0.755N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/6 (17%) 1/8 (13%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 1/6.00 1/8.00 0/10.00 1/10.00 0/1.22 |
|POLY-3 PERCENT (g) | 0.0% 16.7% 12.5% 0.0% 10.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 1/6 (17%) 1/8 (13%) 0/10 (0%) 1/10 (10%) 0/0 (0%) |
|FIRST INCIDENCE | --- 92 (T) 92 (T) --- 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.705 P=0.398 P=0.455 (e) P=0.500 (e) |
|POLY 3 | P=0.569 P=0.396 P=0.455 (e) P=0.500 (e) |
|POLY 1.5 | P=0.609 P=0.396 P=0.455 (e) P=0.500 (e) |
|POLY 6 | P=0.560 P=0.396 P=0.455 (e) P=0.500 (e) |
|LOGISTIC REGRESSION| (e) P=0.398 P=0.455 (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.426N P=0.375 P=0.444 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.759 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 2/8 (25%) 0/7 (0%) 1/10 (10%) 4/10 (40%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 2/8.00 0/7.00 1/10.00 4/10.00 0/0.51 |
|POLY-3 PERCENT (g) | 0.0% 25.0% 0.0% 10.0% 40.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 2/8 (25%) 0/7 (0%) 1/10 (10%) 4/10 (40%) 0/0 (0%) |
|FIRST INCIDENCE | --- 92 (T) --- 92 (T) 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.049 * P=0.185 (e) P=0.500 P=0.051 (e) |
|POLY 3 | P=0.013 * P=0.172 (e) P=0.500 P=0.033 * (e) |
|POLY 1.5 | P=0.028 * P=0.172 (e) P=0.500 P=0.033 * (e) |
|POLY 6 | P=0.012 * P=0.172 (e) P=0.500 P=0.033 * (e) |
|LOGISTIC REGRESSION| (e) P=0.185 (e) P=0.500 P=0.051 (e) |
|COCH-ARM / FISHERS | P=0.601N P=0.183 (e) P=0.500 P=0.043 * (e) |
|ORDER RESTRICTED | P=0.729 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/6 (0%) 0/8 (0%) 0/10 (0%) 3/10 (30%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/6.00 0/8.00 0/10.00 3/10.00 2/3.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 30.0% 63.0% |
|TERMINAL (d) | 0/10 (0%) 0/6 (0%) 0/8 (0%) 0/10 (0%) 3/10 (30%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 92 (T) 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.111 P=0.214 |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.095 P=0.060 |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.095 P=0.093 |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.095 P=0.046 * |
|LOGISTIC REGRESSION| P=0.187 (e) (e) (e) P=0.111 (e) |
|COCH-ARM / FISHERS | P=0.022 * (e) (e) (e) P=0.105 P=0.237 |
|ORDER RESTRICTED | P=0.011 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/8 (0%) 0/7 (0%) 0/10 (0%) 2/10 (20%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/8.00 0/7.00 0/10.00 2/10.00 9/9.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 20.0% 99.4% |
|TERMINAL (d) | 0/10 (0%) 0/8 (0%) 0/7 (0%) 0/10 (0%) 2/10 (20%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 92 (T) 23 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.234 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.227 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.227 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.227 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.083 (e) (e) (e) P=0.234 (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.237 P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 1/10 (10%) 2/10 (20%) 2/10 (20%) 0/9 (0%) 0/9 (0%) |
|POLY-3 RATE (b) | 3/10.00 1/10.00 2/10.00 2/10.00 0/9.00 0/1.12 |
|POLY-3 PERCENT (g) | 30.0% 10.0% 20.0% 20.0% 0.0% 0.0% |
|TERMINAL (d) | 3/10 (30%) 1/10 (10%) 2/10 (20%) 2/10 (20%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.196N P=0.293N P=0.500N P=0.500N P=0.129N P=1.000N |
|POLY 3 | P=0.109N P=0.292N P=0.500N P=0.500N P=0.114N P=0.582N |
|POLY 1.5 | P=0.102N P=0.292N P=0.500N P=0.500N P=0.114N P=0.431N |
|POLY 6 | P=0.110N P=0.292N P=0.500N P=0.500N P=0.114N P=0.651N |
|LOGISTIC REGRESSION| P=0.196N P=0.293N P=0.500N P=0.500N (e) (e) |
|COCH-ARM / FISHERS | P=0.056N P=0.291N P=0.500N P=0.500N P=0.124N P=0.124N |
|ORDER RESTRICTED | P=0.672N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|POLY-3 RATE (b) | 0/10.00 1/10.00 1/10.00 0/10.00 0/10.00 0/0.46 |
|POLY-3 PERCENT (g) | 0.0% 10.0% 10.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 92 (T) 92 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.600N P=0.500 P=0.500 (e) (e) (e) |
|POLY 3 | P=0.392N P=0.500 P=0.500 (e) (e) (e) |
|POLY 1.5 | P=0.380N P=0.500 P=0.500 (e) (e) (e) |
|POLY 6 | P=0.393N P=0.500 P=0.500 (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.500 P=0.500 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.345N P=0.500 P=0.500 (e) (e) (e) |
|ORDER RESTRICTED | P=0.809N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/9 (11%) 0/9 (0%) |
|POLY-3 RATE (b) | 1/10.00 0/10.00 1/10.00 0/10.00 1/9.00 0/1.12 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 10.0% 0.0% 11.1% 0.0% |
|TERMINAL (d) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/9 (11%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (T) --- 92 (T) --- 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.717 P=0.500N P=0.766 P=0.500N P=0.743 P=1.000N |
|POLY 3 | P=0.570 P=0.500N P=0.760 P=0.500N P=0.737 P=0.738N |
|POLY 1.5 | P=0.604 P=0.500N P=0.760 P=0.500N P=0.737 P=0.692N |
|POLY 6 | P=0.563 P=0.500N P=0.760 P=0.500N P=0.737 P=0.757N |
|LOGISTIC REGRESSION| P=0.717 (e) P=0.766 (e) P=0.743 (e) |
|COCH-ARM / FISHERS | P=0.465N P=0.500N P=0.763N P=0.500N P=0.737 P=0.526N |
|ORDER RESTRICTED | P=0.757N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 1/10 (10%) 0/9 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 2/10.00 1/10.00 0/0.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 20.0% 10.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 1/10 (10%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 92 (T) 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.266 (e) (e) P=0.234 P=0.500 (e) |
|POLY 3 | P=0.127 (e) (e) P=0.227 P=0.500 (e) |
|POLY 1.5 | P=0.161 (e) (e) P=0.227 P=0.500 (e) |
|POLY 6 | P=0.125 (e) (e) P=0.227 P=0.500 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.234 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.628 (e) (e) P=0.237 P=0.500 (e) |
|ORDER RESTRICTED | P=0.787 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular: Lymphocyte |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 7/9 (78%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/9.00 7/7.64 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 91.6% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.971 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular: Lymphocyte |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/9 (89%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 8/8.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 99.8% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 24 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.717 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/6 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 1/10.00 0/10.00 0/10.00 0/1.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 92 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.856N (e) P=0.500 (e) (e) (e) |
|POLY 3 | P=0.635N (e) P=0.500 (e) (e) (e) |
|POLY 1.5 | P=0.602N (e) P=0.500 (e) (e) (e) |
|POLY 6 | P=0.644N (e) P=0.500 (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.500 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.632N (e) P=0.500 (e) (e) (e) |
|ORDER RESTRICTED | P=0.795N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 2/10 (20%) 0/9 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 2/10.00 2/10.00 0/0.50 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 20.0% 20.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 2/10 (20%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 92 (T) 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.072 (e) (e) P=0.234 P=0.234 (e) |
|POLY 3 | P=0.022 * (e) (e) P=0.227 P=0.227 (e) |
|POLY 1.5 | P=0.039 * (e) (e) P=0.227 P=0.227 (e) |
|POLY 6 | P=0.021 * (e) (e) P=0.227 P=0.227 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.234 P=0.234 (e) |
|COCH-ARM / FISHERS | P=0.497 (e) (e) P=0.237 P=0.237 (e) |
|ORDER RESTRICTED | P=0.772 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric: Lymphocyte |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/6 (83%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 5/5.10 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 98.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.112 (e) (e) (e) (e) P=0.438 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric: Lymphocyte |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/9 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 9/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 24 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mammary Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 0/1.22 |
|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%) 0/10 (0%) 0/0 (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 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mammary Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 6/6 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 6/6.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 23 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 1/1 (100%) 0/0 (0%) 2/10 (20%) 0/10 (0%) 0/9 (0%) |
|POLY-3 RATE (b) | 2/10.00 1/1.00 0/0.00 2/10.00 0/10.00 0/0.50 |
|POLY-3 PERCENT (g) | 20.0% 100.0% 0.0% 20.0% 0.0% 0.0% |
|TERMINAL (d) | 2/10 (20%) 1/1 (100%) 0/0 (0%) 2/10 (20%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 92 (T) 92 (T) --- 92 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.168N P=0.305 P=1.000N P=0.707 P=0.234N P=1.000N |
|POLY 3 | (e) P=0.286 (e) P=0.702 P=0.227N P=0.678N |
|POLY 1.5 | (e) P=0.286 (e) P=0.702 P=0.227N P=0.580N |
|POLY 6 | (e) P=0.286 (e) P=0.702 P=0.227N P=0.705N |
|LOGISTIC REGRESSION| P=0.168N P=0.305 (e) P=0.707 (e) (e) |
|COCH-ARM / FISHERS | P=0.049N* P=0.273 P=1.000 P=0.709N P=0.237N P=0.263N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Ovary: Interstitium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Ovary: Interstitium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/0 (0%) 0/10 (0%) 5/10 (50%) 9/9 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/1.00 0/0.00 0/10.00 5/10.00 9/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 50.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/1 (0%) 0/0 (0%) 0/10 (0%) 5/10 (50%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 92 (T) 23 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.022 * P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) P=0.008 ** P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) P=0.008 ** P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) P=0.008 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.022 * (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.016 * P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 6/9 (67%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 6/6.75 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 88.9% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.984 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.003 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 8/10 (80%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 8/8.07 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 99.1% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 24 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.720 (e) (e) (e) (e) P=0.996 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Preputial Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/1.00 0/0.00 0/0.00 0/10.00 9/9.10 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 98.9% |
|TERMINAL (d) | 0/10 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.256 (e) (e) (e) (e) P=0.494 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Preputial Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 8/9 (89%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/9.00 8/8.10 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 98.7% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.260 (e) (e) (e) (e) P=0.491 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 9/9 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 9/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 23 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001N** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen: Lymphocyte |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 7/10 (70%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 7/7.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 97.5% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.092 (e) (e) (e) (e) P=0.149 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.002 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen: Lymphocyte |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 23 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 29
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Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Mucosa |
| Erosion Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 2/3 (67%) 1/1 (100%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 2/3.00 1/1.00 0/10.00 0/1.22 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 66.7% 100.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 2/3 (67%) 1/1 (100%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 92 (T) 92 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.549N (e) P=0.034 * P=0.077 (e) (e) |
|POLY 3 | (e) (e) P=0.003 ** P=0.091N (e) (e) |
|POLY 1.5 | (e) (e) P=0.003 ** P=0.091N (e) (e) |
|POLY 6 | (e) (e) P=0.003 ** P=0.091N (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.034 * P=0.077 (e) (e) |
|COCH-ARM / FISHERS | P=0.171N (e) P=0.038 * P=0.091 (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Mucosa |
| Erosion Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/1.00 0/1.00 0/0.00 0/10.00 0/0.51 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/10 (0%) 0/0 (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) |
|=================================================================================================================================|
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Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Glandular: Mucosa |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 2/3.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 66.7% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 32 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.046 * |
|POLY 3 | (e) (e) (e) (e) (e) P=0.057 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.086 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.045 * |
|LOGISTIC REGRESSION| P=0.641 (e) (e) (e) (e) P=0.924 |
|COCH-ARM / FISHERS | P=0.089 (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Glandular: Mucosa |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 7/10 (70%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 7/7.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 98.1% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 23 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.766 (e) (e) (e) (e) P=0.995 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.002 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 4/4.59 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 87.1% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.010 * |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.002 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.508 (e) (e) (e) (e) P=0.809 |
|COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.043 * |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thymus |
| Depletion Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 8/8 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 8/8.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 26 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thymus |
| Depletion Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 9/9 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 9/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 24 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05195 TEST: 03 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENATE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.75 7.5 15 30 60 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/2 (0%) 0/0 (0%) 0/9 (0%) 10/10 (100%) 6/10 (60%) |
|POLY-3 RATE (b) | 0/10.00 0/2.00 0/0.00 0/9.00 10/10.00 6/6.25 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 100.0% 96.0% |
|TERMINAL (d) | 0/10 (0%) 0/2 (0%) 0/0 (0%) 0/9 (0%) 10/10 (100%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 92 (T) 23 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** P=0.003 ** |
|POLY 3 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P<0.001 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** P=0.005 ** |
|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).