TDMS Study 05196-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: TSI Mason Research SODIUM SELENITE DATE: 10/19/04
EXPERIMENT: 05196 TEST: 03 TIME: 08:35:52
TEST TYPE: SUBCHRON 90-DAY PAGE: 1
CONT: N01-ES-75146 ROUTE: DOSED WATER NTP C#: C04308
PATHOLOGIST: S. EUSTIS M. ELWELL HA CAS: 10102-18-8
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 PPM
INCLUDE 002 0 PPM
INCLUDE 003 2 PPM
INCLUDE 004 2 PPM
INCLUDE 005 4 PPM
INCLUDE 006 4 PPM
INCLUDE 007 8 PPM
INCLUDE 008 8 PPM
INCLUDE 009 16 PPM
INCLUDE 010 16 PPM
INCLUDE 011 32 PPM
INCLUDE 012 32 PPM
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: TSI Mason Research SODIUM SELENITE DATE: 10/19/04
EXPERIMENT: 05196 TEST: 03 TIME: 08:35:52
TEST TYPE: SUBCHRON 90-DAY
CONT: N01-ES-75146 ROUTE: DOSED WATER NTP C#: C04308
PATHOLOGIST: S. EUSTIS M. ELWELL HA CAS: 10102-18-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF SODIUM SELENITE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex: Zona Fasciculata Vacuolization Cytoplasmic
Kidney: Papilla Degeneration
Kidney: Renal Tubule Dilatation
Liver Fatty Change
Hepatodiaphragmatic Nodule
Lymph Node, Mesenteric Congestion
Pigmentation Hemosiderin
Spleen Pigmentation Hemosiderin
Thymus Depletion Lymphoid
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Bone Marrow Pigmentation Hemosiderin
Bone Marrow: Femoral Depletion Cellular
Bone: Distal, Femur, Metaphysis Atrophy
Clitoral Gland Atrophy
Kidney Mineralization Focal
Kidney: Papilla Degeneration
Kidney: Renal Tubule Dilatation Focal
Liver Atrophy
Hepatodiaphragmatic Nodule
Liver: Kupffer Cell Pigmentation Hemosiderin
Lymph Node, Mesenteric Pigmentation Hemosiderin
Mammary Gland Atrophy
Ovary Cyst
Pancreas Atrophy
Salivary Glands Atrophy
Spleen Depletion Lymphoid
Thymus Depletion Lymphoid
Uterus: Endometrium Atrophy
Uterus: Lumen Dilatation
===============================================================
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex: Zona Fasciculata |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 10/10.00 0/0.00 0/0.00 0/0.00 0/0.00 4/10.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 0.0% 40.0% |
|TERMINAL (d) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004N** (e) (e) (e) (e) P=0.009N** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001N** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001N** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001N** |
|LOGISTIC REGRESSION| P=0.004N** (e) (e) (e) (e) P=0.009N** |
|COCH-ARM / FISHERS | P=0.004N** (e) (e) (e) (e) P=0.005N** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex: Zona Fasciculata |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/8.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (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: 05196 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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 2/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 56 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.010 * (e) (e) (e) (e) P=0.228 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.227 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.227 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.227 |
|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) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow: Femoral |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow: Femoral |
| 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%) 8/8 (100%) |
|FIRST INCIDENCE | --- --- --- --- --- 56 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001N** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001N** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001N** |
|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: 05196 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone: Distal, Femur, Metaphysis |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone: Distal, Femur, Metaphysis |
| 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%) 8/8 (100%) |
|FIRST INCIDENCE | --- --- --- --- --- 56 |
|-------------------| |
|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: 05196 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | 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 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Clitoral Gland |
| 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%) 8/8 (100%) |
|FIRST INCIDENCE | --- --- --- --- --- 56 |
|-------------------| |
|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: 05196 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/10 (70%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/10 (60%) |
|POLY-3 RATE (b) | 7/10.00 0/0.00 0/0.00 0/0.00 0/0.00 6/10.00 |
|POLY-3 PERCENT (g) | 70.0% 0.0% 0.0% 0.0% 0.0% 60.0% |
|TERMINAL (d) | 7/10 (70%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/10 (60%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.410N P=1.000 P=1.000 P=1.000 P=1.000N P=0.500N |
|POLY 3 | (e) (e) (e) (e) (e) P=0.500N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.500N |
|POLY 6 | (e) (e) (e) (e) (e) P=0.500N |
|LOGISTIC REGRESSION| P=0.410N (e) (e) (e) (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.407N P=1.000 P=1.000 P=1.000 P=1.000 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/8.65 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.174N P=1.000N P=1.000N P=1.000N P=1.000N P=0.284N |
|POLY 3 | (e) (e) (e) (e) (e) P=0.262N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.248N |
|POLY 6 | (e) (e) (e) (e) (e) P=0.275N |
|LOGISTIC REGRESSION| P=0.174N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.132N P=1.000 P=1.000 P=1.000 P=1.000 P=0.237N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 8/10 (80%) |
|POLY-3 RATE (b) | 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 8/10.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% 80.0% |
|TERMINAL (d) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 6/8 (75%) |
|FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 56 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.627N (e) (e) (e) (e) P=0.664N |
|POLY 3 | P=0.008N** (e) (e) (e) (e) P=0.227N |
|POLY 1.5 | P=0.008N** (e) (e) (e) (e) P=0.227N |
|POLY 6 | P=0.008N** (e) (e) (e) (e) P=0.227N |
|LOGISTIC REGRESSION| P=0.627N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.010N* (e) (e) (e) (e) P=0.237N |
|ORDER RESTRICTED | P=0.007N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Papilla |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 5/10 (50%) 7/10 (70%) |
|POLY-3 RATE (b) | 1/10.00 0/10.00 1/10.00 2/10.00 5/10.00 7/10.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 10.0% 20.0% 50.0% 70.0% |
|TERMINAL (d) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 5/10 (50%) 7/10 (70%) |
|FIRST INCIDENCE | 92 (T) --- 92 (T) 92 (T) 92 (T) 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500N P=0.766 P=0.500 P=0.077 P=0.013 * |
|POLY 3 | P<0.001 ** P=0.500N P=0.760 P=0.500 P=0.061 P=0.003 ** |
|POLY 1.5 | P<0.001 ** P=0.500N P=0.760 P=0.500 P=0.061 P=0.003 ** |
|POLY 6 | P<0.001 ** P=0.500N P=0.760 P=0.500 P=0.061 P=0.003 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.766 P=0.500 P=0.077 P=0.013 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.763N P=0.500 P=0.070 P=0.010 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Papilla |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 3/10 (30%) 6/10 (60%) 8/10 (80%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 1/10.00 3/10.00 6/10.00 8/10.00 9/9.42 |
|POLY-3 PERCENT (g) | 0.0% 10.0% 30.0% 60.0% 80.0% 95.5% |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 3/10 (30%) 6/10 (60%) 8/10 (80%) 8/8 (100%) |
|FIRST INCIDENCE | --- 92 (T) 92 (T) 92 (T) 92 (T) 56 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500 P=0.111 P=0.009 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.500 P=0.095 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.500 P=0.095 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.500 P=0.095 P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.500 P=0.111 P=0.009 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.105 P=0.005 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 3/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 30.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |
|FIRST INCIDENCE | --- --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.111 |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.095 |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.095 |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.095 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.111 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.105 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/8.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (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: 05196 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 3/10 (30%) 3/10 (30%) 6/10 (60%) 2/10 (20%) 2/10 (20%) |
|POLY-3 RATE (b) | 3/10.00 3/10.00 3/10.00 6/10.00 2/10.00 2/10.00 |
|POLY-3 PERCENT (g) | 30.0% 30.0% 30.0% 60.0% 20.0% 20.0% |
|TERMINAL (d) | 3/10 (30%) 3/10 (30%) 3/10 (30%) 6/10 (60%) 2/10 (20%) 2/10 (20%) |
|FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.255N P=0.683 P=0.683 P=0.190 P=0.500N P=0.500N |
|POLY 3 | P=0.255N P=0.678 P=0.678 P=0.186 P=0.500N P=0.500N |
|POLY 1.5 | P=0.255N P=0.678 P=0.678 P=0.186 P=0.500N P=0.500N |
|POLY 6 | P=0.255N P=0.678 P=0.678 P=0.186 P=0.500N P=0.500N |
|LOGISTIC REGRESSION| P=0.255N P=0.683 P=0.683 P=0.190 P=0.500N P=0.500N |
|COCH-ARM / FISHERS | P=0.253N P=0.686N P=0.686N P=0.185 P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.366N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 1/10.00 1/10.00 0/10.00 4/8.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.0% 10.0% 0.0% 46.3% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 4/8 (50%) |
|FIRST INCIDENCE | --- --- 92 (T) 92 (T) --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.500 P=0.500 (e) P=0.028 * |
|POLY 3 | P<0.001 ** (e) P=0.500 P=0.500 (e) P=0.018 * |
|POLY 1.5 | P<0.001 ** (e) P=0.500 P=0.500 (e) P=0.023 * |
|POLY 6 | P<0.001 ** (e) P=0.500 P=0.500 (e) P=0.015 * |
|LOGISTIC REGRESSION| (e) (e) P=0.500 P=0.500 (e) P=0.028 * |
|COCH-ARM / FISHERS | P=0.003 ** (e) P=0.500 P=0.500 (e) P=0.043 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Regeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 9/10 (90%) 9/10 (90%) 9/10 (90%) 10/10 (100%) 8/10 (80%) |
|POLY-3 RATE (b) | 10/10.00 9/10.00 9/10.00 9/10.00 10/10.00 8/10.00 |
|POLY-3 PERCENT (g) | 100.0% 90.0% 90.0% 90.0% 100.0% 80.0% |
|TERMINAL (d) | 10/10 (100%) 9/10 (90%) 9/10 (90%) 9/10 (90%) 10/10 (100%) 8/10 (80%) |
|FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.220N P=0.500N P=0.500N P=0.500N (e) P=0.234N |
|POLY 3 | P=0.222N P=0.500N P=0.500N P=0.500N (e) P=0.227N |
|POLY 1.5 | P=0.222N P=0.500N P=0.500N P=0.500N (e) P=0.227N |
|POLY 6 | P=0.222N P=0.500N P=0.500N P=0.500N (e) P=0.227N |
|LOGISTIC REGRESSION| P=0.220N P=0.500N P=0.500N P=0.500N (e) P=0.234N |
|COCH-ARM / FISHERS | P=0.218N P=0.500N P=0.500N P=0.500N (e) P=0.237N |
|ORDER RESTRICTED | P=0.090N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Regeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/8.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (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: 05196 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/3 (0%) 0/3 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/3.00 0/3.00 0/0.00 0/2.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/3 (0%) 0/3 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/1.00 0/3.00 0/10.00 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%) 0/1 (0%) 0/3 (0%) 0/10 (0%) 0/10 (0%) 8/8 (100%) |
|FIRST INCIDENCE | --- --- --- --- --- 56 |
|-------------------| |
|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: 05196 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/3 (0%) 3/3 (100%) 0/0 (0%) 0/2 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 5/10.00 0/3.00 3/3.00 0/0.00 0/2.00 0/10.00 |
|POLY-3 PERCENT (g) | 50.0% 0.0% 100.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 5/10 (50%) 0/3 (0%) 3/3 (100%) 0/0 (0%) 0/2 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 92 (T) --- 92 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.008N** P=0.198N P=0.198 P=1.000 P=0.308N P=0.022N* |
|POLY 3 | (e) P=0.183N P=0.183 (e) P=0.303N P=0.008N** |
|POLY 1.5 | (e) P=0.183N P=0.183 (e) P=0.303N P=0.008N** |
|POLY 6 | (e) P=0.183N P=0.183 (e) P=0.303N P=0.008N** |
|LOGISTIC REGRESSION| P=0.008N** (e) P=0.198 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.007N** P=0.196N P=0.196 P=1.000 P=0.318N P=0.016N* |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/1.00 0/3.00 0/10.00 0/10.00 0/8.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) 0/10 (0%) 0/8 (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: 05196 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/3 (0%) 0/3 (0%) 0/0 (0%) 1/2 (50%) 2/10 (20%) |
|POLY-3 RATE (b) | 2/10.00 0/3.00 0/3.00 0/0.00 1/2.00 2/10.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 50.0% 20.0% |
|TERMINAL (d) | 2/10 (20%) 0/3 (0%) 0/3 (0%) 0/0 (0%) 1/2 (50%) 2/10 (20%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.422 P=0.527N P=0.527N P=1.000 P=0.500 P=0.707 |
|POLY 3 | (e) P=0.526N P=0.526N (e) P=0.500 P=0.702 |
|POLY 1.5 | (e) P=0.526N P=0.526N (e) P=0.500 P=0.702 |
|POLY 6 | (e) P=0.526N P=0.526N (e) P=0.500 P=0.702 |
|LOGISTIC REGRESSION| P=0.422 (e) (e) (e) P=0.500 P=0.707 |
|COCH-ARM / FISHERS | P=0.420 P=0.577N P=0.577N P=1.000 P=0.455 P=0.709N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/10 (60%) 0/1 (0%) 1/3 (33%) 3/10 (30%) 3/10 (30%) 5/10 (50%) |
|POLY-3 RATE (b) | 6/10.00 0/1.00 1/3.00 3/10.00 3/10.00 5/8.65 |
|POLY-3 PERCENT (g) | 60.0% 0.0% 33.3% 30.0% 30.0% 57.8% |
|TERMINAL (d) | 6/10 (60%) 0/1 (0%) 1/3 (33%) 3/10 (30%) 3/10 (30%) 5/8 (63%) |
|FIRST INCIDENCE | 92 (T) --- 92 (T) 92 (T) 92 (T) 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.398 P=0.464N P=0.442N P=0.190N P=0.190N P=0.643 |
|POLY 3 | P=0.481 P=0.463N P=0.443N P=0.186N P=0.186N P=0.641N |
|POLY 1.5 | P=0.512 P=0.463N P=0.443N P=0.186N P=0.186N P=0.589N |
|POLY 6 | P=0.454 P=0.463N P=0.443N P=0.186N P=0.186N P=0.664 |
|LOGISTIC REGRESSION| P=0.398 (e) P=0.442N P=0.190N P=0.190N P=0.643 |
|COCH-ARM / FISHERS | P=0.571 P=0.455N P=0.437N P=0.185N P=0.185N P=0.500N |
|ORDER RESTRICTED | P=0.218N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 3/3 (100%) 3/3 (100%) 0/0 (0%) 2/2 (100%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 3/3.00 3/3.00 0/0.00 2/2.00 0/10.00 |
|POLY-3 PERCENT (g) | 10.0% 100.0% 100.0% 0.0% 100.0% 0.0% |
|TERMINAL (d) | 1/10 (10%) 3/3 (100%) 3/3 (100%) 0/0 (0%) 2/2 (100%) 0/10 (0%) |
|FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) --- 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.048N* P=0.015 * P=0.015 * P=1.000N P=0.043 * P=0.500N |
|POLY 3 | (e) P<0.001 ** P<0.001 ** (e) P=0.005 ** P=0.500N |
|POLY 1.5 | (e) P<0.001 ** P<0.001 ** (e) P=0.005 ** P=0.500N |
|POLY 6 | (e) P<0.001 ** P<0.001 ** (e) P=0.005 ** P=0.500N |
|LOGISTIC REGRESSION| P=0.048N* P=0.015 * P=0.015 * (e) P=0.043 * (e) |
|COCH-ARM / FISHERS | P=0.045N* P=0.014 * P=0.014 * P=1.000 P=0.045 * P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 1/1 (100%) 3/3 (100%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/10.00 1/1.00 3/3.00 2/10.00 0/10.00 0/8.65 |
|POLY-3 PERCENT (g) | 20.0% 100.0% 100.0% 20.0% 0.0% 0.0% |
|TERMINAL (d) | 2/10 (20%) 1/1 (100%) 3/3 (100%) 2/10 (20%) 0/10 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.020N* P=0.305 P=0.040 * P=0.707 P=0.234N P=0.284N |
|POLY 3 | P=0.002N** P=0.286 P=0.010 * P=0.702 P=0.227N P=0.262N |
|POLY 1.5 | P=0.002N** P=0.286 P=0.010 * P=0.702 P=0.227N P=0.248N |
|POLY 6 | P=0.003N** P=0.286 P=0.010 * P=0.702 P=0.227N P=0.275N |
|LOGISTIC REGRESSION| P=0.020N* P=0.305 P=0.040 * P=0.707 (e) (e) |
|COCH-ARM / FISHERS | P=0.013N* P=0.273 P=0.035 * P=0.709N P=0.237N P=0.237N |
|ORDER RESTRICTED | P=0.003N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/3 (0%) 0/3 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/3.00 0/3.00 0/0.00 0/2.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/3 (0%) 0/3 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) 0/10 (0%) 6/10 (60%) |
|POLY-3 RATE (b) | 0/10.00 0/1.00 0/3.00 0/10.00 0/10.00 6/9.23 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 65.0% |
|TERMINAL (d) | 0/10 (0%) 0/1 (0%) 0/3 (0%) 0/10 (0%) 0/10 (0%) 5/8 (63%) |
|FIRST INCIDENCE | --- --- --- --- --- 69 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.005 ** |
|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<0.001 ** (e) (e) (e) (e) P=0.006 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.005 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.380N P=1.000 P=1.000 P=1.000 P=1.000N P=0.500N |
|POLY 3 | (e) (e) (e) (e) (e) P=0.500N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.500N |
|POLY 6 | (e) (e) (e) (e) (e) P=0.500N |
|LOGISTIC REGRESSION| P=0.380N (e) (e) (e) (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.377N P=1.000 P=1.000 P=1.000 P=1.000 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/10.00 0/1.00 0/0.00 0/0.00 0/0.00 1/8.65 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 0.0% 11.6% |
|TERMINAL (d) | 1/10 (10%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.558 P=0.923N P=1.000 P=1.000 P=1.000 P=0.716 |
|POLY 3 | (e) P=0.913N (e) (e) (e) P=0.728 |
|POLY 1.5 | (e) P=0.913N (e) (e) (e) P=0.740 |
|POLY 6 | (e) P=0.913N (e) (e) (e) P=0.716 |
|LOGISTIC REGRESSION| P=0.558 (e) (e) (e) (e) P=0.716 |
|COCH-ARM / FISHERS | P=0.622 P=0.909N P=1.000 P=1.000 P=1.000 P=0.763N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Acute Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|FIRST INCIDENCE | --- --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.309 (e) (e) (e) (e) P=0.500 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.500 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.304 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Acute Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 3/10.00 0/1.00 0/0.00 0/0.00 0/0.00 0/8.65 |
|POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/10 (30%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.101N P=0.695N P=1.000N P=1.000N P=1.000N P=0.151N |
|POLY 3 | (e) P=0.689N (e) (e) (e) P=0.123N |
|POLY 1.5 | (e) P=0.689N (e) (e) (e) P=0.112N |
|POLY 6 | (e) P=0.689N (e) (e) (e) P=0.135N |
|LOGISTIC REGRESSION| P=0.101N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.068N P=0.727N P=1.000 P=1.000 P=1.000 P=0.105N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 2/10.00 0/0.00 0/10.00 0/10.00 0/8.00 2/10.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) 2/10 (20%) |
|FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.349 P=1.000N P=0.234N P=0.234N P=0.284N P=0.707 |
|POLY 3 | (e) (e) P=0.227N P=0.227N P=0.280N P=0.702 |
|POLY 1.5 | (e) (e) P=0.227N P=0.227N P=0.280N P=0.702 |
|POLY 6 | (e) (e) P=0.227N P=0.227N P=0.280N P=0.702 |
|LOGISTIC REGRESSION| P=0.349 (e) (e) (e) (e) P=0.707 |
|COCH-ARM / FISHERS | P=0.347 P=1.000 P=0.237N P=0.237N P=0.294N P=0.709N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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 0/8.65 |
|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%) 0/8 (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: 05196 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Depletion Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/10.00 0/10.00 0/8.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) 1/10 (10%) |
|FIRST INCIDENCE | --- --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.145 (e) (e) (e) (e) P=0.500 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.500 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.143 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Depletion Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/1.00 0/1.00 0/0.00 0/10.00 2/8.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 23.1% |
|TERMINAL (d) | 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/10 (0%) 2/8 (25%) |
|FIRST INCIDENCE | --- --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.057 (e) (e) (e) (e) P=0.185 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.192 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.204 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.182 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.185 |
|COCH-ARM / FISHERS | P=0.076 (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/10.00 0/10.00 0/10.00 5/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 50.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|FIRST INCIDENCE | --- --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.022 * |
|POLY 3 | (e) (e) (e) (e) (e) P=0.008 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.008 ** |
|POLY 6 | (e) (e) (e) (e) (e) P=0.008 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.022 * |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.016 * |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/1.00 0/1.00 0/0.00 0/10.00 2/8.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 23.1% |
|TERMINAL (d) | 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/10 (0%) 2/8 (25%) |
|FIRST INCIDENCE | --- --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.057 (e) (e) (e) (e) P=0.185 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.192 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.204 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.182 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.185 |
|COCH-ARM / FISHERS | P=0.076 (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 0/0.00 0/10.00 0/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 10/10 (100%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** (e) P<0.001N** P<0.001N** (e) (e) |
|POLY 3 | (e) (e) P<0.001N** P<0.001N** (e) (e) |
|POLY 1.5 | (e) (e) P<0.001N** P<0.001N** (e) (e) |
|POLY 6 | (e) (e) P<0.001N** P<0.001N** (e) (e) |
|LOGISTIC REGRESSION| P=0.002 ** (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.002 ** (e) P<0.001N** P<0.001N** (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 0/1.00 0/1.00 0/0.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 10/10 (100%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 10/10 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) 56 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007 ** P=0.077N P=0.077N (e) (e) (e) |
|POLY 3 | (e) P=0.091 P=0.091 (e) (e) (e) |
|POLY 1.5 | (e) P=0.091 P=0.091 (e) (e) (e) |
|POLY 6 | (e) P=0.091 P=0.091 (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.007 ** (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.179 P=0.091N P=0.091N (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mammary Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/7 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/7.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mammary Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%) 4/10 (40%) 8/9 (89%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/8.00 4/10.00 8/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 40.0% 88.9% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%) 4/10 (40%) 6/7 (86%) |
|FIRST INCIDENCE | --- --- --- --- 92 (T) 56 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.051 P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) P=0.033 * P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) P=0.033 * P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) P=0.033 * P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.051 (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.043 * P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | 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 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/9 (11%) 0/0 (0%) 1/1 (100%) 2/2 (100%) 1/1 (100%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/9.00 0/0.00 1/1.00 2/2.00 1/1.00 0/8.65 |
|POLY-3 PERCENT (g) | 11.1% 0.0% 100.0% 100.0% 100.0% 0.0% |
|TERMINAL (d) | 1/9 (11%) 0/0 (0%) 1/1 (100%) 2/2 (100%) 1/1 (100%) 0/8 (0%) |
|FIRST INCIDENCE | 92 (T) --- 92 (T) 92 (T) 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.192N P=1.000 P=0.227 P=0.055 P=0.227 P=0.523N |
|POLY 3 | (e) (e) P=0.171 P=0.009 ** P=0.171 P=0.508N |
|POLY 1.5 | (e) (e) P=0.171 P=0.009 ** P=0.171 P=0.497N |
|POLY 6 | (e) (e) P=0.171 P=0.009 ** P=0.171 P=0.518N |
|LOGISTIC REGRESSION| P=0.192N (e) P=0.227 P=0.055 P=0.227 (e) |
|COCH-ARM / FISHERS | P=0.129N P=1.000 P=0.200 P=0.055 P=0.200 P=0.474N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pancreas |
| 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%) 8/8 (100%) |
|FIRST INCIDENCE | --- --- --- --- --- 56 |
|-------------------| |
|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: 05196 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | 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%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 1/10 (10%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/10.00 1/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 10.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 1/10 (10%) 8/8 (100%) |
|FIRST INCIDENCE | --- --- --- --- 92 (T) 56 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.500 P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) P=0.500 P<0.001N** |
|POLY 1.5 | (e) (e) (e) (e) P=0.500 P<0.001N** |
|POLY 6 | (e) (e) (e) (e) P=0.500 P<0.001N** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.500 P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Depletion Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Depletion Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 5/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 50.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 3/8 (38%) |
|FIRST INCIDENCE | --- --- --- --- --- 56 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.021 * |
|POLY 3 | (e) (e) (e) (e) (e) P=0.008 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.008 ** |
|POLY 6 | (e) (e) (e) (e) (e) P=0.008 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) (e) (e) P=0.016 * |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 0/0.00 0/10.00 0/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 10/10 (100%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** (e) P<0.001N** P<0.001N** (e) (e) |
|POLY 3 | (e) (e) P<0.001 ** P<0.001 ** (e) (e) |
|POLY 1.5 | (e) (e) P<0.001 ** P<0.001 ** (e) (e) |
|POLY 6 | (e) (e) P<0.001 ** P<0.001 ** (e) (e) |
|LOGISTIC REGRESSION| P=0.002 ** (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.002 ** (e) P<0.001N** P<0.001N** (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 0/0.00 0/0.00 0/0.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 92 (T) --- --- --- 92 (T) 56 |
|-------------------| |
|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: 05196 TEST: 03 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thymus |
| Depletion Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/10.00 0/10.00 0/10.00 4/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 40.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 4/10 (40%) |
|FIRST INCIDENCE | --- --- --- --- --- 92 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.051 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.033 * |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.033 * |
|POLY 6 | (e) (e) (e) (e) (e) P=0.033 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.051 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.043 * |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 2 4 8 16 32 |
| | 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%) 6/7 (86%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/10.00 6/7.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 85.7% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) 6/7 (86%) |
|FIRST INCIDENCE | --- --- --- --- --- 92 (T) |
|-------------------| |
|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) P<0.001 ** |
|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: 05196 TEST: 03 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | 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 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) 2/10 (20%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/2.00 0/10.00 2/10.00 9/9.23 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 20.0% 97.6% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) 2/10 (20%) 8/8 (100%) |
|FIRST INCIDENCE | --- --- --- --- 92 (T) 69 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.234 P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) P=0.227 P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) P=0.227 P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) P=0.227 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.234 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.237 P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/19/04 EXPERIMENT: 05196 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM SELENITE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus: Lumen |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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 2 4 8 16 32 |
| | PPM PPM PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus: Lumen |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/0 (0%) 2/2 (100%) 4/10 (40%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 0/0.00 2/2.00 4/10.00 2/10.00 0/8.65 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 100.0% 40.0% 20.0% 0.0% |
|TERMINAL (d) | 1/10 (10%) 0/0 (0%) 2/2 (100%) 4/10 (40%) 2/10 (20%) 0/8 (0%) |
|FIRST INCIDENCE | 92 (T) --- 92 (T) 92 (T) 92 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.134N P=1.000 P=0.043 * P=0.157 P=0.500 P=0.545N |
|POLY 3 | (e) (e) P=0.005 ** P=0.148 P=0.500 P=0.529N |
|POLY 1.5 | (e) (e) P=0.005 ** P=0.148 P=0.500 P=0.518N |
|POLY 6 | (e) (e) P=0.005 ** P=0.148 P=0.500 P=0.538N |
|LOGISTIC REGRESSION| P=0.134N (e) P=0.043 * P=0.157 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.091N P=1.000 P=0.045 * P=0.152 P=0.500 P=0.500N |
|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).