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).