TDMS Study 88127-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus PENTAERYTHRITOL TRIACRYLATE (PETA) DATE: 07/12/02 EXPERIMENT: 88127 TEST: 06 TIME: 08:41:06 TEST TYPE: SUBCHRON 26-WEEK PAGE: 1 CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 88127B PATHOLOGIST: TOFT, JOHN CAS: 3524-68-3 ------------------------------------------------------------------------------------------------------------------------------------ Final#2 REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus PENTAERYTHRITOL TRIACRYLATE (PETA) DATE: 07/12/02 EXPERIMENT: 88127 TEST: 06 TIME: 08:41:06 TEST TYPE: SUBCHRON 26-WEEK CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 88127B PATHOLOGIST: TOFT, JOHN CAS: 3524-68-3 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF PENTAERYTHRITOL TRIACRYLATE (PETA) =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex Hypertrophy Myelodysplasia Adrenal Medulla Infiltration Cellular Myelodysplasia Epididymis Infiltration Cellular Inflammation Chronic Myelodysplasia Heart Infiltration Cellular Myelodysplasia Kidney Infiltration Cellular Myelodysplasia Nephropathy Liver Infiltration Cellular Inflammation Chronic Myelodysplasia Lung Infiltration Cellular Inflammation Chronic Myelodysplasia Lymph Node, Mandibular Infiltration Cellular Infiltration Cellular Plasma Cell Myelodysplasia Lymph Node, Mesenteric Infiltration Cellular Myelodysplasia Lymph Node: Mediastinal Infiltration Cellular Skin: Epidermis, Skin, Site of Application Hyperplasia Skin: Skin, Site of Application Hyperkeratosis Inflammation Chronic Spleen Depletion Cellular Hematopoietic Cell Proliferation Infiltration Cellular Myelodysplasia Stomach, Forestomach Hyperkeratosis Testes: Unilateral, Germinal Epithelium Degeneration Thymus Atrophy Myelodysplasia =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex: Capsule Hyperplasia Kidney: Cortex Cyst Kidney: Renal Tubule Necrosis Liver Hematopoietic Cell Proliferation NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus PENTAERYTHRITOL TRIACRYLATE (PETA) DATE: 07/12/02 EXPERIMENT: 88127 TEST: 06 TIME: 08:41:06 TEST TYPE: SUBCHRON 26-WEEK CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 88127B PATHOLOGIST: TOFT, JOHN CAS: 3524-68-3 Infiltration Cellular Pigmentation Lymph Node Hematopoietic Cell Proliferation Lymph Node, Mandibular Hematopoietic Cell Proliferation Infiltration Cellular Lymph Node: Mediastinal Infiltration Cellular Skin: Epidermis, Skin, Site of Application Hyperplasia Skin: Skin, Site of Application Hyperkeratosis Inflammation Chronic Spleen Hematopoietic Cell Proliferation Stomach, Forestomach Hyperkeratosis Thymus Atrophy Thymus: Thymocyte Necrosis =============================================================== Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE (PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/15 (47%) 10/15 (67%) 3/15 (20%) 5/15 (33%) 1/15 (7%) 3/15 (20%) | |POLY-3 RATE (b) | 7/13.43 10/14.34 3/15.00 5/15.00 1/14.39 3/13.53 | |POLY-3 PERCENT (g) | 52.1% 69.7% 20.0% 33.3% 7.0% 22.2% | |TERMINAL (d) | 7/12 (58%) 10/14 (71%) 3/15 (20%) 5/15 (33%) 1/12 (8%) 3/10 (30%) | |FIRST INCIDENCE | 185 (T) 185 (T) 185 (T) 185 (T) 185 (T) 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.040N* P=0.389 P=0.053N P=0.186N P=0.017N* P=0.190N | |POLY 3 | P=0.010N* P=0.285 P=0.076N P=0.266N P=0.007N** P=0.106N | |POLY 1.5 | P=0.009N** P=0.258 P=0.093N P=0.303N P=0.009N** P=0.111N | |POLY 6 | P=0.011N* P=0.329 P=0.059N P=0.224N P=0.005N** P=0.106N | |LOGISTIC REGRESSION| P=0.040N* P=0.389 P=0.053N P=0.186N P=0.017N* P=0.190N | |COCH-ARM / FISHERS | P=0.013N* P=0.231 P=0.123N P=0.355N P=0.018N* P=0.123N | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/14.39 2/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 14.8% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 2/10 (20%) | |FIRST INCIDENCE | --- --- --- --- --- 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** (e) (e) (e) (e) P=0.195 | |POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.232 | |POLY 1.5 | P=0.009 ** (e) (e) (e) (e) P=0.232 | |POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.228 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.195 | |COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.241 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Cortex: Capsule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/14.39 0/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (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) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Cortex: Capsule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 4/15 (27%) 7/15 (47%) 2/15 (13%) 1/15 (7%) 2/15 (13%) | |POLY-3 RATE (b) | 1/12.95 4/14.05 7/12.72 2/14.77 1/14.94 2/11.35 | |POLY-3 PERCENT (g) | 7.7% 28.5% 55.1% 13.5% 6.7% 17.6% | |TERMINAL (d) | 1/12 (8%) 4/14 (29%) 7/12 (58%) 1/12 (8%) 0/13 (0%) 1/9 (11%) | |FIRST INCIDENCE | 186 (T) 186 (T) 186 (T) 167 85 134 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.309N P=0.215 P=0.017 * P=0.517 P=0.735N P=0.414 | |POLY 3 | P=0.193N P=0.187 P=0.008 ** P=0.546 P=0.728N P=0.452 | |POLY 1.5 | P=0.189N P=0.181 P=0.009 ** P=0.538 P=0.735N P=0.470 | |POLY 6 | P=0.200N P=0.191 P=0.007 ** P=0.547 P=0.725N P=0.434 | |LOGISTIC REGRESSION| P=0.205N P=0.215 P=0.017 * P=0.518 P=0.698 P=0.482 | |COCH-ARM / FISHERS | P=0.191N P=0.165 P=0.018 * P=0.500 P=0.759N P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Medulla | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/14.39 2/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 14.8% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 2/10 (20%) | |FIRST INCIDENCE | --- --- --- --- --- 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** (e) (e) (e) (e) P=0.195 | |POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.232 | |POLY 1.5 | P=0.009 ** (e) (e) (e) (e) P=0.232 | |POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.228 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.195 | |COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.241 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Medulla | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/13.63 0/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Medulla | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/14.39 2/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 14.8% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 2/10 (20%) | |FIRST INCIDENCE | --- --- --- --- --- 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** (e) (e) (e) (e) P=0.195 | |POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.232 | |POLY 1.5 | P=0.009 ** (e) (e) (e) (e) P=0.232 | |POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.228 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.195 | |COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.241 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Medulla | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/13.63 0/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Epididymis | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 5/15 (33%) 5/15 (33%) | |POLY-3 RATE (b) | 0/13.43 0/13.34 0/15.00 0/15.00 5/14.39 5/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 34.8% 37.0% | |TERMINAL (d) | 0/12 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 5/12 (42%) 5/10 (50%) | |FIRST INCIDENCE | --- --- --- --- 185 (T) 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.025 * P=0.013 * | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.021 * P=0.016 * | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.019 * P=0.016 * | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.022 * P=0.014 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.025 * P=0.013 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.021 * P=0.021 * | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Epididymis | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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 | | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Epididymis | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 1/14 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 4/15 (27%) | |POLY-3 RATE (b) | 0/13.43 1/13.34 0/15.00 0/15.00 0/14.39 4/14.51 | |POLY-3 PERCENT (g) | 0.0% 7.5% 0.0% 0.0% 0.0% 27.6% | |TERMINAL (d) | 0/12 (0%) 1/13 (8%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 1/10 (10%) | |FIRST INCIDENCE | --- 185 (T) --- --- --- 138 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.516 (e) (e) (e) P=0.065 | |POLY 3 | P<0.001 ** P=0.499 (e) (e) (e) P=0.054 | |POLY 1.5 | P<0.001 ** P=0.493 (e) (e) (e) P=0.050 | |POLY 6 | P<0.001 ** P=0.506 (e) (e) (e) P=0.057 | |LOGISTIC REGRESSION| P=0.003 ** P=0.516 (e) (e) (e) P=0.036 * | |COCH-ARM / FISHERS | P=0.002 ** P=0.483 (e) (e) (e) P=0.050 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Epididymis | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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 | | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 8 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Epididymis | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 5/15 (33%) | |POLY-3 RATE (b) | 0/13.43 0/13.34 0/15.00 0/15.00 0/14.39 5/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 37.0% | |TERMINAL (d) | 0/12 (0%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 5/10 (50%) | |FIRST INCIDENCE | --- --- --- --- --- 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.013 * | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.016 * | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.016 * | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.014 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.013 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.021 * | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Epididymis | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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 | | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 9 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Epididymis: Unilateral | | Hypospermia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 1/14 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) | |POLY-3 RATE (b) | 1/13.95 1/13.34 0/15.00 0/15.00 0/14.39 2/13.79 | |POLY-3 PERCENT (g) | 7.2% 7.5% 0.0% 0.0% 0.0% 14.5% | |TERMINAL (d) | 0/12 (0%) 1/13 (8%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 1/10 (10%) | |FIRST INCIDENCE | 145 185 (T) --- --- --- 167 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.182 P=0.751N P=0.486N P=0.486N P=0.486N P=0.488 | |POLY 3 | P=0.215 P=0.751 P=0.486N P=0.486N P=0.494N P=0.496 | |POLY 1.5 | P=0.220 P=0.748 P=0.491N P=0.491N P=0.496N P=0.498 | |POLY 6 | P=0.209 P=0.755 P=0.479N P=0.479N P=0.493N P=0.490 | |LOGISTIC REGRESSION| P=0.241 P=0.720 P=0.981N P=0.981N P=0.928N P=0.460 | |COCH-ARM / FISHERS | P=0.224 P=0.741 P=0.500N P=0.500N P=0.500N P=0.500 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Epididymis: Unilateral | | Hypospermia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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 | | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 10 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Heart | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/14.39 3/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 22.2% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 3/10 (30%) | |FIRST INCIDENCE | --- --- --- --- --- 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.083 | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.105 | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.106 | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.102 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.083 | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.112 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Heart | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 1/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 9.3% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 1/9 (11%) | |FIRST INCIDENCE | --- --- --- --- --- 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.073 (e) (e) (e) (e) P=0.443 | |POLY 3 | P=0.090 (e) (e) (e) (e) P=0.462 | |POLY 1.5 | P=0.095 (e) (e) (e) (e) P=0.477 | |POLY 6 | P=0.085 (e) (e) (e) (e) P=0.447 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.443 | |COCH-ARM / FISHERS | P=0.105 (e) (e) (e) (e) P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 11 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Heart | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 3/15 (20%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) | |POLY-3 RATE (b) | 0/13.43 3/14.34 0/15.00 0/15.00 1/14.41 0/13.53 | |POLY-3 PERCENT (g) | 0.0% 20.9% 0.0% 0.0% 6.9% 0.0% | |TERMINAL (d) | 0/12 (0%) 3/14 (21%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- 185 (T) --- --- 184 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.363N P=0.143 (e) (e) P=0.516 (e) | |POLY 3 | P=0.295N P=0.117 (e) (e) P=0.514 (e) | |POLY 1.5 | P=0.294N P=0.112 (e) (e) P=0.509 (e) | |POLY 6 | P=0.298N P=0.125 (e) (e) P=0.519 (e) | |LOGISTIC REGRESSION| P=0.332N P=0.143 (e) (e) P=0.520 (e) | |COCH-ARM / FISHERS | P=0.299N P=0.112 (e) (e) P=0.500 (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Heart | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) | |POLY-3 RATE (b) | 0/12.95 1/14.05 0/12.72 0/14.49 0/14.03 1/10.72 | |POLY-3 PERCENT (g) | 0.0% 7.1% 0.0% 0.0% 0.0% 9.3% | |TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 1/9 (11%) | |FIRST INCIDENCE | --- 186 (T) --- --- --- 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.300 P=0.531 (e) (e) (e) P=0.443 | |POLY 3 | P=0.346 P=0.516 (e) (e) (e) P=0.462 | |POLY 1.5 | P=0.353 P=0.512 (e) (e) (e) P=0.477 | |POLY 6 | P=0.341 P=0.519 (e) (e) (e) P=0.447 | |LOGISTIC REGRESSION| (e) P=0.531 (e) (e) (e) P=0.443 | |COCH-ARM / FISHERS | P=0.364 P=0.500 (e) (e) (e) P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 12 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Heart | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/14.39 3/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 22.2% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 3/10 (30%) | |FIRST INCIDENCE | --- --- --- --- --- 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.083 | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.105 | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.106 | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.102 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.083 | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.112 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Heart | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 13 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 2/15 (13%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 1/15.00 2/15.00 0/14.39 0/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 6.7% 13.3% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 1/15 (7%) 2/15 (13%) 0/12 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- 185 (T) 185 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.507N (e) P=0.545 P=0.286 (e) (e) | |POLY 3 | P=0.430N (e) P=0.522 P=0.257 (e) (e) | |POLY 1.5 | P=0.431N (e) P=0.513 P=0.246 (e) (e) | |POLY 6 | P=0.433N (e) P=0.533 P=0.271 (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.545 P=0.286 (e) (e) | |COCH-ARM / FISHERS | P=0.436N (e) P=0.500 P=0.241 (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 14 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 3/15 (20%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 2/14.39 3/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 13.9% 22.2% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 2/12 (17%) 3/10 (30%) | |FIRST INCIDENCE | --- --- --- --- 185 (T) 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.235 P=0.083 | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.247 P=0.105 | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.241 P=0.106 | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.253 P=0.102 | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.235 P=0.083 | |COCH-ARM / FISHERS | P=0.002 ** (e) (e) (e) P=0.241 P=0.112 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 15 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 0/15 (0%) 4/15 (27%) 4/15 (27%) 3/15 (20%) 0/15 (0%) | |POLY-3 RATE (b) | 1/13.43 0/14.34 4/15.00 4/15.00 3/14.39 0/13.53 | |POLY-3 PERCENT (g) | 7.4% 0.0% 26.7% 26.7% 20.9% 0.0% | |TERMINAL (d) | 1/12 (8%) 0/14 (0%) 4/15 (27%) 4/15 (27%) 3/12 (25%) 0/10 (0%) | |FIRST INCIDENCE | 185 (T) --- 185 (T) 185 (T) 185 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.417N P=0.469N P=0.240 P=0.240 P=0.296 P=0.536N | |POLY 3 | P=0.297N P=0.487N P=0.198 P=0.198 P=0.323 P=0.499N | |POLY 1.5 | P=0.287N P=0.493N P=0.183 P=0.183 P=0.313 P=0.499N | |POLY 6 | P=0.319N P=0.479N P=0.218 P=0.218 P=0.332 P=0.501N | |LOGISTIC REGRESSION| P=0.417N (e) P=0.240 P=0.240 P=0.296 (e) | |COCH-ARM / FISHERS | P=0.286N P=0.500N P=0.165 P=0.165 P=0.299 P=0.500N | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 2/15 (13%) 1/15 (7%) 1/15 (7%) 1/15 (7%) 1/15 (7%) | |POLY-3 RATE (b) | 1/12.95 2/14.05 1/13.51 1/14.49 1/14.03 1/10.72 | |POLY-3 PERCENT (g) | 7.7% 14.2% 7.4% 6.9% 7.1% 9.3% | |TERMINAL (d) | 1/12 (8%) 2/14 (14%) 0/12 (0%) 1/12 (8%) 1/13 (8%) 1/9 (11%) | |FIRST INCIDENCE | 186 (T) 186 (T) 109 186 (T) 186 (T) 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.593N P=0.555 P=0.752N P=0.765 P=0.747N P=0.700 | |POLY 3 | P=0.528N P=0.529 P=0.752N P=0.736N P=0.743N P=0.718 | |POLY 1.5 | P=0.517N P=0.522 P=0.755N P=0.739N P=0.746N P=0.736 | |POLY 6 | P=0.534N P=0.533 P=0.753N P=0.739N P=0.742N P=0.699 | |LOGISTIC REGRESSION| P=0.508N P=0.555 P=0.760N P=0.765 P=0.747N P=0.700 | |COCH-ARM / FISHERS | P=0.495N P=0.500 P=0.759N P=0.759N P=0.759N P=0.759N | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 16 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 4/15 (27%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/14.39 4/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 29.6% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 4/10 (40%) | |FIRST INCIDENCE | --- --- --- --- --- 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.034 * | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.043 * | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.045 * | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.041 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.034 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.050 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 17 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/15 (40%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 6/13.43 1/15.00 0/15.00 0/15.00 0/14.39 0/13.53 | |POLY-3 PERCENT (g) | 44.7% 6.7% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 6/12 (50%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 0/10 (0%) | |FIRST INCIDENCE | 185 (T) 129 --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.017N* P=0.032N* P=0.005N** P=0.005N** P=0.011N* P=0.018N* | |POLY 3 | P=0.007N** P=0.020N* P=0.003N** P=0.003N** P=0.003N** P=0.004N** | |POLY 1.5 | P=0.006N** P=0.025N* P=0.003N** P=0.003N** P=0.004N** P=0.005N** | |POLY 6 | P=0.008N** P=0.015N* P=0.002N** P=0.002N** P=0.002N** P=0.004N** | |LOGISTIC REGRESSION| P=0.013N* P=0.045N* (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.013N* P=0.040N* P=0.008N** P=0.008N** P=0.008N** P=0.008N** | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/15 (20%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) | |POLY-3 RATE (b) | 3/12.95 0/14.05 0/12.72 0/14.49 0/14.03 2/10.72 | |POLY-3 PERCENT (g) | 23.2% 0.0% 0.0% 0.0% 0.0% 18.7% | |TERMINAL (d) | 3/12 (25%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 2/9 (22%) | |FIRST INCIDENCE | 186 (T) --- --- --- --- 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.331 P=0.089N P=0.113N P=0.113N P=0.100N P=0.641N | |POLY 3 | P=0.407 P=0.090N P=0.107N P=0.085N P=0.090N P=0.591N | |POLY 1.5 | P=0.409 P=0.094N P=0.106N P=0.088N P=0.093N P=0.556N | |POLY 6 | P=0.411 P=0.088N P=0.110N P=0.087N P=0.089N P=0.628N | |LOGISTIC REGRESSION| P=0.331 (e) (e) (e) (e) P=0.641N | |COCH-ARM / FISHERS | P=0.428 P=0.112N P=0.112N P=0.112N P=0.112N P=0.500N | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 18 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney: Cortex | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 1/15 (7%) 0/15 (0%) 1/15 (7%) 1/15 (7%) 1/15 (7%) | |POLY-3 RATE (b) | 0/13.43 1/15.00 0/15.00 1/15.00 1/14.39 1/13.53 | |POLY-3 PERCENT (g) | 0.0% 6.7% 0.0% 6.7% 7.0% 7.4% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 1/15 (7%) 1/12 (8%) 1/10 (10%) | |FIRST INCIDENCE | --- 129 --- 185 (T) 185 (T) 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.279 P=0.500 (e) P=0.545 P=0.500 P=0.464 | |POLY 3 | P=0.328 P=0.522 (e) P=0.522 P=0.514 P=0.501 | |POLY 1.5 | P=0.337 P=0.513 (e) P=0.513 P=0.508 P=0.501 | |POLY 6 | P=0.312 P=0.533 (e) P=0.533 P=0.519 P=0.499 | |LOGISTIC REGRESSION| P=0.360 (e) (e) P=0.545 P=0.500 P=0.464 | |COCH-ARM / FISHERS | P=0.343 P=0.500 (e) P=0.500 P=0.500 P=0.500 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney: Cortex | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 2/11.50 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 17.4% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 1/9 (11%) | |FIRST INCIDENCE | --- --- --- --- --- 113 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.007 ** (e) (e) (e) (e) P=0.208 | |POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.202 | |POLY 1.5 | P=0.008 ** (e) (e) (e) (e) P=0.213 | |POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.191 | |LOGISTIC REGRESSION| P=0.018 * (e) (e) (e) (e) P=0.248 | |COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.241 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 19 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/14.39 0/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (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) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 2/11.91 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 16.8% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 98 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.008 ** (e) (e) (e) (e) P=0.219 | |POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.210 | |POLY 1.5 | P=0.009 ** (e) (e) (e) (e) P=0.218 | |POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.202 | |LOGISTIC REGRESSION| P=0.022 * (e) (e) (e) (e) P=0.269 | |COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.241 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 20 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Regeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 2/15 (13%) 0/15 (0%) 3/15 (20%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 1/13.43 2/14.34 0/15.00 3/15.00 0/14.39 0/13.53 | |POLY-3 PERCENT (g) | 7.4% 14.0% 0.0% 20.0% 0.0% 0.0% | |TERMINAL (d) | 1/12 (8%) 2/14 (14%) 0/15 (0%) 3/15 (20%) 0/12 (0%) 0/10 (0%) | |FIRST INCIDENCE | 185 (T) 185 (T) --- 185 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.208N P=0.555 P=0.455N P=0.383 P=0.500N P=0.536N | |POLY 3 | P=0.159N P=0.523 P=0.478N P=0.340 P=0.486N P=0.499N | |POLY 1.5 | P=0.156N P=0.513 P=0.487N P=0.322 P=0.492N P=0.499N | |POLY 6 | P=0.166N P=0.537 P=0.467N P=0.362 P=0.481N P=0.501N | |LOGISTIC REGRESSION| P=0.208N P=0.555 (e) P=0.383 (e) (e) | |COCH-ARM / FISHERS | P=0.158N P=0.500 P=0.500N P=0.299 P=0.500N P=0.500N | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Regeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 1/15 (7%) 0/15 (0%) 2/15 (13%) 1/15 (7%) 0/15 (0%) | |POLY-3 RATE (b) | 1/12.95 1/14.05 0/12.72 2/14.49 1/14.03 0/10.72 | |POLY-3 PERCENT (g) | 7.7% 7.1% 0.0% 13.8% 7.1% 0.0% | |TERMINAL (d) | 1/12 (8%) 1/14 (7%) 0/12 (0%) 2/12 (17%) 1/13 (8%) 0/9 (0%) | |FIRST INCIDENCE | 186 (T) 186 (T) --- 186 (T) 186 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.421N P=0.730N P=0.500N P=0.500 P=0.747N P=0.557N | |POLY 3 | P=0.389N P=0.743N P=0.504N P=0.540 P=0.743N P=0.538N | |POLY 1.5 | P=0.372N P=0.747N P=0.503N P=0.535 P=0.746N P=0.523N | |POLY 6 | P=0.405N P=0.740N P=0.507N P=0.536 P=0.742N P=0.553N | |LOGISTIC REGRESSION| P=0.421N P=0.730N (e) P=0.500 P=0.747N (e) | |COCH-ARM / FISHERS | P=0.343N P=0.759N P=0.500N P=0.500 P=0.759N P=0.500N | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 21 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 0/15 (0%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 2/14.39 0/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 13.9% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 2/12 (17%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- 185 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.348 (e) (e) (e) P=0.235 (e) | |POLY 3 | P=0.373 (e) (e) (e) P=0.247 (e) | |POLY 1.5 | P=0.391 (e) (e) (e) P=0.241 (e) | |POLY 6 | P=0.343 (e) (e) (e) P=0.253 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.235 (e) | |COCH-ARM / FISHERS | P=0.414 (e) (e) (e) P=0.241 (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 1/15 (7%) 6/15 (40%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 1/14.59 1/14.03 6/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.9% 7.1% 56.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 1/13 (8%) 6/9 (67%) | |FIRST INCIDENCE | --- --- --- 180 186 (T) 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.516 P=0.516 P=0.003 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.524 P=0.516 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.520 P=0.513 P=0.002 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.522 P=0.517 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.511 P=0.516 P=0.003 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P=0.500 P=0.008 ** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 22 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 5/15 (33%) 3/15 (20%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 5/14.39 3/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 34.8% 22.2% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 5/12 (42%) 3/10 (30%) | |FIRST INCIDENCE | --- --- --- --- 185 (T) 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.025 * P=0.083 | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.021 * P=0.105 | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.019 * P=0.106 | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.022 * P=0.102 | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.025 * P=0.083 | |COCH-ARM / FISHERS | P=0.002 ** (e) (e) (e) P=0.021 * P=0.112 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) 2/15 (13%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 3/14.03 2/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 21.4% 18.7% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 3/13 (23%) 2/9 (22%) | |FIRST INCIDENCE | --- --- --- --- 186 (T) 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** (e) (e) (e) P=0.128 P=0.173 | |POLY 3 | P=0.004 ** (e) (e) (e) P=0.120 P=0.188 | |POLY 1.5 | P=0.006 ** (e) (e) (e) P=0.117 P=0.203 | |POLY 6 | P=0.003 ** (e) (e) (e) P=0.121 P=0.172 | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.128 P=0.173 | |COCH-ARM / FISHERS | P=0.014 * (e) (e) (e) P=0.112 P=0.241 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 23 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/15 (33%) 11/15 (73%) 10/15 (67%) 13/15 (87%) 13/15 (87%) 5/15 (33%) | |POLY-3 RATE (b) | 5/13.43 11/15.00 10/15.00 13/15.00 13/14.67 5/14.19 | |POLY-3 PERCENT (g) | 37.2% 73.3% 66.7% 86.7% 88.6% 35.2% | |TERMINAL (d) | 5/12 (42%) 10/14 (71%) 10/15 (67%) 13/15 (87%) 12/12 (100%) 2/10 (20%) | |FIRST INCIDENCE | 185 (T) 129 185 (T) 185 (T) 166 160 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.540 P=0.081 P=0.186 P=0.022 * P=0.003 ** P=0.562 | |POLY 3 | P=0.145N P=0.051 P=0.111 P=0.004 ** P=0.002 ** P=0.611N | |POLY 1.5 | P=0.146N P=0.039 * P=0.090 P=0.002 ** P=0.002 ** P=0.626N | |POLY 6 | P=0.150N P=0.072 P=0.144 P=0.007 ** P=0.003 ** P=0.592N | |LOGISTIC REGRESSION| P=0.206N P=0.041 * P=0.186 P=0.022 * P=0.007 ** P=0.647N | |COCH-ARM / FISHERS | P=0.174N P=0.033 * P=0.072 P=0.004 ** P=0.004 ** P=0.650N | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 12/15 (80%) 14/15 (93%) 11/15 (73%) 14/15 (93%) 13/15 (87%) 11/15 (73%) | |POLY-3 RATE (b) | 12/12.95 14/14.05 11/12.72 14/14.86 13/14.10 11/11.68 | |POLY-3 PERCENT (g) | 92.6% 99.7% 86.5% 94.2% 92.2% 94.1% | |TERMINAL (d) | 12/12 (100%) 14/14 (100%) 11/12 (92%) 12/12 (100%) 12/13 (92%) 9/9 (100%) | |FIRST INCIDENCE | 186 (T) 186 (T) 186 (T) 167 182 134 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.069 P=1.000 P=0.500N P=0.265 P=0.752N P=0.194 | |POLY 3 | P=0.605N P=0.524 P=0.560N P=0.737 P=0.762N P=0.797 | |POLY 1.5 | P=0.454N P=0.425 P=0.540N P=0.629 P=0.726 P=0.729N | |POLY 6 | P=0.540 P=0.616 P=0.625N P=0.797 P=0.744N P=0.735 | |LOGISTIC REGRESSION| P=0.157 P=1.000 P=0.500N P=0.562 P=0.659N P=0.390 | |COCH-ARM / FISHERS | P=0.277N P=0.299 P=0.500N P=0.299 P=0.500 P=0.500N | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 24 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 5/15 (33%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/14.39 5/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 37.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 5/10 (50%) | |FIRST INCIDENCE | --- --- --- --- --- 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.013 * | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.016 * | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.016 * | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.014 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.013 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.021 * | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 25 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/13.43 1/14.34 1/15.00 0/15.00 0/14.39 0/13.53 | |POLY-3 PERCENT (g) | 0.0% 7.0% 6.7% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/14 (7%) 1/15 (7%) 0/15 (0%) 0/12 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- 185 (T) 185 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.376N P=0.531 P=0.545 (e) (e) (e) | |POLY 3 | P=0.320N P=0.513 P=0.522 (e) (e) (e) | |POLY 1.5 | P=0.326N P=0.507 P=0.513 (e) (e) (e) | |POLY 6 | P=0.314N P=0.521 P=0.533 (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.531 P=0.545 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.332N P=0.500 P=0.500 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/15 (73%) 11/15 (73%) 9/15 (60%) 13/15 (87%) 5/15 (33%) 2/15 (13%) | |POLY-3 RATE (b) | 11/12.95 11/14.05 9/12.72 13/14.59 5/14.03 2/11.35 | |POLY-3 PERCENT (g) | 84.9% 78.3% 70.8% 89.1% 35.6% 17.6% | |TERMINAL (d) | 11/12 (92%) 11/14 (79%) 9/12 (75%) 12/12 (100%) 5/13 (39%) 1/9 (11%) | |FIRST INCIDENCE | 186 (T) 186 (T) 186 (T) 180 186 (T) 134 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.356N P=0.296N P=0.249 P=0.011N* P=0.007N** | |POLY 3 | P<0.001N** P=0.521N P=0.346N P=0.598 P=0.007N** P<0.001N** | |POLY 1.5 | P<0.001N** P=0.560N P=0.345N P=0.547 P=0.009N** P<0.001N** | |POLY 6 | P<0.001N** P=0.494N P=0.372N P=0.591 P=0.006N** P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.356N P=0.296N P=0.330 P=0.011N* P=0.003N** | |COCH-ARM / FISHERS | P<0.001N** P=0.659N P=0.350N P=0.326 P=0.033N* P<0.001N** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 26 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 1/15 (7%) 1/15 (7%) | |POLY-3 RATE (b) | 1/13.43 0/14.34 1/15.00 0/15.00 1/14.39 1/13.53 | |POLY-3 PERCENT (g) | 7.4% 0.0% 6.7% 0.0% 7.0% 7.4% | |TERMINAL (d) | 1/12 (8%) 0/14 (0%) 1/15 (7%) 0/15 (0%) 1/12 (8%) 1/10 (10%) | |FIRST INCIDENCE | 185 (T) --- 185 (T) --- 185 (T) 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.360 P=0.469N P=0.714N P=0.455N P=0.765 P=0.724 | |POLY 3 | P=0.430 P=0.487N P=0.736N P=0.478N P=0.746N P=0.760N | |POLY 1.5 | P=0.440 P=0.493N P=0.746N P=0.487N P=0.751N P=0.760N | |POLY 6 | P=0.412 P=0.479N P=0.723N P=0.467N P=0.740N P=0.761 | |LOGISTIC REGRESSION| P=0.360 (e) P=0.714N (e) P=0.765 P=0.724 | |COCH-ARM / FISHERS | P=0.450 P=0.500N P=0.759N P=0.500N P=0.759N P=0.759N | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Liver: Hepatocyte | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/15 (13%) 2/15 (13%) 2/15 (13%) 3/15 (20%) 4/15 (27%) 2/15 (13%) | |POLY-3 RATE (b) | 2/12.95 2/14.05 2/12.72 3/14.49 4/14.03 2/11.06 | |POLY-3 PERCENT (g) | 15.4% 14.2% 15.7% 20.7% 28.5% 18.1% | |TERMINAL (d) | 2/12 (17%) 2/14 (14%) 2/12 (17%) 3/12 (25%) 4/13 (31%) 1/9 (11%) | |FIRST INCIDENCE | 186 (T) 186 (T) 186 (T) 186 (T) 186 (T) 162 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.321 P=0.644N P=0.704 P=0.500 P=0.364 P=0.592 | |POLY 3 | P=0.358 P=0.670N P=0.694 P=0.553 P=0.365 P=0.642 | |POLY 1.5 | P=0.401 P=0.676N P=0.695 P=0.547 P=0.359 P=0.664 | |POLY 6 | P=0.324 P=0.665N P=0.688 P=0.548 P=0.368 P=0.620 | |LOGISTIC REGRESSION| P=0.355 P=0.644N P=0.704 P=0.500 P=0.364 P=0.641 | |COCH-ARM / FISHERS | P=0.490 P=0.701N P=0.701N P=0.500 P=0.326 P=0.701N | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 27 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lung | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 3/15 (20%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 1/14.39 3/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.0% 22.2% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 1/12 (8%) 3/10 (30%) | |FIRST INCIDENCE | --- --- --- --- 185 (T) 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.500 P=0.083 | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.514 P=0.105 | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.508 P=0.106 | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.519 P=0.102 | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.500 P=0.083 | |COCH-ARM / FISHERS | P=0.002 ** (e) (e) (e) P=0.500 P=0.112 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lung | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 1/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 9.3% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 1/9 (11%) | |FIRST INCIDENCE | --- --- --- --- --- 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.073 (e) (e) (e) (e) P=0.443 | |POLY 3 | P=0.090 (e) (e) (e) (e) P=0.462 | |POLY 1.5 | P=0.095 (e) (e) (e) (e) P=0.477 | |POLY 6 | P=0.085 (e) (e) (e) (e) P=0.447 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.443 | |COCH-ARM / FISHERS | P=0.105 (e) (e) (e) (e) P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 28 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 2/15 (13%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 1/14.39 2/13.57 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.0% 14.7% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 1/12 (8%) 1/10 (10%) | |FIRST INCIDENCE | --- --- --- --- 185 (T) 182 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** (e) (e) (e) P=0.500 P=0.211 | |POLY 3 | P=0.012 * (e) (e) (e) P=0.514 P=0.232 | |POLY 1.5 | P=0.013 * (e) (e) (e) P=0.508 P=0.233 | |POLY 6 | P=0.011 * (e) (e) (e) P=0.519 P=0.230 | |LOGISTIC REGRESSION| P=0.009 ** (e) (e) (e) P=0.500 P=0.223 | |COCH-ARM / FISHERS | P=0.014 * (e) (e) (e) P=0.500 P=0.241 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 1/15 (7%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 1/14.49 0/14.03 1/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.9% 0.0% 9.3% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 1/12 (8%) 0/13 (0%) 1/9 (11%) | |FIRST INCIDENCE | --- --- --- 186 (T) --- 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.172 (e) (e) P=0.500 (e) P=0.443 | |POLY 3 | P=0.195 (e) (e) P=0.522 (e) P=0.462 | |POLY 1.5 | P=0.208 (e) (e) P=0.519 (e) P=0.477 | |POLY 6 | P=0.182 (e) (e) P=0.520 (e) P=0.447 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.500 (e) P=0.443 | |COCH-ARM / FISHERS | P=0.230 (e) (e) P=0.500 (e) P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 29 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lung | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/14.39 3/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 22.2% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 3/10 (30%) | |FIRST INCIDENCE | --- --- --- --- --- 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.083 | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.105 | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.106 | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.102 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.083 | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.112 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lung | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 30 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/14 (0%) 0/15 (0%) 0/14 (0%) 0/13 (0%) 0/15 (0%) 0/14 (0%) | |POLY-3 RATE (b) | 0/13.07 0/14.34 0/14.00 0/13.00 0/14.39 0/12.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/14 (0%) 0/13 (0%) 0/12 (0%) 0/9 (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) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/14 (0%) 0/13 (0%) 0/12 (0%) 0/15 (0%) 2/14 (14%) | |POLY-3 RATE (b) | 0/12.95 0/13.05 0/10.72 0/11.49 0/14.03 2/10.57 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 18.9% | |TERMINAL (d) | 0/12 (0%) 0/13 (0%) 0/10 (0%) 0/9 (0%) 0/13 (0%) 2/9 (22%) | |FIRST INCIDENCE | --- --- --- --- --- 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.006 ** (e) (e) (e) (e) P=0.173 | |POLY 3 | P=0.009 ** (e) (e) (e) (e) P=0.184 | |POLY 1.5 | P=0.009 ** (e) (e) (e) (e) P=0.196 | |POLY 6 | P=0.009 ** (e) (e) (e) (e) P=0.170 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.173 | |COCH-ARM / FISHERS | P=0.012 * (e) (e) (e) (e) P=0.224 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 31 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) 0/15 (0%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 3/14.39 0/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 20.9% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 3/12 (25%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- 185 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.237 (e) (e) (e) P=0.113 (e) | |POLY 3 | P=0.263 (e) (e) (e) P=0.118 (e) | |POLY 1.5 | P=0.282 (e) (e) (e) P=0.113 (e) | |POLY 6 | P=0.234 (e) (e) (e) P=0.122 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.113 (e) | |COCH-ARM / FISHERS | P=0.315 (e) (e) (e) P=0.112 (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 8/13 (62%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 1/14.03 8/10.03 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.1% 79.7% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 1/13 (8%) 8/9 (89%) | |FIRST INCIDENCE | --- --- --- --- 186 (T) 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.516 P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.516 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.513 P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.517 P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.516 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.500 P<0.001 ** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 32 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 2/15 (13%) 1/15 (7%) 2/15 (13%) 1/15 (7%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 2/15.00 1/15.00 2/14.41 1/13.75 | |POLY-3 PERCENT (g) | 0.0% 0.0% 13.3% 6.7% 13.9% 7.3% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 2/15 (13%) 1/15 (7%) 1/12 (8%) 0/10 (0%) | |FIRST INCIDENCE | --- --- 185 (T) 185 (T) 184 170 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.259 (e) P=0.286 P=0.545 P=0.249 P=0.500 | |POLY 3 | P=0.344 (e) P=0.257 P=0.522 P=0.247 P=0.505 | |POLY 1.5 | P=0.349 (e) P=0.246 P=0.513 P=0.241 P=0.503 | |POLY 6 | P=0.333 (e) P=0.271 P=0.533 P=0.253 P=0.505 | |LOGISTIC REGRESSION| P=0.340 (e) P=0.286 P=0.545 P=0.251 P=0.488 | |COCH-ARM / FISHERS | P=0.350 (e) P=0.241 P=0.500 P=0.241 P=0.500 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/15 (20%) 0/15 (0%) 1/15 (7%) 5/15 (33%) 3/15 (20%) 1/13 (8%) | |POLY-3 RATE (b) | 3/13.09 0/14.05 1/12.72 5/15.00 3/14.03 1/10.03 | |POLY-3 PERCENT (g) | 22.9% 0.0% 7.9% 33.3% 21.4% 10.0% | |TERMINAL (d) | 2/12 (17%) 0/14 (0%) 1/12 (8%) 2/12 (17%) 3/13 (23%) 1/9 (11%) | |FIRST INCIDENCE | 177 --- 186 (T) 167 186 (T) 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.551 P=0.099N P=0.310N P=0.382 P=0.632N P=0.419N | |POLY 3 | P=0.529 P=0.092N P=0.307N P=0.427 P=0.638N P=0.400N | |POLY 1.5 | P=0.562 P=0.095N P=0.303N P=0.410 P=0.642N P=0.383N | |POLY 6 | P=0.499 P=0.092N P=0.317N P=0.431 P=0.640N P=0.419N | |LOGISTIC REGRESSION| P=0.591 P=0.099N P=0.303N P=0.377 P=0.639N P=0.400N | |COCH-ARM / FISHERS | P=0.546N P=0.112N P=0.299N P=0.341 P=0.674N P=0.356N | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 33 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 5/15 (33%) 6/15 (40%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 5/14.39 6/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 34.8% 44.4% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 5/12 (42%) 6/10 (60%) | |FIRST INCIDENCE | --- --- --- --- 185 (T) 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.025 * P=0.005 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.021 * P=0.005 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.019 * P=0.005 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.022 * P=0.004 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.025 * P=0.005 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.021 * P=0.008 ** | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 2/15 (13%) 2/13 (15%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 1/14.49 2/14.03 2/10.03 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.9% 14.3% 19.9% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 1/12 (8%) 2/13 (15%) 2/9 (22%) | |FIRST INCIDENCE | --- --- --- 186 (T) 186 (T) 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.012 * (e) (e) P=0.500 P=0.253 P=0.173 | |POLY 3 | P=0.013 * (e) (e) P=0.522 P=0.250 P=0.172 | |POLY 1.5 | P=0.015 * (e) (e) P=0.519 P=0.246 P=0.180 | |POLY 6 | P=0.011 * (e) (e) P=0.520 P=0.251 P=0.165 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.500 P=0.253 P=0.173 | |COCH-ARM / FISHERS | P=0.021 * (e) (e) P=0.500 P=0.241 P=0.206 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 34 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Infiltration Cellular Plasma Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 6/15 (40%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 1/14.39 6/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.0% 44.4% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 1/12 (8%) 6/10 (60%) | |FIRST INCIDENCE | --- --- --- --- 185 (T) 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.500 P=0.005 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.514 P=0.005 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.508 P=0.005 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.519 P=0.004 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.500 P=0.005 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.500 P=0.008 ** | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Infiltration Cellular Plasma Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 1/13 (8%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 1/14.03 1/10.03 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.1% 10.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 1/13 (8%) 1/9 (11%) | |FIRST INCIDENCE | --- --- --- --- 186 (T) 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.065 (e) (e) (e) P=0.516 P=0.443 | |POLY 3 | P=0.065 (e) (e) (e) P=0.516 P=0.449 | |POLY 1.5 | P=0.070 (e) (e) (e) P=0.513 P=0.456 | |POLY 6 | P=0.060 (e) (e) (e) P=0.517 P=0.441 | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.516 P=0.443 | |COCH-ARM / FISHERS | P=0.085 (e) (e) (e) P=0.500 P=0.464 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 35 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/14.39 2/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 14.8% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 2/10 (20%) | |FIRST INCIDENCE | --- --- --- --- --- 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** (e) (e) (e) (e) P=0.195 | |POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.232 | |POLY 1.5 | P=0.009 ** (e) (e) (e) (e) P=0.232 | |POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.228 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.195 | |COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.241 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 0/10.03 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 36 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Necrosis Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 0/15 (0%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 2/14.72 0/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 13.6% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- 163 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.382 (e) (e) (e) P=0.273 (e) | |POLY 3 | P=0.366 (e) (e) (e) P=0.253 (e) | |POLY 1.5 | P=0.388 (e) (e) (e) P=0.244 (e) | |POLY 6 | P=0.332 (e) (e) (e) P=0.263 (e) | |LOGISTIC REGRESSION| P=0.425 (e) (e) (e) P=0.171 (e) | |COCH-ARM / FISHERS | P=0.414 (e) (e) (e) P=0.241 (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Necrosis Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/13 (0%) | |POLY-3 RATE (b) | 0/12.95 1/15.00 1/13.72 0/14.49 0/14.03 0/10.03 | |POLY-3 PERCENT (g) | 0.0% 6.7% 7.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE | --- 67 5 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.334N P=0.514 P=0.500 (e) (e) (e) | |POLY 3 | P=0.323N P=0.529 P=0.511 (e) (e) (e) | |POLY 1.5 | P=0.330N P=0.523 P=0.512 (e) (e) (e) | |POLY 6 | P=0.318N P=0.532 P=0.509 (e) (e) (e) | |LOGISTIC REGRESSION| P=0.215N P=0.327 (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.351N P=0.500 P=0.500 (e) (e) (e) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 37 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/12 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 4/15 (27%) 2/14 (14%) | |POLY-3 RATE (b) | 0/11.59 0/14.34 0/15.00 0/15.00 4/14.39 2/12.57 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 27.8% 15.9% | |TERMINAL (d) | 0/11 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 4/12 (33%) 2/10 (20%) | |FIRST INCIDENCE | --- --- --- --- 185 (T) 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** (e) (e) (e) P=0.064 P=0.213 | |POLY 3 | P=0.006 ** (e) (e) (e) P=0.072 P=0.248 | |POLY 1.5 | P=0.007 ** (e) (e) (e) P=0.073 P=0.256 | |POLY 6 | P=0.004 ** (e) (e) (e) P=0.069 P=0.236 | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.064 P=0.213 | |COCH-ARM / FISHERS | P=0.012 * (e) (e) (e) P=0.078 P=0.280 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/14 (0%) 4/15 (27%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.09 0/14.05 0/12.72 0/13.63 4/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 28.5% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 4/13 (31%) 0/9 (0%) | |FIRST INCIDENCE | --- --- --- --- 186 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.170 (e) (e) (e) P=0.064 (e) | |POLY 3 | P=0.089 (e) (e) (e) P=0.063 (e) | |POLY 1.5 | P=0.131 (e) (e) (e) P=0.062 (e) | |POLY 6 | P=0.058 (e) (e) (e) P=0.063 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.064 (e) | |COCH-ARM / FISHERS | P=0.257 (e) (e) (e) P=0.057 (e) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 38 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/12 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/14 (21%) | |POLY-3 RATE (b) | 0/11.59 0/14.34 0/15.00 0/15.00 0/14.39 3/12.57 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 23.9% | |TERMINAL (d) | 0/11 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 3/10 (30%) | |FIRST INCIDENCE | --- --- --- --- --- 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.096 | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.116 | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.124 | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.106 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.096 | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.140 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.09 0/14.05 0/12.72 0/13.63 0/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 39 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/14 (0%) 0/15 (0%) 0/14 (0%) 0/13 (0%) 4/15 (27%) 2/14 (14%) | |POLY-3 RATE (b) | 0/13.07 0/14.34 0/14.00 0/13.00 4/14.39 2/12.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 27.8% 16.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/14 (0%) 0/13 (0%) 4/12 (33%) 2/9 (22%) | |FIRST INCIDENCE | --- --- --- --- 185 (T) 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003 ** (e) (e) (e) P=0.054 P=0.173 | |POLY 3 | P=0.006 ** (e) (e) (e) P=0.056 P=0.220 | |POLY 1.5 | P=0.007 ** (e) (e) (e) P=0.055 P=0.225 | |POLY 6 | P=0.004 ** (e) (e) (e) P=0.056 P=0.211 | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.054 P=0.173 | |COCH-ARM / FISHERS | P=0.013 * (e) (e) (e) P=0.057 P=0.241 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/14 (0%) 0/13 (0%) 0/12 (0%) 3/15 (20%) 1/14 (7%) | |POLY-3 RATE (b) | 0/12.95 0/13.05 0/10.72 0/11.49 3/14.03 1/10.57 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 21.4% 9.5% | |TERMINAL (d) | 0/12 (0%) 0/13 (0%) 0/10 (0%) 0/9 (0%) 3/13 (23%) 1/9 (11%) | |FIRST INCIDENCE | --- --- --- --- 186 (T) 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.050 (e) (e) (e) P=0.128 P=0.443 | |POLY 3 | P=0.039 * (e) (e) (e) P=0.120 P=0.459 | |POLY 1.5 | P=0.049 * (e) (e) (e) P=0.117 P=0.470 | |POLY 6 | P=0.030 * (e) (e) (e) P=0.121 P=0.446 | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.128 P=0.443 | |COCH-ARM / FISHERS | P=0.080 (e) (e) (e) P=0.112 P=0.483 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 40 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |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 | | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 2/15 (13%) 0/15 (0%) | |POLY-3 RATE (b) | 1/13.92 0/14.05 0/12.72 1/14.77 2/14.03 0/10.72 | |POLY-3 PERCENT (g) | 7.2% 0.0% 0.0% 6.8% 14.3% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 2/13 (15%) 0/9 (0%) | |FIRST INCIDENCE | 63 --- --- 167 186 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.614 P=0.500N P=0.514N P=0.745N P=0.519 P=0.514N | |POLY 3 | P=0.517 P=0.498N P=0.518N P=0.747N P=0.503 P=0.551N | |POLY 1.5 | P=0.571 P=0.499N P=0.514N P=0.749N P=0.503 P=0.535N | |POLY 6 | P=0.464 P=0.496N P=0.522N P=0.748N P=0.504 P=0.567N | |LOGISTIC REGRESSION| P=0.572N (e) P=0.389N P=0.462 P=0.400 P=0.383N | |COCH-ARM / FISHERS | P=0.622N P=0.500N P=0.500N P=0.759N P=0.500 P=0.500N | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 41 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) 0/15 (0%) | |POLY-3 RATE (b) | 1/13.43 0/13.34 0/15.00 0/15.00 3/14.39 0/13.53 | |POLY-3 PERCENT (g) | 7.4% 0.0% 0.0% 0.0% 20.9% 0.0% | |TERMINAL (d) | 1/12 (8%) 0/13 (0%) 0/15 (0%) 0/15 (0%) 3/12 (25%) 0/10 (0%) | |FIRST INCIDENCE | 185 (T) --- --- --- 185 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.446 P=0.484N P=0.455N P=0.455N P=0.296 P=0.536N | |POLY 3 | P=0.482 P=0.501N P=0.478N P=0.478N P=0.323 P=0.499N | |POLY 1.5 | P=0.506 P=0.507N P=0.487N P=0.487N P=0.313 P=0.499N | |POLY 6 | P=0.445 P=0.494N P=0.467N P=0.467N P=0.332 P=0.501N | |LOGISTIC REGRESSION| P=0.446 (e) (e) (e) P=0.296 (e) | |COCH-ARM / FISHERS | P=0.531 P=0.517N P=0.500N P=0.500N P=0.299 P=0.500N | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/15 (20%) 0/15 (0%) 2/14 (14%) 2/15 (13%) 4/15 (27%) 2/15 (13%) | |POLY-3 RATE (b) | 3/12.95 0/14.05 2/12.51 2/14.49 4/14.03 2/10.72 | |POLY-3 PERCENT (g) | 23.2% 0.0% 16.0% 13.8% 28.5% 18.7% | |TERMINAL (d) | 3/12 (25%) 0/14 (0%) 2/12 (17%) 2/12 (17%) 4/13 (31%) 2/9 (22%) | |FIRST INCIDENCE | 186 (T) --- 186 (T) 186 (T) 186 (T) 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.241 P=0.089N P=0.500N P=0.500N P=0.549 P=0.641N | |POLY 3 | P=0.251 P=0.090N P=0.517N P=0.446N P=0.547 P=0.591N | |POLY 1.5 | P=0.299 P=0.094N P=0.523N P=0.453N P=0.539 P=0.556N | |POLY 6 | P=0.210 P=0.088N P=0.519N P=0.452N P=0.551 P=0.628N | |LOGISTIC REGRESSION| P=0.241 (e) P=0.500N P=0.500N P=0.549 P=0.641N | |COCH-ARM / FISHERS | P=0.406 P=0.112N P=0.535N P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 42 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Skin: Epidermis, Skin, Site of Application | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 3/15 (20%) 8/15 (53%) 10/15 (67%) 14/15 (93%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 3/15.00 8/15.00 10/14.67 14/15.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 20.0% 53.3% 68.2% 93.3% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 3/15 (20%) 8/15 (53%) 9/12 (75%) 9/10 (90%) | |FIRST INCIDENCE | --- --- 185 (T) 185 (T) 166 138 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.157 P=0.005 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.127 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.118 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.139 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.157 P=0.005 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.112 P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Skin: Epidermis, Skin, Site of Application | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 5/15 (33%) 14/15 (93%) 14/15 (93%) 14/15 (93%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 5/13.51 14/15.00 14/14.10 14/14.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 37.0% 93.3% 99.3% 100.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 4/12 (33%) 11/12 (92%) 13/13 (100%) 9/9 (100%) | |FIRST INCIDENCE | --- --- 109 167 182 98 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.031 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.018 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.017 * P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.018 * P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.021 * P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 43 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Skin: Skin, Site of Application | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 0/15 (0%) 2/15 (13%) 6/15 (40%) 10/15 (67%) 13/15 (87%) | |POLY-3 RATE (b) | 1/14.07 0/14.34 2/15.00 6/15.00 10/14.68 13/15.00 | |POLY-3 PERCENT (g) | 7.1% 0.0% 13.3% 40.0% 68.1% 86.7% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 2/15 (13%) 6/15 (40%) 8/12 (67%) 8/10 (80%) | |FIRST INCIDENCE | 132 --- 185 (T) 185 (T) 166 138 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.514N P=0.552 P=0.083 P=0.004 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.496N P=0.523 P=0.043 * P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.498N P=0.513 P=0.039 * P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.492N P=0.535 P=0.049 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.484N P=0.218 P=0.015 * P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.500 P=0.040 * P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Skin: Skin, Site of Application | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 0/15 (0%) 4/15 (27%) 14/15 (93%) 11/15 (73%) 13/15 (87%) | |POLY-3 RATE (b) | 1/13.09 0/14.05 4/13.51 14/15.00 11/14.94 13/14.00 | |POLY-3 PERCENT (g) | 7.6% 0.0% 29.6% 93.3% 73.6% 92.8% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 3/12 (25%) 11/12 (92%) 10/13 (77%) 8/9 (89%) | |FIRST INCIDENCE | 177 --- 109 167 85 98 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.485N P=0.179 P<0.001 ** P=0.002 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.486N P=0.169 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.489N P=0.167 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.485N P=0.165 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.496N P=0.163 P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.165 P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 44 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Skin: Skin, Site of Application | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 5/15 (33%) 12/15 (80%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 2/15.00 5/14.39 12/14.19 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 13.3% 34.8% 84.6% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 2/15 (13%) 5/12 (42%) 9/10 (90%) | |FIRST INCIDENCE | --- --- --- 185 (T) 185 (T) 160 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.286 P=0.025 * P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.257 P=0.021 * P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.246 P=0.019 * P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.271 P=0.022 * P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.286 P=0.025 * P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.241 P=0.021 * P<0.001 ** | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Skin: Skin, Site of Application | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 9/15 (60%) 10/15 (67%) 15/15 (100%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 1/12.72 9/14.77 10/14.03 15/15.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 7.9% 60.9% 71.3% 100.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 1/12 (8%) 8/12 (67%) 10/13 (77%) 9/9 (100%) | |FIRST INCIDENCE | --- --- 186 (T) 167 186 (T) 27 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.496 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.497 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.493 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 45 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Depletion Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 2/15 (13%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 2/14.98 2/14.01 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 13.4% 14.3% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- 163 167 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.013 * (e) (e) (e) P=0.282 P=0.249 | |POLY 3 | P=0.012 * (e) (e) (e) P=0.257 P=0.240 | |POLY 1.5 | P=0.013 * (e) (e) (e) P=0.246 P=0.237 | |POLY 6 | P=0.011 * (e) (e) (e) P=0.271 P=0.244 | |LOGISTIC REGRESSION| P=0.019 * (e) (e) (e) P=0.085 P=0.211 | |COCH-ARM / FISHERS | P=0.015 * (e) (e) (e) P=0.241 P=0.241 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Depletion Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/15 (13%) 1/15 (7%) 2/15 (13%) 1/15 (7%) 2/15 (13%) 3/15 (20%) | |POLY-3 RATE (b) | 2/14.05 1/15.00 2/14.20 1/14.63 2/15.00 3/12.81 | |POLY-3 PERCENT (g) | 14.2% 6.7% 14.1% 6.8% 13.3% 23.4% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE | 63 67 5 177 85 113 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.197 P=0.484N P=0.678 P=0.483N P=0.658N P=0.439 | |POLY 3 | P=0.203 P=0.477N P=0.695N P=0.486N P=0.674N P=0.456 | |POLY 1.5 | P=0.210 P=0.481N P=0.693N P=0.486N P=0.679N P=0.466 | |POLY 6 | P=0.197 P=0.476N P=0.698N P=0.491N P=0.673N P=0.444 | |LOGISTIC REGRESSION| P=0.434 P=0.716N P=0.744N P=0.770N P=0.554 P=0.617 | |COCH-ARM / FISHERS | P=0.238 P=0.500N P=0.701N P=0.500N P=0.701N P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 46 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 2/15 (13%) 1/15 (7%) 2/15 (13%) 9/15 (60%) 8/15 (53%) | |POLY-3 RATE (b) | 1/13.43 2/15.00 1/15.00 2/15.00 9/14.39 8/13.57 | |POLY-3 PERCENT (g) | 7.4% 13.3% 6.7% 13.3% 62.5% 58.9% | |TERMINAL (d) | 1/12 (8%) 1/14 (7%) 1/15 (7%) 2/15 (13%) 9/12 (75%) 7/10 (70%) | |FIRST INCIDENCE | 185 (T) 129 185 (T) 185 (T) 185 (T) 182 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.536 P=0.714N P=0.580 P=0.002 ** P=0.003 ** | |POLY 3 | P<0.001 ** P=0.539 P=0.736N P=0.539 P<0.001 ** P=0.003 ** | |POLY 1.5 | P<0.001 ** P=0.523 P=0.746N P=0.523 P<0.001 ** P=0.003 ** | |POLY 6 | P<0.001 ** P=0.558 P=0.723N P=0.558 P<0.001 ** P=0.002 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.430 P=0.714N P=0.580 P=0.002 ** P=0.003 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.759N P=0.500 P=0.003 ** P=0.007 ** | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 11/15 (73%) 11/15 (73%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 2/14.49 11/14.03 11/11.91 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 13.8% 78.4% 92.3% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 2/12 (17%) 11/13 (85%) 9/9 (100%) | |FIRST INCIDENCE | --- --- --- 186 (T) 186 (T) 98 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.235 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.258 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.254 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.254 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.235 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.241 P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 47 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 4/15 (27%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 1/14.39 4/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.0% 29.6% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 1/12 (8%) 4/10 (40%) | |FIRST INCIDENCE | --- --- --- --- 185 (T) 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.500 P=0.034 * | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.514 P=0.043 * | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.508 P=0.045 * | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.519 P=0.041 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.500 P=0.034 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.500 P=0.050 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 1/15 (7%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 1/14.03 1/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.1% 9.3% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 1/13 (8%) 1/9 (11%) | |FIRST INCIDENCE | --- --- --- --- 186 (T) 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.065 (e) (e) (e) P=0.516 P=0.443 | |POLY 3 | P=0.068 (e) (e) (e) P=0.516 P=0.462 | |POLY 1.5 | P=0.080 (e) (e) (e) P=0.513 P=0.477 | |POLY 6 | P=0.059 (e) (e) (e) P=0.517 P=0.447 | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.516 P=0.443 | |COCH-ARM / FISHERS | P=0.104 (e) (e) (e) P=0.500 P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 48 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 4/15 (27%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/14.39 4/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 29.6% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 4/10 (40%) | |FIRST INCIDENCE | --- --- --- --- --- 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.034 * | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.043 * | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.045 * | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.041 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.034 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.050 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 0/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 49 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Necrosis Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 1/15 (7%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 2/14.68 1/13.88 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 13.6% 7.2% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- 166 160 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.078 (e) (e) (e) P=0.266 P=0.531 | |POLY 3 | P=0.080 (e) (e) (e) P=0.252 P=0.507 | |POLY 1.5 | P=0.084 (e) (e) (e) P=0.243 P=0.504 | |POLY 6 | P=0.074 (e) (e) (e) P=0.262 P=0.508 | |LOGISTIC REGRESSION| P=0.106 (e) (e) (e) P=0.186 P=0.458 | |COCH-ARM / FISHERS | P=0.091 (e) (e) (e) P=0.241 P=0.500 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Necrosis Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 0/15 (0%) 1/15 (7%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 1/15.00 1/13.72 0/14.49 1/14.10 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 6.7% 7.3% 0.0% 7.1% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 0/9 (0%) | |FIRST INCIDENCE | --- 67 5 --- 182 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.501N P=0.514 P=0.500 (e) P=0.531 (e) | |POLY 3 | P=0.512N P=0.529 P=0.511 (e) P=0.517 (e) | |POLY 1.5 | P=0.501N P=0.523 P=0.512 (e) P=0.514 (e) | |POLY 6 | P=0.521N P=0.532 P=0.509 (e) P=0.519 (e) | |LOGISTIC REGRESSION| P=0.375N P=0.327 (e) (e) P=0.512 (e) | |COCH-ARM / FISHERS | P=0.479N P=0.500 P=0.500 (e) P=0.500 (e) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 50 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/15 (13%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 3/15 (20%) 4/15 (27%) | |POLY-3 RATE (b) | 2/14.48 0/14.34 1/15.00 0/15.00 3/15.00 4/14.74 | |POLY-3 PERCENT (g) | 13.8% 0.0% 6.7% 0.0% 20.0% 27.2% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 1/15 (7%) 0/15 (0%) 0/12 (0%) 0/10 (0%) | |FIRST INCIDENCE | 132 --- 185 (T) --- 163 138 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.016 * P=0.239N P=0.458N P=0.224N P=0.553 P=0.357 | |POLY 3 | P=0.017 * P=0.233N P=0.488N P=0.223N P=0.517 P=0.335 | |POLY 1.5 | P=0.017 * P=0.233N P=0.493N P=0.227N P=0.510 P=0.332 | |POLY 6 | P=0.016 * P=0.233N P=0.481N P=0.219N P=0.525 P=0.337 | |LOGISTIC REGRESSION| P=0.018 * P=0.268N P=0.585 P=0.978N P=0.142 P=0.173 | |COCH-ARM / FISHERS | P=0.018 * P=0.241N P=0.500N P=0.241N P=0.500 P=0.326 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 0/15 (0%) 3/15 (20%) 3/15 (20%) 4/15 (27%) 4/15 (27%) | |POLY-3 RATE (b) | 1/13.92 0/14.05 3/15.00 3/15.00 4/15.00 4/13.04 | |POLY-3 PERCENT (g) | 7.2% 0.0% 20.0% 20.0% 26.7% 30.7% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 2/13 (15%) 1/9 (11%) | |FIRST INCIDENCE | 63 --- 5 167 85 98 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.033 * P=0.500N P=0.309 P=0.335 P=0.212 P=0.164 | |POLY 3 | P=0.034 * P=0.498N P=0.326 P=0.326 P=0.187 P=0.139 | |POLY 1.5 | P=0.037 * P=0.499N P=0.320 P=0.320 P=0.181 P=0.145 | |POLY 6 | P=0.030 * P=0.496N P=0.331 P=0.331 P=0.191 P=0.132 | |LOGISTIC REGRESSION| P=0.108 (e) P=0.164 P=0.100 P=0.067 P=0.217 | |COCH-ARM / FISHERS | P=0.047 * P=0.500N P=0.299 P=0.299 P=0.165 P=0.165 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 51 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/14.39 0/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (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) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/14.49 2/14.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 14.3% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 2/13 (15%) 0/9 (0%) | |FIRST INCIDENCE | --- --- --- --- 186 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.351 (e) (e) (e) P=0.253 (e) | |POLY 3 | P=0.247 (e) (e) (e) P=0.250 (e) | |POLY 1.5 | P=0.301 (e) (e) (e) P=0.246 (e) | |POLY 6 | P=0.198 (e) (e) (e) P=0.251 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.253 (e) | |COCH-ARM / FISHERS | P=0.414 (e) (e) (e) P=0.241 (e) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 52 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 1/15.00 0/15.00 0/14.39 0/13.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 6.7% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 1/15 (7%) 0/15 (0%) 0/12 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- 185 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.608N (e) P=0.545 (e) (e) (e) | |POLY 3 | P=0.541N (e) P=0.522 (e) (e) (e) | |POLY 1.5 | P=0.549N (e) P=0.513 (e) (e) (e) | |POLY 6 | P=0.531N (e) P=0.533 (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.545 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.561N (e) P=0.500 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 0/15 (0%) | |POLY-3 RATE (b) | 1/12.95 0/14.05 0/12.72 0/14.49 2/14.03 0/10.72 | |POLY-3 PERCENT (g) | 7.7% 0.0% 0.0% 0.0% 14.3% 0.0% | |TERMINAL (d) | 1/12 (8%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 2/13 (15%) 0/9 (0%) | |FIRST INCIDENCE | 186 (T) --- --- --- 186 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.588 P=0.469N P=0.500N P=0.500N P=0.529 P=0.557N | |POLY 3 | P=0.498 P=0.484N P=0.504N P=0.478N P=0.528 P=0.538N | |POLY 1.5 | P=0.550 P=0.488N P=0.503N P=0.480N P=0.524 P=0.523N | |POLY 6 | P=0.446 P=0.481N P=0.507N P=0.480N P=0.530 P=0.553N | |LOGISTIC REGRESSION| P=0.588 (e) (e) (e) P=0.529 (e) | |COCH-ARM / FISHERS | P=0.646 P=0.500N P=0.500N P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 53 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Testes | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/15 (13%) 1/15 (7%) 0/15 (0%) 1/15 (7%) 1/15 (7%) 0/15 (0%) | |POLY-3 RATE (b) | 2/13.43 1/14.34 0/15.00 1/15.00 1/14.39 0/13.53 | |POLY-3 PERCENT (g) | 14.9% 7.0% 0.0% 6.7% 7.0% 0.0% | |TERMINAL (d) | 2/12 (17%) 1/14 (7%) 0/15 (0%) 1/15 (7%) 1/12 (8%) 0/10 (0%) | |FIRST INCIDENCE | 185 (T) 185 (T) --- 185 (T) 185 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.290N P=0.445N P=0.188N P=0.420N P=0.500N P=0.276N | |POLY 3 | P=0.251N P=0.477N P=0.206N P=0.461N P=0.475N P=0.228N | |POLY 1.5 | P=0.242N P=0.487N P=0.216N P=0.477N P=0.485N P=0.229N | |POLY 6 | P=0.264N P=0.463N P=0.195N P=0.441N P=0.467N P=0.231N | |LOGISTIC REGRESSION| P=0.290N P=0.445N (e) P=0.420N P=0.500N (e) | |COCH-ARM / FISHERS | P=0.230N P=0.500N P=0.241N P=0.500N P=0.500N P=0.241N | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Testes | | 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 | | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 54 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Testes: Unilateral, Germinal Epithelium | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 1/15 (7%) 0/15 (0%) 2/15 (13%) 1/15 (7%) 4/15 (27%) | |POLY-3 RATE (b) | 1/13.95 1/14.34 0/15.00 2/15.00 1/14.39 4/14.38 | |POLY-3 PERCENT (g) | 7.2% 7.0% 0.0% 13.3% 7.0% 27.8% | |TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/15 (0%) 2/15 (13%) 1/12 (8%) 2/10 (20%) | |FIRST INCIDENCE | 145 185 (T) --- 185 (T) 185 (T) 138 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.013 * P=0.743N P=0.486N P=0.560 P=0.753N P=0.170 | |POLY 3 | P=0.024 * P=0.755N P=0.486N P=0.526 P=0.754N P=0.170 | |POLY 1.5 | P=0.024 * P=0.757N P=0.491N P=0.515 P=0.756N P=0.168 | |POLY 6 | P=0.022 * P=0.751N P=0.479N P=0.538 P=0.753N P=0.170 | |LOGISTIC REGRESSION| P=0.033 * P=0.732 P=0.981N P=0.310 P=0.653 P=0.111 | |COCH-ARM / FISHERS | P=0.025 * P=0.759N P=0.500N P=0.500 P=0.759N P=0.165 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Testes: Unilateral, Germinal Epithelium | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | | |POLY-3 RATE (b) | | |POLY-3 PERCENT (g) | | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 55 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/15 (27%) 1/15 (7%) 2/15 (13%) 0/15 (0%) 4/14 (29%) 5/14 (36%) | |POLY-3 RATE (b) | 4/15.00 1/14.34 2/15.00 0/15.00 4/13.68 5/14.00 | |POLY-3 PERCENT (g) | 26.7% 7.0% 13.3% 0.0% 29.2% 35.7% | |TERMINAL (d) | 1/12 (8%) 1/14 (7%) 2/15 (13%) 0/15 (0%) 2/11 (18%) 1/10 (10%) | |FIRST INCIDENCE | 132 185 (T) 185 (T) --- 166 138 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.042 * P=0.165N P=0.274N P=0.053N P=0.628N P=0.490 | |POLY 3 | P=0.046 * P=0.177N P=0.327N P=0.045N* P=0.601 P=0.452 | |POLY 1.5 | P=0.045 * P=0.171N P=0.327N P=0.045N* P=0.607 P=0.452 | |POLY 6 | P=0.047 * P=0.182N P=0.327N P=0.045N* P=0.591 P=0.452 | |LOGISTIC REGRESSION| P=0.058 P=0.237N P=0.274N (e) P=0.410 (e) | |COCH-ARM / FISHERS | P=0.047 * P=0.165N P=0.326N P=0.050N P=0.617 P=0.450 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/15 (20%) 0/15 (0%) 2/15 (13%) 2/14 (14%) 3/14 (21%) 6/15 (40%) | |POLY-3 RATE (b) | 3/15.00 0/14.05 2/14.00 2/13.91 3/14.00 6/14.66 | |POLY-3 PERCENT (g) | 20.0% 0.0% 14.3% 14.4% 21.4% 40.9% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/11 (0%) 1/12 (8%) 1/9 (11%) | |FIRST INCIDENCE | 63 --- 109 167 85 27 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.009 ** P=0.120N P=0.507N P=0.468N P=0.625N P=0.207 | |POLY 3 | P=0.012 * P=0.118N P=0.533N P=0.536N P=0.637 P=0.202 | |POLY 1.5 | P=0.012 * P=0.116N P=0.533N P=0.534N P=0.637 P=0.208 | |POLY 6 | P=0.011 * P=0.119N P=0.533N P=0.539N P=0.637 P=0.194 | |LOGISTIC REGRESSION| P=0.035 * P=0.136N P=0.485N (e) (e) P=0.778N | |COCH-ARM / FISHERS | P=0.011 * P=0.112N P=0.500N P=0.535N P=0.639 P=0.213 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 56 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Thymus | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/14 (0%) 3/14 (21%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 0/13.39 3/12.75 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 23.5% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/11 (0%) 3/10 (30%) | |FIRST INCIDENCE | --- --- --- --- --- 185 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.083 | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.093 | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.093 | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.092 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.083 | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.100 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Thymus | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/14 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/12.95 0/14.05 0/12.72 0/13.49 0/13.03 0/10.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/11 (0%) 0/12 (0%) 0/9 (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) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 57 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Thymus: Thymocyte | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/14 (14%) 0/14 (0%) | |POLY-3 RATE (b) | 0/13.43 0/14.34 0/15.00 0/15.00 2/13.72 0/12.75 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 14.6% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/11 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- 163 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.382 (e) (e) (e) P=0.273 (e) | |POLY 3 | P=0.355 (e) (e) (e) P=0.235 (e) | |POLY 1.5 | P=0.373 (e) (e) (e) P=0.227 (e) | |POLY 6 | P=0.328 (e) (e) (e) P=0.245 (e) | |LOGISTIC REGRESSION| P=0.406 (e) (e) (e) P=0.162 (e) | |COCH-ARM / FISHERS | P=0.397 (e) (e) (e) P=0.224 (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Thymus: Thymocyte | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 1/15 (7%) 2/15 (13%) 2/14 (14%) 0/14 (0%) 5/15 (33%) | |POLY-3 RATE (b) | 0/12.95 1/15.00 2/14.20 2/13.86 0/13.03 5/13.31 | |POLY-3 PERCENT (g) | 0.0% 6.7% 14.1% 14.4% 0.0% 37.6% | |TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/12 (0%) 0/11 (0%) 0/12 (0%) 1/9 (11%) | |FIRST INCIDENCE | --- 67 5 167 --- 98 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.007 ** P=0.514 P=0.240 P=0.265 (e) P=0.026 * | |POLY 3 | P=0.008 ** P=0.529 P=0.253 P=0.247 (e) P=0.017 * | |POLY 1.5 | P=0.009 ** P=0.523 P=0.249 P=0.241 (e) P=0.017 * | |POLY 6 | P=0.008 ** P=0.532 P=0.254 P=0.248 (e) P=0.017 * | |LOGISTIC REGRESSION| P=0.028 * P=0.327 P=0.244 P=0.198 (e) P=0.032 * | |COCH-ARM / FISHERS | P=0.011 * P=0.500 P=0.241 P=0.224 (e) P=0.021 * | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 58 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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 | | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) | |POLY-3 RATE (b) | 1/12.95 0/14.05 0/12.72 0/14.49 0/14.03 2/10.72 | |POLY-3 PERCENT (g) | 7.7% 0.0% 0.0% 0.0% 0.0% 18.7% | |TERMINAL (d) | 1/12 (8%) 0/14 (0%) 0/12 (0%) 0/12 (0%) 0/13 (0%) 2/9 (22%) | |FIRST INCIDENCE | 186 (T) --- --- --- --- 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.051 P=0.469N P=0.500N P=0.500N P=0.484N P=0.396 | |POLY 3 | P=0.082 P=0.484N P=0.504N P=0.478N P=0.484N P=0.432 | |POLY 1.5 | P=0.083 P=0.488N P=0.503N P=0.480N P=0.487N P=0.458 | |POLY 6 | P=0.082 P=0.481N P=0.507N P=0.480N P=0.483N P=0.405 | |LOGISTIC REGRESSION| P=0.051 (e) (e) (e) (e) P=0.396 | |COCH-ARM / FISHERS | P=0.091 P=0.500N P=0.500N P=0.500N P=0.500N P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88127 TEST: 06 Page 59 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - PENTAERYTHRITOL TRIACRYLATE ( PETA) Terminal Sacrifice at 27 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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 | | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/15 (73%) 9/15 (60%) 7/15 (47%) 10/15 (67%) 11/15 (73%) 7/15 (47%) | |POLY-3 RATE (b) | 11/12.95 9/14.05 7/12.72 10/14.49 11/14.10 7/10.72 | |POLY-3 PERCENT (g) | 84.9% 64.1% 55.1% 69.0% 78.0% 65.3% | |TERMINAL (d) | 11/12 (92%) 9/14 (64%) 7/12 (58%) 10/12 (83%) 10/13 (77%) 7/9 (78%) | |FIRST INCIDENCE | 186 (T) 186 (T) 186 (T) 186 (T) 182 186 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.422 P=0.123N P=0.083N P=0.500N P=0.516N P=0.396N | |POLY 3 | P=0.532N P=0.212N P=0.101N P=0.295N P=0.514N P=0.250N | |POLY 1.5 | P=0.420N P=0.241N P=0.105N P=0.325N P=0.546N P=0.175N | |POLY 6 | P=0.470 P=0.193N P=0.108N P=0.305N P=0.492N P=0.372N | |LOGISTIC REGRESSION| P=0.433 P=0.123N P=0.083N P=0.500N P=0.450N P=0.396N | |COCH-ARM / FISHERS | P=0.249N P=0.350N P=0.132N P=0.500N P=0.659N P=0.132N | |=================================================================================================================================| (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).