TDMS Study 88133-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) DATE: 07/12/02 EXPERIMENT: 88133 TEST: 06 TIME: 08:52:59 TEST TYPE: SUBCHRON 26-WEEK PAGE: 1 CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 88133B PATHOLOGIST: TOFT, JOHN CAS: 15625-89-5 ------------------------------------------------------------------------------------------------------------------------------------ Final#2 REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 0 MG/KG INCLUDE 002 0 MG/KG INCLUDE 003 0.75 MG/KG INCLUDE 004 0.75 MG/KG INCLUDE 005 1.5 MG/KG INCLUDE 006 1.5 MG/KG INCLUDE 007 3 MG/KG INCLUDE 008 3 MG/KG INCLUDE 009 6 MG/KG INCLUDE 010 6 MG/KG INCLUDE 011 12 MG/KG INCLUDE 012 12 MG/KG NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) DATE: 07/12/02 EXPERIMENT: 88133 TEST: 06 TIME: 08:52:59 TEST TYPE: SUBCHRON 26-WEEK CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 88133B PATHOLOGIST: TOFT, JOHN CAS: 15625-89-5 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Epididymis Inflammation Chronic Epididymis: Unilateral Hypospermia Kidney Inflammation Chronic Liver Hematopoietic Cell Proliferation Infiltration Cellular Lymph Node Hyperplasia Inflammation Chronic Lymph Node, Mandibular Hematopoietic Cell Proliferation Infiltration Cellular Lymph Node: Mediastinal Infiltration Cellular Infiltration Cellular Plasma Cell Inflammation Chronic Skin: Epidermis, Skin, Site of Application Hyperplasia Skin: Skin, Site of Application Hyperkeratosis Inflammation Chronic Spleen Atrophy Hematopoietic Cell Proliferation Stomach, Forestomach Hyperkeratosis Testes: Unilateral, Germinal Epithelium Degeneration Thymus Atrophy =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Kidney Inflammation Chronic Nephropathy Liver Hematopoietic Cell Proliferation Inflammation Chronic Myelodysplasia Pigmentation Lymph Node Hematopoietic Cell Proliferation Hyperplasia Lymph Node, Mandibular Hematopoietic Cell Proliferation Infiltration Cellular Plasma Cell Lymph Node, Mesenteric Hematopoietic Cell Proliferation Infiltration Cellular Lymph Node: Inguinal Infiltration Cellular Plasma Cell Myelodysplasia Lymph Node: Mediastinal Hematopoietic Cell Proliferation Infiltration Cellular Infiltration Cellular Plasma Cell Skin: Epidermis, Skin, Site of Application NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) DATE: 07/12/02 EXPERIMENT: 88133 TEST: 06 TIME: 08:52:59 TEST TYPE: SUBCHRON 26-WEEK CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 88133B PATHOLOGIST: TOFT, JOHN CAS: 15625-89-5 Hyperplasia Hyperplasia Focal Skin: Skin, Site of Application Hyperkeratosis Inflammation Chronic Spleen Hematopoietic Cell Proliferation Myelodysplasia Thyroid Gland Inflammation Chronic =============================================================== Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 5/15 (33%) 9/15 (60%) 8/15 (53%) 5/15 (33%) 5/15 (33%) | |POLY-3 RATE (b) | 7/14.15 5/15.00 9/12.73 8/14.33 5/13.93 5/14.43 | |POLY-3 PERCENT (g) | 49.5% 33.3% 70.7% 55.9% 35.9% 34.7% | |TERMINAL (d) | 7/14 (50%) 5/15 (33%) 9/12 (75%) 8/14 (57%) 5/13 (39%) 4/11 (36%) | |FIRST INCIDENCE | 192 (T) 192 (T) 192 (T) 192 (T) 192 (T) 161 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.390N P=0.300N P=0.188 P=0.500 P=0.416N P=0.542N | |POLY 3 | P=0.186N P=0.309N P=0.234 P=0.514 P=0.367N P=0.339N | |POLY 1.5 | P=0.182N P=0.322N P=0.267 P=0.514 P=0.363N P=0.339N | |POLY 6 | P=0.201N P=0.302N P=0.209 P=0.507 P=0.374N P=0.353N | |LOGISTIC REGRESSION| P=0.213N P=0.300N P=0.188 P=0.500 P=0.416N P=0.356N | |COCH-ARM / FISHERS | P=0.192N P=0.355N P=0.358 P=0.500 P=0.355N P=0.355N | |=================================================================================================================================| | | | | | 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) | 0/15.00 0/14.85 0/12.32 0/14.27 0/14.59 0/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/14 (0%) 0/12 (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: 88133 TEST: 06 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 2/15 (13%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) | |POLY-3 RATE (b) | 0/14.15 2/15.00 0/12.73 0/14.33 0/13.93 3/14.02 | |POLY-3 PERCENT (g) | 0.0% 13.3% 0.0% 0.0% 0.0% 21.4% | |TERMINAL (d) | 0/14 (0%) 2/15 (13%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 3/11 (27%) | |FIRST INCIDENCE | --- 192 (T) --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.025 * P=0.251 (e) (e) (e) P=0.076 | |POLY 3 | P=0.044 * P=0.245 (e) (e) (e) P=0.103 | |POLY 1.5 | P=0.043 * P=0.241 (e) (e) (e) P=0.106 | |POLY 6 | P=0.043 * P=0.247 (e) (e) (e) P=0.096 | |LOGISTIC REGRESSION| (e) P=0.251 (e) (e) (e) P=0.076 | |COCH-ARM / FISHERS | P=0.045 * P=0.241 (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 | |=================================================================================================================================| | | |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: 88133 TEST: 06 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 4/15 (27%) 0/15 (0%) 2/15 (13%) 1/15 (7%) 1/15 (7%) 2/15 (13%) | |POLY-3 RATE (b) | 4/14.15 0/15.00 2/13.18 1/14.33 1/13.93 2/14.02 | |POLY-3 PERCENT (g) | 28.3% 0.0% 15.2% 7.0% 7.2% 14.3% | |TERMINAL (d) | 4/14 (29%) 0/15 (0%) 1/12 (8%) 1/14 (7%) 1/13 (8%) 2/11 (18%) | |FIRST INCIDENCE | 192 (T) --- 157 192 (T) 192 (T) 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.599 P=0.048N* P=0.400N P=0.166N P=0.189N P=0.449N | |POLY 3 | P=0.529N P=0.038N* P=0.361N P=0.157N P=0.166N P=0.330N | |POLY 1.5 | P=0.520N P=0.040N* P=0.354N P=0.157N P=0.164N P=0.324N | |POLY 6 | P=0.541N P=0.037N* P=0.363N P=0.159N P=0.168N P=0.348N | |LOGISTIC REGRESSION| P=0.508N (e) P=0.353N P=0.166N P=0.189N P=0.449N | |COCH-ARM / FISHERS | P=0.508N P=0.050N P=0.326N P=0.165N P=0.165N P=0.326N | |=================================================================================================================================| | | | | | 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: 88133 TEST: 06 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 0/15 (0%) 2/15 (13%) 1/15 (7%) 0/15 (0%) 1/15 (7%) 5/15 (33%) | |POLY-3 RATE (b) | 0/14.15 2/15.00 1/12.73 0/14.33 1/13.93 5/14.02 | |POLY-3 PERCENT (g) | 0.0% 13.3% 7.9% 0.0% 7.2% 35.7% | |TERMINAL (d) | 0/14 (0%) 2/15 (13%) 1/12 (8%) 0/14 (0%) 1/13 (8%) 5/11 (46%) | |FIRST INCIDENCE | --- 192 (T) 192 (T) --- 192 (T) 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.251 P=0.469 (e) P=0.485 P=0.012 * | |POLY 3 | P=0.003 ** P=0.245 P=0.479 (e) P=0.497 P=0.016 * | |POLY 1.5 | P=0.003 ** P=0.241 P=0.485 (e) P=0.498 P=0.017 * | |POLY 6 | P=0.002 ** P=0.247 P=0.474 (e) P=0.495 P=0.013 * | |LOGISTIC REGRESSION| (e) P=0.251 P=0.469 (e) P=0.485 P=0.012 * | |COCH-ARM / FISHERS | P=0.004 ** P=0.241 P=0.500 (e) P=0.500 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 | |=================================================================================================================================| | | |Kidney | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 2/15 (13%) 0/15 (0%) 0/15 (0%) 3/15 (20%) | |POLY-3 RATE (b) | 0/15.00 0/14.85 2/12.32 0/14.27 0/14.59 3/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 16.2% 0.0% 0.0% 21.5% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 2/12 (17%) 0/14 (0%) 0/14 (0%) 3/12 (25%) | |FIRST INCIDENCE | --- --- 193 (T) --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.022 * (e) P=0.188 (e) (e) P=0.079 | |POLY 3 | P=0.022 * (e) P=0.188 (e) (e) P=0.092 | |POLY 1.5 | P=0.024 * (e) P=0.197 (e) (e) P=0.097 | |POLY 6 | P=0.021 * (e) P=0.184 (e) (e) P=0.087 | |LOGISTIC REGRESSION| (e) (e) P=0.188 (e) (e) P=0.079 | |COCH-ARM / FISHERS | P=0.032 * (e) P=0.241 (e) (e) P=0.112 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 3/15 (20%) 6/15 (40%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) | |POLY-3 RATE (b) | 3/14.15 6/15.00 0/12.73 0/14.33 0/13.93 3/14.02 | |POLY-3 PERCENT (g) | 21.2% 40.0% 0.0% 0.0% 0.0% 21.4% | |TERMINAL (d) | 3/14 (21%) 6/15 (40%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 3/11 (27%) | |FIRST INCIDENCE | 192 (T) 192 (T) --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.525N P=0.252 P=0.143N P=0.115N P=0.128N P=0.551 | |POLY 3 | P=0.371N P=0.246 P=0.125N P=0.103N P=0.108N P=0.668 | |POLY 1.5 | P=0.379N P=0.237 P=0.119N P=0.103N P=0.107N P=0.669N | |POLY 6 | P=0.369N P=0.251 P=0.130N P=0.104N P=0.109N P=0.650 | |LOGISTIC REGRESSION| P=0.525N P=0.252 (e) (e) (e) P=0.551 | |COCH-ARM / FISHERS | P=0.411N P=0.213 P=0.112N P=0.112N P=0.112N P=0.674N | |=================================================================================================================================| | | | | | 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) | 4/15 (27%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) | |POLY-3 RATE (b) | 4/15.00 0/14.85 0/12.32 0/14.27 0/14.59 1/13.93 | |POLY-3 PERCENT (g) | 26.7% 0.0% 0.0% 0.0% 0.0% 7.2% | |TERMINAL (d) | 4/15 (27%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/14 (0%) 1/12 (8%) | |FIRST INCIDENCE | 193 (T) --- --- --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.347N P=0.065N P=0.086N P=0.065N P=0.065N P=0.240N | |POLY 3 | P=0.267N P=0.046N* P=0.073N P=0.051N P=0.048N* P=0.186N | |POLY 1.5 | P=0.274N P=0.046N* P=0.066N P=0.049N* P=0.047N* P=0.177N | |POLY 6 | P=0.262N P=0.047N* P=0.077N P=0.053N P=0.051N P=0.197N | |LOGISTIC REGRESSION| P=0.347N (e) (e) (e) (e) P=0.240N | |COCH-ARM / FISHERS | P=0.313N P=0.050N P=0.050N P=0.050N P=0.050N P=0.165N | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 2/15 (13%) 1/15 (7%) 5/15 (33%) 4/15 (27%) 4/15 (27%) 0/15 (0%) | |POLY-3 RATE (b) | 2/14.15 1/15.00 5/12.73 4/14.33 4/13.93 0/14.02 | |POLY-3 PERCENT (g) | 14.1% 6.7% 39.3% 27.9% 28.7% 0.0% | |TERMINAL (d) | 2/14 (14%) 1/15 (7%) 5/12 (42%) 4/14 (29%) 4/13 (31%) 0/11 (0%) | |FIRST INCIDENCE | 192 (T) 192 (T) 192 (T) 192 (T) 192 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.245N P=0.475N P=0.135 P=0.326 P=0.289 P=0.290N | |POLY 3 | P=0.174N P=0.479N P=0.147 P=0.332 P=0.318 P=0.233N | |POLY 1.5 | P=0.163N P=0.485N P=0.160 P=0.333 P=0.321 P=0.230N | |POLY 6 | P=0.196N P=0.476N P=0.138 P=0.329 P=0.314 P=0.241N | |LOGISTIC REGRESSION| P=0.245N P=0.475N P=0.135 P=0.326 P=0.289 (e) | |COCH-ARM / FISHERS | P=0.162N P=0.500N P=0.195 P=0.326 P=0.326 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 | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Regeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 1/15 (7%) | |POLY-3 RATE (b) | 0/15.00 1/14.85 0/12.32 0/14.27 2/14.59 1/13.93 | |POLY-3 PERCENT (g) | 0.0% 6.7% 0.0% 0.0% 13.7% 7.2% | |TERMINAL (d) | 0/15 (0%) 1/14 (7%) 0/12 (0%) 0/14 (0%) 2/14 (14%) 1/12 (8%) | |FIRST INCIDENCE | --- 193 (T) --- --- 193 (T) 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.186 P=0.486 (e) (e) P=0.221 P=0.455 | |POLY 3 | P=0.212 P=0.498 (e) (e) P=0.225 P=0.485 | |POLY 1.5 | P=0.218 P=0.499 (e) (e) P=0.228 P=0.491 | |POLY 6 | P=0.204 P=0.496 (e) (e) P=0.221 P=0.479 | |LOGISTIC REGRESSION| (e) P=0.486 (e) (e) P=0.221 P=0.455 | |COCH-ARM / FISHERS | P=0.219 P=0.500 (e) (e) P=0.241 P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 1/15 (7%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 6/15 (40%) | |POLY-3 RATE (b) | 1/15.00 0/15.00 1/12.73 0/14.33 0/13.93 6/14.02 | |POLY-3 PERCENT (g) | 6.7% 0.0% 7.9% 0.0% 0.0% 42.8% | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 1/12 (8%) 0/14 (0%) 0/13 (0%) 6/11 (55%) | |FIRST INCIDENCE | 101 --- 192 (T) --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.500N P=0.727 P=0.500N P=0.514N P=0.024 * | |POLY 3 | P<0.001 ** P=0.500N P=0.723 P=0.509N P=0.515N P=0.025 * | |POLY 1.5 | P<0.001 ** P=0.500N P=0.734 P=0.506N P=0.510N P=0.029 * | |POLY 6 | P<0.001 ** P=0.500N P=0.715 P=0.512N P=0.518N P=0.020 * | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.691N (e) P=0.421N P=0.032 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.759N P=0.500N P=0.500N P=0.040 * | |=================================================================================================================================| | | | | | 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%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 6/15 (40%) | |POLY-3 RATE (b) | 0/15.00 0/14.85 1/12.32 0/14.27 0/14.59 6/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 8.1% 0.0% 0.0% 43.1% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 1/12 (8%) 0/14 (0%) 0/14 (0%) 6/12 (50%) | |FIRST INCIDENCE | --- --- 193 (T) --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.455 (e) (e) P=0.005 ** | |POLY 3 | P<0.001 ** (e) P=0.461 (e) (e) P=0.003 ** | |POLY 1.5 | P<0.001 ** (e) P=0.470 (e) (e) P=0.004 ** | |POLY 6 | P<0.001 ** (e) P=0.457 (e) (e) P=0.003 ** | |LOGISTIC REGRESSION| (e) (e) P=0.455 (e) (e) P=0.005 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 (e) (e) P=0.008 ** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 8 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 0/15 (0%) 5/15 (33%) | |POLY-3 RATE (b) | 0/14.15 0/15.00 0/12.73 0/14.33 0/13.93 5/14.02 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 35.7% | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 5/11 (46%) | |FIRST INCIDENCE | --- --- --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.012 * | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.016 * | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.017 * | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.013 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.012 * | |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 | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 1/15 (7%) | |POLY-3 RATE (b) | 0/15.00 0/14.85 1/12.32 0/14.27 0/14.59 1/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 8.1% 0.0% 0.0% 7.2% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 1/12 (8%) 0/14 (0%) 0/14 (0%) 1/12 (8%) | |FIRST INCIDENCE | --- --- 193 (T) --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.289 (e) P=0.455 (e) (e) P=0.455 | |POLY 3 | P=0.294 (e) P=0.461 (e) (e) P=0.485 | |POLY 1.5 | P=0.301 (e) P=0.470 (e) (e) P=0.491 | |POLY 6 | P=0.288 (e) P=0.457 (e) (e) P=0.479 | |LOGISTIC REGRESSION| (e) (e) P=0.455 (e) (e) P=0.455 | |COCH-ARM / FISHERS | P=0.316 (e) P=0.500 (e) (e) P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 9 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 7/15 (47%) 10/15 (67%) 8/15 (53%) 8/15 (53%) 7/15 (47%) 8/15 (53%) | |POLY-3 RATE (b) | 7/14.15 10/15.00 8/13.60 8/14.33 7/13.93 8/14.02 | |POLY-3 PERCENT (g) | 49.5% 66.7% 58.8% 55.9% 50.2% 57.1% | |TERMINAL (d) | 7/14 (50%) 10/15 (67%) 7/12 (58%) 8/14 (57%) 7/13 (54%) 8/11 (73%) | |FIRST INCIDENCE | 192 (T) 192 (T) 95 192 (T) 192 (T) 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.340 P=0.300 P=0.344 P=0.500 P=0.572 P=0.234 | |POLY 3 | P=0.499N P=0.290 P=0.457 P=0.514 P=0.629 P=0.490 | |POLY 1.5 | P=0.476N P=0.272 P=0.469 P=0.514 P=0.633 P=0.505 | |POLY 6 | P=0.547N P=0.299 P=0.441 P=0.507 P=0.621 P=0.448 | |LOGISTIC REGRESSION| P=0.469N P=0.300 P=0.440 P=0.500 P=0.572 P=0.234 | |COCH-ARM / FISHERS | P=0.469N P=0.231 P=0.500 P=0.500 P=0.642N 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 | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 15/15 (100%) 14/15 (93%) 13/15 (87%) 13/15 (87%) 14/15 (93%) 8/15 (53%) | |POLY-3 RATE (b) | 15/15.00 14/15.00 13/13.07 13/14.27 14/14.59 8/13.93 | |POLY-3 PERCENT (g) | 100.0% 93.3% 99.5% 91.1% 96.0% 57.5% | |TERMINAL (d) | 15/15 (100%) 13/14 (93%) 12/12 (100%) 13/14 (93%) 14/14 (100%) 8/12 (67%) | |FIRST INCIDENCE | 193 (T) 183 122 193 (T) 193 (T) 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002N** P=0.753N P=0.471 P=0.486N P=1.000N P=0.033N* | |POLY 3 | P<0.001N** P=0.500N P=1.000N P=0.386N P=0.748N P=0.003N** | |POLY 1.5 | P<0.001N** P=0.500N P=0.988N P=0.312N P=0.614N P=0.002N** | |POLY 6 | P<0.001N** P=0.500N P=1.000N P=0.458N P=0.964N P=0.004N** | |LOGISTIC REGRESSION| P<0.001N** (e) (e) P=0.486N P=1.000N P=0.033N* | |COCH-ARM / FISHERS | P<0.001N** P=0.500N P=0.241N P=0.241N P=0.500N P=0.003N** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 10 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 1/15 (7%) | |POLY-3 RATE (b) | 0/14.15 0/15.00 0/12.73 0/14.33 0/13.93 1/14.02 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 7.1% | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 1/11 (9%) | |FIRST INCIDENCE | --- --- --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.082 (e) (e) (e) (e) P=0.452 | |POLY 3 | P=0.106 (e) (e) (e) (e) P=0.498 | |POLY 1.5 | P=0.107 (e) (e) (e) (e) P=0.501 | |POLY 6 | P=0.103 (e) (e) (e) (e) P=0.491 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.452 | |COCH-ARM / FISHERS | P=0.105 (e) (e) (e) (e) 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 | |=================================================================================================================================| | | |Liver | | 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) | 0/15.00 0/14.85 0/12.32 0/14.27 0/14.59 2/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 14.4% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/14 (0%) 2/12 (17%) | |FIRST INCIDENCE | --- --- --- --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.008 ** (e) (e) (e) (e) P=0.188 | |POLY 3 | P=0.009 ** (e) (e) (e) (e) P=0.214 | |POLY 1.5 | P=0.009 ** (e) (e) (e) (e) P=0.221 | |POLY 6 | P=0.009 ** (e) (e) (e) (e) P=0.208 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.188 | |COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.241 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 11 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 2/15 (13%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/14.15 2/15.00 0/12.73 0/14.33 0/13.93 0/14.02 | |POLY-3 PERCENT (g) | 0.0% 13.3% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/14 (0%) 2/15 (13%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- 192 (T) --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.317N P=0.251 (e) (e) (e) (e) | |POLY 3 | P=0.260N P=0.245 (e) (e) (e) (e) | |POLY 1.5 | P=0.266N P=0.241 (e) (e) (e) (e) | |POLY 6 | P=0.256N P=0.247 (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.251 (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.286N P=0.241 (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 | |=================================================================================================================================| | | |Liver | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 12/15 (80%) 15/15 (100%) 12/15 (80%) 13/15 (87%) 14/15 (93%) 4/15 (27%) | |POLY-3 RATE (b) | 12/15.00 15/15.00 12/12.32 13/14.27 14/15.00 4/13.93 | |POLY-3 PERCENT (g) | 80.0% 100.0% 97.4% 91.1% 93.3% 28.7% | |TERMINAL (d) | 12/15 (80%) 14/14 (100%) 12/12 (100%) 13/14 (93%) 13/14 (93%) 4/12 (33%) | |FIRST INCIDENCE | 193 (T) 183 193 (T) 193 (T) 162 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.068 P=0.157 P=0.324 P=0.192 P=0.022N* | |POLY 3 | P<0.001N** P=0.106 P=0.207 P=0.371 P=0.298 P=0.003N** | |POLY 1.5 | P<0.001N** P=0.106 P=0.317 P=0.417 P=0.298 P=0.003N** | |POLY 6 | P<0.001N** P=0.106 P=0.163 P=0.336 P=0.298 P=0.005N** | |LOGISTIC REGRESSION| P<0.001N** (e) P=0.157 P=0.324 (e) P=0.022N* | |COCH-ARM / FISHERS | P<0.001N** P=0.112 P=0.674N P=0.500 P=0.299 P=0.005N** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 12 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 2/15 (13%) 2/15 (13%) 2/15 (13%) 0/15 (0%) 1/15 (7%) 1/15 (7%) | |POLY-3 RATE (b) | 2/15.00 2/15.00 2/12.73 0/14.33 1/13.93 1/14.02 | |POLY-3 PERCENT (g) | 13.3% 13.3% 15.7% 0.0% 7.2% 7.1% | |TERMINAL (d) | 1/14 (7%) 2/15 (13%) 2/12 (17%) 0/14 (0%) 1/13 (8%) 1/11 (9%) | |FIRST INCIDENCE | 101 192 (T) 192 (T) --- 192 (T) 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.379N P=0.678N P=0.641 P=0.240N P=0.525N P=0.556N | |POLY 3 | P=0.325N P=0.698 P=0.637 P=0.242N P=0.526N P=0.524N | |POLY 1.5 | P=0.319N P=0.698 P=0.655 P=0.238N P=0.518N P=0.513N | |POLY 6 | P=0.334N P=0.698 P=0.624 P=0.246N P=0.532N P=0.540N | |LOGISTIC REGRESSION| P=0.317N P=0.678N P=0.662N P=0.284N P=0.479N P=0.612N | |COCH-ARM / FISHERS | P=0.310N P=0.701N P=0.701N P=0.241N 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 | |=================================================================================================================================| | | |Liver: Hepatocyte | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/15 (27%) 2/15 (13%) 1/15 (7%) 2/15 (13%) 1/15 (7%) 1/15 (7%) | |POLY-3 RATE (b) | 4/15.00 2/14.85 1/12.32 2/14.27 1/14.59 1/13.93 | |POLY-3 PERCENT (g) | 26.7% 13.5% 8.1% 14.0% 6.9% 7.2% | |TERMINAL (d) | 4/15 (27%) 2/14 (14%) 1/12 (8%) 2/14 (14%) 1/14 (7%) 1/12 (8%) | |FIRST INCIDENCE | 193 (T) 193 (T) 193 (T) 193 (T) 193 (T) 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.198N P=0.360N P=0.240N P=0.360N P=0.189N P=0.240N | |POLY 3 | P=0.155N P=0.332N P=0.230N P=0.352N P=0.171N P=0.186N | |POLY 1.5 | P=0.154N P=0.330N P=0.214N P=0.343N P=0.168N P=0.177N | |POLY 6 | P=0.159N P=0.336N P=0.238N P=0.359N P=0.177N P=0.197N | |LOGISTIC REGRESSION| P=0.198N P=0.360N P=0.240N P=0.360N P=0.189N P=0.240N | |COCH-ARM / FISHERS | P=0.162N P=0.326N P=0.165N P=0.326N P=0.165N P=0.165N | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 13 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 2/15 (13%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/14 (14%) | |POLY-3 RATE (b) | 0/14.15 2/15.00 0/12.73 0/14.33 0/13.93 2/13.02 | |POLY-3 PERCENT (g) | 0.0% 13.3% 0.0% 0.0% 0.0% 15.4% | |TERMINAL (d) | 0/14 (0%) 2/15 (13%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 2/10 (20%) | |FIRST INCIDENCE | --- 192 (T) --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.123 P=0.251 (e) (e) (e) P=0.164 | |POLY 3 | P=0.183 P=0.245 (e) (e) (e) P=0.211 | |POLY 1.5 | P=0.181 P=0.241 (e) (e) (e) P=0.215 | |POLY 6 | P=0.181 P=0.247 (e) (e) (e) P=0.202 | |LOGISTIC REGRESSION| (e) P=0.251 (e) (e) (e) P=0.164 | |COCH-ARM / FISHERS | P=0.176 P=0.241 (e) (e) (e) P=0.224 | |=================================================================================================================================| | | | | | 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%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 0/15.00 0/14.85 1/12.32 0/14.27 0/14.59 0/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 8.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 1/12 (8%) 0/14 (0%) 0/14 (0%) 0/12 (0%) | |FIRST INCIDENCE | --- --- 193 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.581N (e) P=0.455 (e) (e) (e) | |POLY 3 | P=0.585N (e) P=0.461 (e) (e) (e) | |POLY 1.5 | P=0.581N (e) P=0.470 (e) (e) (e) | |POLY 6 | P=0.587N (e) P=0.457 (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.455 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.561N (e) P=0.500 (e) (e) (e) | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 14 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 0/13 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 0/14 (0%) | |POLY-3 RATE (b) | 0/12.15 0/13.00 0/11.73 0/14.33 0/12.93 0/13.16 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/13 (0%) 0/11 (0%) 0/14 (0%) 0/12 (0%) 0/11 (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) | 0/11 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/13 (0%) 2/12 (17%) | |POLY-3 RATE (b) | 0/11.00 0/13.85 0/10.32 0/9.27 0/12.59 2/10.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 18.3% | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/9 (0%) 0/12 (0%) 2/9 (22%) | |FIRST INCIDENCE | --- --- --- --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.007 ** (e) (e) (e) (e) P=0.190 | |POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.226 | |POLY 1.5 | P=0.008 ** (e) (e) (e) (e) P=0.235 | |POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.217 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.190 | |COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.261 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 15 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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 | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/13 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 4/14 (29%) | |POLY-3 RATE (b) | 0/12.15 0/13.00 0/11.73 0/14.33 0/12.93 4/13.16 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 30.4% | |TERMINAL (d) | 0/12 (0%) 0/13 (0%) 0/11 (0%) 0/14 (0%) 0/12 (0%) 4/11 (36%) | |FIRST INCIDENCE | --- --- --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.044 * | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.051 | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.053 | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.047 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.044 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.057 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/11 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/13 (0%) 2/12 (17%) | |POLY-3 RATE (b) | 0/11.00 0/13.85 0/10.32 0/9.27 0/12.59 2/10.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 18.3% | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/9 (0%) 0/12 (0%) 2/9 (22%) | |FIRST INCIDENCE | --- --- --- --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.007 ** (e) (e) (e) (e) P=0.190 | |POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.226 | |POLY 1.5 | P=0.008 ** (e) (e) (e) (e) P=0.235 | |POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.217 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.190 | |COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.261 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 16 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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 | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/13 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 3/14 (21%) | |POLY-3 RATE (b) | 0/12.15 0/13.00 0/11.73 0/14.33 0/12.93 3/13.16 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 22.8% | |TERMINAL (d) | 0/12 (0%) 0/13 (0%) 0/11 (0%) 0/14 (0%) 0/12 (0%) 3/11 (27%) | |FIRST INCIDENCE | --- --- --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.098 | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.118 | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.120 | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.112 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.098 | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.124 | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/11 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/13 (0%) 0/12 (0%) | |POLY-3 RATE (b) | 0/11.00 0/13.85 0/10.32 0/9.27 0/12.59 0/10.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/9 (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: 88133 TEST: 06 Page 17 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/14 (0%) 2/13 (15%) | |POLY-3 RATE (b) | 0/14.15 0/14.00 0/12.73 0/14.33 0/13.82 2/12.03 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 16.6% | |TERMINAL (d) | 0/14 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 2/10 (20%) | |FIRST INCIDENCE | --- --- --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.005 ** (e) (e) (e) (e) P=0.164 | |POLY 3 | P=0.006 ** (e) (e) (e) (e) P=0.193 | |POLY 1.5 | P=0.006 ** (e) (e) (e) (e) P=0.197 | |POLY 6 | P=0.006 ** (e) (e) (e) (e) P=0.184 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.164 | |COCH-ARM / FISHERS | P=0.007 ** (e) (e) (e) (e) P=0.206 | |=================================================================================================================================| | | | | | 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%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 6/15 (40%) | |POLY-3 RATE (b) | 0/15.00 0/14.85 1/12.32 0/14.27 0/14.59 6/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 8.1% 0.0% 0.0% 43.1% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 1/12 (8%) 0/14 (0%) 0/14 (0%) 6/12 (50%) | |FIRST INCIDENCE | --- --- 193 (T) --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.455 (e) (e) P=0.005 ** | |POLY 3 | P<0.001 ** (e) P=0.461 (e) (e) P=0.003 ** | |POLY 1.5 | P<0.001 ** (e) P=0.470 (e) (e) P=0.004 ** | |POLY 6 | P<0.001 ** (e) P=0.457 (e) (e) P=0.003 ** | |LOGISTIC REGRESSION| (e) (e) P=0.455 (e) (e) P=0.005 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 (e) (e) P=0.008 ** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 18 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 1/14 (7%) 1/15 (7%) 0/15 (0%) 1/14 (7%) 1/13 (8%) | |POLY-3 RATE (b) | 0/14.15 1/14.00 1/13.18 0/14.33 1/14.00 1/12.03 | |POLY-3 PERCENT (g) | 0.0% 7.1% 7.6% 0.0% 7.1% 8.3% | |TERMINAL (d) | 0/14 (0%) 1/14 (7%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 1/10 (10%) | |FIRST INCIDENCE | --- 192 (T) 157 --- 180 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.376 P=0.500 P=0.485 (e) P=0.500 P=0.433 | |POLY 3 | P=0.371 P=0.498 P=0.486 (e) P=0.498 P=0.468 | |POLY 1.5 | P=0.378 P=0.495 P=0.489 (e) P=0.495 P=0.471 | |POLY 6 | P=0.356 P=0.500 P=0.485 (e) P=0.500 P=0.459 | |LOGISTIC REGRESSION| P=0.359 P=0.500 P=0.557 (e) P=0.448 P=0.433 | |COCH-ARM / FISHERS | P=0.376 P=0.483 P=0.500 (e) P=0.483 P=0.464 | |=================================================================================================================================| | | | | | 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) | 1/15 (7%) 3/15 (20%) 3/15 (20%) 0/15 (0%) 3/15 (20%) 3/15 (20%) | |POLY-3 RATE (b) | 1/15.00 3/14.85 3/13.29 0/14.27 3/15.00 3/13.93 | |POLY-3 PERCENT (g) | 6.7% 20.2% 22.6% 0.0% 20.0% 21.5% | |TERMINAL (d) | 1/15 (7%) 3/14 (21%) 2/12 (17%) 0/14 (0%) 2/14 (14%) 3/12 (25%) | |FIRST INCIDENCE | 193 (T) 193 (T) 63 --- 162 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.245 P=0.273 P=0.245 P=0.514N P=0.285 P=0.220 | |POLY 3 | P=0.272 P=0.295 P=0.254 P=0.510N P=0.298 P=0.270 | |POLY 1.5 | P=0.282 P=0.296 P=0.264 P=0.507N P=0.298 P=0.281 | |POLY 6 | P=0.261 P=0.291 P=0.248 P=0.513N P=0.298 P=0.259 | |LOGISTIC REGRESSION| P=0.287 P=0.273 P=0.448 (e) (e) P=0.220 | |COCH-ARM / FISHERS | P=0.295 P=0.299 P=0.299 P=0.500N P=0.299 P=0.299 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 19 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/14 (0%) 4/13 (31%) | |POLY-3 RATE (b) | 0/14.15 0/14.00 0/12.73 0/14.33 0/13.82 4/12.03 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 33.3% | |TERMINAL (d) | 0/14 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 4/10 (40%) | |FIRST INCIDENCE | --- --- --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.023 * | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.025 * | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.027 * | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.022 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.023 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.035 * | |=================================================================================================================================| | | | | | 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%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 1/15 (7%) | |POLY-3 RATE (b) | 0/15.00 0/14.85 1/12.32 0/14.27 0/14.59 1/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 8.1% 0.0% 0.0% 7.2% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 1/12 (8%) 0/14 (0%) 0/14 (0%) 1/12 (8%) | |FIRST INCIDENCE | --- --- 193 (T) --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.289 (e) P=0.455 (e) (e) P=0.455 | |POLY 3 | P=0.294 (e) P=0.461 (e) (e) P=0.485 | |POLY 1.5 | P=0.301 (e) P=0.470 (e) (e) P=0.491 | |POLY 6 | P=0.288 (e) P=0.457 (e) (e) P=0.479 | |LOGISTIC REGRESSION| (e) (e) P=0.455 (e) (e) P=0.455 | |COCH-ARM / FISHERS | P=0.316 (e) P=0.500 (e) (e) P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 20 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/14 (0%) 1/13 (8%) | |POLY-3 RATE (b) | 0/14.15 0/14.00 0/12.73 0/14.33 0/13.82 1/12.03 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 8.3% | |TERMINAL (d) | 0/14 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 1/10 (10%) | |FIRST INCIDENCE | --- --- --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.075 (e) (e) (e) (e) P=0.433 | |POLY 3 | P=0.091 (e) (e) (e) (e) P=0.468 | |POLY 1.5 | P=0.092 (e) (e) (e) (e) P=0.471 | |POLY 6 | P=0.088 (e) (e) (e) (e) P=0.459 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.433 | |COCH-ARM / FISHERS | P=0.091 (e) (e) (e) (e) P=0.464 | |=================================================================================================================================| | | | | | 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%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 2/15 (13%) | |POLY-3 RATE (b) | 0/15.00 0/14.85 1/12.32 0/14.27 0/14.59 2/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 8.1% 0.0% 0.0% 14.4% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 1/12 (8%) 0/14 (0%) 0/14 (0%) 2/12 (17%) | |FIRST INCIDENCE | --- --- 193 (T) --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.047 * (e) P=0.455 (e) (e) P=0.188 | |POLY 3 | P=0.053 (e) P=0.461 (e) (e) P=0.214 | |POLY 1.5 | P=0.055 (e) P=0.470 (e) (e) P=0.221 | |POLY 6 | P=0.051 (e) P=0.457 (e) (e) P=0.208 | |LOGISTIC REGRESSION| (e) (e) P=0.455 (e) (e) P=0.188 | |COCH-ARM / FISHERS | P=0.060 (e) P=0.500 (e) (e) P=0.241 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 21 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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 | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/14 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/12 (0%) | |POLY-3 RATE (b) | 0/14.15 0/14.00 0/11.73 0/14.33 0/13.93 0/11.44 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/14 (0%) 0/14 (0%) 0/11 (0%) 0/14 (0%) 0/13 (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 | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/14 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 4/15 (27%) | |POLY-3 RATE (b) | 0/15.00 0/14.00 0/12.07 0/14.27 0/14.59 4/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 28.7% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/14 (0%) 4/12 (33%) | |FIRST INCIDENCE | --- --- --- --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.033 * | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.036 * | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.039 * | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.033 * | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.033 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.050 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 22 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 0/15 (0%) 0/14 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 1/12 (8%) | |POLY-3 RATE (b) | 0/14.15 0/14.00 0/11.73 0/14.33 0/13.93 1/11.44 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 8.7% | |TERMINAL (d) | 0/14 (0%) 0/14 (0%) 0/11 (0%) 0/14 (0%) 0/13 (0%) 1/10 (10%) | |FIRST INCIDENCE | --- --- --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.077 (e) (e) (e) (e) P=0.433 | |POLY 3 | P=0.086 (e) (e) (e) (e) P=0.457 | |POLY 1.5 | P=0.086 (e) (e) (e) (e) P=0.458 | |POLY 6 | P=0.085 (e) (e) (e) (e) P=0.453 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.433 | |COCH-ARM / FISHERS | P=0.085 (e) (e) (e) (e) P=0.444 | |=================================================================================================================================| | | | | | 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) | 0/15 (0%) 0/14 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) | |POLY-3 RATE (b) | 0/15.00 0/14.00 0/12.07 0/14.27 0/14.59 2/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 14.4% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/14 (0%) 2/12 (17%) | |FIRST INCIDENCE | --- --- --- --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.008 ** (e) (e) (e) (e) P=0.188 | |POLY 3 | P=0.010 * (e) (e) (e) (e) P=0.214 | |POLY 1.5 | P=0.010 * (e) (e) (e) (e) P=0.221 | |POLY 6 | P=0.010 * (e) (e) (e) (e) P=0.208 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.188 | |COCH-ARM / FISHERS | P=0.012 * (e) (e) (e) (e) P=0.241 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 23 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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: Inguinal | | Infiltration Cellular Plasma Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/13 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 0/14 (0%) | |POLY-3 RATE (b) | 0/12.15 0/13.00 0/11.73 0/14.33 0/12.93 0/13.16 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/13 (0%) 0/11 (0%) 0/14 (0%) 0/12 (0%) 0/11 (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: Inguinal | | Infiltration Cellular Plasma Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/11 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/13 (0%) 2/12 (17%) | |POLY-3 RATE (b) | 0/11.00 0/13.85 0/10.32 0/9.27 0/12.59 2/10.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 18.3% | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/9 (0%) 0/12 (0%) 2/9 (22%) | |FIRST INCIDENCE | --- --- --- --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.007 ** (e) (e) (e) (e) P=0.190 | |POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.226 | |POLY 1.5 | P=0.008 ** (e) (e) (e) (e) P=0.235 | |POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.217 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.190 | |COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.261 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 24 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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: Inguinal | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/13 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 0/14 (0%) | |POLY-3 RATE (b) | 0/12.15 0/13.00 0/11.73 0/14.33 0/12.93 0/13.16 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/13 (0%) 0/11 (0%) 0/14 (0%) 0/12 (0%) 0/11 (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: Inguinal | | Myelodysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/11 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/13 (0%) 2/12 (17%) | |POLY-3 RATE (b) | 0/11.00 0/13.85 0/10.32 0/9.27 0/12.59 2/10.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 18.3% | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/9 (0%) 0/12 (0%) 2/9 (22%) | |FIRST INCIDENCE | --- --- --- --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.007 ** (e) (e) (e) (e) P=0.190 | |POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.226 | |POLY 1.5 | P=0.008 ** (e) (e) (e) (e) P=0.235 | |POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.217 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.190 | |COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.261 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 25 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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 | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/13 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 1/14 (7%) | |POLY-3 RATE (b) | 0/12.15 0/13.00 0/11.73 0/14.33 0/12.93 1/13.16 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 7.6% | |TERMINAL (d) | 0/12 (0%) 0/13 (0%) 0/11 (0%) 0/14 (0%) 0/12 (0%) 1/11 (9%) | |FIRST INCIDENCE | --- --- --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.093 (e) (e) (e) (e) P=0.483 | |POLY 3 | P=0.110 (e) (e) (e) (e) P=0.516 | |POLY 1.5 | P=0.111 (e) (e) (e) (e) P=0.518 | |POLY 6 | P=0.108 (e) (e) (e) (e) P=0.510 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.483 | |COCH-ARM / FISHERS | P=0.108 (e) (e) (e) (e) P=0.519 | |=================================================================================================================================| | | | | | 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 | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/11 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/13 (0%) 5/12 (42%) | |POLY-3 RATE (b) | 0/11.00 0/13.85 0/10.32 0/9.27 0/12.59 5/10.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 45.8% | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/9 (0%) 0/12 (0%) 5/9 (56%) | |FIRST INCIDENCE | --- --- --- --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.011 * | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.010 * | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.012 * | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.008 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.011 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.024 * | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 26 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 0/13 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 3/14 (21%) | |POLY-3 RATE (b) | 0/12.15 0/13.00 0/11.73 0/14.33 0/12.93 3/13.16 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 22.8% | |TERMINAL (d) | 0/12 (0%) 0/13 (0%) 0/11 (0%) 0/14 (0%) 0/12 (0%) 3/11 (27%) | |FIRST INCIDENCE | --- --- --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.098 | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.118 | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.120 | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.112 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.098 | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.124 | |=================================================================================================================================| | | | | | 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) | 0/11 (0%) 0/14 (0%) 1/13 (8%) 0/10 (0%) 0/13 (0%) 2/12 (17%) | |POLY-3 RATE (b) | 0/11.00 0/13.85 1/10.32 0/9.27 0/12.59 2/10.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 9.7% 0.0% 0.0% 18.3% | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 1/10 (10%) 0/9 (0%) 0/12 (0%) 2/9 (22%) | |FIRST INCIDENCE | --- --- 193 (T) --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.042 * (e) P=0.481 (e) (e) P=0.190 | |POLY 3 | P=0.050 (e) P=0.487 (e) (e) P=0.226 | |POLY 1.5 | P=0.052 (e) P=0.498 (e) (e) P=0.235 | |POLY 6 | P=0.048 * (e) P=0.482 (e) (e) P=0.217 | |LOGISTIC REGRESSION| (e) (e) P=0.481 (e) (e) P=0.190 | |COCH-ARM / FISHERS | P=0.059 (e) P=0.542 (e) (e) P=0.261 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 27 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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 Plasma Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/13 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 3/14 (21%) | |POLY-3 RATE (b) | 0/12.15 0/13.00 0/11.73 0/14.33 0/12.93 3/13.16 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 22.8% | |TERMINAL (d) | 0/12 (0%) 0/13 (0%) 0/11 (0%) 0/14 (0%) 0/12 (0%) 3/11 (27%) | |FIRST INCIDENCE | --- --- --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.098 | |POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.118 | |POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.120 | |POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.112 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.098 | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.124 | |=================================================================================================================================| | | | | | 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 Plasma Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/11 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/13 (0%) 2/12 (17%) | |POLY-3 RATE (b) | 0/11.00 0/13.85 0/10.32 0/9.27 0/12.59 2/10.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 18.3% | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/9 (0%) 0/12 (0%) 2/9 (22%) | |FIRST INCIDENCE | --- --- --- --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.007 ** (e) (e) (e) (e) P=0.190 | |POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.226 | |POLY 1.5 | P=0.008 ** (e) (e) (e) (e) P=0.235 | |POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.217 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.190 | |COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.261 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 28 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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 | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/13 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 2/14 (14%) | |POLY-3 RATE (b) | 0/12.15 0/13.00 0/11.73 0/14.33 0/12.93 2/13.16 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 15.2% | |TERMINAL (d) | 0/12 (0%) 0/13 (0%) 0/11 (0%) 0/14 (0%) 0/12 (0%) 2/11 (18%) | |FIRST INCIDENCE | --- --- --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.008 ** (e) (e) (e) (e) P=0.216 | |POLY 3 | P=0.009 ** (e) (e) (e) (e) P=0.249 | |POLY 1.5 | P=0.010 * (e) (e) (e) (e) P=0.251 | |POLY 6 | P=0.009 ** (e) (e) (e) (e) P=0.242 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.216 | |COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.259 | |=================================================================================================================================| | | | | | 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 | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/11 (0%) 0/14 (0%) 0/13 (0%) 0/10 (0%) 0/13 (0%) 0/12 (0%) | |POLY-3 RATE (b) | 0/11.00 0/13.85 0/10.32 0/9.27 0/12.59 0/10.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/10 (0%) 0/9 (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: 88133 TEST: 06 Page 29 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 2/15 (13%) 1/15 (7%) 1/15 (7%) 1/14 (7%) 1/15 (7%) 2/15 (13%) | |POLY-3 RATE (b) | 2/14.15 1/15.00 1/12.73 1/13.33 1/13.93 2/14.02 | |POLY-3 PERCENT (g) | 14.1% 6.7% 7.9% 7.5% 7.2% 14.3% | |TERMINAL (d) | 2/14 (14%) 1/15 (7%) 1/12 (8%) 1/13 (8%) 1/13 (8%) 2/11 (18%) | |FIRST INCIDENCE | 192 (T) 192 (T) 192 (T) 192 (T) 192 (T) 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.363 P=0.475N P=0.555N P=0.527N P=0.527N P=0.610 | |POLY 3 | P=0.455 P=0.479N P=0.538N P=0.521N P=0.505N P=0.696 | |POLY 1.5 | P=0.461 P=0.485N P=0.527N P=0.521N P=0.504N P=0.697N | |POLY 6 | P=0.442 P=0.476N P=0.546N P=0.524N P=0.508N P=0.683 | |LOGISTIC REGRESSION| P=0.363 P=0.475N P=0.555N P=0.527N P=0.527N P=0.610 | |COCH-ARM / FISHERS | P=0.458 P=0.500N P=0.500N P=0.527N P=0.500N P=0.701N | |=================================================================================================================================| | | | | | 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) | 1/15 (7%) 0/15 (0%) 2/15 (13%) 1/15 (7%) 2/15 (13%) 2/15 (13%) | |POLY-3 RATE (b) | 1/15.00 0/14.85 2/12.32 1/14.27 2/14.59 2/13.93 | |POLY-3 PERCENT (g) | 6.7% 0.0% 16.2% 7.0% 13.7% 14.4% | |TERMINAL (d) | 1/15 (7%) 0/14 (0%) 2/12 (17%) 1/14 (7%) 2/14 (14%) 2/12 (17%) | |FIRST INCIDENCE | 193 (T) --- 193 (T) 193 (T) 193 (T) 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.189 P=0.514N P=0.420 P=0.749 P=0.475 P=0.420 | |POLY 3 | P=0.216 P=0.502N P=0.431 P=0.749 P=0.490 P=0.474 | |POLY 1.5 | P=0.226 P=0.501N P=0.446 P=0.753 P=0.495 P=0.483 | |POLY 6 | P=0.207 P=0.504N P=0.423 P=0.746 P=0.484 P=0.463 | |LOGISTIC REGRESSION| P=0.189 (e) P=0.420 P=0.749 P=0.475 P=0.420 | |COCH-ARM / FISHERS | P=0.236 P=0.500N P=0.500 P=0.759N P=0.500 P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 30 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 0/15 (0%) 6/15 (40%) 14/15 (93%) 15/15 (100%) | |POLY-3 RATE (b) | 0/14.15 0/15.00 0/12.73 6/14.33 14/14.82 15/15.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 41.9% 94.4% 100.0% | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/12 (0%) 6/14 (43%) 13/13 (100%) 11/11 (100%) | |FIRST INCIDENCE | --- --- --- 192 (T) 92 161 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.012 * P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.005 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.005 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.005 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.012 * P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.008 ** 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%) 1/15 (7%) 4/15 (27%) 15/15 (100%) 15/15 (100%) | |POLY-3 RATE (b) | 0/15.00 0/14.85 1/12.32 4/14.27 15/15.00 15/15.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 8.1% 28.0% 100.0% 100.0% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 1/12 (8%) 4/14 (29%) 14/14 (100%) 12/12 (100%) | |FIRST INCIDENCE | --- --- 193 (T) 193 (T) 162 118 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.455 P=0.048 * P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.461 P=0.039 * P<0.001N** P<0.001N** | |POLY 1.5 | P<0.001 ** (e) P=0.470 P=0.041 * P<0.001N** P<0.001N** | |POLY 6 | P<0.001 ** (e) P=0.457 P=0.038 * P<0.001N** P<0.001N** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.455 P=0.048 * (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P=0.050 P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 31 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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 Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 1/15 (7%) 0/15 (0%) | |POLY-3 RATE (b) | 0/14.15 0/15.00 1/12.73 0/14.33 1/13.93 0/14.02 | |POLY-3 PERCENT (g) | 0.0% 0.0% 7.9% 0.0% 7.2% 0.0% | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 1/12 (8%) 0/14 (0%) 1/13 (8%) 0/11 (0%) | |FIRST INCIDENCE | --- --- 192 (T) --- 192 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.683 (e) P=0.469 (e) P=0.485 (e) | |POLY 3 | P=0.696 (e) P=0.479 (e) P=0.497 (e) | |POLY 1.5 | P=0.691N (e) P=0.485 (e) P=0.498 (e) | |POLY 6 | P=0.679 (e) P=0.474 (e) P=0.495 (e) | |LOGISTIC REGRESSION| (e) (e) P=0.469 (e) P=0.485 (e) | |COCH-ARM / FISHERS | P=0.684N (e) P=0.500 (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 | |=================================================================================================================================| | | |Skin: Epidermis, Skin, Site of Application | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 1/15 (7%) 8/15 (53%) | |POLY-3 RATE (b) | 0/15.00 0/14.85 0/12.32 1/14.27 1/14.59 8/14.70 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.0% 6.9% 54.4% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 1/14 (7%) 1/14 (7%) 7/12 (58%) | |FIRST INCIDENCE | --- --- --- 193 (T) 193 (T) 118 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.486 P=0.486 P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.490 P=0.494 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.493 P=0.497 P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.487 P=0.491 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.486 P=0.486 P=0.003 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P=0.500 P<0.001 ** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 32 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 15/15 (100%) 14/15 (93%) 12/15 (80%) | |POLY-3 RATE (b) | 0/14.15 0/15.00 1/13.18 15/15.00 14/14.82 12/15.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 7.6% 100.0% 94.4% 80.0% | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/12 (0%) 14/14 (100%) 13/13 (100%) 8/11 (73%) | |FIRST INCIDENCE | --- --- 157 132 92 161 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.485 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.486 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.489 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.485 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.557 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 ** | |=================================================================================================================================| | | | | | 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) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 7/15 (47%) 14/15 (93%) 13/15 (87%) | |POLY-3 RATE (b) | 0/15.00 0/14.85 1/12.32 7/14.27 14/15.00 13/14.23 | |POLY-3 PERCENT (g) | 0.0% 0.0% 8.1% 49.1% 93.3% 91.4% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 1/12 (8%) 7/14 (50%) 13/14 (93%) 11/12 (92%) | |FIRST INCIDENCE | --- --- 193 (T) 193 (T) 162 176 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.455 P=0.004 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.461 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.470 P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.457 P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.455 P=0.004 ** (e) P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P=0.003 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 33 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 1/15 (7%) 1/15 (7%) 9/15 (60%) 12/15 (80%) | |POLY-3 RATE (b) | 0/14.15 0/15.00 1/12.73 1/15.00 9/13.93 12/14.59 | |POLY-3 PERCENT (g) | 0.0% 0.0% 7.9% 6.7% 64.6% 82.3% | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 1/12 (8%) 0/14 (0%) 9/13 (69%) 9/11 (82%) | |FIRST INCIDENCE | --- --- 192 (T) 132 192 (T) 161 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) P=0.469 P=0.514 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.479 P=0.512 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.485 P=0.508 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.474 P=0.513 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.469 P=0.324 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P=0.500 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 | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) 14/15 (93%) 12/15 (80%) | |POLY-3 RATE (b) | 0/15.00 0/14.85 0/12.32 3/14.27 14/15.00 12/13.99 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 21.0% 93.3% 85.8% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 3/14 (21%) 13/14 (93%) 11/12 (92%) | |FIRST INCIDENCE | --- --- --- 193 (T) 162 189 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) P=0.104 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) P=0.097 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) P=0.100 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) P=0.094 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.104 (e) P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.112 P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 34 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 1/15 (7%) 4/15 (27%) | |POLY-3 RATE (b) | 0/14.15 0/15.00 1/13.18 0/14.33 1/14.11 4/15.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 7.6% 0.0% 7.1% 26.7% | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- --- 157 --- 180 161 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** (e) P=0.485 (e) P=0.500 P=0.062 | |POLY 3 | P<0.001 ** (e) P=0.486 (e) P=0.499 P=0.052 | |POLY 1.5 | P<0.001 ** (e) P=0.489 (e) P=0.499 P=0.050 | |POLY 6 | P<0.001 ** (e) P=0.485 (e) P=0.500 P=0.054 | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.557 (e) P=0.503 P=0.033 * | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 (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 | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 1/15 (7%) 3/15 (20%) 1/15 (7%) 2/15 (13%) 1/15 (7%) | |POLY-3 RATE (b) | 0/15.00 1/15.00 3/15.00 1/15.00 2/15.00 1/13.99 | |POLY-3 PERCENT (g) | 0.0% 6.7% 20.0% 6.7% 13.3% 7.2% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 1/14 (7%) 0/12 (0%) | |FIRST INCIDENCE | --- 183 63 124 162 189 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.545 P=0.500 P=0.113 P=0.500 P=0.232 P=0.471 | |POLY 3 | P=0.522 P=0.500 P=0.106 P=0.500 P=0.232 P=0.486 | |POLY 1.5 | P=0.536 P=0.500 P=0.106 P=0.500 P=0.232 P=0.491 | |POLY 6 | P=0.507 P=0.500 P=0.106 P=0.500 P=0.232 P=0.481 | |LOGISTIC REGRESSION| P=0.610 (e) (e) (e) (e) P=0.506 | |COCH-ARM / FISHERS | P=0.562 P=0.500 P=0.112 P=0.500 P=0.241 P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 35 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 4/15 (27%) 1/15 (7%) 2/15 (13%) 6/15 (40%) 8/15 (53%) | |POLY-3 RATE (b) | 1/15.00 4/15.00 1/12.73 2/14.33 6/13.93 8/14.02 | |POLY-3 PERCENT (g) | 6.7% 26.7% 7.9% 14.0% 43.1% 57.1% | |TERMINAL (d) | 0/14 (0%) 4/15 (27%) 1/12 (8%) 2/14 (14%) 6/13 (46%) 8/11 (73%) | |FIRST INCIDENCE | 101 192 (T) 192 (T) 192 (T) 192 (T) 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.192 P=0.727 P=0.500 P=0.039 * P=0.003 ** | |POLY 3 | P<0.001 ** P=0.163 P=0.723 P=0.484 P=0.025 * P=0.002 ** | |POLY 1.5 | P<0.001 ** P=0.163 P=0.734 P=0.490 P=0.027 * P=0.002 ** | |POLY 6 | P<0.001 ** P=0.163 P=0.715 P=0.478 P=0.023 * P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.192 P=0.691N P=0.422 P=0.042 * P=0.007 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.165 P=0.759N P=0.500 P=0.040 * 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) | 7/15 (47%) 13/15 (87%) 9/15 (60%) 6/15 (40%) 8/15 (53%) 10/15 (67%) | |POLY-3 RATE (b) | 7/15.00 13/14.85 9/12.32 6/14.27 8/14.59 10/14.70 | |POLY-3 PERCENT (g) | 46.7% 87.5% 73.0% 42.1% 54.8% 68.0% | |TERMINAL (d) | 7/15 (47%) 13/14 (93%) 9/12 (75%) 6/14 (43%) 8/14 (57%) 9/12 (75%) | |FIRST INCIDENCE | 193 (T) 193 (T) 193 (T) 193 (T) 193 (T) 118 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.274 P=0.012 * P=0.141 P=0.565N P=0.425 P=0.086 | |POLY 3 | P=0.526 P=0.016 * P=0.159 P=0.547N P=0.470 P=0.211 | |POLY 1.5 | P=0.526 P=0.018 * P=0.197 P=0.531N P=0.483 P=0.222 | |POLY 6 | P=0.506 P=0.014 * P=0.143 P=0.560N P=0.452 P=0.194 | |LOGISTIC REGRESSION| P=0.460 P=0.012 * P=0.141 P=0.565N P=0.425 P=0.268 | |COCH-ARM / FISHERS | P=0.482 P=0.025 * P=0.358 P=0.500N P=0.500 P=0.231 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 36 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 1/15 (7%) 1/15 (7%) 0/15 (0%) | |POLY-3 RATE (b) | 0/14.15 1/15.00 1/13.67 1/14.33 1/13.93 0/14.02 | |POLY-3 PERCENT (g) | 0.0% 6.7% 7.3% 7.0% 7.2% 0.0% | |TERMINAL (d) | 0/14 (0%) 1/15 (7%) 0/12 (0%) 1/14 (7%) 1/13 (8%) 0/11 (0%) | |FIRST INCIDENCE | --- 192 (T) 74 192 (T) 192 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.484N P=0.514 P=0.500 P=0.500 P=0.485 (e) | |POLY 3 | P=0.446N P=0.512 P=0.493 P=0.503 P=0.497 (e) | |POLY 1.5 | P=0.441N P=0.508 P=0.496 P=0.503 P=0.498 (e) | |POLY 6 | P=0.457N P=0.513 P=0.490 P=0.501 P=0.495 (e) | |LOGISTIC REGRESSION| P=0.485N P=0.514 (e) P=0.500 P=0.485 (e) | |COCH-ARM / FISHERS | P=0.438N P=0.500 P=0.500 P=0.500 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 | |=================================================================================================================================| | | |Spleen | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/15 (13%) 2/15 (13%) 2/15 (13%) 0/15 (0%) 0/15 (0%) 0/15 (0%) | |POLY-3 RATE (b) | 2/15.00 2/14.85 2/12.32 0/14.27 0/14.59 0/13.93 | |POLY-3 PERCENT (g) | 13.3% 13.5% 16.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/15 (13%) 2/14 (14%) 2/12 (17%) 0/14 (0%) 0/14 (0%) 0/12 (0%) | |FIRST INCIDENCE | 193 (T) 193 (T) 193 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.062N P=0.676 P=0.617 P=0.251N P=0.251N P=0.286N | |POLY 3 | P=0.053N P=0.695 P=0.624 P=0.243N P=0.238N P=0.249N | |POLY 1.5 | P=0.052N P=0.696 P=0.642 P=0.239N P=0.235N P=0.242N | |POLY 6 | P=0.054N P=0.692 P=0.616 P=0.246N P=0.242N P=0.256N | |LOGISTIC REGRESSION| P=0.062N P=0.676 P=0.617 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.053N P=0.701N P=0.701N P=0.241N P=0.241N P=0.241N | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 37 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 0/15 (0%) | |POLY-3 RATE (b) | 0/14.15 0/15.00 0/12.73 0/14.33 0/13.93 0/14.02 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 0/11 (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 | |=================================================================================================================================| | | |Spleen | | 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) | 0/15.00 0/14.85 0/12.32 0/14.27 0/14.59 2/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 14.4% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/14 (0%) 2/12 (17%) | |FIRST INCIDENCE | --- --- --- --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.008 ** (e) (e) (e) (e) P=0.188 | |POLY 3 | P=0.009 ** (e) (e) (e) (e) P=0.214 | |POLY 1.5 | P=0.009 ** (e) (e) (e) (e) P=0.221 | |POLY 6 | P=0.009 ** (e) (e) (e) (e) P=0.208 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.188 | |COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.241 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 38 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 1/15 (7%) 3/15 (20%) | |POLY-3 RATE (b) | 0/14.15 0/15.00 1/13.60 0/14.33 1/13.93 3/14.59 | |POLY-3 PERCENT (g) | 0.0% 0.0% 7.4% 0.0% 7.2% 20.6% | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/12 (0%) 0/14 (0%) 1/13 (8%) 0/11 (0%) | |FIRST INCIDENCE | --- --- 95 --- 192 (T) 161 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.009 ** (e) P=0.486 (e) P=0.485 P=0.115 | |POLY 3 | P=0.008 ** (e) P=0.492 (e) P=0.497 P=0.111 | |POLY 1.5 | P=0.008 ** (e) P=0.494 (e) P=0.498 P=0.111 | |POLY 6 | P=0.008 ** (e) P=0.489 (e) P=0.495 P=0.110 | |LOGISTIC REGRESSION| P=0.004 ** (e) P=0.772 (e) P=0.485 P=0.092 | |COCH-ARM / FISHERS | P=0.009 ** (e) P=0.500 (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 | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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) | 0/15.00 0/14.85 0/12.32 0/14.27 0/14.59 0/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/14 (0%) 0/12 (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: 88133 TEST: 06 Page 39 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 1/15 (7%) | |POLY-3 RATE (b) | 2/14.15 0/15.00 1/13.18 0/14.33 0/13.93 1/14.02 | |POLY-3 PERCENT (g) | 14.1% 0.0% 7.6% 0.0% 0.0% 7.1% | |TERMINAL (d) | 2/14 (14%) 0/15 (0%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 1/11 (9%) | |FIRST INCIDENCE | 192 (T) --- 157 --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.593N P=0.221N P=0.545N P=0.236N P=0.252N P=0.587N | |POLY 3 | P=0.563N P=0.218N P=0.525N P=0.228N P=0.234N P=0.503N | |POLY 1.5 | P=0.559N P=0.222N P=0.520N P=0.228N P=0.233N P=0.498N | |POLY 6 | P=0.565N P=0.216N P=0.526N P=0.230N P=0.236N P=0.516N | |LOGISTIC REGRESSION| P=0.552N (e) P=0.499N (e) (e) P=0.587N | |COCH-ARM / FISHERS | P=0.550N P=0.241N P=0.500N P=0.241N P=0.241N 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 | |=================================================================================================================================| | | |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: 88133 TEST: 06 Page 40 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 4/15 (27%) 0/15 (0%) 3/15 (20%) 1/15 (7%) 1/15 (7%) 2/15 (13%) | |POLY-3 RATE (b) | 4/14.15 0/15.00 3/14.06 1/14.33 1/13.93 2/14.02 | |POLY-3 PERCENT (g) | 28.3% 0.0% 21.3% 7.0% 7.2% 14.3% | |TERMINAL (d) | 4/14 (29%) 0/15 (0%) 1/12 (8%) 1/14 (7%) 1/13 (8%) 2/11 (18%) | |FIRST INCIDENCE | 192 (T) --- 95 192 (T) 192 (T) 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.520N P=0.048N* P=0.573N P=0.166N P=0.189N P=0.449N | |POLY 3 | P=0.462N P=0.038N* P=0.504N P=0.157N P=0.166N P=0.330N | |POLY 1.5 | P=0.451N P=0.040N* P=0.506N P=0.157N P=0.164N P=0.324N | |POLY 6 | P=0.475N P=0.037N* P=0.501N P=0.159N P=0.168N P=0.348N | |LOGISTIC REGRESSION| P=0.446N (e) P=0.449N P=0.166N P=0.189N P=0.449N | |COCH-ARM / FISHERS | P=0.434N P=0.050N P=0.500N P=0.165N P=0.165N P=0.326N | |=================================================================================================================================| | | | | | 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: 88133 TEST: 06 Page 41 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 1/15 (7%) 0/15 (0%) 1/14 (7%) 0/15 (0%) 2/15 (13%) 5/15 (33%) | |POLY-3 RATE (b) | 1/14.15 0/15.00 1/12.18 0/14.33 2/15.00 5/15.00 | |POLY-3 PERCENT (g) | 7.1% 0.0% 8.2% 0.0% 13.3% 33.3% | |TERMINAL (d) | 1/14 (7%) 0/15 (0%) 0/11 (0%) 0/14 (0%) 0/13 (0%) 1/11 (9%) | |FIRST INCIDENCE | 192 (T) --- 157 --- 92 161 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** P=0.486N P=0.725 P=0.500N P=0.491 P=0.086 | |POLY 3 | P<0.001 ** P=0.488N P=0.727 P=0.497N P=0.521 P=0.094 | |POLY 1.5 | P<0.001 ** P=0.492N P=0.731 P=0.497N P=0.515 P=0.089 | |POLY 6 | P<0.001 ** P=0.487N P=0.726 P=0.499N P=0.524 P=0.096 | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.774 (e) P=0.526 P=0.071 | |COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.741 P=0.500N P=0.500 P=0.084 | |=================================================================================================================================| | | | | | 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) | 0/15 (0%) 1/15 (7%) 3/15 (20%) 2/15 (13%) 2/15 (13%) 3/15 (20%) | |POLY-3 RATE (b) | 0/15.00 1/15.00 3/15.00 2/15.00 2/15.00 3/15.00 | |POLY-3 PERCENT (g) | 0.0% 6.7% 20.0% 13.3% 13.3% 20.0% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 1/14 (7%) 1/14 (7%) 0/12 (0%) | |FIRST INCIDENCE | --- 183 63 124 162 118 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.146 P=0.500 P=0.113 P=0.232 P=0.232 P=0.112 | |POLY 3 | P=0.146 P=0.500 P=0.106 P=0.232 P=0.232 P=0.106 | |POLY 1.5 | P=0.146 P=0.500 P=0.106 P=0.232 P=0.232 P=0.106 | |POLY 6 | P=0.146 P=0.500 P=0.106 P=0.232 P=0.232 P=0.106 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.143 P=0.500 P=0.112 P=0.241 P=0.241 P=0.112 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 42 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) | |POLY-3 RATE (b) | 0/14.15 0/15.00 0/11.73 0/14.33 0/13.93 1/14.43 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 6.9% | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/11 (0%) 0/14 (0%) 0/13 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- --- --- --- --- 161 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.117 (e) (e) (e) (e) P=0.514 | |POLY 3 | P=0.111 (e) (e) (e) (e) P=0.504 | |POLY 1.5 | P=0.111 (e) (e) (e) (e) P=0.504 | |POLY 6 | P=0.110 (e) (e) (e) (e) P=0.500 | |LOGISTIC REGRESSION| P=0.078 (e) (e) (e) (e) P=0.410 | |COCH-ARM / FISHERS | P=0.107 (e) (e) (e) (e) 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 | |=================================================================================================================================| | | |Thymus: Thymocyte | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/15 (0%) 0/15 (0%) 2/15 (13%) 1/15 (7%) 0/15 (0%) 1/15 (7%) | |POLY-3 RATE (b) | 0/15.00 0/14.85 2/14.04 1/15.00 0/14.59 1/13.99 | |POLY-3 PERCENT (g) | 0.0% 0.0% 14.3% 6.7% 0.0% 7.2% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/14 (0%) 0/12 (0%) | |FIRST INCIDENCE | --- --- 63 124 --- 189 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.518 (e) P=0.224 P=0.500 (e) P=0.471 | |POLY 3 | P=0.497 (e) P=0.216 P=0.500 (e) P=0.486 | |POLY 1.5 | P=0.506 (e) P=0.219 P=0.500 (e) P=0.491 | |POLY 6 | P=0.489 (e) P=0.216 P=0.500 (e) P=0.481 | |LOGISTIC REGRESSION| P=0.406 (e) P=0.829 (e) (e) P=0.506 | |COCH-ARM / FISHERS | P=0.525 (e) P=0.241 P=0.500 (e) P=0.500 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 43 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | | MG/KG MG/KG | |=================================================================================================================================| | | |Thyroid Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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) | 0/14.15 0/15.00 0/12.73 0/14.33 0/13.93 1/14.02 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 7.1% | |TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 1/11 (9%) | |FIRST INCIDENCE | --- --- --- --- --- 192 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.082 (e) (e) (e) (e) P=0.452 | |POLY 3 | P=0.106 (e) (e) (e) (e) P=0.498 | |POLY 1.5 | P=0.107 (e) (e) (e) (e) P=0.501 | |POLY 6 | P=0.103 (e) (e) (e) (e) P=0.491 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.452 | |COCH-ARM / FISHERS | P=0.105 (e) (e) (e) (e) 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 | |=================================================================================================================================| | | |Thyroid Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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) | 0/15.00 0/14.85 0/12.32 0/14.27 0/14.59 2/13.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 14.4% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/14 (0%) 2/12 (17%) | |FIRST INCIDENCE | --- --- --- --- --- 193 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.008 ** (e) (e) (e) (e) P=0.188 | |POLY 3 | P=0.009 ** (e) (e) (e) (e) P=0.214 | |POLY 1.5 | P=0.009 ** (e) (e) (e) (e) P=0.221 | |POLY 6 | P=0.009 ** (e) (e) (e) (e) P=0.208 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.188 | |COCH-ARM / FISHERS | P=0.011 * (e) (e) (e) (e) P=0.241 | |=================================================================================================================================| Date: 07/12/02 EXPERIMENT: 88133 TEST: 06 Page 44 Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE (TMPTA) Terminal Sacrifice at 28 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) | 10/15 (67%) 11/15 (73%) 7/15 (47%) 8/15 (53%) 8/15 (53%) 9/15 (60%) | |POLY-3 RATE (b) | 10/15.00 11/14.85 7/12.32 8/14.27 8/14.59 9/13.99 | |POLY-3 PERCENT (g) | 66.7% 74.1% 56.8% 56.1% 54.8% 64.4% | |TERMINAL (d) | 10/15 (67%) 11/14 (79%) 7/12 (58%) 8/14 (57%) 8/14 (57%) 8/12 (67%) | |FIRST INCIDENCE | 193 (T) 193 (T) 193 (T) 193 (T) 193 (T) 189 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.493 P=0.384 P=0.483N P=0.443N P=0.443N P=0.489 | |POLY 3 | P=0.428N P=0.484 P=0.449N P=0.419N P=0.391N P=0.600N | |POLY 1.5 | P=0.411N P=0.492 P=0.394N P=0.397N P=0.376N P=0.563N | |POLY 6 | P=0.456N P=0.470 P=0.476N P=0.437N P=0.412N P=0.637N | |LOGISTIC REGRESSION| P=0.566 P=0.384 P=0.483N P=0.443N P=0.443N P=0.596 | |COCH-ARM / FISHERS | P=0.425N P=0.500 P=0.231N P=0.355N P=0.355N P=0.500N | |=================================================================================================================================| (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).