TDMS Study 88138-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus BENZOPHENONE DATE: 06/01/04 EXPERIMENT: 88138 TEST: 04 TIME: 13:43:41 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-55388 ROUTE: DOSED FEED NTP C#: 88138B PATHOLOGIST: MISSING CAS: 119-61-9 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#2 MICE REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus BENZOPHENONE DATE: 06/01/04 EXPERIMENT: 88138 TEST: 04 TIME: 13:43:41 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55388 ROUTE: DOSED FEED NTP C#: 88138B PATHOLOGIST: MISSING CAS: 119-61-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF BENZOPHENONE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Harderian Gland Infiltration Cellular Lymphoid Kidney Metaplasia Osseous Kidney: Cortex Cyst Liver Clear Cell Focus Infiltration Cellular Lymphoid Inflammation Chronic Liver: Hepatocyte Degeneration Cystic Multinucleated Necrosis Liver: Hepatocyte, Centrilobular Hypertrophy Lung Infiltration Cellular Lymphoid Lung: Alveolus Infiltration Cellular Histiocyte Nose: Olfactory Epithelium Metaplasia Preputial Gland Inflammation Chronic Preputial Gland: Duct Ectasia Prostate Infiltration Cellular Lymphoid Salivary Glands Infiltration Cellular Lymphoid Spleen: Lymphoid Follicle Hyperplasia Lymphoid Stomach, Glandular: Glands Ectasia Testes Mineralization Thymus Atrophy Ectopic Parathyroid Gland Thyroid Gland Inflammation Chronic =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex Hyperplasia Adrenal Cortex: Subcapsular Hyperplasia Bone Marrow Myelofibrosis Brain Hemorrhage Clitoral Gland Inflammation Chronic Eye Atrophy Islets, Pancreatic Hyperplasia Kidney Mineralization Nephropathy Liver Eosinophilic Focus Inflammation Chronic Liver: Hepatocyte Multinucleated Necrosis Vacuolization Cytoplasmic Liver: Hepatocyte, Centrilobular Hypertrophy Lung Infiltration Cellular Lymphoid Pigmentation Lymph Node, Mandibular Hyperplasia Lymphoid Mesentery: Fat Fibrosis Inflammation Chronic NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus BENZOPHENONE DATE: 06/01/04 EXPERIMENT: 88138 TEST: 04 TIME: 13:43:41 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55388 ROUTE: DOSED FEED NTP C#: 88138B PATHOLOGIST: MISSING CAS: 119-61-9 Necrosis Nose: Olfactory Epithelium Metaplasia Ovary Pigmentation Pancreas Infiltration Cellular Lymphoid Pituitary Gland: Pars Distalis Cyst Hyperplasia Skeletal Muscle Infiltration Cellular Lymphoid Spleen Hematopoietic Cell Proliferation Hemorrhage Spleen: Lymphoid Follicle Hyperplasia Lymphoid Thymus Atrophy Cyst Hyperplasia Lymphoid Thyroid Gland: Follicle Degeneration Urinary Bladder Infiltration Cellular Lymphoid =============================================================== Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Fatty | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 2/48.41 0/48.51 |0/46.52 0/46.76 0/46.69 0/42.51 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.1% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 2/44 (5%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 730 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.599 (e) P=0.238 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.604 (e) P=0.240 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.601 (e) P=0.239 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.606 (e) P=0.240 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.238 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.249 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 10/50 (20%) 9/50 (18%) 6/50 (12%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 7/47.92 10/47.72 9/48.41 6/48.51 |2/46.52 0/46.76 0/46.69 0/42.51 | |POLY-3 PERCENT (g) | 14.6% 21.0% 18.6% 12.4% |4.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 7/44 (16%) 9/44 (21%) 9/44 (21%) 6/45 (13%) |2/40 (5%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 730 (T) 585 730 (T) 730 (T) |729 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.328N P=0.298 P=0.392 P=0.483N |P=0.131N P=0.228N P=0.233N P=0.296N | |POLY 3 | P=0.334N P=0.294 P=0.401 P=0.490N |P=0.113N P=0.236N P=0.236N P=0.258N | |POLY 1.5 | P=0.339N P=0.295 P=0.399 P=0.493N |P=0.114N P=0.237N P=0.238N P=0.252N | |POLY 6 | P=0.332N P=0.293 P=0.402 P=0.489N |P=0.111N P=0.235N P=0.235N P=0.265N | |LOGISTIC REGRESSION| P=0.329N P=0.287 P=0.392 P=0.483N |P=0.131N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.348N P=0.298 P=0.393 P=0.500N |P=0.116N P=0.247N P=0.247N P=0.253N | |ORDER RESTRICTED | P=0.362N (e) (e) (e) |P=0.036N* (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 26/50 (52%) 22/50 (44%) 24/50 (48%) 18/50 (36%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 26/48.02 22/47.23 24/48.44 18/48.51 |1/46.52 1/46.76 0/46.69 0/42.51 | |POLY-3 PERCENT (g) | 54.1% 46.6% 49.6% 37.1% |2.2% 2.1% 0.0% 0.0% | |TERMINAL (d) | 25/44 (57%) 22/44 (50%) 23/44 (52%) 18/45 (40%) |1/40 (3%) 1/42 (2%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 703 730 (T) 722 730 (T) |729 (T) 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.061N P=0.267N P=0.418N P=0.061N |P=0.268N P=0.751N P=0.495N P=0.551N | |POLY 3 | P=0.065N P=0.296N P=0.402N P=0.067N |P=0.241N P=0.759N P=0.499N P=0.518N | |POLY 1.5 | P=0.071N P=0.287N P=0.407N P=0.071N |P=0.241N P=0.760N P=0.500N P=0.513N | |POLY 6 | P=0.061N P=0.308N P=0.403N P=0.065N |P=0.241N P=0.758N P=0.498N P=0.524N | |LOGISTIC REGRESSION| P=0.057N P=0.286N P=0.399N P=0.060N |P=0.268N P=0.751N (e) (e) | |COCH-ARM / FISHERS | P=0.082N P=0.274N P=0.421N P=0.079N |P=0.238N P=0.753N P=0.500N P=0.505N | |ORDER RESTRICTED | P=0.066N (e) (e) (e) |P=0.270N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex: Subcapsular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 50/50 (100%) 46/50 (92%) 46/50 (92%) 47/50 (94%) |49/50 (98%) 49/50 (98%) 49/50 (98%) 49/49 (100%) | |POLY-3 RATE (b) | 50/50.00 46/49.05 46/49.82 47/50.00 |49/49.18 49/49.08 49/49.85 49/49.00 | |POLY-3 PERCENT (g) | 100.0% 93.8% 92.3% 94.0% |99.6% 99.8% 98.3% 100.0% | |TERMINAL (d) | 44/44 (100%) 42/44 (96%) 41/44 (93%) 42/45 (93%) |40/40 (100%) 42/42 (100%) 41/41 (100%) 31/31 (100%) | |FIRST INCIDENCE | 463 449 585 568 |456 522 204 344 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.214N P=0.201N P=0.207N P=0.206N |P=0.007 ** P=0.400N P=0.496N P=0.035 * | |POLY 3 | P=0.158N P=0.092N P=0.064N P=0.119N |P=0.741 P=1.000 P=0.653N P=1.000 | |POLY 1.5 | P=0.181N P=0.074N P=0.062N P=0.119N |P=0.570 P=0.950 P=0.693N P=0.909 | |POLY 6 | P=0.134N P=0.135N P=0.069N P=0.119N |P=0.802N P=1.000 P=0.671N P=1.000 | |LOGISTIC REGRESSION| P=0.181N P=0.067N P=0.062N (e) |P=0.183 (e) P=0.708 P=0.252 | |COCH-ARM / FISHERS | P=0.216N P=0.059N P=0.059N P=0.121N |P=0.316 P=0.753N P=0.753N P=0.505 | |ORDER RESTRICTED | P=0.077N (e) (e) (e) |P=0.436 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) | |POLY-3 RATE (b) | 0/47.92 1/47.23 0/48.41 0/48.51 |0/46.52 0/46.76 2/46.69 0/42.51 | |POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 0.0% |0.0% 0.0% 4.3% 0.0% | |TERMINAL (d) | 0/44 (0%) 1/44 (2%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 2/41 (5%) 0/31 (0%) | |FIRST INCIDENCE | --- 730 (T) --- --- |--- --- 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.563N P=0.500 (e) (e) |P=0.544 (e) P=0.244 (e) | |POLY 3 | P=0.567N P=0.497 (e) (e) |P=0.549 (e) P=0.238 (e) | |POLY 1.5 | P=0.567N P=0.498 (e) (e) |P=0.566 (e) P=0.237 (e) | |POLY 6 | P=0.568N P=0.496 (e) (e) |P=0.527 (e) P=0.239 (e) | |LOGISTIC REGRESSION| (e) P=0.500 (e) (e) |(e) (e) P=0.244 (e) | |COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.591 (e) P=0.247 (e) | |ORDER RESTRICTED | P=0.376N (e) (e) (e) |P=0.249 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Myelofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |18/50 (36%) 30/50 (60%) 20/50 (40%) 26/50 (52%) | |POLY-3 RATE (b) | 0/46.92 0/47.23 0/48.41 0/48.51 |18/47.02 30/47.38 20/46.69 26/46.34 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |38.3% 63.3% 42.8% 56.1% | |TERMINAL (d) | 0/43 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |16/40 (40%) 28/42 (67%) 20/41 (49%) 18/31 (58%) | |FIRST INCIDENCE | --- --- --- --- |606 561 729 (T) 344 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.020 * P=0.022 * P=0.451 P=0.012 * | |POLY 3 | (e) (e) (e) (e) |P=0.171 P=0.011 * P=0.406 P=0.061 | |POLY 1.5 | (e) (e) (e) (e) |P=0.184 P=0.011 * P=0.406 P=0.067 | |POLY 6 | (e) (e) (e) (e) |P=0.153 P=0.010 * P=0.402 P=0.053 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.133 P=0.013 * P=0.435 P=0.062 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.208 P=0.014 * P=0.418 P=0.079 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.057 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |0/46.52 0/46.76 0/46.69 2/44.45 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.5% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 400 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.222 | |POLY 3 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.227 | |POLY 1.5 | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.231 | |POLY 6 | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.222 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.064 (e) (e) P=0.348 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.026 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Brain | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |0/46.52 1/46.76 2/46.69 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.1% 4.3% 0.0% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 1/42 (2%) 2/41 (5%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.635 P=0.510 P=0.244 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.643N P=0.501 P=0.238 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.633N P=0.500 P=0.237 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.631 P=0.502 P=0.239 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.510 P=0.244 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.616N P=0.500 P=0.247 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.327 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |8/50 (16%) 1/49 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | |8/46.94 1/46.68 0/46.69 2/43.72 | |POLY-3 PERCENT (g) | |17.1% 2.1% 0.0% 4.6% | |TERMINAL (d) | |7/40 (18%) 1/42 (2%) 0/41 (0%) 1/31 (3%) | |FIRST INCIDENCE | |608 729 (T) --- 645 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.042N* P=0.016N* P=0.005N** P=0.096N | |POLY 3 | |P=0.024N* P=0.016N* P=0.004N** P=0.058N | |POLY 1.5 | |P=0.024N* P=0.016N* P=0.004N** P=0.053N | |POLY 6 | |P=0.024N* P=0.016N* P=0.004N** P=0.064N | |LOGISTIC REGRESSION| |P=0.027N* P=0.018N* P=0.005N** P=0.054N | |COCH-ARM / FISHERS | |P=0.026N* P=0.017N* P=0.003N** P=0.046N* | |ORDER RESTRICTED | |P<0.001N** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Granuloma Sperm | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | | |POLY-3 RATE (b) | 1/47.92 2/47.62 2/48.41 1/48.51 | | |POLY-3 PERCENT (g) | 2.1% 4.2% 4.1% 2.1% | | |TERMINAL (d) | 1/44 (2%) 1/44 (2%) 2/44 (5%) 1/45 (2%) | | |FIRST INCIDENCE | 730 (T) 620 730 (T) 730 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.547N P=0.495 P=0.500 P=0.757N | | |POLY 3 | P=0.549N P=0.498 P=0.504 P=0.758N | | |POLY 1.5 | P=0.551N P=0.499 P=0.503 P=0.758N | | |POLY 6 | P=0.548N P=0.498 P=0.504 P=0.757N | | |LOGISTIC REGRESSION| P=0.566N P=0.512 P=0.500 P=0.757N | | |COCH-ARM / FISHERS | P=0.556N P=0.500 P=0.500 P=0.753N | | |ORDER RESTRICTED | P=0.542N (e) (e) (e) | | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 32/50 (64%) 27/50 (54%) 30/50 (60%) 31/50 (62%) | | |POLY-3 RATE (b) | 32/49.14 27/49.48 30/48.82 31/49.47 | | |POLY-3 PERCENT (g) | 65.1% 54.6% 61.5% 62.7% | | |TERMINAL (d) | 29/44 (66%) 23/44 (52%) 27/44 (61%) 27/45 (60%) | | |FIRST INCIDENCE | 463 449 679 606 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.517N P=0.231N P=0.422N P=0.449N | | |POLY 3 | P=0.509 P=0.194N P=0.434N P=0.482N | | |POLY 1.5 | P=0.504 P=0.199N P=0.427N P=0.490N | | |POLY 6 | P=0.517 P=0.188N P=0.444N P=0.470N | | |LOGISTIC REGRESSION| P=0.496 P=0.196N P=0.399N P=0.498N | | |COCH-ARM / FISHERS | P=0.500 P=0.208N P=0.418N P=0.500N | | |ORDER RESTRICTED | P=0.451N (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 4/50 (8%) 0/50 (0%) | | |POLY-3 RATE (b) | 0/47.92 0/47.23 4/48.41 0/48.51 | | |POLY-3 PERCENT (g) | 0.0% 0.0% 8.3% 0.0% | | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 4/44 (9%) 0/45 (0%) | | |FIRST INCIDENCE | --- --- 730 (T) --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.507 (e) P=0.063 (e) | | |POLY 3 | P=0.512 (e) P=0.062 (e) | | |POLY 1.5 | P=0.508 (e) P=0.062 (e) | | |POLY 6 | P=0.515 (e) P=0.062 (e) | | |LOGISTIC REGRESSION| (e) (e) P=0.063 (e) | | |COCH-ARM / FISHERS | P=0.500 (e) P=0.059 (e) | | |ORDER RESTRICTED | P=0.111 (e) (e) (e) | | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Eye | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |2/46.52 0/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |1/40 (3%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |728 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.133N P=0.232N P=0.237N P=0.300N | |POLY 3 | (e) (e) (e) (e) |P=0.111N P=0.236N P=0.236N P=0.253N | |POLY 1.5 | (e) (e) (e) (e) |P=0.112N P=0.237N P=0.238N P=0.247N | |POLY 6 | (e) (e) (e) (e) |P=0.110N P=0.235N P=0.235N P=0.261N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.129N P=0.234N P=0.236N P=0.291N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.247N P=0.247N P=0.247N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.035N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Eye: Cornea | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 1/47.66 2/48.93 1/48.51 |0/46.52 0/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 2.1% 4.1% 2.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 1/45 (2%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- 606 585 730 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.375 P=0.496 P=0.247 P=0.504 |(e) (e) (e) (e) | |POLY 3 | P=0.373 P=0.499 P=0.242 P=0.502 |(e) (e) (e) (e) | |POLY 1.5 | P=0.371 P=0.499 P=0.240 P=0.502 |(e) (e) (e) (e) | |POLY 6 | P=0.375 P=0.499 P=0.243 P=0.503 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.264 P=0.527 P=0.151 P=0.504 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.366 P=0.500 P=0.247 P=0.500 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.230 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 8 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 3/50 (6%) 3/50 (6%) 1/49 (2%) | |POLY-3 RATE (b) | 2/47.92 3/47.23 3/48.41 2/48.51 |0/46.52 3/46.95 3/46.69 1/42.75 | |POLY-3 PERCENT (g) | 4.2% 6.4% 6.2% 4.1% |0.0% 6.4% 6.4% 2.3% | |TERMINAL (d) | 2/44 (5%) 3/44 (7%) 3/44 (7%) 2/45 (4%) |0/40 (0%) 2/42 (5%) 3/41 (7%) 1/31 (3%) | |FIRST INCIDENCE | 730 (T) 730 (T) 730 (T) 730 (T) |--- 680 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.532N P=0.500 P=0.500 P=0.686N |P=0.426 P=0.130 P=0.126 P=0.449 | |POLY 3 | P=0.535N P=0.493 P=0.505 P=0.689N |P=0.474 P=0.120 P=0.119 P=0.483 | |POLY 1.5 | P=0.537N P=0.496 P=0.503 P=0.690N |P=0.490 P=0.120 P=0.119 P=0.488 | |POLY 6 | P=0.533N P=0.491 P=0.505 P=0.688N |P=0.454 P=0.122 P=0.120 P=0.477 | |LOGISTIC REGRESSION| P=0.532N P=0.500 P=0.500 P=0.686N |P=0.481 P=0.121 P=0.126 P=0.449 | |COCH-ARM / FISHERS | P=0.544N P=0.500 P=0.500 P=0.691N |P=0.518 P=0.121 P=0.121 P=0.495 | |ORDER RESTRICTED | P=0.586N (e) (e) (e) |P=0.165 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 37/50 (74%) 33/50 (66%) 24/50 (48%) 29/50 (58%) |29/50 (58%) 27/50 (54%) 27/50 (54%) 23/49 (47%) | |POLY-3 RATE (b) | 37/49.41 33/50.00 24/48.44 29/49.22 |29/46.68 27/48.47 27/47.52 23/43.99 | |POLY-3 PERCENT (g) | 74.9% 66.0% 49.6% 58.9% |62.1% 55.7% 56.8% 52.3% | |TERMINAL (d) | 32/44 (73%) 27/44 (61%) 23/44 (52%) 27/45 (60%) |27/40 (68%) 23/42 (55%) 25/41 (61%) 18/31 (58%) | |FIRST INCIDENCE | 463 449 722 606 |708 522 478 536 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.045N* P=0.301N P=0.010N* P=0.070N |P=0.484 P=0.332N P=0.368N P=0.562 | |POLY 3 | P=0.047N* P=0.227N P=0.007N** P=0.068N |P=0.226N P=0.333N P=0.375N P=0.227N | |POLY 1.5 | P=0.045N* P=0.238N P=0.006N** P=0.068N |P=0.202N P=0.371N P=0.400N P=0.212N | |POLY 6 | P=0.052N P=0.215N P=0.009N** P=0.071N |P=0.255N P=0.291N P=0.351N P=0.245N | |LOGISTIC REGRESSION| P=0.046N* P=0.238N P=0.006N** P=0.067N |P=0.251N P=0.408N P=0.394N P=0.317N | |COCH-ARM / FISHERS | P=0.045N* P=0.257N P=0.007N** P=0.069N |P=0.160N P=0.420N P=0.420N P=0.184N | |ORDER RESTRICTED | P=0.021N* (e) (e) (e) |P=0.276N (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 9 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Heart | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 3/50 (6%) 3/50 (6%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 3/48.66 5/47.72 3/49.11 3/48.51 |2/46.94 1/46.76 1/47.40 0/43.42 | |POLY-3 PERCENT (g) | 6.2% 10.5% 6.1% 6.2% |4.3% 2.1% 2.1% 0.0% | |TERMINAL (d) | 2/44 (5%) 4/44 (9%) 1/44 (2%) 3/45 (7%) |1/40 (3%) 1/42 (2%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 463 585 589 730 (T) |606 729 (T) 478 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.451N P=0.358 P=0.656N P=0.653N |P=0.176N P=0.494N P=0.497N P=0.275N | |POLY 3 | P=0.461N P=0.346 P=0.658N P=0.660 |P=0.163N P=0.501N P=0.497N P=0.255N | |POLY 1.5 | P=0.462N P=0.350 P=0.659N P=0.661 |P=0.160N P=0.501N P=0.499N P=0.248N | |POLY 6 | P=0.462N P=0.344 P=0.655N P=0.660 |P=0.168N P=0.502N P=0.495N P=0.264N | |LOGISTIC REGRESSION| P=0.553N P=0.384 P=0.547 P=0.602 |P=0.121N P=0.499N P=0.440N P=0.213N | |COCH-ARM / FISHERS | P=0.463N P=0.357 P=0.661N P=0.661N |P=0.153N P=0.500N P=0.500N P=0.247N | |ORDER RESTRICTED | P=0.536N (e) (e) (e) |P=0.133N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Intestine Small, Jejunum: Peyer's Patch | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 3/50 (6%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 1/48.41 0/48.51 |0/46.52 3/46.76 0/46.69 1/43.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 0.0% |0.0% 6.4% 0.0% 2.3% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 1/44 (2%) 0/45 (0%) |0/40 (0%) 3/42 (7%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 730 (T) --- |--- 729 (T) --- 645 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.696 (e) P=0.500 (e) |P=0.578 P=0.130 (e) P=0.491 | |POLY 3 | P=0.700 (e) P=0.502 (e) |P=0.613 P=0.120 (e) P=0.488 | |POLY 1.5 | P=0.698 (e) P=0.501 (e) |P=0.621 P=0.119 (e) P=0.492 | |POLY 6 | P=0.702 (e) P=0.502 (e) |P=0.604 P=0.120 (e) P=0.482 | |LOGISTIC REGRESSION| (e) (e) P=0.500 (e) |P=0.627 P=0.130 (e) P=0.534 | |COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.633N P=0.121 (e) P=0.500 | |ORDER RESTRICTED | P=0.383 (e) (e) (e) |P=0.274 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 10 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/47.92 1/47.23 0/48.41 0/48.51 |3/46.93 1/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 2.1% 2.1% 0.0% 0.0% |6.4% 2.1% 0.0% 0.0% | |TERMINAL (d) | 1/44 (2%) 1/44 (2%) 0/44 (0%) 0/45 (0%) |2/40 (5%) 1/42 (2%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 730 (T) 730 (T) --- --- |610 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.233N P=0.762 P=0.500N P=0.496N |P=0.053N P=0.294N P=0.119N P=0.157N | |POLY 3 | P=0.235N P=0.757 P=0.498N P=0.498N |P=0.044N* P=0.307N P=0.120N P=0.133N | |POLY 1.5 | P=0.236N P=0.758 P=0.499N P=0.498N |P=0.044N* P=0.307N P=0.120N P=0.128N | |POLY 6 | P=0.235N P=0.756 P=0.498N P=0.497N |P=0.044N* P=0.307N P=0.120N P=0.141N | |LOGISTIC REGRESSION| P=0.233N P=0.762 (e) (e) |P=0.043N* P=0.305N P=0.118N P=0.114N | |COCH-ARM / FISHERS | P=0.235N P=0.753N P=0.500N P=0.500N |P=0.044N* P=0.309N P=0.121N P=0.121N | |ORDER RESTRICTED | P=0.246N (e) (e) (e) |P=0.026N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Hydronephrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |2/46.60 0/46.76 0/46.69 1/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.3% 0.0% 0.0% 2.3% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |1/40 (3%) 0/42 (0%) 0/41 (0%) 1/31 (3%) | |FIRST INCIDENCE | --- --- --- --- |709 --- --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.523N P=0.234N P=0.240N P=0.582N | |POLY 3 | (e) (e) (e) (e) |P=0.458N P=0.236N P=0.237N P=0.525N | |POLY 1.5 | (e) (e) (e) (e) |P=0.460N P=0.237N P=0.238N P=0.515N | |POLY 6 | (e) (e) (e) (e) |P=0.456N P=0.236N P=0.236N P=0.537N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.488N P=0.236N P=0.237N P=0.542N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.461N P=0.247N P=0.247N P=0.500N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.145N (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 11 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 4/50 (8%) |4/50 (8%) 1/50 (2%) 3/50 (6%) 3/50 (6%) | |POLY-3 RATE (b) | 1/48.02 1/47.23 1/48.41 4/48.51 |4/46.52 1/46.76 3/46.69 3/43.72 | |POLY-3 PERCENT (g) | 2.1% 2.1% 2.1% 8.3% |8.6% 2.1% 6.4% 6.9% | |TERMINAL (d) | 0/44 (0%) 1/44 (2%) 1/44 (2%) 4/45 (9%) |4/40 (10%) 1/42 (2%) 3/41 (7%) 2/31 (7%) | |FIRST INCIDENCE | 703 730 (T) 730 (T) 730 (T) |729 (T) 729 (T) 729 (T) 645 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.072 P=0.758 P=0.760 P=0.188 |P=0.485 P=0.165N P=0.486N P=0.621N | |POLY 3 | P=0.069 P=0.757 P=0.759N P=0.182 |P=0.572 P=0.177N P=0.498N P=0.534N | |POLY 1.5 | P=0.069 P=0.758 P=0.759N P=0.182 |P=0.578N P=0.179N P=0.501N P=0.521N | |POLY 6 | P=0.070 P=0.755 P=0.759N P=0.182 |P=0.559 P=0.176N P=0.495N P=0.549N | |LOGISTIC REGRESSION| P=0.071 P=0.762 P=0.761 P=0.183 |P=0.556 P=0.165N P=0.486N P=0.546N | |COCH-ARM / FISHERS | P=0.067 P=0.753N P=0.753N P=0.181 |P=0.563N P=0.181N P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.079 (e) (e) (e) |P=0.390N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 44/50 (88%) 44/50 (88%) 45/50 (90%) 45/50 (90%) |41/50 (82%) 45/50 (90%) 43/50 (86%) 39/50 (78%) | |POLY-3 RATE (b) | 44/49.81 44/50.00 45/49.82 45/49.22 |41/47.85 45/48.79 43/49.50 39/47.39 | |POLY-3 PERCENT (g) | 88.4% 88.0% 90.3% 91.4% |85.7% 92.2% 86.9% 82.3% | |TERMINAL (d) | 39/44 (89%) 38/44 (86%) 40/44 (91%) 43/45 (96%) |37/40 (93%) 40/42 (95%) 37/41 (90%) 27/31 (87%) | |FIRST INCIDENCE | 463 449 585 606 |456 522 204 344 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.535 P=0.580 P=0.505 P=0.603 |P=0.072 P=0.382 P=0.492 P=0.102 | |POLY 3 | P=0.328 P=0.601N P=0.502 P=0.429 |P=0.232N P=0.230 P=0.551 P=0.429N | |POLY 1.5 | P=0.363 P=0.610N P=0.501 P=0.460 |P=0.225N P=0.200 P=0.488 P=0.421N | |POLY 6 | P=0.282 P=0.585N P=0.503 P=0.386 |P=0.242N P=0.283 P=0.619 P=0.435N | |LOGISTIC REGRESSION| P=0.417 P=0.607N P=0.496 P=0.536 |P=0.315N P=0.182 P=0.375 P=0.549N | |COCH-ARM / FISHERS | P=0.409 P=0.620N P=0.500 P=0.500 |P=0.217N P=0.194 P=0.393 P=0.402N | |ORDER RESTRICTED | P=0.468 (e) (e) (e) |P=0.252N (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 12 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 1/47.23 2/48.63 0/48.51 |1/46.94 0/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 2.1% 4.1% 0.0% |2.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/44 (0%) 1/44 (2%) 1/44 (2%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- 730 (T) 671 --- |608 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.610N P=0.500 P=0.242 (e) |P=0.312N P=0.504N P=0.500N P=0.513N | |POLY 3 | P=0.610N P=0.497 P=0.241 (e) |P=0.297N P=0.501N P=0.501N P=0.516N | |POLY 1.5 | P=0.612N P=0.498 P=0.240 (e) |P=0.301N P=0.501N P=0.501N P=0.509N | |POLY 6 | P=0.609N P=0.496 P=0.242 (e) |P=0.292N P=0.501N P=0.501N P=0.523N | |LOGISTIC REGRESSION| P=0.625N P=0.500 P=0.218 (e) |P=0.273N P=0.479N P=0.463N P=0.441N | |COCH-ARM / FISHERS | P=0.616N P=0.500 P=0.247 (e) |P=0.306N P=0.500N P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.323N (e) (e) (e) |P=0.135N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Metaplasia Osseous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 1/50 (2%) 8/50 (16%) |1/50 (2%) 2/50 (4%) 4/50 (8%) 2/50 (4%) | |POLY-3 RATE (b) | 4/47.92 2/47.23 1/48.88 8/48.51 |1/46.52 2/46.76 4/46.69 2/43.65 | |POLY-3 PERCENT (g) | 8.4% 4.2% 2.1% 16.5% |2.2% 4.3% 8.6% 4.6% | |TERMINAL (d) | 4/44 (9%) 2/44 (5%) 0/44 (0%) 8/45 (18%) |1/40 (3%) 2/42 (5%) 4/41 (10%) 0/31 (0%) | |FIRST INCIDENCE | 730 (T) 730 (T) 589 730 (T) |729 (T) 729 (T) 729 (T) 675 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.061 P=0.337N P=0.181N P=0.188 |P=0.279 P=0.517 P=0.187 P=0.428 | |POLY 3 | P=0.057 P=0.344N P=0.173N P=0.184 |P=0.345 P=0.502 P=0.180 P=0.478 | |POLY 1.5 | P=0.056 P=0.342N P=0.175N P=0.182 |P=0.361 P=0.501 P=0.179 P=0.486 | |POLY 6 | P=0.057 P=0.347N P=0.171N P=0.185 |P=0.327 P=0.503 P=0.182 P=0.468 | |LOGISTIC REGRESSION| P=0.058 P=0.337N P=0.196N P=0.188 |P=0.337 P=0.517 P=0.187 P=0.483 | |COCH-ARM / FISHERS | P=0.056 P=0.339N P=0.181N P=0.178 |P=0.387 P=0.500 P=0.181 P=0.500 | |ORDER RESTRICTED | P=0.021 * (e) (e) (e) |P=0.261 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 13 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 49/50 (98%) 50/50 (100%) 50/50 (100%) 50/50 (100%)|15/50 (30%) 31/50 (62%) 36/50 (72%) 49/50 (98%) | |POLY-3 RATE (b) | 49/50.00 50/50.00 50/50.00 50/50.00 |15/47.35 31/47.99 36/47.81 49/49.17 | |POLY-3 PERCENT (g) | 98.0% 100.0% 100.0% 100.0% |31.7% 64.6% 75.3% 99.7% | |TERMINAL (d) | 43/44 (98%) 44/44 (100%) 44/44 (100%) 45/45 (100%)|13/40 (33%) 26/42 (62%) 31/41 (76%) 31/31 (100%) | |FIRST INCIDENCE | 463 449 585 568 |606 561 555 344 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.510N P=0.488 P=0.506 P=0.604N |P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** | |POLY 3 | P=0.306 P=0.500 P=0.500 P=0.500 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P=0.306 P=0.500 P=0.500 P=0.500 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P=0.306 P=0.500 P=0.500 P=0.500 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P=0.306 P=0.500 P=0.500 P=0.500 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P=0.121 (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 49/50 (98%) 48/50 (96%) 50/50 (100%) 50/50 (100%)|21/50 (42%) 33/50 (66%) 31/50 (62%) 30/50 (60%) | |POLY-3 RATE (b) | 49/49.41 48/49.05 50/50.00 50/50.00 |21/47.02 33/47.18 31/48.48 30/45.22 | |POLY-3 PERCENT (g) | 99.2% 97.9% 100.0% 100.0% |44.7% 70.0% 63.9% 66.3% | |TERMINAL (d) | 44/44 (100%) 44/44 (100%) 44/44 (100%) 45/45 (100%)|19/40 (48%) 31/42 (74%) 28/41 (68%) 23/31 (74%) | |FIRST INCIDENCE | 463 449 585 568 |606 641 204 344 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.517 P=0.513N P=0.505 P=0.614N |P=0.003 ** P=0.022 * P=0.046 * P=0.003 ** | |POLY 3 | P=0.346 P=0.658N P=0.927 P=0.927 |P=0.055 P=0.009 ** P=0.042 * P=0.026 * | |POLY 1.5 | P=0.249 P=0.562N P=0.714 P=0.714 |P=0.073 P=0.010 * P=0.040 * P=0.034 * | |POLY 6 | P=0.667 P=0.903N P=1.000 P=1.000 |P=0.038 * P=0.009 ** P=0.043 * P=0.017 * | |LOGISTIC REGRESSION| P=0.371 P=0.562N P=0.814 P=0.801 |P=0.056 P=0.012 * P=0.035 * P=0.023 * | |COCH-ARM / FISHERS | P=0.188 P=0.500N P=0.500 P=0.500 |P=0.109 P=0.013 * P=0.036 * P=0.055 | |ORDER RESTRICTED | P=0.173 (e) (e) (e) |P=0.017 * (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 14 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Kidney: Cortex | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 8/50 (16%) 12/50 (24%) 22/50 (44%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 4/47.92 8/47.23 12/48.88 22/48.51 |0/46.52 1/47.68 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 8.4% 16.9% 24.6% 45.4% |0.0% 2.1% 0.0% 0.0% | |TERMINAL (d) | 4/44 (9%) 8/44 (18%) 11/44 (25%) 22/45 (49%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 730 (T) 730 (T) 589 730 (T) |--- 316 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.177 P=0.029 * P<0.001 ** |P=0.567N P=0.500 (e) (e) | |POLY 3 | P<0.001 ** P=0.170 P=0.029 * P<0.001 ** |P=0.566N P=0.505 (e) (e) | |POLY 1.5 | P<0.001 ** P=0.174 P=0.028 * P<0.001 ** |P=0.567N P=0.503 (e) (e) | |POLY 6 | P<0.001 ** P=0.167 P=0.029 * P<0.001 ** |P=0.565N P=0.506 (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** P=0.177 P=0.029 * P<0.001 ** |P=0.464N (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.178 P=0.027 * P<0.001 ** |P=0.567N P=0.500 (e) (e) | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.397N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 4/50 (8%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |2/46.52 0/46.76 1/46.69 4/43.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.3% 0.0% 2.1% 9.1% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |2/40 (5%) 0/42 (0%) 1/41 (2%) 1/31 (3%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) --- 729 (T) 606 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.067 P=0.228N P=0.491N P=0.248 | |POLY 3 | (e) (e) (e) (e) |P=0.099 P=0.236N P=0.499N P=0.311 | |POLY 1.5 | (e) (e) (e) (e) |P=0.102 P=0.237N P=0.501N P=0.321 | |POLY 6 | (e) (e) (e) (e) |P=0.096 P=0.235N P=0.497N P=0.300 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.101 (e) P=0.491N P=0.321 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.108 P=0.247N P=0.500N P=0.339 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.062 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 15 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 5/50 (10%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 4/48.07 2/47.23 5/48.59 0/48.51 |3/46.93 0/46.76 1/46.69 2/43.71 | |POLY-3 PERCENT (g) | 8.3% 4.2% 10.3% 0.0% |6.4% 0.0% 2.1% 4.6% | |TERMINAL (d) | 3/44 (7%) 2/44 (5%) 4/44 (9%) 0/45 (0%) |2/40 (5%) 0/42 (0%) 1/41 (2%) 0/31 (0%) | |FIRST INCIDENCE | 690 730 (T) 683 --- |610 --- 729 (T) 677 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.093N P=0.340N P=0.498 P=0.062N |P=0.598 P=0.117N P=0.298N P=0.580N | |POLY 3 | P=0.089N P=0.346N P=0.507 P=0.059N |P=0.565N P=0.119N P=0.307N P=0.532N | |POLY 1.5 | P=0.091N P=0.342N P=0.505 P=0.060N |P=0.562N P=0.120N P=0.308N P=0.520N | |POLY 6 | P=0.088N P=0.350N P=0.507 P=0.059N |P=0.569N P=0.120N P=0.307N P=0.547N | |LOGISTIC REGRESSION| P=0.092N P=0.344N P=0.502 P=0.062N |P=0.551N P=0.120N P=0.304N P=0.491N | |COCH-ARM / FISHERS | P=0.095N P=0.339N P=0.500 P=0.059N |P=0.556N P=0.121N P=0.309N P=0.500N | |ORDER RESTRICTED | P=0.054N (e) (e) (e) |P=0.207N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 7/50 (14%) 7/50 (14%) 12/50 (24%) |3/50 (6%) 2/50 (4%) 4/50 (8%) 4/50 (8%) | |POLY-3 RATE (b) | 2/47.92 7/47.23 7/48.41 12/48.51 |3/46.52 2/46.76 4/46.69 4/43.84 | |POLY-3 PERCENT (g) | 4.2% 14.8% 14.5% 24.7% |6.5% 4.3% 8.6% 9.1% | |TERMINAL (d) | 2/44 (5%) 7/44 (16%) 7/44 (16%) 12/45 (27%) |3/40 (8%) 2/42 (5%) 4/41 (10%) 3/31 (10%) | |FIRST INCIDENCE | 730 (T) 730 (T) 730 (T) 730 (T) |729 (T) 729 (T) 729 (T) 606 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.005 ** P=0.081 P=0.081 P=0.005 ** |P=0.210 P=0.478N P=0.514 P=0.378 | |POLY 3 | P=0.004 ** P=0.076 P=0.082 P=0.004 ** |P=0.299 P=0.498N P=0.502 P=0.468 | |POLY 1.5 | P=0.004 ** P=0.077 P=0.081 P=0.004 ** |P=0.311 P=0.499N P=0.499 P=0.480 | |POLY 6 | P=0.004 ** P=0.074 P=0.082 P=0.004 ** |P=0.284 P=0.496N P=0.505 P=0.453 | |LOGISTIC REGRESSION| P=0.005 ** P=0.081 P=0.081 P=0.005 ** |P=0.286 P=0.478N P=0.514 P=0.468 | |COCH-ARM / FISHERS | P=0.004 ** P=0.080 P=0.080 P=0.004 ** |P=0.331 P=0.500N P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.002 ** (e) (e) (e) |P=0.391 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 16 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 8/50 (16%) 11/50 (22%) 10/50 (20%) |2/50 (4%) 2/50 (4%) 7/50 (14%) 7/50 (14%) | |POLY-3 RATE (b) | 5/48.20 8/47.23 11/48.41 10/48.51 |2/46.52 2/46.76 7/46.69 7/43.49 | |POLY-3 PERCENT (g) | 10.4% 16.9% 22.7% 20.6% |4.3% 4.3% 15.0% 16.1% | |TERMINAL (d) | 4/44 (9%) 8/44 (18%) 11/44 (25%) 10/45 (22%) |2/40 (5%) 2/42 (5%) 7/41 (17%) 6/31 (19%) | |FIRST INCIDENCE | 652 730 (T) 730 (T) 730 (T) |729 (T) 729 (T) 729 (T) 711 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.124 P=0.274 P=0.087 P=0.143 |P=0.007 ** P=0.677N P=0.086 P=0.037 * | |POLY 3 | P=0.119 P=0.263 P=0.086 P=0.133 |P=0.018 * P=0.692N P=0.080 P=0.063 | |POLY 1.5 | P=0.118 P=0.269 P=0.086 P=0.133 |P=0.021 * P=0.693N P=0.079 P=0.069 | |POLY 6 | P=0.119 P=0.256 P=0.084 P=0.132 |P=0.016 * P=0.690N P=0.081 P=0.057 | |LOGISTIC REGRESSION| P=0.124 P=0.265 P=0.089 P=0.137 |P=0.009 ** P=0.677N P=0.086 P=0.042 * | |COCH-ARM / FISHERS | P=0.113 P=0.277 P=0.086 P=0.131 |P=0.027 * P=0.691N P=0.080 P=0.080 | |ORDER RESTRICTED | P=0.109 (e) (e) (e) |P=0.042 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |18/50 (36%) 11/50 (22%) 20/50 (40%) 19/50 (38%) | |POLY-3 RATE (b) | 2/48.66 1/47.23 0/48.41 0/48.51 |18/47.60 11/46.76 20/47.77 19/45.99 | |POLY-3 PERCENT (g) | 4.1% 2.1% 0.0% 0.0% |37.8% 23.5% 41.9% 41.3% | |TERMINAL (d) | 1/44 (2%) 1/44 (2%) 0/44 (0%) 0/45 (0%) |13/40 (33%) 11/42 (26%) 16/41 (39%) 11/31 (36%) | |FIRST INCIDENCE | 463 730 (T) --- --- |606 729 (T) 555 344 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.101N P=0.502N P=0.240N P=0.237N |P=0.067 P=0.082N P=0.448 P=0.236 | |POLY 3 | P=0.100N P=0.510N P=0.239N P=0.238N |P=0.203 P=0.099N P=0.423 P=0.447 | |POLY 1.5 | P=0.100N P=0.507N P=0.238N P=0.238N |P=0.217 P=0.096N P=0.416 P=0.469 | |POLY 6 | P=0.099N P=0.514N P=0.239N P=0.238N |P=0.186 P=0.105N P=0.429 P=0.415 | |LOGISTIC REGRESSION| P=0.138N P=0.465N P=0.388N P=0.383N |P=0.210 P=0.089N P=0.416 P=0.492 | |COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |P=0.240 P=0.093N P=0.418 P=0.500 | |ORDER RESTRICTED | P=0.075N (e) (e) (e) |P=0.213 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 17 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/47.92 2/47.23 0/48.41 1/48.51 |0/46.52 0/46.76 0/46.69 1/43.70 | |POLY-3 PERCENT (g) | 0.0% 4.2% 0.0% 2.1% |0.0% 0.0% 0.0% 2.3% | |TERMINAL (d) | 0/44 (0%) 2/44 (5%) 0/44 (0%) 1/45 (2%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- 730 (T) --- 730 (T) |--- --- --- 651 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.545 P=0.238 (e) P=0.504 |P=0.187 (e) (e) P=0.486 | |POLY 3 | P=0.543 P=0.234 (e) P=0.502 |P=0.190 (e) (e) P=0.488 | |POLY 1.5 | P=0.542 P=0.235 (e) P=0.502 |P=0.194 (e) (e) P=0.492 | |POLY 6 | P=0.544 P=0.233 (e) P=0.503 |P=0.187 (e) (e) P=0.482 | |LOGISTIC REGRESSION| (e) P=0.238 (e) P=0.504 |P=0.214 (e) (e) P=0.530 | |COCH-ARM / FISHERS | P=0.539 P=0.247 (e) P=0.500 |P=0.198 (e) (e) P=0.500 | |ORDER RESTRICTED | P=0.324 (e) (e) (e) |P=0.109 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 10/50 (20%) 0/50 (0%) 4/50 (8%) |36/50 (72%) 38/50 (76%) 35/50 (70%) 35/50 (70%) | |POLY-3 RATE (b) | 6/47.92 10/47.72 0/48.41 4/48.51 |36/46.68 38/47.16 35/48.18 35/47.13 | |POLY-3 PERCENT (g) | 12.5% 21.0% 0.0% 8.3% |77.1% 80.6% 72.7% 74.3% | |TERMINAL (d) | 6/44 (14%) 9/44 (21%) 0/44 (0%) 4/45 (9%) |34/40 (85%) 36/42 (86%) 31/41 (76%) 24/31 (77%) | |FIRST INCIDENCE | 730 (T) 585 --- 730 (T) |708 641 478 400 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.095N P=0.208 P=0.018N* P=0.355N |P=0.070 P=0.575 P=0.430N P=0.103 | |POLY 3 | P=0.092N P=0.203 P=0.015N* P=0.362N |P=0.326N P=0.435 P=0.393N P=0.466N | |POLY 1.5 | P=0.094N P=0.205 P=0.015N* P=0.365N |P=0.349N P=0.417 P=0.448N P=0.485N | |POLY 6 | P=0.091N P=0.203 P=0.015N* P=0.361N |P=0.303N P=0.462 P=0.333N P=0.446N | |LOGISTIC REGRESSION| P=0.096N P=0.199 (e) P=0.355N |P=0.520 P=0.448 P=0.476N P=0.516 | |COCH-ARM / FISHERS | P=0.101N P=0.207 P=0.013N* P=0.370N |P=0.375N P=0.410 P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.025N* (e) (e) (e) |P=0.418N (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 18 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 33/50 (66%) 47/50 (94%) 44/50 (88%) 42/50 (84%) |44/50 (88%) 40/50 (80%) 41/50 (82%) 36/50 (72%) | |POLY-3 RATE (b) | 33/48.97 47/50.00 44/49.78 42/49.18 |44/48.02 40/47.70 41/49.80 36/46.70 | |POLY-3 PERCENT (g) | 67.4% 94.0% 88.4% 85.4% |91.6% 83.9% 82.3% 77.1% | |TERMINAL (d) | 29/44 (66%) 41/44 (93%) 39/44 (89%) 40/45 (89%) |38/40 (95%) 37/42 (88%) 34/41 (83%) 28/31 (90%) | |FIRST INCIDENCE | 540 449 585 568 |606 561 204 400 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.162 P=0.004 ** P=0.022 * P=0.062 |P=0.343 P=0.110N P=0.264N P=0.490 | |POLY 3 | P=0.059 P<0.001 ** P=0.009 ** P=0.028 * |P=0.038N* P=0.186N P=0.138N P=0.036N* | |POLY 1.5 | P=0.064 P<0.001 ** P=0.009 ** P=0.029 * |P=0.035N* P=0.191N P=0.182N P=0.034N* | |POLY 6 | P=0.049 * P<0.001 ** P=0.010 * P=0.024 * |P=0.049N* P=0.193N P=0.108N P=0.047N* | |LOGISTIC REGRESSION| P=0.080 P<0.001 ** P=0.010 * P=0.038 * |P=0.072N P=0.157N P=0.299N P=0.080N | |COCH-ARM / FISHERS | P=0.072 P<0.001 ** P=0.008 ** P=0.032 * |P=0.038N* P=0.207N P=0.288N P=0.039N* | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.032N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 9/50 (18%) 15/50 (30%) 13/50 (26%) |2/50 (4%) 5/50 (10%) 3/50 (6%) 2/50 (4%) | |POLY-3 RATE (b) | 8/48.20 9/47.72 15/48.41 13/48.79 |2/46.52 5/46.76 3/46.69 2/43.42 | |POLY-3 PERCENT (g) | 16.6% 18.9% 31.0% 26.7% |4.3% 10.7% 6.4% 4.6% | |TERMINAL (d) | 7/44 (16%) 8/44 (18%) 15/44 (34%) 12/45 (27%) |2/40 (5%) 5/42 (12%) 3/41 (7%) 2/31 (7%) | |FIRST INCIDENCE | 652 585 730 (T) 656 |729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.113 P=0.497 P=0.077 P=0.181 |P=0.557N P=0.236 P=0.511 P=0.600 | |POLY 3 | P=0.107 P=0.491 P=0.076 P=0.170 |P=0.459N P=0.218 P=0.502 P=0.669 | |POLY 1.5 | P=0.104 P=0.495 P=0.077 P=0.168 |P=0.445N P=0.217 P=0.499 P=0.678 | |POLY 6 | P=0.108 P=0.487 P=0.074 P=0.171 |P=0.477N P=0.220 P=0.504 P=0.657 | |LOGISTIC REGRESSION| P=0.108 P=0.497 P=0.080 P=0.169 |P=0.557N P=0.236 P=0.511 P=0.600 | |COCH-ARM / FISHERS | P=0.099 P=0.500 P=0.077 P=0.163 |P=0.420N P=0.218 P=0.500 P=0.691N | |ORDER RESTRICTED | P=0.116 (e) (e) (e) |P=0.450 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 19 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Tension Lipidosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |4/50 (8%) 8/50 (16%) 3/50 (6%) 7/50 (14%) | |POLY-3 RATE (b) | 1/47.92 1/47.23 0/48.41 1/48.65 |4/46.52 8/46.76 3/46.69 7/44.58 | |POLY-3 PERCENT (g) | 2.1% 2.1% 0.0% 2.1% |8.6% 17.1% 6.4% 15.7% | |TERMINAL (d) | 1/44 (2%) 1/44 (2%) 0/44 (0%) 0/45 (0%) |4/40 (10%) 8/42 (19%) 3/41 (7%) 5/31 (16%) | |FIRST INCIDENCE | 730 (T) 730 (T) --- 695 |729 (T) 729 (T) 729 (T) 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.607N P=0.762 P=0.500N P=0.753N |P=0.196 P=0.200 P=0.486N P=0.155 | |POLY 3 | P=0.613N P=0.757 P=0.498N P=0.757N |P=0.323 P=0.179 P=0.498N P=0.237 | |POLY 1.5 | P=0.614N P=0.758 P=0.499N P=0.758N |P=0.333 P=0.178 P=0.501N P=0.246 | |POLY 6 | P=0.612N P=0.756 P=0.498N P=0.756N |P=0.311 P=0.181 P=0.495N P=0.224 | |LOGISTIC REGRESSION| P=0.616N P=0.762 (e) P=0.759 |P=0.321 P=0.200 P=0.486N P=0.263 | |COCH-ARM / FISHERS | P=0.616N P=0.753N P=0.500N P=0.753N |P=0.351 P=0.178 P=0.500N P=0.262 | |ORDER RESTRICTED | P=0.528N (e) (e) (e) |P=0.237 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver: Bile Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 3/47.23 0/48.41 1/48.51 |0/46.52 0/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 6.4% 0.0% 2.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/44 (0%) 3/44 (7%) 0/44 (0%) 1/45 (2%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- 730 (T) --- 730 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.626N P=0.121 (e) P=0.504 |(e) (e) (e) (e) | |POLY 3 | P=0.632N P=0.116 (e) P=0.502 |(e) (e) (e) (e) | |POLY 1.5 | P=0.632N P=0.117 (e) P=0.502 |(e) (e) (e) (e) | |POLY 6 | P=0.632N P=0.115 (e) P=0.503 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.121 (e) P=0.504 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.633N P=0.121 (e) P=0.500 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.267 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 20 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 5/50 (10%) 30/50 (60%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 5/48.41 30/49.04 |0/46.52 0/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 10.3% 61.2% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 5/44 (11%) 29/45 (64%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 730 (T) 568 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.034 * P<0.001 ** |(e) (e) (e) (e) | |POLY 3 | P<0.001 ** (e) P=0.032 * P<0.001 ** |(e) (e) (e) (e) | |POLY 1.5 | P<0.001 ** (e) P=0.031 * P<0.001 ** |(e) (e) (e) (e) | |POLY 6 | P<0.001 ** (e) P=0.032 * P<0.001 ** |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.034 * P<0.001 ** |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.028 * P<0.001 ** |(e) (e) (e) (e) | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Multinucleated | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 41/50 (82%) 47/50 (94%) 48/50 (96%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/47.92 41/48.85 47/50.00 48/49.88 |0/46.52 0/46.76 0/46.69 2/43.62 | |POLY-3 PERCENT (g) | 0.0% 83.9% 94.0% 96.2% |0.0% 0.0% 0.0% 4.6% | |TERMINAL (d) | 0/44 (0%) 37/44 (84%) 41/44 (93%) 44/45 (98%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 1/31 (3%) | |FIRST INCIDENCE | --- 554 585 568 |--- --- --- 677 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.032 * (e) (e) P=0.197 | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.043 * (e) (e) P=0.223 | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.044 * (e) (e) P=0.228 | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.042 * (e) (e) P=0.217 | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.045 * (e) (e) P=0.230 | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.046 * (e) (e) P=0.247 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.025 * (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 21 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 6/50 (12%) 8/50 (16%) 8/50 (16%) |3/50 (6%) 5/50 (10%) 4/50 (8%) 0/50 (0%) | |POLY-3 RATE (b) | 1/47.92 6/48.24 8/49.27 8/49.20 |3/47.36 5/48.32 4/47.71 0/43.42 | |POLY-3 PERCENT (g) | 2.1% 12.4% 16.2% 16.3% |6.3% 10.4% 8.4% 0.0% | |TERMINAL (d) | 1/44 (2%) 3/44 (7%) 5/44 (11%) 5/45 (11%) |0/40 (0%) 2/42 (5%) 2/41 (5%) 0/31 (0%) | |FIRST INCIDENCE | 730 (T) 585 585 606 |606 316 204 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.037 * P=0.062 P=0.021 * P=0.023 * |P=0.114N P=0.366 P=0.504 P=0.149N | |POLY 3 | P=0.031 * P=0.057 P=0.018 * P=0.018 * |P=0.103N P=0.368 P=0.504 P=0.135N | |POLY 1.5 | P=0.030 * P=0.057 P=0.017 * P=0.017 * |P=0.093N P=0.365 P=0.504 P=0.129N | |POLY 6 | P=0.033 * P=0.059 P=0.019 * P=0.019 * |P=0.116N P=0.370 P=0.502 P=0.144N | |LOGISTIC REGRESSION| P=0.017 * P=0.063 P=0.013 * P=0.015 * |P=0.036N* P=0.350 P=0.550 P=0.089N | |COCH-ARM / FISHERS | P=0.028 * P=0.056 P=0.015 * P=0.015 * |P=0.079N P=0.357 P=0.500 P=0.121N | |ORDER RESTRICTED | P=0.020 * (e) (e) (e) |P=0.082N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 44/50 (88%) 45/50 (90%) 46/50 (92%) 44/50 (88%) |41/50 (82%) 43/50 (86%) 39/50 (78%) 34/50 (68%) | |POLY-3 RATE (b) | 44/48.47 45/48.28 46/48.92 44/49.22 |41/47.52 43/49.10 39/47.69 34/44.89 | |POLY-3 PERCENT (g) | 90.8% 93.2% 94.0% 89.4% |86.3% 87.6% 81.8% 75.7% | |TERMINAL (d) | 41/44 (93%) 42/44 (96%) 44/44 (100%) 42/45 (93%) |37/40 (93%) 38/42 (91%) 36/41 (88%) 29/31 (94%) | |FIRST INCIDENCE | 652 585 589 606 |606 316 555 400 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.402N P=0.492 P=0.363 P=0.504N |P=0.413 P=0.582 P=0.309N P=0.402 | |POLY 3 | P=0.421N P=0.473 P=0.404 P=0.545N |P=0.065N P=0.547 P=0.370N P=0.133N | |POLY 1.5 | P=0.467N P=0.485 P=0.400 P=0.572N |P=0.043N* P=0.488 P=0.396N P=0.104N | |POLY 6 | P=0.391N P=0.459 P=0.370 P=0.531N |P=0.115N P=0.601 P=0.345N P=0.197N | |LOGISTIC REGRESSION| P=0.377N P=0.346 P=0.393 P=0.555N |P=0.070N P=0.393 P=0.356N P=0.193N | |COCH-ARM / FISHERS | P=0.547N P=0.500 P=0.370 P=0.620N |P=0.026N* P=0.393 P=0.402N P=0.083N | |ORDER RESTRICTED | P=0.415N (e) (e) (e) |P=0.102N (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 22 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte, Centrilobular | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 44/50 (88%) 50/50 (100%) 48/50 (96%) |0/50 (0%) 29/50 (58%) 44/50 (88%) 37/50 (74%) | |POLY-3 RATE (b) | 0/47.92 44/48.43 50/50.00 48/49.88 |0/46.52 29/48.08 44/49.35 37/47.04 | |POLY-3 PERCENT (g) | 0.0% 90.9% 100.0% 96.2% |0.0% 60.3% 89.2% 78.7% | |TERMINAL (d) | 0/44 (0%) 42/44 (96%) 44/44 (100%) 44/45 (98%) |0/40 (0%) 26/42 (62%) 39/41 (95%) 26/31 (84%) | |FIRST INCIDENCE | --- 449 585 568 |--- 561 204 400 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 32/50 (64%) 38/50 (76%) 47/50 (94%) 36/50 (72%) |33/50 (66%) 44/50 (88%) 44/50 (88%) 35/50 (70%) | |POLY-3 RATE (b) | 32/49.41 38/48.71 47/49.81 36/48.51 |33/47.70 44/48.79 44/49.80 35/47.57 | |POLY-3 PERCENT (g) | 64.8% 78.0% 94.4% 74.2% |69.2% 90.2% 88.4% 73.6% | |TERMINAL (d) | 27/44 (61%) 35/44 (80%) 42/44 (96%) 36/45 (80%) |31/40 (78%) 39/42 (93%) 37/41 (90%) 26/31 (84%) | |FIRST INCIDENCE | 463 554 585 730 (T) |456 522 204 344 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.292 P=0.162 P=0.003 ** P=0.319 |P=0.029 * P=0.023 * P=0.021 * P=0.034 * | |POLY 3 | P=0.150 P=0.107 P<0.001 ** P=0.212 |P=0.522N P=0.007 ** P=0.015 * P=0.400 | |POLY 1.5 | P=0.174 P=0.118 P<0.001 ** P=0.234 |P=0.505N P=0.006 ** P=0.011 * P=0.409 | |POLY 6 | P=0.116 P=0.097 P<0.001 ** P=0.178 |P=0.541 P=0.009 ** P=0.022 * P=0.378 | |LOGISTIC REGRESSION| P=0.243 P=0.130 P<0.001 ** P=0.285 |P=0.526 P=0.007 ** P=0.008 ** P=0.357 | |COCH-ARM / FISHERS | P=0.207 P=0.138 P<0.001 ** P=0.260 |P=0.500N P=0.008 ** P=0.008 ** P=0.415 | |ORDER RESTRICTED | P=0.010 * (e) (e) (e) |P=0.037 * (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 23 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 1/47.92 2/47.23 1/48.59 1/48.51 |0/46.52 1/46.76 1/46.69 0/43.42 | |POLY-3 PERCENT (g) | 2.1% 4.2% 2.1% 2.1% |0.0% 2.1% 2.1% 0.0% | |TERMINAL (d) | 1/44 (2%) 2/44 (5%) 0/44 (0%) 1/45 (2%) |0/40 (0%) 1/42 (2%) 1/41 (2%) 0/31 (0%) | |FIRST INCIDENCE | 730 (T) 730 (T) 683 730 (T) |--- 729 (T) 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.522N P=0.500 P=0.760 P=0.757N |P=0.653N P=0.510 P=0.505 (e) | |POLY 3 | P=0.525N P=0.495 P=0.757N P=0.758N |P=0.612N P=0.501 P=0.501 (e) | |POLY 1.5 | P=0.527N P=0.497 P=0.758N P=0.758N |P=0.605N P=0.500 P=0.500 (e) | |POLY 6 | P=0.524N P=0.493 P=0.757N P=0.757N |P=0.620N P=0.502 P=0.502 (e) | |LOGISTIC REGRESSION| P=0.527N P=0.500 P=0.755 P=0.757N |(e) P=0.510 P=0.505 (e) | |COCH-ARM / FISHERS | P=0.530N P=0.500 P=0.753N P=0.753N |P=0.595N P=0.500 P=0.500 (e) | |ORDER RESTRICTED | P=0.577N (e) (e) (e) |P=0.405 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lung | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |0/46.52 0/46.76 0/46.69 2/43.62 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.6% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 1/31 (3%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 677 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.032 * (e) (e) P=0.197 | |POLY 3 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.223 | |POLY 1.5 | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.228 | |POLY 6 | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.217 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.230 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.025 * (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 24 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 7/50 (14%) 8/50 (16%) 4/50 (8%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 6/48.20 7/47.23 8/48.41 4/48.51 |1/46.52 1/46.76 2/46.78 2/43.42 | |POLY-3 PERCENT (g) | 12.5% 14.8% 16.5% 8.3% |2.2% 2.1% 4.3% 4.6% | |TERMINAL (d) | 5/44 (11%) 7/44 (16%) 8/44 (18%) 4/45 (9%) |1/40 (3%) 1/42 (2%) 1/41 (2%) 2/31 (7%) | |FIRST INCIDENCE | 652 730 (T) 730 (T) 730 (T) |729 (T) 729 (T) 704 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.279N P=0.496 P=0.387 P=0.358N |P=0.251 P=0.751N P=0.503 P=0.411 | |POLY 3 | P=0.285N P=0.484 P=0.390 P=0.366N |P=0.309 P=0.759N P=0.502 P=0.476 | |POLY 1.5 | P=0.288N P=0.491 P=0.390 P=0.367N |P=0.320 P=0.760N P=0.500 P=0.485 | |POLY 6 | P=0.284N P=0.476 P=0.387 P=0.367N |P=0.295 P=0.758N P=0.505 P=0.464 | |LOGISTIC REGRESSION| P=0.278N P=0.487 P=0.394 P=0.364N |P=0.288 P=0.751N P=0.502 P=0.411 | |COCH-ARM / FISHERS | P=0.294N P=0.500 P=0.387 P=0.370N |P=0.337 P=0.753N P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.281N (e) (e) (e) |P=0.411 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolus | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |2/47.69 0/46.76 0/46.69 3/43.62 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.2% 0.0% 0.0% 6.9% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 2/31 (7%) | |FIRST INCIDENCE | --- --- --- --- |456 --- --- 677 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.203 P=0.242N P=0.240N P=0.432 | |POLY 3 | (e) (e) (e) (e) |P=0.236 P=0.242N P=0.242N P=0.459 | |POLY 1.5 | (e) (e) (e) (e) |P=0.239 P=0.240N P=0.241N P=0.475 | |POLY 6 | (e) (e) (e) (e) |P=0.233 P=0.243N P=0.243N P=0.442 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.294 P=0.175N P=0.143N P=0.585 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.245 P=0.247N P=0.247N P=0.500 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.082 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 25 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolus | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 7/48.11 1/47.23 1/48.41 3/48.51 |1/46.93 0/46.76 0/46.69 2/43.62 | |POLY-3 PERCENT (g) | 14.6% 2.1% 2.1% 6.2% |2.1% 0.0% 0.0% 4.6% | |TERMINAL (d) | 6/44 (14%) 1/44 (2%) 1/44 (2%) 3/45 (7%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 1/31 (3%) | |FIRST INCIDENCE | 679 730 (T) 730 (T) 730 (T) |610 --- --- 677 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.152N P=0.035N* P=0.034N* P=0.153N |P=0.211 P=0.500N P=0.496N P=0.449 | |POLY 3 | P=0.149N P=0.032N* P=0.030N* P=0.155N |P=0.237 P=0.501N P=0.501N P=0.474 | |POLY 1.5 | P=0.151N P=0.032N* P=0.030N* P=0.156N |P=0.240 P=0.501N P=0.501N P=0.484 | |POLY 6 | P=0.147N P=0.033N* P=0.030N* P=0.155N |P=0.234 P=0.501N P=0.501N P=0.462 | |LOGISTIC REGRESSION| P=0.151N P=0.034N* P=0.032N* P=0.153N |P=0.264 P=0.480N P=0.464N P=0.528 | |COCH-ARM / FISHERS | P=0.157N P=0.030N* P=0.030N* P=0.159N |P=0.246 P=0.500N P=0.500N P=0.500 | |ORDER RESTRICTED | P=0.014N* (e) (e) (e) |P=0.114 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/48 (10%) 1/50 (2%) 6/49 (12%) 5/47 (11%) |4/50 (8%) 20/50 (40%) 12/50 (24%) 9/49 (18%) | |POLY-3 RATE (b) | 5/46.27 1/47.23 6/48.31 5/46.45 |4/46.52 20/47.53 12/47.50 9/43.51 | |POLY-3 PERCENT (g) | 10.8% 2.1% 12.4% 10.8% |8.6% 42.1% 25.3% 20.7% | |TERMINAL (d) | 5/44 (11%) 1/44 (2%) 3/43 (7%) 3/43 (7%) |4/40 (10%) 18/42 (43%) 10/41 (24%) 7/31 (23%) | |FIRST INCIDENCE | 730 (T) 730 (T) 585 568 |729 (T) 595 478 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.347 P=0.104N P=0.494 P=0.621 |P=0.242 P<0.001 ** P=0.033 * P=0.054 | |POLY 3 | P=0.352 P=0.097N P=0.530 P=0.627N |P=0.398 P<0.001 ** P=0.028 * P=0.090 | |POLY 1.5 | P=0.343 P=0.095N P=0.525 P=0.627 |P=0.422 P<0.001 ** P=0.027 * P=0.097 | |POLY 6 | P=0.362 P=0.099N P=0.535 P=0.622N |P=0.366 P<0.001 ** P=0.030 * P=0.082 | |LOGISTIC REGRESSION| P=0.285 P=0.104N P=0.491 P=0.593 |P=0.423 P<0.001 ** P=0.028 * P=0.100 | |COCH-ARM / FISHERS | P=0.328 P=0.093N P=0.515 P=0.616 |P=0.466 P<0.001 ** P=0.027 * P=0.109 | |ORDER RESTRICTED | P=0.306 (e) (e) (e) |P=0.012 * (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 26 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 2/50 (4%) 0/49 (0%) 2/48 (4%) |6/50 (12%) 12/49 (24%) 6/49 (12%) 4/50 (8%) | |POLY-3 RATE (b) | 2/46.92 2/47.23 0/47.59 2/46.65 |6/46.52 12/47.13 6/45.94 4/43.84 | |POLY-3 PERCENT (g) | 4.3% 4.2% 0.0% 4.3% |12.9% 25.5% 13.1% 9.1% | |TERMINAL (d) | 2/43 (5%) 2/44 (5%) 0/44 (0%) 2/44 (5%) |6/40 (15%) 11/42 (26%) 5/41 (12%) 3/31 (10%) | |FIRST INCIDENCE | 730 (T) 730 (T) --- 730 (T) |729 (T) 595 704 606 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.549N P=0.686N P=0.233N P=0.686N |P=0.264N P=0.115 P=0.606N P=0.523N | |POLY 3 | P=0.561N P=0.691N P=0.234N P=0.692 |P=0.164N P=0.099 P=0.612 P=0.407N | |POLY 1.5 | P=0.563N P=0.689N P=0.235N P=0.690 |P=0.152N P=0.095 P=0.606 P=0.393N | |POLY 6 | P=0.560N P=0.693N P=0.233N P=0.693 |P=0.178N P=0.103 P=0.619 P=0.425N | |LOGISTIC REGRESSION| P=0.549N P=0.686N (e) P=0.686N |P=0.170N P=0.097 P=0.622 P=0.421N | |COCH-ARM / FISHERS | P=0.566N P=0.684N P=0.247N P=0.684 |P=0.134N P=0.088 P=0.606 P=0.370N | |ORDER RESTRICTED | P=0.442N (e) (e) (e) |P=0.142N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Lumbar | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 0/1 (0%) 0/3 (0%) 0/5 (0%) |1/8 (13%) 1/12 (8%) 0/11 (0%) 2/15 (13%) | |POLY-3 RATE (b) | 0/0.81 0/1.00 0/2.60 0/4.88 |1/6.27 1/11.16 0/9.83 2/12.29 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |15.9% 9.0% 0.0% 16.3% | |TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/1 (0%) 0/4 (0%) |0/3 (0%) 1/9 (11%) 0/7 (0%) 0/4 (0%) | |FIRST INCIDENCE | --- --- --- --- |608 729 (T) --- 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.332 P=0.647N P=0.496N P=0.467 | |POLY 3 | (e) (e) (e) (e) |P=0.505 P=0.626N P=0.410N P=0.733 | |POLY 1.5 | (e) (e) (e) (e) |P=0.515 P=0.642N P=0.420N P=0.728 | |POLY 6 | (e) (e) (e) (e) |P=0.488 P=0.607N P=0.397N P=0.733 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.550 P=0.730N P=0.512N P=0.700 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.524 P=0.653N P=0.421N P=0.743N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.475 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 27 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 1/1 (100%) 1/3 (33%) 0/5 (0%) |2/8 (25%) 5/12 (42%) 4/11 (36%) 4/15 (27%) | |POLY-3 RATE (b) | 0/0.81 1/1.00 1/2.82 0/4.88 |2/6.35 5/11.16 4/10.65 4/11.98 | |POLY-3 PERCENT (g) | 0.0% 100.0% 35.5% 0.0% |31.5% 44.8% 37.6% 33.4% | |TERMINAL (d) | 0/0 (0%) 1/1 (100%) 0/1 (0%) 0/4 (0%) |0/3 (0%) 5/9 (56%) 2/7 (29%) 2/4 (50%) | |FIRST INCIDENCE | --- 730 (T) 671 --- |608 729 (T) 478 606 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.314N P=1.000N P=0.504 (e) |P=0.282 P=0.594 P=0.466 P=0.341 | |POLY 3 | P=0.119N P=1.000N P=0.715 (e) |P=0.486N P=0.485 P=0.600 P=0.667 | |POLY 1.5 | P=0.144N P=1.000N P=0.703 (e) |P=0.466N P=0.449 P=0.558 P=0.664 | |POLY 6 | P=0.081N P=1.000N P=0.737 (e) |P=0.522N P=0.523 P=0.644 P=0.660 | |LOGISTIC REGRESSION| P=0.312N P=1.000N (e) (e) |P=0.474N P=0.581 P=0.436 P=0.689 | |COCH-ARM / FISHERS | P=0.217N P=0.500 P=0.750 (e) |P=0.446N P=0.392 P=0.494 P=0.712N | |ORDER RESTRICTED | P=0.373N (e) (e) (e) |P=0.621 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 0/1 (0%) 0/3 (0%) 0/5 (0%) |0/8 (0%) 0/12 (0%) 2/11 (18%) 1/15 (7%) | |POLY-3 RATE (b) | 0/0.81 0/1.00 0/2.60 0/4.88 |0/5.85 0/11.16 2/9.93 1/12.26 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 20.1% 8.2% | |TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/1 (0%) 0/4 (0%) |0/3 (0%) 0/9 (0%) 1/7 (14%) 0/4 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 704 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.211 (e) P=0.326 P=0.496 | |POLY 3 | (e) (e) (e) (e) |P=0.358 (e) P=0.358 P=0.644 | |POLY 1.5 | (e) (e) (e) (e) |P=0.364 (e) P=0.334 P=0.637 | |POLY 6 | (e) (e) (e) (e) |P=0.339 (e) P=0.393 P=0.652 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.389 (e) P=0.394 P=0.560 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.365 (e) P=0.322 P=0.652 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.309 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 28 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Renal | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 0/1 (0%) 0/3 (0%) 0/5 (0%) |0/8 (0%) 3/12 (25%) 0/11 (0%) 1/15 (7%) | |POLY-3 RATE (b) | 0/0.81 0/1.00 0/2.60 0/4.88 |0/5.85 3/11.16 0/9.83 1/12.26 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 26.9% 0.0% 8.2% | |TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/1 (0%) 0/4 (0%) |0/3 (0%) 3/9 (33%) 0/7 (0%) 0/4 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 729 (T) --- 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.629 P=0.356 (e) P=0.496 | |POLY 3 | (e) (e) (e) (e) |P=0.419N P=0.245 (e) P=0.644 | |POLY 1.5 | (e) (e) (e) (e) |P=0.440N P=0.218 (e) P=0.637 | |POLY 6 | (e) (e) (e) (e) |P=0.398N P=0.283 (e) P=0.652 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.466N P=0.356 (e) P=0.560 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.475N P=0.193 (e) P=0.652 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.363N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 1/2 (50%) 5/8 (63%) 1/5 (20%) |1/6 (17%) 2/9 (22%) 8/11 (73%) 4/9 (44%) | |POLY-3 RATE (b) | 0/0.00 1/1.61 5/7.82 1/4.88 |1/5.10 2/8.71 8/10.66 4/8.22 | |POLY-3 PERCENT (g) | 0.0% 62.0% 64.0% 20.5% |19.6% 23.0% 75.1% 48.7% | |TERMINAL (d) | 0/0 (0%) 1/1 (100%) 3/5 (60%) 0/3 (0%) |1/3 (33%) 2/7 (29%) 7/9 (78%) 0/1 (0%) | |FIRST INCIDENCE | --- 730 (T) 585 568 |729 (T) 729 (T) 704 606 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.562N P=1.000 P=0.244 P=0.508 |P=0.004 ** P=0.716N P=0.130 P=0.104 | |POLY 3 | (e) (e) (e) (e) |P=0.131 P=0.688 P=0.045 * P=0.317 | |POLY 1.5 | (e) (e) (e) (e) |P=0.134 P=0.668 P=0.036 * P=0.306 | |POLY 6 | (e) (e) (e) (e) |P=0.122 P=0.716 P=0.065 P=0.332 | |LOGISTIC REGRESSION| P=0.204N P=1.000 (e) (e) |P=0.087 P=0.716N P=0.106 P=0.292 | |COCH-ARM / FISHERS | P=0.205N P=1.000 P=1.000 P=1.000 |P=0.148 P=0.659 P=0.043 * P=0.294 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.114 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 29 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 0/2 (0%) 0/8 (0%) 0/5 (0%) |0/6 (0%) 0/9 (0%) 4/11 (36%) 0/9 (0%) | |POLY-3 RATE (b) | 0/0.00 0/1.61 0/7.14 0/4.35 |0/5.10 0/8.71 4/10.66 0/7.29 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 37.5% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/5 (0%) 0/3 (0%) |0/3 (0%) 0/7 (0%) 3/9 (33%) 0/1 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 704 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.317 (e) P=0.185 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.518 (e) P=0.162 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.566 (e) P=0.147 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.416 (e) P=0.189 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.434 (e) P=0.195 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.598 (e) P=0.139 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.212 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 1/2 (50%) 5/8 (63%) 2/5 (40%) |1/6 (17%) 3/9 (33%) 7/11 (64%) 3/9 (33%) | |POLY-3 RATE (b) | 0/0.00 1/1.61 5/7.81 2/4.88 |1/5.51 3/8.71 7/10.90 3/8.02 | |POLY-3 PERCENT (g) | 0.0% 62.0% 64.1% 41.0% |18.1% 34.5% 64.2% 37.4% | |TERMINAL (d) | 0/0 (0%) 1/1 (100%) 3/5 (60%) 1/3 (33%) |0/3 (0%) 3/7 (43%) 6/9 (67%) 0/1 (0%) | |FIRST INCIDENCE | --- 730 (T) 585 568 |608 729 (T) 634 606 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.510 P=1.000 P=0.244 P=0.508 |P=0.049 * P=0.546 P=0.177 P=0.276 | |POLY 3 | (e) (e) (e) (e) |P=0.332 P=0.477 P=0.099 P=0.439 | |POLY 1.5 | (e) (e) (e) (e) |P=0.358 P=0.467 P=0.089 P=0.448 | |POLY 6 | (e) (e) (e) (e) |P=0.286 P=0.490 P=0.115 P=0.420 | |LOGISTIC REGRESSION| P=0.455N P=1.000 (e) (e) |P=0.420 P=0.359 P=0.052 P=0.454 | |COCH-ARM / FISHERS | P=0.450N P=1.000 P=1.000 P=1.000 |P=0.384 P=0.462 P=0.088 P=0.462 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.203 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 30 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 1/2 (50%) 3/8 (38%) 0/5 (0%) |0/6 (0%) 1/9 (11%) 2/11 (18%) 1/9 (11%) | |POLY-3 RATE (b) | 0/0.00 1/1.61 3/7.33 0/4.35 |0/5.10 1/8.71 2/10.56 1/7.36 | |POLY-3 PERCENT (g) | 0.0% 62.0% 40.9% 0.0% |0.0% 11.5% 18.9% 13.6% | |TERMINAL (d) | 0/0 (0%) 1/1 (100%) 2/5 (40%) 0/3 (0%) |0/3 (0%) 1/7 (14%) 2/9 (22%) 0/1 (0%) | |FIRST INCIDENCE | --- 730 (T) 679 --- |--- 729 (T) 729 (T) 712 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.255N P=1.000N P=0.504 (e) |P=0.163 P=0.669 P=0.500 P=0.455 | |POLY 3 | (e) (e) (e) (e) |P=0.412 P=0.604 P=0.408 P=0.574 | |POLY 1.5 | (e) (e) (e) (e) |P=0.432 P=0.593 P=0.393 P=0.577 | |POLY 6 | (e) (e) (e) (e) |P=0.371 P=0.619 P=0.430 P=0.563 | |LOGISTIC REGRESSION| P=0.099N P=1.000N (e) (e) |P=0.217 P=0.669 P=0.500 P=0.500 | |COCH-ARM / FISHERS | P=0.126N P=1.000 P=1.000 (e) |P=0.448 P=0.600 P=0.404 P=0.600 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.370 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 1/2 (50%) 5/8 (63%) 0/5 (0%) |1/6 (17%) 4/9 (44%) 9/11 (82%) 4/9 (44%) | |POLY-3 RATE (b) | 0/0.00 1/1.61 5/7.82 0/4.35 |1/5.10 4/8.71 9/11.00 4/8.22 | |POLY-3 PERCENT (g) | 0.0% 62.0% 64.0% 0.0% |19.6% 45.9% 81.8% 48.7% | |TERMINAL (d) | 0/0 (0%) 1/1 (100%) 3/5 (60%) 0/3 (0%) |1/3 (33%) 4/7 (57%) 7/9 (78%) 0/1 (0%) | |FIRST INCIDENCE | --- 730 (T) 585 --- |729 (T) 729 (T) 634 606 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.258N P=1.000N P=0.244 (e) |P=0.011 * P=0.500 P=0.073 P=0.104 | |POLY 3 | (e) (e) (e) (e) |P=0.279 P=0.350 P=0.017 * P=0.317 | |POLY 1.5 | (e) (e) (e) (e) |P=0.271 P=0.323 P=0.010 * P=0.306 | |POLY 6 | (e) (e) (e) (e) |P=0.282 P=0.391 P=0.036 * P=0.332 | |LOGISTIC REGRESSION| P=0.059N P=1.000N (e) (e) |P=0.203 P=0.500 P=0.032 * P=0.292 | |COCH-ARM / FISHERS | P=0.060N P=1.000 P=1.000 (e) |P=0.270 P=0.294 P=0.018 * P=0.294 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.093 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 31 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Nose | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 2/47.92 0/47.23 1/48.41 2/48.51 |1/46.52 0/46.76 1/46.73 1/43.42 | |POLY-3 PERCENT (g) | 4.2% 0.0% 2.1% 4.1% |2.2% 0.0% 2.1% 2.3% | |TERMINAL (d) | 2/44 (5%) 0/44 (0%) 1/44 (2%) 2/45 (4%) |1/40 (3%) 0/42 (0%) 0/41 (0%) 1/31 (3%) | |FIRST INCIDENCE | 730 (T) --- 730 (T) 730 (T) |729 (T) --- 718 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.477 P=0.238N P=0.500N P=0.686N |P=0.473 P=0.490N P=0.755N P=0.704 | |POLY 3 | P=0.477 P=0.241N P=0.496N P=0.689N |P=0.516 P=0.499N P=0.759N P=0.745 | |POLY 1.5 | P=0.474 P=0.239N P=0.497N P=0.690N |P=0.525 P=0.500N P=0.760 P=0.751 | |POLY 6 | P=0.479 P=0.242N P=0.496N P=0.688N |P=0.504 P=0.498N P=0.758N P=0.737 | |LOGISTIC REGRESSION| P=0.477 (e) P=0.500N P=0.686N |P=0.503 (e) P=0.761N P=0.704 | |COCH-ARM / FISHERS | P=0.469 P=0.247N P=0.500N P=0.691N |P=0.539 P=0.500N P=0.753N P=0.753N | |ORDER RESTRICTED | P=0.411N (e) (e) (e) |P=0.512 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Nose: Nasolacrimal Duct | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 2/48.60 1/48.51 |1/46.94 0/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.1% 2.1% |2.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 1/44 (2%) 1/45 (2%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 679 730 (T) |606 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.252 (e) P=0.240 P=0.504 |P=0.312N P=0.508N P=0.504N P=0.513N | |POLY 3 | P=0.252 (e) P=0.241 P=0.502 |P=0.297N P=0.501N P=0.501N P=0.516N | |POLY 1.5 | P=0.250 (e) P=0.240 P=0.502 |P=0.301N P=0.501N P=0.501N P=0.509N | |POLY 6 | P=0.254 (e) P=0.241 P=0.503 |P=0.292N P=0.501N P=0.501N P=0.523N | |LOGISTIC REGRESSION| P=0.240 (e) P=0.223 P=0.504 |P=0.273N P=0.479N P=0.462N P=0.439N | |COCH-ARM / FISHERS | P=0.246 (e) P=0.247 P=0.500 |P=0.306N P=0.500N P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.170 (e) (e) (e) |P=0.135N (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 32 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 24/50 (48%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 39/50 (78%) | |POLY-3 RATE (b) | 0/47.92 2/47.23 2/48.41 24/48.51 |0/46.52 0/46.76 0/46.69 39/47.40 | |POLY-3 PERCENT (g) | 0.0% 4.2% 4.1% 49.5% |0.0% 0.0% 0.0% 82.3% | |TERMINAL (d) | 0/44 (0%) 2/44 (5%) 2/44 (5%) 24/45 (53%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 27/31 (87%) | |FIRST INCIDENCE | --- 730 (T) 730 (T) 730 (T) |--- --- --- 344 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.238 P=0.238 P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** | |POLY 3 | P<0.001 ** P=0.234 P=0.240 P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.235 P=0.239 P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** | |POLY 6 | P<0.001 ** P=0.233 P=0.240 P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** | |LOGISTIC REGRESSION| (e) P=0.238 P=0.238 P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.247 P=0.247 P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |48/49 (98%) 48/50 (96%) 46/50 (92%) 45/50 (90%) | |POLY-3 RATE (b) | |48/49.00 48/48.98 46/48.31 45/48.37 | |POLY-3 PERCENT (g) | |98.0% 98.0% 95.2% 93.0% | |TERMINAL (d) | |39/40 (98%) 42/42 (100%) 40/41 (98%) 28/31 (90%) | |FIRST INCIDENCE | |456 522 478 400 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.057 P=0.402N P=0.312N P=0.136 | |POLY 3 | |P=0.106N P=0.766 P=0.422N P=0.241N | |POLY 1.5 | |P=0.079N P=0.709N P=0.340N P=0.183N | |POLY 6 | |P=0.128N P=0.737 P=0.513N P=0.285N | |LOGISTIC REGRESSION| |P=0.161N P=0.635N P=0.269N P=0.200N | |COCH-ARM / FISHERS | |P=0.056N P=0.508N P=0.187N P=0.107N | |ORDER RESTRICTED | |P=0.144N (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 33 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |22/49 (45%) 17/50 (34%) 17/50 (34%) 14/50 (28%) | |POLY-3 RATE (b) | |22/46.99 17/48.31 17/48.05 14/44.98 | |POLY-3 PERCENT (g) | |46.8% 35.2% 35.4% 31.1% | |TERMINAL (d) | |18/40 (45%) 13/42 (31%) 14/41 (34%) 8/31 (26%) | |FIRST INCIDENCE | |610 316 478 536 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.278N P=0.183N P=0.195N P=0.281N | |POLY 3 | |P=0.097N P=0.171N P=0.177N P=0.090N | |POLY 1.5 | |P=0.085N P=0.176N P=0.184N P=0.078N | |POLY 6 | |P=0.110N P=0.168N P=0.169N P=0.103N | |LOGISTIC REGRESSION| |P=0.070N P=0.182N P=0.191N P=0.093N | |COCH-ARM / FISHERS | |P=0.064N P=0.183N P=0.183N P=0.062N | |ORDER RESTRICTED | |P=0.093N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/49 (4%) 5/50 (10%) 3/50 (6%) 4/50 (8%) | |POLY-3 RATE (b) | |2/46.76 5/48.31 3/46.69 4/44.46 | |POLY-3 PERCENT (g) | |4.3% 10.4% 6.4% 9.0% | |TERMINAL (d) | |0/40 (0%) 1/42 (2%) 3/41 (7%) 0/31 (0%) | |FIRST INCIDENCE | |606 316 729 (T) 536 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.302 P=0.225 P=0.505 P=0.278 | |POLY 3 | |P=0.353 P=0.230 P=0.499 P=0.314 | |POLY 1.5 | |P=0.368 P=0.228 P=0.501 P=0.326 | |POLY 6 | |P=0.336 P=0.233 P=0.498 P=0.302 | |LOGISTIC REGRESSION| |P=0.506 P=0.281 P=0.513 P=0.441 | |COCH-ARM / FISHERS | |P=0.398 P=0.226 P=0.510 P=0.349 | |ORDER RESTRICTED | |P=0.317 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 34 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/49 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | |2/46.75 1/46.84 1/46.84 0/43.42 | |POLY-3 PERCENT (g) | |4.3% 2.1% 2.1% 0.0% | |TERMINAL (d) | |1/40 (3%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | |608 709 690 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.180N P=0.497N P=0.495N P=0.275N | |POLY 3 | |P=0.162N P=0.499N P=0.499N P=0.254N | |POLY 1.5 | |P=0.158N P=0.498N P=0.499N P=0.246N | |POLY 6 | |P=0.167N P=0.500N P=0.499N P=0.264N | |LOGISTIC REGRESSION| |P=0.135N P=0.472N P=0.465N P=0.193N | |COCH-ARM / FISHERS | |P=0.150N P=0.492N P=0.492N P=0.242N | |ORDER RESTRICTED | |P=0.132N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |0/49 (0%) 4/50 (8%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | |0/46.33 4/46.94 2/46.69 0/43.42 | |POLY-3 PERCENT (g) | |0.0% 8.5% 4.3% 0.0% | |TERMINAL (d) | |0/40 (0%) 2/42 (5%) 2/41 (5%) 0/31 (0%) | |FIRST INCIDENCE | |--- 703 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.415N P=0.069 P=0.244 (e) | |POLY 3 | |P=0.373N P=0.062 P=0.239 (e) | |POLY 1.5 | |P=0.357N P=0.062 P=0.239 (e) | |POLY 6 | |P=0.391N P=0.063 P=0.239 (e) | |LOGISTIC REGRESSION| |P=0.366N P=0.064 P=0.244 (e) | |COCH-ARM / FISHERS | |P=0.331N P=0.061 P=0.253 (e) | |ORDER RESTRICTED | |P=0.191 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 35 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |6/49 (12%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | |POLY-3 RATE (b) | |6/46.33 2/47.08 3/46.69 1/43.42 | |POLY-3 PERCENT (g) | |13.0% 4.3% 6.4% 2.3% | |TERMINAL (d) | |6/40 (15%) 1/42 (2%) 3/41 (7%) 1/31 (3%) | |FIRST INCIDENCE | |729 (T) 641 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.087N P=0.121N P=0.229N P=0.107N | |POLY 3 | |P=0.060N P=0.128N P=0.238N P=0.067N | |POLY 1.5 | |P=0.057N P=0.129N P=0.239N P=0.062N | |POLY 6 | |P=0.065N P=0.126N P=0.237N P=0.074N | |LOGISTIC REGRESSION| |P=0.065N P=0.131N P=0.229N P=0.107N | |COCH-ARM / FISHERS | |P=0.051N P=0.128N P=0.233N P=0.053N | |ORDER RESTRICTED | |P=0.029N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 1/48.41 2/48.51 |1/46.52 2/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 4.1% |2.2% 4.3% 0.0% 0.0% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 1/44 (2%) 2/45 (4%) |1/40 (3%) 2/42 (5%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 730 (T) 730 (T) |729 (T) 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.073 (e) P=0.500 P=0.243 |P=0.224N P=0.517 P=0.495N P=0.551N | |POLY 3 | P=0.072 (e) P=0.502 P=0.240 |P=0.194N P=0.502 P=0.499N P=0.514N | |POLY 1.5 | P=0.072 (e) P=0.501 P=0.239 |P=0.192N P=0.501 P=0.500N P=0.508N | |POLY 6 | P=0.073 (e) P=0.502 P=0.241 |P=0.196N P=0.503 P=0.498N P=0.520N | |LOGISTIC REGRESSION| (e) (e) P=0.500 P=0.243 |P=0.224N P=0.517 (e) (e) | |COCH-ARM / FISHERS | P=0.070 (e) P=0.500 P=0.247 |P=0.188N P=0.500 P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.076 (e) (e) (e) |P=0.182N (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 36 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 11/50 (22%) 8/50 (16%) 8/50 (16%) |20/50 (40%) 24/50 (48%) 33/50 (66%) 18/50 (36%) | |POLY-3 RATE (b) | 14/47.92 11/47.66 8/48.41 8/48.51 |20/46.52 24/47.39 33/47.09 18/44.27 | |POLY-3 PERCENT (g) | 29.2% 23.1% 16.5% 16.5% |43.0% 50.6% 70.1% 40.7% | |TERMINAL (d) | 14/44 (32%) 10/44 (23%) 8/44 (18%) 8/45 (18%) |20/40 (50%) 23/42 (55%) 31/41 (76%) 14/31 (45%) | |FIRST INCIDENCE | 730 (T) 606 730 (T) 730 (T) |729 (T) 522 645 637 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.072N P=0.323N P=0.110N P=0.100N |P=0.217 P=0.338 P=0.007 ** P=0.373 | |POLY 3 | P=0.075N P=0.327N P=0.106N P=0.105N |P=0.504N P=0.295 P=0.005 ** P=0.495N | |POLY 1.5 | P=0.078N P=0.326N P=0.109N P=0.108N |P=0.458N P=0.284 P=0.005 ** P=0.468N | |POLY 6 | P=0.074N P=0.327N P=0.105N P=0.103N |P=0.528 P=0.309 P=0.006 ** P=0.522N | |LOGISTIC REGRESSION| P=0.072N P=0.341N P=0.110N P=0.100N |P=0.490 P=0.282 P=0.006 ** P=0.566 | |COCH-ARM / FISHERS | P=0.082N P=0.322N P=0.114N P=0.114N |P=0.378N P=0.273 P=0.008 ** P=0.418N | |ORDER RESTRICTED | P=0.095N (e) (e) (e) |P=0.135N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 0/47.92 1/47.23 1/48.41 1/48.51 |1/46.52 1/46.76 1/46.69 2/43.51 | |POLY-3 PERCENT (g) | 0.0% 2.1% 2.1% 2.1% |2.2% 2.1% 2.1% 4.6% | |TERMINAL (d) | 0/44 (0%) 1/44 (2%) 1/44 (2%) 1/45 (2%) |1/40 (3%) 1/42 (2%) 1/41 (2%) 1/31 (3%) | |FIRST INCIDENCE | --- 730 (T) 730 (T) 730 (T) |729 (T) 729 (T) 729 (T) 705 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.390 P=0.500 P=0.500 P=0.504 |P=0.270 P=0.751N P=0.756N P=0.418 | |POLY 3 | P=0.391 P=0.497 P=0.502 P=0.502 |P=0.330 P=0.759N P=0.760N P=0.477 | |POLY 1.5 | P=0.389 P=0.498 P=0.501 P=0.502 |P=0.338 P=0.760N P=0.760 P=0.486 | |POLY 6 | P=0.392 P=0.496 P=0.502 P=0.503 |P=0.320 P=0.758N P=0.758N P=0.466 | |LOGISTIC REGRESSION| (e) P=0.500 P=0.500 P=0.504 |P=0.308 P=0.751N P=0.756N P=0.462 | |COCH-ARM / FISHERS | P=0.384 P=0.500 P=0.500 P=0.500 |P=0.351 P=0.753N P=0.753N P=0.500 | |ORDER RESTRICTED | P=0.327 (e) (e) (e) |P=0.383 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 37 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Parathyroid Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/46 (0%) 0/38 (0%) 0/45 (0%) 0/36 (0%) |0/42 (0%) 0/41 (0%) 3/40 (8%) 1/40 (3%) | |POLY-3 RATE (b) | 0/44.07 0/35.66 0/43.44 0/34.51 |0/39.91 0/38.68 3/38.82 1/35.97 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 7.7% 2.8% | |TERMINAL (d) | 0/41 (0%) 0/33 (0%) 0/40 (0%) 0/31 (0%) |0/36 (0%) 0/34 (0%) 2/35 (6%) 0/24 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 704 400 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.189 (e) P=0.118 P=0.496 | |POLY 3 | (e) (e) (e) (e) |P=0.208 (e) P=0.113 P=0.479 | |POLY 1.5 | (e) (e) (e) (e) |P=0.218 (e) P=0.111 P=0.484 | |POLY 6 | (e) (e) (e) (e) |P=0.193 (e) P=0.115 P=0.473 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.362 (e) P=0.113 P=0.908 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.236 (e) P=0.112 P=0.488 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.109 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 4/50 (8%) 5/49 (10%) 3/47 (6%) | |POLY-3 RATE (b) | 0/45.92 0/46.80 0/48.41 0/48.51 |2/46.52 4/46.76 5/45.69 3/41.69 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.3% 8.6% 10.9% 7.2% | |TERMINAL (d) | 0/42 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |2/40 (5%) 4/42 (10%) 5/40 (13%) 1/30 (3%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) 672 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.309 P=0.359 P=0.216 P=0.401 | |POLY 3 | (e) (e) (e) (e) |P=0.389 P=0.340 P=0.209 P=0.450 | |POLY 1.5 | (e) (e) (e) (e) |P=0.403 P=0.338 P=0.207 P=0.459 | |POLY 6 | (e) (e) (e) (e) |P=0.372 P=0.342 P=0.211 P=0.439 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.376 P=0.359 P=0.216 P=0.458 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.425 P=0.339 P=0.210 P=0.470 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.320 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 38 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/48 (15%) 5/49 (10%) 5/50 (10%) 4/50 (8%) |5/50 (10%) 3/50 (6%) 2/49 (4%) 0/47 (0%) | |POLY-3 RATE (b) | 7/45.92 5/47.22 5/48.63 4/48.51 |5/47.02 3/46.76 2/45.69 0/41.28 | |POLY-3 PERCENT (g) | 15.3% 10.6% 10.3% 8.3% |10.6% 6.4% 4.4% 0.0% | |TERMINAL (d) | 7/42 (17%) 4/44 (9%) 4/44 (9%) 4/45 (9%) |2/40 (5%) 3/42 (7%) 2/40 (5%) 0/30 (0%) | |FIRST INCIDENCE | 730 (T) 606 671 730 (T) |606 729 (T) 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.202N P=0.352N P=0.349N P=0.223N |P=0.033N* P=0.345N P=0.225N P=0.060N | |POLY 3 | P=0.203N P=0.360N P=0.340N P=0.231N |P=0.025N* P=0.360N P=0.228N P=0.043N* | |POLY 1.5 | P=0.205N P=0.362N P=0.344N P=0.234N |P=0.023N* P=0.359N P=0.228N P=0.040N* | |POLY 6 | P=0.202N P=0.356N P=0.336N P=0.229N |P=0.027N* P=0.361N P=0.229N P=0.047N* | |LOGISTIC REGRESSION| P=0.204N P=0.365N P=0.342N P=0.223N |P=0.023N* P=0.356N P=0.225N P=0.038N* | |COCH-ARM / FISHERS | P=0.208N P=0.365N P=0.351N P=0.239N |P=0.022N* P=0.357N P=0.226N P=0.033N* | |ORDER RESTRICTED | P=0.223N (e) (e) (e) |P=0.021N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |14/50 (28%) 14/50 (28%) 13/49 (27%) 3/47 (6%) | |POLY-3 RATE (b) | 1/45.92 1/46.80 0/48.41 0/48.51 |14/46.93 14/46.76 13/45.99 3/41.28 | |POLY-3 PERCENT (g) | 2.2% 2.1% 0.0% 0.0% |29.8% 29.9% 28.3% 7.3% | |TERMINAL (d) | 1/42 (2%) 1/44 (2%) 0/44 (0%) 0/45 (0%) |13/40 (33%) 14/42 (33%) 12/40 (30%) 3/30 (10%) | |FIRST INCIDENCE | 730 (T) 730 (T) --- --- |610 729 (T) 645 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.227N P=0.751N P=0.491N P=0.486N |P=0.015N* P=0.531N P=0.497N P=0.017N* | |POLY 3 | P=0.229N P=0.756N P=0.489N P=0.489N |P=0.007N** P=0.584 P=0.525N P=0.006N** | |POLY 1.5 | P=0.229N P=0.756N P=0.490N P=0.490N |P=0.005N** P=0.585 P=0.529N P=0.005N** | |POLY 6 | P=0.229N P=0.756N P=0.489N P=0.488N |P=0.009N** P=0.583 P=0.519N P=0.008N** | |LOGISTIC REGRESSION| P=0.227N P=0.751N (e) (e) |P=0.008N** P=0.576N P=0.519N P=0.009N** | |COCH-ARM / FISHERS | P=0.229N P=0.747N P=0.490N P=0.490N |P=0.004N** P=0.588N P=0.525N P=0.005N** | |ORDER RESTRICTED | P=0.241N (e) (e) (e) |P=0.009N** (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 39 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 21/50 (42%) 23/50 (46%) 25/50 (50%) 32/50 (64%) | | |POLY-3 RATE (b) | 21/47.92 23/47.72 25/49.29 32/50.00 | | |POLY-3 PERCENT (g) | 43.8% 48.2% 50.7% 64.0% | | |TERMINAL (d) | 21/44 (48%) 22/44 (50%) 22/44 (50%) 27/45 (60%) | | |FIRST INCIDENCE | 730 (T) 585 589 568 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.022 * P=0.418 P=0.277 P=0.036 * | | |POLY 3 | P=0.022 * P=0.411 P=0.317 P=0.034 * | | |POLY 1.5 | P=0.018 * P=0.415 P=0.300 P=0.028 * | | |POLY 6 | P=0.029 * P=0.410 P=0.337 P=0.043 * | | |LOGISTIC REGRESSION| P=0.015 * P=0.378 P=0.289 P=0.024 * | | |COCH-ARM / FISHERS | P=0.013 * P=0.420 P=0.274 P=0.022 * | | |ORDER RESTRICTED | P=0.030 * (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland: Duct | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 20/50 (40%) 15/50 (30%) 15/50 (30%) 28/50 (56%) | | |POLY-3 RATE (b) | 20/48.66 15/47.37 15/49.06 28/49.57 | | |POLY-3 PERCENT (g) | 41.1% 31.7% 30.6% 56.5% | | |TERMINAL (d) | 19/44 (43%) 14/44 (32%) 13/44 (30%) 24/45 (53%) | | |FIRST INCIDENCE | 463 695 589 568 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.040 * P=0.202N P=0.205N P=0.109 | | |POLY 3 | P=0.033 * P=0.227N P=0.191N P=0.091 | | |POLY 1.5 | P=0.030 * P=0.218N P=0.195N P=0.086 | | |POLY 6 | P=0.037 * P=0.234N P=0.185N P=0.100 | | |LOGISTIC REGRESSION| P=0.030 * P=0.212N P=0.206N P=0.078 | | |COCH-ARM / FISHERS | P=0.028 * P=0.201N P=0.201N P=0.080 | | |ORDER RESTRICTED | P=0.015 * (e) (e) (e) | | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 40 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 32/50 (64%) 43/50 (86%) 46/50 (92%) 28/50 (56%) | | |POLY-3 RATE (b) | 32/48.95 43/49.13 46/49.78 28/48.51 | | |POLY-3 PERCENT (g) | 65.4% 87.5% 92.4% 57.7% | | |TERMINAL (d) | 29/44 (66%) 39/44 (89%) 41/44 (93%) 28/45 (62%) | | |FIRST INCIDENCE | 540 449 585 730 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.066N P=0.017 * P=0.003 ** P=0.226N | | |POLY 3 | P=0.075N P=0.007 ** P<0.001 ** P=0.284N | | |POLY 1.5 | P=0.070N P=0.008 ** P<0.001 ** P=0.275N | | |POLY 6 | P=0.087N P=0.006 ** P<0.001 ** P=0.303N | | |LOGISTIC REGRESSION| P=0.063N P=0.009 ** P<0.001 ** P=0.240N | | |COCH-ARM / FISHERS | P=0.081N P=0.010 * P<0.001 ** P=0.270N | | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Salivary Glands | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 31/50 (62%) 40/50 (80%) 40/50 (80%) 28/50 (56%) |27/50 (54%) 34/50 (68%) 30/50 (60%) 28/50 (56%) | |POLY-3 RATE (b) | 31/49.41 40/49.61 40/49.52 28/48.51 |27/47.17 34/49.71 30/48.60 28/45.55 | |POLY-3 PERCENT (g) | 62.8% 80.6% 80.8% 57.7% |57.2% 68.4% 61.7% 61.5% | |TERMINAL (d) | 26/44 (59%) 35/44 (80%) 35/44 (80%) 28/45 (62%) |23/40 (58%) 28/42 (67%) 26/41 (63%) 21/31 (68%) | |FIRST INCIDENCE | 463 449 589 730 (T) |610 316 204 344 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.132N P=0.066 P=0.069 P=0.305N |P=0.136 P=0.191 P=0.393 P=0.113 | |POLY 3 | P=0.175N P=0.038 * P=0.036 * P=0.381N |P=0.502 P=0.175 P=0.405 P=0.418 | |POLY 1.5 | P=0.157N P=0.038 * P=0.037 * P=0.363N |P=0.525N P=0.148 P=0.385 P=0.453 | |POLY 6 | P=0.208N P=0.037 * P=0.035 * P=0.414N |P=0.432 P=0.205 P=0.415 P=0.367 | |LOGISTIC REGRESSION| P=0.136N P=0.041 * P=0.039 * P=0.323N |P=0.496N P=0.109 P=0.339 P=0.372 | |COCH-ARM / FISHERS | P=0.143N P=0.038 * P=0.038 * P=0.342N |P=0.451N P=0.109 P=0.343 P=0.500 | |ORDER RESTRICTED | P=0.041N* (e) (e) (e) |P=0.401 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 41 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Skeletal Muscle | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 0/1 (0%) 0/2 (0%) 0/0 (0%) |0/2 (0%) 3/4 (75%) 2/2 (100%) 0/4 (0%) | |POLY-3 RATE (b) | 0/0.71 0/0.61 0/1.82 0/0.00 |0/1.51 3/3.90 2/2.00 0/2.68 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 77.0% 100.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |0/0 (0%) 2/2 (100%) 2/2 (100%) 0/1 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 709 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.184N P=0.510 P=1.000N (e) | |POLY 3 | (e) (e) (e) (e) |P=0.226N P=0.240 P<0.001 ** (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.176N P=0.198 P<0.001 ** (e) | |POLY 6 | (e) (e) (e) (e) |P=0.283N P=0.319 P=0.058 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.254N (e) P=1.000N (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.221N P=0.200 P=0.167 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.116N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 4/50 (8%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |0/46.52 4/46.76 1/46.80 0/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 8.6% 2.1% 0.0% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 4/42 (10%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 700 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.362N P=0.070 P=0.500 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.318N P=0.061 P=0.501 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.309N P=0.061 P=0.500 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.329N P=0.061 P=0.503 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.325N P=0.070 P=0.501 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.296N P=0.059 P=0.500 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.163N (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 42 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 7/50 (14%) 9/50 (18%) 14/50 (28%) |16/50 (32%) 35/50 (70%) 32/50 (64%) 27/50 (54%) | |POLY-3 RATE (b) | 11/49.74 7/49.05 9/49.53 14/49.86 |16/47.60 35/48.43 32/47.92 27/47.63 | |POLY-3 PERCENT (g) | 22.1% 14.3% 18.2% 28.1% |33.6% 72.3% 66.8% 56.7% | |TERMINAL (d) | 7/44 (16%) 3/44 (7%) 4/44 (9%) 10/45 (22%) |11/40 (28%) 30/42 (71%) 28/41 (68%) 13/31 (42%) | |FIRST INCIDENCE | 463 449 585 568 |606 522 204 344 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.199 P=0.239N P=0.404N P=0.355 |P=0.010 * P<0.001 ** P=0.004 ** P=0.008 ** | |POLY 3 | P=0.169 P=0.228N P=0.406N P=0.326 |P=0.079 P<0.001 ** P<0.001 ** P=0.018 * | |POLY 1.5 | P=0.167 P=0.224N P=0.405N P=0.325 |P=0.084 P<0.001 ** P<0.001 ** P=0.018 * | |POLY 6 | P=0.172 P=0.231N P=0.407N P=0.328 |P=0.071 P<0.001 ** P<0.001 ** P=0.016 * | |LOGISTIC REGRESSION| P=0.088 P=0.118N P=0.423N P=0.253 |P=0.086 P<0.001 ** P<0.001 ** P=0.026 * | |COCH-ARM / FISHERS | P=0.164 P=0.218N P=0.402N P=0.322 |P=0.097 P<0.001 ** P<0.001 ** P=0.021 * | |ORDER RESTRICTED | P=0.172 (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 0/48.41 0/48.51 |0/46.52 0/46.76 0/46.69 2/43.95 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.6% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 638 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.224 | |POLY 3 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.225 | |POLY 1.5 | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.229 | |POLY 6 | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.220 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.054 (e) (e) P=0.262 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.025 * (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 43 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 17/50 (34%) 31/50 (62%) 34/50 (68%) 32/50 (64%) |24/50 (48%) 36/50 (72%) 37/50 (74%) 22/50 (44%) | |POLY-3 RATE (b) | 17/48.27 31/48.15 34/48.64 32/48.51 |24/46.60 36/47.16 37/47.62 22/45.30 | |POLY-3 PERCENT (g) | 35.2% 64.4% 69.9% 66.0% |51.5% 76.3% 77.7% 48.6% | |TERMINAL (d) | 15/44 (34%) 29/44 (66%) 32/44 (73%) 32/45 (71%) |23/40 (58%) 34/42 (81%) 34/41 (83%) 19/31 (61%) | |FIRST INCIDENCE | 679 585 679 730 (T) |709 641 478 400 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.008 ** P=0.005 ** P<0.001 ** P=0.003 ** |P=0.304 P=0.017 * P=0.007 ** P=0.295 | |POLY 3 | P=0.004 ** P=0.003 ** P<0.001 ** P=0.002 ** |P=0.222N P=0.008 ** P=0.005 ** P=0.471N | |POLY 1.5 | P=0.004 ** P=0.003 ** P<0.001 ** P=0.002 ** |P=0.200N P=0.009 ** P=0.005 ** P=0.449N | |POLY 6 | P=0.003 ** P=0.003 ** P<0.001 ** P<0.001 ** |P=0.270N P=0.008 ** P=0.005 ** P=0.509N | |LOGISTIC REGRESSION| P=0.007 ** P=0.003 ** P<0.001 ** P=0.002 ** |P=0.332N P=0.009 ** P=0.006 ** P=0.540N | |COCH-ARM / FISHERS | P=0.005 ** P=0.004 ** P<0.001 ** P=0.002 ** |P=0.184N P=0.012 * P=0.007 ** P=0.421N | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.024N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/47.92 2/47.23 0/48.41 0/48.51 |1/46.94 0/46.76 0/46.69 1/43.75 | |POLY-3 PERCENT (g) | 2.1% 4.2% 0.0% 0.0% |2.1% 0.0% 0.0% 2.3% | |TERMINAL (d) | 1/44 (2%) 2/44 (5%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 730 (T) 730 (T) --- --- |606 --- --- 638 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.185N P=0.500 P=0.500N P=0.496N |P=0.586 P=0.508N P=0.504N P=0.751 | |POLY 3 | P=0.187N P=0.495 P=0.498N P=0.498N |P=0.584 P=0.501N P=0.501N P=0.745 | |POLY 1.5 | P=0.187N P=0.497 P=0.499N P=0.498N |P=0.588 P=0.501N P=0.501N P=0.751 | |POLY 6 | P=0.186N P=0.493 P=0.498N P=0.497N |P=0.580 P=0.501N P=0.501N P=0.737 | |LOGISTIC REGRESSION| P=0.185N P=0.500 (e) (e) |P=0.639 P=0.479N P=0.462N P=0.715N | |COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.595 P=0.500N P=0.500N P=0.753N | |ORDER RESTRICTED | P=0.163N (e) (e) (e) |P=0.378 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 44 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 1/47.92 2/47.23 1/48.59 1/48.65 |1/46.94 1/46.86 1/47.03 1/43.75 | |POLY-3 PERCENT (g) | 2.1% 4.2% 2.1% 2.1% |2.1% 2.1% 2.1% 2.3% | |TERMINAL (d) | 1/44 (2%) 2/44 (5%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 730 (T) 730 (T) 683 695 |606 703 634 638 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.520N P=0.500 P=0.760 P=0.753N |P=0.615 P=0.756 P=0.755N P=0.751 | |POLY 3 | P=0.524N P=0.495 P=0.757N P=0.757N |P=0.608 P=0.760 P=0.760N P=0.745 | |POLY 1.5 | P=0.526N P=0.497 P=0.758N P=0.758N |P=0.617 P=0.760 P=0.760 P=0.751 | |POLY 6 | P=0.522N P=0.493 P=0.757N P=0.756N |P=0.596 P=0.760 P=0.759N P=0.737 | |LOGISTIC REGRESSION| P=0.537N P=0.500 P=0.755 P=0.759 |P=0.587N P=0.758N P=0.737N P=0.715N | |COCH-ARM / FISHERS | P=0.530N P=0.500 P=0.753N P=0.753N |P=0.634 P=0.753N P=0.753N P=0.753N | |ORDER RESTRICTED | P=0.577N (e) (e) (e) |P=0.725 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/47.92 2/47.23 1/48.59 1/48.51 |1/46.94 1/46.86 0/46.69 1/43.75 | |POLY-3 PERCENT (g) | 2.1% 4.2% 2.1% 2.1% |2.1% 2.1% 0.0% 2.3% | |TERMINAL (d) | 1/44 (2%) 2/44 (5%) 0/44 (0%) 1/45 (2%) |0/40 (0%) 0/42 (0%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 730 (T) 730 (T) 683 730 (T) |606 703 --- 638 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.522N P=0.500 P=0.760 P=0.757N |P=0.638N P=0.756 P=0.504N P=0.751 | |POLY 3 | P=0.525N P=0.495 P=0.757N P=0.758N |P=0.619N P=0.760 P=0.501N P=0.745 | |POLY 1.5 | P=0.527N P=0.497 P=0.758N P=0.758N |P=0.618N P=0.760 P=0.501N P=0.751 | |POLY 6 | P=0.524N P=0.493 P=0.757N P=0.757N |P=0.620N P=0.760 P=0.501N P=0.737 | |LOGISTIC REGRESSION| P=0.527N P=0.500 P=0.755 P=0.757N |P=0.578N P=0.758N P=0.462N P=0.715N | |COCH-ARM / FISHERS | P=0.530N P=0.500 P=0.753N P=0.753N |P=0.616N P=0.753N P=0.500N P=0.753N | |ORDER RESTRICTED | P=0.577N (e) (e) (e) |P=0.552N (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 45 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular: Glands | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 13/50 (26%) 18/50 (36%) 5/50 (10%) |18/50 (36%) 16/50 (32%) 22/50 (44%) 10/50 (20%) | |POLY-3 RATE (b) | 7/48.66 13/47.37 18/48.88 5/49.04 |18/46.52 16/46.76 22/46.80 10/44.20 | |POLY-3 PERCENT (g) | 14.4% 27.4% 36.8% 10.2% |38.7% 34.2% 47.0% 22.6% | |TERMINAL (d) | 6/44 (14%) 12/44 (27%) 17/44 (39%) 4/45 (9%) |18/40 (45%) 16/42 (38%) 21/41 (51%) 9/31 (29%) | |FIRST INCIDENCE | 463 695 589 568 |729 (T) 729 (T) 700 435 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.252N P=0.109 P=0.011 * P=0.366N |P=0.269N P=0.342N P=0.293 P=0.198N | |POLY 3 | P=0.248N P=0.092 P=0.009 ** P=0.374N |P=0.097N P=0.407N P=0.273 P=0.074N | |POLY 1.5 | P=0.254N P=0.096 P=0.009 ** P=0.377N |P=0.084N P=0.413N P=0.266 P=0.067N | |POLY 6 | P=0.241N P=0.088 P=0.009 ** P=0.372N |P=0.117N P=0.400N P=0.282 P=0.085N | |LOGISTIC REGRESSION| P=0.277N P=0.105 P=0.009 ** P=0.439N |P=0.137N P=0.342N P=0.265 P=0.094N | |COCH-ARM / FISHERS | P=0.271N P=0.105 P=0.010 * P=0.380N |P=0.070N P=0.417N P=0.270 P=0.059N | |ORDER RESTRICTED | P=0.034N* (e) (e) (e) |P=0.060N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular: Glands | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 3/50 (6%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 1/48.41 1/48.51 |0/46.52 3/46.76 0/46.69 2/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 2.1% |0.0% 6.4% 0.0% 4.6% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 1/44 (2%) 1/45 (2%) |0/40 (0%) 3/42 (7%) 0/41 (0%) 2/31 (7%) | |FIRST INCIDENCE | --- --- 730 (T) 730 (T) |--- 729 (T) --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.241 (e) P=0.500 P=0.504 |P=0.265 P=0.130 (e) P=0.184 | |POLY 3 | P=0.241 (e) P=0.502 P=0.502 |P=0.329 P=0.120 (e) P=0.222 | |POLY 1.5 | P=0.240 (e) P=0.501 P=0.502 |P=0.336 P=0.119 (e) P=0.228 | |POLY 6 | P=0.243 (e) P=0.502 P=0.503 |P=0.319 P=0.120 (e) P=0.215 | |LOGISTIC REGRESSION| (e) (e) P=0.500 P=0.504 |(e) P=0.130 (e) P=0.184 | |COCH-ARM / FISHERS | P=0.235 (e) P=0.500 P=0.500 |P=0.351 P=0.121 (e) P=0.247 | |ORDER RESTRICTED | P=0.254 (e) (e) (e) |P=0.141 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 46 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Testes | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/50 (8%) 12/50 (24%) | | |POLY-3 RATE (b) | 0/47.92 1/47.23 4/48.44 12/49.08 | | |POLY-3 PERCENT (g) | 0.0% 2.1% 8.3% 24.5% | | |TERMINAL (d) | 0/44 (0%) 1/44 (2%) 3/44 (7%) 10/45 (22%) | | |FIRST INCIDENCE | --- 730 (T) 722 606 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.500 P=0.066 P<0.001 ** | | |POLY 3 | P<0.001 ** P=0.497 P=0.062 P<0.001 ** | | |POLY 1.5 | P<0.001 ** P=0.498 P=0.062 P<0.001 ** | | |POLY 6 | P<0.001 ** P=0.496 P=0.062 P<0.001 ** | | |LOGISTIC REGRESSION| P<0.001 ** P=0.500 P=0.064 P<0.001 ** | | |COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.059 P<0.001 ** | | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Testes: Germinal Epithelium | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 2/50 (4%) | | |POLY-3 RATE (b) | 0/47.92 3/47.23 1/48.41 2/48.94 | | |POLY-3 PERCENT (g) | 0.0% 6.4% 2.1% 4.1% | | |TERMINAL (d) | 0/44 (0%) 3/44 (7%) 1/44 (2%) 1/45 (2%) | | |FIRST INCIDENCE | --- 730 (T) 730 (T) 606 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.347 P=0.121 P=0.500 P=0.244 | | |POLY 3 | P=0.347 P=0.116 P=0.502 P=0.242 | | |POLY 1.5 | P=0.344 P=0.117 P=0.501 P=0.240 | | |POLY 6 | P=0.350 P=0.115 P=0.502 P=0.244 | | |LOGISTIC REGRESSION| P=0.323 P=0.121 P=0.500 P=0.173 | | |COCH-ARM / FISHERS | P=0.337 P=0.121 P=0.500 P=0.247 | | |ORDER RESTRICTED | P=0.186 (e) (e) (e) | | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 47 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 12/46 (26%) 9/48 (19%) 6/46 (13%) 5/47 (11%) |8/46 (17%) 7/50 (14%) 3/50 (6%) 13/50 (26%) | |POLY-3 RATE (b) | 12/45.15 9/47.57 6/45.01 5/46.35 |8/44.27 7/49.39 3/47.22 13/45.70 | |POLY-3 PERCENT (g) | 26.6% 18.9% 13.3% 10.8% |18.1% 14.2% 6.4% 28.5% | |TERMINAL (d) | 8/40 (20%) 5/43 (12%) 5/42 (12%) 3/43 (7%) |4/38 (11%) 2/42 (5%) 0/41 (0%) 2/31 (7%) | |FIRST INCIDENCE | 540 449 683 656 |606 316 634 536 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.033N* P=0.290N P=0.093N P=0.051N |P=0.060 P=0.470N P=0.102N P=0.103 | |POLY 3 | P=0.031N* P=0.265N P=0.094N P=0.045N* |P=0.100 P=0.409N P=0.079N P=0.180 | |POLY 1.5 | P=0.031N* P=0.267N P=0.093N P=0.046N* |P=0.107 P=0.417N P=0.079N P=0.193 | |POLY 6 | P=0.031N* P=0.264N P=0.096N P=0.046N* |P=0.095 P=0.404N P=0.080N P=0.171 | |LOGISTIC REGRESSION| P=0.054N P=0.236N P=0.112N P=0.067N |P=0.200 P=0.356N P=0.072N P=0.244 | |COCH-ARM / FISHERS | P=0.032N* P=0.272N P=0.094N P=0.048N* |P=0.125 P=0.429N P=0.076N P=0.221 | |ORDER RESTRICTED | P=0.032N* (e) (e) (e) |P=0.032 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 16/46 (35%) 25/48 (52%) 20/46 (43%) 20/47 (43%) |23/46 (50%) 35/50 (70%) 31/50 (62%) 24/50 (48%) | |POLY-3 RATE (b) | 16/44.02 25/46.05 20/44.83 20/45.94 |23/44.27 35/48.16 31/48.80 24/45.91 | |POLY-3 PERCENT (g) | 36.4% 54.3% 44.6% 43.5% |52.0% 72.7% 63.5% 52.3% | |TERMINAL (d) | 15/40 (38%) 24/43 (56%) 20/42 (48%) 20/43 (47%) |20/38 (53%) 31/42 (74%) 27/41 (66%) 18/31 (58%) | |FIRST INCIDENCE | 703 606 730 (T) 730 (T) |606 561 204 400 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.505 P=0.083 P=0.321 P=0.354 |P=0.264 P=0.047 * P=0.154 P=0.198 | |POLY 3 | P=0.466 P=0.065 P=0.282 P=0.316 |P=0.313N P=0.029 * P=0.177 P=0.572 | |POLY 1.5 | P=0.452 P=0.065 P=0.275 P=0.307 |P=0.274N P=0.030 * P=0.174 P=0.561N | |POLY 6 | P=0.478 P=0.065 P=0.289 P=0.324 |P=0.369N P=0.030 * P=0.176 P=0.529 | |LOGISTIC REGRESSION| P=0.499 P=0.062 P=0.318 P=0.348 |P=0.280N P=0.028 * P=0.161 P=0.570 | |COCH-ARM / FISHERS | P=0.424 P=0.069 P=0.261 P=0.289 |P=0.222N P=0.036 * P=0.164 P=0.503N | |ORDER RESTRICTED | P=0.226 (e) (e) (e) |P=0.223 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 48 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Ectopic Parathyroid Gland | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/46 (4%) 0/48 (0%) 0/46 (0%) 0/47 (0%) |1/46 (2%) 3/50 (6%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 2/44.02 0/45.62 0/44.83 0/45.94 |1/43.68 3/46.76 1/46.69 1/43.48 | |POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |2.3% 6.4% 2.1% 2.3% | |TERMINAL (d) | 1/40 (3%) 0/43 (0%) 0/42 (0%) 0/43 (0%) |1/38 (3%) 3/42 (7%) 1/41 (2%) 0/31 (0%) | |FIRST INCIDENCE | 703 --- --- --- |729 (T) 729 (T) 729 (T) 714 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.113N P=0.234N P=0.234N P=0.232N |P=0.524N P=0.342 P=0.745N P=0.713 | |POLY 3 | P=0.112N P=0.229N P=0.233N P=0.228N |P=0.450N P=0.330 P=0.746N P=0.760 | |POLY 1.5 | P=0.112N P=0.229N P=0.235N P=0.229N |P=0.439N P=0.332 P=0.745N P=0.754N | |POLY 6 | P=0.112N P=0.230N P=0.232N P=0.226N |P=0.462N P=0.329 P=0.746N P=0.751 | |LOGISTIC REGRESSION| P=0.114N P=0.228N P=0.239N P=0.235N |P=0.488N P=0.342 P=0.745N P=0.752 | |COCH-ARM / FISHERS | P=0.114N P=0.237N P=0.247N P=0.242N |P=0.420N P=0.341 P=0.731N P=0.731N | |ORDER RESTRICTED | P=0.026N* (e) (e) (e) |P=0.454N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/46 (0%) 0/48 (0%) 0/46 (0%) 0/47 (0%) |0/46 (0%) 8/50 (16%) 5/50 (10%) 2/50 (4%) | |POLY-3 RATE (b) | 0/43.92 0/45.62 0/44.83 0/45.94 |0/43.68 8/46.76 5/46.78 2/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 17.1% 10.7% 4.6% | |TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/42 (0%) 0/43 (0%) |0/38 (0%) 8/42 (19%) 4/41 (10%) 2/31 (7%) | |FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 704 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.462 P=0.007 ** P=0.040 * P=0.195 | |POLY 3 | (e) (e) (e) (e) |P=0.549 P=0.005 ** P=0.037 * P=0.236 | |POLY 1.5 | (e) (e) (e) (e) |P=0.563N P=0.005 ** P=0.037 * P=0.243 | |POLY 6 | (e) (e) (e) (e) |P=0.511 P=0.005 ** P=0.036 * P=0.227 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.506 P=0.007 ** P=0.039 * P=0.195 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.515N P=0.004 ** P=0.035 * P=0.269 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.045 * (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 49 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 0/47.92 0/47.23 1/48.41 1/48.51 |0/46.52 1/46.76 2/46.78 2/43.42 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 2.1% |0.0% 2.1% 4.3% 4.6% | |TERMINAL (d) | 0/44 (0%) 0/44 (0%) 1/44 (2%) 1/45 (2%) |0/40 (0%) 1/42 (2%) 1/41 (2%) 2/31 (7%) | |FIRST INCIDENCE | --- --- 730 (T) 730 (T) |--- 729 (T) 704 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.241 (e) P=0.500 P=0.504 |P=0.106 P=0.510 P=0.240 P=0.184 | |POLY 3 | P=0.241 (e) P=0.502 P=0.502 |P=0.140 P=0.501 P=0.239 P=0.222 | |POLY 1.5 | P=0.240 (e) P=0.501 P=0.502 |P=0.148 P=0.500 P=0.237 P=0.228 | |POLY 6 | P=0.243 (e) P=0.502 P=0.503 |P=0.131 P=0.502 P=0.240 P=0.215 | |LOGISTIC REGRESSION| (e) (e) P=0.500 P=0.504 |P=0.129 P=0.510 P=0.238 P=0.184 | |COCH-ARM / FISHERS | P=0.235 (e) P=0.500 P=0.500 |P=0.160 P=0.500 P=0.247 P=0.247 | |ORDER RESTRICTED | P=0.254 (e) (e) (e) |P=0.144 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 2/48.02 0/47.23 0/48.41 0/48.51 |0/46.52 1/47.08 2/47.40 0/43.42 | |POLY-3 PERCENT (g) | 4.2% 0.0% 0.0% 0.0% |0.0% 2.1% 4.2% 0.0% | |TERMINAL (d) | 1/44 (2%) 0/44 (0%) 0/44 (0%) 0/45 (0%) |0/40 (0%) 0/42 (0%) 1/41 (2%) 0/31 (0%) | |FIRST INCIDENCE | 703 --- --- --- |--- 641 478 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.115N P=0.242N P=0.240N P=0.237N |P=0.648N P=0.509 P=0.245 (e) | |POLY 3 | P=0.112N P=0.241N P=0.236N P=0.235N |P=0.644N P=0.502 P=0.242 (e) | |POLY 1.5 | P=0.113N P=0.240N P=0.236N P=0.236N |P=0.633N P=0.501 P=0.239 (e) | |POLY 6 | P=0.112N P=0.243N P=0.236N P=0.235N |P=0.629 P=0.504 P=0.244 (e) | |LOGISTIC REGRESSION| P=0.115N P=0.238N P=0.239N P=0.239N |P=0.558N P=0.510 P=0.269 (e) | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.616N P=0.500 P=0.247 (e) | |ORDER RESTRICTED | P=0.029N* (e) (e) (e) |P=0.329 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 50 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicle | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/48.02 0/47.23 0/48.41 1/48.51 |0/46.52 1/46.76 0/46.69 0/43.42 | |POLY-3 PERCENT (g) | 4.2% 0.0% 0.0% 2.1% |0.0% 2.1% 0.0% 0.0% | |TERMINAL (d) | 1/44 (2%) 0/44 (0%) 0/44 (0%) 1/45 (2%) |0/40 (0%) 1/42 (2%) 0/41 (0%) 0/31 (0%) | |FIRST INCIDENCE | 703 --- --- 730 (T) |--- 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.457N P=0.242N P=0.240N P=0.495N |P=0.609N P=0.510 (e) (e) | |POLY 3 | P=0.458N P=0.241N P=0.236N P=0.496N |P=0.568N P=0.501 (e) (e) | |POLY 1.5 | P=0.459N P=0.240N P=0.236N P=0.497N |P=0.568N P=0.500 (e) (e) | |POLY 6 | P=0.456N P=0.243N P=0.236N P=0.496N |P=0.567N P=0.502 (e) (e) | |LOGISTIC REGRESSION| P=0.458N P=0.238N P=0.239N P=0.498N |(e) P=0.510 (e) (e) | |COCH-ARM / FISHERS | P=0.461N P=0.247N P=0.247N P=0.500N |P=0.567N P=0.500 (e) (e) | |ORDER RESTRICTED | P=0.130N (e) (e) (e) |P=0.394N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicle | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 9/50 (18%) 6/50 (12%) 6/50 (12%) |17/50 (34%) 19/50 (38%) 12/50 (24%) 9/50 (18%) | |POLY-3 RATE (b) | 12/48.02 9/47.37 6/49.08 6/48.51 |17/47.85 19/46.95 12/48.01 9/43.52 | |POLY-3 PERCENT (g) | 25.0% 19.0% 12.2% 12.4% |35.5% 40.5% 25.0% 20.7% | |TERMINAL (d) | 11/44 (25%) 8/44 (18%) 4/44 (9%) 6/45 (13%) |13/40 (33%) 18/42 (43%) 10/41 (24%) 8/31 (26%) | |FIRST INCIDENCE | 703 695 589 730 (T) |606 680 204 704 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.062N P=0.315N P=0.102N P=0.089N |P=0.084N P=0.480 P=0.182N P=0.180N | |POLY 3 | P=0.059N P=0.324N P=0.086N P=0.091N |P=0.032N* P=0.388 P=0.184N P=0.089N | |POLY 1.5 | P=0.061N P=0.319N P=0.090N P=0.092N |P=0.025N* P=0.400 P=0.184N P=0.073N | |POLY 6 | P=0.058N P=0.328N P=0.083N P=0.090N |P=0.043N* P=0.373 P=0.188N P=0.114N | |LOGISTIC REGRESSION| P=0.061N P=0.330N P=0.097N P=0.089N |P=0.023N* P=0.422 P=0.184N P=0.077N | |COCH-ARM / FISHERS | P=0.065N P=0.312N P=0.096N P=0.096N |P=0.018N* P=0.418 P=0.189N P=0.055N | |ORDER RESTRICTED | P=0.073N (e) (e) (e) |P=0.052N (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 51 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Tooth | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/20 (5%) 0/31 (0%) 3/33 (9%) 0/21 (0%) |0/21 (0%) 0/29 (0%) 0/24 (0%) 0/20 (0%) | |POLY-3 RATE (b) | 1/19.41 0/29.11 3/31.82 0/20.06 |0/20.57 0/28.41 0/23.48 0/18.14 | |POLY-3 PERCENT (g) | 5.2% 0.0% 9.4% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/19 (5%) 0/27 (0%) 2/29 (7%) 0/18 (0%) |0/20 (0%) 0/26 (0%) 0/21 (0%) 0/13 (0%) | |FIRST INCIDENCE | 730 (T) --- 679 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.524N P=0.430N P=0.425 P=0.511N |(e) (e) (e) (e) | |POLY 3 | P=0.514N P=0.418N P=0.494 P=0.493N |(e) (e) (e) (e) | |POLY 1.5 | P=0.514N P=0.416N P=0.495 P=0.492N |(e) (e) (e) (e) | |POLY 6 | P=0.517N P=0.421N P=0.490 P=0.497N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.516N (e) P=0.497 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.516N P=0.392N P=0.512 P=0.488N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.365N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Tooth | | Malformation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/20 (15%) 1/31 (3%) 3/33 (9%) 0/21 (0%) |0/21 (0%) 0/29 (0%) 1/24 (4%) 0/20 (0%) | |POLY-3 RATE (b) | 3/19.41 1/29.11 3/31.82 0/20.06 |0/20.57 0/28.41 1/23.48 0/18.14 | |POLY-3 PERCENT (g) | 15.5% 3.4% 9.4% 0.0% |0.0% 0.0% 4.3% 0.0% | |TERMINAL (d) | 3/19 (16%) 1/27 (4%) 2/29 (7%) 0/18 (0%) |0/20 (0%) 0/26 (0%) 1/21 (5%) 0/13 (0%) | |FIRST INCIDENCE | 730 (T) 730 (T) 679 --- |--- --- 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.133N P=0.186N P=0.491N P=0.127N |P=0.648 (e) P=0.510 (e) | |POLY 3 | P=0.113N P=0.167N P=0.421N P=0.105N |P=0.649 (e) P=0.526 (e) | |POLY 1.5 | P=0.114N P=0.164N P=0.419N P=0.104N |P=0.664 (e) P=0.527 (e) | |POLY 6 | P=0.114N P=0.171N P=0.425N P=0.107N |P=0.626 (e) P=0.525 (e) | |LOGISTIC REGRESSION| P=0.118N P=0.186N P=0.419N (e) |(e) (e) P=0.510 (e) | |COCH-ARM / FISHERS | P=0.117N P=0.161N P=0.406N P=0.107N |P=0.685 (e) P=0.533 (e) | |ORDER RESTRICTED | P=0.067N (e) (e) (e) |P=0.405 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 52 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Tooth: Gingiva | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 18/20 (90%) 30/31 (97%) 32/33 (97%) 20/21 (95%) |21/21 (100%) 29/29 (100%) 24/24 (100%) 20/20 (100%) | |POLY-3 RATE (b) | 18/20.00 30/31.00 32/33.00 20/21.00 |21/21.00 29/29.00 24/24.00 20/20.00 | |POLY-3 PERCENT (g) | 90.0% 96.8% 97.0% 95.2% |100.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 17/19 (90%) 26/27 (96%) 28/29 (97%) 17/18 (94%) |20/20 (100%) 26/26 (100%) 21/21 (100%) 13/13 (100%) | |FIRST INCIDENCE | 540 449 585 568 |606 641 645 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.293 P=0.105 P=0.100 P=0.239 |(e) (e) (e) (e) | |POLY 3 | P=0.417 P=0.348 P=0.327 P=0.483 |(e) (e) (e) (e) | |POLY 1.5 | P=0.417 P=0.348 P=0.327 P=0.483 |(e) (e) (e) (e) | |POLY 6 | P=0.417 P=0.348 P=0.327 P=0.483 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.416 P=0.338 P=0.316 P=0.481 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.313 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Urinary Bladder | | Infiltration Cellular Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 24/50 (48%) 24/50 (48%) 32/50 (64%) 23/50 (46%) |37/50 (74%) 38/49 (78%) 40/50 (80%) 39/50 (78%) | |POLY-3 RATE (b) | 24/48.07 24/47.85 32/49.59 23/48.51 |37/47.60 38/48.08 40/48.52 39/46.58 | |POLY-3 PERCENT (g) | 49.9% 50.2% 64.5% 47.4% |77.7% 79.0% 82.4% 83.7% | |TERMINAL (d) | 23/44 (52%) 22/44 (50%) 29/44 (66%) 23/45 (51%) |32/40 (80%) 33/41 (81%) 35/41 (85%) 27/31 (87%) | |FIRST INCIDENCE | 690 585 585 730 (T) |606 316 478 400 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.478N P=0.578 P=0.084 P=0.457N |P=0.012 * P=0.564 P=0.398 P=0.031 * | |POLY 3 | P=0.497N P=0.572 P=0.103 P=0.483N |P=0.243 P=0.537 P=0.371 P=0.310 | |POLY 1.5 | P=0.506N P=0.574 P=0.093 P=0.487N |P=0.286 P=0.500 P=0.336 P=0.347 | |POLY 6 | P=0.495N P=0.572 P=0.114 P=0.483N |P=0.194 P=0.566 P=0.403 P=0.261 | |LOGISTIC REGRESSION| P=0.483N P=0.542 P=0.086 P=0.465N |P=0.237 P=0.428 P=0.310 P=0.230 | |COCH-ARM / FISHERS | P=0.529N P=0.579N P=0.079 P=0.500N |P=0.369 P=0.430 P=0.318 P=0.408 | |ORDER RESTRICTED | P=0.360N (e) (e) (e) |P=0.359 (e) (e) (e) | |=================================================================================================================================| Date: 06/01/04 EXPERIMENT: 88138 TEST: 04 Page 53 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - BENZOPHENONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |5/49 (10%) 4/50 (8%) 2/50 (4%) 2/50 (4%) | |POLY-3 RATE (b) | |5/46.83 4/46.76 2/46.84 2/43.42 | |POLY-3 PERCENT (g) | |10.7% 8.6% 4.3% 4.6% | |TERMINAL (d) | |3/40 (8%) 4/42 (10%) 1/41 (2%) 2/31 (7%) | |FIRST INCIDENCE | |608 729 (T) 690 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.204N P=0.478N P=0.217N P=0.316N | |POLY 3 | |P=0.149N P=0.501N P=0.216N P=0.248N | |POLY 1.5 | |P=0.141N P=0.497N P=0.215N P=0.233N | |POLY 6 | |P=0.158N P=0.505N P=0.217N P=0.268N | |LOGISTIC REGRESSION| |P=0.144N P=0.490N P=0.204N P=0.227N | |COCH-ARM / FISHERS | |P=0.127N P=0.487N P=0.210N P=0.210N | |ORDER RESTRICTED | |P=0.199N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM | | | | | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |47/49 (96%) 45/50 (90%) 44/50 (88%) 43/50 (86%) | |POLY-3 RATE (b) | |47/47.84 45/48.90 44/49.35 43/48.18 | |POLY-3 PERCENT (g) | |98.3% 92.0% 89.2% 89.3% | |TERMINAL (d) | |40/40 (100%) 40/42 (95%) 39/41 (95%) 29/31 (94%) | |FIRST INCIDENCE | |606 522 204 400 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.066 P=0.215N P=0.215N P=0.147 | |POLY 3 | |P=0.072N P=0.154N P=0.061N P=0.059N | |POLY 1.5 | |P=0.072N P=0.189N P=0.085N P=0.068N | |POLY 6 | |P=0.080N P=0.115N P=0.046N* P=0.053N | |LOGISTIC REGRESSION| |P=0.152N P=0.280N P=0.174N P=0.203N | |COCH-ARM / FISHERS | |P=0.080N P=0.226N P=0.141N P=0.085N | |ORDER RESTRICTED | |P=0.059N (e) (e) (e) | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Number of tumor-bearing animals / Poly-3 number (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (g) Poly-3 adjusted lifetime tumor incidence. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).