TDMS Study 96010-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) DATE: 03/26/03 EXPERIMENT: 96010 TEST: 04 TIME: 10:44:15 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: 96010A PATHOLOGIST: HEATH, JAMES E. CAS: 7775-09-9 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#1/MICE REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) DATE: 03/26/03 EXPERIMENT: 96010 TEST: 04 TIME: 10:44:15 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: 96010A PATHOLOGIST: HEATH, JAMES E. CAS: 7775-09-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF WATER DISINFECTION BYPRODUCTS (SODIUM =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex Hyperplasia Focal Adrenal Cortex: Capsule Hyperplasia Bone Marrow Hyperplasia Epididymis Atypia Cellular Heart Cardiomyopathy Intestine Small, Jejunum: Epithelium Hyperplasia Liver Basophilic Focus Hematopoietic Cell Proliferation Mixed Cell Focus Liver: Bile Duct Hyperplasia Nose Inflammation Chronic Pancreas Cyst Pituitary Gland: Pars Distalis Cyst Preputial Gland Cyst Inflammation Chronic Seminal Vesicle Inflammation Chronic Skin Edema Ulcer Stomach, Forestomach Cyst =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Bone Marrow Hyperplasia Clitoral Gland Inflammation Chronic Eye Inflammation Chronic Islets, Pancreatic Hyperplasia Liver Basophilic Focus Clear Cell Focus Liver: Hepatocyte Karyomegaly Lung Foreign Body Hyperplasia Lymphoid Infiltration Cellular Histiocyte Lymph Node, Mesenteric Hemorrhage Ovary Thrombosis Ovary: Follicle Hemorrhage Ovary: Granulosa Cell Hyperplasia Thyroid Gland Degeneration Cystic Thyroid Gland: Follicular Cell Cyst Hypertrophy Urinary Bladder Hyperplasia Lymphoid Uterus Hyperplasia Cystic =============================================================== Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Accessory Adrenal Cortical Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 5/50 (10%) 3/50 (6%) 5/50 (10%) |4/50 (8%) 2/49 (4%) 7/49 (14%) 7/50 (14%) | |POLY-3 RATE (b) | 6/45.15 5/47.28 3/46.95 5/44.19 |4/44.38 2/44.88 7/42.43 7/44.58 | |POLY-3 PERCENT (g) | 13.3% 10.6% 6.4% 11.3% |9.0% 4.5% 16.5% 15.7% | |TERMINAL (d) | 5/38 (13%) 5/41 (12%) 1/41 (2%) 4/33 (12%) |1/36 (3%) 1/34 (3%) 5/31 (16%) 5/35 (14%) | |FIRST INCIDENCE | 561 729 (T) 667 616 |591 568 618 142 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.508N P=0.451N P=0.211N P=0.581N |P=0.103 P=0.340N P=0.219 P=0.263 | |POLY 3 | P=0.436N P=0.468N P=0.223N P=0.515N |P=0.097 P=0.332N P=0.234 P=0.263 | |POLY 1.5 | P=0.429N P=0.480N P=0.230N P=0.508N |P=0.100 P=0.337N P=0.234 P=0.264 | |POLY 6 | P=0.445N P=0.453N P=0.215N P=0.525N |P=0.094 P=0.327N P=0.232 P=0.261 | |LOGISTIC REGRESSION| P=0.429N P=0.468N P=0.248N P=0.507N |P=0.107 P=0.371N P=0.240 P=0.274 | |COCH-ARM / FISHERS | P=0.419N P=0.500N P=0.243N P=0.500N |P=0.103 P=0.349N P=0.251 P=0.262 | |ORDER RESTRICTED | P=0.391N (e) (e) (e) |P=0.122 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Fatty | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/44.60 1/47.28 0/46.48 2/43.80 |0/43.63 0/44.35 0/42.00 0/43.40 | |POLY-3 PERCENT (g) | 2.2% 2.1% 0.0% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/38 (3%) 1/41 (2%) 0/41 (0%) 2/33 (6%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.318 P=0.745N P=0.485N P=0.451 |(e) (e) (e) (e) | |POLY 3 | P=0.360 P=0.747N P=0.492N P=0.494 |(e) (e) (e) (e) | |POLY 1.5 | P=0.363 P=0.752N P=0.494N P=0.497 |(e) (e) (e) (e) | |POLY 6 | P=0.355 P=0.741N P=0.489N P=0.489 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.318 P=0.745N (e) P=0.451 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.366 P=0.753N P=0.500N P=0.500 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.258 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 6/50 (12%) 7/50 (14%) 9/50 (18%) |0/50 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 4/44.72 6/47.28 7/46.48 9/43.84 |0/43.63 0/44.35 1/42.00 0/43.40 | |POLY-3 PERCENT (g) | 8.9% 12.7% 15.1% 20.5% |0.0% 0.0% 2.4% 0.0% | |TERMINAL (d) | 3/38 (8%) 6/41 (15%) 7/41 (17%) 8/33 (24%) |0/36 (0%) 0/34 (0%) 1/31 (3%) 0/35 (0%) | |FIRST INCIDENCE | 699 729 (T) 729 (T) 719 |--- --- 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.042 * P=0.421 P=0.305 P=0.075 |P=0.687 (e) P=0.470 (e) | |POLY 3 | P=0.076 P=0.405 P=0.283 P=0.106 |P=0.689 (e) P=0.492 (e) | |POLY 1.5 | P=0.081 P=0.392 P=0.277 P=0.111 |P=0.690 (e) P=0.491 (e) | |POLY 6 | P=0.068 P=0.421 P=0.289 P=0.099 |P=0.690 (e) P=0.493 (e) | |LOGISTIC REGRESSION| P=0.050 P=0.440 P=0.299 P=0.090 |(e) (e) P=0.470 (e) | |COCH-ARM / FISHERS | P=0.088 P=0.370 P=0.262 P=0.117 |P=0.694 (e) P=0.495 (e) | |ORDER RESTRICTED | P=0.094 (e) (e) (e) |P=0.374 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 16/50 (32%) 11/50 (22%) 11/50 (22%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 9/44.60 16/47.41 11/46.48 11/44.40 |0/43.63 0/44.35 0/42.00 0/43.40 | |POLY-3 PERCENT (g) | 20.2% 33.8% 23.7% 24.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 9/38 (24%) 13/41 (32%) 11/41 (27%) 10/33 (30%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 713 729 (T) 535 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.380 P=0.127 P=0.475 P=0.273 |(e) (e) (e) (e) | |POLY 3 | P=0.540 P=0.108 P=0.441 P=0.395 |(e) (e) (e) (e) | |POLY 1.5 | P=0.542N P=0.097 P=0.428 P=0.399 |(e) (e) (e) (e) | |POLY 6 | P=0.524 P=0.124 P=0.454 P=0.387 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.468 P=0.143 P=0.475 P=0.364 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.534N P=0.083 P=0.402 P=0.402 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.345 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Adrenal Cortex: Capsule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 1/50 (2%) 8/50 (16%) |0/50 (0%) 0/49 (0%) 1/49 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 5/44.60 3/47.34 1/46.48 8/44.86 |0/43.63 0/44.35 1/42.00 2/44.56 | |POLY-3 PERCENT (g) | 11.2% 6.3% 2.2% 17.8% |0.0% 0.0% 2.4% 4.5% | |TERMINAL (d) | 5/38 (13%) 1/41 (2%) 1/41 (2%) 6/33 (18%) |0/36 (0%) 0/34 (0%) 1/31 (3%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 721 729 (T) 535 |--- --- 729 (T) 447 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.094 P=0.314N P=0.086N P=0.206 |P=0.073 (e) P=0.470 P=0.247 | |POLY 3 | P=0.134 P=0.324N P=0.092N P=0.278 |P=0.072 (e) P=0.492 P=0.242 | |POLY 1.5 | P=0.136 P=0.337N P=0.095N P=0.278 |P=0.071 (e) P=0.491 P=0.239 | |POLY 6 | P=0.129 P=0.309N P=0.089N P=0.276 |P=0.073 (e) P=0.493 P=0.246 | |LOGISTIC REGRESSION| P=0.133 P=0.292N P=0.086N P=0.269 |P=0.077 (e) P=0.470 P=0.273 | |COCH-ARM / FISHERS | P=0.142 P=0.357N P=0.102N P=0.277 |P=0.071 (e) P=0.495 P=0.247 | |ORDER RESTRICTED | P=0.046 * (e) (e) (e) |P=0.077 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/48 (2%) 1/49 (2%) 0/49 (0%) |2/50 (4%) 0/49 (0%) 2/49 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 1/43.98 1/45.28 1/45.48 0/42.80 |2/43.63 0/44.35 2/42.00 1/43.40 | |POLY-3 PERCENT (g) | 2.3% 2.2% 2.2% 0.0% |4.6% 0.0% 4.8% 2.3% | |TERMINAL (d) | 1/38 (3%) 1/39 (3%) 1/40 (3%) 0/32 (0%) |2/36 (6%) 0/34 (0%) 2/31 (7%) 1/35 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |729 (T) --- 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.345N P=0.756N P=0.750N P=0.534N |P=0.539N P=0.251N P=0.641 P=0.510N | |POLY 3 | P=0.319N P=0.754N P=0.753N P=0.505N |P=0.539N P=0.233N P=0.681 P=0.502N | |POLY 1.5 | P=0.316N P=0.758N P=0.755N P=0.503N |P=0.537N P=0.236N P=0.678 P=0.503N | |POLY 6 | P=0.324N P=0.749N P=0.751N P=0.510N |P=0.542N P=0.229N P=0.682 P=0.500N | |LOGISTIC REGRESSION| P=0.345N P=0.756N P=0.750N (e) |P=0.539N (e) P=0.641 P=0.510N | |COCH-ARM / FISHERS | P=0.310N P=0.747 P=0.753N P=0.500N |P=0.529N P=0.253N P=0.684 P=0.500N | |ORDER RESTRICTED | P=0.332N (e) (e) (e) |P=0.415N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Bone | | Fracture | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 1/44.60 1/47.28 0/46.48 2/43.80 |0/43.63 0/45.35 1/43.33 1/43.40 | |POLY-3 PERCENT (g) | 2.2% 2.1% 0.0% 4.6% |0.0% 0.0% 2.3% 2.3% | |TERMINAL (d) | 1/38 (3%) 1/41 (2%) 0/41 (0%) 2/33 (6%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 1/35 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |--- --- 34 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.318 P=0.745N P=0.485N P=0.451 |P=0.235 (e) P=0.496 P=0.494 | |POLY 3 | P=0.360 P=0.747N P=0.492N P=0.494 |P=0.231 (e) P=0.499 P=0.499 | |POLY 1.5 | P=0.363 P=0.752N P=0.494N P=0.497 |P=0.232 (e) P=0.498 P=0.498 | |POLY 6 | P=0.355 P=0.741N P=0.489N P=0.489 |P=0.231 (e) P=0.498 P=0.500 | |LOGISTIC REGRESSION| P=0.318 P=0.745N (e) P=0.451 |P=0.284 (e) (e) P=0.494 | |COCH-ARM / FISHERS | P=0.366 P=0.753N P=0.500N P=0.500 |P=0.236 (e) P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.258 (e) (e) (e) |P=0.250 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Bone | | Hyperostosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 4/50 (8%) 3/50 (6%) | |POLY-3 RATE (b) | 1/44.97 1/47.28 0/46.48 0/43.80 |1/43.63 1/45.35 4/42.33 3/43.40 | |POLY-3 PERCENT (g) | 2.2% 2.1% 0.0% 0.0% |2.3% 2.2% 9.5% 6.9% | |TERMINAL (d) | 0/38 (0%) 1/41 (2%) 0/41 (0%) 0/33 (0%) |1/36 (3%) 1/35 (3%) 4/31 (13%) 3/35 (9%) | |FIRST INCIDENCE | 625 729 (T) --- --- |729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.246N P=0.744N P=0.491N P=0.505N |P=0.155 P=0.756 P=0.136 P=0.295 | |POLY 3 | P=0.236N P=0.749N P=0.493N P=0.505N |P=0.155 P=0.752N P=0.169 P=0.303 | |POLY 1.5 | P=0.236N P=0.753N P=0.495N P=0.503N |P=0.157 P=0.755N P=0.169 P=0.302 | |POLY 6 | P=0.236N P=0.744N P=0.492N P=0.509N |P=0.155 P=0.748N P=0.168 P=0.305 | |LOGISTIC REGRESSION| P=0.233N P=0.745 P=0.566N P=0.494N |P=0.155 P=0.756 P=0.136 P=0.295 | |COCH-ARM / FISHERS | P=0.236N P=0.753N P=0.500N P=0.500N |P=0.164 P=0.753N P=0.181 P=0.309 | |ORDER RESTRICTED | P=0.256N (e) (e) (e) |P=0.164 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 21/49 (43%) 12/50 (24%) 13/50 (26%) 15/50 (30%) |14/50 (28%) 28/50 (56%) 29/50 (58%) 31/50 (62%) | |POLY-3 RATE (b) | 21/47.37 12/48.71 13/49.20 15/46.97 |14/44.95 28/49.24 29/47.62 31/48.28 | |POLY-3 PERCENT (g) | 44.3% 24.6% 26.4% 31.9% |31.2% 56.9% 60.9% 64.2% | |TERMINAL (d) | 13/38 (34%) 7/41 (17%) 6/41 (15%) 4/33 (12%) |11/36 (31%) 16/35 (46%) 17/31 (55%) 20/35 (57%) | |FIRST INCIDENCE | 561 574 558 535 |440 461 27 142 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.340N P=0.038N* P=0.066N P=0.264N |P=0.005 ** P=0.011 * P=0.002 ** P=0.002 ** | |POLY 3 | P=0.216N P=0.033N* P=0.050N P=0.151N |P=0.003 ** P=0.009 ** P=0.003 ** P<0.001 ** | |POLY 1.5 | P=0.209N P=0.034N* P=0.053N P=0.145N |P=0.002 ** P=0.006 ** P=0.002 ** P<0.001 ** | |POLY 6 | P=0.224N P=0.031N* P=0.047N* P=0.158N |P=0.004 ** P=0.014 * P=0.004 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.119N P=0.051N P=0.074N P=0.102N |P=0.002 ** P=0.004 ** P=0.003 ** P<0.001 ** | |COCH-ARM / FISHERS | P=0.194N P=0.037N* P=0.060N P=0.131N |P=0.002 ** P=0.004 ** P=0.002 ** P<0.001 ** | |ORDER RESTRICTED | P=0.060N (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Bone Marrow | | Myelofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 0/44.53 0/47.28 0/46.48 0/43.80 |1/43.63 2/45.35 1/42.33 2/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 4.4% 2.4% 4.6% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |1/36 (3%) 2/35 (6%) 1/31 (3%) 2/35 (6%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.432 P=0.490 P=0.728 P=0.490 | |POLY 3 | (e) (e) (e) (e) |P=0.438 P=0.514 P=0.754 P=0.498 | |POLY 1.5 | (e) (e) (e) (e) |P=0.438 P=0.509 P=0.754 P=0.497 | |POLY 6 | (e) (e) (e) (e) |P=0.438 P=0.520 P=0.754 P=0.500 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.432 P=0.490 P=0.728 P=0.490 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.444 P=0.500 P=0.753N P=0.500 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.441 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |0/47 (0%) 2/47 (4%) 0/47 (0%) 4/49 (8%) | |POLY-3 RATE (b) | |0/41.57 2/43.05 0/39.58 4/42.79 | |POLY-3 PERCENT (g) | |0.0% 4.7% 0.0% 9.4% | |TERMINAL (d) | |0/34 (0%) 1/33 (3%) 0/29 (0%) 3/34 (9%) | |FIRST INCIDENCE | |--- 717 --- 618 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.037 * P=0.242 (e) P=0.066 | |POLY 3 | |P=0.035 * P=0.245 (e) P=0.063 | |POLY 1.5 | |P=0.035 * P=0.241 (e) P=0.063 | |POLY 6 | |P=0.035 * P=0.250 (e) P=0.065 | |LOGISTIC REGRESSION| |P=0.035 * P=0.252 (e) P=0.066 | |COCH-ARM / FISHERS | |P=0.038 * P=0.247 (e) P=0.064 | |ORDER RESTRICTED | |P=0.012 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Epididymis | | Atypia Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 6/50 (12%) 4/50 (8%) 3/50 (6%) | | |POLY-3 RATE (b) | 1/44.93 6/48.51 4/47.24 3/45.00 | | |POLY-3 PERCENT (g) | 2.2% 12.4% 8.5% 6.7% | | |TERMINAL (d) | 0/38 (0%) 2/41 (5%) 2/41 (5%) 0/33 (0%) | | |FIRST INCIDENCE | 638 577 562 465 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.422 P=0.083 P=0.206 P=0.306 | | |POLY 3 | P=0.461 P=0.070 P=0.194 P=0.306 | | |POLY 1.5 | P=0.463 P=0.064 P=0.189 P=0.306 | | |POLY 6 | P=0.454 P=0.077 P=0.200 P=0.303 | | |LOGISTIC REGRESSION| P=0.506 P=0.035 * P=0.136 P=0.314 | | |COCH-ARM / FISHERS | P=0.463 P=0.056 P=0.181 P=0.309 | | |ORDER RESTRICTED | P=0.166 (e) (e) (e) | | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Eye | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |3/50 (6%) 3/48 (6%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.86 0/47.28 3/46.72 0/43.80 |3/43.63 3/44.87 0/42.33 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 6.4% 0.0% |6.9% 6.7% 0.0% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 2/41 (5%) 0/33 (0%) |3/36 (8%) 1/35 (3%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- 667 --- |729 (T) 673 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.506 (e) P=0.141 (e) |P=0.039N* P=0.656N P=0.148N P=0.126N | |POLY 3 | P=0.515 (e) P=0.130 (e) |P=0.034N* P=0.649N P=0.124N P=0.119N | |POLY 1.5 | P=0.527 (e) P=0.128 (e) |P=0.034N* P=0.661N P=0.124N P=0.120N | |POLY 6 | P=0.496 (e) P=0.133 (e) |P=0.034N* P=0.634N P=0.124N P=0.118N | |LOGISTIC REGRESSION| P=0.539 (e) P=0.127 (e) |P=0.035N* P=0.645N (e) (e) | |COCH-ARM / FISHERS | P=0.543 (e) P=0.125 (e) |P=0.034N* P=0.641 P=0.121N P=0.121N | |ORDER RESTRICTED | P=0.174 (e) (e) (e) |P=0.055N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Eye: Cornea | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/48 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.86 0/47.28 0/46.48 0/43.80 |2/43.63 1/44.65 0/42.33 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.6% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |2/36 (6%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 719 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.109N P=0.503N P=0.272N P=0.244N | |POLY 3 | (e) (e) (e) (e) |P=0.104N P=0.492N P=0.244N P=0.238N | |POLY 1.5 | (e) (e) (e) (e) |P=0.103N P=0.500N P=0.244N P=0.239N | |POLY 6 | (e) (e) (e) (e) |P=0.105N P=0.482N P=0.244N P=0.237N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.103N P=0.475N (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.100N P=0.515N P=0.247N P=0.247N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.075N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 8 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Harderian Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 1/44.60 3/47.35 3/46.72 2/43.19 |0/43.63 0/45.35 0/42.33 0/43.00 | |POLY-3 PERCENT (g) | 2.2% 6.3% 6.4% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/38 (3%) 2/41 (5%) 2/41 (5%) 1/33 (3%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 713 667 711 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.414 P=0.341 P=0.340 P=0.461 |(e) (e) (e) (e) | |POLY 3 | P=0.455 P=0.327 P=0.322 P=0.489 |(e) (e) (e) (e) | |POLY 1.5 | P=0.460 P=0.319 P=0.316 P=0.491 |(e) (e) (e) (e) | |POLY 6 | P=0.447 P=0.338 P=0.329 P=0.486 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.449 P=0.342 P=0.318 P=0.480 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.468 P=0.309 P=0.309 P=0.492 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.357 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/49 (2%) 1/50 (2%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 0/46.48 2/44.73 |1/43.13 1/45.35 1/41.73 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.5% |2.3% 2.2% 2.4% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 1/33 (3%) |0/36 (0%) 1/35 (3%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- 288 |710 729 (T) 723 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.040 * (e) (e) P=0.224 |P=0.326N P=0.755N P=0.744 P=0.511N | |POLY 3 | P=0.044 * (e) (e) P=0.238 |P=0.316N P=0.749N P=0.753 P=0.499N | |POLY 1.5 | P=0.045 * (e) (e) P=0.239 |P=0.315N P=0.751N P=0.754 P=0.498N | |POLY 6 | P=0.043 * (e) (e) P=0.235 |P=0.317N P=0.747N P=0.753 P=0.499N | |LOGISTIC REGRESSION| P=0.071 (e) (e) P=0.236 |P=0.316N P=0.748N P=0.755 P=0.498N | |COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |P=0.309N P=0.747N P=0.753N P=0.495N | |ORDER RESTRICTED | P=0.030 * (e) (e) (e) |P=0.327N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 9 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Heart | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/45.04 1/47.28 1/46.48 1/44.22 |0/43.05 0/45.35 0/41.71 0/43.40 | |POLY-3 PERCENT (g) | 4.4% 2.1% 2.2% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/38 (3%) 1/41 (2%) 1/41 (2%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 603 729 (T) 729 (T) 605 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.438N P=0.477N P=0.480N P=0.514N |(e) (e) (e) (e) | |POLY 3 | P=0.418N P=0.483N P=0.489N P=0.506N |(e) (e) (e) (e) | |POLY 1.5 | P=0.415N P=0.489N P=0.492N P=0.503N |(e) (e) (e) (e) | |POLY 6 | P=0.424N P=0.476N P=0.486N P=0.511N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.398N P=0.521N P=0.517N P=0.492N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.409N P=0.500N P=0.500N P=0.500N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.411N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Heart | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/49 (2%) 0/50 (0%) 1/49 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 1/45.15 0/47.28 0/46.48 2/43.93 |1/43.50 0/45.35 1/41.78 2/44.24 | |POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 4.6% |2.3% 0.0% 2.4% 4.5% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 1/33 (3%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 561 --- --- 694 |597 --- 712 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.223 P=0.496N P=0.500N P=0.475 |P=0.246 P=0.495N P=0.757 P=0.509 | |POLY 3 | P=0.238 P=0.491N P=0.494N P=0.490 |P=0.247 P=0.492N P=0.752 P=0.506 | |POLY 1.5 | P=0.241 P=0.494N P=0.496N P=0.495 |P=0.247 P=0.493N P=0.753 P=0.505 | |POLY 6 | P=0.233 P=0.487N P=0.493N P=0.484 |P=0.247 P=0.490N P=0.750 P=0.508 | |LOGISTIC REGRESSION| P=0.264 P=0.613N P=0.640N P=0.506 |P=0.266 P=0.550N P=0.756N P=0.541 | |COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 |P=0.251 P=0.495N P=0.753N P=0.508 | |ORDER RESTRICTED | P=0.122 (e) (e) (e) |P=0.228 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 10 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Intestine Large, Cecum | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/47 (2%) 3/49 (6%) 4/49 (8%) 2/48 (4%) |4/44 (9%) 6/47 (13%) 6/47 (13%) 6/47 (13%) | |POLY-3 RATE (b) | 1/43.16 3/46.28 4/45.72 2/42.79 |4/40.25 6/43.71 6/40.59 6/42.42 | |POLY-3 PERCENT (g) | 2.3% 6.5% 8.8% 4.7% |9.9% 13.7% 14.8% 14.1% | |TERMINAL (d) | 1/38 (3%) 3/40 (8%) 4/41 (10%) 1/33 (3%) |4/36 (11%) 5/35 (14%) 3/31 (10%) 3/35 (9%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 640 |729 (T) 706 712 618 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.391 P=0.324 P=0.203 P=0.470 |P=0.333 P=0.360 P=0.297 P=0.371 | |POLY 3 | P=0.438 P=0.331 P=0.196 P=0.497 |P=0.368 P=0.422 P=0.374 P=0.403 | |POLY 1.5 | P=0.445 P=0.326 P=0.195 P=0.500 |P=0.370 P=0.420 P=0.381 P=0.403 | |POLY 6 | P=0.428 P=0.337 P=0.198 P=0.494 |P=0.371 P=0.423 P=0.362 P=0.406 | |LOGISTIC REGRESSION| P=0.432 P=0.324 P=0.203 P=0.506 |P=0.353 P=0.410 P=0.340 P=0.398 | |COCH-ARM / FISHERS | P=0.462 P=0.324 P=0.194 P=0.508 |P=0.386 P=0.413 P=0.413 P=0.413 | |ORDER RESTRICTED | P=0.300 (e) (e) (e) |P=0.434 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Intestine Small, Duodenum: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 1/49 (2%) 1/49 (2%) |0/46 (0%) 0/47 (0%) 2/47 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.91 0/47.28 1/45.72 1/43.22 |0/41.64 0/43.62 2/40.85 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 2.3% |0.0% 0.0% 4.9% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 1/41 (2%) 1/33 (3%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- 662 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.202 (e) P=0.515 P=0.472 |P=0.593 (e) P=0.230 (e) | |POLY 3 | P=0.223 (e) P=0.508 P=0.497 |P=0.586 (e) P=0.233 (e) | |POLY 1.5 | P=0.228 (e) P=0.506 P=0.499 |P=0.594 (e) P=0.233 (e) | |POLY 6 | P=0.216 (e) P=0.510 P=0.494 |P=0.579 (e) P=0.233 (e) | |LOGISTIC REGRESSION| (e) (e) P=0.515 P=0.472 |P=0.610 (e) P=0.238 (e) | |COCH-ARM / FISHERS | P=0.236 (e) P=0.505 P=0.505 |P=0.611 (e) P=0.253 (e) | |ORDER RESTRICTED | P=0.248 (e) (e) (e) |P=0.243 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 11 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Intestine Small, Jejunum: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/47 (0%) 0/49 (0%) 0/50 (0%) 2/50 (4%) |0/45 (0%) 0/47 (0%) 0/47 (0%) 0/47 (0%) | |POLY-3 RATE (b) | 0/43.09 0/47.07 0/46.48 2/43.80 |0/41.46 0/42.98 0/40.58 0/41.27 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 2/33 (6%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.033 * (e) (e) P=0.208 |(e) (e) (e) (e) | |POLY 3 | P=0.045 * (e) (e) P=0.241 |(e) (e) (e) (e) | |POLY 1.5 | P=0.046 * (e) (e) P=0.244 |(e) (e) (e) (e) | |POLY 6 | P=0.044 * (e) (e) P=0.235 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) P=0.208 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.049 * (e) (e) P=0.263 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.031 * (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 31/48 (65%) 25/50 (50%) 28/50 (56%) 23/50 (46%) |9/46 (20%) 6/47 (13%) 4/49 (8%) 3/49 (6%) | |POLY-3 RATE (b) | 31/47.31 25/47.34 28/47.73 23/45.15 |9/42.91 6/45.01 4/42.51 3/43.04 | |POLY-3 PERCENT (g) | 65.5% 52.8% 58.7% 51.0% |21.0% 13.3% 9.4% 7.0% | |TERMINAL (d) | 23/38 (61%) 23/41 (56%) 24/41 (59%) 19/33 (58%) |8/36 (22%) 5/35 (14%) 3/31 (10%) 2/35 (6%) | |FIRST INCIDENCE | 484 721 543 535 |524 461 574 681 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.311N P=0.095N P=0.230N P=0.235N |P=0.048N* P=0.305N P=0.177N P=0.068N | |POLY 3 | P=0.139N P=0.144N P=0.315N P=0.108N |P=0.039N* P=0.252N P=0.116N P=0.057N | |POLY 1.5 | P=0.109N P=0.127N P=0.289N P=0.080N |P=0.036N* P=0.261N P=0.113N P=0.055N | |POLY 6 | P=0.187N P=0.166N P=0.349N P=0.155N |P=0.041N* P=0.241N P=0.120N P=0.058N | |LOGISTIC REGRESSION| P=0.102N P=0.097N P=0.256N P=0.059N |P=0.032N* P=0.285N P=0.106N P=0.055N | |COCH-ARM / FISHERS | P=0.072N P=0.105N P=0.254N P=0.050N |P=0.030N* P=0.272N P=0.093N P=0.047N* | |ORDER RESTRICTED | P=0.117N (e) (e) (e) |P=0.035N* (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 12 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 14/49 (29%) 10/50 (20%) 9/50 (18%) 10/50 (20%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 14/44.65 10/47.71 9/46.69 10/43.80 |0/43.63 0/44.92 0/42.00 0/43.40 | |POLY-3 PERCENT (g) | 31.4% 21.0% 19.3% 22.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 13/38 (34%) 9/41 (22%) 8/41 (20%) 10/33 (30%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 699 604 673 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.365N P=0.178N P=0.123N P=0.371N |(e) (e) (e) (e) | |POLY 3 | P=0.258N P=0.183N P=0.137N P=0.253N |(e) (e) (e) (e) | |POLY 1.5 | P=0.244N P=0.201N P=0.145N P=0.243N |(e) (e) (e) (e) | |POLY 6 | P=0.280N P=0.160N P=0.127N P=0.268N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.292N P=0.166N P=0.123N P=0.304N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.220N P=0.224N P=0.157N P=0.224N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.201N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Kidney | | Hydronephrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 1/49 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 1/44.53 2/47.79 2/46.91 1/43.80 |0/43.63 0/44.92 1/42.00 1/44.16 | |POLY-3 PERCENT (g) | 2.3% 4.2% 4.3% 2.3% |0.0% 0.0% 2.4% 2.3% | |TERMINAL (d) | 1/38 (3%) 1/41 (2%) 0/41 (0%) 1/33 (3%) |0/36 (0%) 0/35 (0%) 1/31 (3%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 574 672 729 (T) |--- --- 729 (T) 455 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.596N P=0.527 P=0.529 P=0.730 |P=0.234 (e) P=0.470 P=0.500 | |POLY 3 | P=0.567N P=0.525 P=0.518 P=0.757 |P=0.237 (e) P=0.492 P=0.502 | |POLY 1.5 | P=0.561N P=0.517 P=0.513 P=0.760 |P=0.237 (e) P=0.491 P=0.501 | |POLY 6 | P=0.575N P=0.536 P=0.525 P=0.754 |P=0.238 (e) P=0.493 P=0.505 | |LOGISTIC REGRESSION| P=0.520N P=0.485 P=0.496 P=0.730 |P=0.253 (e) P=0.470 P=0.577 | |COCH-ARM / FISHERS | P=0.550N P=0.508 P=0.508 P=0.747N |P=0.237 (e) P=0.495 P=0.500 | |ORDER RESTRICTED | P=0.567 (e) (e) (e) |P=0.243 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 13 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Kidney | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/49 (16%) 6/50 (12%) 4/50 (8%) 11/50 (22%) |8/50 (16%) 9/49 (18%) 6/49 (12%) 8/50 (16%) | |POLY-3 RATE (b) | 8/45.08 6/47.28 4/46.72 11/44.04 |8/44.52 9/45.48 6/42.00 8/44.17 | |POLY-3 PERCENT (g) | 17.8% 12.7% 8.6% 25.0% |18.0% 19.8% 14.3% 18.1% | |TERMINAL (d) | 7/38 (18%) 6/41 (15%) 3/41 (7%) 10/33 (30%) |6/36 (17%) 5/35 (14%) 6/31 (19%) 7/35 (20%) | |FIRST INCIDENCE | 561 729 (T) 667 664 |591 673 729 (T) 447 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.114 P=0.332N P=0.147N P=0.203 |P=0.516N P=0.507 P=0.491N P=0.588 | |POLY 3 | P=0.180 P=0.350N P=0.159N P=0.283 |P=0.505N P=0.519 P=0.432N P=0.602 | |POLY 1.5 | P=0.190 P=0.360N P=0.163N P=0.297 |P=0.500N P=0.506 P=0.429N P=0.601 | |POLY 6 | P=0.168 P=0.335N P=0.154N P=0.266 |P=0.515N P=0.539 P=0.440N P=0.600 | |LOGISTIC REGRESSION| P=0.165 P=0.340N P=0.163N P=0.278 |P=0.501N P=0.507 P=0.415N P=0.604 | |COCH-ARM / FISHERS | P=0.207 P=0.371N P=0.168N P=0.323 |P=0.483N P=0.482 P=0.403N P=0.607N | |ORDER RESTRICTED | P=0.093 (e) (e) (e) |P=0.582N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 1/50 (2%) 4/50 (8%) 5/50 (10%) |3/50 (6%) 2/49 (4%) 4/49 (8%) 5/50 (10%) | |POLY-3 RATE (b) | 5/45.08 1/47.28 4/46.48 5/44.54 |3/43.63 2/45.13 4/42.43 5/43.40 | |POLY-3 PERCENT (g) | 11.1% 2.1% 8.6% 11.2% |6.9% 4.4% 9.4% 11.5% | |TERMINAL (d) | 4/38 (11%) 1/41 (2%) 4/41 (10%) 3/33 (9%) |3/36 (8%) 1/35 (3%) 2/31 (7%) 5/35 (14%) | |FIRST INCIDENCE | 561 729 (T) 729 (T) 595 |729 (T) 673 618 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.302 P=0.091N P=0.458N P=0.564 |P=0.192 P=0.497N P=0.440 P=0.339 | |POLY 3 | P=0.359 P=0.091N P=0.481N P=0.623 |P=0.190 P=0.485N P=0.485 P=0.353 | |POLY 1.5 | P=0.368 P=0.094N P=0.484N P=0.629 |P=0.193 P=0.494N P=0.479 P=0.352 | |POLY 6 | P=0.347 P=0.086N P=0.477N P=0.617 |P=0.186 P=0.472N P=0.490 P=0.356 | |LOGISTIC REGRESSION| P=0.381 P=0.102N P=0.480N P=0.612N |P=0.190 P=0.479N P=0.479 P=0.339 | |COCH-ARM / FISHERS | P=0.384 P=0.098N P=0.487N P=0.617N |P=0.202 P=0.510N P=0.489 P=0.357 | |ORDER RESTRICTED | P=0.331 (e) (e) (e) |P=0.249 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 14 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Kidney | | Metaplasia Osseous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/49 (14%) 5/50 (10%) 3/50 (6%) 4/50 (8%) |0/50 (0%) 1/49 (2%) 3/49 (6%) 2/50 (4%) | |POLY-3 RATE (b) | 7/44.53 5/47.31 3/46.48 4/43.80 |0/43.63 1/44.92 3/42.26 2/43.40 | |POLY-3 PERCENT (g) | 15.7% 10.6% 6.5% 9.1% |0.0% 2.2% 7.1% 4.6% | |TERMINAL (d) | 7/38 (18%) 4/41 (10%) 3/41 (7%) 4/33 (12%) |0/36 (0%) 1/35 (3%) 2/31 (7%) 2/35 (6%) | |FIRST INCIDENCE | 729 (T) 722 729 (T) 729 (T) |--- 729 (T) 661 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.266N P=0.326N P=0.128N P=0.345N |P=0.161 P=0.494 P=0.107 P=0.232 | |POLY 3 | P=0.206N P=0.337N P=0.140N P=0.270N |P=0.159 P=0.506 P=0.113 P=0.236 | |POLY 1.5 | P=0.200N P=0.350N P=0.144N P=0.263N |P=0.160 P=0.502 P=0.112 P=0.235 | |POLY 6 | P=0.214N P=0.319N P=0.135N P=0.278N |P=0.158 P=0.511 P=0.114 P=0.237 | |LOGISTIC REGRESSION| P=0.249N P=0.296N P=0.128N P=0.345N |P=0.158 P=0.494 P=0.114 P=0.232 | |COCH-ARM / FISHERS | P=0.188N P=0.365N P=0.151N P=0.251N |P=0.165 P=0.495 P=0.117 P=0.247 | |ORDER RESTRICTED | P=0.177N (e) (e) (e) |P=0.103 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 37/49 (76%) 42/50 (84%) 43/50 (86%) 36/50 (72%) |14/50 (28%) 11/49 (22%) 14/49 (29%) 12/50 (24%) | |POLY-3 RATE (b) | 37/46.38 42/49.82 43/48.44 36/48.20 |14/44.50 11/45.25 14/42.93 12/45.15 | |POLY-3 PERCENT (g) | 79.8% 84.3% 88.8% 74.7% |31.5% 24.3% 32.6% 26.6% | |TERMINAL (d) | 33/38 (87%) 36/41 (88%) 38/41 (93%) 25/33 (76%) |11/36 (31%) 7/35 (20%) 10/31 (32%) 8/35 (23%) | |FIRST INCIDENCE | 561 431 558 288 |591 673 602 455 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.265 P=0.407 P=0.301 P=0.332 |P=0.487N P=0.333N P=0.444 P=0.436N | |POLY 3 | P=0.244N P=0.373 P=0.162 P=0.361N |P=0.440N P=0.301N P=0.546 P=0.391N | |POLY 1.5 | P=0.256N P=0.296 P=0.151 P=0.390N |P=0.447N P=0.316N P=0.537 P=0.403N | |POLY 6 | P=0.236N P=0.488 P=0.185 P=0.325N |P=0.433N P=0.283N P=0.551 P=0.377N | |LOGISTIC REGRESSION| P=0.349N P=0.251 P=0.177 P=0.481N |P=0.464N P=0.280N P=0.543 P=0.416N | |COCH-ARM / FISHERS | P=0.281N P=0.212 P=0.142 P=0.433N |P=0.440N P=0.343N P=0.563 P=0.410N | |ORDER RESTRICTED | P=0.160N (e) (e) (e) |P=0.478N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 15 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Accumulation, Hyaline Droplet | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/49 (2%) 2/49 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 0/44.53 1/47.35 1/46.71 0/43.80 |2/44.09 1/44.98 2/42.07 1/43.40 | |POLY-3 PERCENT (g) | 0.0% 2.1% 2.1% 0.0% |4.5% 2.2% 4.8% 2.3% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |1/36 (3%) 0/35 (0%) 1/31 (3%) 1/35 (3%) | |FIRST INCIDENCE | --- 713 668 --- |591 713 712 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.621N P=0.529 P=0.524 (e) |P=0.461N P=0.494N P=0.659 P=0.509N | |POLY 3 | P=0.600N P=0.512 P=0.510 (e) |P=0.457N P=0.493N P=0.677 P=0.506N | |POLY 1.5 | P=0.597N P=0.508 P=0.507 (e) |P=0.453N P=0.498N P=0.677 P=0.505N | |POLY 6 | P=0.604N P=0.518 P=0.513 (e) |P=0.460N P=0.487N P=0.676 P=0.506N | |LOGISTIC REGRESSION| P=0.581N P=0.509 P=0.486 (e) |P=0.448N P=0.523N P=0.684 P=0.500N | |COCH-ARM / FISHERS | P=0.592N P=0.505 P=0.505 (e) |P=0.443N P=0.508N P=0.684 P=0.500N | |ORDER RESTRICTED | P=0.412 (e) (e) (e) |P=0.450N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/50 (4%) 0/50 (0%) 3/50 (6%) |1/50 (2%) 0/49 (0%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/44.53 2/47.82 0/46.48 3/44.96 |1/44.13 0/44.92 0/42.00 1/44.16 | |POLY-3 PERCENT (g) | 2.3% 4.2% 0.0% 6.7% |2.3% 0.0% 0.0% 2.3% | |TERMINAL (d) | 1/38 (3%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 574 --- 570 |576 --- --- 455 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.222 P=0.530 P=0.485N P=0.298 |P=0.587 P=0.513N P=0.518N P=0.753 | |POLY 3 | P=0.242 P=0.525 P=0.491N P=0.309 |P=0.589 P=0.496N P=0.510N P=0.761N | |POLY 1.5 | P=0.243 P=0.517 P=0.493N P=0.309 |P=0.590 P=0.499N P=0.510N P=0.760 | |POLY 6 | P=0.241 P=0.536 P=0.489N P=0.309 |P=0.587 P=0.493N P=0.511N P=0.760N | |LOGISTIC REGRESSION| P=0.335 P=0.484 (e) P=0.365 |P=0.650 P=0.583N P=0.464N P=0.723N | |COCH-ARM / FISHERS | P=0.246 P=0.508 P=0.495N P=0.316 |P=0.595 P=0.505N P=0.505N P=0.753N | |ORDER RESTRICTED | P=0.183 (e) (e) (e) |P=0.401N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 16 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/49 (0%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/45.08 0/47.28 0/46.48 2/44.49 |1/43.88 0/44.92 0/42.00 1/43.85 | |POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 4.5% |2.3% 0.0% 0.0% 2.3% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 561 --- --- 605 |660 --- --- 597 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.238 P=0.496N P=0.500N P=0.494 |P=0.597 P=0.476N P=0.500N P=0.752N | |POLY 3 | P=0.241 P=0.490N P=0.494N P=0.495 |P=0.588 P=0.495N P=0.509N P=0.761 | |POLY 1.5 | P=0.244 P=0.493N P=0.495N P=0.499 |P=0.590 P=0.498N P=0.509N P=0.759 | |POLY 6 | P=0.238 P=0.486N P=0.493N P=0.492 |P=0.586 P=0.492N P=0.509N P=0.759N | |LOGISTIC REGRESSION| P=0.368 P=0.480N P=0.611N P=0.613 |P=0.611 P=0.524N P=0.499N P=0.752N | |COCH-ARM / FISHERS | P=0.249 P=0.495N P=0.495N P=0.508 |P=0.595 P=0.505N P=0.505N P=0.753N | |ORDER RESTRICTED | P=0.126 (e) (e) (e) |P=0.401 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |3/50 (6%) 1/49 (2%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/44.53 2/47.85 1/46.71 1/43.80 |3/43.63 1/44.92 0/42.00 1/44.39 | |POLY-3 PERCENT (g) | 0.0% 4.2% 2.1% 2.3% |6.9% 2.2% 0.0% 2.3% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 1/33 (3%) |3/36 (8%) 1/35 (3%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- 577 668 729 (T) |729 (T) 729 (T) --- 142 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.472 P=0.263 P=0.524 P=0.472 |P=0.211N P=0.315N P=0.148N P=0.314N | |POLY 3 | P=0.488 P=0.254 P=0.510 P=0.497 |P=0.205N P=0.295N P=0.125N P=0.299N | |POLY 1.5 | P=0.494 P=0.248 P=0.507 P=0.499 |P=0.204N P=0.301N P=0.126N P=0.301N | |POLY 6 | P=0.481 P=0.261 P=0.513 P=0.493 |P=0.207N P=0.286N P=0.125N P=0.296N | |LOGISTIC REGRESSION| P=0.548 P=0.222 P=0.486 P=0.472 |P=0.174N P=0.315N (e) P=0.260N | |COCH-ARM / FISHERS | P=0.505 P=0.253 P=0.505 P=0.505 |P=0.200N P=0.316N P=0.125N P=0.309N | |ORDER RESTRICTED | P=0.288 (e) (e) (e) |P=0.079N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 17 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |2/49 (4%) 0/50 (0%) 2/49 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 2/43.91 2/47.28 0/46.48 0/43.80 |2/43.57 0/45.35 2/42.07 1/43.40 | |POLY-3 PERCENT (g) | 4.6% 4.2% 0.0% 0.0% |4.6% 0.0% 4.8% 2.3% | |TERMINAL (d) | 2/38 (5%) 2/41 (5%) 0/41 (0%) 0/33 (0%) |2/36 (6%) 0/35 (0%) 1/31 (3%) 1/35 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- |729 (T) --- 711 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.096N P=0.667N P=0.222N P=0.270N |P=0.544N P=0.244N P=0.653 P=0.510N | |POLY 3 | P=0.084N P=0.667N P=0.225N P=0.238N |P=0.538N P=0.228N P=0.682 P=0.501N | |POLY 1.5 | P=0.083N P=0.672N P=0.226N P=0.234N |P=0.536N P=0.231N P=0.680 P=0.501N | |POLY 6 | P=0.085N P=0.659N P=0.223N P=0.242N |P=0.541N P=0.224N P=0.683 P=0.500N | |LOGISTIC REGRESSION| P=0.096N P=0.667N (e) (e) |P=0.541N (e) P=0.681 P=0.510N | |COCH-ARM / FISHERS | P=0.082N P=0.676N P=0.237N P=0.237N |P=0.526N P=0.242N P=0.691N P=0.492N | |ORDER RESTRICTED | P=0.116N (e) (e) (e) |P=0.414N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |5/49 (10%) 0/50 (0%) 4/49 (8%) 1/50 (2%) | |POLY-3 RATE (b) | 0/43.91 2/47.28 3/46.93 4/44.19 |5/43.57 0/45.35 4/42.00 1/43.40 | |POLY-3 PERCENT (g) | 0.0% 4.2% 6.4% 9.1% |11.5% 0.0% 9.5% 2.3% | |TERMINAL (d) | 0/38 (0%) 2/41 (5%) 1/41 (2%) 3/33 (9%) |5/36 (14%) 0/35 (0%) 4/31 (13%) 1/35 (3%) | |FIRST INCIDENCE | --- 729 (T) 667 616 |729 (T) --- 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.032 * P=0.255 P=0.142 P=0.052 |P=0.174N P=0.035N* P=0.595N P=0.108N | |POLY 3 | P=0.044 * P=0.254 P=0.131 P=0.061 |P=0.166N P=0.027N* P=0.523N P=0.102N | |POLY 1.5 | P=0.046 * P=0.251 P=0.129 P=0.062 |P=0.164N P=0.028N* P=0.524N P=0.102N | |POLY 6 | P=0.042 * P=0.259 P=0.134 P=0.059 |P=0.169N P=0.026N* P=0.523N P=0.100N | |LOGISTIC REGRESSION| P=0.050 P=0.255 P=0.121 P=0.066 |P=0.174N (e) P=0.595N P=0.108N | |COCH-ARM / FISHERS | P=0.051 P=0.258 P=0.129 P=0.064 |P=0.158N P=0.027N* P=0.500N P=0.098N | |ORDER RESTRICTED | P=0.036 * (e) (e) (e) |P=0.044N* (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 18 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 12/48 (25%) 19/50 (38%) 19/50 (38%) 13/50 (26%) |3/49 (6%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 12/43.91 19/47.28 19/47.28 13/43.80 |3/44.61 0/45.35 1/42.71 0/43.40 | |POLY-3 PERCENT (g) | 27.3% 40.2% 40.2% 29.7% |6.7% 0.0% 2.3% 0.0% | |TERMINAL (d) | 12/38 (32%) 19/41 (46%) 17/41 (42%) 13/33 (39%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 543 729 (T) |576 --- 486 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.372 P=0.135 P=0.143 P=0.332 |P=0.093N P=0.122N P=0.319N P=0.130N | |POLY 3 | P=0.523N P=0.140 P=0.140 P=0.497 |P=0.086N P=0.116N P=0.321N P=0.123N | |POLY 1.5 | P=0.494N P=0.131 P=0.132 P=0.515 |P=0.086N P=0.116N P=0.320N P=0.122N | |POLY 6 | P=0.518 P=0.155 P=0.151 P=0.472 |P=0.087N P=0.115N P=0.324N P=0.125N | |LOGISTIC REGRESSION| P=0.483 P=0.135 P=0.134 P=0.332 |P=0.058N P=0.114N P=0.215N P=0.085N | |COCH-ARM / FISHERS | P=0.444N P=0.122 P=0.122 P=0.547 |P=0.085N P=0.117N P=0.309N P=0.117N | |ORDER RESTRICTED | P=0.280 (e) (e) (e) |P=0.022N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 11/48 (23%) 10/50 (20%) 5/50 (10%) 11/50 (22%) |9/49 (18%) 9/50 (18%) 13/49 (27%) 7/50 (14%) | |POLY-3 RATE (b) | 11/45.46 10/47.78 5/46.48 11/45.22 |9/44.16 9/45.64 13/42.96 7/43.79 | |POLY-3 PERCENT (g) | 24.2% 20.9% 10.8% 24.3% |20.4% 19.7% 30.3% 16.0% | |TERMINAL (d) | 7/38 (18%) 8/41 (20%) 5/41 (12%) 7/33 (21%) |7/36 (19%) 6/35 (17%) 11/31 (36%) 6/35 (17%) | |FIRST INCIDENCE | 561 604 729 (T) 535 |639 682 486 618 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.464 P=0.424N P=0.071N P=0.493 |P=0.413N P=0.596N P=0.148 P=0.405N | |POLY 3 | P=0.522N P=0.449N P=0.075N P=0.591 |P=0.405N P=0.573N P=0.207 P=0.399N | |POLY 1.5 | P=0.506N P=0.454N P=0.073N P=0.584N |P=0.399N P=0.579N P=0.206 P=0.396N | |POLY 6 | P=0.544N P=0.442N P=0.080N P=0.567 |P=0.409N P=0.562N P=0.206 P=0.398N | |LOGISTIC REGRESSION| P=0.473N P=0.476N P=0.075N P=0.533N |P=0.400N P=0.558N P=0.204 P=0.393N | |COCH-ARM / FISHERS | P=0.480N P=0.458N P=0.072N P=0.553N |P=0.367N P=0.584N P=0.234 P=0.376N | |ORDER RESTRICTED | P=0.337N (e) (e) (e) |P=0.316N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 19 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 0/50 (0%) 0/50 (0%) 4/50 (8%) |7/49 (14%) 4/50 (8%) 3/49 (6%) 8/50 (16%) | |POLY-3 RATE (b) | 1/44.16 0/47.28 0/46.48 4/45.25 |7/44.79 4/46.31 3/42.39 8/44.56 | |POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 8.8% |15.6% 8.6% 7.1% 18.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 1/33 (3%) |4/36 (11%) 2/35 (6%) 2/31 (7%) 6/35 (17%) | |FIRST INCIDENCE | 661 --- --- 535 |591 461 618 142 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.024 * P=0.477N P=0.481N P=0.174 |P=0.342 P=0.263N P=0.206N P=0.491 | |POLY 3 | P=0.026 * P=0.486N P=0.490N P=0.186 |P=0.336 P=0.242N P=0.180N P=0.496 | |POLY 1.5 | P=0.027 * P=0.489N P=0.491N P=0.187 |P=0.344 P=0.246N P=0.177N P=0.503 | |POLY 6 | P=0.026 * P=0.483N P=0.489N P=0.184 |P=0.327 P=0.237N P=0.184N P=0.488 | |LOGISTIC REGRESSION| P=0.059 P=0.503N P=0.512N P=0.256 |P=0.389 P=0.257N P=0.157N P=0.560 | |COCH-ARM / FISHERS | P=0.029 * P=0.490N P=0.490N P=0.194 |P=0.361 P=0.251N P=0.159N P=0.517 | |ORDER RESTRICTED | P=0.012 * (e) (e) (e) |P=0.222 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |4/49 (8%) 7/50 (14%) 3/49 (6%) 5/50 (10%) | |POLY-3 RATE (b) | 0/43.91 1/47.28 1/46.48 0/43.80 |4/43.57 7/45.45 3/42.00 5/43.40 | |POLY-3 PERCENT (g) | 0.0% 2.1% 2.2% 0.0% |9.2% 15.4% 7.1% 11.5% | |TERMINAL (d) | 0/38 (0%) 1/41 (2%) 1/41 (2%) 0/33 (0%) |4/36 (11%) 6/35 (17%) 3/31 (10%) 5/35 (14%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) --- |729 (T) 706 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.631N P=0.515 P=0.515 (e) |P=0.554 P=0.251 P=0.582N P=0.482 | |POLY 3 | P=0.599N P=0.515 P=0.511 (e) |P=0.562N P=0.285 P=0.520N P=0.497 | |POLY 1.5 | P=0.595N P=0.512 P=0.510 (e) |P=0.559N P=0.279 P=0.521N P=0.498 | |POLY 6 | P=0.604N P=0.519 P=0.513 (e) |P=0.562N P=0.296 P=0.520N P=0.500 | |LOGISTIC REGRESSION| (e) P=0.515 P=0.515 (e) |P=0.552 P=0.302 P=0.582N P=0.482 | |COCH-ARM / FISHERS | P=0.589N P=0.510 P=0.510 (e) |P=0.539N P=0.274 P=0.500N P=0.513 | |ORDER RESTRICTED | P=0.414 (e) (e) (e) |P=0.516N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 20 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Infiltration Cellular Mixed Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |7/49 (14%) 7/50 (14%) 8/49 (16%) 7/50 (14%) | |POLY-3 RATE (b) | 2/43.91 1/47.28 1/46.48 0/43.80 |7/43.78 7/45.35 8/42.74 7/43.70 | |POLY-3 PERCENT (g) | 4.6% 2.1% 2.2% 0.0% |16.0% 15.4% 18.7% 16.0% | |TERMINAL (d) | 2/38 (5%) 1/41 (2%) 1/41 (2%) 0/33 (0%) |6/36 (17%) 7/35 (20%) 6/31 (19%) 6/35 (17%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |674 729 (T) 486 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.171N P=0.473N P=0.473N P=0.270N |P=0.512 P=0.601 P=0.396 P=0.601 | |POLY 3 | P=0.155N P=0.474N P=0.480N P=0.238N |P=0.525 P=0.586N P=0.480 P=0.613 | |POLY 1.5 | P=0.152N P=0.480N P=0.482N P=0.234N |P=0.527 P=0.592N P=0.475 P=0.612 | |POLY 6 | P=0.159N P=0.467N P=0.478N P=0.242N |P=0.527 P=0.577N P=0.483 P=0.612N | |LOGISTIC REGRESSION| P=0.171N P=0.473N P=0.473N (e) |P=0.522 P=0.556N P=0.470 P=0.614N | |COCH-ARM / FISHERS | P=0.147N P=0.485N P=0.485N P=0.237N |P=0.552 P=0.597N P=0.500 P=0.597N | |ORDER RESTRICTED | P=0.118N (e) (e) (e) |P=0.646 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 9/50 (18%) 8/50 (16%) 7/50 (14%) |7/49 (14%) 2/50 (4%) 3/49 (6%) 3/50 (6%) | |POLY-3 RATE (b) | 2/44.62 9/47.31 8/46.48 7/44.08 |7/43.57 2/45.39 3/42.00 3/43.50 | |POLY-3 PERCENT (g) | 4.5% 19.0% 17.2% 15.9% |16.1% 4.4% 7.1% 6.9% | |TERMINAL (d) | 1/38 (3%) 8/41 (20%) 8/41 (20%) 6/33 (18%) |7/36 (19%) 1/35 (3%) 3/31 (10%) 2/35 (6%) | |FIRST INCIDENCE | 484 722 729 (T) 652 |729 (T) 719 729 (T) 705 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.103 P=0.039 * P=0.061 P=0.059 |P=0.188N P=0.087N P=0.221N P=0.170N | |POLY 3 | P=0.155 P=0.032 * P=0.052 P=0.075 |P=0.176N P=0.069N P=0.171N P=0.157N | |POLY 1.5 | P=0.168 P=0.031 * P=0.052 P=0.080 |P=0.174N P=0.072N P=0.173N P=0.158N | |POLY 6 | P=0.140 P=0.034 * P=0.052 P=0.070 |P=0.177N P=0.064N P=0.169N P=0.153N | |LOGISTIC REGRESSION| P=0.159 P=0.031 * P=0.054 P=0.092 |P=0.181N P=0.064N P=0.221N P=0.156N | |COCH-ARM / FISHERS | P=0.195 P=0.030 * P=0.053 P=0.090 |P=0.165N P=0.075N P=0.159N P=0.151N | |ORDER RESTRICTED | P=0.061 (e) (e) (e) |P=0.072N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 21 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Necrosis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/48 (8%) 6/50 (12%) 7/50 (14%) 6/50 (12%) |5/49 (10%) 1/50 (2%) 4/49 (8%) 1/50 (2%) | |POLY-3 RATE (b) | 4/44.45 6/48.82 7/47.47 6/44.80 |5/44.28 1/45.35 4/42.03 1/43.57 | |POLY-3 PERCENT (g) | 9.0% 12.3% 14.8% 13.4% |11.3% 2.2% 9.5% 2.3% | |TERMINAL (d) | 3/38 (8%) 3/41 (7%) 4/41 (10%) 2/33 (6%) |3/36 (8%) 1/35 (3%) 3/31 (10%) 0/35 (0%) | |FIRST INCIDENCE | 562 431 570 570 |597 729 (T) 723 685 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.275 P=0.423 P=0.315 P=0.327 |P=0.148N P=0.106N P=0.569N P=0.107N | |POLY 3 | P=0.325 P=0.430 P=0.300 P=0.374 |P=0.142N P=0.096N P=0.533N P=0.105N | |POLY 1.5 | P=0.338 P=0.416 P=0.294 P=0.381 |P=0.140N P=0.097N P=0.529N P=0.103N | |POLY 6 | P=0.310 P=0.448 P=0.309 P=0.367 |P=0.143N P=0.094N P=0.539N P=0.105N | |LOGISTIC REGRESSION| P=0.456 P=0.327 P=0.264 P=0.417 |P=0.140N P=0.099N P=0.521N P=0.098N | |COCH-ARM / FISHERS | P=0.362 P=0.397 P=0.286 P=0.397 |P=0.132N P=0.098N P=0.500N P=0.098N | |ORDER RESTRICTED | P=0.378 (e) (e) (e) |P=0.058N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver | | Tension Lipidosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/49 (4%) 3/50 (6%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/43.91 0/47.28 1/46.48 0/43.80 |2/43.57 3/45.45 0/42.00 1/43.40 | |POLY-3 PERCENT (g) | 2.3% 0.0% 2.2% 0.0% |4.6% 6.6% 0.0% 2.3% | |TERMINAL (d) | 1/38 (3%) 0/41 (0%) 1/41 (2%) 0/33 (0%) |2/36 (6%) 2/35 (6%) 0/31 (0%) 1/35 (3%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) --- |729 (T) 706 --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.434N P=0.485N P=0.745N P=0.528N |P=0.258N P=0.499 P=0.272N P=0.510N | |POLY 3 | P=0.410N P=0.485N P=0.748N P=0.501N |P=0.245N P=0.519 P=0.245N P=0.501N | |POLY 1.5 | P=0.405N P=0.488N P=0.749N P=0.497N |P=0.245N P=0.514 P=0.246N P=0.501N | |POLY 6 | P=0.415N P=0.481N P=0.746N P=0.505N |P=0.245N P=0.528 P=0.245N P=0.500N | |LOGISTIC REGRESSION| P=0.434N (e) P=0.745N (e) |P=0.249N P=0.533 (e) P=0.510N | |COCH-ARM / FISHERS | P=0.398N P=0.490N P=0.742N P=0.490N |P=0.238N P=0.510 P=0.247N P=0.492N | |ORDER RESTRICTED | P=0.252N (e) (e) (e) |P=0.200N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 22 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.91 0/47.28 0/46.48 2/44.06 |0/43.57 0/45.35 0/42.00 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 1/33 (3%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- 657 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.036 * (e) (e) P=0.219 |(e) (e) (e) (e) | |POLY 3 | P=0.044 * (e) (e) P=0.238 |(e) (e) (e) (e) | |POLY 1.5 | P=0.045 * (e) (e) P=0.241 |(e) (e) (e) (e) | |POLY 6 | P=0.043 * (e) (e) P=0.234 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.050 (e) (e) P=0.247 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.048 * (e) (e) P=0.258 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.030 * (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |2/49 (4%) 2/50 (4%) 2/49 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 1/44.45 0/47.28 0/46.48 2/44.50 |2/44.11 2/45.41 2/42.30 2/44.60 | |POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 4.5% |4.5% 4.4% 4.7% 4.5% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 1/35 (3%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 561 --- --- 595 |639 714 661 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.238 P=0.496N P=0.500N P=0.497 |P=0.586 P=0.667N P=0.684 P=0.688N | |POLY 3 | P=0.244 P=0.488N P=0.491N P=0.500 |P=0.594 P=0.683N P=0.679 P=0.690N | |POLY 1.5 | P=0.247 P=0.490N P=0.491N P=0.505 |P=0.593 P=0.685N P=0.679 P=0.691N | |POLY 6 | P=0.241 P=0.485N P=0.491N P=0.495 |P=0.596N P=0.681N P=0.678 P=0.688N | |LOGISTIC REGRESSION| P=0.376 P=0.473N P=0.604N P=0.626 |P=0.563N P=0.691N P=0.690N P=0.602N | |COCH-ARM / FISHERS | P=0.252 P=0.490N P=0.490N P=0.515 |P=0.591N P=0.684N P=0.691N P=0.684N | |ORDER RESTRICTED | P=0.130 (e) (e) (e) |P=0.734 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 23 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Karyomegaly | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 3/50 (6%) | |POLY-3 RATE (b) | 0/43.91 0/47.28 1/46.70 1/44.19 |0/43.57 0/45.35 0/42.00 3/43.56 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 2.3% |0.0% 0.0% 0.0% 6.9% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 2/35 (6%) | |FIRST INCIDENCE | --- --- 672 618 |--- --- --- 688 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.223 (e) P=0.519 P=0.500 |P=0.012 * (e) (e) P=0.120 | |POLY 3 | P=0.228 (e) P=0.512 P=0.501 |P=0.011 * (e) (e) P=0.118 | |POLY 1.5 | P=0.233 (e) P=0.511 P=0.504 |P=0.011 * (e) (e) P=0.118 | |POLY 6 | P=0.221 (e) P=0.515 P=0.498 |P=0.011 * (e) (e) P=0.119 | |LOGISTIC REGRESSION| P=0.295 (e) P=0.494 P=0.565 |P=0.011 * (e) (e) P=0.120 | |COCH-ARM / FISHERS | P=0.240 (e) P=0.510 P=0.510 |P=0.012 * (e) (e) P=0.125 | |ORDER RESTRICTED | P=0.252 (e) (e) (e) |P=0.008 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |4/49 (8%) 3/50 (6%) 6/49 (12%) 4/50 (8%) | |POLY-3 RATE (b) | 2/43.91 0/47.28 0/46.48 3/43.80 |4/44.34 3/46.68 6/42.98 4/44.38 | |POLY-3 PERCENT (g) | 4.6% 0.0% 0.0% 6.9% |9.0% 6.4% 14.0% 9.0% | |TERMINAL (d) | 2/38 (5%) 0/41 (0%) 0/41 (0%) 3/33 (9%) |2/36 (6%) 0/35 (0%) 2/31 (7%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 729 (T) |576 492 602 618 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.197 P=0.222N P=0.222N P=0.435 |P=0.473 P=0.492N P=0.332 P=0.626N | |POLY 3 | P=0.242 P=0.221N P=0.225N P=0.499 |P=0.467 P=0.472N P=0.350 P=0.643N | |POLY 1.5 | P=0.246 P=0.224N P=0.226N P=0.506 |P=0.469 P=0.480N P=0.347 P=0.643 | |POLY 6 | P=0.237 P=0.216N P=0.223N P=0.489 |P=0.469 P=0.462N P=0.353 P=0.637N | |LOGISTIC REGRESSION| P=0.197 (e) (e) P=0.435 |P=0.525 P=0.497N P=0.372 P=0.610N | |COCH-ARM / FISHERS | P=0.254 P=0.237N P=0.237N P=0.520 |P=0.492 P=0.489N P=0.370 P=0.631N | |ORDER RESTRICTED | P=0.096 (e) (e) (e) |P=0.435 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 24 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver: Kupffer Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 1/50 (2%) 1/49 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 0/43.91 0/47.28 0/46.48 0/43.80 |0/43.57 1/45.42 1/42.00 2/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 2.4% 4.6% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 1/31 (3%) 2/35 (6%) | |FIRST INCIDENCE | --- --- --- --- |--- 713 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.148 P=0.521 P=0.470 P=0.232 | |POLY 3 | (e) (e) (e) (e) |P=0.149 P=0.508 P=0.493 P=0.236 | |POLY 1.5 | (e) (e) (e) (e) |P=0.150 P=0.506 P=0.492 P=0.237 | |POLY 6 | (e) (e) (e) (e) |P=0.149 P=0.512 P=0.493 P=0.237 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.147 P=0.509 P=0.470 P=0.232 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.156 P=0.505 P=0.500 P=0.253 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.116 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Liver: Kupffer Cell | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |3/49 (6%) 4/50 (8%) 4/49 (8%) 7/50 (14%) | |POLY-3 RATE (b) | 2/44.16 0/47.28 1/46.48 0/43.80 |3/44.25 4/45.43 4/42.39 7/43.95 | |POLY-3 PERCENT (g) | 4.5% 0.0% 2.2% 0.0% |6.8% 8.8% 9.4% 15.9% | |TERMINAL (d) | 1/38 (3%) 0/41 (0%) 1/41 (2%) 0/33 (0%) |1/36 (3%) 2/35 (6%) 3/31 (10%) 5/35 (14%) | |FIRST INCIDENCE | 663 --- 729 (T) --- |591 713 618 618 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.203N P=0.216N P=0.469N P=0.261N |P=0.104 P=0.509 P=0.451 P=0.162 | |POLY 3 | P=0.190N P=0.222N P=0.482N P=0.239N |P=0.098 P=0.514 P=0.477 P=0.154 | |POLY 1.5 | P=0.187N P=0.225N P=0.483N P=0.235N |P=0.100 P=0.512 P=0.477 P=0.155 | |POLY 6 | P=0.194N P=0.218N P=0.481N P=0.245N |P=0.097 P=0.519 P=0.475 P=0.154 | |LOGISTIC REGRESSION| P=0.183N P=0.234N P=0.485N P=0.227N |P=0.101 P=0.512 P=0.497 P=0.162 | |COCH-ARM / FISHERS | P=0.182N P=0.237N P=0.485N P=0.237N |P=0.110 P=0.511 P=0.500 P=0.167 | |ORDER RESTRICTED | P=0.075N (e) (e) (e) |P=0.119 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 25 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lung | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 11/50 (22%) 7/50 (14%) 8/50 (16%) |5/50 (10%) 8/50 (16%) 3/49 (6%) 5/50 (10%) | |POLY-3 RATE (b) | 6/45.23 11/47.28 7/47.45 8/44.39 |5/44.57 8/45.97 3/41.40 5/43.80 | |POLY-3 PERCENT (g) | 13.3% 23.3% 14.8% 18.0% |11.2% 17.4% 7.3% 11.4% | |TERMINAL (d) | 4/38 (11%) 11/41 (27%) 4/41 (10%) 6/33 (18%) |2/36 (6%) 5/35 (14%) 2/30 (7%) 3/35 (9%) | |FIRST INCIDENCE | 623 729 (T) 570 640 |588 552 711 667 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.380 P=0.189 P=0.557 P=0.310 |P=0.419N P=0.286 P=0.416N P=0.623N | |POLY 3 | P=0.479 P=0.165 P=0.537 P=0.371 |P=0.415N P=0.295 P=0.397N P=0.620 | |POLY 1.5 | P=0.488 P=0.157 P=0.524 P=0.379 |P=0.411N P=0.290 P=0.392N P=0.621 | |POLY 6 | P=0.464 P=0.174 P=0.550 P=0.360 |P=0.420N P=0.301 P=0.408N P=0.619 | |LOGISTIC REGRESSION| P=0.481 P=0.179 P=0.483 P=0.377 |P=0.406N P=0.276 P=0.380N P=0.628 | |COCH-ARM / FISHERS | P=0.500 P=0.143 P=0.500 P=0.387 |P=0.394N P=0.277 P=0.369N P=0.630N | |ORDER RESTRICTED | P=0.400 (e) (e) (e) |P=0.374N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lung | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/44.60 0/47.28 0/46.48 1/43.83 |2/44.25 0/45.35 0/41.33 0/43.40 | |POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 2.3% |4.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/38 (3%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |1/36 (3%) 0/35 (0%) 0/30 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 721 |524 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.567 P=0.485N P=0.485N P=0.732 |P=0.123N P=0.245N P=0.267N P=0.248N | |POLY 3 | P=0.584 P=0.488N P=0.492N P=0.757 |P=0.117N P=0.232N P=0.252N P=0.241N | |POLY 1.5 | P=0.588 P=0.493N P=0.494N P=0.758 |P=0.117N P=0.234N P=0.251N P=0.241N | |POLY 6 | P=0.579 P=0.483N P=0.489N P=0.754 |P=0.119N P=0.229N P=0.255N P=0.241N | |LOGISTIC REGRESSION| P=0.580 (e) (e) P=0.750 |P=0.105N P=0.270N P=0.218N P=0.223N | |COCH-ARM / FISHERS | P=0.595 P=0.500N P=0.500N P=0.753N |P=0.116N P=0.247N P=0.253N P=0.247N | |ORDER RESTRICTED | P=0.390 (e) (e) (e) |P=0.031N* (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 26 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 4/50 (8%) 5/50 (10%) |5/50 (10%) 8/50 (16%) 6/49 (12%) 4/50 (8%) | |POLY-3 RATE (b) | 5/45.85 3/47.31 4/46.48 5/44.39 |5/43.63 8/46.03 6/41.79 4/43.40 | |POLY-3 PERCENT (g) | 10.9% 6.3% 8.6% 11.3% |11.5% 17.4% 14.4% 9.2% | |TERMINAL (d) | 2/38 (5%) 2/41 (5%) 4/41 (10%) 3/33 (9%) |5/36 (14%) 5/35 (14%) 4/30 (13%) 4/35 (11%) | |FIRST INCIDENCE | 561 722 729 (T) 640 |729 (T) 552 602 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.407 P=0.322N P=0.461N P=0.578 |P=0.345N P=0.272 P=0.391 P=0.518N | |POLY 3 | P=0.455 P=0.339N P=0.491N P=0.610 |P=0.329N P=0.311 P=0.470 P=0.503N | |POLY 1.5 | P=0.467 P=0.345N P=0.492N P=0.619 |P=0.328N P=0.298 P=0.467 P=0.505N | |POLY 6 | P=0.440 P=0.333N P=0.494N P=0.597 |P=0.328N P=0.329 P=0.472 P=0.500N | |LOGISTIC REGRESSION| P=0.487 P=0.396N P=0.527N P=0.625N |P=0.329N P=0.302 P=0.459 P=0.518N | |COCH-ARM / FISHERS | P=0.483 P=0.357N P=0.500N P=0.630N |P=0.315N P=0.277 P=0.486 P=0.500N | |ORDER RESTRICTED | P=0.523 (e) (e) (e) |P=0.371N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lung | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 5/50 (10%) 7/50 (14%) 6/50 (12%) |10/50 (20%) 8/50 (16%) 3/49 (6%) 9/50 (18%) | |POLY-3 RATE (b) | 4/44.60 5/47.28 7/46.48 6/44.12 |10/44.05 8/45.35 3/41.33 9/43.40 | |POLY-3 PERCENT (g) | 9.0% 10.6% 15.1% 13.6% |22.7% 17.6% 7.3% 20.7% | |TERMINAL (d) | 4/38 (11%) 5/41 (12%) 7/41 (17%) 5/33 (15%) |9/36 (25%) 8/35 (23%) 3/30 (10%) 9/35 (26%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 640 |606 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.200 P=0.548 P=0.305 P=0.294 |P=0.453N P=0.417N P=0.068N P=0.525N | |POLY 3 | P=0.277 P=0.536 P=0.285 P=0.362 |P=0.447N P=0.370N P=0.044N* P=0.515N | |POLY 1.5 | P=0.285 P=0.522 P=0.277 P=0.366 |P=0.442N P=0.379N P=0.044N* P=0.513N | |POLY 6 | P=0.264 P=0.554 P=0.293 P=0.356 |P=0.453N P=0.358N P=0.045N* P=0.516N | |LOGISTIC REGRESSION| P=0.238 P=0.548 P=0.305 P=0.344 |P=0.446N P=0.336N P=0.045N* P=0.496N | |COCH-ARM / FISHERS | P=0.296 P=0.500 P=0.262 P=0.370 |P=0.423N P=0.398N P=0.039N* P=0.500N | |ORDER RESTRICTED | P=0.354 (e) (e) (e) |P=0.225N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 27 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 5/50 (10%) 9/50 (18%) 10/50 (20%) |1/50 (2%) 1/50 (2%) 3/49 (6%) 5/50 (10%) | |POLY-3 RATE (b) | 8/45.49 5/47.28 9/47.94 10/45.14 |1/43.63 1/45.35 3/41.37 5/44.24 | |POLY-3 PERCENT (g) | 17.6% 10.6% 18.8% 22.2% |2.3% 2.2% 7.3% 11.3% | |TERMINAL (d) | 5/38 (13%) 5/41 (12%) 5/41 (12%) 4/33 (12%) |1/36 (3%) 1/35 (3%) 2/30 (7%) 3/35 (9%) | |FIRST INCIDENCE | 603 729 (T) 543 595 |729 (T) 729 (T) 719 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.154 P=0.233N P=0.560 P=0.335 |P=0.031 * P=0.756 P=0.255 P=0.105 | |POLY 3 | P=0.202 P=0.251N P=0.547 P=0.390 |P=0.030 * P=0.752N P=0.286 P=0.104 | |POLY 1.5 | P=0.208 P=0.260N P=0.531 P=0.393 |P=0.030 * P=0.755N P=0.287 P=0.102 | |POLY 6 | P=0.195 P=0.242N P=0.564 P=0.384 |P=0.030 * P=0.748N P=0.284 P=0.108 | |LOGISTIC REGRESSION| P=0.223 P=0.256N P=0.465 P=0.395 |P=0.030 * P=0.756 P=0.276 P=0.103 | |COCH-ARM / FISHERS | P=0.217 P=0.277N P=0.500 P=0.398 |P=0.031 * P=0.753N P=0.301 P=0.102 | |ORDER RESTRICTED | P=0.247 (e) (e) (e) |P=0.047 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lung | | Metaplasia Osseous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/49 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.60 2/47.28 0/46.48 0/43.80 |0/43.63 1/45.35 2/41.40 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 4.2% 0.0% 0.0% |0.0% 2.2% 4.8% 0.0% | |TERMINAL (d) | 0/38 (0%) 2/41 (5%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 1/35 (3%) 1/30 (3%) 0/35 (0%) | |FIRST INCIDENCE | --- 729 (T) --- --- |--- 729 (T) 712 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.434N P=0.255 (e) (e) |P=0.627N P=0.494 P=0.217 (e) | |POLY 3 | P=0.396N P=0.250 (e) (e) |P=0.621N P=0.508 P=0.225 (e) | |POLY 1.5 | P=0.399N P=0.245 (e) (e) |P=0.621N P=0.505 P=0.226 (e) | |POLY 6 | P=0.394N P=0.257 (e) (e) |P=0.619N P=0.511 P=0.225 (e) | |LOGISTIC REGRESSION| (e) P=0.255 (e) (e) |P=0.623N P=0.494 P=0.223 (e) | |COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |P=0.616N P=0.500 P=0.242 (e) | |ORDER RESTRICTED | P=0.262N (e) (e) (e) |P=0.315 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 28 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lung | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 4/50 (8%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 0/46.48 0/43.80 |1/44.25 4/46.59 1/41.37 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 8.6% 2.4% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 1/35 (3%) 0/30 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |524 513 719 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.179N P=0.185 P=0.747 P=0.508N | |POLY 3 | (e) (e) (e) (e) |P=0.168N P=0.195 P=0.746 P=0.504N | |POLY 1.5 | (e) (e) (e) (e) |P=0.168N P=0.189 P=0.747 P=0.503N | |POLY 6 | (e) (e) (e) (e) |P=0.168N P=0.203 P=0.743 P=0.504N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.146N P=0.114 P=0.749N P=0.453N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.164N P=0.181 P=0.747 P=0.500N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.117N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 5/50 (10%) |2/50 (4%) 2/50 (4%) 1/49 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 2/44.60 3/47.28 1/46.48 5/43.80 |2/43.63 2/46.01 1/41.33 2/43.40 | |POLY-3 PERCENT (g) | 4.5% 6.4% 2.2% 11.4% |4.6% 4.4% 2.4% 4.6% | |TERMINAL (d) | 2/38 (5%) 3/41 (7%) 1/41 (2%) 5/33 (15%) |2/36 (6%) 1/35 (3%) 1/30 (3%) 2/35 (6%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 513 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.106 P=0.535 P=0.473N P=0.162 |P=0.592N P=0.686 P=0.564N P=0.685 | |POLY 3 | P=0.152 P=0.526 P=0.486N P=0.208 |P=0.588N P=0.675N P=0.519N P=0.692 | |POLY 1.5 | P=0.155 P=0.516 P=0.490N P=0.212 |P=0.586N P=0.682N P=0.518N P=0.691 | |POLY 6 | P=0.147 P=0.539 P=0.481N P=0.202 |P=0.590N P=0.666N P=0.521N P=0.694N | |LOGISTIC REGRESSION| P=0.106 P=0.535 P=0.473N P=0.162 |P=0.584N P=0.682 P=0.564N P=0.685 | |COCH-ARM / FISHERS | P=0.160 P=0.500 P=0.500N P=0.218 |P=0.578N P=0.691N P=0.508N P=0.691N | |ORDER RESTRICTED | P=0.130 (e) (e) (e) |P=0.626N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 29 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 14/49 (29%) 14/48 (29%) 16/45 (36%) 16/49 (33%) |12/46 (26%) 7/46 (15%) 7/49 (14%) 10/49 (20%) | |POLY-3 RATE (b) | 14/43.97 14/46.81 16/42.99 16/43.61 |12/41.35 7/44.35 7/41.37 10/42.40 | |POLY-3 PERCENT (g) | 31.8% 29.9% 37.2% 36.7% |29.0% 15.8% 16.9% 23.6% | |TERMINAL (d) | 14/38 (37%) 13/41 (32%) 13/37 (35%) 13/33 (39%) |10/34 (29%) 2/34 (6%) 7/31 (23%) 10/34 (29%) | |FIRST INCIDENCE | 729 (T) 668 562 595 |591 461 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.162 P=0.490N P=0.393 P=0.255 |P=0.466N P=0.156N P=0.205N P=0.402N | |POLY 3 | P=0.290 P=0.511N P=0.381 P=0.400 |P=0.449N P=0.111N P=0.146N P=0.376N | |POLY 1.5 | P=0.309 P=0.550N P=0.354 P=0.406 |P=0.426N P=0.124N P=0.139N P=0.364N | |POLY 6 | P=0.267 P=0.466N P=0.414 P=0.389 |P=0.478N P=0.099N P=0.159N P=0.392N | |LOGISTIC REGRESSION| P=0.247 P=0.440N P=0.361 P=0.336 |P=0.414N P=0.166N P=0.141N P=0.358N | |COCH-ARM / FISHERS | P=0.336 P=0.563 P=0.307 P=0.413 |P=0.381N P=0.151N P=0.119N P=0.340N | |ORDER RESTRICTED | P=0.434 (e) (e) (e) |P=0.196N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/49 (14%) 10/48 (21%) 9/45 (20%) 9/49 (18%) |18/46 (39%) 16/46 (35%) 18/49 (37%) 15/49 (31%) | |POLY-3 RATE (b) | 7/44.77 10/46.73 9/43.21 9/44.27 |18/40.93 16/42.85 18/41.73 15/43.32 | |POLY-3 PERCENT (g) | 15.6% 21.4% 20.8% 20.3% |44.0% 37.3% 43.1% 34.6% | |TERMINAL (d) | 5/38 (13%) 8/41 (20%) 6/37 (16%) 5/33 (15%) |16/34 (47%) 14/34 (41%) 15/31 (48%) 13/34 (38%) | |FIRST INCIDENCE | 561 698 558 570 |639 714 662 455 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.296 P=0.368 P=0.397 P=0.323 |P=0.349N P=0.401N P=0.457 P=0.331N | |POLY 3 | P=0.386 P=0.331 P=0.362 P=0.382 |P=0.266N P=0.345N P=0.558N P=0.254N | |POLY 1.5 | P=0.396 P=0.313 P=0.349 P=0.387 |P=0.261N P=0.368N P=0.547N P=0.257N | |POLY 6 | P=0.372 P=0.350 P=0.375 P=0.375 |P=0.274N P=0.324N P=0.578N P=0.253N | |LOGISTIC REGRESSION| P=0.422 P=0.305 P=0.295 P=0.394 |P=0.300N P=0.284N P=0.588N P=0.272N | |COCH-ARM / FISHERS | P=0.411 P=0.281 P=0.322 P=0.393 |P=0.240N P=0.415N P=0.488N P=0.256N | |ORDER RESTRICTED | P=0.425 (e) (e) (e) |P=0.298N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 30 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/47 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |1/47 (2%) 1/49 (2%) 0/49 (0%) 2/49 (4%) | |POLY-3 RATE (b) | 2/43.78 1/47.40 0/46.48 1/44.06 |1/42.08 1/44.92 0/41.33 2/43.16 | |POLY-3 PERCENT (g) | 4.6% 2.1% 0.0% 2.3% |2.4% 2.2% 0.0% 4.6% | |TERMINAL (d) | 1/38 (3%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/34 (0%) 1/35 (3%) 0/30 (0%) 1/34 (3%) | |FIRST INCIDENCE | 638 698 --- 657 |576 729 (T) --- 455 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.391N P=0.464N P=0.224N P=0.522N |P=0.360 P=0.756 P=0.518N P=0.492 | |POLY 3 | P=0.358N P=0.472N P=0.224N P=0.498N |P=0.367 P=0.746N P=0.504N P=0.509 | |POLY 1.5 | P=0.356N P=0.475N P=0.224N P=0.491N |P=0.368 P=0.749N P=0.502N P=0.508 | |POLY 6 | P=0.361N P=0.468N P=0.225N P=0.507N |P=0.366 P=0.742N P=0.506N P=0.510 | |LOGISTIC REGRESSION| P=0.318N P=0.487N P=0.228N P=0.449N |P=0.409 P=0.761 P=0.433N P=0.614 | |COCH-ARM / FISHERS | P=0.352N P=0.477N P=0.232N P=0.477N |P=0.375 P=0.742N P=0.490N P=0.516 | |ORDER RESTRICTED | P=0.218N (e) (e) (e) |P=0.278 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/47 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/47 (4%) 0/49 (0%) 0/49 (0%) 1/49 (2%) | |POLY-3 RATE (b) | 0/43.45 0/47.28 0/46.48 0/43.80 |2/42.04 0/44.92 0/41.33 1/42.63 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.8% 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |1/34 (3%) 0/35 (0%) 0/30 (0%) 0/34 (0%) | |FIRST INCIDENCE | --- --- --- --- |591 --- --- 667 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.463N P=0.239N P=0.259N P=0.494N | |POLY 3 | (e) (e) (e) (e) |P=0.461N P=0.222N P=0.241N P=0.495N | |POLY 1.5 | (e) (e) (e) (e) |P=0.458N P=0.225N P=0.239N P=0.494N | |POLY 6 | (e) (e) (e) (e) |P=0.465N P=0.218N P=0.243N P=0.494N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.440N P=0.238N P=0.215N P=0.467N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.452N P=0.237N P=0.237N P=0.484N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.127N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 31 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/47 (4%) 0/50 (0%) 4/50 (8%) 1/50 (2%) |2/47 (4%) 2/49 (4%) 1/49 (2%) 2/49 (4%) | |POLY-3 RATE (b) | 2/43.45 0/47.28 4/46.48 1/43.80 |2/41.57 2/44.92 1/41.33 2/42.40 | |POLY-3 PERCENT (g) | 4.6% 0.0% 8.6% 2.3% |4.8% 4.5% 2.4% 4.7% | |TERMINAL (d) | 2/38 (5%) 0/41 (0%) 4/41 (10%) 1/33 (3%) |2/34 (6%) 2/35 (6%) 1/30 (3%) 2/34 (6%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.572 P=0.222N P=0.372 P=0.549N |P=0.586N P=0.685N P=0.544N P=0.696 | |POLY 3 | P=0.592N P=0.219N P=0.369 P=0.497N |P=0.578N P=0.666N P=0.502N P=0.687N | |POLY 1.5 | P=0.579N P=0.221N P=0.368 P=0.490N |P=0.576N P=0.672N P=0.501N P=0.687N | |POLY 6 | P=0.589 P=0.215N P=0.369 P=0.506N |P=0.580N P=0.657N P=0.503N P=0.685N | |LOGISTIC REGRESSION| P=0.572 (e) P=0.372 P=0.549N |P=0.586N P=0.685N P=0.544N P=0.696 | |COCH-ARM / FISHERS | P=0.558N P=0.232N P=0.369 P=0.477N |P=0.565N P=0.676N P=0.484N P=0.676N | |ORDER RESTRICTED | P=0.338 (e) (e) (e) |P=0.607N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/47 (9%) 6/50 (12%) 2/50 (4%) 4/50 (8%) |4/47 (9%) 2/49 (4%) 0/49 (0%) 1/49 (2%) | |POLY-3 RATE (b) | 4/43.70 6/47.54 2/46.48 4/44.19 |4/42.04 2/44.92 0/41.33 1/42.40 | |POLY-3 PERCENT (g) | 9.2% 12.6% 4.3% 9.1% |9.5% 4.5% 0.0% 2.4% | |TERMINAL (d) | 3/38 (8%) 4/41 (10%) 2/41 (5%) 2/33 (6%) |3/34 (9%) 2/35 (6%) 0/30 (0%) 1/34 (3%) | |FIRST INCIDENCE | 663 668 729 (T) 640 |591 729 (T) --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.511N P=0.431 P=0.301N P=0.587 |P=0.092N P=0.328N P=0.079N P=0.183N | |POLY 3 | P=0.428N P=0.424 P=0.309N P=0.637N |P=0.085N P=0.307N P=0.062N P=0.175N | |POLY 1.5 | P=0.418N P=0.417 P=0.309N P=0.627N |P=0.084N P=0.312N P=0.061N P=0.174N | |POLY 6 | P=0.441N P=0.434 P=0.310N P=0.637 |P=0.086N P=0.298N P=0.063N P=0.175N | |LOGISTIC REGRESSION| P=0.431N P=0.418 P=0.306N P=0.630N |P=0.086N P=0.309N P=0.061N P=0.172N | |COCH-ARM / FISHERS | P=0.400N P=0.410 P=0.310N P=0.607N |P=0.080N P=0.319N P=0.054N P=0.168N | |ORDER RESTRICTED | P=0.382N (e) (e) (e) |P=0.037N* (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 32 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 11/47 (23%) 6/50 (12%) 6/50 (12%) 9/50 (18%) |10/47 (21%) 8/49 (16%) 11/49 (22%) 6/49 (12%) | |POLY-3 RATE (b) | 11/43.45 6/47.35 6/46.72 9/44.60 |10/42.00 8/45.72 11/41.37 6/42.70 | |POLY-3 PERCENT (g) | 25.3% 12.7% 12.8% 20.2% |23.8% 17.5% 26.6% 14.1% | |TERMINAL (d) | 11/38 (29%) 5/41 (12%) 5/41 (12%) 6/33 (18%) |9/34 (27%) 5/35 (14%) 10/30 (33%) 5/34 (15%) | |FIRST INCIDENCE | 729 (T) 713 667 570 |606 561 719 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.529 P=0.105N P=0.105N P=0.523N |P=0.235N P=0.369N P=0.379 P=0.201N | |POLY 3 | P=0.436N P=0.100N P=0.105N P=0.374N |P=0.223N P=0.321N P=0.484 P=0.191N | |POLY 1.5 | P=0.425N P=0.106N P=0.108N P=0.364N |P=0.217N P=0.339N P=0.491 P=0.192N | |POLY 6 | P=0.452N P=0.092N P=0.102N P=0.387N |P=0.228N P=0.295N P=0.475 P=0.187N | |LOGISTIC REGRESSION| P=0.478N P=0.085N P=0.106N P=0.410N |P=0.218N P=0.336N P=0.489 P=0.187N | |COCH-ARM / FISHERS | P=0.404N P=0.113N P=0.113N P=0.342N |P=0.192N P=0.360N P=0.543 P=0.181N | |ORDER RESTRICTED | P=0.167N (e) (e) (e) |P=0.209N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/47 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/47 (2%) 2/49 (4%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/43.45 0/47.28 0/46.48 0/43.80 |1/41.57 2/44.92 0/41.33 0/42.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.4% 4.5% 0.0% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |1/34 (3%) 2/35 (6%) 0/30 (0%) 0/34 (0%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.195N P=0.510 P=0.525N P=0.500N | |POLY 3 | (e) (e) (e) (e) |P=0.186N P=0.527 P=0.501N P=0.496N | |POLY 1.5 | (e) (e) (e) (e) |P=0.186N P=0.521 P=0.501N P=0.496N | |POLY 6 | (e) (e) (e) (e) |P=0.185N P=0.536 P=0.502N P=0.495N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.195N P=0.510 (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.182N P=0.516 P=0.490N P=0.490N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.179N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 33 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/3 (0%) 0/0 (0%) 0/1 (0%) 0/3 (0%) |1/7 (14%) 1/5 (20%) 2/11 (18%) 0/9 (0%) | |POLY-3 RATE (b) | 0/1.27 0/0.00 0/1.00 0/1.86 |1/5.75 1/4.24 2/9.85 0/6.72 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |17.4% 23.6% 20.3% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |1/5 (20%) 1/3 (33%) 1/6 (17%) 0/5 (0%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 661 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.326N P=0.653 P=0.543 P=0.500N | |POLY 3 | (e) (e) (e) (e) |P=0.279N P=0.697 P=0.689 P=0.468N | |POLY 1.5 | (e) (e) (e) (e) |P=0.277N P=0.693 P=0.679 P=0.466N | |POLY 6 | (e) (e) (e) (e) |P=0.286N P=0.701 P=0.696 P=0.474N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.272N P=0.653 P=0.688 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.247N P=0.682 P=0.674 P=0.438N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.277N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |5/50 (10%) 11/50 (22%) 8/50 (16%) 10/50 (20%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 0/46.48 0/43.80 |5/44.17 11/46.31 8/43.14 10/45.34 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |11.3% 23.8% 18.6% 22.1% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |3/36 (8%) 6/35 (17%) 5/31 (16%) 4/35 (11%) | |FIRST INCIDENCE | --- --- --- --- |591 561 618 455 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.200 P=0.102 P=0.221 P=0.144 | |POLY 3 | (e) (e) (e) (e) |P=0.211 P=0.100 P=0.259 P=0.140 | |POLY 1.5 | (e) (e) (e) (e) |P=0.203 P=0.094 P=0.258 P=0.134 | |POLY 6 | (e) (e) (e) (e) |P=0.225 P=0.109 P=0.259 P=0.150 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.198 P=0.092 P=0.259 P=0.133 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.204 P=0.086 P=0.277 P=0.131 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.150 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 34 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Mesentery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/9 (11%) 0/10 (0%) 0/10 (0%) 2/8 (25%) |0/30 (0%) 0/32 (0%) 0/27 (0%) 1/24 (4%) | |POLY-3 RATE (b) | 1/7.50 0/9.21 0/9.01 2/7.15 |0/25.00 0/29.43 0/23.16 1/22.04 | |POLY-3 PERCENT (g) | 13.3% 0.0% 0.0% 28.0% |0.0% 0.0% 0.0% 4.5% | |TERMINAL (d) | 1/5 (20%) 0/9 (0%) 0/7 (0%) 0/4 (0%) |0/18 (0%) 0/21 (0%) 0/14 (0%) 1/17 (6%) | |FIRST INCIDENCE | 729 (T) --- --- 570 |--- --- --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.208 P=0.383N P=0.433N P=0.474 |P=0.185 (e) (e) P=0.489 | |POLY 3 | P=0.191 P=0.459N P=0.463N P=0.482 |P=0.171 (e) (e) P=0.475 | |POLY 1.5 | P=0.195 P=0.470N P=0.470N P=0.470 |P=0.168 (e) (e) P=0.467 | |POLY 6 | P=0.181 P=0.437N P=0.452N P=0.503 |P=0.173 (e) (e) P=0.484 | |LOGISTIC REGRESSION| P=0.215 (e) (e) P=0.484 |(e) (e) (e) P=0.489 | |COCH-ARM / FISHERS | P=0.201 P=0.474N P=0.474N P=0.453 |P=0.164 (e) (e) P=0.444 | |ORDER RESTRICTED | P=0.094 (e) (e) (e) |P=0.100 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/9 (33%) 8/10 (80%) 6/10 (60%) 5/8 (63%) |21/30 (70%) 24/32 (75%) 20/27 (74%) 16/24 (67%) | |POLY-3 RATE (b) | 3/7.83 8/10.00 6/9.24 5/7.15 |21/28.75 24/30.98 20/24.79 16/23.36 | |POLY-3 PERCENT (g) | 38.3% 80.0% 64.9% 69.9% |73.1% 77.5% 80.7% 68.5% | |TERMINAL (d) | 2/5 (40%) 7/9 (78%) 5/7 (71%) 3/4 (75%) |11/18 (61%) 16/21 (76%) 12/14 (86%) 11/17 (65%) | |FIRST INCIDENCE | 638 431 668 570 |524 552 618 540 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.190 P=0.278 P=0.370 P=0.247 |P=0.202N P=0.534 P=0.409 P=0.241N | |POLY 3 | P=0.291 P=0.081 P=0.268 P=0.232 |P=0.393N P=0.462 P=0.366 P=0.478N | |POLY 1.5 | P=0.298 P=0.061 P=0.256 P=0.236 |P=0.396N P=0.454 P=0.420 P=0.486N | |POLY 6 | P=0.280 P=0.124 P=0.291 P=0.231 |P=0.408N P=0.464 P=0.290 P=0.483N | |LOGISTIC REGRESSION| P=0.278 P=0.057 P=0.327 P=0.208 |P=0.343N P=0.476 P=0.520 P=0.531N | |COCH-ARM / FISHERS | P=0.307 P=0.055 P=0.242 P=0.238 |P=0.416N P=0.438 P=0.482 P=0.511N | |ORDER RESTRICTED | P=0.144 (e) (e) (e) |P=0.387N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 35 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Nose | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/44.60 1/47.28 0/46.48 2/44.61 |0/43.63 0/45.35 0/42.33 0/43.40 | |POLY-3 PERCENT (g) | 2.2% 2.1% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/38 (3%) 1/41 (2%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 465 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.336 P=0.745N P=0.485N P=0.478 |(e) (e) (e) (e) | |POLY 3 | P=0.364 P=0.747N P=0.492N P=0.500 |(e) (e) (e) (e) | |POLY 1.5 | P=0.365 P=0.752N P=0.494N P=0.501 |(e) (e) (e) (e) | |POLY 6 | P=0.360 P=0.741N P=0.489N P=0.498 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.389 P=0.745N (e) P=0.510 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.366 P=0.753N P=0.500N P=0.500 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.266 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Nose | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/44.60 2/47.28 1/46.48 5/45.36 |0/43.63 0/45.35 0/42.33 0/43.40 | |POLY-3 PERCENT (g) | 2.2% 4.2% 2.2% 11.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/38 (3%) 2/41 (5%) 1/41 (2%) 1/33 (3%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 465 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.036 * P=0.527 P=0.745N P=0.099 |(e) (e) (e) (e) | |POLY 3 | P=0.047 * P=0.520 P=0.751N P=0.105 |(e) (e) (e) (e) | |POLY 1.5 | P=0.047 * P=0.512 P=0.754N P=0.104 |(e) (e) (e) (e) | |POLY 6 | P=0.046 * P=0.530 P=0.748N P=0.106 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.055 P=0.527 P=0.745N P=0.106 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.047 * P=0.500 P=0.753N P=0.102 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.038 * (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 36 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Ovary | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |3/45 (7%) 2/45 (4%) 4/47 (9%) 3/50 (6%) | |POLY-3 RATE (b) | |3/39.57 2/41.78 4/40.91 3/44.12 | |POLY-3 PERCENT (g) | |7.6% 4.8% 9.8% 6.8% | |TERMINAL (d) | |3/32 (9%) 1/34 (3%) 2/30 (7%) 2/35 (6%) | |FIRST INCIDENCE | |729 (T) 714 542 475 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.513 P=0.471N P=0.472 P=0.629N | |POLY 3 | |P=0.548 P=0.475N P=0.518 P=0.612N | |POLY 1.5 | |P=0.547 P=0.486N P=0.511 P=0.616N | |POLY 6 | |P=0.550 P=0.459N P=0.529 P=0.604N | |LOGISTIC REGRESSION| |P=0.558 P=0.444N P=0.510 P=0.614N | |COCH-ARM / FISHERS | |P=0.560 P=0.500N P=0.525 P=0.610N | |ORDER RESTRICTED | |P=0.560 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |10/45 (22%) 15/45 (33%) 14/47 (30%) 13/50 (26%) | |POLY-3 RATE (b) | |10/39.57 15/42.11 14/41.83 13/43.65 | |POLY-3 PERCENT (g) | |25.3% 35.6% 33.5% 29.8% | |TERMINAL (d) | |10/32 (31%) 13/34 (38%) 10/30 (33%) 11/35 (31%) | |FIRST INCIDENCE | |729 (T) 674 486 688 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.434 P=0.222 P=0.188 P=0.396 | |POLY 3 | |P=0.478 P=0.218 P=0.284 P=0.415 | |POLY 1.5 | |P=0.478 P=0.196 P=0.265 P=0.409 | |POLY 6 | |P=0.488 P=0.255 P=0.310 P=0.433 | |LOGISTIC REGRESSION| |P=0.468 P=0.269 P=0.251 P=0.430 | |COCH-ARM / FISHERS | |P=0.512 P=0.173 P=0.279 P=0.426 | |ORDER RESTRICTED | |P=0.359 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 37 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Ovary | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |3/45 (7%) 1/45 (2%) 1/47 (2%) 0/50 (0%) | |POLY-3 RATE (b) | |3/40.53 1/41.72 1/40.25 0/43.40 | |POLY-3 PERCENT (g) | |7.4% 2.4% 2.5% 0.0% | |TERMINAL (d) | |1/32 (3%) 1/34 (3%) 1/30 (3%) 0/35 (0%) | |FIRST INCIDENCE | |524 729 (T) 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.073N P=0.291N P=0.327N P=0.118N | |POLY 3 | |P=0.067N P=0.295N P=0.307N P=0.106N | |POLY 1.5 | |P=0.066N P=0.300N P=0.306N P=0.105N | |POLY 6 | |P=0.068N P=0.287N P=0.308N P=0.106N | |LOGISTIC REGRESSION| |P=0.058N P=0.344N P=0.268N P=0.078N | |COCH-ARM / FISHERS | |P=0.062N P=0.308N P=0.292N P=0.103N | |ORDER RESTRICTED | |P=0.031N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Ovary: Follicle | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |1/45 (2%) 4/45 (9%) 4/47 (9%) 9/50 (18%) | |POLY-3 RATE (b) | |1/39.57 4/41.72 4/40.25 9/43.79 | |POLY-3 PERCENT (g) | |2.5% 9.6% 9.9% 20.6% | |TERMINAL (d) | |1/32 (3%) 4/34 (12%) 4/30 (13%) 8/35 (23%) | |FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 618 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.007 ** P=0.197 P=0.159 P=0.014 * | |POLY 3 | |P=0.007 ** P=0.194 P=0.183 P=0.012 * | |POLY 1.5 | |P=0.007 ** P=0.187 P=0.181 P=0.012 * | |POLY 6 | |P=0.007 ** P=0.205 P=0.185 P=0.013 * | |LOGISTIC REGRESSION| |P=0.007 ** P=0.197 P=0.159 P=0.014 * | |COCH-ARM / FISHERS | |P=0.009 ** P=0.180 P=0.194 P=0.012 * | |ORDER RESTRICTED | |P=0.005 ** (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 38 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Ovary: Granulosa Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |0/45 (0%) 0/45 (0%) 3/47 (6%) 7/50 (14%) | |POLY-3 RATE (b) | |0/39.57 0/41.72 3/40.25 7/44.00 | |POLY-3 PERCENT (g) | |0.0% 0.0% 7.5% 15.9% | |TERMINAL (d) | |0/32 (0%) 0/34 (0%) 3/30 (10%) 6/35 (17%) | |FIRST INCIDENCE | |--- --- 729 (T) 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P<0.001 ** (e) P=0.109 P=0.012 * | |POLY 3 | |P<0.001 ** (e) P=0.121 P=0.011 * | |POLY 1.5 | |P<0.001 ** (e) P=0.120 P=0.011 * | |POLY 6 | |P<0.001 ** (e) P=0.122 P=0.011 * | |LOGISTIC REGRESSION| |P<0.001 ** (e) P=0.109 P=0.013 * | |COCH-ARM / FISHERS | |P<0.001 ** (e) P=0.129 P=0.009 ** | |ORDER RESTRICTED | |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Pancreas | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/46 (4%) 1/47 (2%) 0/49 (0%) 1/48 (2%) | |POLY-3 RATE (b) | 0/43.91 0/47.28 0/46.48 0/43.80 |2/42.28 1/44.26 0/42.00 1/42.44 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.7% 2.3% 0.0% 2.4% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |2/36 (6%) 1/35 (3%) 0/31 (0%) 1/35 (3%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.378N P=0.510N P=0.272N P=0.510N | |POLY 3 | (e) (e) (e) (e) |P=0.365N P=0.484N P=0.238N P=0.499N | |POLY 1.5 | (e) (e) (e) (e) |P=0.363N P=0.488N P=0.236N P=0.497N | |POLY 6 | (e) (e) (e) (e) |P=0.368N P=0.478N P=0.241N P=0.498N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.378N P=0.510N (e) P=0.510N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.354N P=0.492N P=0.232N P=0.484N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.224N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 39 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Pancreas | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/46 (0%) 1/47 (2%) 1/49 (2%) 0/48 (0%) | |POLY-3 RATE (b) | 0/43.91 0/47.28 0/46.48 2/44.54 |0/42.28 1/44.26 1/42.00 0/42.44 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.5% |0.0% 2.3% 2.4% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 1/33 (3%) |0/36 (0%) 1/35 (3%) 1/31 (3%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- 465 |--- 729 (T) 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.040 * (e) (e) P=0.224 |P=0.601N P=0.494 P=0.470 (e) | |POLY 3 | P=0.045 * (e) (e) P=0.240 |P=0.598N P=0.509 P=0.499 (e) | |POLY 1.5 | P=0.046 * (e) (e) P=0.242 |P=0.596N P=0.507 P=0.501 (e) | |POLY 6 | P=0.044 * (e) (e) P=0.237 |P=0.598N P=0.513 P=0.496 (e) | |LOGISTIC REGRESSION| P=0.087 (e) (e) P=0.317 |(e) P=0.494 P=0.470 (e) | |COCH-ARM / FISHERS | P=0.048 * (e) (e) P=0.258 |P=0.586N P=0.505 P=0.516 (e) | |ORDER RESTRICTED | P=0.031 * (e) (e) (e) |P=0.403N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Parathyroid Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/46 (0%) 1/48 (2%) 2/47 (4%) 1/49 (2%) |1/45 (2%) 1/47 (2%) 2/48 (4%) 2/47 (4%) | |POLY-3 RATE (b) | 0/42.34 1/45.51 2/43.48 1/43.58 |1/40.35 1/42.62 2/41.18 2/40.40 | |POLY-3 PERCENT (g) | 0.0% 2.2% 4.6% 2.3% |2.5% 2.4% 4.9% 5.0% | |TERMINAL (d) | 0/37 (0%) 1/40 (3%) 2/38 (5%) 0/33 (0%) |1/33 (3%) 0/34 (0%) 1/30 (3%) 2/32 (6%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 595 |729 (T) 727 683 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.337 P=0.516 P=0.244 P=0.509 |P=0.326 P=0.757N P=0.478 P=0.489 | |POLY 3 | P=0.362 P=0.514 P=0.243 P=0.506 |P=0.329 P=0.749N P=0.507 P=0.500 | |POLY 1.5 | P=0.369 P=0.512 P=0.243 P=0.508 |P=0.333 P=0.750N P=0.507 P=0.503 | |POLY 6 | P=0.353 P=0.518 P=0.243 P=0.503 |P=0.326 P=0.744N P=0.509 P=0.501 | |LOGISTIC REGRESSION| P=0.392 P=0.516 P=0.244 P=0.593 |P=0.327 P=0.741N P=0.506 P=0.489 | |COCH-ARM / FISHERS | P=0.382 P=0.511 P=0.253 P=0.516 |P=0.349 P=0.742N P=0.524 P=0.516 | |ORDER RESTRICTED | P=0.231 (e) (e) (e) |P=0.435 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 40 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Peripheral Nerve | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 1/1 (100%) 0/2 (0%) 0/1 (0%) |0/0 (0%) 0/0 (0%) 1/2 (50%) 2/2 (100%) | |POLY-3 RATE (b) | 0/0.00 1/1.00 0/1.35 0/0.06 |0/0.00 0/0.00 1/1.30 2/2.00 | |POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 0.0% |0.0% 0.0% 77.1% 100.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 604 --- --- |--- --- 662 667 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.570N (e) (e) (e) |P=0.237 (e) P=0.500 (e) | |POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.613N (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.396N (e) (e) (e) |P=0.500 (e) P=1.000 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/47 (0%) 0/47 (0%) 0/45 (0%) 0/49 (0%) |1/46 (2%) 2/45 (4%) 2/48 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.10 0/44.28 0/42.54 0/42.80 |1/41.52 2/41.26 2/40.71 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.4% 4.9% 4.9% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/38 (0%) 0/38 (0%) 0/32 (0%) |1/35 (3%) 2/32 (6%) 2/30 (7%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.296N P=0.469 P=0.446 P=0.500N | |POLY 3 | (e) (e) (e) (e) |P=0.286N P=0.498 P=0.493 P=0.491N | |POLY 1.5 | (e) (e) (e) (e) |P=0.283N P=0.495 P=0.496 P=0.490N | |POLY 6 | (e) (e) (e) (e) |P=0.289N P=0.502 P=0.490 P=0.492N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.296N P=0.469 P=0.446 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.270N P=0.492 P=0.516 P=0.479N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.213N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 41 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/47 (2%) 1/47 (2%) 2/45 (4%) 5/49 (10%) |0/46 (0%) 0/45 (0%) 0/48 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/42.10 1/44.35 2/42.76 5/42.80 |0/41.52 0/41.26 0/40.71 1/43.40 | |POLY-3 PERCENT (g) | 2.4% 2.3% 4.7% 11.7% |0.0% 0.0% 0.0% 2.3% | |TERMINAL (d) | 1/37 (3%) 0/38 (0%) 1/38 (3%) 5/32 (16%) |0/35 (0%) 0/32 (0%) 0/30 (0%) 1/35 (3%) | |FIRST INCIDENCE | 729 (T) 713 673 729 (T) |--- --- --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.017 * P=0.741N P=0.515 P=0.072 |P=0.207 (e) (e) P=0.500 | |POLY 3 | P=0.029 * P=0.749N P=0.505 P=0.104 |P=0.205 (e) (e) P=0.509 | |POLY 1.5 | P=0.030 * P=0.753N P=0.498 P=0.108 |P=0.207 (e) (e) P=0.510 | |POLY 6 | P=0.027 * P=0.744N P=0.513 P=0.099 |P=0.204 (e) (e) P=0.508 | |LOGISTIC REGRESSION| P=0.025 * P=0.749N P=0.495 P=0.072 |(e) (e) (e) P=0.500 | |COCH-ARM / FISHERS | P=0.033 * P=0.753N P=0.484 P=0.112 |P=0.211 (e) (e) P=0.521 | |ORDER RESTRICTED | P=0.036 * (e) (e) (e) |P=0.129 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/47 (0%) 0/47 (0%) 0/45 (0%) 0/49 (0%) |3/46 (7%) 3/45 (7%) 3/48 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 0/42.10 0/44.28 0/42.54 0/42.80 |3/41.52 3/41.26 3/40.71 1/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |7.2% 7.3% 7.4% 2.3% | |TERMINAL (d) | 0/37 (0%) 0/38 (0%) 0/38 (0%) 0/32 (0%) |3/35 (9%) 3/32 (9%) 3/30 (10%) 1/35 (3%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.220N P=0.622 P=0.591 P=0.305N | |POLY 3 | (e) (e) (e) (e) |P=0.208N P=0.660 P=0.654 P=0.289N | |POLY 1.5 | (e) (e) (e) (e) |P=0.204N P=0.656 P=0.657 P=0.286N | |POLY 6 | (e) (e) (e) (e) |P=0.211N P=0.660N P=0.649 P=0.290N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.220N P=0.622 P=0.591 P=0.305N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.190N P=0.651 P=0.641N P=0.278N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.263N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 42 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Preputial Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 22/50 (44%) 26/50 (52%) 15/50 (30%) 29/50 (58%) | | |POLY-3 RATE (b) | 22/47.74 26/47.94 15/47.22 29/46.39 | | |POLY-3 PERCENT (g) | 46.1% 54.2% 31.8% 62.5% | | |TERMINAL (d) | 14/38 (37%) 23/41 (56%) 13/41 (32%) 20/33 (61%) | | |FIRST INCIDENCE | 484 577 570 465 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.068 P=0.416 P=0.085N P=0.071 | | |POLY 3 | P=0.124 P=0.276 P=0.109N P=0.078 | | |POLY 1.5 | P=0.141 P=0.280 P=0.105N P=0.092 | | |POLY 6 | P=0.102 P=0.269 P=0.121N P=0.060 | | |LOGISTIC REGRESSION| P=0.155 P=0.289 P=0.113N P=0.112 | | |COCH-ARM / FISHERS | P=0.169 P=0.274 P=0.107N P=0.115 | | |ORDER RESTRICTED | P=0.047 * (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 28/50 (56%) 27/50 (54%) 18/50 (36%) 21/50 (42%) | | |POLY-3 RATE (b) | 28/47.20 27/48.03 18/47.45 21/45.80 | | |POLY-3 PERCENT (g) | 59.3% 56.2% 37.9% 45.9% | | |TERMINAL (d) | 22/38 (58%) 22/41 (54%) 15/41 (37%) 14/33 (42%) | | |FIRST INCIDENCE | 484 577 562 465 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.191N P=0.350N P=0.024N* P=0.279N | | |POLY 3 | P=0.068N P=0.460N P=0.027N* P=0.133N | | |POLY 1.5 | P=0.062N P=0.473N P=0.028N* P=0.123N | | |POLY 6 | P=0.080N P=0.441N P=0.026N* P=0.151N | | |LOGISTIC REGRESSION| P=0.065N P=0.433N P=0.030N* P=0.120N | | |COCH-ARM / FISHERS | P=0.057N P=0.500N P=0.035N* P=0.115N | | |ORDER RESTRICTED | P=0.064N (e) (e) (e) | | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 43 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 3/50 (6%) 5/50 (10%) | | |POLY-3 RATE (b) | 1/44.60 4/47.79 3/46.48 5/44.36 | | |POLY-3 PERCENT (g) | 2.2% 8.4% 6.5% 11.3% | | |TERMINAL (d) | 1/38 (3%) 3/41 (7%) 3/41 (7%) 3/33 (9%) | | |FIRST INCIDENCE | 729 (T) 574 729 (T) 570 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.078 P=0.206 P=0.333 P=0.085 | | |POLY 3 | P=0.108 P=0.201 P=0.320 P=0.100 | | |POLY 1.5 | P=0.110 P=0.192 P=0.315 P=0.101 | | |POLY 6 | P=0.104 P=0.212 P=0.325 P=0.098 | | |LOGISTIC REGRESSION| P=0.110 P=0.171 P=0.333 P=0.101 | | |COCH-ARM / FISHERS | P=0.113 P=0.181 P=0.309 P=0.102 | | |ORDER RESTRICTED | P=0.076 (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Salivary Glands | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/48 (0%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 1/46.48 2/43.83 |0/42.53 0/43.74 0/41.37 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 1/41 (2%) 1/33 (3%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- 729 (T) 721 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.052 (e) P=0.515 P=0.212 |(e) (e) (e) (e) | |POLY 3 | P=0.065 (e) P=0.508 P=0.233 |(e) (e) (e) (e) | |POLY 1.5 | P=0.067 (e) P=0.506 P=0.235 |(e) (e) (e) (e) | |POLY 6 | P=0.063 (e) P=0.511 P=0.230 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.056 (e) P=0.515 P=0.224 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.070 (e) P=0.500 P=0.247 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.072 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 44 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Salivary Glands | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 3/50 (6%) 6/50 (12%) 4/50 (8%) |16/48 (33%) 21/47 (45%) 15/49 (31%) 18/50 (36%) | |POLY-3 RATE (b) | 7/44.60 3/47.28 6/46.48 4/43.80 |16/43.42 21/44.04 15/42.58 18/43.95 | |POLY-3 PERCENT (g) | 15.7% 6.4% 12.9% 9.1% |36.9% 47.7% 35.2% 41.0% | |TERMINAL (d) | 7/38 (18%) 3/41 (7%) 6/41 (15%) 4/33 (12%) |13/36 (36%) 18/35 (51%) 12/31 (39%) 16/35 (46%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |630 682 486 618 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.411N P=0.128N P=0.441N P=0.345N |P=0.470 P=0.198 P=0.508 P=0.390 | |POLY 3 | P=0.342N P=0.135N P=0.468N P=0.271N |P=0.532 P=0.208 P=0.527N P=0.431 | |POLY 1.5 | P=0.332N P=0.144N P=0.479N P=0.267N |P=0.530N P=0.199 P=0.519N P=0.444 | |POLY 6 | P=0.359N P=0.124N P=0.457N P=0.278N |P=0.507 P=0.214 P=0.547N P=0.413 | |LOGISTIC REGRESSION| P=0.411N P=0.128N P=0.441N P=0.345N |P=0.523 P=0.244 P=0.535N P=0.439 | |COCH-ARM / FISHERS | P=0.316N P=0.159N P=0.500N P=0.262N |P=0.481N P=0.178 P=0.472N P=0.474 | |ORDER RESTRICTED | P=0.263N (e) (e) (e) |P=0.522 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Seminal Vesicle | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | | |POLY-3 RATE (b) | 0/44.60 1/47.28 0/46.48 2/43.80 | | |POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 4.6% | | |TERMINAL (d) | 0/38 (0%) 1/41 (2%) 0/41 (0%) 2/33 (6%) | | |FIRST INCIDENCE | --- 729 (T) --- 729 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.110 P=0.515 (e) P=0.208 | | |POLY 3 | P=0.137 P=0.512 (e) P=0.233 | | |POLY 1.5 | P=0.138 P=0.507 (e) P=0.235 | | |POLY 6 | P=0.135 P=0.517 (e) P=0.230 | | |LOGISTIC REGRESSION| (e) P=0.515 (e) P=0.208 | | |COCH-ARM / FISHERS | P=0.140 P=0.500 (e) P=0.247 | | |ORDER RESTRICTED | P=0.072 (e) (e) (e) | | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 45 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Seminal Vesicle | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | |POLY-3 RATE (b) | 3/44.60 0/47.28 1/46.48 0/43.80 | | |POLY-3 PERCENT (g) | 6.7% 0.0% 2.2% 0.0% | | |TERMINAL (d) | 3/38 (8%) 0/41 (0%) 1/41 (2%) 0/33 (0%) | | |FIRST INCIDENCE | 729 (T) --- 729 (T) --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.096N P=0.108N P=0.278N P=0.147N | | |POLY 3 | P=0.090N P=0.109N P=0.291N P=0.122N | | |POLY 1.5 | P=0.088N P=0.113N P=0.296N P=0.120N | | |POLY 6 | P=0.093N P=0.104N P=0.286N P=0.124N | | |LOGISTIC REGRESSION| P=0.096N (e) P=0.278N (e) | | |COCH-ARM / FISHERS | P=0.086N P=0.121N P=0.309N P=0.121N | | |ORDER RESTRICTED | P=0.022N* (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Skin | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |0/48 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 0/46.48 3/44.59 |0/42.09 1/45.35 0/42.33 1/43.40 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.7% |0.0% 2.2% 0.0% 2.3% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/35 (0%) 1/35 (3%) 0/31 (0%) 1/35 (3%) | |FIRST INCIDENCE | --- --- --- 618 |--- 729 (T) --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.010 * (e) (e) P=0.117 |P=0.404 P=0.500 (e) P=0.500 | |POLY 3 | P=0.010 * (e) (e) P=0.118 |P=0.408 P=0.515 (e) P=0.506 | |POLY 1.5 | P=0.011 * (e) (e) P=0.119 |P=0.408 P=0.513 (e) P=0.506 | |POLY 6 | P=0.010 * (e) (e) P=0.118 |P=0.409 P=0.518 (e) P=0.506 | |LOGISTIC REGRESSION| P=0.016 * (e) (e) P=0.123 |(e) P=0.500 (e) P=0.500 | |COCH-ARM / FISHERS | P=0.012 * (e) (e) P=0.121 |P=0.411 P=0.510 (e) P=0.510 | |ORDER RESTRICTED | P=0.008 ** (e) (e) (e) |P=0.257 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 46 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Skin | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/44.60 0/47.28 0/46.48 0/43.80 |0/42.09 0/45.35 0/42.33 0/43.40 | |POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/38 (5%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/35 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.122N P=0.222N P=0.222N P=0.270N |(e) (e) (e) (e) | |POLY 3 | P=0.116N P=0.224N P=0.228N P=0.241N |(e) (e) (e) (e) | |POLY 1.5 | P=0.115N P=0.229N P=0.231N P=0.239N |(e) (e) (e) (e) | |POLY 6 | P=0.117N P=0.218N P=0.225N P=0.244N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.122N (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.031N* (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/48 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 0/44.60 0/47.28 0/46.48 0/43.80 |0/42.09 0/45.35 1/43.00 2/44.99 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 2.3% 4.5% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/35 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 503 142 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.069 (e) P=0.496 P=0.235 | |POLY 3 | (e) (e) (e) (e) |P=0.074 (e) P=0.504 P=0.252 | |POLY 1.5 | (e) (e) (e) (e) |P=0.073 (e) P=0.504 P=0.250 | |POLY 6 | (e) (e) (e) (e) |P=0.074 (e) P=0.504 P=0.254 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.085 (e) P=0.589 P=0.308 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.073 (e) P=0.510 P=0.258 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.084 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 47 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 21/48 (44%) 17/50 (34%) 18/50 (36%) 21/50 (42%) |39/49 (80%) 39/48 (81%) 35/49 (71%) 39/50 (78%) | |POLY-3 RATE (b) | 21/46.42 17/48.74 18/49.41 21/47.89 |39/47.38 39/46.92 35/44.21 39/47.88 | |POLY-3 PERCENT (g) | 45.2% 34.9% 36.4% 43.9% |82.3% 83.1% 79.2% 81.5% | |TERMINAL (d) | 14/38 (37%) 11/41 (27%) 10/41 (24%) 7/33 (21%) |31/36 (86%) 31/35 (89%) 26/31 (84%) 31/35 (89%) | |FIRST INCIDENCE | 561 574 558 535 |440 461 602 142 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.309 P=0.202N P=0.274N P=0.451 |P=0.472 P=0.529 P=0.545 P=0.513 | |POLY 3 | P=0.488 P=0.206N P=0.252N P=0.528N |P=0.471N P=0.569 P=0.451N P=0.565N | |POLY 1.5 | P=0.488 P=0.211N P=0.264N P=0.529N |P=0.446N P=0.549 P=0.415N P=0.547N | |POLY 6 | P=0.493 P=0.199N P=0.239N P=0.521N |P=0.504N P=0.592 P=0.480N P=0.592N | |LOGISTIC REGRESSION| P=0.467N P=0.245N P=0.314N P=0.454N |P=0.498N P=0.558 P=0.342N P=0.546N | |COCH-ARM / FISHERS | P=0.504 P=0.217N P=0.282N P=0.512N |P=0.394N P=0.520 P=0.241N P=0.521N | |ORDER RESTRICTED | P=0.396N (e) (e) (e) |P=0.589N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Spleen | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/48 (17%) 9/50 (18%) 10/50 (20%) 8/50 (16%) |11/49 (22%) 10/48 (21%) 5/49 (10%) 9/50 (18%) | |POLY-3 RATE (b) | 8/43.91 9/47.28 10/46.48 8/43.80 |11/43.57 10/44.61 5/42.25 9/43.70 | |POLY-3 PERCENT (g) | 18.2% 19.0% 21.5% 18.3% |25.2% 22.4% 11.8% 20.6% | |TERMINAL (d) | 8/38 (21%) 9/41 (22%) 10/41 (24%) 8/33 (24%) |11/36 (31%) 10/35 (29%) 4/31 (13%) 8/35 (23%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 662 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.411 P=0.570 P=0.466 P=0.486 |P=0.322N P=0.530N P=0.139N P=0.422N | |POLY 3 | P=0.538 P=0.567 P=0.449 P=0.606 |P=0.298N P=0.475N P=0.092N P=0.397N | |POLY 1.5 | P=0.540N P=0.553 P=0.443 P=0.597N |P=0.296N P=0.496N P=0.095N P=0.400N | |POLY 6 | P=0.510 P=0.586 P=0.456 P=0.589 |P=0.297N P=0.447N P=0.088N P=0.386N | |LOGISTIC REGRESSION| P=0.411 P=0.570 P=0.466 P=0.486 |P=0.315N P=0.530N P=0.095N P=0.395N | |COCH-ARM / FISHERS | P=0.507N P=0.537 P=0.435 P=0.572N |P=0.274N P=0.521N P=0.085N P=0.382N | |ORDER RESTRICTED | P=0.649 (e) (e) (e) |P=0.233N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 48 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Spleen | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |28/49 (57%) 30/48 (63%) 28/49 (57%) 27/50 (54%) | |POLY-3 RATE (b) | 0/43.91 3/48.22 1/46.48 1/44.06 |28/45.87 30/45.09 28/43.82 27/45.83 | |POLY-3 PERCENT (g) | 0.0% 6.2% 2.2% 2.3% |61.1% 66.5% 63.9% 58.9% | |TERMINAL (d) | 0/38 (0%) 1/41 (2%) 1/41 (2%) 0/33 (0%) |22/36 (61%) 24/35 (69%) 20/31 (65%) 21/35 (60%) | |FIRST INCIDENCE | --- 574 729 (T) 657 |524 673 602 455 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.567 P=0.138 P=0.515 P=0.490 |P=0.478N P=0.401 P=0.336 P=0.546N | |POLY 3 | P=0.586 P=0.136 P=0.511 P=0.501 |P=0.387N P=0.370 P=0.475 P=0.502N | |POLY 1.5 | P=0.591 P=0.132 P=0.510 P=0.503 |P=0.383N P=0.368 P=0.479 P=0.498N | |POLY 6 | P=0.579 P=0.143 P=0.513 P=0.498 |P=0.387N P=0.381 P=0.479 P=0.501N | |LOGISTIC REGRESSION| P=0.566N P=0.107 P=0.515 P=0.534 |P=0.425N P=0.480 P=0.499 P=0.502N | |COCH-ARM / FISHERS | P=0.602 P=0.129 P=0.510 P=0.510 |P=0.332N P=0.371 P=0.581N P=0.455N | |ORDER RESTRICTED | P=0.245 (e) (e) (e) |P=0.488N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |1/49 (2%) 2/48 (4%) 1/49 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 1/44.24 0/47.28 1/46.70 3/45.11 |1/44.08 2/44.66 1/42.07 2/44.16 | |POLY-3 PERCENT (g) | 2.3% 0.0% 2.1% 6.7% |2.3% 4.5% 2.4% 4.5% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 1/35 (3%) | |FIRST INCIDENCE | 638 --- 672 570 |576 719 712 455 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.092 P=0.482N P=0.742N P=0.312 |P=0.429 P=0.496 P=0.747 P=0.489 | |POLY 3 | P=0.096 P=0.487N P=0.749N P=0.312 |P=0.443 P=0.505 P=0.750 P=0.501 | |POLY 1.5 | P=0.097 P=0.489N P=0.750N P=0.314 |P=0.444 P=0.499 P=0.751 P=0.501 | |POLY 6 | P=0.093 P=0.484N P=0.747N P=0.309 |P=0.442 P=0.512 P=0.750 P=0.502 | |LOGISTIC REGRESSION| P=0.177 P=0.502N P=0.750 P=0.422 |P=0.481 P=0.468 P=0.748N P=0.611 | |COCH-ARM / FISHERS | P=0.101 P=0.490N P=0.742N P=0.324 |P=0.455 P=0.492 P=0.753N P=0.508 | |ORDER RESTRICTED | P=0.083 (e) (e) (e) |P=0.443 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 49 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 2/44.53 0/47.28 0/46.48 0/43.80 |0/43.57 0/45.35 0/42.33 0/43.12 | |POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/38 (5%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.122N P=0.222N P=0.222N P=0.270N |(e) (e) (e) (e) | |POLY 3 | P=0.113N P=0.224N P=0.228N P=0.241N |(e) (e) (e) (e) | |POLY 1.5 | P=0.112N P=0.228N P=0.230N P=0.238N |(e) (e) (e) (e) | |POLY 6 | P=0.114N P=0.218N P=0.225N P=0.244N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.122N (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.113N P=0.242N P=0.242N P=0.242N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.031N* (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Diverticulum | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |2/49 (4%) 1/50 (2%) 1/50 (2%) 2/49 (4%) | |POLY-3 RATE (b) | 1/44.53 1/47.28 0/46.48 2/43.80 |2/43.57 1/45.35 1/42.33 2/43.88 | |POLY-3 PERCENT (g) | 2.3% 2.1% 0.0% 4.6% |4.6% 2.2% 2.4% 4.6% | |TERMINAL (d) | 1/38 (3%) 1/41 (2%) 0/41 (0%) 2/33 (6%) |2/36 (6%) 1/35 (3%) 1/31 (3%) 1/35 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |729 (T) 729 (T) 729 (T) 455 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.318 P=0.745N P=0.485N P=0.451 |P=0.543 P=0.510N P=0.552N P=0.686 | |POLY 3 | P=0.361 P=0.747N P=0.491N P=0.494 |P=0.551 P=0.486N P=0.510N P=0.692N | |POLY 1.5 | P=0.365 P=0.751N P=0.493N P=0.499 |P=0.549 P=0.490N P=0.509N P=0.693 | |POLY 6 | P=0.356 P=0.741N P=0.489N P=0.489 |P=0.553 P=0.480N P=0.512N P=0.687N | |LOGISTIC REGRESSION| P=0.318 P=0.745N (e) P=0.451 |P=0.556 P=0.510N P=0.552N P=0.677N | |COCH-ARM / FISHERS | P=0.371 P=0.747N P=0.495N P=0.508 |P=0.554 P=0.492N P=0.492N P=0.691N | |ORDER RESTRICTED | P=0.259 (e) (e) (e) |P=0.543N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 50 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 3/50 (6%) 0/49 (0%) | |POLY-3 RATE (b) | 0/44.53 0/47.28 0/46.48 0/43.80 |0/43.57 0/45.35 3/42.37 0/43.12 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 7.1% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 2/31 (7%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 720 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.529 (e) P=0.101 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.532 (e) P=0.113 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.531 (e) P=0.114 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.535 (e) P=0.113 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.531 (e) P=0.111 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.538 (e) P=0.125 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.157 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 1/50 (2%) 2/50 (4%) 2/49 (4%) | |POLY-3 RATE (b) | 0/44.53 1/47.28 0/46.48 0/43.80 |0/43.57 1/45.39 2/43.10 2/44.04 | |POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 0.0% |0.0% 2.2% 4.6% 4.5% | |TERMINAL (d) | 0/38 (0%) 1/41 (2%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- 729 (T) --- --- |--- 719 542 455 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.593N P=0.515 (e) (e) |P=0.156 P=0.505 P=0.235 P=0.240 | |POLY 3 | P=0.560N P=0.512 (e) (e) |P=0.160 P=0.508 P=0.235 P=0.239 | |POLY 1.5 | P=0.563N P=0.508 (e) (e) |P=0.157 P=0.506 P=0.234 P=0.237 | |POLY 6 | P=0.557N P=0.517 (e) (e) |P=0.164 P=0.512 P=0.236 P=0.243 | |LOGISTIC REGRESSION| (e) P=0.515 (e) (e) |P=0.176 P=0.511 P=0.273 P=0.297 | |COCH-ARM / FISHERS | P=0.565N P=0.505 (e) (e) |P=0.158 P=0.505 P=0.253 P=0.247 | |ORDER RESTRICTED | P=0.394N (e) (e) (e) |P=0.153 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 51 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 2/50 (4%) 4/50 (8%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 2/50 (4%) 2/49 (4%) | |POLY-3 RATE (b) | 2/44.97 2/47.71 4/48.04 2/44.08 |0/43.57 0/45.35 2/42.40 2/43.12 | |POLY-3 PERCENT (g) | 4.5% 4.2% 8.3% 4.5% |0.0% 0.0% 4.7% 4.6% | |TERMINAL (d) | 1/38 (3%) 1/41 (2%) 1/41 (2%) 1/33 (3%) |0/36 (0%) 0/35 (0%) 1/31 (3%) 2/35 (6%) | |FIRST INCIDENCE | 603 604 543 652 |--- --- 712 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.509 P=0.669N P=0.362 P=0.665 |P=0.084 (e) P=0.220 P=0.232 | |POLY 3 | P=0.518 P=0.672N P=0.368 P=0.687 |P=0.081 (e) P=0.231 P=0.235 | |POLY 1.5 | P=0.530 P=0.679N P=0.359 P=0.692 |P=0.081 (e) P=0.232 P=0.234 | |POLY 6 | P=0.502 P=0.663N P=0.379 P=0.681 |P=0.081 (e) P=0.230 P=0.236 | |LOGISTIC REGRESSION| P=0.501N P=0.677 P=0.251 P=0.673N |P=0.082 (e) P=0.229 P=0.232 | |COCH-ARM / FISHERS | P=0.551 P=0.684N P=0.349 P=0.684N |P=0.084 (e) P=0.253 P=0.247 | |ORDER RESTRICTED | P=0.515 (e) (e) (e) |P=0.111 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |2/49 (4%) 0/50 (0%) 3/50 (6%) 3/49 (6%) | |POLY-3 RATE (b) | 1/44.97 1/47.28 2/47.43 1/44.08 |2/44.16 0/45.35 3/42.39 3/44.66 | |POLY-3 PERCENT (g) | 2.2% 2.1% 4.2% 2.3% |4.5% 0.0% 7.1% 6.7% | |TERMINAL (d) | 0/38 (0%) 1/41 (2%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 1/31 (3%) 0/35 (0%) | |FIRST INCIDENCE | 603 729 (T) 570 652 |576 --- 720 447 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.578 P=0.747N P=0.513 P=0.758 |P=0.224 P=0.238N P=0.458 P=0.489 | |POLY 3 | P=0.572 P=0.749N P=0.519 P=0.756 |P=0.231 P=0.231N P=0.481 P=0.505 | |POLY 1.5 | P=0.581 P=0.752N P=0.514 P=0.759 |P=0.228 P=0.232N P=0.486 P=0.500 | |POLY 6 | P=0.561 P=0.745N P=0.525 P=0.753 |P=0.235 P=0.229N P=0.476 P=0.512 | |LOGISTIC REGRESSION| P=0.525N P=0.753 P=0.395 P=0.716N |P=0.251 P=0.235N P=0.499 P=0.612 | |COCH-ARM / FISHERS | P=0.596 P=0.747N P=0.508 P=0.747N |P=0.230 P=0.242N P=0.510 P=0.500 | |ORDER RESTRICTED | P=0.588 (e) (e) (e) |P=0.229 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 52 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 7/50 (14%) 2/50 (4%) 4/50 (8%) |3/49 (6%) 4/50 (8%) 9/50 (18%) 6/49 (12%) | |POLY-3 RATE (b) | 3/45.51 7/48.35 2/47.07 4/45.62 |3/44.90 4/45.94 9/44.15 6/44.64 | |POLY-3 PERCENT (g) | 6.6% 14.5% 4.3% 8.8% |6.7% 8.7% 20.4% 13.4% | |TERMINAL (d) | 1/38 (3%) 4/41 (10%) 1/41 (2%) 1/33 (3%) |0/36 (0%) 2/35 (6%) 3/31 (10%) 3/35 (9%) | |FIRST INCIDENCE | 562 574 543 288 |440 561 542 455 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.548N P=0.201 P=0.477N P=0.480 |P=0.157 P=0.502 P=0.060 P=0.242 | |POLY 3 | P=0.501N P=0.184 P=0.485N P=0.501 |P=0.150 P=0.512 P=0.055 P=0.239 | |POLY 1.5 | P=0.496N P=0.176 P=0.487N P=0.506 |P=0.148 P=0.510 P=0.055 P=0.236 | |POLY 6 | P=0.509N P=0.196 P=0.482N P=0.494 |P=0.154 P=0.518 P=0.056 P=0.243 | |LOGISTIC REGRESSION| P=0.321N P=0.124 P=0.574N P=0.654N |P=0.179 P=0.502 P=0.083 P=0.305 | |COCH-ARM / FISHERS | P=0.490N P=0.167 P=0.490N P=0.511 |P=0.157 P=0.511 P=0.065 P=0.243 | |ORDER RESTRICTED | P=0.382N (e) (e) (e) |P=0.105 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 1/43.91 2/47.35 1/46.48 0/43.80 |0/43.57 0/44.61 0/42.33 0/43.12 | |POLY-3 PERCENT (g) | 2.3% 4.2% 2.2% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/38 (3%) 1/41 (2%) 1/41 (2%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 713 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.276N P=0.534 P=0.745N P=0.528N |(e) (e) (e) (e) | |POLY 3 | P=0.250N P=0.526 P=0.748N P=0.501N |(e) (e) (e) (e) | |POLY 1.5 | P=0.247N P=0.521 P=0.749N P=0.497N |(e) (e) (e) (e) | |POLY 6 | P=0.255N P=0.534 P=0.746N P=0.505N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.260N P=0.536 P=0.745N (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.239N P=0.515 P=0.742N P=0.490N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.241N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 53 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 1/48 (2%) 2/50 (4%) 0/49 (0%) | |POLY-3 RATE (b) | 0/43.91 0/47.28 0/46.48 0/43.80 |0/43.57 1/44.70 2/43.03 0/43.12 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 4.7% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/41 (0%) 0/33 (0%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 706 503 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.631N P=0.520 P=0.225 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.620N P=0.505 P=0.234 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.621N P=0.501 P=0.234 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.618N P=0.511 P=0.235 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.595N P=0.499 P=0.273 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.614N P=0.495 P=0.253 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.322 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Testes: Germinal Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 5/50 (10%) 3/50 (6%) 4/50 (8%) | | |POLY-3 RATE (b) | 1/44.93 5/47.78 3/46.69 4/44.42 | | |POLY-3 PERCENT (g) | 2.2% 10.5% 6.4% 9.0% | | |TERMINAL (d) | 0/38 (0%) 3/41 (7%) 2/41 (5%) 1/33 (3%) | | |FIRST INCIDENCE | 638 604 673 640 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.217 P=0.130 P=0.334 P=0.169 | | |POLY 3 | P=0.256 P=0.116 P=0.319 P=0.175 | | |POLY 1.5 | P=0.260 P=0.111 P=0.315 P=0.177 | | |POLY 6 | P=0.250 P=0.124 P=0.323 P=0.172 | | |LOGISTIC REGRESSION| P=0.271 P=0.090 P=0.293 P=0.182 | | |COCH-ARM / FISHERS | P=0.264 P=0.102 P=0.309 P=0.181 | | |ORDER RESTRICTED | P=0.169 (e) (e) (e) | | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 54 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 11/43 (26%) 13/43 (30%) 4/40 (10%) 13/44 (30%) |5/48 (10%) 7/44 (16%) 5/48 (10%) 9/48 (19%) | |POLY-3 RATE (b) | 11/41.26 13/42.85 4/38.58 13/42.11 |5/43.97 7/41.56 5/42.42 9/45.96 | |POLY-3 PERCENT (g) | 26.7% 30.3% 10.4% 30.9% |11.4% 16.9% 11.8% 19.6% | |TERMINAL (d) | 6/34 (18%) 8/36 (22%) 1/33 (3%) 3/30 (10%) |0/35 (0%) 3/34 (9%) 0/30 (0%) 1/35 (3%) | |FIRST INCIDENCE | 561 574 543 465 |524 568 503 142 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.402 P=0.479 P=0.055N P=0.361 |P=0.185 P=0.405 P=0.610 P=0.213 | |POLY 3 | P=0.493 P=0.448 P=0.055N P=0.428 |P=0.213 P=0.339 P=0.608 P=0.217 | |POLY 1.5 | P=0.495 P=0.431 P=0.056N P=0.425 |P=0.206 P=0.333 P=0.609 P=0.210 | |POLY 6 | P=0.492 P=0.466 P=0.056N P=0.434 |P=0.218 P=0.347 P=0.605 P=0.225 | |LOGISTIC REGRESSION| P=0.428N P=0.217 P=0.077N P=0.512 |P=0.232 P=0.247 P=0.570N P=0.191 | |COCH-ARM / FISHERS | P=0.505 P=0.405 P=0.058N P=0.431 |P=0.194 P=0.318 P=0.630N P=0.193 | |ORDER RESTRICTED | P=0.307 (e) (e) (e) |P=0.211 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Thymus | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/43 (2%) 3/43 (7%) 4/40 (10%) 4/44 (9%) |3/48 (6%) 0/44 (0%) 1/48 (2%) 1/48 (2%) | |POLY-3 RATE (b) | 1/39.03 3/41.31 4/37.25 4/38.62 |3/42.41 0/40.66 1/40.71 1/42.10 | |POLY-3 PERCENT (g) | 2.6% 7.3% 10.7% 10.4% |7.1% 0.0% 2.5% 2.4% | |TERMINAL (d) | 1/34 (3%) 3/36 (8%) 4/33 (12%) 4/30 (13%) |2/35 (6%) 0/34 (0%) 1/30 (3%) 1/35 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |630 --- 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.106 P=0.325 P=0.169 P=0.142 |P=0.302N P=0.122N P=0.353N P=0.304N | |POLY 3 | P=0.145 P=0.326 P=0.163 P=0.174 |P=0.301N P=0.126N P=0.320N P=0.307N | |POLY 1.5 | P=0.151 P=0.317 P=0.161 P=0.178 |P=0.298N P=0.129N P=0.318N P=0.308N | |POLY 6 | P=0.136 P=0.336 P=0.166 P=0.169 |P=0.305N P=0.122N P=0.323N P=0.307N | |LOGISTIC REGRESSION| P=0.106 P=0.325 P=0.169 P=0.142 |P=0.294N P=0.134N P=0.315N P=0.305N | |COCH-ARM / FISHERS | P=0.164 P=0.308 P=0.158 P=0.187 |P=0.289N P=0.138N P=0.308N P=0.308N | |ORDER RESTRICTED | P=0.146 (e) (e) (e) |P=0.105N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 55 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Thymus | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/43 (5%) 1/43 (2%) 0/40 (0%) 0/44 (0%) |5/48 (10%) 3/44 (7%) 4/48 (8%) 2/48 (4%) | |POLY-3 RATE (b) | 2/39.03 1/41.31 0/37.25 0/38.62 |5/42.05 3/40.66 4/40.71 2/42.49 | |POLY-3 PERCENT (g) | 5.1% 2.4% 0.0% 0.0% |11.9% 7.4% 9.8% 4.7% | |TERMINAL (d) | 2/34 (6%) 1/36 (3%) 0/33 (0%) 0/30 (0%) |5/35 (14%) 3/34 (9%) 4/30 (13%) 1/35 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- |729 (T) 729 (T) 729 (T) 618 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.113N P=0.480N P=0.245N P=0.266N |P=0.204N P=0.371N P=0.598N P=0.215N | |POLY 3 | P=0.104N P=0.480N P=0.247N P=0.239N |P=0.195N P=0.374N P=0.520N P=0.211N | |POLY 1.5 | P=0.103N P=0.488N P=0.250N P=0.237N |P=0.196N P=0.386N P=0.520N P=0.215N | |POLY 6 | P=0.105N P=0.470N P=0.244N P=0.242N |P=0.193N P=0.361N P=0.523N P=0.204N | |LOGISTIC REGRESSION| P=0.113N P=0.480N (e) (e) |P=0.196N P=0.371N P=0.598N P=0.214N | |COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.265N P=0.241N |P=0.189N P=0.407N P=0.500N P=0.218N | |ORDER RESTRICTED | P=0.075N (e) (e) (e) |P=0.180N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Thyroid Gland | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 13/48 (27%) 17/50 (34%) 14/48 (29%) 15/50 (30%) |25/48 (52%) 28/50 (56%) 34/49 (69%) 32/50 (64%) | |POLY-3 RATE (b) | 13/44.78 17/47.35 14/45.12 15/45.78 |25/44.64 28/45.88 34/44.45 32/45.94 | |POLY-3 PERCENT (g) | 29.0% 35.9% 31.0% 32.8% |56.0% 61.0% 76.5% 69.7% | |TERMINAL (d) | 11/38 (29%) 16/41 (39%) 12/39 (31%) 9/33 (27%) |20/35 (57%) 24/35 (69%) 25/31 (81%) 26/35 (74%) | |FIRST INCIDENCE | 562 713 607 465 |524 673 503 447 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.291 P=0.345 P=0.537 P=0.302 |P=0.075 P=0.366 P=0.020 * P=0.127 | |POLY 3 | P=0.474 P=0.315 P=0.509 P=0.438 |P=0.069 P=0.391 P=0.028 * P=0.122 | |POLY 1.5 | P=0.484 P=0.308 P=0.506 P=0.444 |P=0.072 P=0.402 P=0.030 * P=0.128 | |POLY 6 | P=0.462 P=0.327 P=0.514 P=0.431 |P=0.068 P=0.389 P=0.029 * P=0.121 | |LOGISTIC REGRESSION| P=0.457 P=0.348 P=0.512 P=0.453 |P=0.062 P=0.482 P=0.034 * P=0.127 | |COCH-ARM / FISHERS | P=0.506 P=0.301 P=0.500 P=0.462 |P=0.104 P=0.426 P=0.062 P=0.161 | |ORDER RESTRICTED | P=0.525 (e) (e) (e) |P=0.055 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 56 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |0/48 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/43.91 0/47.28 0/44.48 0/43.80 |0/42.57 0/45.35 0/42.00 2/44.39 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.5% | |TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/39 (0%) 0/33 (0%) |0/35 (0%) 0/35 (0%) 0/31 (0%) 1/35 (3%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 142 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.049 * (e) (e) P=0.242 | |POLY 3 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.246 | |POLY 1.5 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.246 | |POLY 6 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.248 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.052 (e) (e) P=0.435 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.048 * (e) (e) P=0.258 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.033 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 0/50 (0%) 1/48 (2%) 2/50 (4%) |3/48 (6%) 2/50 (4%) 5/49 (10%) 14/50 (28%) | |POLY-3 RATE (b) | 2/43.91 0/47.28 1/44.48 2/44.12 |3/43.35 2/45.96 5/43.39 14/44.79 | |POLY-3 PERCENT (g) | 4.6% 0.0% 2.3% 4.5% |6.9% 4.4% 11.5% 31.3% | |TERMINAL (d) | 2/38 (5%) 0/41 (0%) 1/39 (3%) 1/33 (3%) |1/35 (3%) 0/35 (0%) 3/31 (10%) 11/35 (31%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) 640 |606 561 27 447 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.425 P=0.222N P=0.491N P=0.657 |P<0.001 ** P=0.482N P=0.327 P=0.005 ** | |POLY 3 | P=0.461 P=0.221N P=0.495N P=0.692N |P<0.001 ** P=0.473N P=0.356 P=0.003 ** | |POLY 1.5 | P=0.468 P=0.224N P=0.497N P=0.688N |P<0.001 ** P=0.477N P=0.357 P=0.003 ** | |POLY 6 | P=0.452 P=0.216N P=0.494N P=0.691 |P<0.001 ** P=0.467N P=0.355 P=0.003 ** | |LOGISTIC REGRESSION| P=0.466 (e) P=0.491N P=0.692N |P<0.001 ** P=0.492N P=0.478 P=0.005 ** | |COCH-ARM / FISHERS | P=0.479 P=0.237N P=0.500N P=0.676N |P<0.001 ** P=0.480N P=0.369 P=0.004 ** | |ORDER RESTRICTED | P=0.403N (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 57 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Tooth | | Malformation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/2 (100%) 4/4 (100%) 0/1 (0%) 2/3 (67%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 RATE (b) | 2/2.00 4/4.00 0/1.00 2/2.26 |0/0.00 0/0.00 0/0.00 0/0.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% 0.0% 88.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/1 (100%) 3/3 (100%) 0/1 (0%) 2/2 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 561 721 --- 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.277N (e) P=0.234N P=0.527N |(e) (e) (e) (e) | |POLY 3 | P=0.246N (e) P=0.333 P=0.991N |(e) (e) (e) (e) | |POLY 1.5 | P=0.223N (e) P=0.333 P=0.825N |(e) (e) (e) (e) | |POLY 6 | P=0.269N (e) P=0.333 P=1.000N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.347N (e) (e) P=0.527N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.236N (e) P=0.333N P=0.600N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.169N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Urinary Bladder | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |4/49 (8%) 12/50 (24%) 4/50 (8%) 5/50 (10%) | |POLY-3 RATE (b) | 0/43.98 1/47.28 1/46.48 0/43.80 |4/44.21 12/45.63 4/42.33 5/43.85 | |POLY-3 PERCENT (g) | 0.0% 2.1% 2.2% 0.0% |9.1% 26.3% 9.5% 11.4% | |TERMINAL (d) | 0/38 (0%) 1/41 (2%) 1/41 (2%) 0/33 (0%) |2/36 (6%) 10/35 (29%) 4/31 (13%) 4/35 (11%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) --- |606 674 729 (T) 597 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.631N P=0.515 P=0.515 (e) |P=0.371N P=0.032 * P=0.578 P=0.495 | |POLY 3 | P=0.597N P=0.514 P=0.511 (e) |P=0.360N P=0.029 * P=0.620 P=0.495 | |POLY 1.5 | P=0.594N P=0.511 P=0.509 (e) |P=0.357N P=0.029 * P=0.625 P=0.497 | |POLY 6 | P=0.601N P=0.519 P=0.513 (e) |P=0.362N P=0.030 * P=0.612 P=0.495 | |LOGISTIC REGRESSION| (e) P=0.515 P=0.515 (e) |P=0.360N P=0.034 * P=0.630 P=0.507 | |COCH-ARM / FISHERS | P=0.592N P=0.505 P=0.505 (e) |P=0.334N P=0.030 * P=0.631N P=0.513 | |ORDER RESTRICTED | P=0.414 (e) (e) (e) |P=0.250N (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 58 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Urinary Bladder: Transitional Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.98 2/47.79 0/46.48 1/43.80 |0/43.57 0/45.35 1/43.03 0/43.40 | |POLY-3 PERCENT (g) | 0.0% 4.2% 0.0% 2.3% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/38 (0%) 1/41 (2%) 0/41 (0%) 1/33 (3%) |0/36 (0%) 0/35 (0%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- 574 --- 729 (T) |--- --- 486 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.513 P=0.258 (e) P=0.472 |P=0.689 (e) P=0.500 (e) | |POLY 3 | P=0.540 P=0.256 (e) P=0.499 |P=0.686 (e) P=0.498 (e) | |POLY 1.5 | P=0.542 P=0.251 (e) P=0.501 |P=0.688 (e) P=0.497 (e) | |POLY 6 | P=0.536 P=0.263 (e) P=0.495 |P=0.686 (e) P=0.498 (e) | |LOGISTIC REGRESSION| P=0.554 P=0.196 (e) P=0.472 |P=0.766 (e) P=0.630 (e) | |COCH-ARM / FISHERS | P=0.543 P=0.253 (e) P=0.505 |P=0.697 (e) P=0.505 (e) | |ORDER RESTRICTED | P=0.324 (e) (e) (e) |P=0.378 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Uterus | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | |1/43.63 0/45.35 2/42.33 1/43.40 | |POLY-3 PERCENT (g) | |2.3% 0.0% 4.7% 2.3% | |TERMINAL (d) | |1/36 (3%) 0/35 (0%) 2/31 (7%) 1/35 (3%) | |FIRST INCIDENCE | |729 (T) --- 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.489 P=0.506N P=0.448 P=0.756 | |POLY 3 | |P=0.490 P=0.492N P=0.489 P=0.760 | |POLY 1.5 | |P=0.492 P=0.495N P=0.489 P=0.759 | |POLY 6 | |P=0.489 P=0.489N P=0.488 P=0.761N | |LOGISTIC REGRESSION| |P=0.489 (e) P=0.448 P=0.756 | |COCH-ARM / FISHERS | |P=0.500 P=0.500N P=0.500 P=0.753N | |ORDER RESTRICTED | |P=0.366 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 59 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Uterus | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |45/50 (90%) 45/50 (90%) 40/50 (80%) 41/50 (82%) | |POLY-3 RATE (b) | |45/46.82 45/49.32 40/47.19 41/47.17 | |POLY-3 PERCENT (g) | |96.1% 91.3% 84.8% 86.9% | |TERMINAL (d) | |36/36 (100%) 33/35 (94%) 26/31 (84%) 31/35 (89%) | |FIRST INCIDENCE | |524 461 486 447 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.287N P=0.550 P=0.568N P=0.319N | |POLY 3 | |P=0.074N P=0.267N P=0.048N* P=0.082N | |POLY 1.5 | |P=0.090N P=0.399N P=0.094N P=0.124N | |POLY 6 | |P=0.064N P=0.155N P=0.023N* P=0.053N | |LOGISTIC REGRESSION| |P=0.137N P=0.517N P=0.184N P=0.204N | |COCH-ARM / FISHERS | |P=0.105N P=0.630N P=0.131N P=0.194N | |ORDER RESTRICTED | |P=0.058N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Uterus | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | |0/43.63 0/45.35 2/42.72 0/43.40 | |POLY-3 PERCENT (g) | |0.0% 0.0% 4.7% 0.0% | |TERMINAL (d) | |0/36 (0%) 0/35 (0%) 1/31 (3%) 0/35 (0%) | |FIRST INCIDENCE | |--- --- 618 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.593 (e) P=0.226 (e) | |POLY 3 | |P=0.588 (e) P=0.232 (e) | |POLY 1.5 | |P=0.589 (e) P=0.232 (e) | |POLY 6 | |P=0.589 (e) P=0.233 (e) | |LOGISTIC REGRESSION| |P=0.597 (e) P=0.238 (e) | |COCH-ARM / FISHERS | |P=0.595 (e) P=0.247 (e) | |ORDER RESTRICTED | |P=0.242 (e) (e) (e) | |=================================================================================================================================| Date: 03/26/03 EXPERIMENT: 96010 TEST: 04 Page 60 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (SODIUM Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L | | | | | |=================================================================================================================================| | | |Uterus | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | |0/43.63 2/45.35 1/42.72 0/43.40 | |POLY-3 PERCENT (g) | |0.0% 4.4% 2.3% 0.0% | |TERMINAL (d) | |0/36 (0%) 2/35 (6%) 0/31 (0%) 0/35 (0%) | |FIRST INCIDENCE | |--- 729 (T) 618 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.465N P=0.232 P=0.505 (e) | |POLY 3 | |P=0.461N P=0.246 P=0.496 (e) | |POLY 1.5 | |P=0.463N P=0.243 P=0.495 (e) | |POLY 6 | |P=0.459N P=0.250 P=0.497 (e) | |LOGISTIC REGRESSION| |P=0.463N P=0.232 P=0.522 (e) | |COCH-ARM / FISHERS | |P=0.461N P=0.247 P=0.500 (e) | |ORDER RESTRICTED | |P=0.328 (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). --multipart-boundary Content-type: text/plain Range: bytes 516911-516911/516911 --multipart-boundary--