TDMS Study 96017-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID) DATE: 05/19/04 EXPERIMENT: 96017 TEST: 06 TIME: 09:30:16 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96017 PATHOLOGIST: HEATH, JAMES CAS: 631-64-1 ------------------------------------------------------------------------------------------------------------------------------------ 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 (DIBROMOACETIC ACID) DATE: 05/19/04 EXPERIMENT: 96017 TEST: 06 TIME: 09:30:16 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96017 PATHOLOGIST: HEATH, JAMES CAS: 631-64-1 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF WATER DISINFECTION BYPRODUCTS (DIBROMOAC =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex: Capsule Hyperplasia Bone Marrow Hyperplasia Eye Cataract Harderian Gland Hyperplasia Focal Islets, Pancreatic Hyperplasia Kidney Nephropathy Kidney: Renal Tubule Pigmentation Liver Clear Cell Focus Lung Hemorrhage Hyperplasia Lymphoid Lymph Node, Mandibular Hyperplasia Lymphoid Pigmentation Lymph Node, Mesenteric Atrophy Parathyroid Gland Cyst Preputial Gland Cyst Seminal Vesicle Degeneration Spleen Hematopoietic Cell Proliferation Stomach, Forestomach Inflammation Chronic Thyroid Gland: Follicular Cell Hyperplasia =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Liver Hepatodiaphragmatic Nodule Liver: Centrilobular Necrosis Lymph Node, Mesenteric Hemorrhage Ovary Cyst Pancreas Atrophy Cyst Spleen Hematopoietic Cell Proliferation Thyroid Gland Degeneration Cystic Thyroid Gland: Follicular Cell Hyperplasia Urinary Bladder Edema =============================================================== Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Adrenal Cortex | | Accessory Adrenal Cortical Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/49 (14%) 5/50 (10%) 4/50 (8%) 6/50 (12%) |9/50 (18%) 11/50 (22%) 6/50 (12%) 9/49 (18%) | |POLY-3 RATE (b) | 7/42.70 5/45.99 4/43.74 6/43.93 |9/46.04 11/45.88 6/44.64 9/45.17 | |POLY-3 PERCENT (g) | 16.4% 10.9% 9.2% 13.7% |19.6% 24.0% 13.4% 19.9% | |TERMINAL (d) | 6/31 (19%) 5/38 (13%) 4/34 (12%) 5/31 (16%) |7/38 (18%) 10/35 (29%) 5/32 (16%) 7/32 (22%) | |FIRST INCIDENCE | 601 729 (T) 729 (T) 623 |710 601 634 715 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.552 P=0.252N P=0.212N P=0.496N |P=0.503N P=0.331 P=0.415N P=0.452 | |POLY 3 | P=0.505N P=0.327N P=0.246N P=0.478N |P=0.385N P=0.397 P=0.309N P=0.586 | |POLY 1.5 | P=0.494N P=0.343N P=0.247N P=0.478N |P=0.381N P=0.397 P=0.299N P=0.586 | |POLY 6 | P=0.523N P=0.310N P=0.246N P=0.483N |P=0.399N P=0.397 P=0.328N P=0.578 | |LOGISTIC REGRESSION| P=0.525N P=0.301N P=0.237N P=0.479N |P=0.402N P=0.386 P=0.346N P=0.529 | |COCH-ARM / FISHERS | P=0.485N P=0.365N P=0.251N P=0.484N |P=0.381N P=0.402 P=0.288N P=0.584 | |ORDER RESTRICTED | P=0.374N (e) (e) (e) |P=0.427N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 7/50 (14%) 5/50 (10%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/49 (2%) | |POLY-3 RATE (b) | 4/42.54 7/46.02 5/43.74 1/43.55 |0/45.94 2/45.70 0/44.30 1/45.07 | |POLY-3 PERCENT (g) | 9.4% 15.2% 11.4% 2.3% |0.0% 4.4% 0.0% 2.2% | |TERMINAL (d) | 3/31 (10%) 6/38 (16%) 5/34 (15%) 1/31 (3%) |0/38 (0%) 1/35 (3%) 0/32 (0%) 1/32 (3%) | |FIRST INCIDENCE | 655 721 729 (T) 729 (T) |--- 659 --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.076N P=0.387 P=0.550 P=0.179N |P=0.632N P=0.236 (e) P=0.466 | |POLY 3 | P=0.058N P=0.307 P=0.517 P=0.171N |P=0.617N P=0.236 (e) P=0.496 | |POLY 1.5 | P=0.056N P=0.293 P=0.516 P=0.171N |P=0.615N P=0.236 (e) P=0.496 | |POLY 6 | P=0.063N P=0.324 P=0.517 P=0.174N |P=0.622N P=0.236 (e) P=0.494 | |LOGISTIC REGRESSION| P=0.070N P=0.338 P=0.526 P=0.171N |P=0.611N P=0.239 (e) P=0.466 | |COCH-ARM / FISHERS | P=0.057N P=0.274 P=0.513 P=0.175N |P=0.612N P=0.247 (e) P=0.495 | |ORDER RESTRICTED | P=0.086N (e) (e) (e) |P=0.321 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 12/49 (24%) 11/50 (22%) 13/50 (26%) 6/50 (12%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 12/42.26 11/46.48 13/43.88 6/43.55 |0/45.94 1/45.44 0/44.30 0/45.07 | |POLY-3 PERCENT (g) | 28.4% 23.7% 29.6% 13.8% |0.0% 2.2% 0.0% 0.0% | |TERMINAL (d) | 12/31 (39%) 10/38 (26%) 12/34 (35%) 6/31 (19%) |0/38 (0%) 1/35 (3%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 582 691 729 (T) |--- 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.139N P=0.286N P=0.585N P=0.083N |P=0.437N P=0.484 (e) (e) | |POLY 3 | P=0.106N P=0.396N P=0.545 P=0.078N |P=0.422N P=0.498 (e) (e) | |POLY 1.5 | P=0.098N P=0.431N P=0.535 P=0.081N |P=0.420N P=0.498 (e) (e) | |POLY 6 | P=0.121N P=0.354N P=0.555 P=0.078N |P=0.426N P=0.497 (e) (e) | |LOGISTIC REGRESSION| P=0.130N P=0.353N P=0.565 P=0.083N |(e) P=0.484 (e) (e) | |COCH-ARM / FISHERS | P=0.094N P=0.478N P=0.523 P=0.088N |P=0.417N P=0.500 (e) (e) | |ORDER RESTRICTED | P=0.086N (e) (e) (e) |P=0.382N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Adrenal Cortex: Capsule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/49 (14%) 4/50 (8%) 1/50 (2%) 5/50 (10%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/49 (2%) | |POLY-3 RATE (b) | 7/43.02 4/45.99 1/43.74 5/43.55 |0/45.94 1/45.44 0/44.30 1/45.07 | |POLY-3 PERCENT (g) | 16.3% 8.7% 2.3% 11.5% |0.0% 2.2% 0.0% 2.2% | |TERMINAL (d) | 6/31 (19%) 4/38 (11%) 1/34 (3%) 5/31 (16%) |0/38 (0%) 1/35 (3%) 0/32 (0%) 1/32 (3%) | |FIRST INCIDENCE | 458 729 (T) 729 (T) 729 (T) |--- 729 (T) --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.397N P=0.163N P=0.024N* P=0.373N |P=0.448 P=0.484 (e) P=0.466 | |POLY 3 | P=0.357N P=0.223N P=0.028N* P=0.369N |P=0.477 P=0.498 (e) P=0.496 | |POLY 1.5 | P=0.347N P=0.235N P=0.028N* P=0.366N |P=0.478 P=0.498 (e) P=0.496 | |POLY 6 | P=0.372N P=0.208N P=0.027N* P=0.377N |P=0.474 P=0.497 (e) P=0.494 | |LOGISTIC REGRESSION| P=0.357N P=0.229N P=0.030N* P=0.359N |(e) P=0.484 (e) P=0.466 | |COCH-ARM / FISHERS | P=0.337N P=0.251N P=0.028N* P=0.365N |P=0.478 P=0.500 (e) P=0.495 | |ORDER RESTRICTED | P=0.106N (e) (e) (e) |P=0.247 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 1/49 (2%) | |POLY-3 RATE (b) | 1/42.26 1/45.99 0/43.74 1/43.55 |0/45.94 2/45.44 1/44.30 1/45.07 | |POLY-3 PERCENT (g) | 2.4% 2.2% 0.0% 2.3% |0.0% 4.4% 2.3% 2.2% | |TERMINAL (d) | 1/31 (3%) 1/38 (3%) 0/34 (0%) 1/31 (3%) |0/38 (0%) 2/35 (6%) 1/32 (3%) 1/32 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |--- 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.606N P=0.716N P=0.482N P=0.762 |P=0.551 P=0.220 P=0.466 P=0.466 | |POLY 3 | P=0.578N P=0.742N P=0.493N P=0.754N |P=0.593 P=0.235 P=0.493 P=0.496 | |POLY 1.5 | P=0.576N P=0.748N P=0.494N P=0.754N |P=0.593 P=0.235 P=0.496 P=0.496 | |POLY 6 | P=0.581N P=0.734N P=0.492N P=0.756N |P=0.588 P=0.234 P=0.487 P=0.494 | |LOGISTIC REGRESSION| P=0.606N P=0.716N (e) P=0.762 |(e) P=0.220 P=0.466 P=0.466 | |COCH-ARM / FISHERS | P=0.575N P=0.747N P=0.495N P=0.747N |P=0.593 P=0.247 P=0.500 P=0.495 | |ORDER RESTRICTED | P=0.525N (e) (e) (e) |P=0.267 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Bone | | 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) | 0/42.26 0/45.99 0/43.74 0/43.55 |1/45.94 2/45.70 1/44.41 2/45.59 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 4.4% 2.3% 4.4% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |1/38 (3%) 1/35 (3%) 0/32 (0%) 1/32 (3%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 659 701 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.458 P=0.486 P=0.724 P=0.468 | |POLY 3 | (e) (e) (e) (e) |P=0.485 P=0.498 P=0.753 P=0.497 | |POLY 1.5 | (e) (e) (e) (e) |P=0.487 P=0.498 P=0.757 P=0.498 | |POLY 6 | (e) (e) (e) (e) |P=0.482 P=0.499 P=0.747 P=0.496 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.495 P=0.499 P=0.752 P=0.510 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.490 P=0.500 P=0.753N P=0.500 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.440 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 22/47 (47%) 22/50 (44%) 28/50 (56%) 32/50 (64%) |20/50 (40%) 26/50 (52%) 24/50 (48%) 20/50 (40%) | |POLY-3 RATE (b) | 22/44.87 22/48.70 28/49.55 32/48.17 |20/47.88 26/48.05 24/49.09 20/48.79 | |POLY-3 PERCENT (g) | 49.0% 45.2% 56.5% 66.4% |41.8% 54.1% 48.9% 41.0% | |TERMINAL (d) | 12/31 (39%) 14/38 (37%) 13/34 (38%) 18/31 (58%) |12/38 (32%) 16/35 (46%) 8/32 (25%) 5/32 (16%) | |FIRST INCIDENCE | 435 297 367 469 |555 383 479 430 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.016 * P=0.326N P=0.288 P=0.081 |P=0.503N P=0.139 P=0.181 P=0.439 | |POLY 3 | P=0.016 * P=0.434N P=0.301 P=0.064 |P=0.280N P=0.156 P=0.309 P=0.551N | |POLY 1.5 | P=0.017 * P=0.447N P=0.277 P=0.065 |P=0.302N P=0.157 P=0.296 P=0.568N | |POLY 6 | P=0.016 * P=0.422N P=0.330 P=0.062 |P=0.254N P=0.152 P=0.322 P=0.530N | |LOGISTIC REGRESSION| P=0.023 * P=0.549N P=0.231 P=0.064 |P=0.291N P=0.162 P=0.331 P=0.555N | |COCH-ARM / FISHERS | P=0.018 * P=0.471N P=0.241 P=0.067 |P=0.320N P=0.158 P=0.273 P=0.581N | |ORDER RESTRICTED | P=0.042 * (e) (e) (e) |P=0.376N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.26 0/45.99 0/43.74 0/43.55 |0/45.94 2/44.62 0/44.30 0/45.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.5% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 721 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.252N P=0.228 (e) (e) | |POLY 3 | (e) (e) (e) (e) |P=0.229N P=0.231 (e) (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.227N P=0.231 (e) (e) | |POLY 6 | (e) (e) (e) (e) |P=0.232N P=0.230 (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.235N P=0.230 (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.226N P=0.242 (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.245N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Epididymis | | Atypia Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 4/50 (8%) 2/50 (4%) 6/50 (12%) | | |POLY-3 RATE (b) | 5/43.07 4/46.30 2/44.19 6/44.20 | | |POLY-3 PERCENT (g) | 11.6% 8.6% 4.5% 13.6% | | |TERMINAL (d) | 3/31 (10%) 2/38 (5%) 1/34 (3%) 4/31 (13%) | | |FIRST INCIDENCE | 596 659 596 563 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.363 P=0.396N P=0.198N P=0.502 | | |POLY 3 | P=0.402 P=0.455N P=0.205N P=0.518 | | |POLY 1.5 | P=0.411 P=0.469N P=0.206N P=0.519 | | |POLY 6 | P=0.387 P=0.439N P=0.205N P=0.511 | | |LOGISTIC REGRESSION| P=0.418 P=0.487N P=0.211N P=0.516 | | |COCH-ARM / FISHERS | P=0.418 P=0.487N P=0.210N P=0.514 | | |ORDER RESTRICTED | P=0.318 (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Epididymis | | Granuloma Sperm | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | | |POLY-3 RATE (b) | 1/42.26 2/46.25 2/44.19 2/43.55 | | |POLY-3 PERCENT (g) | 2.4% 4.3% 4.5% 4.6% | | |TERMINAL (d) | 1/31 (3%) 1/38 (3%) 1/34 (3%) 2/31 (7%) | | |FIRST INCIDENCE | 729 (T) 659 596 729 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.416 P=0.566 P=0.524 P=0.500 | | |POLY 3 | P=0.445 P=0.531 P=0.516 P=0.510 | | |POLY 1.5 | P=0.451 P=0.521 P=0.512 P=0.510 | | |POLY 6 | P=0.435 P=0.544 P=0.520 P=0.508 | | |LOGISTIC REGRESSION| P=0.449 P=0.521 P=0.507 P=0.500 | | |COCH-ARM / FISHERS | P=0.453 P=0.508 P=0.508 P=0.508 | | |ORDER RESTRICTED | P=0.477 (e) (e) (e) | | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Eye | | Cataract | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/50 (2%) 1/50 (2%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 0/42.26 1/45.99 1/43.74 6/43.55 |0/45.94 0/45.44 2/44.32 2/45.85 | |POLY-3 PERCENT (g) | 0.0% 2.2% 2.3% 13.8% |0.0% 0.0% 4.5% 4.4% | |TERMINAL (d) | 0/31 (0%) 1/38 (3%) 1/34 (3%) 6/31 (19%) |0/38 (0%) 0/35 (0%) 1/32 (3%) 0/32 (0%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |--- --- 724 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.541 P=0.518 P=0.017 * |P=0.062 (e) P=0.206 P=0.252 | |POLY 3 | P=0.002 ** P=0.517 P=0.507 P=0.016 * |P=0.067 (e) P=0.229 P=0.237 | |POLY 1.5 | P=0.002 ** P=0.511 P=0.506 P=0.017 * |P=0.066 (e) P=0.233 P=0.236 | |POLY 6 | P=0.002 ** P=0.523 P=0.508 P=0.016 * |P=0.067 (e) P=0.223 P=0.237 | |LOGISTIC REGRESSION| (e) P=0.541 P=0.518 P=0.017 * |P=0.070 (e) P=0.207 P=0.272 | |COCH-ARM / FISHERS | P=0.002 ** P=0.505 P=0.505 P=0.014 * |P=0.067 (e) P=0.247 P=0.247 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.109 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Eye | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 3/50 (6%) | |POLY-3 RATE (b) | 0/42.26 0/45.99 2/43.74 2/43.55 |2/45.94 2/46.28 3/44.34 3/45.70 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.6% 4.6% |4.4% 4.3% 6.8% 6.6% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 2/34 (6%) 2/31 (7%) |2/38 (5%) 0/35 (0%) 2/32 (6%) 1/32 (3%) | |FIRST INCIDENCE | --- --- 729 (T) 729 (T) |729 (T) 487 718 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.054 (e) P=0.259 P=0.238 |P=0.305 P=0.677 P=0.423 P=0.451 | |POLY 3 | P=0.064 (e) P=0.245 P=0.244 |P=0.345 P=0.691N P=0.484 P=0.498 | |POLY 1.5 | P=0.066 (e) P=0.244 P=0.244 |P=0.347 P=0.693N P=0.492 P=0.497 | |POLY 6 | P=0.060 (e) P=0.245 P=0.242 |P=0.341 P=0.690N P=0.471 P=0.497 | |LOGISTIC REGRESSION| (e) (e) P=0.259 P=0.238 |P=0.362 P=0.673N P=0.436 P=0.503 | |COCH-ARM / FISHERS | P=0.068 (e) P=0.253 P=0.253 |P=0.351 P=0.691N P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.121 (e) (e) (e) |P=0.494 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Eye: Cornea | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 4/50 (8%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.26 0/45.99 1/43.74 1/43.55 |1/45.94 0/45.44 4/44.34 0/45.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 2.3% |2.2% 0.0% 9.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 1/34 (3%) 1/31 (3%) |1/38 (3%) 0/35 (0%) 3/32 (9%) 0/32 (0%) | |FIRST INCIDENCE | --- --- 729 (T) 729 (T) |729 (T) --- 718 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.183 (e) P=0.518 P=0.500 |P=0.532 P=0.516N P=0.134 P=0.534N | |POLY 3 | P=0.199 (e) P=0.507 P=0.506 |P=0.579 P=0.502N P=0.168 P=0.504N | |POLY 1.5 | P=0.202 (e) P=0.506 P=0.506 |P=0.580 P=0.502N P=0.173 P=0.503N | |POLY 6 | P=0.192 (e) P=0.508 P=0.505 |P=0.575 P=0.503N P=0.159 P=0.506N | |LOGISTIC REGRESSION| (e) (e) P=0.518 P=0.500 |P=0.549 (e) P=0.138 (e) | |COCH-ARM / FISHERS | P=0.203 (e) P=0.505 P=0.505 |P=0.583 P=0.500N P=0.181 P=0.500N | |ORDER RESTRICTED | P=0.257 (e) (e) (e) |P=0.216N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Harderian Gland | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |2/49 (4%) 4/50 (8%) 4/50 (8%) 2/50 (4%) | |POLY-3 RATE (b) | 5/42.72 1/45.99 1/43.74 1/43.55 |2/46.68 4/45.44 4/44.55 2/45.13 | |POLY-3 PERCENT (g) | 11.7% 2.2% 2.3% 2.3% |4.3% 8.8% 9.0% 4.4% | |TERMINAL (d) | 3/31 (10%) 1/38 (3%) 1/34 (3%) 1/31 (3%) |0/38 (0%) 4/35 (11%) 2/32 (6%) 2/32 (6%) | |FIRST INCIDENCE | 631 729 (T) 729 (T) 729 (T) |555 729 (T) 668 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.143N P=0.072N P=0.093N P=0.109N |P=0.505N P=0.313 P=0.299 P=0.663 | |POLY 3 | P=0.130N P=0.085N P=0.095N P=0.096N |P=0.463N P=0.325 P=0.316 P=0.682 | |POLY 1.5 | P=0.124N P=0.090N P=0.096N P=0.096N |P=0.452N P=0.333 P=0.329 P=0.689 | |POLY 6 | P=0.138N P=0.080N P=0.096N P=0.099N |P=0.479N P=0.316 P=0.297 P=0.672 | |LOGISTIC REGRESSION| P=0.126N P=0.087N P=0.095N P=0.096N |P=0.430N P=0.380 P=0.400 P=0.630N | |COCH-ARM / FISHERS | P=0.120N P=0.098N P=0.098N P=0.098N |P=0.435N P=0.349 P=0.349 P=0.684N | |ORDER RESTRICTED | P=0.024N* (e) (e) (e) |P=0.433 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 8 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Heart | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/49 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 1/43.02 0/45.99 0/43.74 0/43.55 |0/45.94 1/44.57 0/44.30 2/46.07 | |POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |0.0% 2.2% 0.0% 4.3% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 1/35 (3%) 0/32 (0%) 1/32 (3%) | |FIRST INCIDENCE | 458 --- --- --- |--- 729 (T) --- 279 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.361N P=0.492N P=0.496N P=0.488N |P=0.161 P=0.484 (e) P=0.221 | |POLY 3 | P=0.373N P=0.487N P=0.497N P=0.498N |P=0.180 P=0.494 (e) P=0.238 | |POLY 1.5 | P=0.370N P=0.491N P=0.496N P=0.496N |P=0.181 P=0.494 (e) P=0.238 | |POLY 6 | P=0.377N P=0.481N P=0.497N P=0.500N |P=0.178 P=0.494 (e) P=0.236 | |LOGISTIC REGRESSION| P=0.432N P=0.456N P=0.453N P=0.759N |P=0.244 P=0.484 (e) P=0.365 | |COCH-ARM / FISHERS | P=0.365N P=0.495N P=0.495N P=0.495N |P=0.181 P=0.495 (e) P=0.247 | |ORDER RESTRICTED | P=0.118N (e) (e) (e) |P=0.075 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Heart | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 1/49 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 3/43.50 0/45.99 2/45.40 1/43.84 |0/45.94 1/44.60 1/44.61 2/45.63 | |POLY-3 PERCENT (g) | 6.9% 0.0% 4.4% 2.3% |0.0% 2.2% 2.2% 4.4% | |TERMINAL (d) | 1/31 (3%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 435 --- 367 652 |--- 721 643 596 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.474N P=0.110N P=0.490N P=0.300N |P=0.167 P=0.489 P=0.486 P=0.233 | |POLY 3 | P=0.482N P=0.109N P=0.481N P=0.302N |P=0.176 P=0.494 P=0.494 P=0.236 | |POLY 1.5 | P=0.474N P=0.112N P=0.483N P=0.300N |P=0.176 P=0.494 P=0.497 P=0.236 | |POLY 6 | P=0.495N P=0.105N P=0.480N P=0.307N |P=0.174 P=0.494 P=0.489 P=0.235 | |LOGISTIC REGRESSION| P=0.525N P=0.131N P=0.551N P=0.344N |P=0.187 P=0.494 P=0.514 P=0.255 | |COCH-ARM / FISHERS | P=0.465N P=0.117N P=0.490N P=0.301N |P=0.176 P=0.495 P=0.500 P=0.247 | |ORDER RESTRICTED | P=0.178N (e) (e) (e) |P=0.116 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 9 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Intestine Large, Cecum | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/43 (5%) 2/49 (4%) 3/48 (6%) 1/46 (2%) |2/47 (4%) 1/46 (2%) 0/49 (0%) 3/46 (7%) | |POLY-3 RATE (b) | 2/38.04 2/45.31 3/42.49 1/41.04 |2/44.69 1/42.14 0/43.36 3/43.16 | |POLY-3 PERCENT (g) | 5.3% 4.4% 7.1% 2.4% |4.5% 2.4% 0.0% 7.0% | |TERMINAL (d) | 2/31 (7%) 1/38 (3%) 3/34 (9%) 1/31 (3%) |2/38 (5%) 1/35 (3%) 0/32 (0%) 2/32 (6%) | |FIRST INCIDENCE | 729 (T) 684 729 (T) 729 (T) |729 (T) 729 (T) --- 596 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.450N P=0.621N P=0.542 P=0.500N |P=0.272 P=0.529N P=0.277N P=0.442 | |POLY 3 | P=0.414N P=0.630N P=0.550 P=0.473N |P=0.308 P=0.521N P=0.244N P=0.484 | |POLY 1.5 | P=0.409N P=0.636N P=0.551 P=0.473N |P=0.310 P=0.516N P=0.237N P=0.487 | |POLY 6 | P=0.427N P=0.623N P=0.547 P=0.478N |P=0.303 P=0.524N P=0.254N P=0.480 | |LOGISTIC REGRESSION| P=0.433N P=0.630N P=0.542 P=0.500N |P=0.310 P=0.529N (e) P=0.503 | |COCH-ARM / FISHERS | P=0.405N P=0.641N P=0.553 P=0.474N |P=0.311 P=0.508N P=0.237N P=0.490 | |ORDER RESTRICTED | P=0.419N (e) (e) (e) |P=0.179 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Intestine Small, Jejunum | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/44 (0%) 0/49 (0%) 2/46 (4%) 2/45 (4%) |0/46 (0%) 2/47 (4%) 0/49 (0%) 2/43 (5%) | |POLY-3 RATE (b) | 0/38.51 0/45.14 2/40.63 2/39.97 |0/43.63 2/43.12 0/43.86 2/39.98 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.9% 5.0% |0.0% 4.6% 0.0% 5.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 2/34 (6%) 1/31 (3%) |0/38 (0%) 2/35 (6%) 0/32 (0%) 2/32 (6%) | |FIRST INCIDENCE | --- --- 729 (T) 694 |--- 729 (T) --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.055 (e) P=0.259 P=0.237 |P=0.308 P=0.220 (e) P=0.201 | |POLY 3 | P=0.060 (e) P=0.249 P=0.245 |P=0.322 P=0.234 (e) P=0.218 | |POLY 1.5 | P=0.062 (e) P=0.249 P=0.245 |P=0.326 P=0.237 (e) P=0.219 | |POLY 6 | P=0.058 (e) P=0.247 P=0.244 |P=0.315 P=0.232 (e) P=0.215 | |LOGISTIC REGRESSION| P=0.057 (e) P=0.259 P=0.244 |(e) P=0.220 (e) P=0.201 | |COCH-ARM / FISHERS | P=0.062 (e) P=0.258 P=0.253 |P=0.332 P=0.253 (e) P=0.231 | |ORDER RESTRICTED | P=0.122 (e) (e) (e) |P=0.102 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 10 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 34/46 (74%) 32/50 (64%) 26/50 (52%) 13/49 (27%) |2/49 (4%) 5/49 (10%) 3/49 (6%) 3/46 (7%) | |POLY-3 RATE (b) | 34/44.32 32/47.58 26/44.70 13/44.65 |2/45.58 5/45.12 3/44.36 3/42.85 | |POLY-3 PERCENT (g) | 76.7% 67.3% 58.2% 29.1% |4.4% 11.1% 6.8% 7.0% | |TERMINAL (d) | 24/31 (77%) 27/38 (71%) 22/34 (65%) 8/31 (26%) |2/38 (5%) 3/35 (9%) 2/32 (6%) 3/32 (9%) | |FIRST INCIDENCE | 435 573 604 489 |729 (T) 682 634 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.096N P=0.039N* P<0.001N** |P=0.563N P=0.196 P=0.434 P=0.421 | |POLY 3 | P<0.001N** P=0.214N P=0.042N* P<0.001N** |P=0.526N P=0.212 P=0.488 P=0.472 | |POLY 1.5 | P<0.001N** P=0.217N P=0.032N* P<0.001N** |P=0.525N P=0.213 P=0.494 P=0.472 | |POLY 6 | P<0.001N** P=0.204N P=0.060N P<0.001N** |P=0.532N P=0.212 P=0.476 P=0.470 | |LOGISTIC REGRESSION| P<0.001N** P=0.176N P=0.019N* P<0.001N** |P=0.525N P=0.209 P=0.490 P=0.421 | |COCH-ARM / FISHERS | P<0.001N** P=0.205N P=0.022N* P<0.001N** |P=0.525N P=0.218 P=0.500 P=0.470 | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.383 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/49 (18%) 13/50 (26%) 14/50 (28%) 11/50 (22%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 1/49 (2%) | |POLY-3 RATE (b) | 9/42.32 13/45.99 14/44.70 11/44.29 |0/45.58 1/45.70 0/44.30 1/45.07 | |POLY-3 PERCENT (g) | 21.3% 28.3% 31.3% 24.8% |0.0% 2.2% 0.0% 2.2% | |TERMINAL (d) | 8/31 (26%) 13/38 (34%) 12/34 (35%) 6/31 (19%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 1/32 (3%) | |FIRST INCIDENCE | 715 729 (T) 573 659 |--- 659 --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.357 P=0.423 P=0.232 P=0.397 |P=0.467 P=0.509 (e) P=0.466 | |POLY 3 | P=0.484 P=0.304 P=0.205 P=0.445 |P=0.476 P=0.501 (e) P=0.498 | |POLY 1.5 | P=0.487 P=0.280 P=0.196 P=0.436 |P=0.479 P=0.502 (e) P=0.499 | |POLY 6 | P=0.477 P=0.332 P=0.215 P=0.453 |P=0.472 P=0.500 (e) P=0.495 | |LOGISTIC REGRESSION| P=0.421 P=0.402 P=0.193 P=0.417 |P=0.480 P=0.529 (e) P=0.466 | |COCH-ARM / FISHERS | P=0.484 P=0.251 P=0.185 P=0.421 |P=0.481 P=0.505 (e) P=0.500 | |ORDER RESTRICTED | P=0.374 (e) (e) (e) |P=0.249 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 11 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Kidney | | Hydronephrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 2/50 (4%) 0/50 (0%) 4/50 (8%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | |POLY-3 RATE (b) | 4/42.57 2/46.74 0/43.74 4/44.02 |0/45.58 0/45.44 1/44.30 1/45.25 | |POLY-3 PERCENT (g) | 9.4% 4.3% 0.0% 9.1% |0.0% 0.0% 2.3% 2.2% | |TERMINAL (d) | 2/31 (7%) 0/38 (0%) 0/34 (0%) 2/31 (7%) |0/38 (0%) 0/35 (0%) 1/32 (3%) 0/32 (0%) | |FIRST INCIDENCE | 669 582 --- 623 |--- --- 729 (T) 682 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.468 P=0.274N P=0.059N P=0.633 |P=0.187 (e) P=0.466 P=0.495 | |POLY 3 | P=0.494 P=0.295N P=0.056N P=0.625N |P=0.203 (e) P=0.494 P=0.499 | |POLY 1.5 | P=0.504 P=0.309N P=0.057N P=0.626N |P=0.202 (e) P=0.499 P=0.499 | |POLY 6 | P=0.479 P=0.279N P=0.056N P=0.628N |P=0.201 (e) P=0.487 P=0.496 | |LOGISTIC REGRESSION| P=0.516 P=0.343N P=0.058N P=0.629N |P=0.200 (e) P=0.466 P=0.503 | |COCH-ARM / FISHERS | P=0.514 P=0.329N P=0.056N P=0.631N |P=0.200 (e) P=0.505 P=0.500 | |ORDER RESTRICTED | P=0.256N (e) (e) (e) |P=0.246 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Kidney | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 5/50 (10%) 6/50 (12%) 5/50 (10%) |7/49 (14%) 2/50 (4%) 5/50 (10%) 8/49 (16%) | |POLY-3 RATE (b) | 5/42.31 5/45.99 6/43.94 5/43.64 |7/45.66 2/45.47 5/44.34 8/45.94 | |POLY-3 PERCENT (g) | 11.8% 10.9% 13.7% 11.5% |15.3% 4.4% 11.3% 17.4% | |TERMINAL (d) | 4/31 (13%) 5/38 (13%) 4/34 (12%) 4/31 (13%) |6/38 (16%) 1/35 (3%) 4/32 (13%) 5/32 (16%) | |FIRST INCIDENCE | 717 729 (T) 691 707 |710 721 718 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.455 P=0.497N P=0.557 P=0.622 |P=0.104 P=0.104N P=0.504N P=0.392 | |POLY 3 | P=0.522 P=0.577N P=0.527 P=0.611N |P=0.154 P=0.079N P=0.400N P=0.505 | |POLY 1.5 | P=0.533 P=0.594N P=0.521 P=0.612N |P=0.153 P=0.078N P=0.384N P=0.504 | |POLY 6 | P=0.504 P=0.557N P=0.533 P=0.615N |P=0.152 P=0.081N P=0.425N P=0.502 | |LOGISTIC REGRESSION| P=0.475 P=0.518N P=0.530 P=0.629 |P=0.143 P=0.086N P=0.475N P=0.496 | |COCH-ARM / FISHERS | P=0.541 P=0.617N P=0.514 P=0.617N |P=0.149 P=0.075N P=0.365N P=0.500 | |ORDER RESTRICTED | P=0.663 (e) (e) (e) |P=0.208 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 12 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 7/50 (14%) 4/50 (8%) 5/50 (10%) |3/49 (6%) 8/50 (16%) 6/50 (12%) 8/49 (16%) | |POLY-3 RATE (b) | 3/42.26 7/45.99 4/43.74 5/43.79 |3/45.58 8/45.84 6/44.30 8/45.32 | |POLY-3 PERCENT (g) | 7.1% 15.2% 9.2% 11.4% |6.6% 17.5% 13.6% 17.7% | |TERMINAL (d) | 3/31 (10%) 7/38 (18%) 4/34 (12%) 3/31 (10%) |3/38 (8%) 7/35 (20%) 6/32 (19%) 6/32 (19%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 691 |729 (T) 615 729 (T) 676 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.495 P=0.249 P=0.551 P=0.355 |P=0.140 P=0.079 P=0.162 P=0.062 | |POLY 3 | P=0.550N P=0.193 P=0.519 P=0.376 |P=0.206 P=0.100 P=0.227 P=0.096 | |POLY 1.5 | P=0.547N P=0.182 P=0.516 P=0.374 |P=0.211 P=0.102 P=0.239 P=0.098 | |POLY 6 | P=0.558N P=0.208 P=0.521 P=0.375 |P=0.196 P=0.098 P=0.210 P=0.092 | |LOGISTIC REGRESSION| P=0.504 P=0.249 P=0.551 P=0.360 |P=0.190 P=0.098 P=0.162 P=0.085 | |COCH-ARM / FISHERS | P=0.548N P=0.167 P=0.511 P=0.369 |P=0.214 P=0.106 P=0.254 P=0.100 | |ORDER RESTRICTED | P=0.374 (e) (e) (e) |P=0.094 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Kidney | | Metaplasia Osseous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/49 (12%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 6/42.59 3/46.51 2/43.74 2/43.66 |0/45.58 0/45.44 0/44.30 0/45.07 | |POLY-3 PERCENT (g) | 14.1% 6.5% 4.6% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/31 (13%) 1/38 (3%) 2/34 (6%) 1/31 (3%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 662 659 729 (T) 702 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.153N P=0.170N P=0.116N P=0.147N |(e) (e) (e) (e) | |POLY 3 | P=0.131N P=0.200N P=0.123N P=0.124N |(e) (e) (e) (e) | |POLY 1.5 | P=0.125N P=0.214N P=0.125N P=0.124N |(e) (e) (e) (e) | |POLY 6 | P=0.142N P=0.185N P=0.123N P=0.126N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.125N P=0.215N P=0.120N P=0.126N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.119N P=0.233N P=0.128N P=0.128N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.069N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 13 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 36/49 (73%) 44/50 (88%) 42/50 (84%) 39/50 (78%) |14/49 (29%) 8/50 (16%) 15/50 (30%) 12/49 (24%) | |POLY-3 RATE (b) | 36/46.07 44/47.62 42/47.50 39/46.87 |14/45.75 8/45.70 15/44.86 12/45.82 | |POLY-3 PERCENT (g) | 78.1% 92.4% 88.4% 83.2% |30.6% 17.5% 33.4% 26.2% | |TERMINAL (d) | 27/31 (87%) 37/38 (97%) 32/34 (94%) 29/31 (94%) |11/38 (29%) 5/35 (14%) 11/32 (34%) 9/32 (28%) | |FIRST INCIDENCE | 435 573 431 476 |710 694 629 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.262 P=0.538 P=0.337 P=0.351 |P=0.246 P=0.167N P=0.307 P=0.584N | |POLY 3 | P=0.487N P=0.034 * P=0.128 P=0.352 |P=0.396 P=0.110N P=0.475 P=0.407N | |POLY 1.5 | P=0.465N P=0.037 * P=0.130 P=0.367 |P=0.395 P=0.108N P=0.498 P=0.407N | |POLY 6 | P=0.533N P=0.035 * P=0.136 P=0.327 |P=0.388 P=0.111N P=0.438 P=0.413N | |LOGISTIC REGRESSION| P=0.486N P=0.104 P=0.159 P=0.421 |P=0.355 P=0.118N P=0.387 P=0.433N | |COCH-ARM / FISHERS | P=0.455N P=0.056 P=0.150 P=0.385 |P=0.384 P=0.103N P=0.526 P=0.410N | |ORDER RESTRICTED | P=0.106 (e) (e) (e) |P=0.422 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Accumulation, Hyaline Droplet | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/49 (2%) 1/50 (2%) 2/50 (4%) 2/49 (4%) | |POLY-3 RATE (b) | 0/42.26 0/45.99 1/44.61 0/43.55 |1/45.58 1/45.52 2/45.17 2/45.53 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |2.2% 2.2% 4.4% 4.4% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |1/38 (3%) 0/35 (0%) 0/32 (0%) 1/32 (3%) | |FIRST INCIDENCE | --- --- 367 --- |729 (T) 710 573 596 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.637 (e) P=0.504 (e) |P=0.298 P=0.743 P=0.480 P=0.465 | |POLY 3 | P=0.624 (e) P=0.511 (e) |P=0.314 P=0.760 P=0.497 P=0.500 | |POLY 1.5 | P=0.630 (e) P=0.508 (e) |P=0.314 P=0.759N P=0.502 P=0.500 | |POLY 6 | P=0.614 (e) P=0.513 (e) |P=0.311 P=0.759 P=0.489 P=0.497 | |LOGISTIC REGRESSION| P=0.463 (e) (e) (e) |P=0.294 P=0.761 P=0.561 P=0.504 | |COCH-ARM / FISHERS | P=0.635 (e) P=0.505 (e) |P=0.310 P=0.747N P=0.508 P=0.500 | |ORDER RESTRICTED | P=0.390 (e) (e) (e) |P=0.441 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 14 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |0/49 (0%) 2/50 (4%) 1/50 (2%) 1/49 (2%) | |POLY-3 RATE (b) | 1/42.26 3/47.28 0/43.74 1/43.93 |0/45.58 2/46.27 1/44.65 1/45.25 | |POLY-3 PERCENT (g) | 2.4% 6.3% 0.0% 2.3% |0.0% 4.3% 2.2% 2.2% | |TERMINAL (d) | 1/31 (3%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 562 --- 623 |--- 490 629 682 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.283N P=0.358 P=0.482N P=0.755N |P=0.586 P=0.237 P=0.495 P=0.495 | |POLY 3 | P=0.265N P=0.347 P=0.493N P=0.752N |P=0.593 P=0.241 P=0.496 P=0.499 | |POLY 1.5 | P=0.266N P=0.332 P=0.494N P=0.753N |P=0.595 P=0.241 P=0.500 P=0.499 | |POLY 6 | P=0.265N P=0.365 P=0.492N P=0.752N |P=0.588 P=0.240 P=0.490 P=0.496 | |LOGISTIC REGRESSION| P=0.274N P=0.271 (e) P=0.761N |P=0.571 P=0.313 P=0.539 P=0.503 | |COCH-ARM / FISHERS | P=0.270N P=0.316 P=0.495N P=0.747N |P=0.597 P=0.253 P=0.505 P=0.500 | |ORDER RESTRICTED | P=0.284N (e) (e) (e) |P=0.272 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 1/42.26 1/45.99 1/43.74 3/43.55 |0/45.58 0/45.44 0/44.30 0/45.07 | |POLY-3 PERCENT (g) | 2.4% 2.2% 2.3% 6.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 1/38 (3%) 1/34 (3%) 3/31 (10%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.131 P=0.716N P=0.741N P=0.304 |(e) (e) (e) (e) | |POLY 3 | P=0.156 P=0.742N P=0.753N P=0.316 |(e) (e) (e) (e) | |POLY 1.5 | P=0.159 P=0.748N P=0.754N P=0.316 |(e) (e) (e) (e) | |POLY 6 | P=0.150 P=0.734N P=0.752N P=0.313 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.131 P=0.716N P=0.741N P=0.304 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.161 P=0.747N P=0.747N P=0.316 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.191 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 15 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 3/50 (6%) 2/50 (4%) 7/50 (14%) |1/49 (2%) 0/50 (0%) 3/50 (6%) 1/49 (2%) | |POLY-3 RATE (b) | 1/42.72 3/46.25 2/44.60 7/44.95 |1/45.58 0/45.44 3/45.03 1/45.07 | |POLY-3 PERCENT (g) | 2.3% 6.5% 4.5% 15.6% |2.2% 0.0% 6.7% 2.2% | |TERMINAL (d) | 0/31 (0%) 2/38 (5%) 0/34 (0%) 3/31 (10%) |1/38 (3%) 0/35 (0%) 1/32 (3%) 1/32 (3%) | |FIRST INCIDENCE | 596 659 573 469 |729 (T) --- 479 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.020 * P=0.364 P=0.510 P=0.040 * |P=0.321 P=0.516N P=0.268 P=0.723 | |POLY 3 | P=0.021 * P=0.334 P=0.515 P=0.035 * |P=0.362 P=0.501N P=0.301 P=0.758 | |POLY 1.5 | P=0.021 * P=0.325 P=0.512 P=0.035 * |P=0.363 P=0.499N P=0.307 P=0.759 | |POLY 6 | P=0.021 * P=0.345 P=0.519 P=0.035 * |P=0.358 P=0.502N P=0.291 P=0.755 | |LOGISTIC REGRESSION| P=0.022 * P=0.297 P=0.496 P=0.030 * |P=0.354 (e) P=0.349 P=0.723 | |COCH-ARM / FISHERS | P=0.022 * P=0.316 P=0.508 P=0.032 * |P=0.360 P=0.495N P=0.316 P=0.753N | |ORDER RESTRICTED | P=0.011 * (e) (e) (e) |P=0.262 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/49 (2%) 2/50 (4%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/42.26 0/45.99 1/43.85 0/43.55 |1/45.61 2/45.44 0/44.30 0/45.07 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |2.2% 4.4% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 2/35 (6%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- 699 --- |723 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.620 (e) P=0.505 (e) |P=0.144N P=0.472 P=0.533N P=0.539N | |POLY 3 | P=0.626 (e) P=0.507 (e) |P=0.125N P=0.499 P=0.506N P=0.502N | |POLY 1.5 | P=0.632 (e) P=0.506 (e) |P=0.123N P=0.502 P=0.501N P=0.501N | |POLY 6 | P=0.616 (e) P=0.509 (e) |P=0.128N P=0.496 P=0.513N P=0.505N | |LOGISTIC REGRESSION| P=0.635 (e) P=0.506 (e) |P=0.135N P=0.487 P=0.519N P=0.509N | |COCH-ARM / FISHERS | P=0.635 (e) P=0.505 (e) |P=0.121N P=0.508 P=0.495N P=0.500N | |ORDER RESTRICTED | P=0.388 (e) (e) (e) |P=0.169N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 16 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/49 (0%) 1/50 (2%) 3/50 (6%) 3/49 (6%) | |POLY-3 RATE (b) | 2/42.26 0/45.99 1/43.74 2/43.79 |0/45.58 1/45.58 3/44.49 3/45.07 | |POLY-3 PERCENT (g) | 4.7% 0.0% 2.3% 4.6% |0.0% 2.2% 6.7% 6.7% | |TERMINAL (d) | 2/31 (7%) 0/38 (0%) 1/34 (3%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 1/32 (3%) 3/32 (9%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) 691 |--- 694 692 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.332 P=0.195N P=0.468N P=0.689 |P=0.050 P=0.500 P=0.098 P=0.092 | |POLY 3 | P=0.351 P=0.219N P=0.488N P=0.681N |P=0.062 P=0.500 P=0.114 P=0.117 | |POLY 1.5 | P=0.359 P=0.225N P=0.490N P=0.683N |P=0.063 P=0.501 P=0.118 P=0.118 | |POLY 6 | P=0.340 P=0.212N P=0.486N P=0.682N |P=0.060 P=0.499 P=0.109 P=0.114 | |LOGISTIC REGRESSION| P=0.351 (e) P=0.468N P=0.687N |P=0.062 P=0.508 P=0.114 P=0.092 | |COCH-ARM / FISHERS | P=0.367 P=0.242N P=0.492N P=0.684N |P=0.064 P=0.505 P=0.125 P=0.121 | |ORDER RESTRICTED | P=0.393N (e) (e) (e) |P=0.073 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 10/49 (20%) 13/50 (26%) 23/50 (46%) 13/50 (26%) |3/49 (6%) 1/50 (2%) 8/50 (16%) 5/49 (10%) | |POLY-3 RATE (b) | 10/42.26 13/45.99 23/43.85 13/44.38 |3/45.91 1/45.62 8/44.99 5/45.18 | |POLY-3 PERCENT (g) | 23.7% 28.3% 52.5% 29.3% |6.5% 2.2% 17.8% 11.1% | |TERMINAL (d) | 10/31 (32%) 13/38 (34%) 22/34 (65%) 11/31 (36%) |1/38 (3%) 0/35 (0%) 5/32 (16%) 4/32 (13%) | |FIRST INCIDENCE | 729 (T) 729 (T) 699 476 |658 682 617 702 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.110 P=0.534 P=0.006 ** P=0.309 |P=0.062 P=0.318N P=0.071 P=0.292 | |POLY 3 | P=0.215 P=0.401 P=0.004 ** P=0.363 |P=0.076 P=0.308N P=0.092 P=0.348 | |POLY 1.5 | P=0.225 P=0.373 P=0.004 ** P=0.355 |P=0.078 P=0.304N P=0.098 P=0.352 | |POLY 6 | P=0.192 P=0.436 P=0.003 ** P=0.363 |P=0.071 P=0.311N P=0.083 P=0.337 | |LOGISTIC REGRESSION| P=0.141 P=0.534 P=0.004 ** P=0.335 |P=0.079 P=0.291N P=0.102 P=0.350 | |COCH-ARM / FISHERS | P=0.230 P=0.337 P=0.006 ** P=0.337 |P=0.080 P=0.301N P=0.106 P=0.357 | |ORDER RESTRICTED | P=0.061 (e) (e) (e) |P=0.071 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 17 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 15/49 (31%) 10/50 (20%) 15/50 (30%) 17/50 (34%) |7/49 (14%) 6/50 (12%) 10/50 (20%) 9/49 (18%) | |POLY-3 RATE (b) | 15/42.69 10/46.14 15/44.66 17/44.93 |7/45.58 6/45.44 10/44.63 9/45.11 | |POLY-3 PERCENT (g) | 35.1% 21.7% 33.6% 37.8% |15.4% 13.2% 22.4% 20.0% | |TERMINAL (d) | 13/31 (42%) 9/38 (24%) 12/34 (35%) 12/31 (39%) |7/38 (18%) 6/35 (17%) 8/32 (25%) 8/32 (25%) | |FIRST INCIDENCE | 626 690 596 476 |729 (T) 729 (T) 680 719 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.087 P=0.065N P=0.483N P=0.410 |P=0.120 P=0.565N P=0.181 P=0.256 | |POLY 3 | P=0.149 P=0.118N P=0.529N P=0.484 |P=0.206 P=0.502N P=0.279 P=0.383 | |POLY 1.5 | P=0.157 P=0.136N P=0.543N P=0.470 |P=0.210 P=0.496N P=0.294 P=0.388 | |POLY 6 | P=0.135 P=0.100N P=0.513N P=0.491 |P=0.195 P=0.509N P=0.256 P=0.371 | |LOGISTIC REGRESSION| P=0.127 P=0.087N P=0.539N P=0.451 |P=0.156 P=0.565N P=0.216 P=0.274 | |COCH-ARM / FISHERS | P=0.161 P=0.163N P=0.560N P=0.442 |P=0.209 P=0.484N P=0.314 P=0.393 | |ORDER RESTRICTED | P=0.261 (e) (e) (e) |P=0.308 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/49 (4%) 4/50 (8%) 2/50 (4%) 2/49 (4%) | |POLY-3 RATE (b) | 0/42.26 0/45.99 0/43.74 1/43.55 |2/46.14 4/46.65 2/44.95 2/45.16 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.3% |4.3% 8.6% 4.5% 4.4% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 1/31 (3%) |1/38 (3%) 1/35 (3%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- 729 (T) |555 383 617 717 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.170 (e) (e) P=0.500 |P=0.398N P=0.327 P=0.672 P=0.655 | |POLY 3 | P=0.183 (e) (e) P=0.506 |P=0.383N P=0.342 P=0.684 P=0.686 | |POLY 1.5 | P=0.184 (e) (e) P=0.506 |P=0.377N P=0.344 P=0.692 P=0.690 | |POLY 6 | P=0.179 (e) (e) P=0.505 |P=0.393N P=0.340 P=0.674 P=0.680 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.500 |P=0.390N P=0.439 P=0.632N P=0.691N | |COCH-ARM / FISHERS | P=0.185 (e) (e) P=0.505 |P=0.369N P=0.349 P=0.684N P=0.691N | |ORDER RESTRICTED | P=0.126 (e) (e) (e) |P=0.527N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 18 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) | |POLY-3 RATE (b) | 0/42.26 1/46.44 0/43.74 0/43.55 |0/45.58 0/45.44 0/44.30 2/45.30 | |POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |0.0% 0.0% 0.0% 4.4% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 596 --- --- |--- --- --- 682 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.414N P=0.509 (e) (e) |P=0.041 * (e) (e) P=0.226 | |POLY 3 | P=0.401N P=0.519 (e) (e) |P=0.041 * (e) (e) P=0.236 | |POLY 1.5 | P=0.406N P=0.512 (e) (e) |P=0.041 * (e) (e) P=0.237 | |POLY 6 | P=0.395N P=0.526 (e) (e) |P=0.040 * (e) (e) P=0.233 | |LOGISTIC REGRESSION| P=0.424N P=0.486 (e) (e) |P=0.042 * (e) (e) P=0.238 | |COCH-ARM / FISHERS | P=0.412N P=0.505 (e) (e) |P=0.042 * (e) (e) P=0.247 | |ORDER RESTRICTED | P=0.392N (e) (e) (e) |P=0.029 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/49 (4%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/42.26 0/45.99 0/43.74 0/43.55 |2/45.58 1/45.62 0/44.30 0/45.07 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |2/38 (5%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 682 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.124N P=0.516N P=0.277N P=0.277N | |POLY 3 | (e) (e) (e) (e) |P=0.108N P=0.500N P=0.244N P=0.240N | |POLY 1.5 | (e) (e) (e) (e) |P=0.108N P=0.498N P=0.239N P=0.238N | |POLY 6 | (e) (e) (e) (e) |P=0.111N P=0.501N P=0.252N P=0.243N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.109N P=0.499N (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.107N P=0.492N P=0.242N P=0.247N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.076N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 19 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Infiltration Cellular Mixed Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |7/49 (14%) 7/50 (14%) 4/50 (8%) 9/49 (18%) | |POLY-3 RATE (b) | 2/43.76 4/46.42 2/44.24 2/43.81 |7/45.66 7/46.04 4/44.73 9/46.06 | |POLY-3 PERCENT (g) | 4.6% 8.6% 4.5% 4.6% |15.3% 15.2% 8.9% 19.5% | |TERMINAL (d) | 0/31 (0%) 2/38 (5%) 1/34 (3%) 1/31 (3%) |6/38 (16%) 3/35 (9%) 2/32 (6%) 4/32 (13%) | |FIRST INCIDENCE | 435 659 576 659 |710 659 617 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.391N P=0.404 P=0.677N P=0.681N |P=0.290 P=0.563 P=0.358N P=0.301 | |POLY 3 | P=0.375N P=0.365 P=0.690N P=0.694N |P=0.368 P=0.607N P=0.272N P=0.399 | |POLY 1.5 | P=0.368N P=0.356 P=0.689N P=0.690N |P=0.369 P=0.605N P=0.262N P=0.397 | |POLY 6 | P=0.384N P=0.378 P=0.691N P=0.690 |P=0.361 P=0.606N P=0.289N P=0.399 | |LOGISTIC REGRESSION| P=0.363N P=0.275 P=0.698 P=0.634 |P=0.364 P=0.612 P=0.286N P=0.389 | |COCH-ARM / FISHERS | P=0.360N P=0.349 P=0.684N P=0.684N |P=0.365 P=0.597N P=0.251N P=0.393 | |ORDER RESTRICTED | P=0.528N (e) (e) (e) |P=0.309 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 7/50 (14%) 8/50 (16%) 4/50 (8%) |2/49 (4%) 6/50 (12%) 3/50 (6%) 1/49 (2%) | |POLY-3 RATE (b) | 3/43.46 7/46.48 8/43.74 4/44.07 |2/45.58 6/45.44 3/44.30 1/45.07 | |POLY-3 PERCENT (g) | 6.9% 15.1% 18.3% 9.1% |4.4% 13.2% 6.8% 2.2% | |TERMINAL (d) | 1/31 (3%) 5/38 (13%) 8/34 (24%) 2/31 (7%) |2/38 (5%) 6/35 (17%) 3/32 (9%) 1/32 (3%) | |FIRST INCIDENCE | 458 596 729 (T) 627 |729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.538 P=0.236 P=0.128 P=0.514 |P=0.163N P=0.108 P=0.421 P=0.560N | |POLY 3 | P=0.529N P=0.186 P=0.099 P=0.508 |P=0.123N P=0.132 P=0.487 P=0.504N | |POLY 1.5 | P=0.518N P=0.177 P=0.102 P=0.510 |P=0.121N P=0.135 P=0.497 P=0.502N | |POLY 6 | P=0.548N P=0.197 P=0.095 P=0.503 |P=0.128N P=0.128 P=0.471 P=0.509N | |LOGISTIC REGRESSION| P=0.512N P=0.145 P=0.108 P=0.486 |P=0.163N P=0.108 P=0.421 P=0.560N | |COCH-ARM / FISHERS | P=0.507N P=0.167 P=0.106 P=0.511 |P=0.120N P=0.141 P=0.510 P=0.500N | |ORDER RESTRICTED | P=0.242 (e) (e) (e) |P=0.159N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 20 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Necrosis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/49 (16%) 7/50 (14%) 3/50 (6%) 5/50 (10%) |3/49 (6%) 2/50 (4%) 3/50 (6%) 2/49 (4%) | |POLY-3 RATE (b) | 8/44.20 7/47.09 3/43.74 5/45.07 |3/46.31 2/45.72 3/44.53 2/45.88 | |POLY-3 PERCENT (g) | 18.1% 14.9% 6.9% 11.1% |6.5% 4.4% 6.7% 4.4% | |TERMINAL (d) | 2/31 (7%) 3/38 (8%) 3/34 (9%) 0/31 (0%) |2/38 (5%) 0/35 (0%) 2/32 (6%) 0/32 (0%) | |FIRST INCIDENCE | 482 573 729 (T) 623 |474 659 668 596 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.201N P=0.386N P=0.096N P=0.279N |P=0.528N P=0.517N P=0.602 P=0.526N | |POLY 3 | P=0.168N P=0.447N P=0.100N P=0.262N |P=0.495N P=0.506N P=0.644 P=0.504N | |POLY 1.5 | P=0.161N P=0.463N P=0.097N P=0.262N |P=0.494N P=0.501N P=0.656 P=0.503N | |POLY 6 | P=0.179N P=0.429N P=0.107N P=0.265N |P=0.499N P=0.509N P=0.628 P=0.508N | |LOGISTIC REGRESSION| P=0.150N P=0.537N P=0.096N P=0.287N |P=0.509N P=0.443N P=0.618N P=0.495N | |COCH-ARM / FISHERS | P=0.154N P=0.483N P=0.094N P=0.264N |P=0.496N P=0.490N P=0.651N P=0.500N | |ORDER RESTRICTED | P=0.154N (e) (e) (e) |P=0.516N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver | | Tension Lipidosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |1/49 (2%) 3/50 (6%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/42.26 1/46.48 1/44.19 2/43.55 |1/46.12 3/46.14 0/44.30 0/45.07 | |POLY-3 PERCENT (g) | 0.0% 2.2% 2.3% 4.6% |2.2% 6.5% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 2/31 (7%) |0/38 (0%) 2/35 (6%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 582 596 729 (T) |563 487 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.164 P=0.513 P=0.504 P=0.238 |P=0.085N P=0.293 P=0.500N P=0.496N | |POLY 3 | P=0.175 P=0.519 P=0.509 P=0.244 |P=0.078N P=0.305 P=0.508N P=0.505N | |POLY 1.5 | P=0.177 P=0.513 P=0.507 P=0.244 |P=0.076N P=0.308 P=0.503N P=0.502N | |POLY 6 | P=0.170 P=0.526 P=0.511 P=0.242 |P=0.082N P=0.302 P=0.516N P=0.509N | |LOGISTIC REGRESSION| P=0.176 P=0.488 P=0.500 P=0.238 |P=0.076N P=0.386 P=0.445N P=0.466N | |COCH-ARM / FISHERS | P=0.177 P=0.505 P=0.505 P=0.253 |P=0.075N P=0.316 P=0.495N P=0.500N | |ORDER RESTRICTED | P=0.123 (e) (e) (e) |P=0.118N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 21 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver: Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 4/50 (8%) 0/50 (0%) 5/50 (10%) |0/49 (0%) 1/50 (2%) 4/50 (8%) 4/49 (8%) | |POLY-3 RATE (b) | 4/44.26 4/47.52 0/43.74 5/44.38 |0/45.58 1/45.50 4/46.14 4/45.69 | |POLY-3 PERCENT (g) | 9.0% 8.4% 0.0% 11.3% |0.0% 2.2% 8.7% 8.8% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 1/31 (3%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 435 297 --- 597 |--- 715 479 636 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.493 P=0.585N P=0.065N P=0.497 |P=0.025 * P=0.490 P=0.064 P=0.060 | |POLY 3 | P=0.506 P=0.604N P=0.061N P=0.502 |P=0.025 * P=0.500 P=0.062 P=0.060 | |POLY 1.5 | P=0.517 P=0.614N P=0.060N P=0.507 |P=0.024 * P=0.501 P=0.063 P=0.061 | |POLY 6 | P=0.493 P=0.592N P=0.063N P=0.494 |P=0.024 * P=0.498 P=0.060 P=0.060 | |LOGISTIC REGRESSION| P=0.521 P=0.456 P=0.054N P=0.461 |P=0.016 * P=0.500 P=0.075 P=0.064 | |COCH-ARM / FISHERS | P=0.532 P=0.631N P=0.056N P=0.513 |P=0.024 * P=0.505 P=0.061 P=0.059 | |ORDER RESTRICTED | P=0.262 (e) (e) (e) |P=0.035 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver: Hepatocyte | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/49 (16%) 9/50 (18%) 4/50 (8%) 10/50 (20%) |2/49 (4%) 7/50 (14%) 4/50 (8%) 2/49 (4%) | |POLY-3 RATE (b) | 8/43.46 9/45.99 4/43.74 10/44.63 |2/46.05 7/45.75 4/44.88 2/45.18 | |POLY-3 PERCENT (g) | 18.4% 19.6% 9.2% 22.4% |4.3% 15.3% 8.9% 4.4% | |TERMINAL (d) | 6/31 (19%) 9/38 (24%) 4/34 (12%) 8/31 (26%) |1/38 (3%) 5/35 (14%) 2/32 (6%) 1/32 (3%) | |FIRST INCIDENCE | 458 729 (T) 729 (T) 489 |591 682 629 702 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.386 P=0.547N P=0.142N P=0.408 |P=0.265N P=0.073 P=0.295 P=0.656 | |POLY 3 | P=0.460 P=0.551 P=0.172N P=0.420 |P=0.221N P=0.077 P=0.325 P=0.687 | |POLY 1.5 | P=0.469 P=0.536 P=0.170N P=0.421 |P=0.216N P=0.080 P=0.335 P=0.690 | |POLY 6 | P=0.444 P=0.569 P=0.174N P=0.414 |P=0.232N P=0.075 P=0.311 P=0.681 | |LOGISTIC REGRESSION| P=0.461 P=0.553 P=0.165N P=0.416 |P=0.212N P=0.085 P=0.378 P=0.692N | |COCH-ARM / FISHERS | P=0.475 P=0.518 P=0.168N P=0.416 |P=0.212N P=0.085 P=0.349 P=0.691N | |ORDER RESTRICTED | P=0.327 (e) (e) (e) |P=0.276N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 22 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Liver: Kupffer Cell | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |3/49 (6%) 0/50 (0%) 0/50 (0%) 3/49 (6%) | |POLY-3 RATE (b) | 1/42.26 1/46.04 1/44.02 1/43.92 |3/45.66 0/45.44 0/44.30 3/45.75 | |POLY-3 PERCENT (g) | 2.4% 2.2% 2.3% 2.3% |6.6% 0.0% 0.0% 6.6% | |TERMINAL (d) | 1/31 (3%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |2/38 (5%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 717 653 627 |710 --- --- 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.601 P=0.712N P=0.747N P=0.755N |P=0.301 P=0.137N P=0.156N P=0.616 | |POLY 3 | P=0.620 P=0.741N P=0.752N P=0.752N |P=0.331 P=0.120N P=0.124N P=0.661N | |POLY 1.5 | P=0.620N P=0.748N P=0.754N P=0.753N |P=0.330 P=0.118N P=0.120N P=0.661N | |POLY 6 | P=0.614 P=0.734N P=0.750N P=0.752N |P=0.329 P=0.121N P=0.131N P=0.661 | |LOGISTIC REGRESSION| P=0.618N P=0.732N P=0.758N P=0.760N |P=0.327 P=0.123N P=0.136N P=0.660N | |COCH-ARM / FISHERS | P=0.619N P=0.747N P=0.747N P=0.747N |P=0.328 P=0.117N P=0.117N P=0.661N | |ORDER RESTRICTED | P=0.730N (e) (e) (e) |P=0.186N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lung | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.26 0/45.99 0/43.74 0/43.55 |0/45.94 0/45.44 2/45.00 0/45.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.4% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 617 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.520 (e) P=0.234 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.511 (e) P=0.233 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.513 (e) P=0.235 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.508 (e) P=0.228 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.556 (e) P=0.251 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.518 (e) P=0.247 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.243 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 23 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lung | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/43.47 0/45.99 1/43.82 2/44.34 |0/45.94 0/45.44 0/44.30 0/45.13 | |POLY-3 PERCENT (g) | 4.6% 0.0% 2.3% 4.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 451 --- 708 489 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.345 P=0.233N P=0.494N P=0.688N |(e) (e) (e) (e) | |POLY 3 | P=0.354 P=0.225N P=0.497N P=0.687N |(e) (e) (e) (e) | |POLY 1.5 | P=0.361 P=0.228N P=0.496N P=0.686N |(e) (e) (e) (e) | |POLY 6 | P=0.344 P=0.220N P=0.499N P=0.691N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.336 P=0.234N P=0.504N P=0.620 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.367 P=0.242N P=0.492N P=0.684N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.401N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/50 (0%) 0/50 (0%) 4/50 (8%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 3/50 (6%) | |POLY-3 RATE (b) | 2/43.28 0/45.99 0/43.74 4/44.28 |0/45.94 2/45.47 2/44.81 3/45.31 | |POLY-3 PERCENT (g) | 4.6% 0.0% 0.0% 9.0% |0.0% 4.4% 4.5% 6.6% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 1/31 (3%) |0/38 (0%) 1/35 (3%) 1/32 (3%) 2/32 (6%) | |FIRST INCIDENCE | 451 --- --- 623 |--- 721 573 682 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.067 P=0.224N P=0.240N P=0.345 |P=0.117 P=0.225 P=0.223 P=0.102 | |POLY 3 | P=0.066 P=0.224N P=0.235N P=0.347 |P=0.135 P=0.235 P=0.232 P=0.116 | |POLY 1.5 | P=0.069 P=0.228N P=0.234N P=0.348 |P=0.137 P=0.236 P=0.234 P=0.117 | |POLY 6 | P=0.063 P=0.219N P=0.236N P=0.345 |P=0.133 P=0.234 P=0.226 P=0.115 | |LOGISTIC REGRESSION| P=0.069 P=0.244N P=0.229N P=0.312 |P=0.139 P=0.232 P=0.251 P=0.117 | |COCH-ARM / FISHERS | P=0.073 P=0.242N P=0.242N P=0.349 |P=0.139 P=0.247 P=0.247 P=0.121 | |ORDER RESTRICTED | P=0.035 * (e) (e) (e) |P=0.075 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 24 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lung | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |5/50 (10%) 5/50 (10%) 1/50 (2%) 3/50 (6%) | |POLY-3 RATE (b) | 3/42.26 0/45.99 1/43.74 0/43.55 |5/45.98 5/45.44 1/44.69 3/45.13 | |POLY-3 PERCENT (g) | 7.1% 0.0% 2.3% 0.0% |10.9% 11.0% 2.2% 6.7% | |TERMINAL (d) | 3/31 (10%) 0/38 (0%) 1/34 (3%) 0/31 (0%) |4/38 (11%) 5/35 (14%) 0/32 (0%) 3/32 (9%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) --- |720 729 (T) 618 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.172N P=0.087N P=0.272N P=0.120N |P=0.221N P=0.578 P=0.144N P=0.453N | |POLY 3 | P=0.169N P=0.104N P=0.293N P=0.113N |P=0.169N P=0.623 P=0.108N P=0.367N | |POLY 1.5 | P=0.162N P=0.109N P=0.295N P=0.113N |P=0.167N P=0.625 P=0.105N P=0.364N | |POLY 6 | P=0.178N P=0.099N P=0.291N P=0.114N |P=0.173N P=0.621 P=0.113N P=0.373N | |LOGISTIC REGRESSION| P=0.172N (e) P=0.272N (e) |P=0.179N P=0.595 P=0.108N P=0.424N | |COCH-ARM / FISHERS | P=0.156N P=0.117N P=0.301N P=0.117N |P=0.164N P=0.630N P=0.102N P=0.357N | |ORDER RESTRICTED | P=0.018N* (e) (e) (e) |P=0.191N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 6/50 (12%) 3/50 (6%) 6/50 (12%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 4/50 (8%) | |POLY-3 RATE (b) | 2/42.63 6/46.44 3/44.24 6/44.19 |1/45.97 2/45.84 2/44.70 4/45.31 | |POLY-3 PERCENT (g) | 4.7% 12.9% 6.8% 13.6% |2.2% 4.4% 4.5% 8.8% | |TERMINAL (d) | 1/31 (3%) 5/38 (13%) 2/34 (6%) 4/31 (13%) |0/38 (0%) 1/35 (3%) 0/32 (0%) 3/32 (9%) | |FIRST INCIDENCE | 626 596 576 558 |723 615 622 682 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.231 P=0.197 P=0.529 P=0.139 |P=0.104 P=0.481 P=0.465 P=0.142 | |POLY 3 | P=0.278 P=0.162 P=0.517 P=0.144 |P=0.121 P=0.499 P=0.490 P=0.174 | |POLY 1.5 | P=0.281 P=0.153 P=0.514 P=0.143 |P=0.122 P=0.499 P=0.495 P=0.176 | |POLY 6 | P=0.270 P=0.173 P=0.519 P=0.141 |P=0.117 P=0.500 P=0.482 P=0.172 | |LOGISTIC REGRESSION| P=0.278 P=0.145 P=0.507 P=0.142 |P=0.125 P=0.506 P=0.507 P=0.171 | |COCH-ARM / FISHERS | P=0.280 P=0.141 P=0.510 P=0.141 |P=0.125 P=0.500 P=0.500 P=0.181 | |ORDER RESTRICTED | P=0.126 (e) (e) (e) |P=0.108 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 25 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lung | | Metaplasia Osseous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/42.26 2/45.99 0/43.74 1/43.55 |0/45.94 0/45.44 0/44.30 0/45.13 | |POLY-3 PERCENT (g) | 2.4% 4.4% 0.0% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 2/38 (5%) 0/34 (0%) 1/31 (3%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.429N P=0.571 P=0.482N P=0.762 |(e) (e) (e) (e) | |POLY 3 | P=0.397N P=0.529 P=0.493N P=0.754N |(e) (e) (e) (e) | |POLY 1.5 | P=0.397N P=0.520 P=0.494N P=0.754N |(e) (e) (e) (e) | |POLY 6 | P=0.398N P=0.541 P=0.492N P=0.756N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.429N P=0.571 (e) P=0.762 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.397N P=0.508 P=0.495N P=0.747N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.390N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 6/50 (12%) 6/50 (12%) 7/50 (14%) |3/50 (6%) 3/50 (6%) 0/50 (0%) 4/50 (8%) | |POLY-3 RATE (b) | 2/42.26 6/45.99 6/44.25 7/44.04 |3/45.94 3/45.44 0/44.30 4/45.29 | |POLY-3 PERCENT (g) | 4.7% 13.1% 13.6% 15.9% |6.5% 6.6% 0.0% 8.8% | |TERMINAL (d) | 2/31 (7%) 6/38 (16%) 5/34 (15%) 5/31 (16%) |3/38 (8%) 3/35 (9%) 0/32 (0%) 3/32 (9%) | |FIRST INCIDENCE | 729 (T) 729 (T) 573 637 |729 (T) 729 (T) --- 688 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.101 P=0.206 P=0.164 P=0.086 |P=0.417 P=0.625 P=0.153N P=0.415 | |POLY 3 | P=0.141 P=0.161 P=0.147 P=0.088 |P=0.484 P=0.657 P=0.125N P=0.492 | |POLY 1.5 | P=0.143 P=0.152 P=0.144 P=0.087 |P=0.487 P=0.658 P=0.122N P=0.494 | |POLY 6 | P=0.136 P=0.173 P=0.150 P=0.087 |P=0.477 P=0.656 P=0.131N P=0.488 | |LOGISTIC REGRESSION| P=0.123 P=0.206 P=0.145 P=0.085 |P=0.456 P=0.625 (e) P=0.474 | |COCH-ARM / FISHERS | P=0.142 P=0.141 P=0.141 P=0.085 |P=0.492 P=0.661N P=0.121N P=0.500 | |ORDER RESTRICTED | P=0.086 (e) (e) (e) |P=0.281 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 26 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/48 (10%) 2/50 (4%) 3/48 (6%) 7/48 (15%) |0/48 (0%) 1/49 (2%) 1/47 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 5/42.94 2/46.79 3/42.98 7/43.27 |0/44.45 1/45.27 1/42.40 1/45.24 | |POLY-3 PERCENT (g) | 11.6% 4.3% 7.0% 16.2% |0.0% 2.2% 2.4% 2.2% | |TERMINAL (d) | 2/31 (7%) 0/38 (0%) 0/32 (0%) 1/30 (3%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 514 562 573 558 |--- 487 724 702 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.126 P=0.175N P=0.346N P=0.391 |P=0.397 P=0.500 P=0.472 P=0.480 | |POLY 3 | P=0.115 P=0.183N P=0.355N P=0.384 |P=0.420 P=0.504 P=0.491 P=0.504 | |POLY 1.5 | P=0.120 P=0.190N P=0.356N P=0.384 |P=0.423 P=0.504 P=0.493 P=0.505 | |POLY 6 | P=0.108 P=0.175N P=0.356N P=0.382 |P=0.415 P=0.503 P=0.486 P=0.501 | |LOGISTIC REGRESSION| P=0.124 P=0.245N P=0.363N P=0.354 |P=0.469 P=0.684 P=0.481 P=0.508 | |COCH-ARM / FISHERS | P=0.126 P=0.201N P=0.357N P=0.379 |P=0.429 P=0.505 P=0.495 P=0.510 | |ORDER RESTRICTED | P=0.137 (e) (e) (e) |P=0.319 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 0/50 (0%) 0/48 (0%) 0/48 (0%) |1/48 (2%) 1/49 (2%) 0/47 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 1/42.28 0/45.99 0/41.74 0/41.64 |1/44.45 1/44.57 0/42.38 2/46.19 | |POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 0.0% |2.3% 2.2% 0.0% 4.3% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/32 (0%) 0/30 (0%) |1/38 (3%) 1/35 (3%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 435 --- --- --- |729 (T) 729 (T) --- 430 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.365N P=0.500N P=0.504N P=0.496N |P=0.355 P=0.743 P=0.534N P=0.483 | |POLY 3 | P=0.378N P=0.483N P=0.503N P=0.503N |P=0.386 P=0.760N P=0.509N P=0.513 | |POLY 1.5 | P=0.374N P=0.487N P=0.502N P=0.501N |P=0.386 P=0.759N P=0.507N P=0.513 | |POLY 6 | P=0.382N P=0.479N P=0.504N P=0.506N |P=0.384 P=0.760 P=0.514N P=0.511 | |LOGISTIC REGRESSION| P=0.448N P=0.433N P=0.420N (e) |P=0.431 P=0.743 (e) P=0.607 | |COCH-ARM / FISHERS | P=0.369N P=0.490N P=0.500N P=0.500N |P=0.386 P=0.747N P=0.505N P=0.515 | |ORDER RESTRICTED | P=0.123N (e) (e) (e) |P=0.290 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 27 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 0/50 (0%) 1/48 (2%) 0/48 (0%) |0/48 (0%) 2/49 (4%) 2/47 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 1/41.74 0/45.99 1/41.74 0/41.64 |0/44.45 2/44.57 2/42.70 1/45.18 | |POLY-3 PERCENT (g) | 2.4% 0.0% 2.4% 0.0% |0.0% 4.5% 4.7% 2.2% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 1/32 (3%) 0/30 (0%) |0/38 (0%) 2/35 (6%) 1/32 (3%) 0/32 (0%) | |FIRST INCIDENCE | 662 --- 729 (T) --- |--- 729 (T) 643 717 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.504N P=0.470N P=0.754N P=0.495N |P=0.499 P=0.220 P=0.213 P=0.479 | |POLY 3 | P=0.502N P=0.481N P=0.761 P=0.500N |P=0.536 P=0.238 P=0.228 P=0.503 | |POLY 1.5 | P=0.495N P=0.485N P=0.760N P=0.500N |P=0.540 P=0.239 P=0.230 P=0.505 | |POLY 6 | P=0.511N P=0.476N P=0.759 P=0.504N |P=0.529 P=0.236 P=0.224 P=0.500 | |LOGISTIC REGRESSION| P=0.488N P=0.505N P=0.762N P=0.505N |P=0.543 P=0.220 P=0.238 P=0.502 | |COCH-ARM / FISHERS | P=0.487N P=0.490N P=0.753N P=0.500N |P=0.548 P=0.253 P=0.242 P=0.510 | |ORDER RESTRICTED | P=0.252N (e) (e) (e) |P=0.219 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 15/48 (31%) 14/50 (28%) 6/48 (13%) 7/48 (15%) |13/48 (27%) 6/49 (12%) 8/47 (17%) 9/50 (18%) | |POLY-3 RATE (b) | 15/41.67 14/46.59 6/41.80 7/42.36 |13/45.65 6/45.66 8/42.82 9/45.97 | |POLY-3 PERCENT (g) | 36.0% 30.1% 14.4% 16.5% |28.5% 13.1% 18.7% 19.6% | |TERMINAL (d) | 12/31 (39%) 12/38 (32%) 5/32 (16%) 5/30 (17%) |10/38 (26%) 4/35 (11%) 6/32 (19%) 7/32 (22%) | |FIRST INCIDENCE | 710 596 714 597 |563 490 617 430 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.026N* P=0.269N P=0.020N* P=0.055N |P=0.539 P=0.091N P=0.275N P=0.362N | |POLY 3 | P=0.012N* P=0.357N P=0.018N* P=0.034N* |P=0.426N P=0.059N P=0.202N P=0.226N | |POLY 1.5 | P=0.012N* P=0.395N P=0.020N* P=0.037N* |P=0.415N P=0.057N P=0.189N P=0.216N | |POLY 6 | P=0.014N* P=0.315N P=0.018N* P=0.033N* |P=0.448N P=0.062N P=0.225N P=0.246N | |LOGISTIC REGRESSION| P=0.017N* P=0.321N P=0.020N* P=0.043N* |P=0.398N P=0.051N P=0.179N P=0.198N | |COCH-ARM / FISHERS | P=0.013N* P=0.448N P=0.023N* P=0.044N* |P=0.403N P=0.056N P=0.175N P=0.202N | |ORDER RESTRICTED | P=0.018N* (e) (e) (e) |P=0.130N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 28 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/48 (15%) 8/50 (16%) 1/48 (2%) 7/48 (15%) |18/48 (38%) 25/49 (51%) 17/47 (36%) 23/50 (46%) | |POLY-3 RATE (b) | 7/43.43 8/47.18 1/41.74 7/42.84 |18/45.65 25/46.11 17/44.64 23/46.41 | |POLY-3 PERCENT (g) | 16.1% 17.0% 2.4% 16.3% |39.4% 54.2% 38.1% 49.6% | |TERMINAL (d) | 2/31 (7%) 4/38 (11%) 1/32 (3%) 2/30 (7%) |15/38 (40%) 19/35 (54%) 12/32 (38%) 17/32 (53%) | |FIRST INCIDENCE | 482 573 729 (T) 597 |563 584 507 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.402N P=0.592N P=0.035N* P=0.602 |P=0.257 P=0.079 P=0.466 P=0.092 | |POLY 3 | P=0.381N P=0.569 P=0.034N* P=0.604 |P=0.464 P=0.111 P=0.533N P=0.220 | |POLY 1.5 | P=0.367N P=0.554 P=0.032N* P=0.609 |P=0.476 P=0.115 P=0.530N P=0.232 | |POLY 6 | P=0.403N P=0.585 P=0.037N* P=0.592 |P=0.439 P=0.110 P=0.547N P=0.203 | |LOGISTIC REGRESSION| P=0.345N P=0.475 P=0.033N* P=0.599 |P=0.482 P=0.117 P=0.522N P=0.233 | |COCH-ARM / FISHERS | P=0.353N P=0.535 P=0.029N* P=0.613N |P=0.499 P=0.128 P=0.531N P=0.259 | |ORDER RESTRICTED | P=0.261N (e) (e) (e) |P=0.255 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/46 (9%) 2/49 (4%) 1/49 (2%) 9/47 (19%) |0/49 (0%) 0/49 (0%) 2/48 (4%) 1/45 (2%) | |POLY-3 RATE (b) | 4/41.43 2/45.32 1/43.67 9/42.69 |0/45.58 0/44.88 2/43.21 1/41.11 | |POLY-3 PERCENT (g) | 9.7% 4.4% 2.3% 21.1% |0.0% 0.0% 4.6% 2.4% | |TERMINAL (d) | 0/31 (0%) 1/38 (3%) 0/34 (0%) 4/31 (13%) |0/38 (0%) 0/35 (0%) 1/32 (3%) 0/28 (0%) | |FIRST INCIDENCE | 596 690 714 627 |--- --- 724 721 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.017 * P=0.278N P=0.177N P=0.129 |P=0.162 (e) P=0.206 P=0.473 | |POLY 3 | P=0.016 * P=0.296N P=0.162N P=0.124 |P=0.177 (e) P=0.225 P=0.479 | |POLY 1.5 | P=0.017 * P=0.301N P=0.160N P=0.125 |P=0.179 (e) P=0.229 P=0.481 | |POLY 6 | P=0.015 * P=0.292N P=0.168N P=0.123 |P=0.172 (e) P=0.219 P=0.476 | |LOGISTIC REGRESSION| P=0.020 * P=0.321N P=0.167N P=0.122 |P=0.163 (e) P=0.207 P=0.473 | |COCH-ARM / FISHERS | P=0.020 * P=0.309N P=0.162N P=0.124 |P=0.180 (e) P=0.242 P=0.479 | |ORDER RESTRICTED | P=0.008 ** (e) (e) (e) |P=0.158 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 29 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/46 (2%) 1/49 (2%) 3/49 (6%) 3/47 (6%) |2/49 (4%) 0/49 (0%) 2/48 (4%) 1/45 (2%) | |POLY-3 RATE (b) | 1/40.50 1/45.16 3/43.61 3/41.59 |2/45.62 0/44.88 2/43.19 1/41.33 | |POLY-3 PERCENT (g) | 2.5% 2.2% 6.9% 7.2% |4.4% 0.0% 4.6% 2.4% | |TERMINAL (d) | 1/31 (3%) 1/38 (3%) 3/34 (9%) 3/31 (10%) |1/38 (3%) 0/35 (0%) 2/32 (6%) 0/28 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |720 --- 729 (T) 659 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.113 P=0.716N P=0.338 P=0.304 |P=0.515 P=0.258N P=0.629 P=0.548N | |POLY 3 | P=0.134 P=0.736N P=0.332 P=0.314 |P=0.554 P=0.241N P=0.674 P=0.534N | |POLY 1.5 | P=0.138 P=0.741N P=0.332 P=0.315 |P=0.555 P=0.240N P=0.680 P=0.532N | |POLY 6 | P=0.127 P=0.731N P=0.330 P=0.311 |P=0.548 P=0.242N P=0.664 P=0.540N | |LOGISTIC REGRESSION| P=0.113 P=0.716N P=0.338 P=0.304 |P=0.549 P=0.242N P=0.645 P=0.528N | |COCH-ARM / FISHERS | P=0.139 P=0.737N P=0.333 P=0.317 |P=0.554 P=0.247N P=0.684 P=0.532N | |ORDER RESTRICTED | P=0.243 (e) (e) (e) |P=0.448N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/46 (17%) 5/49 (10%) 9/49 (18%) 7/47 (15%) |1/49 (2%) 1/49 (2%) 1/48 (2%) 5/45 (11%) | |POLY-3 RATE (b) | 8/41.22 5/45.16 9/44.84 7/42.95 |1/45.58 1/45.00 1/43.58 5/41.77 | |POLY-3 PERCENT (g) | 19.4% 11.1% 20.1% 16.3% |2.2% 2.2% 2.3% 12.0% | |TERMINAL (d) | 5/31 (16%) 5/38 (13%) 5/34 (15%) 3/31 (10%) |1/38 (3%) 0/35 (0%) 0/32 (0%) 1/28 (4%) | |FIRST INCIDENCE | 601 729 (T) 521 563 |729 (T) 697 618 596 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.378 P=0.173N P=0.562 P=0.496N |P=0.019 * P=0.749 P=0.741 P=0.079 | |POLY 3 | P=0.448 P=0.218N P=0.577 P=0.465N |P=0.017 * P=0.758 P=0.751 P=0.082 | |POLY 1.5 | P=0.450 P=0.225N P=0.571 P=0.470N |P=0.017 * P=0.758 P=0.753 P=0.082 | |POLY 6 | P=0.443 P=0.211N P=0.575 P=0.464N |P=0.017 * P=0.758 P=0.746 P=0.080 | |LOGISTIC REGRESSION| P=0.446 P=0.208N P=0.559 P=0.483N |P=0.018 * P=0.760 P=0.756N P=0.087 | |COCH-ARM / FISHERS | P=0.446 P=0.236N P=0.558 P=0.482N |P=0.018 * P=0.753N P=0.747 P=0.084 | |ORDER RESTRICTED | P=0.521N (e) (e) (e) |P=0.018 * (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 30 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/46 (4%) 8/49 (16%) 3/49 (6%) 6/47 (13%) |8/49 (16%) 9/49 (18%) 7/48 (15%) 5/45 (11%) | |POLY-3 RATE (b) | 2/40.50 8/45.62 3/43.61 6/41.72 |8/45.68 9/46.69 7/44.48 5/41.84 | |POLY-3 PERCENT (g) | 4.9% 17.5% 6.9% 14.4% |17.5% 19.3% 15.7% 12.0% | |TERMINAL (d) | 2/31 (7%) 7/38 (18%) 3/34 (9%) 5/31 (16%) |6/38 (16%) 5/35 (14%) 4/32 (13%) 2/28 (7%) | |FIRST INCIDENCE | 729 (T) 596 729 (T) 694 |714 383 573 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.367 P=0.086 P=0.542 P=0.132 |P=0.274N P=0.444 P=0.604 P=0.425N | |POLY 3 | P=0.428 P=0.067 P=0.534 P=0.141 |P=0.211N P=0.520 P=0.522N P=0.334N | |POLY 1.5 | P=0.431 P=0.062 P=0.533 P=0.141 |P=0.208N P=0.512 P=0.519N P=0.333N | |POLY 6 | P=0.419 P=0.073 P=0.531 P=0.139 |P=0.220N P=0.528 P=0.531N P=0.340N | |LOGISTIC REGRESSION| P=0.396 P=0.068 P=0.542 P=0.130 |P=0.198N P=0.525 P=0.514N P=0.338N | |COCH-ARM / FISHERS | P=0.430 P=0.056 P=0.530 P=0.141 |P=0.202N P=0.500 P=0.518N P=0.334N | |ORDER RESTRICTED | P=0.138 (e) (e) (e) |P=0.333N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lymph Node: Iliac | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 0/2 (0%) 0/5 (0%) 0/1 (0%) |1/12 (8%) 1/13 (8%) 1/11 (9%) 2/8 (25%) | |POLY-3 RATE (b) | 0/1.00 0/1.68 0/3.48 0/0.64 |1/10.41 1/11.03 1/9.54 2/7.28 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |9.6% 9.1% 10.5% 27.5% | |TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/2 (0%) 0/0 (0%) |1/8 (13%) 1/7 (14%) 1/6 (17%) 2/4 (50%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.134 P=0.738 P=0.702 P=0.249 | |POLY 3 | (e) (e) (e) (e) |P=0.208 P=0.750N P=0.743 P=0.368 | |POLY 1.5 | (e) (e) (e) (e) |P=0.206 P=0.748N P=0.744 P=0.364 | |POLY 6 | (e) (e) (e) (e) |P=0.203 P=0.750N P=0.735 P=0.367 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.134 P=0.738 P=0.702 P=0.249 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.191 P=0.740N P=0.739 P=0.344 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.245 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 31 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Lymph Node: Inguinal | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 0/2 (0%) 1/5 (20%) 0/1 (0%) |0/12 (0%) 2/13 (15%) 0/11 (0%) 0/8 (0%) | |POLY-3 RATE (b) | 0/1.00 0/1.68 1/3.76 0/0.64 |0/10.41 2/11.73 0/9.54 0/7.28 | |POLY-3 PERCENT (g) | 0.0% 0.0% 26.6% 0.0% |0.0% 17.1% 0.0% 0.0% | |TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/2 (0%) 0/0 (0%) |0/8 (0%) 1/7 (14%) 0/6 (0%) 0/4 (0%) | |FIRST INCIDENCE | --- --- 653 --- |--- 490 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.629 (e) P=0.516 (e) |P=0.272N P=0.225 (e) (e) | |POLY 3 | P=0.585 (e) P=0.771 (e) |P=0.279N P=0.256 (e) (e) | |POLY 1.5 | P=0.609 (e) P=0.780 (e) |P=0.280N P=0.252 (e) (e) | |POLY 6 | P=0.546 (e) P=0.760 (e) |P=0.283N P=0.262 (e) (e) | |LOGISTIC REGRESSION| P=0.705 (e) P=0.832 (e) |P=0.355N P=0.273 (e) (e) | |COCH-ARM / FISHERS | P=0.701 (e) P=0.833 (e) |P=0.286N P=0.260 (e) (e) | |ORDER RESTRICTED | P=0.625 (e) (e) (e) |P=0.338N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |5/50 (10%) 6/50 (12%) 2/50 (4%) 5/50 (10%) | |POLY-3 RATE (b) | 0/42.26 0/45.99 0/43.74 0/43.55 |5/46.76 6/46.07 2/44.56 5/45.85 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |10.7% 13.0% 4.5% 10.9% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |3/38 (8%) 2/35 (6%) 1/32 (3%) 1/32 (3%) | |FIRST INCIDENCE | --- --- --- --- |563 615 659 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.462N P=0.467 P=0.272N P=0.572 | |POLY 3 | (e) (e) (e) (e) |P=0.412N P=0.490 P=0.236N P=0.618 | |POLY 1.5 | (e) (e) (e) (e) |P=0.406N P=0.493 P=0.227N P=0.621 | |POLY 6 | (e) (e) (e) (e) |P=0.423N P=0.487 P=0.251N P=0.612 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.389N P=0.509 P=0.204N P=0.614N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.397N P=0.500 P=0.218N P=0.630N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.401N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 32 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/7 (71%) 6/7 (86%) 7/10 (70%) 4/7 (57%) |22/28 (79%) 18/20 (90%) 11/16 (69%) 13/19 (68%) | |POLY-3 RATE (b) | 5/6.75 6/6.55 7/8.86 4/6.86 |22/27.98 18/19.61 11/14.89 13/17.85 | |POLY-3 PERCENT (g) | 74.1% 91.7% 79.0% 58.4% |78.6% 91.8% 73.9% 72.9% | |TERMINAL (d) | 5/6 (83%) 5/5 (100%) 7/8 (88%) 2/4 (50%) |14/19 (74%) 12/12 (100%) 8/8 (100%) 10/13 (77%) | |FIRST INCIDENCE | 729 (T) 684 729 (T) 563 |474 584 634 688 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.536N P=0.275 P=0.702 P=0.621 |P=0.092N P=0.402 P=0.437N P=0.218N | |POLY 3 | P=0.192N P=0.450 P=0.650 P=0.485N |P=0.181N P=0.204 P=0.511N P=0.463N | |POLY 1.5 | P=0.214N P=0.472 P=0.679 P=0.492N |P=0.142N P=0.229 P=0.438N P=0.401N | |POLY 6 | P=0.162N P=0.423 P=0.622 P=0.474N |P=0.260N P=0.165 P=0.636N P=0.557N | |LOGISTIC REGRESSION| P=0.353N P=0.281 P=0.702 P=0.472N |P=0.087N P=0.238 P=0.365N P=0.335N | |COCH-ARM / FISHERS | P=0.231N P=0.500 P=0.686N P=0.500N |P=0.105N P=0.261 P=0.354N P=0.327N | |ORDER RESTRICTED | P=0.231N (e) (e) (e) |P=0.261N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Nose | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/41.89 1/46.14 3/44.31 0/43.55 |0/45.94 0/45.44 0/44.30 1/45.31 | |POLY-3 PERCENT (g) | 2.4% 2.2% 6.8% 0.0% |0.0% 0.0% 0.0% 2.2% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 1/34 (3%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 655 691 596 --- |--- --- --- 682 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.460N P=0.730N P=0.319 P=0.495N |P=0.181 (e) (e) P=0.495 | |POLY 3 | P=0.445N P=0.739N P=0.325 P=0.492N |P=0.183 (e) (e) P=0.497 | |POLY 1.5 | P=0.437N P=0.744N P=0.323 P=0.491N |P=0.184 (e) (e) P=0.498 | |POLY 6 | P=0.460N P=0.733N P=0.327 P=0.495N |P=0.182 (e) (e) P=0.496 | |LOGISTIC REGRESSION| P=0.428N P=0.762 P=0.316 P=0.500N |P=0.187 (e) (e) P=0.507 | |COCH-ARM / FISHERS | P=0.430N P=0.742N P=0.324 P=0.490N |P=0.184 (e) (e) P=0.500 | |ORDER RESTRICTED | P=0.238N (e) (e) (e) |P=0.117 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 33 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Ovary | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |5/49 (10%) 3/47 (6%) 9/47 (19%) 7/49 (14%) | |POLY-3 RATE (b) | |5/44.98 3/42.71 9/43.31 7/45.33 | |POLY-3 PERCENT (g) | |11.1% 7.0% 20.8% 15.4% | |TERMINAL (d) | |4/37 (11%) 3/34 (9%) 5/29 (17%) 6/32 (19%) | |FIRST INCIDENCE | |720 729 (T) 479 659 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.092 P=0.403N P=0.121 P=0.292 | |POLY 3 | |P=0.141 P=0.385N P=0.170 P=0.384 | |POLY 1.5 | |P=0.141 P=0.384N P=0.172 P=0.383 | |POLY 6 | |P=0.138 P=0.385N P=0.164 P=0.381 | |LOGISTIC REGRESSION| |P=0.136 P=0.390N P=0.188 P=0.365 | |COCH-ARM / FISHERS | |P=0.136 P=0.381N P=0.171 P=0.380 | |ORDER RESTRICTED | |P=0.161 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |14/49 (29%) 12/47 (26%) 14/47 (30%) 22/49 (45%) | |POLY-3 RATE (b) | |14/45.45 12/43.05 14/42.22 22/46.08 | |POLY-3 PERCENT (g) | |30.8% 27.9% 33.2% 47.8% | |TERMINAL (d) | |12/37 (32%) 9/34 (27%) 11/29 (38%) 16/32 (50%) | |FIRST INCIDENCE | |591 694 573 596 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.008 ** P=0.498N P=0.330 P=0.031 * | |POLY 3 | |P=0.024 * P=0.472N P=0.497 P=0.071 | |POLY 1.5 | |P=0.024 * P=0.470N P=0.517 P=0.071 | |POLY 6 | |P=0.021 * P=0.471N P=0.464 P=0.068 | |LOGISTIC REGRESSION| |P=0.022 * P=0.468N P=0.467 P=0.069 | |COCH-ARM / FISHERS | |P=0.025 * P=0.458N P=0.537 P=0.071 | |ORDER RESTRICTED | |P=0.039 * (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 34 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Pancreas | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/49 (0%) 1/49 (2%) 1/49 (2%) 3/47 (6%) | |POLY-3 RATE (b) | 0/40.18 0/45.99 0/43.74 0/43.10 |0/45.58 1/44.95 1/44.08 3/43.81 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 2.3% 6.9% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 2/32 (6%) | |FIRST INCIDENCE | --- --- --- --- |--- 710 712 688 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.053 P=0.485 P=0.468 P=0.099 | |POLY 3 | (e) (e) (e) (e) |P=0.057 P=0.497 P=0.493 P=0.111 | |POLY 1.5 | (e) (e) (e) (e) |P=0.058 P=0.498 P=0.497 P=0.112 | |POLY 6 | (e) (e) (e) (e) |P=0.056 P=0.497 P=0.488 P=0.111 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.058 P=0.499 P=0.494 P=0.113 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.058 P=0.500 P=0.500 P=0.113 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.034 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Pancreas | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/49 (0%) 0/49 (0%) 1/49 (2%) 3/47 (6%) | |POLY-3 RATE (b) | 0/40.18 0/45.99 0/43.74 0/43.10 |0/45.58 0/44.88 1/44.01 3/43.81 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 2.3% 6.9% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 1/32 (3%) 2/32 (6%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) 688 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.013 * (e) P=0.466 P=0.099 | |POLY 3 | (e) (e) (e) (e) |P=0.014 * (e) P=0.493 P=0.111 | |POLY 1.5 | (e) (e) (e) (e) |P=0.014 * (e) P=0.496 P=0.112 | |POLY 6 | (e) (e) (e) (e) |P=0.014 * (e) P=0.487 P=0.111 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.015 * (e) P=0.466 P=0.113 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.015 * (e) P=0.500 P=0.113 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.018 * (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 35 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Pancreas: Acinus | | Cytoplasmic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/46 (4%) 2/50 (4%) 2/50 (4%) 0/49 (0%) |1/49 (2%) 0/49 (0%) 0/49 (0%) 0/47 (0%) | |POLY-3 RATE (b) | 2/40.18 2/46.16 2/44.70 0/43.10 |1/45.58 0/44.88 0/44.01 0/43.65 | |POLY-3 PERCENT (g) | 5.0% 4.3% 4.5% 0.0% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/31 (7%) 1/38 (3%) 0/34 (0%) 0/31 (0%) |1/38 (3%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 684 576 --- |729 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.172N P=0.621N P=0.670N P=0.238N |P=0.389N P=0.516N P=0.534N P=0.534N | |POLY 3 | P=0.156N P=0.643N P=0.655N P=0.221N |P=0.373N P=0.503N P=0.507N P=0.509N | |POLY 1.5 | P=0.153N P=0.652N P=0.658N P=0.221N |P=0.372N P=0.502N P=0.504N P=0.508N | |POLY 6 | P=0.163N P=0.634N P=0.653N P=0.224N |P=0.375N P=0.504N P=0.513N P=0.510N | |LOGISTIC REGRESSION| P=0.150N P=0.642N P=0.669N (e) |P=0.389N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.151N P=0.659N P=0.659N P=0.232N |P=0.371N P=0.500N P=0.500N P=0.510N | |ORDER RESTRICTED | P=0.174N (e) (e) (e) |P=0.129N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Parathyroid Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/45 (0%) 2/47 (4%) 3/49 (6%) 4/47 (9%) |2/45 (4%) 1/49 (2%) 1/47 (2%) 3/49 (6%) | |POLY-3 RATE (b) | 0/39.35 2/43.50 3/42.74 4/41.57 |2/41.58 1/44.44 1/41.63 3/44.58 | |POLY-3 PERCENT (g) | 0.0% 4.6% 7.0% 9.6% |4.8% 2.3% 2.4% 6.7% | |TERMINAL (d) | 0/29 (0%) 2/36 (6%) 3/33 (9%) 2/29 (7%) |2/34 (6%) 1/34 (3%) 1/31 (3%) 2/31 (7%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 563 |729 (T) 729 (T) 729 (T) 596 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.045 * P=0.287 P=0.144 P=0.067 |P=0.257 P=0.500N P=0.532N P=0.470 | |POLY 3 | P=0.059 P=0.260 P=0.133 P=0.067 |P=0.302 P=0.477N P=0.500N P=0.532 | |POLY 1.5 | P=0.061 P=0.254 P=0.134 P=0.067 |P=0.303 P=0.475N P=0.493N P=0.533 | |POLY 6 | P=0.057 P=0.266 P=0.132 P=0.066 |P=0.299 P=0.479N P=0.510N P=0.529 | |LOGISTIC REGRESSION| P=0.057 P=0.287 P=0.144 P=0.068 |P=0.298 P=0.500N P=0.532N P=0.538 | |COCH-ARM / FISHERS | P=0.061 P=0.258 P=0.137 P=0.064 |P=0.305 P=0.468N P=0.484N P=0.541 | |ORDER RESTRICTED | P=0.041 * (e) (e) (e) |P=0.318 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 36 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/45 (0%) 0/50 (0%) 0/48 (0%) 0/48 (0%) |2/47 (4%) 3/49 (6%) 1/49 (2%) 1/49 (2%) | |POLY-3 RATE (b) | 0/39.54 0/45.99 0/42.09 0/42.44 |2/43.58 3/44.46 1/43.30 1/44.13 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.6% 6.8% 2.3% 2.3% | |TERMINAL (d) | 0/30 (0%) 0/38 (0%) 0/33 (0%) 0/31 (0%) |2/36 (6%) 2/34 (6%) 1/31 (3%) 1/31 (3%) | |FIRST INCIDENCE | --- --- --- --- |729 (T) 724 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.266N P=0.474 P=0.552N P=0.552N | |POLY 3 | (e) (e) (e) (e) |P=0.221N P=0.509 P=0.502N P=0.496N | |POLY 1.5 | (e) (e) (e) (e) |P=0.218N P=0.512 P=0.495N P=0.492N | |POLY 6 | (e) (e) (e) (e) |P=0.226N P=0.506 P=0.514N P=0.501N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.255N P=0.485 P=0.552N P=0.552N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.212N P=0.520 P=0.484N P=0.484N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.329N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/45 (16%) 7/50 (14%) 7/48 (15%) 5/48 (10%) |2/47 (4%) 2/49 (4%) 1/49 (2%) 1/49 (2%) | |POLY-3 RATE (b) | 7/39.54 7/45.99 7/42.24 5/42.70 |2/43.58 2/44.44 1/43.30 1/44.24 | |POLY-3 PERCENT (g) | 17.7% 15.2% 16.6% 11.7% |4.6% 4.5% 2.3% 2.3% | |TERMINAL (d) | 7/30 (23%) 7/38 (18%) 6/33 (18%) 4/31 (13%) |2/36 (6%) 2/34 (6%) 1/31 (3%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 691 659 |729 (T) 729 (T) 729 (T) 702 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.364N P=0.423N P=0.542N P=0.353N |P=0.361N P=0.675 P=0.552N P=0.546N | |POLY 3 | P=0.304N P=0.493N P=0.562N P=0.324N |P=0.313N P=0.687N P=0.502N P=0.495N | |POLY 1.5 | P=0.298N P=0.509N P=0.562N P=0.327N |P=0.310N P=0.684N P=0.495N P=0.492N | |POLY 6 | P=0.315N P=0.477N P=0.564N P=0.326N |P=0.318N P=0.690N P=0.514N P=0.499N | |LOGISTIC REGRESSION| P=0.348N P=0.423N P=0.575N P=0.346N |P=0.332N P=0.675 P=0.552N P=0.502N | |COCH-ARM / FISHERS | P=0.293N P=0.529N P=0.562N P=0.334N |P=0.304N P=0.676N P=0.484N P=0.484N | |ORDER RESTRICTED | P=0.365N (e) (e) (e) |P=0.436N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 37 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/45 (2%) 0/50 (0%) 1/48 (2%) 0/48 (0%) |4/47 (9%) 9/49 (18%) 4/49 (8%) 7/49 (14%) | |POLY-3 RATE (b) | 1/39.54 0/45.99 1/42.09 0/42.44 |4/43.58 9/44.44 4/43.65 7/45.04 | |POLY-3 PERCENT (g) | 2.5% 0.0% 2.4% 0.0% |9.2% 20.3% 9.2% 15.5% | |TERMINAL (d) | 1/30 (3%) 0/38 (0%) 1/33 (3%) 0/31 (0%) |4/36 (11%) 9/34 (27%) 3/31 (10%) 5/31 (16%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) --- |729 (T) 729 (T) 629 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.501N P=0.453N P=0.741N P=0.493N |P=0.425 P=0.091 P=0.568 P=0.202 | |POLY 3 | P=0.489N P=0.470N P=0.747N P=0.486N |P=0.534 P=0.121 P=0.643N P=0.280 | |POLY 1.5 | P=0.484N P=0.474N P=0.746N P=0.486N |P=0.536 P=0.125 P=0.632N P=0.280 | |POLY 6 | P=0.497N P=0.466N P=0.748N P=0.488N |P=0.530 P=0.117 P=0.629 P=0.277 | |LOGISTIC REGRESSION| P=0.501N (e) P=0.741N (e) |P=0.520 P=0.091 P=0.629 P=0.281 | |COCH-ARM / FISHERS | P=0.479N P=0.474N P=0.736N P=0.484N |P=0.542 P=0.133 P=0.619N P=0.287 | |ORDER RESTRICTED | P=0.237N (e) (e) (e) |P=0.301 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Preputial Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 25/49 (51%) 26/50 (52%) 33/50 (66%) 33/50 (66%) | | |POLY-3 RATE (b) | 25/44.73 26/47.96 33/48.56 33/45.60 | | |POLY-3 PERCENT (g) | 55.9% 54.2% 68.0% 72.4% | | |TERMINAL (d) | 15/31 (48%) 20/38 (53%) 20/34 (59%) 24/31 (77%) | | |FIRST INCIDENCE | 482 562 367 558 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.022 * P=0.327N P=0.207 P=0.112 | | |POLY 3 | P=0.020 * P=0.519N P=0.158 P=0.070 | | |POLY 1.5 | P=0.027 * P=0.560N P=0.131 P=0.081 | | |POLY 6 | P=0.013 * P=0.479N P=0.188 P=0.056 | | |LOGISTIC REGRESSION| P=0.033 * P=0.559N P=0.097 P=0.098 | | |COCH-ARM / FISHERS | P=0.038 * P=0.541 P=0.095 P=0.095 | | |ORDER RESTRICTED | P=0.063 (e) (e) (e) | | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 38 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 21/49 (43%) 30/50 (60%) 24/50 (48%) 28/50 (56%) | | |POLY-3 RATE (b) | 21/44.19 30/47.54 24/46.26 28/46.53 | | |POLY-3 PERCENT (g) | 47.5% 63.1% 51.9% 60.2% | | |TERMINAL (d) | 13/31 (42%) 24/38 (63%) 17/34 (50%) 18/31 (58%) | | |FIRST INCIDENCE | 435 562 573 489 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.199 P=0.280 P=0.467 P=0.149 | | |POLY 3 | P=0.358 P=0.094 P=0.418 P=0.154 | | |POLY 1.5 | P=0.357 P=0.078 P=0.398 P=0.146 | | |POLY 6 | P=0.351 P=0.114 P=0.445 P=0.158 | | |LOGISTIC REGRESSION| P=0.321 P=0.098 P=0.391 P=0.141 | | |COCH-ARM / FISHERS | P=0.345 P=0.066 P=0.378 P=0.134 | | |ORDER RESTRICTED | P=0.170 (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 4/50 (8%) 0/50 (0%) 1/49 (2%) | | |POLY-3 RATE (b) | 0/41.26 4/46.53 0/43.74 1/43.48 | | |POLY-3 PERCENT (g) | 0.0% 8.6% 0.0% 2.3% | | |TERMINAL (d) | 0/30 (0%) 3/38 (8%) 0/34 (0%) 0/31 (0%) | | |FIRST INCIDENCE | --- 562 --- 623 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.306N P=0.094 (e) P=0.509 | | |POLY 3 | P=0.270N P=0.077 (e) P=0.510 | | |POLY 1.5 | P=0.277N P=0.072 (e) P=0.508 | | |POLY 6 | P=0.263N P=0.083 (e) P=0.512 | | |LOGISTIC REGRESSION| P=0.291N P=0.064 (e) P=0.476 | | |COCH-ARM / FISHERS | P=0.290N P=0.064 (e) P=0.505 | | |ORDER RESTRICTED | P=0.241 (e) (e) (e) | | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 39 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Salivary Glands | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/42.26 0/45.99 0/43.74 2/43.55 |0/45.94 0/44.57 0/44.30 0/45.13 | |POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 0/38 (0%) 0/34 (0%) 2/31 (7%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.176 P=0.459N P=0.482N P=0.500 |(e) (e) (e) (e) | |POLY 3 | P=0.192 P=0.483N P=0.493N P=0.510 |(e) (e) (e) (e) | |POLY 1.5 | P=0.196 P=0.489N P=0.494N P=0.510 |(e) (e) (e) (e) | |POLY 6 | P=0.186 P=0.477N P=0.492N P=0.508 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.176 (e) (e) P=0.500 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.201 P=0.495N P=0.495N P=0.508 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.136 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Salivary Glands | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 4/50 (8%) 6/50 (12%) 1/50 (2%) |15/50 (30%) 13/49 (27%) 16/50 (32%) 10/50 (20%) | |POLY-3 RATE (b) | 3/42.37 4/45.99 6/43.74 1/43.55 |15/46.02 13/44.69 16/45.07 10/45.68 | |POLY-3 PERCENT (g) | 7.1% 8.7% 13.7% 2.3% |32.6% 29.1% 35.5% 21.9% | |TERMINAL (d) | 2/31 (7%) 4/38 (11%) 6/34 (18%) 1/31 (3%) |14/38 (37%) 11/35 (31%) 14/32 (44%) 7/32 (22%) | |FIRST INCIDENCE | 703 729 (T) 729 (T) 729 (T) |710 706 617 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.297N P=0.602 P=0.283 P=0.314N |P=0.370N P=0.510N P=0.289 P=0.318N | |POLY 3 | P=0.256N P=0.545 P=0.257 P=0.295N |P=0.201N P=0.447N P=0.471 P=0.179N | |POLY 1.5 | P=0.249N P=0.530 P=0.255 P=0.295N |P=0.203N P=0.445N P=0.486 P=0.180N | |POLY 6 | P=0.270N P=0.561 P=0.257 P=0.298N |P=0.205N P=0.447N P=0.444 P=0.179N | |LOGISTIC REGRESSION| P=0.295N P=0.583 P=0.263 P=0.301N |P=0.238N P=0.466N P=0.389 P=0.201N | |COCH-ARM / FISHERS | P=0.246N P=0.511 P=0.254 P=0.301N |P=0.202N P=0.437N P=0.500 P=0.178N | |ORDER RESTRICTED | P=0.155N (e) (e) (e) |P=0.201N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 40 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Seminal Vesicle | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 5/50 (10%) 1/50 (2%) 0/50 (0%) | | |POLY-3 RATE (b) | 3/42.72 5/46.68 1/43.74 0/43.55 | | |POLY-3 PERCENT (g) | 7.0% 10.7% 2.3% 0.0% | | |TERMINAL (d) | 2/31 (7%) 2/38 (5%) 1/34 (3%) 0/31 (0%) | | |FIRST INCIDENCE | 596 582 729 (T) --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.022N* P=0.448 P=0.280N P=0.121N | | |POLY 3 | P=0.017N* P=0.406 P=0.296N P=0.115N | | |POLY 1.5 | P=0.017N* P=0.390 P=0.297N P=0.114N | | |POLY 6 | P=0.018N* P=0.426 P=0.297N P=0.117N | | |LOGISTIC REGRESSION| P=0.017N* P=0.357 P=0.296N P=0.117N | | |COCH-ARM / FISHERS | P=0.017N* P=0.369 P=0.301N P=0.117N | | |ORDER RESTRICTED | P=0.041N* (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Skin | | Cyst Epithelial Inclusion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.26 2/45.99 0/43.74 0/43.55 |0/45.94 0/45.44 0/44.30 0/45.13 | |POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 2/38 (5%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 729 (T) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.240N P=0.284 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.214N P=0.256 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.218N P=0.250 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.210N P=0.264 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.284 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.225N P=0.253 (e) (e) |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.258N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 41 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Skin | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 2/50 (4%) 0/50 (0%) 3/50 (6%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 3/42.34 2/46.44 0/43.74 3/44.08 |2/45.94 1/45.44 1/44.30 1/45.92 | |POLY-3 PERCENT (g) | 7.1% 4.3% 0.0% 6.8% |4.4% 2.2% 2.3% 2.2% | |TERMINAL (d) | 2/31 (7%) 1/38 (3%) 0/34 (0%) 1/31 (3%) |2/38 (5%) 1/35 (3%) 1/32 (3%) 0/32 (0%) | |FIRST INCIDENCE | 710 596 --- 659 |729 (T) 729 (T) 729 (T) 430 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.552 P=0.429N P=0.112N P=0.659 |P=0.483N P=0.529N P=0.560N P=0.542N | |POLY 3 | P=0.582 P=0.458N P=0.113N P=0.644N |P=0.440N P=0.504N P=0.513N P=0.500N | |POLY 1.5 | P=0.588 P=0.472N P=0.114N P=0.647N |P=0.439N P=0.503N P=0.507N P=0.500N | |POLY 6 | P=0.572 P=0.442N P=0.112N P=0.643N |P=0.444N P=0.505N P=0.523N P=0.502N | |LOGISTIC REGRESSION| P=0.583N P=0.484N P=0.112N P=0.650N |P=0.420N P=0.529N P=0.560N P=0.439N | |COCH-ARM / FISHERS | P=0.583N P=0.490N P=0.117N P=0.651N |P=0.439N P=0.500N P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.330N (e) (e) (e) |P=0.415N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Skin: Epidermis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 2/50 (4%) 0/50 (0%) 3/50 (6%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 3/42.34 2/46.04 0/43.74 3/44.08 |2/45.94 1/45.44 2/44.30 1/45.92 | |POLY-3 PERCENT (g) | 7.1% 4.3% 0.0% 6.8% |4.4% 2.2% 4.5% 2.2% | |TERMINAL (d) | 2/31 (7%) 1/38 (3%) 0/34 (0%) 1/31 (3%) |2/38 (5%) 1/35 (3%) 2/32 (6%) 0/32 (0%) | |FIRST INCIDENCE | 710 717 --- 659 |729 (T) 729 (T) 729 (T) 430 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.544 P=0.413N P=0.112N P=0.659 |P=0.540N P=0.529N P=0.632 P=0.542N | |POLY 3 | P=0.584 P=0.462N P=0.113N P=0.644N |P=0.489N P=0.504N P=0.681 P=0.500N | |POLY 1.5 | P=0.588N P=0.474N P=0.114N P=0.647N |P=0.489N P=0.503N P=0.687 P=0.500N | |POLY 6 | P=0.576 P=0.448N P=0.112N P=0.643N |P=0.493N P=0.505N P=0.670 P=0.502N | |LOGISTIC REGRESSION| P=0.585 P=0.437N P=0.112N P=0.650N |P=0.477N P=0.529N P=0.632 P=0.439N | |COCH-ARM / FISHERS | P=0.583N P=0.490N P=0.117N P=0.651N |P=0.490N P=0.500N P=0.691N P=0.500N | |ORDER RESTRICTED | P=0.330N (e) (e) (e) |P=0.443N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 42 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 18/47 (38%) 20/50 (40%) 28/50 (56%) 38/50 (76%) |34/50 (68%) 42/50 (84%) 35/50 (70%) 34/48 (71%) | |POLY-3 RATE (b) | 18/44.04 20/48.29 28/49.55 38/49.22 |34/47.57 42/48.19 35/48.20 34/47.67 | |POLY-3 PERCENT (g) | 40.9% 41.4% 56.5% 77.2% |71.5% 87.2% 72.6% 71.3% | |TERMINAL (d) | 9/30 (30%) 14/38 (37%) 13/34 (38%) 22/31 (71%) |27/38 (71%) 31/35 (89%) 22/32 (69%) 20/32 (63%) | |FIRST INCIDENCE | 435 297 367 469 |555 383 479 430 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.463N P=0.118 P=0.002 ** |P=0.504 P=0.039 * P=0.198 P=0.283 | |POLY 3 | P<0.001 ** P=0.563 P=0.094 P<0.001 ** |P=0.161N P=0.042 * P=0.542 P=0.583N | |POLY 1.5 | P<0.001 ** P=0.547 P=0.080 P<0.001 ** |P=0.204N P=0.045 * P=0.530 P=0.547 | |POLY 6 | P<0.001 ** P=0.574 P=0.114 P<0.001 ** |P=0.125N P=0.040 * P=0.539 P=0.537N | |LOGISTIC REGRESSION| P<0.001 ** P=0.443 P=0.049 * P<0.001 ** |P=0.275N P=0.038 * P=0.461 P=0.469 | |COCH-ARM / FISHERS | P<0.001 ** P=0.515 P=0.061 P<0.001 ** |P=0.282N P=0.050 P=0.500 P=0.466 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.276N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Spleen | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/47 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |5/50 (10%) 5/50 (10%) 1/50 (2%) 2/48 (4%) | |POLY-3 RATE (b) | 0/40.70 1/46.25 1/43.88 1/43.84 |5/47.01 5/46.06 1/44.64 2/44.76 | |POLY-3 PERCENT (g) | 0.0% 2.2% 2.3% 2.3% |10.6% 10.9% 2.2% 4.5% | |TERMINAL (d) | 0/30 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |2/38 (5%) 3/35 (9%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 659 691 652 |563 584 634 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.412 P=0.534 P=0.511 P=0.510 |P=0.095N P=0.597 P=0.133N P=0.244N | |POLY 3 | P=0.430 P=0.525 P=0.515 P=0.515 |P=0.083N P=0.617 P=0.114N P=0.236N | |POLY 1.5 | P=0.432 P=0.520 P=0.514 P=0.514 |P=0.081N P=0.621 P=0.108N P=0.235N | |POLY 6 | P=0.425 P=0.532 P=0.516 P=0.514 |P=0.086N P=0.613 P=0.123N P=0.242N | |LOGISTIC REGRESSION| P=0.433 P=0.499 P=0.513 P=0.503 |P=0.084N P=0.613N P=0.086N P=0.243N | |COCH-ARM / FISHERS | P=0.431 P=0.515 P=0.515 P=0.515 |P=0.081N P=0.630N P=0.102N P=0.235N | |ORDER RESTRICTED | P=0.342 (e) (e) (e) |P=0.130N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 43 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/47 (9%) 7/50 (14%) 3/50 (6%) 8/50 (16%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 2/48 (4%) | |POLY-3 RATE (b) | 4/41.39 7/47.78 3/44.53 8/45.45 |0/45.94 1/45.58 2/44.55 2/44.26 | |POLY-3 PERCENT (g) | 9.7% 14.7% 6.7% 17.6% |0.0% 2.2% 4.5% 4.5% | |TERMINAL (d) | 1/30 (3%) 1/38 (3%) 0/34 (0%) 2/31 (7%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 626 562 596 558 |--- 694 668 702 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.253 P=0.365 P=0.482N P=0.203 |P=0.147 P=0.500 P=0.216 P=0.214 | |POLY 3 | P=0.294 P=0.349 P=0.460N P=0.224 |P=0.159 P=0.498 P=0.230 P=0.229 | |POLY 1.5 | P=0.298 P=0.327 P=0.462N P=0.219 |P=0.159 P=0.499 P=0.234 P=0.229 | |POLY 6 | P=0.285 P=0.375 P=0.460N P=0.227 |P=0.156 P=0.498 P=0.225 P=0.227 | |LOGISTIC REGRESSION| P=0.303 P=0.254 P=0.471N P=0.197 |P=0.157 P=0.502 P=0.239 P=0.229 | |COCH-ARM / FISHERS | P=0.298 P=0.299 P=0.465N P=0.210 |P=0.156 P=0.500 P=0.247 P=0.237 | |ORDER RESTRICTED | P=0.211 (e) (e) (e) |P=0.149 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/47 (6%) 6/50 (12%) 6/50 (12%) 6/50 (12%) |8/50 (16%) 11/50 (22%) 14/50 (28%) 12/48 (25%) | |POLY-3 RATE (b) | 3/40.70 6/46.02 6/44.02 6/43.55 |8/46.54 11/45.52 14/45.70 12/44.97 | |POLY-3 PERCENT (g) | 7.4% 13.0% 13.6% 13.8% |17.2% 24.2% 30.6% 26.7% | |TERMINAL (d) | 3/30 (10%) 5/38 (13%) 5/34 (15%) 6/31 (19%) |6/38 (16%) 10/35 (29%) 11/32 (34%) 10/32 (31%) | |FIRST INCIDENCE | 729 (T) 721 653 729 (T) |563 710 507 430 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.245 P=0.370 P=0.300 P=0.254 |P=0.120 P=0.245 P=0.061 P=0.135 | |POLY 3 | P=0.312 P=0.306 P=0.281 P=0.275 |P=0.191 P=0.285 P=0.100 P=0.198 | |POLY 1.5 | P=0.321 P=0.292 P=0.278 P=0.277 |P=0.192 P=0.292 P=0.106 P=0.200 | |POLY 6 | P=0.295 P=0.322 P=0.284 P=0.269 |P=0.181 P=0.276 P=0.089 P=0.189 | |LOGISTIC REGRESSION| P=0.258 P=0.353 P=0.277 P=0.254 |P=0.184 P=0.293 P=0.111 P=0.196 | |COCH-ARM / FISHERS | P=0.326 P=0.275 P=0.275 P=0.275 |P=0.183 P=0.306 P=0.114 P=0.197 | |ORDER RESTRICTED | P=0.298 (e) (e) (e) |P=0.155 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 44 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Stomach, Forestomach | | Diverticulum | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/42.26 2/45.99 1/44.24 0/43.55 |0/45.58 0/45.44 0/44.30 0/45.07 | |POLY-3 PERCENT (g) | 0.0% 4.4% 2.3% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 2/38 (5%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 729 (T) 576 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.341N P=0.284 P=0.509 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.316N P=0.256 P=0.509 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.319N P=0.250 P=0.507 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.316N P=0.264 P=0.511 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.322N P=0.284 P=0.501 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.323N P=0.253 P=0.505 (e) |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.336N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Stomach, Forestomach | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 1/42.72 0/45.99 1/44.19 2/44.65 |0/45.58 1/45.44 0/44.30 0/45.07 | |POLY-3 PERCENT (g) | 2.3% 0.0% 2.3% 4.5% |0.0% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 1/35 (3%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 596 --- 596 476 |--- 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.196 P=0.491N P=0.757N P=0.515 |P=0.437N P=0.484 (e) (e) | |POLY 3 | P=0.190 P=0.485N P=0.753N P=0.515 |P=0.423N P=0.499 (e) (e) | |POLY 1.5 | P=0.193 P=0.490N P=0.754N P=0.513 |P=0.420N P=0.501 (e) (e) | |POLY 6 | P=0.184 P=0.480N P=0.752N P=0.515 |P=0.428N P=0.498 (e) (e) | |LOGISTIC REGRESSION| P=0.157 P=0.514N P=0.764 P=0.417 |(e) P=0.484 (e) (e) | |COCH-ARM / FISHERS | P=0.193 P=0.495N P=0.747N P=0.508 |P=0.415N P=0.505 (e) (e) | |ORDER RESTRICTED | P=0.236 (e) (e) (e) |P=0.382N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 45 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 1/50 (2%) 3/50 (6%) 6/50 (12%) |1/49 (2%) 2/50 (4%) 2/50 (4%) 1/49 (2%) | |POLY-3 RATE (b) | 3/42.91 1/45.99 3/44.67 6/44.10 |1/45.66 2/45.70 2/44.68 1/45.23 | |POLY-3 PERCENT (g) | 7.0% 2.2% 6.7% 13.6% |2.2% 4.4% 4.5% 2.2% | |TERMINAL (d) | 2/31 (7%) 1/38 (3%) 1/34 (3%) 4/31 (13%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 514 729 (T) 367 597 |710 682 643 688 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.043 * P=0.247N P=0.627N P=0.248 |P=0.541N P=0.486 P=0.453 P=0.738 | |POLY 3 | P=0.051 P=0.281N P=0.644N P=0.255 |P=0.517N P=0.500 P=0.492 P=0.758 | |POLY 1.5 | P=0.053 P=0.288N P=0.646N P=0.255 |P=0.514N P=0.502 P=0.499 P=0.759 | |POLY 6 | P=0.047 * P=0.272N P=0.643N P=0.251 |P=0.523N P=0.499 P=0.482 P=0.756 | |LOGISTIC REGRESSION| P=0.057 P=0.313N P=0.662 P=0.252 |P=0.515N P=0.509 P=0.523 P=0.761N | |COCH-ARM / FISHERS | P=0.056 P=0.301N P=0.651N P=0.254 |P=0.513N P=0.508 P=0.508 P=0.753N | |ORDER RESTRICTED | P=0.079 (e) (e) (e) |P=0.542 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |1/49 (2%) 1/50 (2%) 1/50 (2%) 3/49 (6%) | |POLY-3 RATE (b) | 2/42.97 2/46.79 2/44.61 2/44.25 |1/45.58 1/45.58 1/44.53 3/45.68 | |POLY-3 PERCENT (g) | 4.7% 4.3% 4.5% 4.5% |2.2% 2.2% 2.3% 6.6% | |TERMINAL (d) | 1/31 (3%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |1/38 (3%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 482 562 431 558 |729 (T) 694 668 596 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.569 P=0.643N P=0.677N P=0.682N |P=0.146 P=0.751 P=0.733 P=0.280 | |POLY 3 | P=0.581 P=0.663N P=0.681N P=0.684N |P=0.158 P=0.761 P=0.755 P=0.306 | |POLY 1.5 | P=0.587N P=0.673N P=0.683N P=0.684N |P=0.158 P=0.759N P=0.760 P=0.306 | |POLY 6 | P=0.570 P=0.650N P=0.679N P=0.685N |P=0.156 P=0.759 P=0.749 P=0.304 | |LOGISTIC REGRESSION| P=0.576 P=0.659 P=0.695 P=0.665 |P=0.152 P=0.762N P=0.757N P=0.308 | |COCH-ARM / FISHERS | P=0.583N P=0.684N P=0.684N P=0.684N |P=0.156 P=0.747N P=0.747N P=0.309 | |ORDER RESTRICTED | P=0.724N (e) (e) (e) |P=0.189 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 46 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 3/50 (6%) 4/50 (8%) 7/50 (14%) |4/49 (8%) 5/50 (10%) 0/50 (0%) 4/49 (8%) | |POLY-3 RATE (b) | 4/43.02 3/46.70 4/45.85 7/44.62 |4/46.04 5/45.85 0/44.30 4/45.34 | |POLY-3 PERCENT (g) | 9.3% 6.4% 8.7% 15.7% |8.7% 10.9% 0.0% 8.8% | |TERMINAL (d) | 3/31 (10%) 1/38 (3%) 1/34 (3%) 3/31 (10%) |2/38 (5%) 1/35 (3%) 0/32 (0%) 2/32 (6%) | |FIRST INCIDENCE | 458 596 367 597 |621 682 --- 688 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.110 P=0.419N P=0.610N P=0.273 |P=0.419N P=0.470 P=0.085N P=0.574 | |POLY 3 | P=0.117 P=0.455N P=0.608N P=0.281 |P=0.366N P=0.497 P=0.065N P=0.635 | |POLY 1.5 | P=0.121 P=0.470N P=0.616N P=0.279 |P=0.360N P=0.502 P=0.062N P=0.639 | |POLY 6 | P=0.111 P=0.435N P=0.600N P=0.284 |P=0.378N P=0.493 P=0.071N P=0.626 | |LOGISTIC REGRESSION| P=0.119 P=0.530N P=0.633 P=0.267 |P=0.355N P=0.513 P=0.057N P=0.643N | |COCH-ARM / FISHERS | P=0.124 P=0.489N P=0.631N P=0.274 |P=0.355N P=0.513 P=0.056N P=0.643N | |ORDER RESTRICTED | P=0.174 (e) (e) (e) |P=0.254N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Stomach, Glandular | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/47 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 1/49 (2%) | |POLY-3 RATE (b) | 2/41.83 2/46.79 1/43.82 0/43.55 |0/45.58 1/45.50 0/44.30 1/45.53 | |POLY-3 PERCENT (g) | 4.8% 4.3% 2.3% 0.0% |0.0% 2.2% 0.0% 2.2% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | 626 562 708 --- |--- 715 --- 596 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.125N P=0.640N P=0.490N P=0.241N |P=0.478 P=0.490 (e) P=0.509 | |POLY 3 | P=0.113N P=0.653N P=0.484N P=0.228N |P=0.479 P=0.500 (e) P=0.500 | |POLY 1.5 | P=0.110N P=0.661N P=0.481N P=0.225N |P=0.480 P=0.501 (e) P=0.500 | |POLY 6 | P=0.119N P=0.644N P=0.488N P=0.233N |P=0.475 P=0.498 (e) P=0.498 | |LOGISTIC REGRESSION| P=0.101N P=0.697N P=0.478N P=0.224N |P=0.470 P=0.500 (e) P=0.521 | |COCH-ARM / FISHERS | P=0.105N P=0.668N P=0.477N P=0.232N |P=0.481 P=0.505 (e) P=0.500 | |ORDER RESTRICTED | P=0.148N (e) (e) (e) |P=0.251 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 47 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Testes: Germinal Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/49 (18%) 4/50 (8%) 4/50 (8%) 8/50 (16%) | | |POLY-3 RATE (b) | 9/43.45 4/46.30 4/44.47 8/44.84 | | |POLY-3 PERCENT (g) | 20.7% 8.6% 9.0% 17.8% | | |TERMINAL (d) | 4/31 (13%) 2/38 (5%) 2/34 (6%) 4/31 (13%) | | |FIRST INCIDENCE | 596 659 596 558 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.381 P=0.075N P=0.110N P=0.510N | | |POLY 3 | P=0.436 P=0.091N P=0.105N P=0.471N | | |POLY 1.5 | P=0.446 P=0.098N P=0.106N P=0.472N | | |POLY 6 | P=0.418 P=0.085N P=0.105N P=0.480N | | |LOGISTIC REGRESSION| P=0.456 P=0.104N P=0.109N P=0.482N | | |COCH-ARM / FISHERS | P=0.455 P=0.109N P=0.109N P=0.482N | | |ORDER RESTRICTED | P=0.176N (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 14/42 (33%) 16/45 (36%) 12/46 (26%) 22/47 (47%) |8/44 (18%) 9/47 (19%) 11/47 (23%) 13/48 (27%) | |POLY-3 RATE (b) | 14/40.05 16/43.58 12/43.62 22/45.15 |8/42.03 9/45.76 11/45.14 13/45.11 | |POLY-3 PERCENT (g) | 35.0% 36.7% 27.5% 48.7% |19.0% 19.7% 24.4% 28.8% | |TERMINAL (d) | 4/29 (14%) 8/34 (24%) 3/32 (9%) 10/31 (32%) |4/34 (12%) 1/34 (3%) 2/32 (6%) 3/32 (9%) | |FIRST INCIDENCE | 435 562 367 563 |555 487 479 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.092 P=0.574N P=0.377N P=0.127 |P=0.111 P=0.490 P=0.272 P=0.161 | |POLY 3 | P=0.130 P=0.524 P=0.309N P=0.143 |P=0.128 P=0.577 P=0.366 P=0.207 | |POLY 1.5 | P=0.133 P=0.514 P=0.306N P=0.143 |P=0.134 P=0.568 P=0.366 P=0.210 | |POLY 6 | P=0.124 P=0.534 P=0.317N P=0.141 |P=0.123 P=0.588 P=0.364 P=0.207 | |LOGISTIC REGRESSION| P=0.114 P=0.410 P=0.340N P=0.101 |P=0.165 P=0.613N P=0.439 P=0.241 | |COCH-ARM / FISHERS | P=0.136 P=0.503 P=0.305N P=0.141 |P=0.145 P=0.560 P=0.362 P=0.222 | |ORDER RESTRICTED | P=0.102 (e) (e) (e) |P=0.225 (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 48 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Thymus | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/42 (0%) 1/45 (2%) 1/46 (2%) 1/47 (2%) |0/44 (0%) 3/47 (6%) 3/47 (6%) 2/48 (4%) | |POLY-3 RATE (b) | 0/36.42 1/41.16 1/40.52 1/42.19 |0/40.66 3/43.02 3/42.14 2/43.37 | |POLY-3 PERCENT (g) | 0.0% 2.4% 2.5% 2.4% |0.0% 7.0% 7.1% 4.6% | |TERMINAL (d) | 0/29 (0%) 1/34 (3%) 1/32 (3%) 1/31 (3%) |0/34 (0%) 3/34 (9%) 3/32 (9%) 2/32 (6%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |--- 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.419 P=0.532 P=0.520 P=0.513 |P=0.363 P=0.121 P=0.110 P=0.225 | |POLY 3 | P=0.454 P=0.524 P=0.521 P=0.529 |P=0.408 P=0.128 P=0.124 P=0.251 | |POLY 1.5 | P=0.453 P=0.520 P=0.520 P=0.527 |P=0.412 P=0.129 P=0.127 P=0.253 | |POLY 6 | P=0.451 P=0.528 P=0.521 P=0.529 |P=0.401 P=0.128 P=0.120 P=0.249 | |LOGISTIC REGRESSION| (e) P=0.532 P=0.520 P=0.513 |(e) P=0.121 P=0.110 P=0.225 | |COCH-ARM / FISHERS | P=0.445 P=0.517 P=0.523 P=0.528 |P=0.421 P=0.133 P=0.133 P=0.269 | |ORDER RESTRICTED | P=0.350 (e) (e) (e) |P=0.140 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Thyroid Gland | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/48 (10%) 8/50 (16%) 3/50 (6%) 6/50 (12%) |10/50 (20%) 26/50 (52%) 16/50 (32%) 14/50 (28%) | |POLY-3 RATE (b) | 5/42.52 8/46.04 3/43.91 6/43.97 |10/46.75 26/46.85 16/45.64 14/46.25 | |POLY-3 PERCENT (g) | 11.8% 17.4% 6.8% 13.7% |21.4% 55.5% 35.1% 30.3% | |TERMINAL (d) | 3/31 (10%) 7/38 (18%) 1/34 (3%) 4/31 (13%) |8/38 (21%) 22/35 (63%) 12/32 (38%) 9/32 (28%) | |FIRST INCIDENCE | 451 717 699 659 |563 490 573 596 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.488N P=0.412 P=0.326N P=0.507 |P=0.393N P<0.001 ** P=0.066 P=0.157 | |POLY 3 | P=0.413N P=0.329 P=0.338N P=0.524 |P=0.232N P<0.001 ** P=0.107 P=0.229 | |POLY 1.5 | P=0.406N P=0.317 P=0.337N P=0.527 |P=0.230N P<0.001 ** P=0.116 P=0.231 | |POLY 6 | P=0.425N P=0.343 P=0.339N P=0.517 |P=0.237N P<0.001 ** P=0.095 P=0.226 | |LOGISTIC REGRESSION| P=0.417N P=0.324 P=0.334N P=0.530 |P=0.238N P<0.001 ** P=0.117 P=0.234 | |COCH-ARM / FISHERS | P=0.398N P=0.304 P=0.335N P=0.529 |P=0.225N P<0.001 ** P=0.127 P=0.241 | |ORDER RESTRICTED | P=0.424N (e) (e) (e) |P=0.033 * (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 49 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/48 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |8/50 (16%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 3/41.70 0/45.99 0/43.74 0/43.55 |8/46.38 1/45.44 1/44.30 2/45.59 | |POLY-3 PERCENT (g) | 7.2% 0.0% 0.0% 0.0% |17.3% 2.2% 2.3% 4.4% | |TERMINAL (d) | 3/31 (10%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |6/38 (16%) 1/35 (3%) 1/32 (3%) 1/32 (3%) | |FIRST INCIDENCE | 729 (T) --- --- --- |621 729 (T) 729 (T) 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.101N P=0.087N P=0.105N P=0.120N |P=0.116N P=0.025N* P=0.033N* P=0.075N | |POLY 3 | P=0.097N P=0.102N P=0.110N P=0.111N |P=0.081N P=0.017N* P=0.019N* P=0.048N* | |POLY 1.5 | P=0.093N P=0.106N P=0.111N P=0.110N |P=0.081N P=0.017N* P=0.017N* P=0.047N* | |POLY 6 | P=0.102N P=0.097N P=0.110N P=0.112N |P=0.083N P=0.017N* P=0.022N* P=0.049N* | |LOGISTIC REGRESSION| P=0.101N (e) (e) (e) |P=0.089N P=0.019N* P=0.021N* P=0.048N* | |COCH-ARM / FISHERS | P=0.092N P=0.114N P=0.114N P=0.114N |P=0.086N P=0.015N* P=0.015N* P=0.046N* | |ORDER RESTRICTED | P=0.006N** (e) (e) (e) |P=0.002N** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Tooth | | Malformation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/5 (100%) 6/6 (100%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) | |POLY-3 RATE (b) | 5/5.00 6/6.00 0/0.00 0/0.00 |0/0.00 0/0.00 1/1.00 0/0.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% 0.0% 0.0% |0.0% 0.0% 100.0% 0.0% | |TERMINAL (d) | 3/3 (100%) 5/5 (100%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 626 717 --- --- |--- --- 680 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (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| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 50 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Urethra | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 3/3 (100%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 RATE (b) | 0/0.00 3/3.00 0/0.00 0/0.00 |0/0.00 0/0.00 0/0.00 0/0.00 | |POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |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 | --- 562 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (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| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Urethra | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 3/3 (100%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 RATE (b) | 0/0.00 3/3.00 0/0.00 0/0.00 |0/0.00 0/0.00 0/0.00 0/0.00 | |POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |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 | --- 562 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (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| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 51 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Urinary Bladder | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |2/50 (4%) 0/49 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/42.26 0/45.99 1/44.37 0/42.64 |2/46.61 0/44.52 0/44.30 0/45.07 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |4.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- 521 --- |517 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.637 (e) P=0.517 (e) |P=0.191N P=0.253N P=0.260N P=0.264N | |POLY 3 | P=0.622 (e) P=0.510 (e) |P=0.176N P=0.248N P=0.249N P=0.245N | |POLY 1.5 | P=0.628 (e) P=0.507 (e) |P=0.176N P=0.246N P=0.243N P=0.243N | |POLY 6 | P=0.611 (e) P=0.512 (e) |P=0.177N P=0.249N P=0.257N P=0.248N | |LOGISTIC REGRESSION| P=0.600 (e) P=0.511 (e) |P=0.190N P=0.197N P=0.215N P=0.246N | |COCH-ARM / FISHERS | P=0.633 (e) P=0.505 (e) |P=0.178N P=0.253N P=0.247N P=0.253N | |ORDER RESTRICTED | P=0.390 (e) (e) (e) |P=0.032N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Urinary Bladder | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/50 (2%) 1/50 (2%) 0/49 (0%) |3/50 (6%) 5/49 (10%) 3/50 (6%) 2/49 (4%) | |POLY-3 RATE (b) | 0/42.26 1/45.99 1/43.74 0/42.64 |3/45.98 5/44.55 3/44.68 2/45.07 | |POLY-3 PERCENT (g) | 0.0% 2.2% 2.3% 0.0% |6.5% 11.2% 6.7% 4.4% | |TERMINAL (d) | 0/31 (0%) 1/38 (3%) 1/34 (3%) 0/31 (0%) |2/38 (5%) 4/35 (11%) 2/32 (6%) 2/32 (6%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) --- |720 721 622 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.539N P=0.541 P=0.518 (e) |P=0.296N P=0.317 P=0.592 P=0.577N | |POLY 3 | P=0.517N P=0.517 P=0.507 (e) |P=0.235N P=0.339 P=0.649 P=0.509N | |POLY 1.5 | P=0.517N P=0.511 P=0.506 (e) |P=0.234N P=0.341 P=0.655 P=0.508N | |POLY 6 | P=0.519N P=0.523 P=0.508 (e) |P=0.241N P=0.337 P=0.638 P=0.514N | |LOGISTIC REGRESSION| (e) P=0.541 P=0.518 (e) |P=0.242N P=0.328 P=0.650 P=0.547N | |COCH-ARM / FISHERS | P=0.519N P=0.505 P=0.505 (e) |P=0.234N P=0.346 P=0.661N P=0.510N | |ORDER RESTRICTED | P=0.411N (e) (e) (e) |P=0.329N (e) (e) (e) | |=================================================================================================================================| Date: 05/19/04 EXPERIMENT: 96017 TEST: 06 Page 52 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Uterus | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 4/50 (8%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | |0/45.94 4/45.44 1/44.65 2/45.39 | |POLY-3 PERCENT (g) | |0.0% 8.8% 2.2% 4.4% | |TERMINAL (d) | |0/38 (0%) 4/35 (11%) 0/32 (0%) 1/32 (3%) | |FIRST INCIDENCE | |--- 729 (T) 629 659 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.556 P=0.053 P=0.495 P=0.226 | |POLY 3 | |P=0.592 P=0.059 P=0.494 P=0.234 | |POLY 1.5 | |P=0.594 P=0.059 P=0.497 P=0.235 | |POLY 6 | |P=0.587 P=0.058 P=0.490 P=0.233 | |LOGISTIC REGRESSION| |P=0.593N P=0.053 P=0.515 P=0.239 | |COCH-ARM / FISHERS | |P=0.590N P=0.059 P=0.500 P=0.247 | |ORDER RESTRICTED | |P=0.151 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 | | | MG/L | MG/L | |=================================================================================================================================| | | |Uterus | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |44/50 (88%) 42/50 (84%) 44/50 (88%) 39/50 (78%) | |POLY-3 RATE (b) | |44/48.05 42/49.09 44/49.16 39/47.56 | |POLY-3 PERCENT (g) | |91.6% 85.6% 89.5% 82.0% | |TERMINAL (d) | |36/38 (95%) 30/35 (86%) 30/32 (94%) 26/32 (81%) | |FIRST INCIDENCE | |563 383 479 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.422 P=0.509 P=0.145 P=0.522 | |POLY 3 | |P=0.178N P=0.262N P=0.499N P=0.127N | |POLY 1.5 | |P=0.175N P=0.308N P=0.543N P=0.138N | |POLY 6 | |P=0.183N P=0.224N P=0.478N P=0.118N | |LOGISTIC REGRESSION| |P=0.168N P=0.422N P=0.572 P=0.140N | |COCH-ARM / FISHERS | |P=0.150N P=0.387N P=0.620N P=0.143N | |ORDER RESTRICTED | |P=0.112N (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).