NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (BROMODICHLOROMETHANE) DATE: 03/25/03 EXPERIMENT: 96018 TEST: 04 TIME: 11:07:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96018 PATHOLOGIST: HEATH, JAMES E. CAS: 75-27-4 ------------------------------------------------------------------------------------------------------------------------------------ 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 (BROMODICHLOROMETHANE) DATE: 03/25/03 EXPERIMENT: 96018 TEST: 04 TIME: 11:07:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96018 PATHOLOGIST: HEATH, JAMES E. CAS: 75-27-4 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF WATER DISINFECTION BYPRODUCTS (BROMODICHL =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Bone Marrow Hyperplasia Myelofibrosis Brain Compression Eye Developmental Malformation Inflammation Chronic Heart Mineralization Intestine Large, Cecum Edema Kidney Nephropathy Liver Cyst Infarct Liver: Centrilobular Necrosis Liver: Hepatocyte Karyomegaly Liver: Kupffer Cell Pigmentation Mammary Gland Hyperplasia Ovary: Granulosa Cell Hyperplasia Spleen Hematopoietic Cell Proliferation Spleen: Lymphoid Follicle Hyperplasia Thymus Atrophy Thyroid Gland Degeneration Cystic Thyroid Gland: Follicular Cell Hyperplasia =============================================================== Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Accessory Adrenal Cortical Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/50 (16%) 5/50 (10%) 5/49 (10%) 10/49 (20%) | |POLY-3 RATE (b) | 8/46.30 5/43.54 5/42.79 10/45.20 | |POLY-3 PERCENT (g) | 17.3% 11.5% 11.7% 22.1% | |TERMINAL (d) | 4/36 (11%) 5/36 (14%) 3/32 (9%) 8/38 (21%) | |FIRST INCIDENCE | 606 729 (T) 663 522 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.280 P=0.295N P=0.358N P=0.435 | |POLY 3 | P=0.236 P=0.316N P=0.328N P=0.375 | |POLY 1.5 | P=0.236 P=0.302N P=0.312N P=0.379 | |POLY 6 | P=0.236 P=0.337N P=0.350N P=0.368 | |LOGISTIC REGRESSION| P=0.235 P=0.301N P=0.308N P=0.379 | |COCH-ARM / FISHERS | P=0.230 P=0.277N P=0.290N P=0.379 | |ORDER RESTRICTED | P=0.199 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/49 (4%) 0/49 (0%) | |POLY-3 RATE (b) | 1/45.47 1/43.54 2/42.48 0/44.46 | |POLY-3 PERCENT (g) | 2.2% 2.3% 4.7% 0.0% | |TERMINAL (d) | 1/36 (3%) 1/36 (3%) 2/32 (6%) 0/38 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.357N P=0.762 P=0.459 P=0.489N | |POLY 3 | P=0.370N P=0.751 P=0.476 P=0.504N | |POLY 1.5 | P=0.371N P=0.754 P=0.483 P=0.504N | |POLY 6 | P=0.370N P=0.747 P=0.468 P=0.505N | |LOGISTIC REGRESSION| P=0.357N P=0.762 P=0.459 (e) | |COCH-ARM / FISHERS | P=0.373N P=0.753N P=0.492 P=0.505N | |ORDER RESTRICTED | P=0.261N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Adrenal Cortex: Zona Reticularis | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/49 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 0/45.47 2/43.54 1/42.91 0/44.46 | |POLY-3 PERCENT (g) | 0.0% 4.6% 2.3% 0.0% | |TERMINAL (d) | 0/36 (0%) 2/36 (6%) 0/32 (0%) 0/38 (0%) | |FIRST INCIDENCE | --- 729 (T) 604 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.455N P=0.238 P=0.491 (e) | |POLY 3 | P=0.471N P=0.227 P=0.488 (e) | |POLY 1.5 | P=0.469N P=0.231 P=0.491 (e) | |POLY 6 | P=0.474N P=0.224 P=0.485 (e) | |LOGISTIC REGRESSION| P=0.467N P=0.238 P=0.524 (e) | |COCH-ARM / FISHERS | P=0.467N P=0.247 P=0.495 (e) | |ORDER RESTRICTED | P=0.314 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/48 (0%) 0/49 (0%) 2/49 (4%) | |POLY-3 RATE (b) | 2/45.47 0/42.17 0/42.48 2/44.60 | |POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 4.5% | |TERMINAL (d) | 2/36 (6%) 0/35 (0%) 0/32 (0%) 1/38 (3%) | |FIRST INCIDENCE | 729 (T) --- --- 693 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.514 P=0.244N P=0.264N P=0.679N | |POLY 3 | P=0.502 P=0.254N P=0.253N P=0.687 | |POLY 1.5 | P=0.501 P=0.252N P=0.248N P=0.687 | |POLY 6 | P=0.503 P=0.257N P=0.258N P=0.688 | |LOGISTIC REGRESSION| P=0.498 (e) (e) P=0.687 | |COCH-ARM / FISHERS | P=0.497 P=0.258N P=0.253N P=0.684 | |ORDER RESTRICTED | P=0.272 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Bone | | Hyperostosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 0/45.47 3/43.54 1/43.97 1/45.46 | |POLY-3 PERCENT (g) | 0.0% 6.9% 2.3% 2.2% | |TERMINAL (d) | 0/36 (0%) 3/36 (8%) 0/33 (0%) 1/39 (3%) | |FIRST INCIDENCE | --- 729 (T) 583 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.609 P=0.121 P=0.496 P=0.516 | |POLY 3 | P=0.588 P=0.111 P=0.493 P=0.500 | |POLY 1.5 | P=0.590 P=0.114 P=0.496 P=0.500 | |POLY 6 | P=0.587 P=0.108 P=0.490 P=0.500 | |LOGISTIC REGRESSION| P=0.592 P=0.121 P=0.532 P=0.516 | |COCH-ARM / FISHERS | P=0.591 P=0.121 P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.213 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 22/50 (44%) 24/50 (48%) 18/50 (36%) 11/50 (22%) | |POLY-3 RATE (b) | 22/47.66 24/47.88 18/46.83 11/45.83 | |POLY-3 PERCENT (g) | 46.2% 50.1% 38.4% 24.0% | |TERMINAL (d) | 12/36 (33%) 15/36 (42%) 9/33 (27%) 9/39 (23%) | |FIRST INCIDENCE | 563 318 486 669 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.008N** P=0.397 P=0.410N P=0.019N* | |POLY 3 | P=0.006N** P=0.428 P=0.291N P=0.019N* | |POLY 1.5 | P=0.005N** P=0.425 P=0.282N P=0.017N* | |POLY 6 | P=0.008N** P=0.419 P=0.303N P=0.023N* | |LOGISTIC REGRESSION| P=0.005N** P=0.446 P=0.258N P=0.016N* | |COCH-ARM / FISHERS | P=0.005N** P=0.421 P=0.270N P=0.016N* | |ORDER RESTRICTED | P=0.010N* (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Bone Marrow | | Myelofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 3/45.65 1/43.54 1/43.71 0/45.46 | |POLY-3 PERCENT (g) | 6.6% 2.3% 2.3% 0.0% | |TERMINAL (d) | 1/36 (3%) 1/36 (3%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | 689 729 (T) 669 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.075N P=0.319N P=0.349N P=0.118N | |POLY 3 | P=0.071N P=0.322N P=0.321N P=0.119N | |POLY 1.5 | P=0.071N P=0.317N P=0.315N P=0.119N | |POLY 6 | P=0.070N P=0.330N P=0.329N P=0.120N | |LOGISTIC REGRESSION| P=0.073N P=0.324N P=0.312N P=0.120N | |COCH-ARM / FISHERS | P=0.073N P=0.309N P=0.309N P=0.121N | |ORDER RESTRICTED | P=0.037N* (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Brain | | Compression | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/45.47 0/43.54 0/43.48 0/45.46 | |POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/36 (6%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.113N P=0.238N P=0.258N P=0.221N | |POLY 3 | P=0.111N P=0.247N P=0.247N P=0.237N | |POLY 1.5 | P=0.112N P=0.244N P=0.243N P=0.237N | |POLY 6 | P=0.111N P=0.251N P=0.252N P=0.237N | |LOGISTIC REGRESSION| P=0.113N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N | |ORDER RESTRICTED | P=0.029N* (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/45.47 2/44.04 1/43.61 0/45.46 | |POLY-3 PERCENT (g) | 0.0% 4.5% 2.3% 0.0% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | --- 649 696 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.461N P=0.221 P=0.480 (e) | |POLY 3 | P=0.464N P=0.230 P=0.492 (e) | |POLY 1.5 | P=0.463N P=0.232 P=0.495 (e) | |POLY 6 | P=0.466N P=0.228 P=0.488 (e) | |LOGISTIC REGRESSION| P=0.465N P=0.249 P=0.499 (e) | |COCH-ARM / FISHERS | P=0.461N P=0.247 P=0.500 (e) | |ORDER RESTRICTED | P=0.316 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/48 (2%) 1/49 (2%) 4/48 (8%) 1/49 (2%) | |POLY-3 RATE (b) | 1/43.91 1/43.11 4/41.70 1/44.76 | |POLY-3 PERCENT (g) | 2.3% 2.3% 9.6% 2.2% | |TERMINAL (d) | 1/35 (3%) 1/36 (3%) 2/31 (7%) 1/39 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 696 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.550 P=0.756N P=0.149 P=0.738N | |POLY 3 | P=0.540 P=0.757 P=0.163 P=0.756N | |POLY 1.5 | P=0.538 P=0.759 P=0.169 P=0.756N | |POLY 6 | P=0.543 P=0.753 P=0.155 P=0.757N | |LOGISTIC REGRESSION| P=0.535 P=0.756N P=0.154 P=0.738N | |COCH-ARM / FISHERS | P=0.532 P=0.747N P=0.181 P=0.747N | |ORDER RESTRICTED | P=0.314 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Eye | | Developmental Malformation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/48 (2%) 0/50 (0%) 0/50 (0%) 4/50 (8%) | |POLY-3 RATE (b) | 1/44.42 0/43.54 0/43.48 4/45.46 | |POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 8.8% | |TERMINAL (d) | 1/36 (3%) 0/36 (0%) 0/33 (0%) 4/39 (10%) | |FIRST INCIDENCE | 729 (T) --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.035 * P=0.500N P=0.517N P=0.204 | |POLY 3 | P=0.028 * P=0.504N P=0.504N P=0.186 | |POLY 1.5 | P=0.028 * P=0.500N P=0.500N P=0.188 | |POLY 6 | P=0.028 * P=0.508N P=0.509N P=0.184 | |LOGISTIC REGRESSION| P=0.035 * (e) (e) P=0.204 | |COCH-ARM / FISHERS | P=0.029 * P=0.490N P=0.490N P=0.194 | |ORDER RESTRICTED | P=0.012 * (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Eye | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/48 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.42 2/44.15 0/43.48 0/45.46 | |POLY-3 PERCENT (g) | 0.0% 4.5% 0.0% 0.0% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | --- 641 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.404N P=0.222 (e) (e) | |POLY 3 | P=0.411N P=0.236 (e) (e) | |POLY 1.5 | P=0.407N P=0.238 (e) (e) | |POLY 6 | P=0.414N P=0.234 (e) (e) | |LOGISTIC REGRESSION| P=0.399N P=0.278 (e) (e) | |COCH-ARM / FISHERS | P=0.398N P=0.258 (e) (e) | |ORDER RESTRICTED | P=0.241N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Eye | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/44.42 0/43.54 0/43.48 2/45.46 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.4% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 2/39 (5%) | |FIRST INCIDENCE | --- --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.055 (e) (e) P=0.256 | |POLY 3 | P=0.047 * (e) (e) P=0.242 | |POLY 1.5 | P=0.047 * (e) (e) P=0.244 | |POLY 6 | P=0.047 * (e) (e) P=0.241 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.256 | |COCH-ARM / FISHERS | P=0.048 * (e) (e) P=0.258 | |ORDER RESTRICTED | P=0.031 * (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Harderian Gland | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 1/45.47 1/43.54 2/43.73 1/45.46 | |POLY-3 PERCENT (g) | 2.2% 2.3% 4.6% 2.2% | |TERMINAL (d) | 1/36 (3%) 1/36 (3%) 1/33 (3%) 1/39 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 663 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.610 P=0.762 P=0.474 P=0.744N | |POLY 3 | P=0.596 P=0.751 P=0.486 P=0.761 | |POLY 1.5 | P=0.595 P=0.754 P=0.492 P=0.760N | |POLY 6 | P=0.598 P=0.747 P=0.480 P=0.760 | |LOGISTIC REGRESSION| P=0.593 P=0.762 P=0.489 P=0.744N | |COCH-ARM / FISHERS | P=0.591 P=0.753N P=0.500 P=0.753N | |ORDER RESTRICTED | P=0.576 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 8 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Heart | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/45.65 0/43.54 0/43.48 0/45.46 | |POLY-3 PERCENT (g) | 6.6% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/36 (3%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | 689 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.050N P=0.132N P=0.144N P=0.118N | |POLY 3 | P=0.043N* P=0.127N P=0.128N P=0.119N | |POLY 1.5 | P=0.044N* P=0.125N P=0.124N P=0.119N | |POLY 6 | P=0.043N* P=0.131N P=0.132N P=0.120N | |LOGISTIC REGRESSION| P=0.048N* P=0.128N P=0.129N P=0.120N | |COCH-ARM / FISHERS | P=0.047N* P=0.121N P=0.121N P=0.121N | |ORDER RESTRICTED | P=0.008N** (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Intestine Large, Cecum | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/49 (20%) 8/48 (17%) 8/48 (17%) 4/49 (8%) | |POLY-3 RATE (b) | 10/44.74 8/43.42 8/42.27 4/44.63 | |POLY-3 PERCENT (g) | 22.4% 18.4% 18.9% 9.0% | |TERMINAL (d) | 9/36 (25%) 6/36 (17%) 7/33 (21%) 4/39 (10%) | |FIRST INCIDENCE | 689 641 669 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.049N* P=0.412N P=0.481N P=0.055N | |POLY 3 | P=0.059N P=0.424N P=0.449N P=0.072N | |POLY 1.5 | P=0.059N P=0.425N P=0.436N P=0.072N | |POLY 6 | P=0.060N P=0.423N P=0.464N P=0.072N | |LOGISTIC REGRESSION| P=0.059N P=0.436N P=0.478N P=0.070N | |COCH-ARM / FISHERS | P=0.061N P=0.416N P=0.416N P=0.074N | |ORDER RESTRICTED | P=0.066N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 9 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Intestine Small, Duodenum: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/48 (2%) 1/48 (2%) 2/46 (4%) 0/46 (0%) | |POLY-3 RATE (b) | 1/44.79 1/42.81 2/40.87 0/43.10 | |POLY-3 PERCENT (g) | 2.2% 2.3% 4.9% 0.0% | |TERMINAL (d) | 1/36 (3%) 1/36 (3%) 1/33 (3%) 0/39 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 707 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.355N P=0.762 P=0.464 P=0.484N | |POLY 3 | P=0.375N P=0.750 P=0.468 P=0.508N | |POLY 1.5 | P=0.377N P=0.753 P=0.474 P=0.508N | |POLY 6 | P=0.371N P=0.748 P=0.464 P=0.506N | |LOGISTIC REGRESSION| P=0.373N P=0.762 P=0.462 (e) | |COCH-ARM / FISHERS | P=0.380N P=0.753N P=0.484 P=0.511N | |ORDER RESTRICTED | P=0.261N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Intestine Small, Ileum: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/45 (0%) 1/46 (2%) 2/49 (4%) 0/49 (0%) | |POLY-3 RATE (b) | 0/42.02 1/42.10 2/43.04 0/45.10 | |POLY-3 PERCENT (g) | 0.0% 2.4% 4.7% 0.0% | |TERMINAL (d) | 0/35 (0%) 1/36 (3%) 1/33 (3%) 0/39 (0%) | |FIRST INCIDENCE | --- 729 (T) 604 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.599N P=0.506 P=0.228 (e) | |POLY 3 | P=0.599N P=0.500 P=0.242 (e) | |POLY 1.5 | P=0.597N P=0.502 P=0.247 (e) | |POLY 6 | P=0.600N P=0.499 P=0.237 (e) | |LOGISTIC REGRESSION| P=0.592N P=0.506 P=0.278 (e) | |COCH-ARM / FISHERS | P=0.594N P=0.505 P=0.269 (e) | |ORDER RESTRICTED | P=0.315N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 10 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/49 (2%) 4/48 (8%) 3/48 (6%) 1/49 (2%) | |POLY-3 RATE (b) | 1/44.91 4/42.54 3/41.70 1/45.10 | |POLY-3 PERCENT (g) | 2.2% 9.4% 7.2% 2.2% | |TERMINAL (d) | 1/36 (3%) 4/36 (11%) 3/33 (9%) 1/39 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.399N P=0.179 P=0.274 P=0.744N | |POLY 3 | P=0.428N P=0.162 P=0.279 P=0.760N | |POLY 1.5 | P=0.427N P=0.165 P=0.287 P=0.760N | |POLY 6 | P=0.429N P=0.159 P=0.270 P=0.760N | |LOGISTIC REGRESSION| P=0.399N P=0.179 P=0.274 P=0.744N | |COCH-ARM / FISHERS | P=0.429N P=0.175 P=0.301 P=0.753N | |ORDER RESTRICTED | P=0.305N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Kidney | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/50 (16%) 5/49 (10%) 5/50 (10%) 3/50 (6%) | |POLY-3 RATE (b) | 8/45.77 5/43.17 5/43.48 3/45.46 | |POLY-3 PERCENT (g) | 17.5% 11.6% 11.5% 6.6% | |TERMINAL (d) | 7/36 (19%) 5/36 (14%) 5/33 (15%) 3/39 (8%) | |FIRST INCIDENCE | 649 729 (T) 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.069N P=0.279N P=0.329N P=0.080N | |POLY 3 | P=0.082N P=0.314N P=0.309N P=0.100N | |POLY 1.5 | P=0.083N P=0.306N P=0.295N P=0.099N | |POLY 6 | P=0.082N P=0.324N P=0.328N P=0.101N | |LOGISTIC REGRESSION| P=0.082N P=0.320N P=0.331N P=0.099N | |COCH-ARM / FISHERS | P=0.085N P=0.290N P=0.277N P=0.100N | |ORDER RESTRICTED | P=0.077N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 11 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 2/49 (4%) 3/50 (6%) 5/50 (10%) | |POLY-3 RATE (b) | 2/45.47 2/43.17 3/43.48 5/45.69 | |POLY-3 PERCENT (g) | 4.4% 4.6% 6.9% 10.9% | |TERMINAL (d) | 2/36 (6%) 2/36 (6%) 3/33 (9%) 4/39 (10%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 669 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.138 P=0.695 P=0.460 P=0.246 | |POLY 3 | P=0.119 P=0.675 P=0.480 P=0.218 | |POLY 1.5 | P=0.119 P=0.678 P=0.488 P=0.218 | |POLY 6 | P=0.120 P=0.671 P=0.469 P=0.219 | |LOGISTIC REGRESSION| P=0.120 P=0.695 P=0.460 P=0.215 | |COCH-ARM / FISHERS | P=0.116 P=0.684 P=0.500 P=0.218 | |ORDER RESTRICTED | P=0.161 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Kidney | | Metaplasia Osseous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 2/45.47 0/43.17 0/43.48 1/45.46 | |POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 2.2% | |TERMINAL (d) | 2/36 (6%) 0/36 (0%) 0/33 (0%) 1/39 (3%) | |FIRST INCIDENCE | 729 (T) --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.443N P=0.238N P=0.258N P=0.472N | |POLY 3 | P=0.457N P=0.249N P=0.247N P=0.500N | |POLY 1.5 | P=0.457N P=0.247N P=0.243N P=0.500N | |POLY 6 | P=0.457N P=0.251N P=0.252N P=0.500N | |LOGISTIC REGRESSION| P=0.443N (e) (e) P=0.472N | |COCH-ARM / FISHERS | P=0.459N P=0.253N P=0.247N P=0.500N | |ORDER RESTRICTED | P=0.134N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 12 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 16/50 (32%) 14/49 (29%) 7/50 (14%) 8/50 (16%) | |POLY-3 RATE (b) | 16/46.32 14/44.20 7/44.01 8/45.63 | |POLY-3 PERCENT (g) | 34.6% 31.7% 15.9% 17.5% | |TERMINAL (d) | 11/36 (31%) 11/36 (31%) 5/33 (15%) 7/39 (18%) | |FIRST INCIDENCE | 649 547 658 686 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.019N* P=0.449N P=0.057N P=0.043N* | |POLY 3 | P=0.019N* P=0.473N P=0.034N* P=0.050N | |POLY 1.5 | P=0.019N* P=0.464N P=0.031N* P=0.049N* | |POLY 6 | P=0.020N* P=0.489N P=0.040N* P=0.053N | |LOGISTIC REGRESSION| P=0.019N* P=0.475N P=0.036N* P=0.049N* | |COCH-ARM / FISHERS | P=0.020N* P=0.440N P=0.028N* P=0.050N | |ORDER RESTRICTED | P=0.029N* (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Accumulation, Hyaline Droplet | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 6/49 (12%) 4/50 (8%) 1/50 (2%) | |POLY-3 RATE (b) | 2/45.49 6/44.72 4/43.77 1/45.69 | |POLY-3 PERCENT (g) | 4.4% 13.4% 9.1% 2.2% | |TERMINAL (d) | 1/36 (3%) 1/36 (3%) 2/33 (6%) 0/39 (0%) | |FIRST INCIDENCE | 724 581 669 669 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.231N P=0.131 P=0.292 P=0.485N | |POLY 3 | P=0.228N P=0.127 P=0.319 P=0.499N | |POLY 1.5 | P=0.229N P=0.125 P=0.326 P=0.499N | |POLY 6 | P=0.228N P=0.131 P=0.311 P=0.498N | |LOGISTIC REGRESSION| P=0.232N P=0.136 P=0.311 P=0.500N | |COCH-ARM / FISHERS | P=0.231N P=0.128 P=0.339 P=0.500N | |ORDER RESTRICTED | P=0.159N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 13 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 2/46.01 0/43.17 2/44.21 1/45.63 | |POLY-3 PERCENT (g) | 4.4% 0.0% 4.5% 2.2% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | 606 --- 583 686 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.525N P=0.259N P=0.663 P=0.503N | |POLY 3 | P=0.522N P=0.252N P=0.680 P=0.503N | |POLY 1.5 | P=0.523N P=0.248N P=0.685 P=0.501N | |POLY 6 | P=0.520N P=0.256N P=0.673 P=0.505N | |LOGISTIC REGRESSION| P=0.543N P=0.224N P=0.666N P=0.506N | |COCH-ARM / FISHERS | P=0.528N P=0.253N P=0.691N P=0.500N | |ORDER RESTRICTED | P=0.418N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 2/45.92 0/43.17 0/43.48 1/45.76 | |POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 2.2% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | 606 --- --- 647 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.456N P=0.251N P=0.260N P=0.497N | |POLY 3 | P=0.456N P=0.251N P=0.250N P=0.501N | |POLY 1.5 | P=0.457N P=0.248N P=0.244N P=0.500N | |POLY 6 | P=0.455N P=0.255N P=0.256N P=0.502N | |LOGISTIC REGRESSION| P=0.466N P=0.229N P=0.226N P=0.508N | |COCH-ARM / FISHERS | P=0.459N P=0.253N P=0.247N P=0.500N | |ORDER RESTRICTED | P=0.135N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 14 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 5/50 (10%) 2/50 (4%) | |POLY-3 RATE (b) | 3/46.28 0/43.54 5/43.73 2/45.46 | |POLY-3 PERCENT (g) | 6.5% 0.0% 11.4% 4.4% | |TERMINAL (d) | 2/36 (6%) 0/36 (0%) 4/33 (12%) 2/39 (5%) | |FIRST INCIDENCE | 423 --- 663 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.573 P=0.124N P=0.320 P=0.469N | |POLY 3 | P=0.552 P=0.130N P=0.326 P=0.508N | |POLY 1.5 | P=0.551 P=0.126N P=0.337 P=0.505N | |POLY 6 | P=0.555 P=0.134N P=0.313 P=0.510N | |LOGISTIC REGRESSION| P=0.544 P=0.093N P=0.366 P=0.507N | |COCH-ARM / FISHERS | P=0.544 P=0.121N P=0.357 P=0.500N | |ORDER RESTRICTED | P=0.269 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 3/50 (6%) | |POLY-3 RATE (b) | 2/45.47 1/43.86 2/43.73 3/46.19 | |POLY-3 PERCENT (g) | 4.4% 2.3% 4.6% 6.5% | |TERMINAL (d) | 2/36 (6%) 0/36 (0%) 1/33 (3%) 2/39 (5%) | |FIRST INCIDENCE | 729 (T) 641 664 472 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.339 P=0.508N P=0.661 P=0.531 | |POLY 3 | P=0.325 P=0.513N P=0.680 P=0.507 | |POLY 1.5 | P=0.322 P=0.509N P=0.685 P=0.505 | |POLY 6 | P=0.328 P=0.516N P=0.673 P=0.509 | |LOGISTIC REGRESSION| P=0.307 P=0.506N P=0.679 P=0.496 | |COCH-ARM / FISHERS | P=0.313 P=0.500N P=0.691N P=0.500 | |ORDER RESTRICTED | P=0.369 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 15 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/45.47 0/43.54 0/43.48 0/45.46 | |POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/36 (6%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.113N P=0.238N P=0.258N P=0.221N | |POLY 3 | P=0.111N P=0.247N P=0.247N P=0.237N | |POLY 1.5 | P=0.112N P=0.244N P=0.243N P=0.237N | |POLY 6 | P=0.111N P=0.251N P=0.252N P=0.237N | |LOGISTIC REGRESSION| P=0.113N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N | |ORDER RESTRICTED | P=0.029N* (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/50 (14%) 4/50 (8%) 8/50 (16%) 4/50 (8%) | |POLY-3 RATE (b) | 7/45.47 4/44.17 8/43.84 4/46.19 | |POLY-3 PERCENT (g) | 15.4% 9.1% 18.3% 8.7% | |TERMINAL (d) | 7/36 (19%) 3/36 (8%) 6/33 (18%) 3/39 (8%) | |FIRST INCIDENCE | 729 (T) 521 664 472 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.277N P=0.261N P=0.424 P=0.220N | |POLY 3 | P=0.293N P=0.277N P=0.469 P=0.252N | |POLY 1.5 | P=0.299N P=0.273N P=0.481 P=0.255N | |POLY 6 | P=0.287N P=0.282N P=0.456 P=0.249N | |LOGISTIC REGRESSION| P=0.309N P=0.282N P=0.428 P=0.261N | |COCH-ARM / FISHERS | P=0.313N P=0.262N P=0.500 P=0.262N | |ORDER RESTRICTED | P=0.261N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 16 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 4/45.70 2/43.54 1/43.48 1/45.46 | |POLY-3 PERCENT (g) | 8.8% 4.6% 2.3% 2.2% | |TERMINAL (d) | 3/36 (8%) 2/36 (6%) 1/33 (3%) 1/39 (3%) | |FIRST INCIDENCE | 669 729 (T) 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.103N P=0.345N P=0.211N P=0.163N | |POLY 3 | P=0.110N P=0.360N P=0.194N P=0.180N | |POLY 1.5 | P=0.110N P=0.352N P=0.188N P=0.179N | |POLY 6 | P=0.109N P=0.369N P=0.203N P=0.181N | |LOGISTIC REGRESSION| P=0.111N P=0.363N P=0.197N P=0.179N | |COCH-ARM / FISHERS | P=0.111N P=0.339N P=0.181N P=0.181N | |ORDER RESTRICTED | P=0.096N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 6/50 (12%) 1/50 (2%) | |POLY-3 RATE (b) | 2/45.47 5/43.54 6/43.48 1/45.46 | |POLY-3 PERCENT (g) | 4.4% 11.5% 13.8% 2.2% | |TERMINAL (d) | 2/36 (6%) 5/36 (14%) 6/33 (18%) 1/39 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.284N P=0.215 P=0.105 P=0.472N | |POLY 3 | P=0.314N P=0.198 P=0.118 P=0.500N | |POLY 1.5 | P=0.315N P=0.204 P=0.124 P=0.500N | |POLY 6 | P=0.313N P=0.192 P=0.111 P=0.500N | |LOGISTIC REGRESSION| P=0.284N P=0.215 P=0.105 P=0.472N | |COCH-ARM / FISHERS | P=0.320N P=0.218 P=0.134 P=0.500N | |ORDER RESTRICTED | P=0.131N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 17 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/45.47 0/43.54 0/43.48 2/45.46 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.4% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 2/39 (5%) | |FIRST INCIDENCE | --- --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.055 (e) (e) P=0.256 | |POLY 3 | P=0.046 * (e) (e) P=0.237 | |POLY 1.5 | P=0.046 * (e) (e) P=0.237 | |POLY 6 | P=0.046 * (e) (e) P=0.237 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.256 | |COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 | |ORDER RESTRICTED | P=0.029 * (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Infiltration Cellular Mixed Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 6/50 (12%) 7/50 (14%) 5/50 (10%) | |POLY-3 RATE (b) | 6/45.47 6/44.75 7/44.32 5/45.60 | |POLY-3 PERCENT (g) | 13.2% 13.4% 15.8% 11.0% | |TERMINAL (d) | 6/36 (17%) 4/36 (11%) 5/33 (15%) 4/39 (10%) | |FIRST INCIDENCE | 729 (T) 521 539 693 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.400N P=0.617 P=0.435 P=0.449N | |POLY 3 | P=0.437N P=0.610 P=0.480 P=0.498N | |POLY 1.5 | P=0.437N P=0.611 P=0.488 P=0.498N | |POLY 6 | P=0.435N P=0.608 P=0.471 P=0.497N | |LOGISTIC REGRESSION| P=0.438N P=0.614 P=0.471 P=0.498N | |COCH-ARM / FISHERS | P=0.442N P=0.620N P=0.500 P=0.500N | |ORDER RESTRICTED | P=0.517N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 18 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/50 (6%) 2/50 (4%) | |POLY-3 RATE (b) | 3/45.53 3/43.54 3/44.08 2/45.46 | |POLY-3 PERCENT (g) | 6.6% 6.9% 6.8% 4.4% | |TERMINAL (d) | 2/36 (6%) 3/36 (8%) 2/33 (6%) 2/39 (5%) | |FIRST INCIDENCE | 715 729 (T) 539 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.372N P=0.654 P=0.616 P=0.473N | |POLY 3 | P=0.393N P=0.642 P=0.647 P=0.501N | |POLY 1.5 | P=0.393N P=0.648 P=0.653 P=0.500N | |POLY 6 | P=0.392N P=0.634 P=0.639 P=0.502N | |LOGISTIC REGRESSION| P=0.393N P=0.628 P=0.661 P=0.498N | |COCH-ARM / FISHERS | P=0.397N P=0.661N P=0.661N P=0.500N | |ORDER RESTRICTED | P=0.503N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Necrosis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 2/50 (4%) 4/50 (8%) | |POLY-3 RATE (b) | 3/45.50 5/45.39 2/43.71 4/45.81 | |POLY-3 PERCENT (g) | 6.6% 11.0% 4.6% 8.7% | |TERMINAL (d) | 2/36 (6%) 1/36 (3%) 1/33 (3%) 3/39 (8%) | |FIRST INCIDENCE | 723 318 669 631 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.562 P=0.342 P=0.547N P=0.534 | |POLY 3 | P=0.538 P=0.355 P=0.518N P=0.504 | |POLY 1.5 | P=0.538 P=0.355 P=0.511N P=0.503 | |POLY 6 | P=0.539 P=0.356 P=0.527N P=0.506 | |LOGISTIC REGRESSION| P=0.527 P=0.406 P=0.526N P=0.500 | |COCH-ARM / FISHERS | P=0.537 P=0.357 P=0.500N P=0.500 | |ORDER RESTRICTED | P=0.550 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 19 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Tension Lipidosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 2/46.01 0/43.54 0/43.48 2/45.46 | |POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 4.4% | |TERMINAL (d) | 1/36 (3%) 0/36 (0%) 0/33 (0%) 2/39 (5%) | |FIRST INCIDENCE | 563 --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.514 P=0.247N P=0.257N P=0.676N | |POLY 3 | P=0.506 P=0.250N P=0.250N P=0.689 | |POLY 1.5 | P=0.505 P=0.245N P=0.245N P=0.692 | |POLY 6 | P=0.508 P=0.255N P=0.257N P=0.687 | |LOGISTIC REGRESSION| P=0.499 P=0.214N P=0.219N P=0.694 | |COCH-ARM / FISHERS | P=0.500 P=0.247N P=0.247N P=0.691N | |ORDER RESTRICTED | P=0.273 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 1/50 (2%) 2/50 (4%) 3/50 (6%) | |POLY-3 RATE (b) | 6/47.38 1/43.97 2/44.16 3/46.50 | |POLY-3 PERCENT (g) | 12.7% 2.3% 4.5% 6.5% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | 563 604 604 522 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.281N P=0.078N P=0.169N P=0.260N | |POLY 3 | P=0.263N P=0.069N P=0.157N P=0.252N | |POLY 1.5 | P=0.265N P=0.064N P=0.147N P=0.247N | |POLY 6 | P=0.261N P=0.076N P=0.171N P=0.259N | |LOGISTIC REGRESSION| P=0.294N P=0.038N* P=0.101N P=0.246N | |COCH-ARM / FISHERS | P=0.273N P=0.056N P=0.134N P=0.243N | |ORDER RESTRICTED | P=0.077N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 20 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Depletion Glycogen | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 3/45.47 2/43.54 1/43.48 0/45.46 | |POLY-3 PERCENT (g) | 6.6% 4.6% 2.3% 0.0% | |TERMINAL (d) | 3/36 (8%) 2/36 (6%) 1/33 (3%) 0/39 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.057N P=0.500N P=0.336N P=0.107N | |POLY 3 | P=0.061N P=0.520N P=0.321N P=0.119N | |POLY 1.5 | P=0.061N P=0.514N P=0.315N P=0.119N | |POLY 6 | P=0.060N P=0.527N P=0.330N P=0.119N | |LOGISTIC REGRESSION| P=0.057N P=0.500N P=0.336N (e) | |COCH-ARM / FISHERS | P=0.062N P=0.500N P=0.309N P=0.121N | |ORDER RESTRICTED | P=0.057N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Karyomegaly | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/45.47 4/43.54 0/43.48 0/45.46 | |POLY-3 PERCENT (g) | 4.4% 9.2% 0.0% 0.0% | |TERMINAL (d) | 2/36 (6%) 4/36 (11%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.057N P=0.336 P=0.258N P=0.221N | |POLY 3 | P=0.061N P=0.317 P=0.247N P=0.237N | |POLY 1.5 | P=0.061N P=0.324 P=0.243N P=0.237N | |POLY 6 | P=0.062N P=0.309 P=0.252N P=0.237N | |LOGISTIC REGRESSION| P=0.057N P=0.336 (e) (e) | |COCH-ARM / FISHERS | P=0.062N P=0.339 P=0.247N P=0.247N | |ORDER RESTRICTED | P=0.049N* (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 21 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 3/50 (6%) 6/50 (12%) 3/50 (6%) | |POLY-3 RATE (b) | 6/46.43 3/44.49 6/45.85 3/45.69 | |POLY-3 PERCENT (g) | 12.9% 6.7% 13.1% 6.6% | |TERMINAL (d) | 2/36 (6%) 1/36 (3%) 1/33 (3%) 2/39 (5%) | |FIRST INCIDENCE | 581 521 455 669 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.274N P=0.276N P=0.567 P=0.239N | |POLY 3 | P=0.278N P=0.263N P=0.612 P=0.250N | |POLY 1.5 | P=0.277N P=0.257N P=0.616 P=0.246N | |POLY 6 | P=0.280N P=0.273N P=0.603 P=0.255N | |LOGISTIC REGRESSION| P=0.296N P=0.216N P=0.560N P=0.243N | |COCH-ARM / FISHERS | P=0.279N P=0.243N P=0.620N P=0.243N | |ORDER RESTRICTED | P=0.242N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver: Kupffer Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/45.97 1/43.69 0/43.48 0/45.46 | |POLY-3 PERCENT (g) | 4.4% 2.3% 0.0% 0.0% | |TERMINAL (d) | 1/36 (3%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | 581 689 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.104N P=0.517N P=0.254N P=0.233N | |POLY 3 | P=0.101N P=0.518N P=0.250N P=0.240N | |POLY 1.5 | P=0.100N P=0.512N P=0.245N P=0.238N | |POLY 6 | P=0.101N P=0.524N P=0.256N P=0.241N | |LOGISTIC REGRESSION| P=0.100N P=0.482N P=0.222N P=0.242N | |COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N | |ORDER RESTRICTED | P=0.076N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 22 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver: Kupffer Cell | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/50 (14%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 7/45.91 0/43.54 2/43.73 1/45.46 | |POLY-3 PERCENT (g) | 15.3% 0.0% 4.6% 2.2% | |TERMINAL (d) | 4/36 (11%) 0/36 (0%) 1/33 (3%) 1/39 (3%) | |FIRST INCIDENCE | 669 --- 664 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.032N* P=0.013N* P=0.117N P=0.031N* | |POLY 3 | P=0.026N* P=0.009N** P=0.091N P=0.031N* | |POLY 1.5 | P=0.026N* P=0.009N** P=0.086N P=0.031N* | |POLY 6 | P=0.025N* P=0.010N* P=0.097N P=0.032N* | |LOGISTIC REGRESSION| P=0.031N* P=0.011N* P=0.089N P=0.032N* | |COCH-ARM / FISHERS | P=0.031N* P=0.006N** P=0.080N P=0.030N* | |ORDER RESTRICTED | P=0.003N** (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lung | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 1/45.91 0/43.54 0/43.48 2/45.46 | |POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 4.4% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 2/39 (5%) | |FIRST INCIDENCE | 604 --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.260 P=0.509N P=0.509N P=0.516 | |POLY 3 | P=0.249 P=0.511N P=0.511N P=0.497 | |POLY 1.5 | P=0.248 P=0.507N P=0.506N P=0.499 | |POLY 6 | P=0.250 P=0.515N P=0.517N P=0.494 | |LOGISTIC REGRESSION| P=0.244 P=0.461N P=0.473N P=0.499 | |COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 | |ORDER RESTRICTED | P=0.131 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 23 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 7/50 (14%) 6/50 (12%) 7/50 (14%) | |POLY-3 RATE (b) | 6/46.03 7/44.18 6/44.12 7/45.94 | |POLY-3 PERCENT (g) | 13.0% 15.8% 13.6% 15.2% | |TERMINAL (d) | 3/36 (8%) 5/36 (14%) 3/33 (9%) 6/39 (15%) | |FIRST INCIDENCE | 604 640 659 587 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.515 P=0.482 P=0.555 P=0.542 | |POLY 3 | P=0.476 P=0.468 P=0.591 P=0.498 | |POLY 1.5 | P=0.477 P=0.478 P=0.602 P=0.500 | |POLY 6 | P=0.475 P=0.458 P=0.577 P=0.496 | |LOGISTIC REGRESSION| P=0.477 P=0.482 P=0.608 P=0.500 | |COCH-ARM / FISHERS | P=0.472 P=0.500 P=0.620N P=0.500 | |ORDER RESTRICTED | P=0.595 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lung | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 4/50 (8%) 1/50 (2%) | |POLY-3 RATE (b) | 1/45.47 0/43.54 4/43.73 1/46.07 | |POLY-3 PERCENT (g) | 2.2% 0.0% 9.2% 2.2% | |TERMINAL (d) | 1/36 (3%) 0/36 (0%) 3/33 (9%) 0/39 (0%) | |FIRST INCIDENCE | 729 (T) --- 663 535 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.465 P=0.500N P=0.158 P=0.754N | |POLY 3 | P=0.465 P=0.509N P=0.167 P=0.758N | |POLY 1.5 | P=0.458 P=0.506N P=0.172 P=0.758N | |POLY 6 | P=0.472 P=0.512N P=0.161 P=0.757N | |LOGISTIC REGRESSION| P=0.442 (e) P=0.162 P=0.753 | |COCH-ARM / FISHERS | P=0.444 P=0.500N P=0.181 P=0.753N | |ORDER RESTRICTED | P=0.177 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 24 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 5/50 (10%) 0/50 (0%) | |POLY-3 RATE (b) | 2/45.53 1/43.54 5/43.67 0/45.46 | |POLY-3 PERCENT (g) | 4.4% 2.3% 11.5% 0.0% | |TERMINAL (d) | 1/36 (3%) 1/36 (3%) 3/33 (9%) 0/39 (0%) | |FIRST INCIDENCE | 715 729 (T) 696 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.302N P=0.512N P=0.178 P=0.234N | |POLY 3 | P=0.302N P=0.516N P=0.199 P=0.237N | |POLY 1.5 | P=0.304N P=0.511N P=0.206 P=0.237N | |POLY 6 | P=0.299N P=0.522N P=0.191 P=0.238N | |LOGISTIC REGRESSION| P=0.310N P=0.525N P=0.187 P=0.237N | |COCH-ARM / FISHERS | P=0.313N P=0.500N P=0.218 P=0.247N | |ORDER RESTRICTED | P=0.119N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lung | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 1/46.01 2/44.07 1/43.91 0/45.46 | |POLY-3 PERCENT (g) | 2.2% 4.5% 2.3% 0.0% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | 563 641 604 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.252N P=0.476 P=0.748 P=0.508N | |POLY 3 | P=0.252N P=0.485 P=0.750 P=0.502N | |POLY 1.5 | P=0.250N P=0.489 P=0.754 P=0.501N | |POLY 6 | P=0.255N P=0.481 P=0.745 P=0.504N | |LOGISTIC REGRESSION| P=0.259N P=0.549 P=0.732N P=0.539N | |COCH-ARM / FISHERS | P=0.247N P=0.500 P=0.753N P=0.500N | |ORDER RESTRICTED | P=0.218N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 25 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 0/45.47 2/43.54 1/43.48 2/45.46 | |POLY-3 PERCENT (g) | 0.0% 4.6% 2.3% 4.4% | |TERMINAL (d) | 0/36 (0%) 2/36 (6%) 1/33 (3%) 2/39 (5%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.270 P=0.238 P=0.483 P=0.256 | |POLY 3 | P=0.246 P=0.227 P=0.491 P=0.237 | |POLY 1.5 | P=0.246 P=0.231 P=0.495 P=0.237 | |POLY 6 | P=0.245 P=0.224 P=0.486 P=0.237 | |LOGISTIC REGRESSION| (e) P=0.238 P=0.483 P=0.256 | |COCH-ARM / FISHERS | P=0.245 P=0.247 P=0.500 P=0.247 | |ORDER RESTRICTED | P=0.155 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Metaplasia Bronchiolar | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/45.47 2/44.03 0/43.48 0/45.46 | |POLY-3 PERCENT (g) | 0.0% 4.5% 0.0% 0.0% | |TERMINAL (d) | 0/36 (0%) 1/36 (3%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | --- 581 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.401N P=0.235 (e) (e) | |POLY 3 | P=0.412N P=0.230 (e) (e) | |POLY 1.5 | P=0.409N P=0.232 (e) (e) | |POLY 6 | P=0.415N P=0.228 (e) (e) | |LOGISTIC REGRESSION| P=0.411N P=0.251 (e) (e) | |COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) | |ORDER RESTRICTED | P=0.241N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 26 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/47 (2%) | |POLY-3 RATE (b) | 2/46.86 0/43.54 1/43.73 1/43.91 | |POLY-3 PERCENT (g) | 4.3% 0.0% 2.3% 2.3% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 0/38 (0%) | |FIRST INCIDENCE | 350 --- 664 424 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.495N P=0.249N P=0.519N P=0.498N | |POLY 3 | P=0.509N P=0.254N P=0.524N P=0.523N | |POLY 1.5 | P=0.512N P=0.249N P=0.515N P=0.522N | |POLY 6 | P=0.505N P=0.260N P=0.534N P=0.522N | |LOGISTIC REGRESSION| P=0.621N P=0.106N P=0.420N P=0.642N | |COCH-ARM / FISHERS | P=0.519N P=0.247N P=0.500N P=0.523N | |ORDER RESTRICTED | P=0.297N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/47 (2%) | |POLY-3 RATE (b) | 1/46.01 2/43.54 0/43.48 1/43.11 | |POLY-3 PERCENT (g) | 2.2% 4.6% 0.0% 2.3% | |TERMINAL (d) | 0/36 (0%) 2/36 (6%) 0/33 (0%) 1/38 (3%) | |FIRST INCIDENCE | 563 729 (T) --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.492N P=0.493 P=0.513N P=0.759N | |POLY 3 | P=0.525N P=0.481 P=0.511N P=0.746 | |POLY 1.5 | P=0.522N P=0.487 P=0.507N P=0.746 | |POLY 6 | P=0.527N P=0.473 P=0.517N P=0.746 | |LOGISTIC REGRESSION| P=0.520N P=0.512 P=0.464N P=0.740 | |COCH-ARM / FISHERS | P=0.519N P=0.500 P=0.500N P=0.737 | |ORDER RESTRICTED | P=0.387N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 27 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) 3/47 (6%) | |POLY-3 RATE (b) | 0/45.47 3/44.11 2/43.61 3/43.74 | |POLY-3 PERCENT (g) | 0.0% 6.8% 4.6% 6.9% | |TERMINAL (d) | 0/36 (0%) 2/36 (6%) 1/33 (3%) 2/38 (5%) | |FIRST INCIDENCE | --- 547 696 522 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.178 P=0.120 P=0.219 P=0.129 | |POLY 3 | P=0.153 P=0.113 P=0.228 P=0.112 | |POLY 1.5 | P=0.150 P=0.115 P=0.232 P=0.110 | |POLY 6 | P=0.156 P=0.111 P=0.223 P=0.114 | |LOGISTIC REGRESSION| P=0.140 P=0.127 P=0.227 P=0.103 | |COCH-ARM / FISHERS | P=0.146 P=0.121 P=0.247 P=0.110 | |ORDER RESTRICTED | P=0.089 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/50 (16%) 9/50 (18%) 6/50 (12%) 9/47 (19%) | |POLY-3 RATE (b) | 8/45.90 9/44.91 6/43.91 9/43.44 | |POLY-3 PERCENT (g) | 17.4% 20.0% 13.7% 20.7% | |TERMINAL (d) | 7/36 (19%) 6/36 (17%) 5/33 (15%) 7/38 (18%) | |FIRST INCIDENCE | 606 521 604 669 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.533 P=0.490 P=0.450N P=0.540 | |POLY 3 | P=0.448 P=0.480 P=0.421N P=0.450 | |POLY 1.5 | P=0.447 P=0.485 P=0.407N P=0.448 | |POLY 6 | P=0.452 P=0.474 P=0.438N P=0.456 | |LOGISTIC REGRESSION| P=0.452 P=0.491 P=0.419N P=0.452 | |COCH-ARM / FISHERS | P=0.442 P=0.500 P=0.387N P=0.444 | |ORDER RESTRICTED | P=0.515 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 28 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 22/50 (44%) 27/50 (54%) 25/50 (50%) 20/47 (43%) | |POLY-3 RATE (b) | 22/47.62 27/44.63 25/44.21 20/43.46 | |POLY-3 PERCENT (g) | 46.2% 60.5% 56.6% 46.0% | |TERMINAL (d) | 17/36 (47%) 23/36 (64%) 21/33 (64%) 19/38 (50%) | |FIRST INCIDENCE | 350 604 658 631 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.207N P=0.203 P=0.218 P=0.347N | |POLY 3 | P=0.414N P=0.118 P=0.214 P=0.577N | |POLY 1.5 | P=0.396N P=0.144 P=0.260 P=0.557N | |POLY 6 | P=0.431N P=0.096 P=0.169 P=0.575 | |LOGISTIC REGRESSION| P=0.338N P=0.165 P=0.281 P=0.517N | |COCH-ARM / FISHERS | P=0.375N P=0.212 P=0.344 P=0.525N | |ORDER RESTRICTED | P=0.334 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/49 (2%) 0/48 (0%) 0/46 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 1/45.36 0/42.17 0/40.29 2/46.99 | |POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 4.3% | |TERMINAL (d) | 0/35 (0%) 0/35 (0%) 0/32 (0%) 0/39 (0%) | |FIRST INCIDENCE | 350 --- --- 424 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.254 P=0.508N P=0.504N P=0.507 | |POLY 3 | P=0.260 P=0.515N P=0.524N P=0.512 | |POLY 1.5 | P=0.258 P=0.512N P=0.520N P=0.510 | |POLY 6 | P=0.263 P=0.517N P=0.527N P=0.515 | |LOGISTIC REGRESSION| P=0.089 P=0.274N P=0.407N P=0.275 | |COCH-ARM / FISHERS | P=0.253 P=0.505N P=0.516N P=0.508 | |ORDER RESTRICTED | P=0.145 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 29 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/49 (0%) 0/48 (0%) 2/46 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 0/44.47 0/42.17 2/40.51 2/45.46 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.9% 4.4% | |TERMINAL (d) | 0/35 (0%) 0/35 (0%) 1/32 (3%) 2/39 (5%) | |FIRST INCIDENCE | --- --- 669 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.103 (e) P=0.217 P=0.262 | |POLY 3 | P=0.093 (e) P=0.216 P=0.242 | |POLY 1.5 | P=0.093 (e) P=0.219 P=0.242 | |POLY 6 | P=0.094 (e) P=0.215 P=0.242 | |LOGISTIC REGRESSION| P=0.094 (e) P=0.221 P=0.262 | |COCH-ARM / FISHERS | P=0.091 (e) P=0.232 P=0.253 | |ORDER RESTRICTED | P=0.101 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/49 (6%) 2/48 (4%) 3/46 (7%) 0/50 (0%) | |POLY-3 RATE (b) | 3/44.47 2/42.17 3/40.35 0/45.46 | |POLY-3 PERCENT (g) | 6.8% 4.7% 7.4% 0.0% | |TERMINAL (d) | 3/35 (9%) 2/35 (6%) 2/32 (6%) 0/39 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 714 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.100N P=0.500N P=0.615 P=0.102N | |POLY 3 | P=0.107N P=0.524N P=0.617 P=0.115N | |POLY 1.5 | P=0.107N P=0.520N P=0.623 P=0.115N | |POLY 6 | P=0.105N P=0.529N P=0.612 P=0.114N | |LOGISTIC REGRESSION| P=0.107N P=0.500N P=0.603 (e) | |COCH-ARM / FISHERS | P=0.110N P=0.510N P=0.631 P=0.117N | |ORDER RESTRICTED | P=0.091N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 30 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/49 (12%) 9/48 (19%) 4/46 (9%) 7/50 (14%) | |POLY-3 RATE (b) | 6/44.47 9/43.18 4/40.88 7/45.46 | |POLY-3 PERCENT (g) | 13.5% 20.8% 9.8% 15.4% | |TERMINAL (d) | 6/35 (17%) 7/35 (20%) 3/32 (9%) 7/39 (18%) | |FIRST INCIDENCE | 729 (T) 547 539 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.456N P=0.283 P=0.423N P=0.585 | |POLY 3 | P=0.511N P=0.265 P=0.423N P=0.517 | |POLY 1.5 | P=0.509N P=0.265 P=0.419N P=0.517 | |POLY 6 | P=0.512N P=0.265 P=0.427N P=0.517 | |LOGISTIC REGRESSION| P=0.504N P=0.255 P=0.428N P=0.585 | |COCH-ARM / FISHERS | P=0.511N P=0.273 P=0.411N P=0.516 | |ORDER RESTRICTED | P=0.439N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node: Iliac | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/16 (19%) 0/9 (0%) 0/7 (0%) 0/4 (0%) | |POLY-3 RATE (b) | 3/14.27 0/6.81 0/6.09 0/3.25 | |POLY-3 PERCENT (g) | 21.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/7 (29%) 0/2 (0%) 0/2 (0%) 0/2 (0%) | |FIRST INCIDENCE | 423 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.119N P=0.282N P=0.282N P=0.280N | |POLY 3 | P=0.136N P=0.272N P=0.295N P=0.465N | |POLY 1.5 | P=0.138N P=0.250N P=0.292N P=0.455N | |POLY 6 | P=0.138N P=0.313N P=0.306N P=0.474N | |LOGISTIC REGRESSION| P=0.152N P=0.214N P=0.357N P=0.421N | |COCH-ARM / FISHERS | P=0.144N P=0.243N P=0.316N P=0.491N | |ORDER RESTRICTED | P=0.324N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 31 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 9/50 (18%) 4/50 (8%) 4/50 (8%) 2/50 (4%) | |POLY-3 RATE (b) | 9/46.11 4/43.54 4/44.23 2/45.63 | |POLY-3 PERCENT (g) | 19.5% 9.2% 9.0% 4.4% | |TERMINAL (d) | 6/36 (17%) 4/36 (11%) 1/33 (3%) 1/39 (3%) | |FIRST INCIDENCE | 606 729 (T) 659 686 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.023N* P=0.129N P=0.165N P=0.026N* | |POLY 3 | P=0.020N* P=0.138N P=0.131N P=0.026N* | |POLY 1.5 | P=0.021N* P=0.130N P=0.125N P=0.026N* | |POLY 6 | P=0.020N* P=0.149N P=0.138N P=0.026N* | |LOGISTIC REGRESSION| P=0.023N* P=0.135N P=0.122N P=0.027N* | |COCH-ARM / FISHERS | P=0.023N* P=0.117N P=0.117N P=0.026N* | |ORDER RESTRICTED | P=0.011N* (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Mesentery | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/21 (0%) 2/17 (12%) 0/16 (0%) 0/17 (0%) | |POLY-3 RATE (b) | 0/17.79 2/15.25 0/14.49 0/15.79 | |POLY-3 PERCENT (g) | 0.0% 13.1% 0.0% 0.0% | |TERMINAL (d) | 0/11 (0%) 1/11 (9%) 0/8 (0%) 0/14 (0%) | |FIRST INCIDENCE | --- 217 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.384N P=0.238 (e) (e) | |POLY 3 | P=0.413N P=0.196 (e) (e) | |POLY 1.5 | P=0.424N P=0.193 (e) (e) | |POLY 6 | P=0.401N P=0.199 (e) (e) | |LOGISTIC REGRESSION| P=0.650N P=0.236 (e) (e) | |COCH-ARM / FISHERS | P=0.444N P=0.193 (e) (e) | |ORDER RESTRICTED | P=0.235N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 32 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 12/21 (57%) 8/17 (47%) 11/16 (69%) 13/17 (76%) | |POLY-3 RATE (b) | 12/20.12 8/14.48 11/15.04 13/16.26 | |POLY-3 PERCENT (g) | 59.7% 55.2% 73.1% 79.9% | |TERMINAL (d) | 6/11 (55%) 7/11 (64%) 8/8 (100%) 12/14 (86%) | |FIRST INCIDENCE | 350 674 658 587 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.529 P=0.219N P=0.428 P=0.488N | |POLY 3 | P=0.082 P=0.535N P=0.315 P=0.164 | |POLY 1.5 | P=0.084 P=0.489N P=0.336 P=0.169 | |POLY 6 | P=0.082 P=0.588N P=0.272 P=0.167 | |LOGISTIC REGRESSION| P=0.124 P=0.395N P=0.336 P=0.177 | |COCH-ARM / FISHERS | P=0.083 P=0.385N P=0.354 P=0.183 | |ORDER RESTRICTED | P=0.098 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Ovary | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/50 (10%) 6/49 (12%) 5/50 (10%) 9/49 (18%) | |POLY-3 RATE (b) | 5/45.50 6/42.99 5/43.73 9/44.87 | |POLY-3 PERCENT (g) | 11.0% 14.0% 11.4% 20.1% | |TERMINAL (d) | 4/36 (11%) 4/35 (11%) 4/33 (12%) 7/38 (18%) | |FIRST INCIDENCE | 723 640 663 647 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.179 P=0.473 P=0.573 P=0.223 | |POLY 3 | P=0.144 P=0.460 P=0.605 P=0.184 | |POLY 1.5 | P=0.144 P=0.467 P=0.615 P=0.184 | |POLY 6 | P=0.146 P=0.453 P=0.594 P=0.185 | |LOGISTIC REGRESSION| P=0.145 P=0.445 P=0.580 P=0.178 | |COCH-ARM / FISHERS | P=0.141 P=0.486 P=0.630N P=0.183 | |ORDER RESTRICTED | P=0.164 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 33 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/50 (16%) 13/49 (27%) 11/50 (22%) 14/49 (29%) | |POLY-3 RATE (b) | 8/46.51 13/43.24 11/44.08 14/45.48 | |POLY-3 PERCENT (g) | 17.2% 30.1% 25.0% 30.8% | |TERMINAL (d) | 6/36 (17%) 11/35 (31%) 10/33 (30%) 10/38 (26%) | |FIRST INCIDENCE | 563 547 539 631 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.180 P=0.146 P=0.240 P=0.144 | |POLY 3 | P=0.129 P=0.116 P=0.259 P=0.098 | |POLY 1.5 | P=0.130 P=0.127 P=0.278 P=0.100 | |POLY 6 | P=0.131 P=0.104 P=0.235 P=0.099 | |LOGISTIC REGRESSION| P=0.135 P=0.134 P=0.287 P=0.103 | |COCH-ARM / FISHERS | P=0.131 P=0.150 P=0.306 P=0.103 | |ORDER RESTRICTED | P=0.098 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Ovary: Corpus Luteum | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 1/49 (2%) 3/50 (6%) 0/49 (0%) | |POLY-3 RATE (b) | 3/45.47 1/43.17 3/43.91 0/44.46 | |POLY-3 PERCENT (g) | 6.6% 2.3% 6.8% 0.0% | |TERMINAL (d) | 3/36 (8%) 0/35 (0%) 2/33 (6%) 0/38 (0%) | |FIRST INCIDENCE | 729 (T) 521 604 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.132N P=0.314N P=0.625 P=0.111N | |POLY 3 | P=0.134N P=0.324N P=0.646 P=0.123N | |POLY 1.5 | P=0.134N P=0.321N P=0.652 P=0.122N | |POLY 6 | P=0.133N P=0.328N P=0.639 P=0.123N | |LOGISTIC REGRESSION| P=0.137N P=0.301N P=0.648 (e) | |COCH-ARM / FISHERS | P=0.137N P=0.316N P=0.661N P=0.125N | |ORDER RESTRICTED | P=0.079N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 34 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Ovary: Granulosa Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 2/49 (4%) | |POLY-3 RATE (b) | 0/45.47 0/42.54 0/43.48 2/44.46 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.5% | |TERMINAL (d) | 0/36 (0%) 0/35 (0%) 0/33 (0%) 2/38 (5%) | |FIRST INCIDENCE | --- --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.053 (e) (e) P=0.250 | |POLY 3 | P=0.045 * (e) (e) P=0.232 | |POLY 1.5 | P=0.045 * (e) (e) P=0.233 | |POLY 6 | P=0.045 * (e) (e) P=0.232 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.250 | |COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.242 | |ORDER RESTRICTED | P=0.028 * (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Pancreas | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/48 (4%) 2/49 (4%) 0/49 (0%) | |POLY-3 RATE (b) | 1/45.47 2/42.54 2/43.37 0/45.10 | |POLY-3 PERCENT (g) | 2.2% 4.7% 4.6% 0.0% | |TERMINAL (d) | 1/36 (3%) 2/36 (6%) 1/33 (3%) 0/39 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 455 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.282N P=0.500 P=0.482 P=0.484N | |POLY 3 | P=0.295N P=0.477 P=0.483 P=0.502N | |POLY 1.5 | P=0.296N P=0.479 P=0.487 P=0.502N | |POLY 6 | P=0.293N P=0.475 P=0.478 P=0.501N | |LOGISTIC REGRESSION| P=0.304N P=0.500 P=0.525 (e) | |COCH-ARM / FISHERS | P=0.299N P=0.485 P=0.492 P=0.505N | |ORDER RESTRICTED | P=0.212N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 35 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Pancreas: Acinus | | Cytoplasmic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 3/48 (6%) 2/49 (4%) 0/49 (0%) | |POLY-3 RATE (b) | 0/45.47 3/42.69 2/42.70 0/45.10 | |POLY-3 PERCENT (g) | 0.0% 7.0% 4.7% 0.0% | |TERMINAL (d) | 0/36 (0%) 2/36 (6%) 1/33 (3%) 0/39 (0%) | |FIRST INCIDENCE | --- 689 707 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.398N P=0.117 P=0.216 (e) | |POLY 3 | P=0.408N P=0.107 P=0.223 (e) | |POLY 1.5 | P=0.409N P=0.108 P=0.227 (e) | |POLY 6 | P=0.407N P=0.107 P=0.219 (e) | |LOGISTIC REGRESSION| P=0.408N P=0.109 P=0.219 (e) | |COCH-ARM / FISHERS | P=0.412N P=0.114 P=0.242 (e) | |ORDER RESTRICTED | P=0.206 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Parathyroid Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/47 (4%) 0/48 (0%) 0/46 (0%) 1/47 (2%) | |POLY-3 RATE (b) | 2/42.53 0/41.54 0/40.04 1/42.46 | |POLY-3 PERCENT (g) | 4.7% 0.0% 0.0% 2.4% | |TERMINAL (d) | 1/33 (3%) 0/34 (0%) 0/31 (0%) 1/36 (3%) | |FIRST INCIDENCE | 715 --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.450N P=0.248N P=0.268N P=0.483N | |POLY 3 | P=0.458N P=0.242N P=0.251N P=0.501N | |POLY 1.5 | P=0.460N P=0.239N P=0.247N P=0.500N | |POLY 6 | P=0.456N P=0.246N P=0.255N P=0.501N | |LOGISTIC REGRESSION| P=0.459N P=0.247N P=0.255N P=0.499N | |COCH-ARM / FISHERS | P=0.463N P=0.242N P=0.253N P=0.500N | |ORDER RESTRICTED | P=0.133N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 36 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Peripheral Nerve | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/5 (60%) 2/4 (50%) 0/1 (0%) 0/1 (0%) | |POLY-3 RATE (b) | 3/4.35 2/3.21 0/0.40 0/0.77 | |POLY-3 PERCENT (g) | 69.0% 62.3% 0.0% 0.0% | |TERMINAL (d) | 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 423 318 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.091N P=0.677 P=0.259N P=0.241N | |POLY 3 | P=0.348N P=0.719N P=0.723N P=0.546N | |POLY 1.5 | P=0.292N P=0.673N P=0.620N P=0.519N | |POLY 6 | P=0.470N P=0.812N P=0.863N P=0.622N | |LOGISTIC REGRESSION| P=0.209N P=0.600N P=0.527N P=0.516N | |COCH-ARM / FISHERS | P=0.211N P=0.643N P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.365N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/49 (2%) 4/50 (8%) 0/49 (0%) 3/49 (6%) | |POLY-3 RATE (b) | 1/44.47 4/44.27 0/43.23 3/44.63 | |POLY-3 PERCENT (g) | 2.3% 9.0% 0.0% 6.7% | |TERMINAL (d) | 1/35 (3%) 2/36 (6%) 0/33 (0%) 3/39 (8%) | |FIRST INCIDENCE | 729 (T) 547 --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.434 P=0.180 P=0.512N P=0.344 | |POLY 3 | P=0.399 P=0.177 P=0.506N P=0.306 | |POLY 1.5 | P=0.400 P=0.179 P=0.503N P=0.306 | |POLY 6 | P=0.398 P=0.175 P=0.509N P=0.307 | |LOGISTIC REGRESSION| P=0.403 P=0.188 (e) P=0.344 | |COCH-ARM / FISHERS | P=0.401 P=0.187 P=0.500N P=0.309 | |ORDER RESTRICTED | P=0.242 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 37 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/49 (12%) 6/50 (12%) 1/49 (2%) 4/49 (8%) | |POLY-3 RATE (b) | 6/44.47 6/43.54 1/43.32 4/44.86 | |POLY-3 PERCENT (g) | 13.5% 13.8% 2.3% 8.9% | |TERMINAL (d) | 6/35 (17%) 6/36 (17%) 0/33 (0%) 3/39 (8%) | |FIRST INCIDENCE | 729 (T) 729 (T) 707 669 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.175N P=0.603N P=0.071N P=0.310N | |POLY 3 | P=0.203N P=0.606 P=0.060N P=0.364N | |POLY 1.5 | P=0.205N P=0.615 P=0.058N P=0.366N | |POLY 6 | P=0.200N P=0.596 P=0.062N P=0.359N | |LOGISTIC REGRESSION| P=0.198N P=0.603N P=0.070N P=0.363N | |COCH-ARM / FISHERS | P=0.210N P=0.606N P=0.056N P=0.370N | |ORDER RESTRICTED | P=0.152N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Salivary Glands | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 25/50 (50%) 22/50 (44%) 26/50 (52%) 20/50 (40%) | |POLY-3 RATE (b) | 25/47.10 22/45.04 26/44.45 20/46.17 | |POLY-3 PERCENT (g) | 53.1% 48.9% 58.5% 43.3% | |TERMINAL (d) | 20/36 (56%) 18/36 (50%) 23/33 (70%) 18/39 (46%) | |FIRST INCIDENCE | 563 521 539 587 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.151N P=0.373N P=0.327 P=0.142N | |POLY 3 | P=0.233N P=0.421N P=0.376 P=0.229N | |POLY 1.5 | P=0.226N P=0.395N P=0.428 P=0.219N | |POLY 6 | P=0.243N P=0.457N P=0.312 P=0.243N | |LOGISTIC REGRESSION| P=0.210N P=0.402N P=0.401 P=0.207N | |COCH-ARM / FISHERS | P=0.229N P=0.344N P=0.500 P=0.211N | |ORDER RESTRICTED | P=0.250N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 38 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Skin | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 2/46.13 0/43.54 0/43.48 1/45.81 | |POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 2.2% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | 606 --- --- 631 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.456N P=0.256N P=0.258N P=0.497N | |POLY 3 | P=0.455N P=0.250N P=0.251N P=0.502N | |POLY 1.5 | P=0.457N P=0.246N P=0.245N P=0.501N | |POLY 6 | P=0.453N P=0.256N P=0.258N P=0.504N | |LOGISTIC REGRESSION| P=0.476N P=0.209N P=0.216N P=0.517N | |COCH-ARM / FISHERS | P=0.461N P=0.247N P=0.247N P=0.500N | |ORDER RESTRICTED | P=0.135N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 42/50 (84%) 30/49 (61%) 32/48 (67%) 29/50 (58%) | |POLY-3 RATE (b) | 42/48.25 30/47.57 32/45.99 29/47.84 | |POLY-3 PERCENT (g) | 87.1% 63.1% 69.6% 60.6% | |TERMINAL (d) | 31/36 (86%) 20/36 (56%) 20/32 (63%) 23/39 (59%) | |FIRST INCIDENCE | 563 318 455 472 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.022N* P=0.043N* P=0.197N P=0.006N** | |POLY 3 | P=0.010N* P=0.005N** P=0.031N* P=0.002N** | |POLY 1.5 | P=0.010N* P=0.006N** P=0.031N* P=0.002N** | |POLY 6 | P=0.013N* P=0.005N** P=0.033N* P=0.003N** | |LOGISTIC REGRESSION| P=0.012N* P=0.012N* P=0.049N* P=0.004N** | |COCH-ARM / FISHERS | P=0.013N* P=0.010N* P=0.039N* P=0.004N** | |ORDER RESTRICTED | P=0.002N** (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 39 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Spleen | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 1/49 (2%) 2/48 (4%) 3/50 (6%) | |POLY-3 RATE (b) | 3/45.47 1/43.17 2/41.61 3/45.46 | |POLY-3 PERCENT (g) | 6.6% 2.3% 4.8% 6.6% | |TERMINAL (d) | 3/36 (8%) 1/36 (3%) 2/32 (6%) 3/39 (8%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.510 P=0.305N P=0.554N P=0.626N | |POLY 3 | P=0.484 P=0.324N P=0.540N P=0.662 | |POLY 1.5 | P=0.483 P=0.321N P=0.532N P=0.662N | |POLY 6 | P=0.485 P=0.328N P=0.551N P=0.662 | |LOGISTIC REGRESSION| P=0.510 P=0.305N P=0.554N P=0.626N | |COCH-ARM / FISHERS | P=0.478 P=0.316N P=0.520N P=0.661N | |ORDER RESTRICTED | P=0.509 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Spleen | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 29/50 (58%) 22/49 (45%) 30/48 (63%) 27/50 (54%) | |POLY-3 RATE (b) | 29/47.49 22/44.67 30/44.68 27/47.62 | |POLY-3 PERCENT (g) | 61.1% 49.3% 67.2% 56.7% | |TERMINAL (d) | 23/36 (64%) 19/36 (53%) 20/32 (63%) 22/39 (56%) | |FIRST INCIDENCE | 350 318 486 424 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.449N P=0.135N P=0.288 P=0.305N | |POLY 3 | P=0.535N P=0.172N P=0.346 P=0.411N | |POLY 1.5 | P=0.533 P=0.159N P=0.359 P=0.414N | |POLY 6 | P=0.519N P=0.193N P=0.345 P=0.409N | |LOGISTIC REGRESSION| P=0.515 P=0.152N P=0.354 P=0.419N | |COCH-ARM / FISHERS | P=0.505 P=0.135N P=0.402 P=0.420N | |ORDER RESTRICTED | P=0.404 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 40 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/50 (10%) 8/49 (16%) 13/48 (27%) 14/50 (28%) | |POLY-3 RATE (b) | 5/45.97 8/43.17 13/41.81 14/45.57 | |POLY-3 PERCENT (g) | 10.9% 18.5% 31.1% 30.7% | |TERMINAL (d) | 4/36 (11%) 8/36 (22%) 11/32 (34%) 13/39 (33%) | |FIRST INCIDENCE | 581 729 (T) 701 703 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.019 * P=0.272 P=0.018 * P=0.030 * | |POLY 3 | P=0.010 * P=0.235 P=0.017 * P=0.016 * | |POLY 1.5 | P=0.011 * P=0.244 P=0.020 * P=0.018 * | |POLY 6 | P=0.009 ** P=0.224 P=0.014 * P=0.015 * | |LOGISTIC REGRESSION| P=0.012 * P=0.238 P=0.017 * P=0.020 * | |COCH-ARM / FISHERS | P=0.012 * P=0.264 P=0.026 * P=0.020 * | |ORDER RESTRICTED | P=0.011 * (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 1/49 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 2/46.04 1/43.67 2/44.10 0/45.46 | |POLY-3 PERCENT (g) | 4.3% 2.3% 4.5% 0.0% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | 563 581 583 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.206N P=0.519N P=0.662 P=0.242N | |POLY 3 | P=0.200N P=0.518N P=0.678 P=0.240N | |POLY 1.5 | P=0.199N P=0.515N P=0.684 P=0.239N | |POLY 6 | P=0.201N P=0.522N P=0.671 P=0.242N | |LOGISTIC REGRESSION| P=0.206N P=0.460N P=0.667N P=0.245N | |COCH-ARM / FISHERS | P=0.199N P=0.508N P=0.691N P=0.247N | |ORDER RESTRICTED | P=0.157N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 41 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 4/49 (8%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/45.47 4/45.38 0/43.48 1/46.10 | |POLY-3 PERCENT (g) | 0.0% 8.8% 0.0% 2.2% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | --- 318 --- 522 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.529N P=0.063 (e) P=0.500 | |POLY 3 | P=0.526N P=0.060 (e) P=0.503 | |POLY 1.5 | P=0.527N P=0.059 (e) P=0.502 | |POLY 6 | P=0.525N P=0.061 (e) P=0.504 | |LOGISTIC REGRESSION| P=0.617N P=0.085 (e) P=0.438 | |COCH-ARM / FISHERS | P=0.528N P=0.056 (e) P=0.500 | |ORDER RESTRICTED | P=0.212 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/45.47 0/43.17 2/44.06 0/45.46 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | --- --- 583 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.594 (e) P=0.223 (e) | |POLY 3 | P=0.603 (e) P=0.230 (e) | |POLY 1.5 | P=0.602 (e) P=0.233 (e) | |POLY 6 | P=0.605 (e) P=0.227 (e) | |LOGISTIC REGRESSION| P=0.589 (e) P=0.253 (e) | |COCH-ARM / FISHERS | P=0.596 (e) P=0.247 (e) | |ORDER RESTRICTED | P=0.241 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 42 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 3/49 (6%) 4/50 (8%) 2/50 (4%) | |POLY-3 RATE (b) | 2/45.99 3/44.89 4/43.57 2/46.70 | |POLY-3 PERCENT (g) | 4.4% 6.7% 9.2% 4.3% | |TERMINAL (d) | 0/36 (0%) 0/36 (0%) 3/33 (9%) 0/39 (0%) | |FIRST INCIDENCE | 581 318 707 522 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.549N P=0.483 P=0.298 P=0.690 | |POLY 3 | P=0.551N P=0.489 P=0.312 P=0.688N | |POLY 1.5 | P=0.553N P=0.489 P=0.323 P=0.690N | |POLY 6 | P=0.549N P=0.488 P=0.300 P=0.687N | |LOGISTIC REGRESSION| P=0.574 P=0.599 P=0.330 P=0.672 | |COCH-ARM / FISHERS | P=0.559N P=0.490 P=0.339 P=0.691N | |ORDER RESTRICTED | P=0.493N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 2/49 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 2/45.63 0/43.17 2/42.87 0/45.46 | |POLY-3 PERCENT (g) | 4.4% 0.0% 4.7% 0.0% | |TERMINAL (d) | 1/36 (3%) 0/36 (0%) 1/33 (3%) 0/39 (0%) | |FIRST INCIDENCE | 689 --- 659 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.243N P=0.251N P=0.663 P=0.234N | |POLY 3 | P=0.242N P=0.250N P=0.671 P=0.238N | |POLY 1.5 | P=0.243N P=0.247N P=0.677 P=0.237N | |POLY 6 | P=0.241N P=0.253N P=0.664 P=0.239N | |LOGISTIC REGRESSION| P=0.247N P=0.247N P=0.682 P=0.237N | |COCH-ARM / FISHERS | P=0.247N P=0.253N P=0.684 P=0.247N | |ORDER RESTRICTED | P=0.116N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 43 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 1/49 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 2/46.01 0/43.17 1/43.10 1/45.63 | |POLY-3 PERCENT (g) | 4.4% 0.0% 2.3% 2.2% | |TERMINAL (d) | 1/36 (3%) 0/36 (0%) 0/33 (0%) 0/39 (0%) | |FIRST INCIDENCE | 563 --- 583 686 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.494N P=0.247N P=0.520N P=0.496N | |POLY 3 | P=0.494N P=0.252N P=0.523N P=0.503N | |POLY 1.5 | P=0.495N P=0.248N P=0.517N P=0.501N | |POLY 6 | P=0.492N P=0.255N P=0.530N P=0.504N | |LOGISTIC REGRESSION| P=0.514N P=0.220N P=0.469N P=0.508N | |COCH-ARM / FISHERS | P=0.499N P=0.253N P=0.508N P=0.500N | |ORDER RESTRICTED | P=0.282N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 9/49 (18%) 3/49 (6%) 6/50 (12%) 4/47 (9%) | |POLY-3 RATE (b) | 9/47.71 3/44.86 6/45.14 4/44.81 | |POLY-3 PERCENT (g) | 18.9% 6.7% 13.3% 8.9% | |TERMINAL (d) | 2/36 (6%) 1/36 (3%) 1/33 (3%) 0/37 (0%) | |FIRST INCIDENCE | 350 318 539 424 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.173N P=0.085N P=0.357N P=0.133N | |POLY 3 | P=0.173N P=0.074N P=0.328N P=0.141N | |POLY 1.5 | P=0.174N P=0.068N P=0.308N P=0.137N | |POLY 6 | P=0.172N P=0.085N P=0.352N P=0.147N | |LOGISTIC REGRESSION| P=0.146N P=0.029N* P=0.187N P=0.069N | |COCH-ARM / FISHERS | P=0.176N P=0.060N P=0.274N P=0.133N | |ORDER RESTRICTED | P=0.105N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 44 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Thymus | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/49 (2%) 3/49 (6%) 4/50 (8%) 2/47 (4%) | |POLY-3 RATE (b) | 1/44.77 3/43.51 4/43.48 2/42.63 | |POLY-3 PERCENT (g) | 2.2% 6.9% 9.2% 4.7% | |TERMINAL (d) | 1/36 (3%) 3/36 (8%) 4/33 (12%) 2/37 (5%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.466 P=0.305 P=0.153 P=0.510 | |POLY 3 | P=0.434 P=0.295 P=0.170 P=0.483 | |POLY 1.5 | P=0.436 P=0.300 P=0.176 P=0.484 | |POLY 6 | P=0.433 P=0.288 P=0.161 P=0.481 | |LOGISTIC REGRESSION| P=0.466 P=0.305 P=0.153 P=0.510 | |COCH-ARM / FISHERS | P=0.437 P=0.309 P=0.187 P=0.484 | |ORDER RESTRICTED | P=0.272 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Thyroid Gland | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 26/50 (52%) 17/49 (35%) 12/49 (24%) 11/50 (22%) | |POLY-3 RATE (b) | 26/48.04 17/43.65 12/43.33 11/46.04 | |POLY-3 PERCENT (g) | 54.1% 39.0% 27.7% 23.9% | |TERMINAL (d) | 19/36 (53%) 14/35 (40%) 9/33 (27%) 9/39 (23%) | |FIRST INCIDENCE | 423 521 663 631 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.085N P=0.014N* P=0.002N** | |POLY 3 | P<0.001N** P=0.104N P=0.008N** P=0.002N** | |POLY 1.5 | P<0.001N** P=0.087N P=0.006N** P<0.001N** | |POLY 6 | P<0.001N** P=0.126N P=0.011N* P=0.002N** | |LOGISTIC REGRESSION| P<0.001N** P=0.074N P=0.005N** P=0.002N** | |COCH-ARM / FISHERS | P<0.001N** P=0.062N P=0.004N** P=0.002N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 45 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 1/49 (2%) 5/49 (10%) 1/50 (2%) | |POLY-3 RATE (b) | 6/46.00 1/42.54 5/43.29 1/45.46 | |POLY-3 PERCENT (g) | 13.0% 2.4% 11.6% 2.2% | |TERMINAL (d) | 4/36 (11%) 1/35 (3%) 3/33 (9%) 1/39 (3%) | |FIRST INCIDENCE | 649 729 (T) 604 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.089N P=0.069N P=0.552N P=0.053N | |POLY 3 | P=0.087N P=0.069N P=0.542N P=0.058N | |POLY 1.5 | P=0.089N P=0.066N P=0.531N P=0.057N | |POLY 6 | P=0.086N P=0.074N P=0.556N P=0.059N | |LOGISTIC REGRESSION| P=0.094N P=0.067N P=0.523N P=0.058N | |COCH-ARM / FISHERS | P=0.095N P=0.059N P=0.514N P=0.056N | |ORDER RESTRICTED | P=0.028N* (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Urinary Bladder | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/48 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/45.47 2/43.54 0/41.61 1/45.81 | |POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 2.2% | |TERMINAL (d) | 0/36 (0%) 0/35 (0%) 0/32 (0%) 0/39 (0%) | |FIRST INCIDENCE | --- 521 --- 631 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.544 P=0.237 (e) P=0.504 | |POLY 3 | P=0.539 P=0.227 (e) P=0.501 | |POLY 1.5 | P=0.539 P=0.229 (e) P=0.501 | |POLY 6 | P=0.540 P=0.226 (e) P=0.502 | |LOGISTIC REGRESSION| P=0.506 P=0.285 (e) P=0.488 | |COCH-ARM / FISHERS | P=0.539 P=0.242 (e) P=0.500 | |ORDER RESTRICTED | P=0.308 (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 46 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Urinary Bladder | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/50 (22%) 7/49 (14%) 4/48 (8%) 10/50 (20%) | |POLY-3 RATE (b) | 11/45.47 7/43.27 4/41.61 10/45.46 | |POLY-3 PERCENT (g) | 24.2% 16.2% 9.6% 22.0% | |TERMINAL (d) | 11/36 (31%) 5/35 (14%) 4/32 (13%) 10/39 (26%) | |FIRST INCIDENCE | 729 (T) 547 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.431N P=0.239N P=0.068N P=0.415N | |POLY 3 | P=0.495N P=0.250N P=0.063N P=0.500N | |POLY 1.5 | P=0.494N P=0.246N P=0.059N P=0.499N | |POLY 6 | P=0.496N P=0.254N P=0.068N P=0.501N | |LOGISTIC REGRESSION| P=0.484N P=0.270N P=0.068N P=0.415N | |COCH-ARM / FISHERS | P=0.498N P=0.232N P=0.054N P=0.500N | |ORDER RESTRICTED | P=0.242N (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Uterus | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/45.47 3/43.54 1/43.48 0/45.46 | |POLY-3 PERCENT (g) | 0.0% 6.9% 2.3% 0.0% | |TERMINAL (d) | 0/36 (0%) 3/36 (8%) 1/33 (3%) 0/39 (0%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.348N P=0.121 P=0.483 (e) | |POLY 3 | P=0.371N P=0.111 P=0.491 (e) | |POLY 1.5 | P=0.369N P=0.114 P=0.495 (e) | |POLY 6 | P=0.374N P=0.108 P=0.486 (e) | |LOGISTIC REGRESSION| (e) P=0.121 P=0.483 (e) | |COCH-ARM / FISHERS | P=0.366N P=0.121 P=0.500 (e) | |ORDER RESTRICTED | P=0.211N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 47 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Uterus | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 45/50 (90%) 45/50 (90%) 43/50 (86%) 46/50 (92%) | |POLY-3 RATE (b) | 45/48.59 45/48.66 43/48.08 46/48.24 | |POLY-3 PERCENT (g) | 92.6% 92.5% 89.4% 95.4% | |TERMINAL (d) | 34/36 (94%) 33/36 (92%) 31/33 (94%) 38/39 (97%) | |FIRST INCIDENCE | 423 318 455 522 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.387N P=0.524 P=0.442 P=0.429N | |POLY 3 | P=0.374 P=0.646N P=0.419N P=0.440 | |POLY 1.5 | P=0.414 P=0.637 P=0.399N P=0.467 | |POLY 6 | P=0.338 P=0.621N P=0.455N P=0.424 | |LOGISTIC REGRESSION| P=0.502 P=0.539 P=0.454N P=0.517 | |COCH-ARM / FISHERS | P=0.453 P=0.630N P=0.380N P=0.500 | |ORDER RESTRICTED | P=0.355 (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Uterus | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 2/45.53 2/43.54 0/43.48 1/45.46 | |POLY-3 PERCENT (g) | 4.4% 4.6% 0.0% 2.2% | |TERMINAL (d) | 1/36 (3%) 2/36 (6%) 0/33 (0%) 1/39 (3%) | |FIRST INCIDENCE | 715 729 (T) --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.285N P=0.684 P=0.271N P=0.484N | |POLY 3 | P=0.298N P=0.678 P=0.248N P=0.501N | |POLY 1.5 | P=0.297N P=0.683 P=0.243N P=0.500N | |POLY 6 | P=0.299N P=0.672 P=0.253N P=0.501N | |LOGISTIC REGRESSION| P=0.294N P=0.669 P=0.255N P=0.500N | |COCH-ARM / FISHERS | P=0.296N P=0.691N P=0.247N P=0.500N | |ORDER RESTRICTED | P=0.259N (e) (e) (e) | |=================================================================================================================================| Date: 03/25/03 EXPERIMENT: 96018 TEST: 04 Page 48 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Uterus | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 0/45.47 1/43.54 2/43.48 2/45.46 | |POLY-3 PERCENT (g) | 0.0% 2.3% 4.6% 4.4% | |TERMINAL (d) | 0/36 (0%) 1/36 (3%) 2/33 (6%) 2/39 (5%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.181 P=0.500 P=0.219 P=0.256 | |POLY 3 | P=0.163 P=0.491 P=0.227 P=0.237 | |POLY 1.5 | P=0.163 P=0.494 P=0.231 P=0.237 | |POLY 6 | P=0.164 P=0.488 P=0.222 P=0.237 | |LOGISTIC REGRESSION| (e) P=0.500 P=0.219 P=0.256 | |COCH-ARM / FISHERS | P=0.160 P=0.500 P=0.247 P=0.247 | |ORDER RESTRICTED | P=0.147 (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).