TDMS Study 96018-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (BROMODICHLOROMETHANE) DATE: 05/24/04 EXPERIMENT: 96018 TEST: 03 TIME: 09:34:02 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96018 PATHOLOGIST: FARNELL, DANIEL R. CAS: 75-27-4 ------------------------------------------------------------------------------------------------------------------------------------ FINAL #2/RATS 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: 05/24/04 EXPERIMENT: 96018 TEST: 03 TIME: 09:34:02 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96018 PATHOLOGIST: FARNELL, DANIEL R. CAS: 75-27-4 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF WATER DISINFECTION BYPRODUCTS (BROMODICHL =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Bone Marrow: Myeloid Cell, Erythroid Cell Hyperplasia Brain Compression Focal Islets, Pancreatic Hyperplasia Focal Kidney Nephropathy Kidney: Renal Tubule Pigmentation Liver Basophilic Focus Clear Cell Focus Degeneration Cystic Focal Inflammation Chronic Mixed Cell Focus Liver: Bile Duct Hyperplasia Liver: Hepatocyte Vacuolization Cytoplasmic Mammary Gland Dilatation Pancreas: Acinus Atrophy Focal Pituitary Gland: Pars Distalis Cytoplasmic Alteration Focal Degeneration Cystic Focal Hyperplasia Focal Prostate Inflammation Chronic Mineralization Focal Skin Cyst Epithelial Inclusion Spleen Hemorrhage Stomach, Glandular: Epithelium Hyperplasia Thyroid Gland: Follicular Cell Hyperplasia =============================================================== Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Accessory Adrenal Cortical Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 14/50 (28%) 8/50 (16%) 8/50 (16%) 14/49 (29%) | |POLY-3 RATE (b) | 14/43.85 8/43.48 8/45.09 14/45.27 | |POLY-3 PERCENT (g) | 31.9% 18.4% 17.7% 30.9% | |TERMINAL (d) | 10/29 (35%) 5/28 (18%) 4/29 (14%) 6/26 (23%) | |FIRST INCIDENCE | 479 660 628 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.336 P=0.141N P=0.122N P=0.489 | |POLY 3 | P=0.440 P=0.110N P=0.093N P=0.550N | |POLY 1.5 | P=0.422 P=0.109N P=0.099N P=0.568N | |POLY 6 | P=0.453 P=0.116N P=0.089N P=0.544N | |LOGISTIC REGRESSION| P=0.386 P=0.111N P=0.100N P=0.559 | |COCH-ARM / FISHERS | P=0.386 P=0.114N P=0.114N P=0.563 | |ORDER RESTRICTED | P=0.231N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Cytoplasmic Alteration Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 2/49 (4%) | |POLY-3 RATE (b) | 1/42.98 3/43.88 3/44.50 2/42.48 | |POLY-3 PERCENT (g) | 2.3% 6.8% 6.7% 4.7% | |TERMINAL (d) | 0/29 (0%) 1/28 (4%) 2/29 (7%) 0/26 (0%) | |FIRST INCIDENCE | 680 498 633 554 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.453 P=0.311 P=0.312 P=0.477 | |POLY 3 | P=0.472 P=0.312 P=0.318 P=0.496 | |POLY 1.5 | P=0.473 P=0.311 P=0.314 P=0.497 | |POLY 6 | P=0.462 P=0.310 P=0.317 P=0.490 | |LOGISTIC REGRESSION| P=0.450 P=0.285 P=0.308 P=0.476 | |COCH-ARM / FISHERS | P=0.468 P=0.309 P=0.309 P=0.492 | |ORDER RESTRICTED | P=0.346 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Necrosis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | |POLY-3 RATE (b) | 2/42.93 0/42.97 1/44.15 1/41.94 | |POLY-3 PERCENT (g) | 4.7% 0.0% 2.3% 2.4% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 1/29 (3%) 0/26 (0%) | |FIRST INCIDENCE | 702 --- 729 (T) 705 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.530N P=0.268N P=0.503N P=0.547N | |POLY 3 | P=0.505N P=0.237N P=0.490N P=0.508N | |POLY 1.5 | P=0.505N P=0.236N P=0.492N P=0.506N | |POLY 6 | P=0.505N P=0.240N P=0.492N P=0.516N | |LOGISTIC REGRESSION| P=0.514N P=0.239N P=0.491N P=0.513N | |COCH-ARM / FISHERS | P=0.506N P=0.247N P=0.500N P=0.508N | |ORDER RESTRICTED | P=0.275N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 9/50 (18%) 5/50 (10%) 8/50 (16%) 12/49 (24%) | |POLY-3 RATE (b) | 9/44.03 5/43.14 8/45.05 12/44.06 | |POLY-3 PERCENT (g) | 20.4% 11.6% 17.8% 27.2% | |TERMINAL (d) | 6/29 (21%) 4/28 (14%) 2/29 (7%) 5/26 (19%) | |FIRST INCIDENCE | 553 683 642 554 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.112 P=0.209N P=0.492N P=0.262 | |POLY 3 | P=0.139 P=0.202N P=0.479N P=0.309 | |POLY 1.5 | P=0.136 P=0.195N P=0.483N P=0.307 | |POLY 6 | P=0.143 P=0.217N P=0.481N P=0.305 | |LOGISTIC REGRESSION| P=0.129 P=0.191N P=0.490N P=0.292 | |COCH-ARM / FISHERS | P=0.128 P=0.194N P=0.500N P=0.294 | |ORDER RESTRICTED | P=0.140 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/50 (22%) 18/50 (36%) 15/50 (30%) 13/49 (27%) | |POLY-3 RATE (b) | 11/43.29 18/44.89 15/44.95 13/42.80 | |POLY-3 PERCENT (g) | 25.4% 40.1% 33.4% 30.4% | |TERMINAL (d) | 8/29 (28%) 10/28 (36%) 12/29 (41%) 8/26 (31%) | |FIRST INCIDENCE | 620 526 605 636 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.414 P=0.087 P=0.251 P=0.305 | |POLY 3 | P=0.511 P=0.104 P=0.278 P=0.392 | |POLY 1.5 | P=0.516 P=0.100 P=0.270 P=0.395 | |POLY 6 | P=0.491 P=0.105 P=0.278 P=0.377 | |LOGISTIC REGRESSION| P=0.496 P=0.091 P=0.271 P=0.358 | |COCH-ARM / FISHERS | P=0.504 P=0.093 P=0.247 P=0.385 | |ORDER RESTRICTED | P=0.284 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 3/45 (7%) 5/49 (10%) 2/49 (4%) | |POLY-3 RATE (b) | 2/43.06 3/39.89 5/43.55 2/41.76 | |POLY-3 PERCENT (g) | 4.6% 7.5% 11.5% 4.8% | |TERMINAL (d) | 0/29 (0%) 2/27 (7%) 4/29 (14%) 2/26 (8%) | |FIRST INCIDENCE | 680 709 721 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.530 P=0.463 P=0.218 P=0.649 | |POLY 3 | P=0.573 P=0.465 P=0.220 P=0.683 | |POLY 1.5 | P=0.575N P=0.463 P=0.217 P=0.687 | |POLY 6 | P=0.552 P=0.462 P=0.218 P=0.673 | |LOGISTIC REGRESSION| P=0.552 P=0.466 P=0.222 P=0.679 | |COCH-ARM / FISHERS | P=0.573N P=0.450 P=0.210 P=0.684 | |ORDER RESTRICTED | P=0.414 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Bone Marrow: Myeloid Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/45 (0%) 3/49 (6%) 1/49 (2%) | |POLY-3 RATE (b) | 2/42.82 0/39.81 3/44.14 1/41.76 | |POLY-3 PERCENT (g) | 4.7% 0.0% 6.8% 2.4% | |TERMINAL (d) | 1/29 (3%) 0/27 (0%) 2/29 (7%) 1/26 (4%) | |FIRST INCIDENCE | 722 --- 526 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.582N P=0.259N P=0.506 P=0.541N | |POLY 3 | P=0.560N P=0.253N P=0.514 P=0.509N | |POLY 1.5 | P=0.555N P=0.255N P=0.507 P=0.506N | |POLY 6 | P=0.568N P=0.254N P=0.518 P=0.517N | |LOGISTIC REGRESSION| P=0.551N P=0.261N P=0.489 P=0.544N | |COCH-ARM / FISHERS | P=0.551N P=0.274N P=0.490 P=0.508N | |ORDER RESTRICTED | P=0.452N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Bone Marrow: Myeloid Cell, Erythroid Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 5/45 (11%) 0/49 (0%) 5/49 (10%) | |POLY-3 RATE (b) | 1/43.18 5/41.48 0/43.51 5/43.00 | |POLY-3 PERCENT (g) | 2.3% 12.1% 0.0% 11.6% | |TERMINAL (d) | 0/29 (0%) 1/27 (4%) 0/29 (0%) 2/26 (8%) | |FIRST INCIDENCE | 620 556 --- 554 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.159 P=0.111 P=0.491N P=0.105 | |POLY 3 | P=0.167 P=0.091 P=0.498N P=0.100 | |POLY 1.5 | P=0.167 P=0.087 P=0.500N P=0.100 | |POLY 6 | P=0.164 P=0.094 P=0.499N P=0.097 | |LOGISTIC REGRESSION| P=0.147 P=0.040 * P=0.548N P=0.088 | |COCH-ARM / FISHERS | P=0.165 P=0.080 P=0.505N P=0.098 | |ORDER RESTRICTED | P=0.052 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Brain | | Compression Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 8/50 (16%) 14/50 (28%) 14/50 (28%) | |POLY-3 RATE (b) | 6/44.19 8/44.04 14/46.55 14/43.91 | |POLY-3 PERCENT (g) | 13.6% 18.2% 30.1% 31.9% | |TERMINAL (d) | 3/29 (10%) 2/28 (7%) 6/29 (21%) 5/26 (19%) | |FIRST INCIDENCE | 526 624 430 605 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.018 * P=0.376 P=0.058 P=0.034 * | |POLY 3 | P=0.017 * P=0.383 P=0.048 * P=0.033 * | |POLY 1.5 | P=0.018 * P=0.388 P=0.045 * P=0.036 * | |POLY 6 | P=0.014 * P=0.374 P=0.049 * P=0.029 * | |LOGISTIC REGRESSION| P=0.020 * P=0.383 P=0.030 * P=0.040 * | |COCH-ARM / FISHERS | P=0.020 * P=0.387 P=0.039 * P=0.039 * | |ORDER RESTRICTED | P=0.028 * (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Brain | | Hemorrhage Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 1/50 (2%) 3/50 (6%) | |POLY-3 RATE (b) | 2/43.54 4/45.24 1/44.39 3/43.52 | |POLY-3 PERCENT (g) | 4.6% 8.8% 2.3% 6.9% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 479 405 665 616 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.536 P=0.342 P=0.486N P=0.500 | |POLY 3 | P=0.542 P=0.355 P=0.493N P=0.500 | |POLY 1.5 | P=0.545 P=0.350 P=0.494N P=0.502 | |POLY 6 | P=0.536 P=0.355 P=0.494N P=0.493 | |LOGISTIC REGRESSION| P=0.436 P=0.214 P=0.571N P=0.450 | |COCH-ARM / FISHERS | P=0.544 P=0.339 P=0.500N P=0.500 | |ORDER RESTRICTED | P=0.507 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Brain | | Hydrocephalus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.79 0/42.97 2/44.82 0/42.45 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- 633 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.595 (e) P=0.253 (e) | |POLY 3 | P=0.587 (e) P=0.247 (e) | |POLY 1.5 | P=0.593 (e) P=0.244 (e) | |POLY 6 | P=0.572 (e) P=0.250 (e) | |LOGISTIC REGRESSION| P=0.577 (e) P=0.201 (e) | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) | |ORDER RESTRICTED | P=0.256 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Brain | | Necrosis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.51 2/44.43 0/44.15 0/42.45 | |POLY-3 PERCENT (g) | 2.3% 4.5% 0.0% 0.0% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 479 405 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.185N P=0.512 P=0.492N P=0.492N | |POLY 3 | P=0.189N P=0.507 P=0.497N P=0.505N | |POLY 1.5 | P=0.188N P=0.506 P=0.497N P=0.502N | |POLY 6 | P=0.192N P=0.505 P=0.499N P=0.512N | |LOGISTIC REGRESSION| P=0.368N P=0.281 P=0.698N P=0.665N | |COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.176N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Eye | | Cataract | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/49 (4%) 1/49 (2%) 7/48 (15%) 0/47 (0%) | |POLY-3 RATE (b) | 2/42.07 1/42.65 7/43.43 0/40.57 | |POLY-3 PERCENT (g) | 4.8% 2.3% 16.1% 0.0% | |TERMINAL (d) | 2/29 (7%) 1/28 (4%) 3/29 (10%) 0/26 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 605 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.411N P=0.512N P=0.087 P=0.262N | |POLY 3 | P=0.389N P=0.495N P=0.085 P=0.245N | |POLY 1.5 | P=0.386N P=0.495N P=0.082 P=0.244N | |POLY 6 | P=0.400N P=0.500N P=0.088 P=0.249N | |LOGISTIC REGRESSION| P=0.391N P=0.512N P=0.084 (e) | |COCH-ARM / FISHERS | P=0.391N P=0.500N P=0.075 P=0.258N | |ORDER RESTRICTED | P=0.097N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Eye: Retina | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/49 (6%) 1/49 (2%) 8/48 (17%) 1/47 (2%) | |POLY-3 RATE (b) | 3/42.07 1/42.65 8/43.66 1/40.89 | |POLY-3 PERCENT (g) | 7.1% 2.3% 18.3% 2.5% | |TERMINAL (d) | 3/29 (10%) 1/28 (4%) 3/29 (10%) 0/26 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 605 644 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.490N P=0.316N P=0.109 P=0.345N | |POLY 3 | P=0.460N P=0.300N P=0.109 P=0.315N | |POLY 1.5 | P=0.460N P=0.300N P=0.103 P=0.315N | |POLY 6 | P=0.465N P=0.304N P=0.114 P=0.318N | |LOGISTIC REGRESSION| P=0.464N P=0.316N P=0.104 P=0.320N | |COCH-ARM / FISHERS | P=0.467N P=0.309N P=0.093 P=0.324N | |ORDER RESTRICTED | P=0.181N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 16/50 (32%) 18/50 (36%) 21/50 (42%) 14/50 (28%) | |POLY-3 RATE (b) | 16/46.51 18/45.23 21/46.21 14/44.13 | |POLY-3 PERCENT (g) | 34.4% 39.8% 45.5% 31.7% | |TERMINAL (d) | 9/29 (31%) 11/28 (39%) 13/29 (45%) 8/26 (31%) | |FIRST INCIDENCE | 354 405 548 605 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.470N P=0.390 P=0.241 P=0.515N | |POLY 3 | P=0.424N P=0.374 P=0.189 P=0.481N | |POLY 1.5 | P=0.394N P=0.394 P=0.194 P=0.452N | |POLY 6 | P=0.463N P=0.347 P=0.184 P=0.519N | |LOGISTIC REGRESSION| P=0.355N P=0.400 P=0.179 P=0.422N | |COCH-ARM / FISHERS | P=0.353N P=0.417 P=0.204 P=0.414N | |ORDER RESTRICTED | P=0.332N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Heart | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/42.79 2/43.23 0/44.15 2/42.90 | |POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 4.7% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- 681 --- 644 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.224 P=0.226 (e) P=0.219 | |POLY 3 | P=0.249 P=0.239 (e) P=0.237 | |POLY 1.5 | P=0.250 P=0.239 (e) P=0.239 | |POLY 6 | P=0.244 P=0.237 (e) P=0.233 | |LOGISTIC REGRESSION| P=0.247 P=0.238 (e) P=0.235 | |COCH-ARM / FISHERS | P=0.247 P=0.247 (e) P=0.247 | |ORDER RESTRICTED | P=0.116 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 2/43.01 0/42.97 0/44.15 0/41.84 | |POLY-3 PERCENT (g) | 4.7% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/29 (3%) 0/28 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 620 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.119N P=0.241N P=0.235N P=0.252N | |POLY 3 | P=0.110N P=0.237N P=0.231N P=0.243N | |POLY 1.5 | P=0.111N P=0.235N P=0.231N P=0.240N | |POLY 6 | P=0.107N P=0.242N P=0.233N P=0.250N | |LOGISTIC REGRESSION| P=0.115N P=0.233N P=0.238N P=0.237N | |COCH-ARM / FISHERS | P=0.114N P=0.242N P=0.242N P=0.247N | |ORDER RESTRICTED | P=0.031N* (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/49 (0%) 3/50 (6%) 1/50 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 0/42.62 3/43.54 1/44.39 0/41.61 | |POLY-3 PERCENT (g) | 0.0% 6.9% 2.3% 0.0% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- 660 665 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.392N P=0.121 P=0.515 (e) | |POLY 3 | P=0.373N P=0.122 P=0.508 (e) | |POLY 1.5 | P=0.369N P=0.123 P=0.507 (e) | |POLY 6 | P=0.384N P=0.121 P=0.508 (e) | |LOGISTIC REGRESSION| P=0.367N P=0.124 P=0.495 (e) | |COCH-ARM / FISHERS | P=0.367N P=0.125 P=0.505 (e) | |ORDER RESTRICTED | P=0.230N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 49/49 (100%) 50/50 (100%) 49/50 (98%) 46/49 (94%) | |POLY-3 RATE (b) | 49/49.00 50/50.00 49/49.85 46/48.22 | |POLY-3 PERCENT (g) | 100.0% 100.0% 98.3% 95.4% | |TERMINAL (d) | 29/29 (100%) 28/28 (100%) 29/29 (100%) 25/26 (96%) | |FIRST INCIDENCE | 354 405 430 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.504 (e) P=0.539N P=0.489 | |POLY 3 | P=0.032N* (e) P=0.572N P=0.172N | |POLY 1.5 | P=0.024N* (e) P=0.537N P=0.142N | |POLY 6 | P=0.055N (e) P=0.650N P=0.248N | |LOGISTIC REGRESSION| P=0.020N* (e) P=0.504N P=0.119N | |COCH-ARM / FISHERS | P=0.020N* (e) P=0.505N P=0.121N | |ORDER RESTRICTED | P=0.029N* (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 10/49 (20%) 13/50 (26%) 7/50 (14%) 3/49 (6%) | |POLY-3 RATE (b) | 10/45.95 13/44.78 7/45.64 3/42.31 | |POLY-3 PERCENT (g) | 21.8% 29.0% 15.3% 7.1% | |TERMINAL (d) | 1/29 (3%) 8/28 (29%) 4/29 (14%) 1/26 (4%) | |FIRST INCIDENCE | 354 498 526 554 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.021N* P=0.312 P=0.301N P=0.060N | |POLY 3 | P=0.015N* P=0.289 P=0.301N P=0.048N* | |POLY 1.5 | P=0.013N* P=0.309 P=0.293N P=0.042N* | |POLY 6 | P=0.020N* P=0.263 P=0.315N P=0.058N | |LOGISTIC REGRESSION| P=0.010N* P=0.334 P=0.344N P=0.031N* | |COCH-ARM / FISHERS | P=0.011N* P=0.337 P=0.282N P=0.035N* | |ORDER RESTRICTED | P=0.017N* (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Angiectasis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 5/50 (10%) 2/50 (4%) | |POLY-3 RATE (b) | 4/42.79 4/43.05 5/44.26 2/42.66 | |POLY-3 PERCENT (g) | 9.4% 9.3% 11.3% 4.7% | |TERMINAL (d) | 4/29 (14%) 3/28 (11%) 4/29 (14%) 1/26 (4%) | |FIRST INCIDENCE | 729 (T) 709 703 672 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.326N P=0.619 P=0.498 P=0.386N | |POLY 3 | P=0.278N P=0.641N P=0.521 P=0.338N | |POLY 1.5 | P=0.276N P=0.639N P=0.515 P=0.335N | |POLY 6 | P=0.288N P=0.641 P=0.522 P=0.348N | |LOGISTIC REGRESSION| P=0.312N P=0.605 P=0.504 P=0.369N | |COCH-ARM / FISHERS | P=0.278N P=0.643N P=0.500 P=0.339N | |ORDER RESTRICTED | P=0.307N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 33/50 (66%) 25/50 (50%) 24/50 (48%) 17/50 (34%) | |POLY-3 RATE (b) | 33/45.53 25/44.29 24/44.93 17/43.23 | |POLY-3 PERCENT (g) | 72.5% 56.5% 53.4% 39.3% | |TERMINAL (d) | 26/29 (90%) 21/28 (75%) 18/29 (62%) 15/26 (58%) | |FIRST INCIDENCE | 459 526 642 486 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003N** P=0.082N P=0.048N* P=0.002N** | |POLY 3 | P<0.001N** P=0.074N P=0.040N* P<0.001N** | |POLY 1.5 | P<0.001N** P=0.072N P=0.042N* P<0.001N** | |POLY 6 | P<0.001N** P=0.081N P=0.039N* P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.061N P=0.027N* P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.078N P=0.053N P<0.001N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Cholangiofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 1/42.79 2/42.97 1/44.78 1/42.45 | |POLY-3 PERCENT (g) | 2.3% 4.7% 2.2% 2.4% | |TERMINAL (d) | 1/29 (3%) 2/28 (7%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | 729 (T) 729 (T) 526 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.556N P=0.488 P=0.753N P=0.738 | |POLY 3 | P=0.530N P=0.501 P=0.751N P=0.759 | |POLY 1.5 | P=0.528N P=0.502 P=0.753N P=0.760N | |POLY 6 | P=0.536N P=0.497 P=0.750N P=0.753 | |LOGISTIC REGRESSION| P=0.530N P=0.488 P=0.728 P=0.738 | |COCH-ARM / FISHERS | P=0.531N P=0.500 P=0.753N P=0.753N | |ORDER RESTRICTED | P=0.581N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 28/50 (56%) 24/50 (48%) 19/50 (38%) 17/50 (34%) | |POLY-3 RATE (b) | 28/43.00 24/43.88 19/44.15 17/42.86 | |POLY-3 PERCENT (g) | 65.1% 54.7% 43.0% 39.7% | |TERMINAL (d) | 25/29 (86%) 22/28 (79%) 19/29 (66%) 15/26 (58%) | |FIRST INCIDENCE | 709 526 729 (T) 637 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.010N* P=0.291N P=0.016N* P=0.030N* | |POLY 3 | P=0.007N** P=0.208N P=0.025N* P=0.011N* | |POLY 1.5 | P=0.009N** P=0.228N P=0.033N* P=0.013N* | |POLY 6 | P=0.007N** P=0.200N P=0.020N* P=0.010N* | |LOGISTIC REGRESSION| P=0.015N* P=0.312N P=0.016N* P=0.032N* | |COCH-ARM / FISHERS | P=0.013N* P=0.274N P=0.054N P=0.022N* | |ORDER RESTRICTED | P=0.009N** (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 4/50 (8%) | |POLY-3 RATE (b) | 2/42.84 1/42.97 1/44.26 4/42.88 | |POLY-3 PERCENT (g) | 4.7% 2.3% 2.3% 9.3% | |TERMINAL (d) | 1/29 (3%) 1/28 (4%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | 718 729 (T) 703 672 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.140 P=0.524N P=0.503N P=0.287 | |POLY 3 | P=0.165 P=0.499N P=0.489N P=0.337 | |POLY 1.5 | P=0.166 P=0.498N P=0.492N P=0.340 | |POLY 6 | P=0.162 P=0.504N P=0.489N P=0.328 | |LOGISTIC REGRESSION| P=0.156 P=0.522N P=0.491N P=0.325 | |COCH-ARM / FISHERS | P=0.165 P=0.500N P=0.500N P=0.339 | |ORDER RESTRICTED | P=0.131 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Degeneration Cystic Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 31/50 (62%) 24/50 (48%) 23/50 (46%) 29/50 (58%) | |POLY-3 RATE (b) | 31/43.97 24/45.18 23/45.49 29/45.16 | |POLY-3 PERCENT (g) | 70.5% 53.1% 50.6% 64.2% | |TERMINAL (d) | 24/29 (83%) 18/28 (64%) 16/29 (55%) 19/26 (73%) | |FIRST INCIDENCE | 620 556 628 554 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.398 P=0.150N P=0.085N P=0.502 | |POLY 3 | P=0.444N P=0.061N P=0.036N* P=0.334N | |POLY 1.5 | P=0.456N P=0.076N P=0.048N* P=0.359N | |POLY 6 | P=0.443N P=0.052N P=0.028N* P=0.328N | |LOGISTIC REGRESSION| P=0.517N P=0.095N P=0.041N* P=0.458N | |COCH-ARM / FISHERS | P=0.490N P=0.114N P=0.080N P=0.419N | |ORDER RESTRICTED | P=0.110N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/50 (8%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.79 1/42.97 4/44.23 0/42.45 | |POLY-3 PERCENT (g) | 0.0% 2.3% 9.0% 0.0% | |TERMINAL (d) | 0/29 (0%) 1/28 (4%) 3/29 (10%) 0/26 (0%) | |FIRST INCIDENCE | --- 729 (T) 709 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.558 P=0.493 P=0.062 (e) | |POLY 3 | P=0.583 P=0.501 P=0.064 (e) | |POLY 1.5 | P=0.591 P=0.501 P=0.063 (e) | |POLY 6 | P=0.564 P=0.498 P=0.064 (e) | |LOGISTIC REGRESSION| P=0.562 P=0.493 P=0.063 (e) | |COCH-ARM / FISHERS | P=0.591 P=0.500 P=0.059 (e) | |ORDER RESTRICTED | P=0.155 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Fibrosis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 3/50 (6%) | |POLY-3 RATE (b) | 1/42.79 1/42.97 1/44.15 3/43.48 | |POLY-3 PERCENT (g) | 2.3% 2.3% 2.3% 6.9% | |TERMINAL (d) | 1/29 (3%) 1/28 (4%) 1/29 (3%) 1/26 (4%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.148 P=0.754 P=0.762 P=0.292 | |POLY 3 | P=0.168 P=0.760N P=0.754N P=0.311 | |POLY 1.5 | P=0.167 P=0.759N P=0.755N P=0.311 | |POLY 6 | P=0.165 P=0.759 P=0.754N P=0.305 | |LOGISTIC REGRESSION| P=0.161 P=0.754 P=0.762 P=0.286 | |COCH-ARM / FISHERS | P=0.163 P=0.753N P=0.753N P=0.309 | |ORDER RESTRICTED | P=0.192 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/50 (10%) 5/50 (10%) 12/50 (24%) 4/50 (8%) | |POLY-3 RATE (b) | 5/43.24 5/43.76 12/46.20 4/43.18 | |POLY-3 PERCENT (g) | 11.6% 11.4% 26.0% 9.3% | |TERMINAL (d) | 3/29 (10%) 2/28 (7%) 6/29 (21%) 2/26 (8%) | |FIRST INCIDENCE | 610 624 430 486 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.524 P=0.612 P=0.069 P=0.551N | |POLY 3 | P=0.533N P=0.623N P=0.069 P=0.501N | |POLY 1.5 | P=0.524N P=0.623N P=0.064 P=0.496N | |POLY 6 | P=0.553 P=0.628N P=0.072 P=0.518N | |LOGISTIC REGRESSION| P=0.531N P=0.628N P=0.052 P=0.499N | |COCH-ARM / FISHERS | P=0.528N P=0.630N P=0.054 P=0.500N | |ORDER RESTRICTED | P=0.270N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Infiltration Cellular Mixed Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 30/50 (60%) 31/50 (62%) 34/50 (68%) 34/50 (68%) | |POLY-3 RATE (b) | 30/46.17 31/47.01 34/48.03 34/47.45 | |POLY-3 PERCENT (g) | 65.0% 66.0% 70.8% 71.7% | |TERMINAL (d) | 22/29 (76%) 21/28 (75%) 21/29 (72%) 18/26 (69%) | |FIRST INCIDENCE | 354 498 430 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.129 P=0.446 P=0.317 P=0.164 | |POLY 3 | P=0.243 P=0.549 P=0.347 P=0.312 | |POLY 1.5 | P=0.233 P=0.529 P=0.316 P=0.299 | |POLY 6 | P=0.243 P=0.569 P=0.382 P=0.316 | |LOGISTIC REGRESSION| P=0.207 P=0.511 P=0.286 P=0.269 | |COCH-ARM / FISHERS | P=0.205 P=0.500 P=0.266 P=0.266 | |ORDER RESTRICTED | P=0.378 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 23/50 (46%) 29/50 (58%) 33/50 (66%) 34/50 (68%) | |POLY-3 RATE (b) | 23/44.55 29/46.18 33/46.05 34/46.72 | |POLY-3 PERCENT (g) | 51.6% 62.8% 71.7% 72.8% | |TERMINAL (d) | 20/29 (69%) 21/28 (75%) 24/29 (83%) 22/26 (85%) | |FIRST INCIDENCE | 459 498 526 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.005 ** P=0.121 P=0.032 * P=0.006 ** | |POLY 3 | P=0.018 * P=0.187 P=0.033 * P=0.024 * | |POLY 1.5 | P=0.019 * P=0.177 P=0.034 * P=0.024 * | |POLY 6 | P=0.014 * P=0.194 P=0.030 * P=0.019 * | |LOGISTIC REGRESSION| P=0.016 * P=0.163 P=0.045 * P=0.021 * | |COCH-ARM / FISHERS | P=0.017 * P=0.158 P=0.035 * P=0.021 * | |ORDER RESTRICTED | P=0.017 * (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 10/50 (20%) 4/50 (8%) | |POLY-3 RATE (b) | 0/42.79 3/42.97 10/44.62 4/42.61 | |POLY-3 PERCENT (g) | 0.0% 7.0% 22.4% 9.4% | |TERMINAL (d) | 0/29 (0%) 3/28 (11%) 7/29 (24%) 3/26 (12%) | |FIRST INCIDENCE | --- 729 (T) 667 686 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.057 P=0.114 P=0.002 ** P=0.053 | |POLY 3 | P=0.069 P=0.119 P<0.001 ** P=0.059 | |POLY 1.5 | P=0.073 P=0.120 P<0.001 ** P=0.061 | |POLY 6 | P=0.060 P=0.116 P<0.001 ** P=0.056 | |LOGISTIC REGRESSION| P=0.061 P=0.114 P<0.001 ** P=0.053 | |COCH-ARM / FISHERS | P=0.079 P=0.121 P<0.001 ** P=0.059 | |ORDER RESTRICTED | P=0.007 ** (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver | | Necrosis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 2/44.43 0/42.97 0/44.15 1/42.45 | |POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | 354 --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.468N P=0.237N P=0.237N P=0.510N | |POLY 3 | P=0.454N P=0.245N P=0.238N P=0.516N | |POLY 1.5 | P=0.457N P=0.241N P=0.238N P=0.508N | |POLY 6 | P=0.450N P=0.250N P=0.241N P=0.529N | |LOGISTIC REGRESSION| P=0.628N P=0.450N P=0.605N P=0.682N | |COCH-ARM / FISHERS | P=0.461N P=0.247N P=0.247N P=0.500N | |ORDER RESTRICTED | P=0.141N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 45/50 (90%) 49/50 (98%) 49/50 (98%) 50/50 (100%) | |POLY-3 RATE (b) | 45/47.87 49/50.00 49/50.00 50/50.00 | |POLY-3 PERCENT (g) | 94.0% 98.0% 98.0% 100.0% | |TERMINAL (d) | 28/29 (97%) 27/28 (96%) 28/29 (97%) 26/26 (100%) | |FIRST INCIDENCE | 459 405 430 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.112 P=0.247 P=0.338 P=0.104 | |POLY 3 | P=0.068 P=0.299 P=0.299 P=0.100 | |POLY 1.5 | P=0.038 * P=0.205 P=0.205 P=0.059 | |POLY 6 | P=0.106 P=0.396 P=0.396 P=0.155 | |LOGISTIC REGRESSION| P=0.022 * P=0.127 P=0.164 P=0.045 * | |COCH-ARM / FISHERS | P=0.016 * P=0.102 P=0.102 P=0.028 * | |ORDER RESTRICTED | P=0.030 * (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Fatty Change | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 36/50 (72%) 34/50 (68%) 36/50 (72%) 40/50 (80%) | |POLY-3 RATE (b) | 36/47.08 34/47.41 36/47.46 40/48.57 | |POLY-3 PERCENT (g) | 76.5% 71.7% 75.9% 82.4% | |TERMINAL (d) | 24/29 (83%) 19/28 (68%) 23/29 (79%) 21/26 (81%) | |FIRST INCIDENCE | 405 405 548 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.110 P=0.498N P=0.545N P=0.161 | |POLY 3 | P=0.198 P=0.382N P=0.570N P=0.317 | |POLY 1.5 | P=0.182 P=0.384N P=0.572N P=0.293 | |POLY 6 | P=0.214 P=0.393N P=0.573N P=0.337 | |LOGISTIC REGRESSION| P=0.158 P=0.399N P=0.524N P=0.247 | |COCH-ARM / FISHERS | P=0.153 P=0.414N P=0.588N P=0.241 | |ORDER RESTRICTED | P=0.255 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/50 (22%) 10/50 (20%) 19/50 (38%) 18/50 (36%) | |POLY-3 RATE (b) | 11/45.09 10/44.80 19/45.17 18/45.46 | |POLY-3 PERCENT (g) | 24.4% 22.3% 42.1% 39.6% | |TERMINAL (d) | 2/29 (7%) 3/28 (11%) 16/29 (55%) 10/26 (39%) | |FIRST INCIDENCE | 553 405 526 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.026 * P=0.526N P=0.082 P=0.083 | |POLY 3 | P=0.030 * P=0.507N P=0.056 P=0.090 | |POLY 1.5 | P=0.032 * P=0.497N P=0.061 P=0.095 | |POLY 6 | P=0.024 * P=0.533N P=0.045 * P=0.075 | |LOGISTIC REGRESSION| P=0.033 * P=0.512N P=0.070 P=0.090 | |COCH-ARM / FISHERS | P=0.033 * P=0.500N P=0.063 P=0.093 | |ORDER RESTRICTED | P=0.049 * (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Liver: Hepatocyte, Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 4/50 (8%) | |POLY-3 RATE (b) | 1/43.18 1/43.15 1/44.78 4/43.59 | |POLY-3 PERCENT (g) | 2.3% 2.3% 2.2% 9.2% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | 620 681 526 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.066 P=0.758N P=0.748N P=0.178 | |POLY 3 | P=0.068 P=0.761 P=0.753N P=0.181 | |POLY 1.5 | P=0.068 P=0.760N P=0.755N P=0.182 | |POLY 6 | P=0.067 P=0.757 P=0.753N P=0.175 | |LOGISTIC REGRESSION| P=0.052 P=0.755 P=0.683 P=0.156 | |COCH-ARM / FISHERS | P=0.067 P=0.753N P=0.753N P=0.181 | |ORDER RESTRICTED | P=0.076 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lung | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) 5/50 (10%) | |POLY-3 RATE (b) | 4/44.66 1/43.25 3/44.83 5/43.93 | |POLY-3 PERCENT (g) | 9.0% 2.3% 6.7% 11.4% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 1/29 (3%) 0/26 (0%) | |FIRST INCIDENCE | 405 651 548 486 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.247 P=0.187N P=0.489N P=0.470 | |POLY 3 | P=0.265 P=0.188N P=0.498N P=0.490 | |POLY 1.5 | P=0.266 P=0.184N P=0.497N P=0.496 | |POLY 6 | P=0.261 P=0.196N P=0.503N P=0.476 | |LOGISTIC REGRESSION| P=0.210 P=0.223N P=0.639N P=0.422 | |COCH-ARM / FISHERS | P=0.264 P=0.181N P=0.500N P=0.500 | |ORDER RESTRICTED | P=0.241 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lung | | Hemorrhage Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 3/42.82 1/43.34 2/44.15 2/42.78 | |POLY-3 PERCENT (g) | 7.0% 2.3% 4.5% 4.7% | |TERMINAL (d) | 2/29 (7%) 0/28 (0%) 2/29 (7%) 1/26 (4%) | |FIRST INCIDENCE | 722 624 729 (T) 636 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.530N P=0.319N P=0.500N P=0.542N | |POLY 3 | P=0.501N P=0.301N P=0.486N P=0.500N | |POLY 1.5 | P=0.499N P=0.301N P=0.489N P=0.497N | |POLY 6 | P=0.506N P=0.303N P=0.487N P=0.510N | |LOGISTIC REGRESSION| P=0.503N P=0.304N P=0.498N P=0.512N | |COCH-ARM / FISHERS | P=0.500N P=0.309N P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.389N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lung | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 1/43.54 1/43.60 0/44.15 2/43.85 | |POLY-3 PERCENT (g) | 2.3% 2.3% 0.0% 4.6% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 459 520 --- 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.375 P=0.753N P=0.496N P=0.515 | |POLY 3 | P=0.369 P=0.760N P=0.497N P=0.502 | |POLY 1.5 | P=0.369 P=0.760N P=0.497N P=0.504 | |POLY 6 | P=0.365 P=0.759 P=0.499N P=0.496 | |LOGISTIC REGRESSION| P=0.155 P=0.665 P=0.729N P=0.243 | |COCH-ARM / FISHERS | P=0.366 P=0.753N P=0.500N P=0.500 | |ORDER RESTRICTED | P=0.273 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Mixed Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 2/42.79 0/42.97 0/44.15 1/42.58 | |POLY-3 PERCENT (g) | 4.7% 0.0% 0.0% 2.4% | |TERMINAL (d) | 2/29 (7%) 0/28 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 695 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.487N P=0.246N P=0.238N P=0.539N | |POLY 3 | P=0.459N P=0.236N P=0.230N P=0.502N | |POLY 1.5 | P=0.460N P=0.236N P=0.232N P=0.499N | |POLY 6 | P=0.455N P=0.239N P=0.230N P=0.510N | |LOGISTIC REGRESSION| P=0.474N (e) (e) P=0.522N | |COCH-ARM / FISHERS | P=0.461N P=0.247N P=0.247N P=0.500N | |ORDER RESTRICTED | P=0.131N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lung | | Inflammation Chronic Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/50 (6%) 2/50 (4%) | |POLY-3 RATE (b) | 0/42.79 2/42.97 3/44.39 2/42.45 | |POLY-3 PERCENT (g) | 0.0% 4.7% 6.8% 4.7% | |TERMINAL (d) | 0/29 (0%) 2/28 (7%) 1/29 (3%) 2/26 (8%) | |FIRST INCIDENCE | --- 729 (T) 697 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.204 P=0.230 P=0.122 P=0.214 | |POLY 3 | P=0.233 P=0.238 P=0.125 P=0.235 | |POLY 1.5 | P=0.238 P=0.239 P=0.123 P=0.237 | |POLY 6 | P=0.220 P=0.234 P=0.125 P=0.229 | |LOGISTIC REGRESSION| P=0.213 P=0.230 P=0.125 P=0.214 | |COCH-ARM / FISHERS | P=0.237 P=0.247 P=0.121 P=0.247 | |ORDER RESTRICTED | P=0.140 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/50 (14%) 6/50 (12%) 9/50 (18%) 5/50 (10%) | |POLY-3 RATE (b) | 7/43.44 6/43.45 9/44.68 5/42.61 | |POLY-3 PERCENT (g) | 16.1% 13.8% 20.1% 11.7% | |TERMINAL (d) | 4/29 (14%) 3/28 (11%) 6/29 (21%) 4/26 (15%) | |FIRST INCIDENCE | 651 681 649 686 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.459N P=0.523N P=0.394 P=0.459N | |POLY 3 | P=0.390N P=0.500N P=0.415 P=0.392N | |POLY 1.5 | P=0.379N P=0.496N P=0.411 P=0.382N | |POLY 6 | P=0.417N P=0.512N P=0.412 P=0.417N | |LOGISTIC REGRESSION| P=0.394N P=0.499N P=0.417 P=0.400N | |COCH-ARM / FISHERS | P=0.376N P=0.500N P=0.393 P=0.380N | |ORDER RESTRICTED | P=0.415N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 2/43.18 0/42.10 0/44.15 1/42.45 | |POLY-3 PERCENT (g) | 4.6% 0.0% 0.0% 2.4% | |TERMINAL (d) | 1/29 (3%) 0/28 (0%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | 620 --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.478N P=0.241N P=0.235N P=0.525N | |POLY 3 | P=0.456N P=0.243N P=0.232N P=0.506N | |POLY 1.5 | P=0.458N P=0.241N P=0.233N P=0.501N | |POLY 6 | P=0.452N P=0.247N P=0.233N P=0.518N | |LOGISTIC REGRESSION| P=0.459N P=0.243N P=0.243N P=0.500N | |COCH-ARM / FISHERS | P=0.459N P=0.253N P=0.247N P=0.500N | |ORDER RESTRICTED | P=0.135N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/42.79 2/42.10 0/44.15 1/42.45 | |POLY-3 PERCENT (g) | 0.0% 4.8% 0.0% 2.4% | |TERMINAL (d) | 0/29 (0%) 2/28 (7%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | --- 729 (T) --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.514 P=0.230 (e) P=0.478 | |POLY 3 | P=0.540 P=0.233 (e) P=0.498 | |POLY 1.5 | P=0.543 P=0.234 (e) P=0.500 | |POLY 6 | P=0.530 P=0.230 (e) P=0.493 | |LOGISTIC REGRESSION| (e) P=0.230 (e) P=0.478 | |COCH-ARM / FISHERS | P=0.541 P=0.242 (e) P=0.500 | |ORDER RESTRICTED | P=0.323 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/25 (8%) 0/28 (0%) 0/26 (0%) 1/26 (4%) | |POLY-3 RATE (b) | 2/22.00 0/24.43 0/22.94 1/21.69 | |POLY-3 PERCENT (g) | 9.1% 0.0% 0.0% 4.6% | |TERMINAL (d) | 0/11 (0%) 0/16 (0%) 0/14 (0%) 0/11 (0%) | |FIRST INCIDENCE | 354 --- --- 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.457N P=0.237N P=0.237N P=0.493N | |POLY 3 | P=0.455N P=0.211N P=0.225N P=0.505N | |POLY 1.5 | P=0.456N P=0.211N P=0.225N P=0.496N | |POLY 6 | P=0.451N P=0.209N P=0.223N P=0.523N | |LOGISTIC REGRESSION| P=0.579 P=0.334N (e) (e) | |COCH-ARM / FISHERS | P=0.459N P=0.218N P=0.235N P=0.485N | |ORDER RESTRICTED | P=0.127N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/25 (12%) 1/28 (4%) 3/26 (12%) 4/26 (15%) | |POLY-3 RATE (b) | 3/20.36 1/24.43 3/22.94 4/21.25 | |POLY-3 PERCENT (g) | 14.7% 4.1% 13.1% 18.8% | |TERMINAL (d) | 3/11 (27%) 1/16 (6%) 3/14 (21%) 3/11 (27%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 637 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.214 P=0.173N P=0.551N P=0.498 | |POLY 3 | P=0.262 P=0.237N P=0.610N P=0.524 | |POLY 1.5 | P=0.272 P=0.247N P=0.623N P=0.528 | |POLY 6 | P=0.243 P=0.227N P=0.597N P=0.509 | |LOGISTIC REGRESSION| P=0.195 P=0.173N P=0.551N P=0.452 | |COCH-ARM / FISHERS | P=0.277 P=0.263N P=0.647N P=0.523 | |ORDER RESTRICTED | P=0.277 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/25 (0%) 0/28 (0%) 1/26 (4%) 2/26 (8%) | |POLY-3 RATE (b) | 0/20.36 0/24.43 1/23.16 2/21.85 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.3% 9.2% | |TERMINAL (d) | 0/11 (0%) 0/16 (0%) 0/14 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- --- 669 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.067 (e) P=0.500 P=0.238 | |POLY 3 | P=0.067 (e) P=0.526 P=0.250 | |POLY 1.5 | P=0.068 (e) P=0.519 P=0.250 | |POLY 6 | P=0.063 (e) P=0.533 P=0.245 | |LOGISTIC REGRESSION| P=0.056 (e) P=0.498 P=0.179 | |COCH-ARM / FISHERS | P=0.067 (e) P=0.510 P=0.255 | |ORDER RESTRICTED | P=0.082 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node: Mediastinal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/25 (12%) 4/28 (14%) 6/26 (23%) 3/26 (12%) | |POLY-3 RATE (b) | 3/21.25 4/25.11 6/23.64 3/21.40 | |POLY-3 PERCENT (g) | 14.1% 15.9% 25.4% 14.0% | |TERMINAL (d) | 2/11 (18%) 2/16 (13%) 4/14 (29%) 1/11 (9%) | |FIRST INCIDENCE | 354 556 548 633 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.526 P=0.614 P=0.326 P=0.657 | |POLY 3 | P=0.538 P=0.594 P=0.286 P=0.665N | |POLY 1.5 | P=0.557 P=0.580 P=0.272 P=0.656N | |POLY 6 | P=0.505 P=0.613 P=0.305 P=0.659 | |LOGISTIC REGRESSION| P=0.571N P=0.513 P=0.211 P=0.662N | |COCH-ARM / FISHERS | P=0.571N P=0.566 P=0.253 P=0.647N | |ORDER RESTRICTED | P=0.495 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/25 (12%) 5/28 (18%) 3/26 (12%) 5/26 (19%) | |POLY-3 RATE (b) | 3/20.36 5/25.45 3/23.02 5/20.92 | |POLY-3 PERCENT (g) | 14.7% 19.7% 13.0% 23.9% | |TERMINAL (d) | 3/11 (27%) 2/16 (13%) 1/14 (7%) 5/11 (46%) | |FIRST INCIDENCE | 729 (T) 556 709 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.296 P=0.486 P=0.588N P=0.333 | |POLY 3 | P=0.336 P=0.483 P=0.608N P=0.363 | |POLY 1.5 | P=0.352 P=0.457 P=0.622N P=0.373 | |POLY 6 | P=0.304 P=0.516 P=0.593N P=0.335 | |LOGISTIC REGRESSION| P=0.312 P=0.436 P=0.554N P=0.333 | |COCH-ARM / FISHERS | P=0.358 P=0.419 P=0.647N P=0.374 | |ORDER RESTRICTED | P=0.366 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/25 (4%) 0/28 (0%) 2/26 (8%) 1/26 (4%) | |POLY-3 RATE (b) | 1/21.11 0/24.43 2/22.94 1/20.92 | |POLY-3 PERCENT (g) | 4.7% 0.0% 8.7% 4.8% | |TERMINAL (d) | 0/11 (0%) 0/16 (0%) 2/14 (14%) 1/11 (9%) | |FIRST INCIDENCE | 459 --- 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.476 P=0.496N P=0.559 P=0.758N | |POLY 3 | P=0.471 P=0.471N P=0.529 P=0.760 | |POLY 1.5 | P=0.487 P=0.473N P=0.524 P=0.757N | |POLY 6 | P=0.443 P=0.468N P=0.534 P=0.748 | |LOGISTIC REGRESSION| P=0.498 P=0.628N P=0.447 P=0.747 | |COCH-ARM / FISHERS | P=0.501 P=0.472N P=0.515 P=0.745N | |ORDER RESTRICTED | P=0.383 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/25 (12%) 7/28 (25%) 0/26 (0%) 5/26 (19%) | |POLY-3 RATE (b) | 3/21.11 7/24.43 0/22.94 5/21.33 | |POLY-3 PERCENT (g) | 14.2% 28.7% 0.0% 23.4% | |TERMINAL (d) | 2/11 (18%) 7/16 (44%) 0/14 (0%) 3/11 (27%) | |FIRST INCIDENCE | 459 729 (T) --- 637 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.457 P=0.309 P=0.093N P=0.339 | |POLY 3 | P=0.513 P=0.206 P=0.098N P=0.354 | |POLY 1.5 | P=0.520 P=0.203 P=0.101N P=0.366 | |POLY 6 | P=0.499 P=0.210 P=0.095N P=0.329 | |LOGISTIC REGRESSION| P=0.496 P=0.225 P=0.133N P=0.372 | |COCH-ARM / FISHERS | P=0.522 P=0.197 P=0.110N P=0.374 | |ORDER RESTRICTED | P=0.279N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Mammary Gland | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/44 (18%) 18/45 (40%) 16/47 (34%) 12/42 (29%) | |POLY-3 RATE (b) | 8/40.17 18/40.66 16/43.49 12/37.23 | |POLY-3 PERCENT (g) | 19.9% 44.3% 36.8% 32.2% | |TERMINAL (d) | 3/27 (11%) 9/26 (35%) 6/27 (22%) 4/20 (20%) | |FIRST INCIDENCE | 526 620 548 605 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.246 P=0.027 * P=0.078 P=0.152 | |POLY 3 | P=0.290 P=0.015 * P=0.069 P=0.163 | |POLY 1.5 | P=0.314 P=0.017 * P=0.070 P=0.177 | |POLY 6 | P=0.248 P=0.014 * P=0.067 P=0.141 | |LOGISTIC REGRESSION| P=0.331 P=0.021 * P=0.066 P=0.192 | |COCH-ARM / FISHERS | P=0.332 P=0.021 * P=0.069 P=0.188 | |ORDER RESTRICTED | P=0.071 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/44 (5%) 3/45 (7%) 2/47 (4%) 1/42 (2%) | |POLY-3 RATE (b) | 2/38.47 3/38.66 2/41.23 1/35.29 | |POLY-3 PERCENT (g) | 5.2% 7.8% 4.9% 2.8% | |TERMINAL (d) | 2/27 (7%) 3/26 (12%) 2/27 (7%) 1/20 (5%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.417N P=0.482 P=0.697 P=0.605N | |POLY 3 | P=0.341N P=0.502 P=0.669N P=0.530N | |POLY 1.5 | P=0.333N P=0.507 P=0.668N P=0.522N | |POLY 6 | P=0.358N P=0.494 P=0.675N P=0.548N | |LOGISTIC REGRESSION| P=0.417N P=0.482 P=0.697 P=0.605N | |COCH-ARM / FISHERS | P=0.327N P=0.511 P=0.666N P=0.518N | |ORDER RESTRICTED | P=0.392N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 28 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 8/15 (53%) 4/13 (31%) 9/14 (64%) 7/15 (47%) | |POLY-3 RATE (b) | 8/14.60 4/11.24 9/12.44 7/12.93 | |POLY-3 PERCENT (g) | 54.8% 35.6% 72.3% 54.2% | |TERMINAL (d) | 6/9 (67%) 4/6 (67%) 3/4 (75%) 5/7 (71%) | |FIRST INCIDENCE | 526 729 (T) 548 605 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.338 P=0.334N P=0.152 P=0.596 | |POLY 3 | P=0.427 P=0.284N P=0.292 P=0.637N | |POLY 1.5 | P=0.488 P=0.253N P=0.343 P=0.572N | |POLY 6 | P=0.322 P=0.329N P=0.232 P=0.572 | |LOGISTIC REGRESSION| P=0.487 P=0.213N P=0.431 P=0.520N | |COCH-ARM / FISHERS | P=0.543 P=0.207N P=0.413 P=0.500N | |ORDER RESTRICTED | P=0.277 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 3/50 (6%) | |POLY-3 RATE (b) | 2/42.87 3/43.05 3/44.15 3/42.45 | |POLY-3 PERCENT (g) | 4.7% 7.0% 6.8% 7.1% | |TERMINAL (d) | 1/29 (3%) 2/28 (7%) 3/29 (10%) 3/26 (12%) | |FIRST INCIDENCE | 709 709 729 (T) 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.385 P=0.469 P=0.495 P=0.446 | |POLY 3 | P=0.432 P=0.502 P=0.513 P=0.495 | |POLY 1.5 | P=0.438 P=0.503 P=0.510 P=0.500 | |POLY 6 | P=0.417 P=0.496 P=0.512 P=0.482 | |LOGISTIC REGRESSION| P=0.388 P=0.484 P=0.504 P=0.448 | |COCH-ARM / FISHERS | P=0.438 P=0.500 P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.514 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 29 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Nose: Nasolacrimal Duct | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 0/42.79 0/42.97 3/44.29 1/42.45 | |POLY-3 PERCENT (g) | 0.0% 0.0% 6.8% 2.4% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 1/29 (3%) 1/26 (4%) | |FIRST INCIDENCE | --- --- 702 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.223 (e) P=0.122 P=0.478 | |POLY 3 | P=0.240 (e) P=0.125 P=0.498 | |POLY 1.5 | P=0.245 (e) P=0.123 P=0.500 | |POLY 6 | P=0.228 (e) P=0.125 P=0.493 | |LOGISTIC REGRESSION| P=0.228 (e) P=0.124 P=0.478 | |COCH-ARM / FISHERS | P=0.247 (e) P=0.121 P=0.500 | |ORDER RESTRICTED | P=0.120 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 31/49 (63%) 20/50 (40%) 23/50 (46%) 21/49 (43%) | |POLY-3 RATE (b) | 31/45.31 20/46.06 23/46.25 21/43.93 | |POLY-3 PERCENT (g) | 68.4% 43.4% 49.7% 47.8% | |TERMINAL (d) | 21/29 (72%) 10/28 (36%) 15/29 (52%) 13/26 (50%) | |FIRST INCIDENCE | 459 520 548 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.174N P=0.057N P=0.101N P=0.122N | |POLY 3 | P=0.078N P=0.011N* P=0.048N* P=0.033N* | |POLY 1.5 | P=0.072N P=0.012N* P=0.051N P=0.030N* | |POLY 6 | P=0.094N P=0.010N* P=0.048N* P=0.041N* | |LOGISTIC REGRESSION| P=0.074N P=0.017N* P=0.052N P=0.035N* | |COCH-ARM / FISHERS | P=0.074N P=0.017N* P=0.064N P=0.034N* | |ORDER RESTRICTED | P=0.025N* (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 30 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Pancreas: Duct | | Cyst Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 16/49 (33%) 14/50 (28%) 17/50 (34%) 11/49 (22%) | |POLY-3 RATE (b) | 16/43.24 14/43.69 17/45.47 11/41.94 | |POLY-3 PERCENT (g) | 37.0% 32.0% 37.4% 26.2% | |TERMINAL (d) | 11/29 (38%) 10/28 (36%) 11/29 (38%) 10/26 (39%) | |FIRST INCIDENCE | 651 620 548 705 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.280N P=0.470N P=0.507 P=0.287N | |POLY 3 | P=0.202N P=0.396N P=0.573 P=0.199N | |POLY 1.5 | P=0.192N P=0.389N P=0.559 P=0.187N | |POLY 6 | P=0.229N P=0.415N P=0.579 P=0.228N | |LOGISTIC REGRESSION| P=0.218N P=0.431N P=0.548 P=0.252N | |COCH-ARM / FISHERS | P=0.188N P=0.388N P=0.528 P=0.183N | |ORDER RESTRICTED | P=0.230N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Pituitary Gland | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/49 (4%) 2/50 (4%) 0/50 (0%) 1/48 (2%) | |POLY-3 RATE (b) | 2/42.35 2/42.97 0/44.15 1/40.83 | |POLY-3 PERCENT (g) | 4.7% 4.7% 0.0% 2.5% | |TERMINAL (d) | 1/29 (3%) 2/28 (7%) 0/29 (0%) 1/25 (4%) | |FIRST INCIDENCE | 654 729 (T) --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.330N P=0.689 P=0.234N P=0.544N | |POLY 3 | P=0.302N P=0.689N P=0.228N P=0.513N | |POLY 1.5 | P=0.301N P=0.686N P=0.228N P=0.508N | |POLY 6 | P=0.305N P=0.692 P=0.230N P=0.525N | |LOGISTIC REGRESSION| P=0.310N P=0.692N P=0.231N P=0.512N | |COCH-ARM / FISHERS | P=0.302N P=0.684N P=0.242N P=0.508N | |ORDER RESTRICTED | P=0.274N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 31 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/49 (4%) 2/50 (4%) 2/50 (4%) 2/48 (4%) | |POLY-3 RATE (b) | 2/42.25 2/43.22 2/44.70 2/40.93 | |POLY-3 PERCENT (g) | 4.7% 4.6% 4.5% 4.9% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 1/29 (3%) 1/25 (4%) | |FIRST INCIDENCE | 702 697 561 705 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.554 P=0.658 P=0.690 P=0.640 | |POLY 3 | P=0.582 P=0.686N P=0.674N P=0.683 | |POLY 1.5 | P=0.586 P=0.684N P=0.677N P=0.687 | |POLY 6 | P=0.570 P=0.692N P=0.675N P=0.672 | |LOGISTIC REGRESSION| P=0.587 P=0.688N P=0.693 P=0.677 | |COCH-ARM / FISHERS | P=0.586 P=0.684N P=0.684N P=0.684 | |ORDER RESTRICTED | P=0.721 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cytoplasmic Alteration Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/49 (14%) 6/50 (12%) 1/50 (2%) 6/48 (13%) | |POLY-3 RATE (b) | 7/43.51 6/44.15 1/44.15 6/41.60 | |POLY-3 PERCENT (g) | 16.1% 13.6% 2.3% 14.4% | |TERMINAL (d) | 3/29 (10%) 3/28 (11%) 1/29 (3%) 5/25 (20%) | |FIRST INCIDENCE | 354 520 729 (T) 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.449N P=0.512N P=0.038N* P=0.588N | |POLY 3 | P=0.399N P=0.489N P=0.028N* P=0.535N | |POLY 1.5 | P=0.393N P=0.485N P=0.028N* P=0.522N | |POLY 6 | P=0.413N P=0.501N P=0.029N* P=0.565N | |LOGISTIC REGRESSION| P=0.400N P=0.500N P=0.035N* P=0.524N | |COCH-ARM / FISHERS | P=0.391N P=0.484N P=0.028N* P=0.516N | |ORDER RESTRICTED | P=0.198N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 32 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Degeneration Cystic Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 3/48 (6%) | |POLY-3 RATE (b) | 1/42.82 0/42.97 0/44.15 3/41.17 | |POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 7.3% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 2/25 (8%) | |FIRST INCIDENCE | 459 --- --- 637 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.077 P=0.496N P=0.496N P=0.281 | |POLY 3 | P=0.080 P=0.499N P=0.494N P=0.291 | |POLY 1.5 | P=0.080 P=0.497N P=0.494N P=0.296 | |POLY 6 | P=0.079 P=0.504N P=0.496N P=0.280 | |LOGISTIC REGRESSION| P=0.073 P=0.644N P=0.728N P=0.274 | |COCH-ARM / FISHERS | P=0.081 P=0.495N P=0.495N P=0.301 | |ORDER RESTRICTED | P=0.033 * (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hemorrhage Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/49 (6%) 5/50 (10%) 1/50 (2%) 3/48 (6%) | |POLY-3 RATE (b) | 3/42.63 5/43.74 1/44.15 3/41.49 | |POLY-3 PERCENT (g) | 7.0% 11.4% 2.3% 7.2% | |TERMINAL (d) | 2/29 (7%) 2/28 (7%) 1/29 (3%) 1/25 (4%) | |FIRST INCIDENCE | 553 654 729 (T) 633 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.468N P=0.361 P=0.302N P=0.625 | |POLY 3 | P=0.434N P=0.370 P=0.292N P=0.650 | |POLY 1.5 | P=0.431N P=0.371 P=0.293N P=0.654 | |POLY 6 | P=0.443N P=0.364 P=0.296N P=0.640 | |LOGISTIC REGRESSION| P=0.434N P=0.366 P=0.299N P=0.650 | |COCH-ARM / FISHERS | P=0.433N P=0.369 P=0.301N P=0.651 | |ORDER RESTRICTED | P=0.328N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 33 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/49 (6%) 2/50 (4%) 2/50 (4%) 7/48 (15%) | |POLY-3 RATE (b) | 3/43.38 2/42.97 2/44.15 7/42.19 | |POLY-3 PERCENT (g) | 6.9% 4.7% 4.5% 16.6% | |TERMINAL (d) | 1/29 (3%) 2/28 (7%) 2/29 (7%) 4/25 (16%) | |FIRST INCIDENCE | 459 729 (T) 729 (T) 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.043 * P=0.506N P=0.494N P=0.140 | |POLY 3 | P=0.049 * P=0.504N P=0.492N P=0.144 | |POLY 1.5 | P=0.050 P=0.497N P=0.489N P=0.149 | |POLY 6 | P=0.047 * P=0.518N P=0.500N P=0.135 | |LOGISTIC REGRESSION| P=0.047 * P=0.516N P=0.552N P=0.128 | |COCH-ARM / FISHERS | P=0.050 P=0.490N P=0.490N P=0.150 | |ORDER RESTRICTED | P=0.038 * (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Pituitary Gland: Rathke's Cleft | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/49 (4%) 2/50 (4%) 0/50 (0%) 0/48 (0%) | |POLY-3 RATE (b) | 2/42.07 2/42.97 0/44.15 0/40.83 | |POLY-3 PERCENT (g) | 4.8% 4.7% 0.0% 0.0% | |TERMINAL (d) | 2/29 (7%) 2/28 (7%) 0/29 (0%) 0/25 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.097N P=0.684 P=0.238N P=0.271N | |POLY 3 | P=0.086N P=0.687N P=0.226N P=0.243N | |POLY 1.5 | P=0.086N P=0.685N P=0.228N P=0.241N | |POLY 6 | P=0.087N P=0.693N P=0.227N P=0.250N | |LOGISTIC REGRESSION| P=0.097N P=0.684 (e) (e) | |COCH-ARM / FISHERS | P=0.087N P=0.684N P=0.242N P=0.253N | |ORDER RESTRICTED | P=0.121N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 34 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Preputial Gland | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/49 (4%) | |POLY-3 RATE (b) | 1/43.62 0/42.97 1/44.15 2/42.07 | |POLY-3 PERCENT (g) | 2.3% 0.0% 2.3% 4.8% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 1/29 (3%) 0/25 (0%) | |FIRST INCIDENCE | 405 --- 729 (T) 633 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.236 P=0.496N P=0.758N P=0.496 | |POLY 3 | P=0.241 P=0.503N P=0.758N P=0.487 | |POLY 1.5 | P=0.242 P=0.501N P=0.758N P=0.491 | |POLY 6 | P=0.238 P=0.507N P=0.760N P=0.480 | |LOGISTIC REGRESSION| P=0.200 P=0.739N P=0.678 P=0.394 | |COCH-ARM / FISHERS | P=0.242 P=0.500N P=0.753N P=0.492 | |ORDER RESTRICTED | P=0.213 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Preputial Gland | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/49 (4%) | |POLY-3 RATE (b) | 2/42.79 1/42.97 1/44.15 2/42.35 | |POLY-3 PERCENT (g) | 4.7% 2.3% 2.3% 4.7% | |TERMINAL (d) | 2/29 (7%) 1/28 (4%) 1/29 (3%) 0/25 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 554 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.530 P=0.512N P=0.500N P=0.676 | |POLY 3 | P=0.552 P=0.499N P=0.489N P=0.691 | |POLY 1.5 | P=0.552 P=0.498N P=0.492N P=0.691 | |POLY 6 | P=0.549 P=0.503N P=0.489N P=0.685 | |LOGISTIC REGRESSION| P=0.548 P=0.512N P=0.500N P=0.683 | |COCH-ARM / FISHERS | P=0.548 P=0.500N P=0.500N P=0.684 | |ORDER RESTRICTED | P=0.535 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 35 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 32/50 (64%) 30/50 (60%) 31/50 (62%) 37/49 (76%) | |POLY-3 RATE (b) | 32/45.09 30/45.87 31/47.16 37/46.05 | |POLY-3 PERCENT (g) | 71.0% 65.4% 65.7% 80.3% | |TERMINAL (d) | 20/29 (69%) 18/28 (64%) 21/29 (72%) 20/25 (80%) | |FIRST INCIDENCE | 553 526 526 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.062 P=0.508N P=0.493N P=0.098 | |POLY 3 | P=0.123 P=0.361N P=0.373N P=0.201 | |POLY 1.5 | P=0.114 P=0.374N P=0.411N P=0.185 | |POLY 6 | P=0.125 P=0.367N P=0.360N P=0.203 | |LOGISTIC REGRESSION| P=0.089 P=0.391N P=0.412N P=0.142 | |COCH-ARM / FISHERS | P=0.095 P=0.418N P=0.500N P=0.152 | |ORDER RESTRICTED | P=0.121 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 29/50 (58%) 33/50 (66%) 35/50 (70%) 38/50 (76%) | |POLY-3 RATE (b) | 29/46.69 33/47.27 35/48.80 38/48.94 | |POLY-3 PERCENT (g) | 62.1% 69.8% 71.7% 77.6% | |TERMINAL (d) | 16/29 (55%) 20/28 (71%) 20/29 (69%) 17/26 (65%) | |FIRST INCIDENCE | 405 520 430 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.044 * P=0.274 P=0.234 P=0.058 | |POLY 3 | P=0.062 P=0.281 P=0.213 P=0.070 | |POLY 1.5 | P=0.052 P=0.280 P=0.192 P=0.060 | |POLY 6 | P=0.070 P=0.270 P=0.223 P=0.078 | |LOGISTIC REGRESSION| P=0.035 * P=0.275 P=0.148 P=0.044 * | |COCH-ARM / FISHERS | P=0.035 * P=0.268 P=0.149 P=0.044 * | |ORDER RESTRICTED | P=0.066 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 36 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Prostate | | Mineralization Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/42.79 0/42.97 0/44.15 2/42.45 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.7% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 2/26 (8%) | |FIRST INCIDENCE | --- --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.039 * (e) (e) P=0.214 | |POLY 3 | P=0.045 * (e) (e) P=0.235 | |POLY 1.5 | P=0.045 * (e) (e) P=0.237 | |POLY 6 | P=0.044 * (e) (e) P=0.229 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.214 | |COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 | |ORDER RESTRICTED | P=0.029 * (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Prostate: Epithelium | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 25/50 (50%) 21/50 (42%) 24/50 (48%) 23/50 (46%) | |POLY-3 RATE (b) | 25/46.09 21/45.12 24/46.23 23/45.43 | |POLY-3 PERCENT (g) | 54.2% 46.6% 51.9% 50.6% | |TERMINAL (d) | 13/29 (45%) 14/28 (50%) 17/29 (59%) 13/26 (50%) | |FIRST INCIDENCE | 526 561 526 554 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.452 P=0.332N P=0.486N P=0.560 | |POLY 3 | P=0.483N P=0.297N P=0.494N P=0.445N | |POLY 1.5 | P=0.468N P=0.278N P=0.483N P=0.423N | |POLY 6 | P=0.522N P=0.341N P=0.537N P=0.497N | |LOGISTIC REGRESSION| P=0.468N P=0.263N P=0.464N P=0.416N | |COCH-ARM / FISHERS | P=0.471N P=0.274N P=0.500N P=0.421N | |ORDER RESTRICTED | P=0.520N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 37 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Skin | | Cyst Epithelial Inclusion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/42.79 0/42.97 0/44.15 2/43.21 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.6% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | --- --- --- 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.045 * (e) (e) P=0.232 | |POLY 3 | P=0.046 * (e) (e) P=0.239 | |POLY 1.5 | P=0.046 * (e) (e) P=0.240 | |POLY 6 | P=0.045 * (e) (e) P=0.234 | |LOGISTIC REGRESSION| P=0.033 * (e) (e) P=0.185 | |COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 | |ORDER RESTRICTED | P=0.030 * (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Spleen | | Angiectasis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/48 (2%) 2/49 (4%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/41.90 2/42.22 0/43.45 0/42.45 | |POLY-3 PERCENT (g) | 2.4% 4.7% 0.0% 0.0% | |TERMINAL (d) | 1/29 (3%) 1/28 (4%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 729 (T) 697 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.205N P=0.485 P=0.500N P=0.522N | |POLY 3 | P=0.184N P=0.503 P=0.493N P=0.497N | |POLY 1.5 | P=0.183N P=0.506 P=0.493N P=0.494N | |POLY 6 | P=0.188N P=0.497 P=0.494N P=0.504N | |LOGISTIC REGRESSION| P=0.192N P=0.490 (e) (e) | |COCH-ARM / FISHERS | P=0.182N P=0.508 P=0.495N P=0.490N | |ORDER RESTRICTED | P=0.166N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 38 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Spleen | | Fibrosis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/48 (8%) 3/49 (6%) 1/49 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 4/41.98 3/42.22 1/43.57 1/42.45 | |POLY-3 PERCENT (g) | 9.5% 7.1% 2.3% 2.4% | |TERMINAL (d) | 3/29 (10%) 2/28 (7%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | 709 697 697 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.112N P=0.527N P=0.187N P=0.217N | |POLY 3 | P=0.087N P=0.497N P=0.167N P=0.174N | |POLY 1.5 | P=0.086N P=0.492N P=0.168N P=0.170N | |POLY 6 | P=0.090N P=0.507N P=0.167N P=0.185N | |LOGISTIC REGRESSION| P=0.098N P=0.524N P=0.170N P=0.210N | |COCH-ARM / FISHERS | P=0.086N P=0.488N P=0.175N P=0.168N | |ORDER RESTRICTED | P=0.106N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/48 (13%) 7/49 (14%) 5/49 (10%) 11/50 (22%) | |POLY-3 RATE (b) | 6/43.95 7/44.11 5/44.85 11/44.60 | |POLY-3 PERCENT (g) | 13.7% 15.9% 11.2% 24.7% | |TERMINAL (d) | 2/29 (7%) 2/28 (7%) 0/29 (0%) 5/26 (19%) | |FIRST INCIDENCE | 354 526 526 485 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.099 P=0.495 P=0.490N P=0.132 | |POLY 3 | P=0.109 P=0.503 P=0.486N P=0.147 | |POLY 1.5 | P=0.114 P=0.507 P=0.486N P=0.155 | |POLY 6 | P=0.101 P=0.498 P=0.485N P=0.134 | |LOGISTIC REGRESSION| P=0.111 P=0.510 P=0.581N P=0.160 | |COCH-ARM / FISHERS | P=0.120 P=0.516 P=0.485N P=0.165 | |ORDER RESTRICTED | P=0.119 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 39 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Spleen | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/41.90 0/42.10 0/43.45 2/42.83 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.7% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | --- --- --- 619 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.044 * (e) (e) P=0.230 | |POLY 3 | P=0.047 * (e) (e) P=0.242 | |POLY 1.5 | P=0.048 * (e) (e) P=0.245 | |POLY 6 | P=0.046 * (e) (e) P=0.235 | |LOGISTIC REGRESSION| P=0.049 * (e) (e) P=0.247 | |COCH-ARM / FISHERS | P=0.049 * (e) (e) P=0.258 | |ORDER RESTRICTED | P=0.031 * (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Spleen | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/48 (4%) 1/49 (2%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 2/42.54 1/42.18 1/43.45 0/42.45 | |POLY-3 PERCENT (g) | 4.7% 2.4% 2.3% 0.0% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 1/29 (3%) 0/26 (0%) | |FIRST INCIDENCE | 553 709 729 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.167N P=0.526N P=0.502N P=0.252N | |POLY 3 | P=0.151N P=0.503N P=0.493N P=0.237N | |POLY 1.5 | P=0.149N P=0.498N P=0.491N P=0.232N | |POLY 6 | P=0.155N P=0.512N P=0.497N P=0.247N | |LOGISTIC REGRESSION| P=0.147N P=0.494N P=0.511N P=0.234N | |COCH-ARM / FISHERS | P=0.147N P=0.492N P=0.492N P=0.237N | |ORDER RESTRICTED | P=0.118N (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 40 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Edema | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 4/50 (8%) | |POLY-3 RATE (b) | 2/42.98 2/43.61 3/44.63 4/44.24 | |POLY-3 PERCENT (g) | 4.7% 4.6% 6.7% 9.0% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 702 620 633 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.201 P=0.674 P=0.502 P=0.314 | |POLY 3 | P=0.227 P=0.689N P=0.517 P=0.350 | |POLY 1.5 | P=0.225 P=0.689N P=0.512 P=0.348 | |POLY 6 | P=0.225 P=0.692N P=0.519 P=0.346 | |LOGISTIC REGRESSION| P=0.193 P=0.692 P=0.505 P=0.295 | |COCH-ARM / FISHERS | P=0.216 P=0.691N P=0.500 P=0.339 | |ORDER RESTRICTED | P=0.315 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Diffuse | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.79 0/42.97 2/44.79 0/42.45 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- 633 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.587 (e) P=0.250 (e) | |POLY 3 | P=0.587 (e) P=0.247 (e) | |POLY 1.5 | P=0.593 (e) P=0.244 (e) | |POLY 6 | P=0.572 (e) P=0.250 (e) | |LOGISTIC REGRESSION| P=0.579 (e) P=0.204 (e) | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) | |ORDER RESTRICTED | P=0.256 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 41 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 1/42.87 2/43.13 2/44.52 1/42.53 | |POLY-3 PERCENT (g) | 2.3% 4.6% 4.5% 2.4% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 709 709 665 709 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.599N P=0.457 P=0.502 P=0.727 | |POLY 3 | P=0.557N P=0.502 P=0.513 P=0.759 | |POLY 1.5 | P=0.554N P=0.503 P=0.509 P=0.760N | |POLY 6 | P=0.567N P=0.498 P=0.515 P=0.753 | |LOGISTIC REGRESSION| P=0.557N P=0.499 P=0.502 P=0.757 | |COCH-ARM / FISHERS | P=0.556N P=0.500 P=0.500 P=0.753N | |ORDER RESTRICTED | P=0.554 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 4/50 (8%) 4/50 (8%) | |POLY-3 RATE (b) | 1/42.87 4/44.32 4/45.09 4/44.26 | |POLY-3 PERCENT (g) | 2.3% 9.0% 8.9% 9.0% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 709 520 633 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.195 P=0.177 P=0.191 P=0.178 | |POLY 3 | P=0.219 P=0.188 P=0.194 P=0.188 | |POLY 1.5 | P=0.217 P=0.186 P=0.189 P=0.186 | |POLY 6 | P=0.216 P=0.189 P=0.198 P=0.186 | |LOGISTIC REGRESSION| P=0.169 P=0.162 P=0.168 P=0.135 | |COCH-ARM / FISHERS | P=0.205 P=0.181 P=0.181 P=0.181 | |ORDER RESTRICTED | P=0.182 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 42 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 4/50 (8%) 6/50 (12%) | |POLY-3 RATE (b) | 2/43.62 5/44.10 4/44.90 6/43.89 | |POLY-3 PERCENT (g) | 4.6% 11.3% 8.9% 13.7% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | 479 520 642 633 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.125 P=0.202 P=0.350 P=0.129 | |POLY 3 | P=0.143 P=0.220 P=0.350 P=0.134 | |POLY 1.5 | P=0.145 P=0.220 P=0.347 P=0.135 | |POLY 6 | P=0.140 P=0.217 P=0.352 P=0.130 | |LOGISTIC REGRESSION| P=0.130 P=0.193 P=0.287 P=0.118 | |COCH-ARM / FISHERS | P=0.142 P=0.218 P=0.339 P=0.134 | |ORDER RESTRICTED | P=0.115 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/49 (4%) 4/50 (8%) 1/50 (2%) 4/50 (8%) | |POLY-3 RATE (b) | 2/42.20 4/44.87 1/44.30 4/43.57 | |POLY-3 PERCENT (g) | 4.7% 8.9% 2.3% 9.2% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | 702 405 691 616 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.342 P=0.331 P=0.500N P=0.321 | |POLY 3 | P=0.368 P=0.366 P=0.483N P=0.352 | |POLY 1.5 | P=0.369 P=0.361 P=0.485N P=0.352 | |POLY 6 | P=0.361 P=0.365 P=0.485N P=0.344 | |LOGISTIC REGRESSION| P=0.323 P=0.295 P=0.485N P=0.342 | |COCH-ARM / FISHERS | P=0.364 P=0.349 P=0.492N P=0.349 | |ORDER RESTRICTED | P=0.318 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 43 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Stomach, Glandular: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/42.07 0/42.97 0/44.15 2/43.92 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.6% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- --- 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.049 * (e) (e) P=0.251 | |POLY 3 | P=0.047 * (e) (e) P=0.247 | |POLY 1.5 | P=0.047 * (e) (e) P=0.247 | |POLY 6 | P=0.047 * (e) (e) P=0.242 | |LOGISTIC REGRESSION| P=0.006 ** (e) (e) P=0.061 | |COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.253 | |ORDER RESTRICTED | P=0.033 * (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Testes | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 8/50 (16%) 9/50 (18%) 9/50 (18%) | |POLY-3 RATE (b) | 6/43.77 8/44.21 9/46.05 9/43.27 | |POLY-3 PERCENT (g) | 13.7% 18.1% 19.5% 20.8% | |TERMINAL (d) | 1/29 (3%) 4/28 (14%) 3/29 (10%) 6/26 (23%) | |FIRST INCIDENCE | 620 561 526 633 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.220 P=0.370 P=0.314 P=0.239 | |POLY 3 | P=0.247 P=0.393 P=0.324 P=0.277 | |POLY 1.5 | P=0.256 P=0.395 P=0.313 P=0.286 | |POLY 6 | P=0.225 P=0.383 P=0.328 P=0.254 | |LOGISTIC REGRESSION| P=0.257 P=0.387 P=0.263 P=0.285 | |COCH-ARM / FISHERS | P=0.257 P=0.387 P=0.288 P=0.288 | |ORDER RESTRICTED | P=0.312 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 44 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Testes: Interstitial Cell | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 3/50 (6%) 3/50 (6%) | |POLY-3 RATE (b) | 3/44.81 2/43.53 3/44.72 3/43.64 | |POLY-3 PERCENT (g) | 6.7% 4.6% 6.7% 6.9% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | 354 620 665 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.506 P=0.496N P=0.648N P=0.658 | |POLY 3 | P=0.512 P=0.513N P=0.662 P=0.650 | |POLY 1.5 | P=0.518 P=0.507N P=0.662N P=0.657 | |POLY 6 | P=0.500 P=0.522N P=0.660 P=0.637 | |LOGISTIC REGRESSION| P=0.423 P=0.627N P=0.498 P=0.511 | |COCH-ARM / FISHERS | P=0.521 P=0.500N P=0.661N P=0.661N | |ORDER RESTRICTED | P=0.632 (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 44/46 (96%) 46/48 (96%) 40/44 (91%) 41/42 (98%) | |POLY-3 RATE (b) | 44/46.00 46/47.36 40/42.32 41/41.92 | |POLY-3 PERCENT (g) | 95.7% 97.1% 94.5% 97.8% | |TERMINAL (d) | 27/29 (93%) 28/28 (100%) 28/29 (97%) 26/26 (100%) | |FIRST INCIDENCE | 354 405 526 448 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.482N P=0.359 P=0.286N P=0.517 | |POLY 3 | P=0.446 P=0.572 P=0.605N P=0.513 | |POLY 1.5 | P=0.459 P=0.626 P=0.479N P=0.522 | |POLY 6 | P=0.430 P=0.474 P=0.685 P=0.495 | |LOGISTIC REGRESSION| P=0.531 P=0.680 P=0.243N P=0.533 | |COCH-ARM / FISHERS | P=0.481 P=0.675 P=0.317N P=0.534 | |ORDER RESTRICTED | P=0.446 (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 45 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicle | | Degeneration Cystic Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/46 (0%) 2/48 (4%) 0/44 (0%) 0/42 (0%) | |POLY-3 RATE (b) | 0/40.05 2/41.28 0/39.67 0/37.14 | |POLY-3 PERCENT (g) | 0.0% 4.8% 0.0% 0.0% | |TERMINAL (d) | 0/29 (0%) 2/28 (7%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- 729 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.424N P=0.230 (e) (e) | |POLY 3 | P=0.423N P=0.244 (e) (e) | |POLY 1.5 | P=0.423N P=0.246 (e) (e) | |POLY 6 | P=0.425N P=0.239 (e) (e) | |LOGISTIC REGRESSION| (e) P=0.230 (e) (e) | |COCH-ARM / FISHERS | P=0.427N P=0.258 (e) (e) | |ORDER RESTRICTED | P=0.268N (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/46 (0%) 0/48 (0%) 0/44 (0%) 2/42 (5%) | |POLY-3 RATE (b) | 0/40.05 0/41.28 0/39.67 2/37.14 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.4% | |TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 2/26 (8%) | |FIRST INCIDENCE | --- --- --- 729 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.039 * (e) (e) P=0.214 | |POLY 3 | P=0.038 * (e) (e) P=0.220 | |POLY 1.5 | P=0.038 * (e) (e) P=0.219 | |POLY 6 | P=0.039 * (e) (e) P=0.219 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.214 | |COCH-ARM / FISHERS | P=0.039 * (e) (e) P=0.225 | |ORDER RESTRICTED | P=0.024 * (e) (e) (e) | |=================================================================================================================================| Date: 05/24/04 EXPERIMENT: 96018 TEST: 03 Page 46 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia Cystic Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/46 (11%) 4/48 (8%) 4/44 (9%) 3/42 (7%) | |POLY-3 RATE (b) | 5/40.24 4/41.28 4/40.01 3/38.02 | |POLY-3 PERCENT (g) | 12.4% 9.7% 10.0% 7.9% | |TERMINAL (d) | 4/29 (14%) 4/28 (14%) 3/29 (10%) 1/26 (4%) | |FIRST INCIDENCE | 680 729 (T) 633 554 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.341N P=0.524N P=0.497N P=0.403N | |POLY 3 | P=0.333N P=0.484N P=0.504N P=0.387N | |POLY 1.5 | P=0.343N P=0.477N P=0.512N P=0.393N | |POLY 6 | P=0.324N P=0.498N P=0.497N P=0.383N | |LOGISTIC REGRESSION| P=0.347N P=0.516N P=0.505N P=0.407N | |COCH-ARM / FISHERS | P=0.358N P=0.473N P=0.529N P=0.409N | |ORDER RESTRICTED | P=0.404N (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).