TDMS Study 96017-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID) DATE: 04/14/04
EXPERIMENT: 96017 TEST: 05 TIME: 09:29:30
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96017
PATHOLOGIST: HERSCHELL, GILES CAS: 631-64-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1 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 (DIBROMOACETIC ACID) DATE: 04/14/04
EXPERIMENT: 96017 TEST: 05 TIME: 09:29:30
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96017
PATHOLOGIST: HERSCHELL, GILES CAS: 631-64-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF WATER DISINFECTION BYPRODUCTS (DIBROMOAC
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
Degeneration Fatty
Eye Cataract
Heart Thrombosis
Kidney Nephropathy
Kidney: Transitional Epithelium Hyperplasia
Liver Basophilic Focus
Degeneration Cystic
Eosinophilic Focus
Inflammation Granulomatous
Mixed Cell Focus
Liver: Bile Duct Hyperplasia
Liver: Centrilobular Necrosis
Liver: Hepatocyte Vacuolization Cytoplasmic
Lung Inflammation Chronic
Lung: Alveolar Epithelium Hyperplasia
Lymph Node, Mesenteric Hyperplasia Lymphoid
Lymph Node: Mediastinal Hyperplasia Lymphoid
Mammary Gland Cyst
Mesentery: Fat Necrosis
Pancreas Atrophy
Pancreas: Acinus Hyperplasia Focal
Pituitary Gland: Pars Distalis Hyperplasia
Hyperplasia Focal
Preputial Gland Cyst
Prostate Inflammation Chronic
Spleen Pigmentation
Stomach, Forestomach: Epithelium Hyperplasia
Stomach, Glandular Edema
Erosion
Testes: Germinal Epithelium Atrophy
Thymus Cyst
Thyroid Gland Ultimobranchial Cyst
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
Clitoral Gland Cyst
Heart Cardiomyopathy
Intestine Large, Colon Edema
Islets, Pancreatic Metaplasia Hepatocyte
Kidney Inflammation Chronic
Nephropathy
Liver Basophilic Focus
Clear Cell Focus
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID) DATE: 04/14/04
EXPERIMENT: 96017 TEST: 05 TIME: 09:29:30
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96017
PATHOLOGIST: HERSCHELL, GILES CAS: 631-64-1
Eosinophilic Focus
Inflammation Granulomatous
Mixed Cell Focus
Lung Inflammation Chronic
Lung: Alveolar Epithelium Hyperplasia
Lymph Node, Mesenteric Hyperplasia Lymphoid
Lymph Node: Mediastinal Hyperplasia Lymphoid
Mammary Gland Cyst
Pancreas Atrophy
Pituitary Gland: Pars Distalis Angiectasis
Spleen Hematopoietic Cell Proliferation
Pigmentation
Stomach, Forestomach Ulcer
Stomach, Forestomach: Epithelium Hyperplasia
Thyroid Gland: C-Cell Hyperplasia
Uterus Inflammation Chronic
Vagina Cyst
Inflammation
===============================================================
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/49 (53%) 18/50 (36%) 20/49 (41%) 14/50 (28%) |17/49 (35%) 8/50 (16%) 6/50 (12%) 6/49 (12%) |
|POLY-3 RATE (b) | 26/42.84 18/43.11 20/39.96 14/40.67 |17/43.58 8/46.25 6/45.78 6/43.47 |
|POLY-3 PERCENT (g) | 60.7% 41.8% 50.1% 34.4% |39.0% 17.3% 13.1% 13.8% |
|TERMINAL (d) | 24/34 (71%) 10/24 (42%) 17/30 (57%) 12/28 (43%) |16/35 (46%) 8/39 (21%) 4/35 (11%) 3/32 (9%) |
|FIRST INCIDENCE | 692 519 590 674 |632 729 (T) 441 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.050N P=0.467N P=0.321N P=0.052N |P=0.036N* P=0.013N* P=0.009N** P=0.015N* |
|POLY 3 | P=0.044N* P=0.054N P=0.218N P=0.010N* |P=0.017N* P=0.017N* P=0.004N** P=0.006N** |
|POLY 1.5 | P=0.037N* P=0.054N P=0.199N P=0.009N** |P=0.016N* P=0.020N* P=0.004N** P=0.006N** |
|POLY 6 | P=0.056N P=0.059N P=0.240N P=0.015N* |P=0.018N* P=0.013N* P=0.003N** P=0.005N** |
|LOGISTIC REGRESSION| P=0.061N P=0.126N P=0.322N P=0.035N* |P=0.020N* P=0.010N* P=0.007N** P=0.009N** |
|COCH-ARM / FISHERS | P=0.031N* P=0.066N P=0.156N P=0.010N* |P=0.018N* P=0.028N* P=0.007N** P=0.008N** |
|ORDER RESTRICTED | P=0.008N** (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Fatty |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 12/50 (24%) 9/49 (18%) 4/50 (8%) |14/49 (29%) 19/50 (38%) 15/50 (30%) 14/49 (29%) |
|POLY-3 RATE (b) | 5/42.73 12/42.94 9/40.28 4/41.38 |14/43.23 19/47.12 15/44.48 14/42.95 |
|POLY-3 PERCENT (g) | 11.7% 28.0% 22.4% 9.7% |32.4% 40.3% 33.7% 32.6% |
|TERMINAL (d) | 4/34 (12%) 6/24 (25%) 5/30 (17%) 2/28 (7%) |14/35 (40%) 16/39 (41%) 14/35 (40%) 12/32 (38%) |
|FIRST INCIDENCE | 693 510 602 512 |729 (T) 520 701 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.172N P=0.017 * P=0.138 P=0.598N |P=0.510N P=0.312 P=0.503 P=0.482 |
|POLY 3 | P=0.153N P=0.050 P=0.157 P=0.520N |P=0.361N P=0.285 P=0.537 P=0.583 |
|POLY 1.5 | P=0.140N P=0.055 P=0.166 P=0.504N |P=0.341N P=0.257 P=0.535 P=0.586 |
|POLY 6 | P=0.171N P=0.042 * P=0.150 P=0.544N |P=0.391N P=0.337 P=0.549 P=0.583 |
|LOGISTIC REGRESSION| P=0.147N P=0.049 * P=0.149 P=0.507N |P=0.442N P=0.311 P=0.555 P=0.523 |
|COCH-ARM / FISHERS | P=0.128N P=0.059 P=0.194 P=0.487N |P=0.316N P=0.217 P=0.526 P=0.588N |
|ORDER RESTRICTED | P=0.141N (e) (e) (e) |P=0.552N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 4/50 (8%) 2/49 (4%) 6/50 (12%) |8/49 (16%) 6/50 (12%) 4/50 (8%) 5/49 (10%) |
|POLY-3 RATE (b) | 6/42.70 4/41.46 2/39.19 6/40.90 |8/44.53 6/46.25 4/44.36 5/42.48 |
|POLY-3 PERCENT (g) | 14.1% 9.7% 5.1% 14.7% |18.0% 13.0% 9.0% 11.8% |
|TERMINAL (d) | 5/34 (15%) 3/24 (13%) 2/30 (7%) 5/28 (18%) |5/35 (14%) 6/39 (15%) 4/35 (11%) 5/32 (16%) |
|FIRST INCIDENCE | 703 721 729 (T) 561 |595 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.475 P=0.585N P=0.180N P=0.489 |P=0.308N P=0.326N P=0.182N P=0.330N |
|POLY 3 | P=0.483 P=0.387N P=0.161N P=0.591 |P=0.263N P=0.357N P=0.177N P=0.306N |
|POLY 1.5 | P=0.493 P=0.369N P=0.152N P=0.612 |P=0.249N P=0.361N P=0.172N P=0.292N |
|POLY 6 | P=0.473 P=0.419N P=0.172N P=0.560 |P=0.285N P=0.347N P=0.183N P=0.326N |
|LOGISTIC REGRESSION| P=0.442 P=0.501N P=0.177N P=0.553 |P=0.257N P=0.361N P=0.167N P=0.281N |
|COCH-ARM / FISHERS | P=0.512 P=0.357N P=0.134N P=0.606N |P=0.231N P=0.371N P=0.168N P=0.276N |
|ORDER RESTRICTED | P=0.369 (e) (e) (e) |P=0.236N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/49 (20%) 12/50 (24%) 13/49 (27%) 8/50 (16%) |18/49 (37%) 19/50 (38%) 21/50 (42%) 17/49 (35%) |
|POLY-3 RATE (b) | 10/42.59 12/43.14 13/39.42 8/43.30 |18/43.64 19/47.11 21/45.29 17/43.53 |
|POLY-3 PERCENT (g) | 23.5% 27.8% 33.0% 18.5% |41.2% 40.3% 46.4% 39.1% |
|TERMINAL (d) | 10/34 (29%) 7/24 (29%) 11/30 (37%) 3/28 (11%) |17/35 (49%) 16/39 (41%) 17/35 (49%) 13/32 (41%) |
|FIRST INCIDENCE | 729 (T) 547 700 356 |611 521 622 621 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.342N P=0.159 P=0.199 P=0.541N |P=0.392 P=0.506N P=0.346 P=0.553 |
|POLY 3 | P=0.283N P=0.416 P=0.237 P=0.380N |P=0.514N P=0.550N P=0.391 P=0.504N |
|POLY 1.5 | P=0.277N P=0.426 P=0.261 P=0.373N |P=0.492N P=0.583N P=0.385 P=0.502N |
|POLY 6 | P=0.296N P=0.394 P=0.214 P=0.398N |P=0.532 P=0.494N P=0.414 P=0.500N |
|LOGISTIC REGRESSION| P=0.316N P=0.364 P=0.184 P=0.369N |P=0.512 P=0.528N P=0.389 P=0.546N |
|COCH-ARM / FISHERS | P=0.279N P=0.426 P=0.317 P=0.379N |P=0.460N P=0.531 P=0.371 P=0.500N |
|ORDER RESTRICTED | P=0.241N (e) (e) (e) |P=0.577N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/49 (0%) 1/50 (2%) |3/49 (6%) 1/50 (2%) 1/50 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/42.59 1/41.42 0/39.19 1/40.64 |3/43.90 1/46.48 1/44.69 1/42.48 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 2.5% |6.8% 2.2% 2.2% 2.4% |
|TERMINAL (d) | 0/34 (0%) 1/24 (4%) 0/30 (0%) 0/28 (0%) |1/35 (3%) 0/39 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | --- 729 (T) --- 651 |633 669 640 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.465 P=0.431 (e) P=0.478 |P=0.333N P=0.263N P=0.304N P=0.328N |
|POLY 3 | P=0.466 P=0.494 (e) P=0.491 |P=0.315N P=0.285N P=0.299N P=0.317N |
|POLY 1.5 | P=0.474 P=0.500 (e) P=0.497 |P=0.307N P=0.290N P=0.298N P=0.311N |
|POLY 6 | P=0.455 P=0.485 (e) P=0.482 |P=0.327N P=0.276N P=0.299N P=0.325N |
|LOGISTIC REGRESSION| P=0.476 P=0.431 (e) P=0.510 |P=0.289N P=0.319N P=0.308N P=0.304N |
|COCH-ARM / FISHERS | P=0.484 P=0.505 (e) P=0.505 |P=0.297N P=0.301N P=0.301N P=0.309N |
|ORDER RESTRICTED | P=0.242 (e) (e) (e) |P=0.192N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 8/50 (16%) 7/49 (14%) 8/50 (16%) |5/49 (10%) 1/50 (2%) 2/50 (4%) 4/49 (8%) |
|POLY-3 RATE (b) | 6/42.59 8/41.65 7/39.30 8/41.01 |5/43.77 1/46.25 2/45.03 4/42.48 |
|POLY-3 PERCENT (g) | 14.1% 19.2% 17.8% 19.5% |11.4% 2.2% 4.4% 9.4% |
|TERMINAL (d) | 6/34 (18%) 5/24 (21%) 6/30 (20%) 6/28 (21%) |3/35 (9%) 1/39 (3%) 1/35 (3%) 4/32 (13%) |
|FIRST INCIDENCE | 729 (T) 697 700 624 |604 729 (T) 506 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.372 P=0.171 P=0.405 P=0.255 |P=0.386 P=0.087N P=0.220N P=0.554N |
|POLY 3 | P=0.379 P=0.367 P=0.438 P=0.356 |P=0.422 P=0.089N P=0.204N P=0.519N |
|POLY 1.5 | P=0.398 P=0.388 P=0.457 P=0.378 |P=0.434 P=0.092N P=0.205N P=0.510N |
|POLY 6 | P=0.358 P=0.334 P=0.417 P=0.327 |P=0.402 P=0.084N P=0.202N P=0.532N |
|LOGISTIC REGRESSION| P=0.331 P=0.241 P=0.395 P=0.299 |P=0.447 P=0.094N P=0.213N P=0.515N |
|COCH-ARM / FISHERS | P=0.427 P=0.403 P=0.500 P=0.403 |P=0.452 P=0.098N P=0.210N P=0.500N |
|ORDER RESTRICTED | P=0.405 (e) (e) (e) |P=0.203N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 4/49 (8%) 2/48 (4%) 5/50 (10%) |5/50 (10%) 8/50 (16%) 5/50 (10%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/42.59 4/41.61 2/39.45 5/41.80 |5/44.23 8/47.91 5/45.63 3/44.22 |
|POLY-3 PERCENT (g) | 4.7% 9.6% 5.1% 12.0% |11.3% 16.7% 11.0% 6.8% |
|TERMINAL (d) | 2/34 (6%) 0/24 (0%) 1/30 (3%) 1/28 (4%) |4/35 (11%) 5/39 (13%) 2/35 (6%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) 618 402 570 |701 392 441 566 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.227 P=0.251 P=0.658 P=0.170 |P=0.181N P=0.347 P=0.621N P=0.397N |
|POLY 3 | P=0.248 P=0.326 P=0.666 P=0.207 |P=0.137N P=0.330 P=0.611N P=0.356N |
|POLY 1.5 | P=0.255 P=0.334 P=0.672 P=0.216 |P=0.134N P=0.309 P=0.617N P=0.356N |
|POLY 6 | P=0.240 P=0.313 P=0.660 P=0.198 |P=0.143N P=0.360 P=0.600N P=0.355N |
|LOGISTIC REGRESSION| P=0.277 P=0.327 P=0.689N P=0.228 |P=0.108N P=0.252 P=0.627 P=0.353N |
|COCH-ARM / FISHERS | P=0.267 P=0.339 P=0.684 P=0.226 |P=0.128N P=0.277 P=0.630N P=0.357N |
|ORDER RESTRICTED | P=0.163 (e) (e) (e) |P=0.227N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 3/48 (6%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/42.59 0/40.86 3/38.73 0/40.35 |0/44.12 1/46.25 0/44.36 2/43.70 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.8% 0.0% |0.0% 2.2% 0.0% 4.6% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 2/30 (7%) 0/28 (0%) |0/35 (0%) 1/39 (3%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- 700 --- |--- 729 (T) --- 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.434 (e) P=0.104 (e) |P=0.164 P=0.522 (e) P=0.237 |
|POLY 3 | P=0.421 (e) P=0.102 (e) |P=0.177 P=0.509 (e) P=0.235 |
|POLY 1.5 | P=0.437 (e) P=0.106 (e) |P=0.178 P=0.506 (e) P=0.236 |
|POLY 6 | P=0.398 (e) P=0.098 (e) |P=0.176 P=0.516 (e) P=0.234 |
|LOGISTIC REGRESSION| P=0.425 (e) P=0.098 (e) |P=0.189 P=0.522 (e) P=0.237 |
|COCH-ARM / FISHERS | P=0.454 (e) P=0.117 (e) |P=0.179 P=0.500 (e) P=0.247 |
|ORDER RESTRICTED | P=0.146 (e) (e) (e) |P=0.073 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Brain |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) 7/50 (14%) 2/50 (4%) |6/50 (12%) 9/50 (18%) 7/50 (14%) 5/50 (10%) |
|POLY-3 RATE (b) | 7/44.99 5/42.84 7/41.08 2/40.56 |6/44.65 9/46.47 7/45.22 5/43.53 |
|POLY-3 PERCENT (g) | 15.6% 11.7% 17.0% 4.9% |13.4% 19.4% 15.5% 11.5% |
|TERMINAL (d) | 1/34 (3%) 1/24 (4%) 3/30 (10%) 1/28 (4%) |4/35 (11%) 7/39 (18%) 3/35 (9%) 3/32 (9%) |
|FIRST INCIDENCE | 591 602 560 674 |651 682 622 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.161N P=0.475N P=0.500 P=0.141N |P=0.362N P=0.386 P=0.514 P=0.541N |
|POLY 3 | P=0.145N P=0.414N P=0.542 P=0.105N |P=0.286N P=0.316 P=0.510 P=0.518N |
|POLY 1.5 | P=0.130N P=0.394N P=0.566 P=0.092N |P=0.274N P=0.305 P=0.507 P=0.510N |
|POLY 6 | P=0.169N P=0.447N P=0.513 P=0.126N |P=0.303N P=0.336 P=0.519 P=0.528N |
|LOGISTIC REGRESSION| P=0.109N P=0.373N P=0.614 P=0.079N |P=0.284N P=0.328 P=0.503 P=0.512N |
|COCH-ARM / FISHERS | P=0.111N P=0.380N P=0.613N P=0.080N |P=0.259N P=0.288 P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.101N (e) (e) (e) |P=0.410N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 3/50 (6%) |1/50 (2%) 5/50 (10%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/43.98 3/43.07 3/41.20 3/41.67 |1/44.47 5/47.89 2/44.75 3/43.62 |
|POLY-3 PERCENT (g) | 2.3% 7.0% 7.3% 7.2% |2.3% 10.4% 4.5% 6.9% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 1/39 (3%) 1/35 (3%) 0/32 (0%) |
|FIRST INCIDENCE | 516 446 423 512 |633 509 618 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.314 P=0.300 P=0.292 P=0.291 |P=0.530 P=0.132 P=0.508 P=0.303 |
|POLY 3 | P=0.308 P=0.297 P=0.282 P=0.286 |P=0.565 P=0.120 P=0.502 P=0.298 |
|POLY 1.5 | P=0.320 P=0.304 P=0.289 P=0.295 |P=0.572 P=0.113 P=0.502 P=0.301 |
|POLY 6 | P=0.296 P=0.285 P=0.274 P=0.275 |P=0.558 P=0.131 P=0.505 P=0.295 |
|LOGISTIC REGRESSION| P=0.393 P=0.224 P=0.391 P=0.318 |P=0.540N P=0.067 P=0.488 P=0.309 |
|COCH-ARM / FISHERS | P=0.337 P=0.309 P=0.309 P=0.309 |P=0.572N P=0.102 P=0.500 P=0.309 |
|ORDER RESTRICTED | P=0.261 (e) (e) (e) |P=0.257 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Brain |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.34 1/41.44 0/39.73 0/40.35 |0/44.12 2/46.25 0/44.36 1/42.95 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 0.0% |0.0% 4.3% 0.0% 2.3% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 2/39 (5%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | --- 724 --- --- |--- 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.423N P=0.439 (e) (e) |P=0.640 P=0.262 (e) P=0.482 |
|POLY 3 | P=0.427N P=0.491 (e) (e) |P=0.602N P=0.248 (e) P=0.495 |
|POLY 1.5 | P=0.422N P=0.496 (e) (e) |P=0.604N P=0.244 (e) P=0.497 |
|POLY 6 | P=0.435N P=0.482 (e) (e) |P=0.601N P=0.255 (e) P=0.491 |
|LOGISTIC REGRESSION| P=0.429N P=0.463 (e) (e) |(e) P=0.262 (e) P=0.482 |
|COCH-ARM / FISHERS | P=0.414N P=0.500 (e) (e) |P=0.606N P=0.247 (e) P=0.500 |
|ORDER RESTRICTED | P=0.386N (e) (e) (e) |P=0.320 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |12/50 (24%) 4/50 (8%) 8/48 (17%) 13/49 (27%) |
|POLY-3 RATE (b) | |12/45.68 4/46.25 8/43.39 13/43.07 |
|POLY-3 PERCENT (g) | |26.3% 8.7% 18.4% 30.2% |
|TERMINAL (d) | |7/35 (20%) 4/39 (10%) 4/33 (12%) 10/31 (32%) |
|FIRST INCIDENCE | |604 729 (T) 622 580 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.062 P=0.020N* P=0.256N P=0.398 |
|POLY 3 | |P=0.079 P=0.023N* P=0.264N P=0.431 |
|POLY 1.5 | |P=0.089 P=0.024N* P=0.259N P=0.452 |
|POLY 6 | |P=0.068 P=0.022N* P=0.265N P=0.402 |
|LOGISTIC REGRESSION| |P=0.094 P=0.026N* P=0.257N P=0.459 |
|COCH-ARM / FISHERS | |P=0.106 P=0.027N* P=0.259N P=0.477 |
|ORDER RESTRICTED | |P=0.101 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 4/50 (8%) 0/48 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | |1/44.12 4/46.25 0/42.36 2/41.95 |
|POLY-3 PERCENT (g) | |2.3% 8.7% 0.0% 4.8% |
|TERMINAL (d) | |1/35 (3%) 4/39 (10%) 0/33 (0%) 2/31 (7%) |
|FIRST INCIDENCE | |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.477N P=0.213 P=0.512N P=0.457 |
|POLY 3 | |P=0.416N P=0.193 P=0.508N P=0.482 |
|POLY 1.5 | |P=0.413N P=0.188 P=0.508N P=0.487 |
|POLY 6 | |P=0.418N P=0.204 P=0.507N P=0.476 |
|LOGISTIC REGRESSION| |P=0.477N P=0.213 (e) P=0.457 |
|COCH-ARM / FISHERS | |P=0.412N P=0.181 P=0.510N P=0.492 |
|ORDER RESTRICTED | |P=0.363N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 2/50 (4%) 5/48 (10%) 3/49 (6%) |
|POLY-3 RATE (b) | |3/44.44 2/46.25 5/42.75 3/41.95 |
|POLY-3 PERCENT (g) | |6.8% 4.3% 11.7% 7.2% |
|TERMINAL (d) | |2/35 (6%) 2/39 (5%) 3/33 (9%) 3/31 (10%) |
|FIRST INCIDENCE | |641 729 (T) 640 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.320 P=0.448N P=0.347 P=0.615 |
|POLY 3 | |P=0.354 P=0.482N P=0.335 P=0.636 |
|POLY 1.5 | |P=0.373 P=0.489N P=0.336 P=0.644 |
|POLY 6 | |P=0.329 P=0.469N P=0.337 P=0.625 |
|LOGISTIC REGRESSION| |P=0.355 P=0.482N P=0.334 P=0.632 |
|COCH-ARM / FISHERS | |P=0.397 P=0.500N P=0.335 P=0.651 |
|ORDER RESTRICTED | |P=0.390 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/43.70 0/41.42 0/39.73 0/40.35 |2/44.12 2/46.44 2/44.36 1/42.95 |
|POLY-3 PERCENT (g) | 6.9% 0.0% 0.0% 0.0% |4.5% 4.3% 4.5% 2.3% |
|TERMINAL (d) | 2/34 (6%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |2/35 (6%) 1/39 (3%) 2/35 (6%) 1/32 (3%) |
|FIRST INCIDENCE | 629 --- --- --- |729 (T) 682 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.102N P=0.171N P=0.151N P=0.153N |P=0.423N P=0.646N P=0.695 P=0.531N |
|POLY 3 | P=0.090N P=0.128N P=0.136N P=0.133N |P=0.386N P=0.675N P=0.692N P=0.509N |
|POLY 1.5 | P=0.092N P=0.123N P=0.130N P=0.126N |P=0.377N P=0.683N P=0.692N P=0.505N |
|POLY 6 | P=0.085N P=0.138N P=0.144N P=0.143N |P=0.401N P=0.662N P=0.690N P=0.515N |
|LOGISTIC REGRESSION| P=0.100N P=0.124N P=0.131N P=0.128N |P=0.407N P=0.672N P=0.695 P=0.531N |
|COCH-ARM / FISHERS | P=0.094N P=0.121N P=0.121N P=0.121N |P=0.365N P=0.691N P=0.691N P=0.500N |
|ORDER RESTRICTED | P=0.011N* (e) (e) (e) |P=0.475N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Eye |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/43.34 0/41.42 0/39.73 1/40.70 |1/44.12 0/46.25 0/44.36 2/43.58 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 0.0% 2.5% |2.3% 0.0% 0.0% 4.6% |
|TERMINAL (d) | 2/34 (6%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |1/35 (3%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 631 |729 (T) --- --- 621 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.563N P=0.318N P=0.266N P=0.551N |P=0.182 P=0.478N P=0.500N P=0.492 |
|POLY 3 | P=0.552N P=0.247N P=0.257N P=0.522N |P=0.189 P=0.491N P=0.499N P=0.496 |
|POLY 1.5 | P=0.554N P=0.241N P=0.250N P=0.512N |P=0.193 P=0.494N P=0.499N P=0.498 |
|POLY 6 | P=0.545N P=0.257N P=0.264N P=0.535N |P=0.184 P=0.484N P=0.498N P=0.494 |
|LOGISTIC REGRESSION| P=0.564N (e) (e) P=0.518N |P=0.206 (e) (e) P=0.503 |
|COCH-ARM / FISHERS | P=0.550N P=0.247N P=0.247N P=0.500N |P=0.199 P=0.500N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.147N (e) (e) (e) |P=0.127 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 41/50 (82%) 43/50 (86%) 41/50 (82%) |37/50 (74%) 29/50 (58%) 34/50 (68%) 35/50 (70%) |
|POLY-3 RATE (b) | 45/47.89 41/48.52 43/46.57 41/45.83 |37/46.21 29/48.41 34/47.18 35/45.96 |
|POLY-3 PERCENT (g) | 94.0% 84.5% 92.3% 89.5% |80.1% 59.9% 72.1% 76.2% |
|TERMINAL (d) | 32/34 (94%) 21/24 (88%) 28/30 (93%) 26/28 (93%) |31/35 (89%) 25/39 (64%) 25/35 (71%) 28/32 (88%) |
|FIRST INCIDENCE | 433 437 253 512 |595 509 430 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500 P=0.176 P=0.330 P=0.341 |P=0.101 P=0.017N* P=0.335N P=0.517 |
|POLY 3 | P=0.524 P=0.105N P=0.540N P=0.320N |P=0.259 P=0.023N* P=0.244N P=0.415N |
|POLY 1.5 | P=0.477N P=0.114N P=0.483N P=0.236N |P=0.309 P=0.035N* P=0.269N P=0.402N |
|POLY 6 | P=0.409 P=0.122N P=0.626N P=0.458N |P=0.191 P=0.012N* P=0.202N P=0.449N |
|LOGISTIC REGRESSION| P=0.399N P=0.193N P=0.583N P=0.271N |P=0.280 P=0.044N* P=0.321N P=0.490N |
|COCH-ARM / FISHERS | P=0.299N P=0.194N P=0.380N P=0.194N |P=0.370 P=0.069N P=0.330N P=0.412N |
|ORDER RESTRICTED | P=0.279N (e) (e) (e) |P=0.179N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.34 4/41.71 1/39.73 1/40.72 |2/44.44 1/46.25 1/44.75 1/43.14 |
|POLY-3 PERCENT (g) | 0.0% 9.6% 2.5% 2.5% |4.5% 2.2% 2.2% 2.3% |
|TERMINAL (d) | 0/34 (0%) 1/24 (4%) 1/30 (3%) 0/28 (0%) |1/35 (3%) 1/39 (3%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 693 729 (T) 624 |641 729 (T) 618 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.381N P=0.040 * P=0.475 P=0.485 |P=0.473N P=0.459N P=0.489N P=0.513N |
|POLY 3 | P=0.379N P=0.055 P=0.483 P=0.488 |P=0.455N P=0.486N P=0.498N P=0.510N |
|POLY 1.5 | P=0.366N P=0.058 P=0.488 P=0.493 |P=0.448N P=0.491N P=0.498N P=0.506N |
|POLY 6 | P=0.398N P=0.050 P=0.476 P=0.480 |P=0.465N P=0.477N P=0.495N P=0.516N |
|LOGISTIC REGRESSION| P=0.370N P=0.052 P=0.475 P=0.509 |P=0.431N P=0.498N P=0.510N P=0.499N |
|COCH-ARM / FISHERS | P=0.350N P=0.059 P=0.500 P=0.500 |P=0.439N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.171 (e) (e) (e) |P=0.418N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 1/49 (2%) 1/48 (2%) 0/50 (0%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 2/48 (4%) |
|POLY-3 RATE (b) | 0/41.99 1/40.50 1/38.73 0/40.35 |0/43.23 0/45.29 0/43.42 2/42.01 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 2.6% 0.0% |0.0% 0.0% 0.0% 4.8% |
|TERMINAL (d) | 0/34 (0%) 1/24 (4%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | --- 729 (T) 700 --- |--- --- --- 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.533N P=0.431 P=0.483 (e) |P=0.035 * (e) (e) P=0.227 |
|POLY 3 | P=0.533N P=0.493 P=0.484 (e) |P=0.039 * (e) (e) P=0.231 |
|POLY 1.5 | P=0.523N P=0.499 P=0.489 (e) |P=0.040 * (e) (e) P=0.232 |
|POLY 6 | P=0.547N P=0.482 P=0.479 (e) |P=0.038 * (e) (e) P=0.230 |
|LOGISTIC REGRESSION| P=0.532N P=0.431 P=0.487 (e) |P=0.040 * (e) (e) P=0.231 |
|COCH-ARM / FISHERS | P=0.511N P=0.505 P=0.500 (e) |P=0.042 * (e) (e) P=0.242 |
|ORDER RESTRICTED | P=0.390 (e) (e) (e) |P=0.027 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Metaplasia Hepatocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |0/47 (0%) 1/49 (2%) 0/49 (0%) 3/48 (6%) |
|POLY-3 RATE (b) | 0/41.99 0/41.42 0/38.61 0/40.35 |0/41.84 1/45.91 0/43.63 3/42.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 0.0% 7.1% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 1/39 (3%) 0/35 (0%) 2/32 (6%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) --- 622 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.047 * P=0.522 (e) P=0.112 |
|POLY 3 | (e) (e) (e) (e) |P=0.056 P=0.519 (e) P=0.120 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.057 P=0.515 (e) P=0.121 |
|POLY 6 | (e) (e) (e) (e) |P=0.054 P=0.524 (e) P=0.118 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.057 P=0.522 (e) P=0.123 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.059 P=0.510 (e) P=0.125 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.021 * (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 0/49 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.59 0/41.42 0/39.19 1/40.38 |0/44.12 0/46.25 0/44.36 0/42.95 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 0.0% 2.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/34 (6%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 723 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.560N P=0.318N P=0.266N P=0.563N |(e) (e) (e) (e) |
|POLY 3 | P=0.548N P=0.243N P=0.256N P=0.519N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.551N P=0.237N P=0.250N P=0.506N |(e) (e) (e) (e) |
|POLY 6 | P=0.541N P=0.254N P=0.263N P=0.536N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.574N (e) (e) P=0.564N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.548N P=0.242N P=0.247N P=0.492N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.144N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/42.59 1/41.50 0/39.19 1/40.38 |0/44.12 2/46.25 0/44.36 2/42.95 |
|POLY-3 PERCENT (g) | 2.4% 2.4% 0.0% 2.5% |0.0% 4.3% 0.0% 4.7% |
|TERMINAL (d) | 1/34 (3%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 2/39 (5%) 0/35 (0%) 2/32 (6%) |
|FIRST INCIDENCE | 729 (T) 710 --- 723 |--- 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.591N P=0.691 P=0.525N P=0.721 |P=0.309 P=0.262 (e) P=0.219 |
|POLY 3 | P=0.586N P=0.755 P=0.517N P=0.749 |P=0.349 P=0.248 (e) P=0.231 |
|POLY 1.5 | P=0.583N P=0.760N P=0.511N P=0.757 |P=0.351 P=0.244 (e) P=0.234 |
|POLY 6 | P=0.589N P=0.745 P=0.522N P=0.738 |P=0.348 P=0.255 (e) P=0.227 |
|LOGISTIC REGRESSION| P=0.605N P=0.737 (e) P=0.724 |(e) P=0.262 (e) P=0.219 |
|COCH-ARM / FISHERS | P=0.576N P=0.747N P=0.500N P=0.747N |P=0.354 P=0.247 (e) P=0.247 |
|ORDER RESTRICTED | P=0.552N (e) (e) (e) |P=0.111 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/42.59 0/41.42 0/39.19 0/40.35 |0/44.12 0/46.25 0/44.36 2/42.95 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.7% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 2/32 (6%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.034 * (e) (e) P=0.219 |
|POLY 3 | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.231 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.234 |
|POLY 6 | (e) (e) (e) (e) |P=0.039 * (e) (e) P=0.227 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.219 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.027 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 43/49 (88%) 48/50 (96%) 46/49 (94%) 47/50 (94%) |18/50 (36%) 32/50 (64%) 37/50 (74%) 40/50 (80%) |
|POLY-3 RATE (b) | 43/46.34 48/48.69 46/46.77 47/47.83 |18/45.68 32/46.59 37/46.96 40/46.61 |
|POLY-3 PERCENT (g) | 92.8% 98.6% 98.4% 98.3% |39.4% 68.7% 78.8% 85.8% |
|TERMINAL (d) | 33/34 (97%) 24/24 (100%) 30/30 (100%) 28/28 (100%)|15/35 (43%) 29/39 (74%) 31/35 (89%) 28/32 (88%) |
|FIRST INCIDENCE | 437 437 253 386 |161 682 430 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223 P=0.004 ** P=0.079 P=0.029 * |P<0.001 ** P=0.017 * P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.183 P=0.145 P=0.173 P=0.171 |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.242 P=0.146 P=0.166 P=0.202 |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.143 P=0.153 P=0.191 P=0.161 |P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.190 P=0.112 P=0.079 P=0.127 |P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.342 P=0.128 P=0.243 P=0.233 |P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P=0.029 * (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 9/50 (18%) 8/49 (16%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/42.66 9/41.58 8/39.61 3/40.64 |0/44.12 0/46.25 2/44.36 2/42.95 |
|POLY-3 PERCENT (g) | 7.0% 21.6% 20.2% 7.4% |0.0% 0.0% 4.5% 4.7% |
|TERMINAL (d) | 2/34 (6%) 7/24 (29%) 7/30 (23%) 2/28 (7%) |0/35 (0%) 0/39 (0%) 2/35 (6%) 2/32 (6%) |
|FIRST INCIDENCE | 711 697 608 651 |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.285N P=0.016 * P=0.065 P=0.577 |P=0.050 (e) P=0.238 P=0.219 |
|POLY 3 | P=0.293N P=0.051 P=0.075 P=0.640 |P=0.059 (e) P=0.238 P=0.231 |
|POLY 1.5 | P=0.271N P=0.058 P=0.081 P=0.655 |P=0.062 (e) P=0.238 P=0.234 |
|POLY 6 | P=0.322N P=0.041 * P=0.068 P=0.619 |P=0.054 (e) P=0.240 P=0.227 |
|LOGISTIC REGRESSION| P=0.311N P=0.026 * P=0.067 P=0.619 |(e) (e) P=0.238 P=0.219 |
|COCH-ARM / FISHERS | P=0.248N P=0.065 P=0.100 P=0.651N |P=0.067 (e) P=0.247 P=0.247 |
|ORDER RESTRICTED | P=0.160 (e) (e) (e) |P=0.111 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 4/50 (8%) 1/50 (2%) 1/50 (2%) |36/50 (72%) 41/50 (82%) 29/50 (58%) 15/50 (30%) |
|POLY-3 RATE (b) | 14/43.34 4/41.42 1/39.73 1/40.35 |36/45.23 41/47.22 29/45.25 15/43.28 |
|POLY-3 PERCENT (g) | 32.3% 9.7% 2.5% 2.5% |79.6% 86.8% 64.1% 34.7% |
|TERMINAL (d) | 14/34 (41%) 4/24 (17%) 1/30 (3%) 1/28 (4%) |32/35 (91%) 37/39 (95%) 27/35 (77%) 14/32 (44%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |602 521 441 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.046N* P<0.001N** P<0.001N** |P<0.001N** P=0.514 P=0.062N P<0.001N** |
|POLY 3 | P<0.001N** P=0.009N** P<0.001N** P<0.001N** |P<0.001N** P=0.236 P=0.065N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.008N** P<0.001N** P<0.001N** |P<0.001N** P=0.207 P=0.075N P<0.001N** |
|POLY 6 | P<0.001N** P=0.011N* P<0.001N** P<0.001N** |P<0.001N** P=0.319 P=0.052N P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.046N* P<0.001N** P<0.001N** |P<0.001N** P=0.445 P=0.053N P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.009N** P<0.001N** P<0.001N** |P<0.001N** P=0.171 P=0.104N P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 19/50 (38%) 16/50 (32%) 21/50 (42%) |8/50 (16%) 4/50 (8%) 14/50 (28%) 18/50 (36%) |
|POLY-3 RATE (b) | 18/43.34 19/42.82 16/39.73 21/41.00 |8/44.12 4/46.37 14/45.04 18/42.95 |
|POLY-3 PERCENT (g) | 41.5% 44.4% 40.3% 51.2% |18.1% 8.6% 31.1% 41.9% |
|TERMINAL (d) | 18/34 (53%) 14/24 (58%) 16/30 (53%) 20/28 (71%) |8/35 (23%) 3/39 (8%) 11/35 (31%) 18/32 (56%) |
|FIRST INCIDENCE | 729 (T) 602 729 (T) 512 |729 (T) 701 640 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.253 P=0.096 P=0.586 P=0.077 |P<0.001 ** P=0.130N P=0.116 P=0.006 ** |
|POLY 3 | P=0.243 P=0.480 P=0.543N P=0.244 |P<0.001 ** P=0.153N P=0.118 P=0.012 * |
|POLY 1.5 | P=0.289 P=0.497 P=0.500N P=0.290 |P<0.001 ** P=0.163N P=0.117 P=0.014 * |
|POLY 6 | P=0.187 P=0.451 P=0.592 P=0.184 |P<0.001 ** P=0.137N P=0.126 P=0.009 ** |
|LOGISTIC REGRESSION| P=0.174 P=0.313 P=0.586 P=0.107 |P<0.001 ** P=0.117N P=0.118 P=0.006 ** |
|COCH-ARM / FISHERS | P=0.355 P=0.500 P=0.417N P=0.341 |P<0.001 ** P=0.178N P=0.114 P=0.020 * |
|ORDER RESTRICTED | P=0.282 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 9/50 (18%) 11/50 (22%) 15/50 (30%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/43.34 9/41.57 11/40.48 15/42.32 |0/44.12 0/46.25 0/44.36 1/42.95 |
|POLY-3 PERCENT (g) | 6.9% 21.7% 27.2% 35.4% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 3/34 (9%) 8/24 (33%) 9/30 (30%) 10/28 (36%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 729 (T) 691 521 570 |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.013 * P=0.011 * P<0.001 ** |P=0.165 (e) (e) P=0.482 |
|POLY 3 | P=0.002 ** P=0.048 * P=0.012 * P<0.001 ** |P=0.178 (e) (e) P=0.495 |
|POLY 1.5 | P=0.002 ** P=0.055 P=0.014 * P<0.001 ** |P=0.181 (e) (e) P=0.497 |
|POLY 6 | P=0.002 ** P=0.039 * P=0.010 * P<0.001 ** |P=0.175 (e) (e) P=0.491 |
|LOGISTIC REGRESSION| P=0.002 ** P=0.022 * P=0.012 * P<0.001 ** |(e) (e) (e) P=0.482 |
|COCH-ARM / FISHERS | P=0.004 ** P=0.061 P=0.020 * P=0.002 ** |P=0.184 (e) (e) P=0.500 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.115 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 4/50 (8%) 3/50 (6%) 9/50 (18%) |4/50 (8%) 4/50 (8%) 5/50 (10%) 9/50 (18%) |
|POLY-3 RATE (b) | 16/44.00 4/41.53 3/39.73 9/40.87 |4/44.12 4/46.37 5/44.49 9/42.95 |
|POLY-3 PERCENT (g) | 36.4% 9.6% 7.6% 22.0% |9.1% 8.6% 11.2% 21.0% |
|TERMINAL (d) | 13/34 (38%) 3/24 (13%) 3/30 (10%) 8/28 (29%) |4/35 (11%) 3/39 (8%) 4/35 (11%) 9/32 (28%) |
|FIRST INCIDENCE | 622 701 729 (T) 571 |729 (T) 699 696 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.281N P=0.022N* P=0.003N** P=0.195N |P=0.024 * P=0.580N P=0.504 P=0.080 |
|POLY 3 | P=0.256N P=0.003N** P<0.001N** P=0.110N |P=0.040 * P=0.616N P=0.505 P=0.103 |
|POLY 1.5 | P=0.252N P=0.002N** P<0.001N** P=0.094N |P=0.044 * P=0.627N P=0.504 P=0.109 |
|POLY 6 | P=0.257N P=0.004N** P=0.002N** P=0.137N |P=0.034 * P=0.596N P=0.511 P=0.095 |
|LOGISTIC REGRESSION| P=0.319N P=0.005N** P=0.002N** P=0.141N |P=0.023 * P=0.575N P=0.518 P=0.080 |
|COCH-ARM / FISHERS | P=0.244N P=0.003N** P<0.001N** P=0.083N |P=0.051 P=0.643N P=0.500 P=0.117 |
|ORDER RESTRICTED | P=0.002N** (e) (e) (e) |P=0.065 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 5/50 (10%) |3/50 (6%) 9/50 (18%) 2/50 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 2/43.34 1/41.57 2/40.15 5/41.35 |3/44.71 9/46.44 2/44.74 5/43.14 |
|POLY-3 PERCENT (g) | 4.6% 2.4% 5.0% 12.1% |6.7% 19.4% 4.5% 11.6% |
|TERMINAL (d) | 2/34 (6%) 0/24 (0%) 1/30 (3%) 3/28 (11%) |1/35 (3%) 8/39 (21%) 1/35 (3%) 4/32 (13%) |
|FIRST INCIDENCE | 729 (T) 691 607 514 |633 682 622 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054 P=0.596N P=0.644 P=0.164 |P=0.438N P=0.098 P=0.494N P=0.323 |
|POLY 3 | P=0.055 P=0.515N P=0.667 P=0.196 |P=0.363N P=0.068 P=0.500N P=0.336 |
|POLY 1.5 | P=0.057 P=0.506N P=0.675 P=0.206 |P=0.354N P=0.065 P=0.499N P=0.346 |
|POLY 6 | P=0.053 P=0.529N P=0.658 P=0.184 |P=0.375N P=0.074 P=0.499N P=0.324 |
|LOGISTIC REGRESSION| P=0.057 P=0.539N P=0.671 P=0.208 |P=0.376N P=0.070 P=0.506N P=0.345 |
|COCH-ARM / FISHERS | P=0.061 P=0.500N P=0.691N P=0.218 |P=0.346N P=0.061 P=0.500N P=0.357 |
|ORDER RESTRICTED | P=0.069 (e) (e) (e) |P=0.340 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 3/50 (6%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.34 0/41.42 0/39.73 0/40.35 |2/44.12 3/46.44 3/44.42 1/42.95 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 6.5% 6.8% 2.3% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |2/35 (6%) 2/39 (5%) 2/35 (6%) 1/32 (3%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 682 715 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.373N P=0.557 P=0.503 P=0.531N |
|POLY 3 | (e) (e) (e) (e) |P=0.332N P=0.523 P=0.503 P=0.509N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.322N P=0.514 P=0.503 P=0.505N |
|POLY 6 | (e) (e) (e) (e) |P=0.347N P=0.540 P=0.507 P=0.515N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.354N P=0.537 P=0.513 P=0.531N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.310N P=0.500 P=0.500 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.358N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |8/50 (16%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 6/43.34 1/41.74 0/39.73 1/40.35 |8/44.47 0/46.25 1/44.36 2/42.95 |
|POLY-3 PERCENT (g) | 13.8% 2.4% 0.0% 2.5% |18.0% 0.0% 2.3% 4.7% |
|TERMINAL (d) | 6/34 (18%) 0/24 (0%) 0/30 (0%) 1/28 (4%) |7/35 (20%) 0/39 (0%) 1/35 (3%) 2/32 (6%) |
|FIRST INCIDENCE | 729 (T) 641 --- 729 (T) |632 --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.059N P=0.120N P=0.024N* P=0.092N |P=0.159N P=0.003N** P=0.018N* P=0.063N |
|POLY 3 | P=0.053N P=0.061N P=0.020N* P=0.067N |P=0.134N P=0.003N** P=0.015N* P=0.050N |
|POLY 1.5 | P=0.053N P=0.058N P=0.018N* P=0.062N |P=0.126N P=0.003N** P=0.016N* P=0.048N* |
|POLY 6 | P=0.051N P=0.067N P=0.022N* P=0.075N |P=0.147N P=0.002N** P=0.015N* P=0.053N |
|LOGISTIC REGRESSION| P=0.065N P=0.075N (e) P=0.092N |P=0.146N P=0.003N** P=0.016N* P=0.055N |
|COCH-ARM / FISHERS | P=0.054N P=0.056N P=0.013N* P=0.056N |P=0.123N P=0.003N** P=0.015N* P=0.046N* |
|ORDER RESTRICTED | P=0.003N** (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 1/50 (2%) 5/50 (10%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 8/43.34 1/41.42 5/40.65 2/40.85 |1/44.12 1/46.44 1/44.65 4/43.19 |
|POLY-3 PERCENT (g) | 18.5% 2.4% 12.3% 4.9% |2.3% 2.2% 2.2% 9.3% |
|TERMINAL (d) | 8/34 (24%) 1/24 (4%) 3/30 (10%) 0/28 (0%) |1/35 (3%) 0/39 (0%) 0/35 (0%) 3/32 (9%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 580 651 |729 (T) 682 651 664 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.210N P=0.052N P=0.362N P=0.088N |P=0.048 * P=0.726N P=0.755N P=0.160 |
|POLY 3 | P=0.188N P=0.018N* P=0.317N P=0.054N |P=0.059 P=0.749N P=0.758N P=0.172 |
|POLY 1.5 | P=0.187N P=0.017N* P=0.306N P=0.050N |P=0.062 P=0.754N P=0.759N P=0.175 |
|POLY 6 | P=0.184N P=0.021N* P=0.326N P=0.060N |P=0.056 P=0.741N P=0.756N P=0.168 |
|LOGISTIC REGRESSION| P=0.211N P=0.052N P=0.339N P=0.069N |P=0.061 P=0.759N P=0.762 P=0.165 |
|COCH-ARM / FISHERS | P=0.183N P=0.015N* P=0.277N P=0.046N* |P=0.065 P=0.753N P=0.753N P=0.181 |
|ORDER RESTRICTED | P=0.021N* (e) (e) (e) |P=0.068 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.34 0/41.42 3/40.65 2/41.20 |1/44.58 0/46.25 0/44.36 1/42.95 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.4% 4.9% |2.2% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 1/30 (3%) 1/28 (4%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | --- --- 578 386 |595 --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066 (e) P=0.100 P=0.218 |P=0.496 P=0.508N P=0.508N P=0.743 |
|POLY 3 | P=0.064 (e) P=0.107 P=0.226 |P=0.501 P=0.493N P=0.501N P=0.752 |
|POLY 1.5 | P=0.067 (e) P=0.110 P=0.232 |P=0.508 P=0.495N P=0.500N P=0.756 |
|POLY 6 | P=0.059 (e) P=0.104 P=0.217 |P=0.492 P=0.487N P=0.501N P=0.748 |
|LOGISTIC REGRESSION| P=0.076 (e) P=0.128 P=0.237 |P=0.527 P=0.551N P=0.535N P=0.760N |
|COCH-ARM / FISHERS | P=0.070 (e) P=0.121 P=0.247 |P=0.518 P=0.500N P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.071 (e) (e) (e) |P=0.387 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 43/50 (86%) 42/50 (84%) 35/50 (70%) 38/50 (76%) |17/50 (34%) 15/50 (30%) 15/50 (30%) 19/50 (38%) |
|POLY-3 RATE (b) | 43/46.95 42/46.85 35/43.12 38/44.96 |17/45.49 15/46.55 15/45.38 19/44.58 |
|POLY-3 PERCENT (g) | 91.6% 89.7% 81.2% 84.5% |37.4% 32.2% 33.1% 42.6% |
|TERMINAL (d) | 32/34 (94%) 22/24 (92%) 26/30 (87%) 25/28 (89%) |13/35 (37%) 13/39 (33%) 13/35 (37%) 14/32 (44%) |
|FIRST INCIDENCE | 433 446 437 386 |595 682 519 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.277N P=0.061 P=0.337N P=0.430 |P=0.148 P=0.283N P=0.418N P=0.319 |
|POLY 3 | P=0.112N P=0.515N P=0.099N P=0.207N |P=0.249 P=0.382N P=0.416N P=0.384 |
|POLY 1.5 | P=0.087N P=0.478N P=0.071N P=0.162N |P=0.270 P=0.393N P=0.411N P=0.399 |
|POLY 6 | P=0.163N P=0.589N P=0.165N P=0.295N |P=0.221 P=0.359N P=0.420N P=0.365 |
|LOGISTIC REGRESSION| P=0.134N P=0.549N P=0.111N P=0.242N |P=0.234 P=0.347N P=0.408N P=0.383 |
|COCH-ARM / FISHERS | P=0.073N P=0.500N P=0.045N* P=0.154N |P=0.298 P=0.415N P=0.415N P=0.418 |
|ORDER RESTRICTED | P=0.122N (e) (e) (e) |P=0.321 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 5/50 (10%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.34 1/41.56 1/39.73 5/42.71 |1/44.23 1/47.10 0/44.36 1/43.48 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 2.5% 11.7% |2.3% 2.1% 0.0% 2.3% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 1/30 (3%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 693 729 (T) 521 |701 392 --- 566 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.471 P=0.475 P=0.032 * |P=0.594N P=0.747N P=0.495N P=0.744 |
|POLY 3 | P=0.006 ** P=0.492 P=0.483 P=0.029 * |P=0.584N P=0.746N P=0.499N P=0.757 |
|POLY 1.5 | P=0.006 ** P=0.497 P=0.488 P=0.030 * |P=0.581N P=0.752N P=0.499N P=0.759 |
|POLY 6 | P=0.006 ** P=0.483 P=0.476 P=0.028 * |P=0.587N P=0.739N P=0.499N P=0.755 |
|LOGISTIC REGRESSION| P=0.007 ** P=0.496 P=0.475 P=0.034 * |P=0.557N P=0.692 P=0.499N P=0.761N |
|COCH-ARM / FISHERS | P=0.007 ** P=0.500 P=0.500 P=0.028 * |P=0.579N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.003 ** (e) (e) (e) |P=0.539N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 6/50 (12%) 12/50 (24%) 12/50 (24%) |3/50 (6%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 14/44.86 6/42.53 12/42.28 12/42.95 |3/45.08 2/46.44 0/44.36 1/43.24 |
|POLY-3 PERCENT (g) | 31.2% 14.1% 28.4% 27.9% |6.7% 4.3% 0.0% 2.3% |
|TERMINAL (d) | 9/34 (27%) 3/24 (13%) 6/30 (20%) 8/28 (29%) |0/35 (0%) 1/39 (3%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 591 437 437 356 |632 682 --- 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.286 P=0.137N P=0.559N P=0.580 |P=0.183N P=0.442N P=0.121N P=0.310N |
|POLY 3 | P=0.315 P=0.047N* P=0.479N P=0.459N |P=0.167N P=0.487N P=0.121N P=0.320N |
|POLY 1.5 | P=0.323 P=0.041N* P=0.458N P=0.430N |P=0.163N P=0.491N P=0.120N P=0.313N |
|POLY 6 | P=0.304 P=0.061N P=0.504N P=0.512N |P=0.173N P=0.478N P=0.123N P=0.330N |
|LOGISTIC REGRESSION| P=0.332 P=0.042N* P=0.444N P=0.415N |P=0.150N P=0.531N P=0.129N P=0.299N |
|COCH-ARM / FISHERS | P=0.336 P=0.039N* P=0.410N P=0.410N |P=0.158N P=0.500N P=0.121N P=0.309N |
|ORDER RESTRICTED | P=0.314N (e) (e) (e) |P=0.116N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver: Serosa |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.34 0/41.42 0/39.73 0/40.35 |2/44.54 2/46.29 0/44.36 0/42.95 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |4.5% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 1/34 (3%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |1/35 (3%) 1/39 (3%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |611 720 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.372N P=0.569N P=0.525N P=0.539N |P=0.077N P=0.657N P=0.235N P=0.250N |
|POLY 3 | P=0.363N P=0.509N P=0.517N P=0.514N |P=0.069N P=0.680N P=0.238N P=0.245N |
|POLY 1.5 | P=0.367N P=0.504N P=0.512N P=0.508N |P=0.068N P=0.685N P=0.237N P=0.242N |
|POLY 6 | P=0.356N P=0.518N P=0.523N P=0.523N |P=0.072N P=0.670N P=0.238N P=0.250N |
|LOGISTIC REGRESSION| P=0.372N (e) (e) (e) |P=0.067N P=0.696N P=0.241N P=0.235N |
|COCH-ARM / FISHERS | P=0.366N P=0.500N P=0.500N P=0.500N |P=0.067N P=0.691N P=0.247N P=0.247N |
|ORDER RESTRICTED | P=0.133N (e) (e) (e) |P=0.122N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 6/50 (12%) 2/50 (4%) |4/50 (8%) 2/50 (4%) 5/50 (10%) 3/50 (6%) |
|POLY-3 RATE (b) | 6/44.77 2/42.58 6/42.94 2/41.00 |4/45.63 2/46.47 5/46.21 3/43.91 |
|POLY-3 PERCENT (g) | 13.4% 4.7% 14.0% 4.9% |8.8% 4.3% 10.8% 6.8% |
|TERMINAL (d) | 3/34 (9%) 0/24 (0%) 2/30 (7%) 1/28 (4%) |0/35 (0%) 0/39 (0%) 1/35 (3%) 2/32 (6%) |
|FIRST INCIDENCE | 222 437 22 512 |595 682 430 254 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.324N P=0.203N P=0.547 P=0.189N |P=0.468 P=0.300N P=0.507 P=0.519N |
|POLY 3 | P=0.325N P=0.149N P=0.592 P=0.162N |P=0.484 P=0.329N P=0.508 P=0.521N |
|POLY 1.5 | P=0.313N P=0.141N P=0.604 P=0.150N |P=0.504 P=0.332N P=0.508 P=0.508N |
|POLY 6 | P=0.339N P=0.163N P=0.576 P=0.180N |P=0.453 P=0.322N P=0.508 P=0.541N |
|LOGISTIC REGRESSION| P=0.198N P=0.134N P=0.439N P=0.115N |P=0.554N P=0.383N P=0.464 P=0.485N |
|COCH-ARM / FISHERS | P=0.292N P=0.134N P=0.620N P=0.134N |P=0.521 P=0.339N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.135N (e) (e) (e) |P=0.533 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/43.82 2/42.63 3/41.17 1/40.35 |1/44.12 1/46.25 0/44.36 1/43.48 |
|POLY-3 PERCENT (g) | 6.9% 4.7% 7.3% 2.5% |2.3% 2.2% 0.0% 2.3% |
|TERMINAL (d) | 1/34 (3%) 0/24 (0%) 0/30 (0%) 1/28 (4%) |1/35 (3%) 1/39 (3%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 622 446 560 729 (T) |729 (T) 729 (T) --- 566 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.328N P=0.556N P=0.593 P=0.372N |P=0.603N P=0.738N P=0.500N P=0.750 |
|POLY 3 | P=0.328N P=0.513N P=0.634 P=0.335N |P=0.582N P=0.750N P=0.499N P=0.758 |
|POLY 1.5 | P=0.315N P=0.503N P=0.641 P=0.321N |P=0.580N P=0.754N P=0.499N P=0.759 |
|POLY 6 | P=0.342N P=0.530N P=0.626 P=0.356N |P=0.584N P=0.743N P=0.498N P=0.756 |
|LOGISTIC REGRESSION| P=0.266N P=0.511N P=0.634N P=0.321N |P=0.571N P=0.738N (e) P=0.760N |
|COCH-ARM / FISHERS | P=0.295N P=0.500N P=0.661N P=0.309N |P=0.579N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.298N (e) (e) (e) |P=0.538N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 27/50 (54%) 26/50 (52%) 28/50 (56%) |45/50 (90%) 47/50 (94%) 46/50 (92%) 45/50 (90%) |
|POLY-3 RATE (b) | 31/45.64 27/44.37 26/42.23 28/42.75 |45/48.62 47/48.48 46/49.36 45/47.49 |
|POLY-3 PERCENT (g) | 67.9% 60.9% 61.6% 65.5% |92.6% 97.0% 93.2% 94.8% |
|TERMINAL (d) | 24/34 (71%) 17/24 (71%) 20/30 (67%) 22/28 (79%) |34/35 (97%) 39/39 (100%) 33/35 (94%) 31/32 (97%) |
|FIRST INCIDENCE | 433 510 402 521 |161 392 430 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.532N P=0.296 P=0.464N P=0.399 |P=0.152 P=0.354N P=0.514 P=0.330 |
|POLY 3 | P=0.535 P=0.309N P=0.339N P=0.494N |P=0.572N P=0.272 P=0.616 P=0.489 |
|POLY 1.5 | P=0.480N P=0.282N P=0.294N P=0.419N |P=0.555N P=0.300 P=0.559 P=0.506 |
|POLY 6 | P=0.457 P=0.352N P=0.396N P=0.594N |P=0.524N P=0.272 P=0.665N P=0.551 |
|LOGISTIC REGRESSION| P=0.535 P=0.331N P=0.348N P=0.507N |P=0.510N P=0.434 P=0.514 P=0.599 |
|COCH-ARM / FISHERS | P=0.389N P=0.272N P=0.210N P=0.342N |P=0.422N P=0.357 P=0.500 P=0.630N |
|ORDER RESTRICTED | P=0.463N (e) (e) (e) |P=0.449 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 28/50 (56%) 27/50 (54%) 35/50 (70%) |31/50 (62%) 31/50 (62%) 40/50 (80%) 36/50 (72%) |
|POLY-3 RATE (b) | 29/44.86 28/43.28 27/42.53 35/46.10 |31/45.90 31/48.06 40/46.80 36/46.01 |
|POLY-3 PERCENT (g) | 64.7% 64.7% 63.5% 75.9% |67.5% 64.5% 85.5% 78.2% |
|TERMINAL (d) | 25/34 (74%) 21/24 (88%) 21/30 (70%) 23/28 (82%) |27/35 (77%) 26/39 (67%) 34/35 (97%) 27/32 (84%) |
|FIRST INCIDENCE | 516 615 402 356 |161 392 430 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.055 P=0.077 P=0.458 P=0.023 * |P=0.006 ** P=0.326N P=0.032 * P=0.087 |
|POLY 3 | P=0.115 P=0.590 P=0.545N P=0.159 |P=0.030 * P=0.462N P=0.025 * P=0.165 |
|POLY 1.5 | P=0.109 P=0.539N P=0.508N P=0.163 |P=0.040 * P=0.521N P=0.029 * P=0.163 |
|POLY 6 | P=0.120 P=0.513 P=0.587N P=0.145 |P=0.023 * P=0.367N P=0.022 * P=0.188 |
|LOGISTIC REGRESSION| P=0.046 * P=0.503 P=0.554 P=0.097 |P=0.040 * P=0.531N P=0.034 * P=0.150 |
|COCH-ARM / FISHERS | P=0.103 P=0.500N P=0.420N P=0.149 |P=0.074 P=0.582N P=0.038 * P=0.198 |
|ORDER RESTRICTED | P=0.158 (e) (e) (e) |P=0.047 * (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 10/50 (20%) 11/50 (22%) |3/50 (6%) 7/50 (14%) 13/50 (26%) 14/50 (28%) |
|POLY-3 RATE (b) | 6/43.34 5/41.92 10/40.82 11/41.52 |3/44.12 7/46.25 13/44.48 14/44.90 |
|POLY-3 PERCENT (g) | 13.8% 11.9% 24.5% 26.5% |6.8% 15.1% 29.2% 31.2% |
|TERMINAL (d) | 6/34 (18%) 2/24 (8%) 7/30 (23%) 8/28 (29%) |3/35 (9%) 7/39 (18%) 12/35 (34%) 9/32 (28%) |
|FIRST INCIDENCE | 729 (T) 641 560 386 |729 (T) 729 (T) 701 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033 * P=0.551 P=0.141 P=0.068 |P<0.001 ** P=0.203 P=0.006 ** P=0.003 ** |
|POLY 3 | P=0.032 * P=0.524N P=0.166 P=0.116 |P=0.002 ** P=0.177 P=0.005 ** P=0.003 ** |
|POLY 1.5 | P=0.036 * P=0.509N P=0.176 P=0.129 |P=0.002 ** P=0.169 P=0.005 ** P=0.003 ** |
|POLY 6 | P=0.027 * P=0.547N P=0.156 P=0.099 |P<0.001 ** P=0.191 P=0.005 ** P=0.003 ** |
|LOGISTIC REGRESSION| P=0.029 * P=0.580N P=0.147 P=0.105 |P<0.001 ** P=0.203 P=0.007 ** P=0.004 ** |
|COCH-ARM / FISHERS | P=0.043 * P=0.500N P=0.207 P=0.143 |P=0.002 ** P=0.159 P=0.006 ** P=0.003 ** |
|ORDER RESTRICTED | P=0.079 (e) (e) (e) |P=0.002 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 5/50 (10%) 2/49 (4%) 2/50 (4%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 3/48 (6%) |
|POLY-3 RATE (b) | 0/43.34 5/42.10 2/39.74 2/40.87 |1/44.44 0/46.25 0/44.36 3/42.25 |
|POLY-3 PERCENT (g) | 0.0% 11.9% 5.0% 4.9% |2.3% 0.0% 0.0% 7.1% |
|TERMINAL (d) | 0/34 (0%) 1/24 (4%) 1/30 (3%) 1/28 (4%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 2/32 (6%) |
|FIRST INCIDENCE | --- 618 560 571 |161 --- --- 602 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.535N P=0.022 * P=0.224 P=0.211 |P=0.058 P=0.500N P=0.500N P=0.288 |
|POLY 3 | P=0.540N P=0.028 * P=0.218 P=0.224 |P=0.057 P=0.492N P=0.500N P=0.287 |
|POLY 1.5 | P=0.525N P=0.029 * P=0.222 P=0.230 |P=0.059 P=0.495N P=0.499N P=0.290 |
|POLY 6 | P=0.560N P=0.025 * P=0.214 P=0.216 |P=0.055 P=0.487N P=0.500N P=0.285 |
|LOGISTIC REGRESSION| P=0.508N P=0.031 * P=0.241 P=0.244 |P=0.067 (e) (e) P=0.284 |
|COCH-ARM / FISHERS | P=0.506N P=0.028 * P=0.242 P=0.247 |P=0.063 P=0.495N P=0.495N P=0.301 |
|ORDER RESTRICTED | P=0.100 (e) (e) (e) |P=0.032 * (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/22 (5%) 0/26 (0%) 1/25 (4%) 2/25 (8%) |0/13 (0%) 0/13 (0%) 2/9 (22%) 0/21 (0%) |
|POLY-3 RATE (b) | 1/19.98 0/19.88 1/21.41 2/20.87 |0/10.03 0/11.92 2/8.10 0/16.93 |
|POLY-3 PERCENT (g) | 5.0% 0.0% 4.7% 9.6% |0.0% 0.0% 24.7% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/10 (0%) 0/16 (0%) 0/11 (0%) |0/7 (0%) 0/9 (0%) 0/4 (0%) 0/9 (0%) |
|FIRST INCIDENCE | 692 --- 608 512 |--- --- 640 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.173 P=0.534N P=0.719 P=0.457 |P=0.504 (e) P=0.254 (e) |
|POLY 3 | P=0.213 P=0.501N P=0.746N P=0.515 |P=0.598 (e) P=0.171 (e) |
|POLY 1.5 | P=0.208 P=0.486N P=0.743N P=0.529 |P=0.617 (e) P=0.165 (e) |
|POLY 6 | P=0.216 P=0.522N P=0.748N P=0.494 |P=0.567 (e) P=0.178 (e) |
|LOGISTIC REGRESSION| P=0.211 P=0.490N P=0.716N P=0.643 |P=0.610 (e) P=0.140 (e) |
|COCH-ARM / FISHERS | P=0.200 P=0.458N P=0.722N P=0.549 |P=0.617 (e) P=0.156 (e) |
|ORDER RESTRICTED | P=0.237 (e) (e) (e) |P=0.242 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/22 (36%) 8/26 (31%) 13/25 (52%) 14/25 (56%) |7/13 (54%) 4/13 (31%) 3/9 (33%) 5/21 (24%) |
|POLY-3 RATE (b) | 8/19.94 8/21.00 13/22.89 14/21.46 |7/10.78 4/12.10 3/8.00 5/17.81 |
|POLY-3 PERCENT (g) | 40.1% 38.1% 56.8% 65.2% |64.9% 33.1% 37.5% 28.1% |
|TERMINAL (d) | 7/15 (47%) 4/10 (40%) 10/16 (63%) 10/11 (91%) |5/7 (71%) 3/9 (33%) 1/4 (25%) 2/9 (22%) |
|FIRST INCIDENCE | 703 618 253 571 |519 682 622 602 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * P=0.324 P=0.142 P=0.008 ** |P=0.410N P=0.122N P=0.301N P=0.275N |
|POLY 3 | P=0.024 * P=0.575N P=0.214 P=0.085 |P=0.122N P=0.128N P=0.230N P=0.050N |
|POLY 1.5 | P=0.028 * P=0.525N P=0.214 P=0.109 |P=0.113N P=0.149N P=0.243N P=0.053N |
|POLY 6 | P=0.019 * P=0.626 P=0.219 P=0.056 |P=0.146N P=0.104N P=0.228N P=0.050N |
|LOGISTIC REGRESSION| P=0.024 * P=0.548 P=0.195 P=0.039 * |P=0.118N P=0.120N P=0.241N P=0.060N |
|COCH-ARM / FISHERS | P=0.034 * P=0.458N P=0.217 P=0.146 |P=0.111N P=0.214N P=0.305N P=0.080N |
|ORDER RESTRICTED | P=0.062 (e) (e) (e) |P=0.027N* (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/22 (9%) 2/26 (8%) 2/25 (8%) 2/25 (8%) |2/13 (15%) 4/13 (31%) 2/9 (22%) 3/21 (14%) |
|POLY-3 RATE (b) | 2/19.84 2/19.99 2/20.99 2/20.14 |2/11.02 4/11.96 2/7.81 3/16.93 |
|POLY-3 PERCENT (g) | 10.1% 10.0% 9.5% 9.9% |18.2% 33.5% 25.6% 17.7% |
|TERMINAL (d) | 2/15 (13%) 1/10 (10%) 2/16 (13%) 1/11 (9%) |1/7 (14%) 3/9 (33%) 1/4 (25%) 3/9 (33%) |
|FIRST INCIDENCE | 729 (T) 701 729 (T) 674 |161 720 640 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.551 P=0.561 P=0.677N P=0.591 |P=0.551N P=0.423 P=0.601 P=0.595 |
|POLY 3 | P=0.578N P=0.695N P=0.677N P=0.693N |P=0.345N P=0.362 P=0.570 P=0.681N |
|POLY 1.5 | P=0.572N P=0.669N P=0.669N P=0.673N |P=0.325N P=0.344 P=0.567 P=0.669N |
|POLY 6 | P=0.583 P=0.667 P=0.682N P=0.678 |P=0.389N P=0.388 P=0.569 P=0.686 |
|LOGISTIC REGRESSION| P=0.571 P=0.610 P=0.677N P=0.655 |P=0.302N P=0.227 P=0.427 P=0.675 |
|COCH-ARM / FISHERS | P=0.566N P=0.629N P=0.645N P=0.645N |P=0.302N P=0.322 P=0.550 P=0.647N |
|ORDER RESTRICTED | P=0.731N (e) (e) (e) |P=0.468N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Mammary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 17/50 (34%) 17/50 (34%) 8/50 (16%) |45/50 (90%) 48/50 (96%) 41/50 (82%) 37/50 (74%) |
|POLY-3 RATE (b) | 15/44.59 17/44.11 17/41.08 8/41.32 |45/48.47 48/48.52 41/47.79 37/48.04 |
|POLY-3 PERCENT (g) | 33.6% 38.5% 41.4% 19.4% |92.8% 98.9% 85.8% 77.0% |
|TERMINAL (d) | 10/34 (29%) 9/24 (38%) 13/30 (43%) 5/28 (18%) |34/35 (97%) 39/39 (100%) 29/35 (83%) 23/32 (72%) |
|FIRST INCIDENCE | 591 446 560 610 |519 509 506 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075N P=0.164 P=0.266 P=0.186N |P=0.194N P=0.430N P=0.275N P=0.237N |
|POLY 3 | P=0.065N P=0.397 P=0.301 P=0.103N |P<0.001N** P=0.133 P=0.205N P=0.024N* |
|POLY 1.5 | P=0.053N P=0.415 P=0.337 P=0.088N |P<0.001N** P=0.175 P=0.183N P=0.024N* |
|POLY 6 | P=0.084N P=0.361 P=0.261 P=0.127N |P<0.001N** P=0.110 P=0.210N P=0.023N* |
|LOGISTIC REGRESSION| P=0.056N P=0.392 P=0.296 P=0.103N |P=0.002N** P=0.232 P=0.173N P=0.036N* |
|COCH-ARM / FISHERS | P=0.041N* P=0.415 P=0.415 P=0.077N |P<0.001N** P=0.218 P=0.194N P=0.033N* |
|ORDER RESTRICTED | P=0.046N* (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 3/50 (6%) 4/50 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/43.34 0/41.42 0/39.73 0/40.35 |2/44.58 3/46.25 4/44.36 3/43.52 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 6.5% 9.0% 6.9% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |1/35 (3%) 3/39 (8%) 4/35 (11%) 1/32 (3%) |
|FIRST INCIDENCE | --- --- --- --- |595 729 (T) 729 (T) 622 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.359 P=0.535 P=0.335 P=0.476 |
|POLY 3 | (e) (e) (e) (e) |P=0.401 P=0.517 P=0.335 P=0.489 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.412 P=0.510 P=0.337 P=0.494 |
|POLY 6 | (e) (e) (e) (e) |P=0.385 P=0.529 P=0.334 P=0.484 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.410 P=0.506 P=0.339 P=0.504 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.427 P=0.500 P=0.339 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.411 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia Atypical |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |5/50 (10%) 2/50 (4%) 4/50 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/43.34 0/41.42 0/39.73 0/40.35 |5/44.12 2/46.25 4/44.36 4/42.95 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |11.3% 4.3% 9.0% 9.3% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |5/35 (14%) 2/39 (5%) 4/35 (11%) 4/32 (13%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.398 P=0.174N P=0.500N P=0.557N |
|POLY 3 | (e) (e) (e) (e) |P=0.450 P=0.197N P=0.497N P=0.517N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.467 P=0.205N P=0.497N P=0.509N |
|POLY 6 | (e) (e) (e) (e) |P=0.424 P=0.184N P=0.492N P=0.527N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.398 P=0.174N P=0.500N P=0.557N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.490 P=0.218N P=0.500N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.415N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/10 (80%) 7/14 (50%) 7/11 (64%) 5/17 (29%) |9/12 (75%) 12/15 (80%) 14/15 (93%) 6/8 (75%) |
|POLY-3 RATE (b) | 8/10.00 7/10.92 7/9.97 5/12.15 |9/11.57 12/13.59 14/14.68 6/7.37 |
|POLY-3 PERCENT (g) | 80.0% 64.1% 70.2% 41.1% |77.8% 88.3% 95.4% 81.4% |
|TERMINAL (d) | 4/6 (67%) 1/2 (50%) 2/3 (67%) 4/7 (57%) |5/7 (71%) 12/12 (100%) 10/10 (100%) 5/5 (100%) |
|FIRST INCIDENCE | 530 437 560 644 |519 729 (T) 430 580 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.130N P=0.375 P=0.427 P=0.218N |P=0.512 P=0.412N P=0.334 P=0.459N |
|POLY 3 | P=0.053N P=0.368N P=0.505N P=0.054N |P=0.490 P=0.428 P=0.207 P=0.655 |
|POLY 1.5 | P=0.033N* P=0.250N P=0.452N P=0.024N* |P=0.502 P=0.484 P=0.211 P=0.675 |
|POLY 6 | P=0.111N P=0.533N P=0.562N P=0.142N |P=0.427 P=0.369 P=0.200 P=0.606 |
|LOGISTIC REGRESSION| P=0.032N* P=0.247N P=0.352N P=0.049N* |P=0.514 P=0.693 P=0.217 P=0.687N |
|COCH-ARM / FISHERS | P=0.027N* P=0.143N P=0.367N P=0.015N* |P=0.490 P=0.557 P=0.216 P=0.693N |
|ORDER RESTRICTED | P=0.027N* (e) (e) (e) |P=0.353 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/49 (20%) 8/50 (16%) 10/49 (20%) 8/50 (16%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 10/43.99 8/41.77 10/39.83 8/40.75 |0/44.12 2/46.25 1/44.36 1/43.19 |
|POLY-3 PERCENT (g) | 22.7% 19.2% 25.1% 19.6% |0.0% 4.3% 2.3% 2.3% |
|TERMINAL (d) | 7/34 (21%) 5/24 (21%) 9/30 (30%) 6/28 (21%) |0/35 (0%) 2/39 (5%) 1/35 (3%) 0/32 (0%) |
|FIRST INCIDENCE | 437 697 521 651 |--- 729 (T) 729 (T) 664 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.503N P=0.561 P=0.481 P=0.559N |P=0.559 P=0.262 P=0.500 P=0.500 |
|POLY 3 | P=0.511N P=0.444N P=0.501 P=0.467N |P=0.589 P=0.248 P=0.501 P=0.496 |
|POLY 1.5 | P=0.481N P=0.410N P=0.533 P=0.427N |P=0.593 P=0.244 P=0.501 P=0.498 |
|POLY 6 | P=0.544 P=0.495N P=0.463 P=0.519N |P=0.584 P=0.255 P=0.502 P=0.494 |
|LOGISTIC REGRESSION| P=0.507N P=0.406N P=0.544 P=0.426N |P=0.582 P=0.262 P=0.500 P=0.502 |
|COCH-ARM / FISHERS | P=0.437N P=0.379N P=0.599N P=0.379N |P=0.599 P=0.247 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.568N (e) (e) (e) |P=0.280 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/49 (29%) 13/50 (26%) 14/49 (29%) 14/50 (28%) |2/50 (4%) 3/50 (6%) 4/50 (8%) 6/50 (12%) |
|POLY-3 RATE (b) | 14/45.70 13/43.11 14/39.94 14/42.94 |2/45.11 3/46.89 4/44.96 6/43.85 |
|POLY-3 PERCENT (g) | 30.6% 30.2% 35.1% 32.6% |4.4% 6.4% 8.9% 13.7% |
|TERMINAL (d) | 7/34 (21%) 7/24 (29%) 12/30 (40%) 6/28 (21%) |0/35 (0%) 2/39 (5%) 2/35 (6%) 2/32 (6%) |
|FIRST INCIDENCE | 433 471 521 521 |519 520 640 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.411 P=0.427 P=0.437 P=0.418 |P=0.063 P=0.524 P=0.342 P=0.131 |
|POLY 3 | P=0.411 P=0.572N P=0.419 P=0.512 |P=0.071 P=0.518 P=0.335 P=0.123 |
|POLY 1.5 | P=0.443 P=0.524N P=0.478 P=0.555 |P=0.076 P=0.511 P=0.337 P=0.128 |
|POLY 6 | P=0.379 P=0.545 P=0.354 P=0.462 |P=0.066 P=0.530 P=0.337 P=0.120 |
|LOGISTIC REGRESSION| P=0.468 P=0.468N P=0.549 P=0.544N |P=0.092 P=0.429 P=0.315 P=0.138 |
|COCH-ARM / FISHERS | P=0.498 P=0.475N P=0.588N P=0.563N |P=0.083 P=0.500 P=0.339 P=0.134 |
|ORDER RESTRICTED | P=0.570 (e) (e) (e) |P=0.089 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |8/50 (16%) 9/50 (18%) 14/50 (28%) 8/50 (16%) |
|POLY-3 RATE (b) | |8/44.56 9/46.37 14/45.06 8/43.63 |
|POLY-3 PERCENT (g) | |18.0% 19.4% 31.1% 18.3% |
|TERMINAL (d) | |7/35 (20%) 8/39 (21%) 12/35 (34%) 6/32 (19%) |
|FIRST INCIDENCE | |604 700 519 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.338 P=0.592 P=0.113 P=0.537 |
|POLY 3 | |P=0.432 P=0.536 P=0.113 P=0.591 |
|POLY 1.5 | |P=0.455 P=0.522 P=0.115 P=0.598 |
|POLY 6 | |P=0.399 P=0.562 P=0.115 P=0.582 |
|LOGISTIC REGRESSION| |P=0.415 P=0.575 P=0.115 P=0.583 |
|COCH-ARM / FISHERS | |P=0.485 P=0.500 P=0.114 P=0.607N |
|ORDER RESTRICTED | |P=0.347 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/48 (48%) 28/50 (56%) 25/48 (52%) 23/49 (47%) |19/47 (40%) 15/50 (30%) 20/49 (41%) 23/48 (48%) |
|POLY-3 RATE (b) | 23/43.14 28/47.18 25/41.73 23/41.54 |19/43.29 15/47.01 20/45.44 23/45.07 |
|POLY-3 PERCENT (g) | 53.3% 59.4% 59.9% 55.4% |43.9% 31.9% 44.0% 51.0% |
|TERMINAL (d) | 19/34 (56%) 13/24 (54%) 18/30 (60%) 18/28 (64%) |15/35 (43%) 13/39 (33%) 15/35 (43%) 14/32 (44%) |
|FIRST INCIDENCE | 530 437 437 570 |519 520 618 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.455N P=0.036 * P=0.226 P=0.261 |P=0.039 * P=0.165N P=0.508 P=0.207 |
|POLY 3 | P=0.532N P=0.355 P=0.344 P=0.512 |P=0.084 P=0.168N P=0.581 P=0.322 |
|POLY 1.5 | P=0.451N P=0.337 P=0.358 P=0.567 |P=0.084 P=0.175N P=0.578 P=0.314 |
|POLY 6 | P=0.448 P=0.356 P=0.331 P=0.432 |P=0.084 P=0.155N P=0.576N P=0.335 |
|LOGISTIC REGRESSION| P=0.402N P=0.263 P=0.291 P=0.439 |P=0.078 P=0.170N P=0.571 P=0.293 |
|COCH-ARM / FISHERS | P=0.338N P=0.275 P=0.419 P=0.543N |P=0.087 P=0.194N P=0.567 P=0.299 |
|ORDER RESTRICTED | P=0.504 (e) (e) (e) |P=0.157 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/48 (6%) 5/50 (10%) 1/48 (2%) 0/49 (0%) |1/47 (2%) 2/50 (4%) 0/49 (0%) 2/48 (4%) |
|POLY-3 RATE (b) | 3/42.09 5/41.50 1/38.61 0/40.00 |1/41.84 2/46.25 0/43.63 2/42.06 |
|POLY-3 PERCENT (g) | 7.1% 12.1% 2.6% 0.0% |2.4% 4.3% 0.0% 4.8% |
|TERMINAL (d) | 2/34 (6%) 4/24 (17%) 1/30 (3%) 0/28 (0%) |1/35 (3%) 2/39 (5%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 703 709 729 (T) --- |729 (T) 729 (T) --- 664 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.021N* P=0.200 P=0.357N P=0.161N |P=0.491 P=0.538 P=0.500N P=0.479 |
|POLY 3 | P=0.020N* P=0.348 P=0.336N P=0.128N |P=0.529 P=0.535 P=0.492N P=0.502 |
|POLY 1.5 | P=0.019N* P=0.366 P=0.327N P=0.121N |P=0.533 P=0.530 P=0.491N P=0.505 |
|POLY 6 | P=0.023N* P=0.318 P=0.348N P=0.137N |P=0.525 P=0.543 P=0.491N P=0.498 |
|LOGISTIC REGRESSION| P=0.022N* P=0.267 P=0.350N P=0.142N |P=0.517 P=0.538 (e) P=0.501 |
|COCH-ARM / FISHERS | P=0.018N* P=0.381 P=0.308N P=0.117N |P=0.537 P=0.523 P=0.490N P=0.508 |
|ORDER RESTRICTED | P=0.037N* (e) (e) (e) |P=0.401 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 14/49 (29%) 13/49 (27%) 9/50 (18%) |32/50 (64%) 24/50 (48%) 23/50 (46%) 23/49 (47%) |
|POLY-3 RATE (b) | 16/44.66 14/42.23 13/41.29 9/41.56 |32/47.14 24/47.47 23/45.59 23/43.95 |
|POLY-3 PERCENT (g) | 35.8% 33.2% 31.5% 21.7% |67.9% 50.6% 50.4% 52.3% |
|TERMINAL (d) | 10/34 (29%) 8/24 (33%) 8/30 (27%) 6/28 (21%) |24/35 (69%) 19/39 (49%) 18/35 (51%) 18/32 (56%) |
|FIRST INCIDENCE | 591 602 560 512 |519 509 622 602 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.115N P=0.431 P=0.490N P=0.205N |P=0.317N P=0.039N* P=0.069N P=0.138N |
|POLY 3 | P=0.088N P=0.486N P=0.422N P=0.110N |P=0.187N P=0.062N P=0.061N P=0.090N |
|POLY 1.5 | P=0.078N P=0.457N P=0.404N P=0.094N |P=0.157N P=0.066N P=0.055N P=0.076N |
|POLY 6 | P=0.105N P=0.532N P=0.442N P=0.138N |P=0.235N P=0.054N P=0.067N P=0.109N |
|LOGISTIC REGRESSION| P=0.085N P=0.489N P=0.419N P=0.108N |P=0.162N P=0.060N P=0.048N* P=0.071N |
|COCH-ARM / FISHERS | P=0.067N P=0.440N P=0.353N P=0.083N |P=0.125N P=0.079N P=0.054N P=0.066N |
|ORDER RESTRICTED | P=0.111N (e) (e) (e) |P=0.076N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/49 (4%) 5/49 (10%) 1/50 (2%) |20/50 (40%) 24/50 (48%) 20/50 (40%) 18/49 (37%) |
|POLY-3 RATE (b) | 1/43.34 2/40.65 5/40.26 1/40.35 |20/45.95 24/47.56 20/47.06 18/44.42 |
|POLY-3 PERCENT (g) | 2.3% 4.9% 12.4% 2.5% |43.5% 50.5% 42.5% 40.5% |
|TERMINAL (d) | 1/34 (3%) 1/24 (4%) 3/30 (10%) 1/28 (4%) |15/35 (43%) 20/39 (51%) 13/35 (37%) 13/32 (41%) |
|FIRST INCIDENCE | 729 (T) 721 560 729 (T) |519 392 430 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.529 P=0.389 P=0.087 P=0.718 |P=0.410N P=0.448 P=0.563N P=0.533N |
|POLY 3 | P=0.507 P=0.478 P=0.084 P=0.745 |P=0.258N P=0.320 P=0.544N P=0.470N |
|POLY 1.5 | P=0.527 P=0.487 P=0.087 P=0.752 |P=0.244N P=0.305 P=0.555N P=0.457N |
|POLY 6 | P=0.481 P=0.463 P=0.082 P=0.734 |P=0.281N P=0.349 P=0.519N P=0.488N |
|LOGISTIC REGRESSION| P=0.532 P=0.420 P=0.095 P=0.718 |P=0.243N P=0.304 P=0.578N P=0.459N |
|COCH-ARM / FISHERS | P=0.550 P=0.492 P=0.098 P=0.753N |P=0.229N P=0.273 P=0.581N P=0.449N |
|ORDER RESTRICTED | P=0.235 (e) (e) (e) |P=0.422N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/43.34 0/40.62 0/39.17 2/40.35 |0/44.12 0/46.25 0/44.36 0/42.48 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 2/28 (7%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.040 * (e) (e) P=0.196 |(e) (e) (e) (e) |
|POLY 3 | P=0.040 * (e) (e) P=0.221 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.041 * (e) (e) P=0.229 |(e) (e) (e) (e) |
|POLY 6 | P=0.039 * (e) (e) P=0.211 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.196 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.044 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.024 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 10/49 (20%) 4/49 (8%) 3/50 (6%) |11/50 (22%) 9/50 (18%) 8/50 (16%) 6/49 (12%) |
|POLY-3 RATE (b) | 6/43.34 10/41.44 4/39.17 3/40.46 |11/45.08 9/47.24 8/45.06 6/43.74 |
|POLY-3 PERCENT (g) | 13.8% 24.1% 10.2% 7.4% |24.4% 19.1% 17.8% 13.7% |
|TERMINAL (d) | 6/34 (18%) 4/24 (17%) 4/30 (13%) 2/28 (7%) |8/35 (23%) 6/39 (15%) 6/35 (17%) 3/32 (9%) |
|FIRST INCIDENCE | 729 (T) 618 729 (T) 701 |604 520 624 580 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054N P=0.079 P=0.449N P=0.344N |P=0.202N P=0.315N P=0.306N P=0.192N |
|POLY 3 | P=0.050N P=0.174 P=0.434N P=0.276N |P=0.153N P=0.356N P=0.303N P=0.155N |
|POLY 1.5 | P=0.045N* P=0.186 P=0.418N P=0.260N |P=0.145N P=0.373N P=0.302N P=0.154N |
|POLY 6 | P=0.057N P=0.158 P=0.451N P=0.298N |P=0.165N P=0.327N P=0.299N P=0.156N |
|LOGISTIC REGRESSION| P=0.056N P=0.136 P=0.449N P=0.334N |P=0.136N P=0.393N P=0.301N P=0.155N |
|COCH-ARM / FISHERS | P=0.040N* P=0.194 P=0.383N P=0.243N |P=0.134N P=0.402N P=0.306N P=0.154N |
|ORDER RESTRICTED | P=0.093N (e) (e) (e) |P=0.156N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 2/49 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/43.34 1/40.62 2/39.28 0/40.35 |0/44.12 0/46.25 0/44.36 1/43.32 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 5.1% 0.0% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/34 (0%) 1/24 (4%) 1/30 (3%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 729 (T) 700 --- |--- --- --- 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.595N P=0.431 P=0.217 (e) |P=0.184 (e) (e) P=0.500 |
|POLY 3 | P=0.601N P=0.487 P=0.216 (e) |P=0.179 (e) (e) P=0.496 |
|POLY 1.5 | P=0.590N P=0.492 P=0.221 (e) |P=0.180 (e) (e) P=0.497 |
|POLY 6 | P=0.616N P=0.478 P=0.211 (e) |P=0.176 (e) (e) P=0.495 |
|LOGISTIC REGRESSION| P=0.604N P=0.431 P=0.210 (e) |P=0.169 (e) (e) P=0.445 |
|COCH-ARM / FISHERS | P=0.576N P=0.495 P=0.242 (e) |P=0.181 (e) (e) P=0.495 |
|ORDER RESTRICTED | P=0.306 (e) (e) (e) |P=0.116 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 5/50 (10%) 0/50 (0%) | |
|POLY-3 RATE (b) | 1/43.48 6/42.90 5/39.73 0/40.35 | |
|POLY-3 PERCENT (g) | 2.3% 14.0% 12.6% 0.0% | |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 5/30 (17%) 0/28 (0%) | |
|FIRST INCIDENCE | 693 602 729 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.147N P=0.046 * P=0.078 P=0.542N | |
|POLY 3 | P=0.144N P=0.053 P=0.081 P=0.515N | |
|POLY 1.5 | P=0.130N P=0.055 P=0.088 P=0.508N | |
|POLY 6 | P=0.164N P=0.049 * P=0.074 P=0.525N | |
|LOGISTIC REGRESSION| P=0.130N P=0.059 P=0.073 P=0.508N | |
|COCH-ARM / FISHERS | P=0.119N P=0.056 P=0.102 P=0.500N | |
|ORDER RESTRICTED | P=0.063N (e) (e) (e) | |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 3/50 (6%) | |
|POLY-3 RATE (b) | 1/43.34 1/41.62 0/39.73 3/40.35 | |
|POLY-3 PERCENT (g) | 2.3% 2.4% 0.0% 7.4% | |
|TERMINAL (d) | 1/34 (3%) 0/24 (0%) 0/30 (0%) 3/28 (11%) | |
|FIRST INCIDENCE | 729 (T) 679 --- 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.150 P=0.709 P=0.525N P=0.237 | |
|POLY 3 | P=0.154 P=0.752 P=0.517N P=0.280 | |
|POLY 1.5 | P=0.158 P=0.757 P=0.512N P=0.292 | |
|POLY 6 | P=0.149 P=0.743 P=0.523N P=0.264 | |
|LOGISTIC REGRESSION| P=0.143 P=0.753 (e) P=0.237 | |
|COCH-ARM / FISHERS | P=0.167 P=0.753N P=0.500N P=0.309 | |
|ORDER RESTRICTED | P=0.089 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 25/50 (50%) 29/50 (58%) 29/50 (58%) | |
|POLY-3 RATE (b) | 23/45.09 25/45.71 29/46.45 29/45.15 | |
|POLY-3 PERCENT (g) | 51.0% 54.7% 62.4% 64.2% | |
|TERMINAL (d) | 17/34 (50%) 13/24 (54%) 17/30 (57%) 18/28 (64%) | |
|FIRST INCIDENCE | 437 437 253 386 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.095 P=0.105 P=0.084 P=0.049 * | |
|POLY 3 | P=0.095 P=0.443 P=0.182 P=0.138 | |
|POLY 1.5 | P=0.102 P=0.446 P=0.165 P=0.150 | |
|POLY 6 | P=0.089 P=0.423 P=0.202 P=0.123 | |
|LOGISTIC REGRESSION| P=0.105 P=0.402 P=0.141 P=0.125 | |
|COCH-ARM / FISHERS | P=0.115 P=0.421 P=0.158 P=0.158 | |
|ORDER RESTRICTED | P=0.150 (e) (e) (e) | |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Salivary Glands |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.34 0/41.42 0/39.19 0/40.35 |0/44.12 0/46.25 1/44.75 2/43.48 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 2.2% 4.6% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 618 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.054 (e) P=0.513 P=0.243 |
|POLY 3 | (e) (e) (e) (e) |P=0.054 (e) P=0.503 P=0.234 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.056 (e) P=0.502 P=0.235 |
|POLY 6 | (e) (e) (e) (e) |P=0.052 (e) P=0.505 P=0.232 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.065 (e) P=0.477 P=0.240 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.059 (e) P=0.500 P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.073 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Skin |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/44.69 2/41.42 4/40.15 1/40.35 |0/44.12 2/46.25 0/44.36 1/43.48 |
|POLY-3 PERCENT (g) | 9.0% 4.8% 10.0% 2.5% |0.0% 4.3% 0.0% 2.3% |
|TERMINAL (d) | 1/34 (3%) 2/24 (8%) 3/30 (10%) 1/28 (4%) |0/35 (0%) 2/39 (5%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 530 729 (T) 608 729 (T) |--- 729 (T) --- 566 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.268N P=0.434N P=0.556 P=0.224N |P=0.631N P=0.262 (e) P=0.500 |
|POLY 3 | P=0.271N P=0.372N P=0.583 P=0.211N |P=0.602N P=0.248 (e) P=0.497 |
|POLY 1.5 | P=0.259N P=0.354N P=0.604 P=0.196N |P=0.603N P=0.244 (e) P=0.498 |
|POLY 6 | P=0.286N P=0.403N P=0.559 P=0.233N |P=0.598N P=0.255 (e) P=0.495 |
|LOGISTIC REGRESSION| P=0.250N P=0.334N P=0.640N P=0.168N |P=0.599N P=0.262 (e) P=0.494 |
|COCH-ARM / FISHERS | P=0.242N P=0.339N P=0.643N P=0.181N |P=0.606N P=0.247 (e) P=0.500 |
|ORDER RESTRICTED | P=0.175N (e) (e) (e) |P=0.322 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 3/50 (6%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.34 0/41.42 2/39.73 1/40.35 |1/44.12 3/46.48 3/44.36 0/42.95 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 5.0% 2.5% |2.3% 6.5% 6.8% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 2/30 (7%) 1/28 (4%) |1/35 (3%) 2/39 (5%) 3/35 (9%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) |729 (T) 669 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.189 (e) P=0.211 P=0.461 |P=0.262N P=0.356 P=0.305 P=0.518N |
|POLY 3 | P=0.182 (e) P=0.218 P=0.486 |P=0.234N P=0.324 P=0.307 P=0.505N |
|POLY 1.5 | P=0.190 (e) P=0.224 P=0.492 |P=0.227N P=0.317 P=0.307 P=0.503N |
|POLY 6 | P=0.173 (e) P=0.211 P=0.477 |P=0.246N P=0.338 P=0.309 P=0.509N |
|LOGISTIC REGRESSION| (e) (e) P=0.211 P=0.461 |P=0.247N P=0.322 P=0.305 (e) |
|COCH-ARM / FISHERS | P=0.199 (e) P=0.247 P=0.500 |P=0.219N P=0.309 P=0.309 P=0.500N |
|ORDER RESTRICTED | P=0.152 (e) (e) (e) |P=0.168N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/49 (4%) 0/49 (0%) |0/47 (0%) 3/49 (6%) 1/50 (2%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/43.34 2/42.19 2/39.19 0/39.99 |0/41.84 3/45.37 1/44.36 0/41.81 |
|POLY-3 PERCENT (g) | 4.6% 4.7% 5.1% 0.0% |0.0% 6.6% 2.3% 0.0% |
|TERMINAL (d) | 2/34 (6%) 1/24 (4%) 2/30 (7%) 0/28 (0%) |0/35 (0%) 2/38 (5%) 1/35 (3%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) 446 729 (T) --- |--- 700 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.167N P=0.602 P=0.650 P=0.282N |P=0.239N P=0.141 P=0.500 (e) |
|POLY 3 | P=0.179N P=0.685 P=0.658 P=0.255N |P=0.205N P=0.134 P=0.512 (e) |
|POLY 1.5 | P=0.173N P=0.691 P=0.666 P=0.249N |P=0.203N P=0.131 P=0.513 (e) |
|POLY 6 | P=0.185N P=0.671 P=0.648 P=0.265N |P=0.206N P=0.138 P=0.511 (e) |
|LOGISTIC REGRESSION| P=0.167N P=0.693N P=0.650 (e) |P=0.222N P=0.137 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.164N P=0.691N P=0.684 P=0.253N |P=0.205N P=0.129 P=0.515 (e) |
|ORDER RESTRICTED | P=0.188N (e) (e) (e) |P=0.238N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 7/49 (14%) 5/49 (10%) |5/47 (11%) 16/49 (33%) 7/50 (14%) 5/48 (10%) |
|POLY-3 RATE (b) | 2/43.34 4/42.07 7/42.46 5/42.24 |5/41.95 16/47.21 7/45.25 5/42.55 |
|POLY-3 PERCENT (g) | 4.6% 9.5% 16.5% 11.8% |11.9% 33.9% 15.5% 11.8% |
|TERMINAL (d) | 2/34 (6%) 1/24 (4%) 2/30 (7%) 0/28 (0%) |4/35 (11%) 11/38 (29%) 5/35 (14%) 3/32 (9%) |
|FIRST INCIDENCE | 729 (T) 618 253 514 |701 392 441 580 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.161 P=0.239 P=0.070 P=0.181 |P=0.112N P=0.016 * P=0.387 P=0.579 |
|POLY 3 | P=0.173 P=0.323 P=0.073 P=0.205 |P=0.058N P=0.012 * P=0.433 P=0.622N |
|POLY 1.5 | P=0.173 P=0.332 P=0.073 P=0.207 |P=0.056N P=0.010 * P=0.432 P=0.619N |
|POLY 6 | P=0.175 P=0.308 P=0.072 P=0.202 |P=0.062N P=0.016 * P=0.434 P=0.626N |
|LOGISTIC REGRESSION| P=0.200 P=0.319 P=0.111 P=0.221 |P=0.058N P=0.009 ** P=0.424 P=0.627N |
|COCH-ARM / FISHERS | P=0.172 P=0.339 P=0.075 P=0.210 |P=0.059N P=0.008 ** P=0.424 P=0.616N |
|ORDER RESTRICTED | P=0.112 (e) (e) (e) |P=0.126N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Spleen |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/49 (4%) 2/49 (4%) |0/47 (0%) 2/49 (4%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/43.34 2/41.42 2/39.19 2/40.63 |0/41.84 2/45.37 0/44.36 0/41.81 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 5.1% 4.9% |0.0% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 2/24 (8%) 2/30 (7%) 0/28 (0%) |0/35 (0%) 1/38 (3%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 631 |--- 700 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.276 P=0.165 P=0.211 P=0.220 |P=0.251N P=0.263 (e) (e) |
|POLY 3 | P=0.270 P=0.227 P=0.215 P=0.223 |P=0.219N P=0.255 (e) (e) |
|POLY 1.5 | P=0.278 P=0.233 P=0.220 P=0.227 |P=0.220N P=0.252 (e) (e) |
|POLY 6 | P=0.261 P=0.217 P=0.210 P=0.217 |P=0.217N P=0.261 (e) (e) |
|LOGISTIC REGRESSION| P=0.272 P=0.165 P=0.211 P=0.239 |P=0.231N P=0.254 (e) (e) |
|COCH-ARM / FISHERS | P=0.287 P=0.247 P=0.242 P=0.242 |P=0.224N P=0.258 (e) (e) |
|ORDER RESTRICTED | P=0.168 (e) (e) (e) |P=0.263N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 4/49 (8%) 0/49 (0%) |8/47 (17%) 9/49 (18%) 6/50 (12%) 1/48 (2%) |
|POLY-3 RATE (b) | 4/43.70 1/41.46 4/40.05 0/39.99 |8/43.29 9/45.47 6/45.77 1/42.10 |
|POLY-3 PERCENT (g) | 9.2% 2.4% 10.0% 0.0% |18.5% 19.8% 13.1% 2.4% |
|TERMINAL (d) | 3/34 (9%) 0/24 (0%) 2/30 (7%) 0/28 (0%) |5/35 (14%) 7/38 (18%) 2/35 (6%) 0/32 (0%) |
|FIRST INCIDENCE | 629 721 602 --- |519 682 506 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179N P=0.274N P=0.557 P=0.088N |P=0.014N* P=0.567 P=0.390N P=0.026N* |
|POLY 3 | P=0.174N P=0.194N P=0.595 P=0.072N |P=0.007N** P=0.545 P=0.343N P=0.017N* |
|POLY 1.5 | P=0.170N P=0.185N P=0.605 P=0.067N |P=0.006N** P=0.544 P=0.340N P=0.016N* |
|POLY 6 | P=0.178N P=0.210N P=0.586 P=0.079N |P=0.008N** P=0.552 P=0.344N P=0.019N* |
|LOGISTIC REGRESSION| P=0.173N P=0.197N P=0.614 P=0.072N |P=0.006N** P=0.541 P=0.350N P=0.016N* |
|COCH-ARM / FISHERS | P=0.164N P=0.181N P=0.631 P=0.061N |P=0.006N** P=0.538 P=0.339N P=0.014N* |
|ORDER RESTRICTED | P=0.043N* (e) (e) (e) |P=0.016N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/49 (10%) 5/49 (10%) 2/50 (4%) |2/50 (4%) 5/50 (10%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.88 5/42.11 5/40.34 2/40.72 |2/45.11 5/47.01 0/44.36 1/43.24 |
|POLY-3 PERCENT (g) | 4.6% 11.9% 12.4% 4.9% |4.4% 10.6% 0.0% 2.3% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 1/30 (3%) 1/28 (4%) |0/35 (0%) 3/39 (8%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 616 471 607 624 |519 520 --- 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.443N P=0.184 P=0.163 P=0.640 |P=0.095N P=0.254 P=0.244N P=0.502N |
|POLY 3 | P=0.432N P=0.199 P=0.182 P=0.667 |P=0.078N P=0.233 P=0.241N P=0.515N |
|POLY 1.5 | P=0.410N P=0.206 P=0.189 P=0.680 |P=0.076N P=0.227 P=0.239N P=0.508N |
|POLY 6 | P=0.460N P=0.187 P=0.177 P=0.649 |P=0.081N P=0.245 P=0.242N P=0.523N |
|LOGISTIC REGRESSION| P=0.368N P=0.207 P=0.212 P=0.690N |P=0.068N P=0.174 P=0.274N P=0.499N |
|COCH-ARM / FISHERS | P=0.381N P=0.210 P=0.210 P=0.691N |P=0.076N P=0.218 P=0.247N P=0.500N |
|ORDER RESTRICTED | P=0.306 (e) (e) (e) |P=0.107N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/49 (8%) 3/49 (6%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.34 4/41.70 3/39.85 1/40.77 |1/44.47 1/46.91 0/44.36 1/43.19 |
|POLY-3 PERCENT (g) | 0.0% 9.6% 7.5% 2.5% |2.3% 2.1% 0.0% 2.3% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 1/30 (3%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 612 560 610 |633 509 --- 664 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491N P=0.054 P=0.107 P=0.486 |P=0.596N P=0.750N P=0.500N P=0.758 |
|POLY 3 | P=0.479N P=0.055 P=0.104 P=0.488 |P=0.584N P=0.749N P=0.500N P=0.754 |
|POLY 1.5 | P=0.463N P=0.057 P=0.107 P=0.494 |P=0.581N P=0.753N P=0.500N P=0.757 |
|POLY 6 | P=0.499N P=0.052 P=0.101 P=0.480 |P=0.589N P=0.741N P=0.500N P=0.751 |
|LOGISTIC REGRESSION| P=0.432N P=0.060 P=0.117 P=0.509 |P=0.559N P=0.705 P=0.517N P=0.760N |
|COCH-ARM / FISHERS | P=0.444N P=0.056 P=0.117 P=0.500 |P=0.579N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.120 (e) (e) (e) |P=0.542N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/49 (10%) 5/49 (10%) 3/50 (6%) |3/50 (6%) 5/50 (10%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.77 5/42.32 5/40.66 3/40.75 |3/45.41 5/46.41 0/44.36 1/43.24 |
|POLY-3 PERCENT (g) | 4.6% 11.8% 12.3% 7.4% |6.6% 10.8% 0.0% 2.3% |
|TERMINAL (d) | 0/34 (0%) 1/24 (4%) 1/30 (3%) 1/28 (4%) |0/35 (0%) 3/39 (8%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 629 471 602 624 |519 700 --- 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.536 P=0.172 P=0.163 P=0.436 |P=0.062N P=0.417 P=0.124N P=0.310N |
|POLY 3 | P=0.533 P=0.202 P=0.186 P=0.467 |P=0.049N* P=0.368 P=0.123N P=0.323N |
|POLY 1.5 | P=0.556 P=0.208 P=0.191 P=0.483 |P=0.047N* P=0.364 P=0.121N P=0.315N |
|POLY 6 | P=0.503 P=0.190 P=0.183 P=0.447 |P=0.052N P=0.379 P=0.125N P=0.333N |
|LOGISTIC REGRESSION| P=0.527N P=0.204 P=0.219 P=0.492 |P=0.043N* P=0.330 P=0.137N P=0.298N |
|COCH-ARM / FISHERS | P=0.545N P=0.210 P=0.210 P=0.500 |P=0.047N* P=0.357 P=0.121N P=0.309N |
|ORDER RESTRICTED | P=0.269 (e) (e) (e) |P=0.076N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 5/49 (10%) 5/49 (10%) 1/50 (2%) |0/50 (0%) 6/50 (12%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 7/45.74 5/41.96 5/40.46 1/40.77 |0/44.12 6/46.93 0/44.36 2/43.19 |
|POLY-3 PERCENT (g) | 15.3% 11.9% 12.4% 2.5% |0.0% 12.8% 0.0% 4.6% |
|TERMINAL (d) | 1/34 (3%) 0/24 (0%) 1/30 (3%) 0/28 (0%) |0/35 (0%) 4/39 (10%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 222 446 560 610 |--- 520 --- 664 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.055N P=0.480N P=0.483N P=0.054N |P=0.361N P=0.025 * (e) P=0.230 |
|POLY 3 | P=0.046N* P=0.441N P=0.467N P=0.044N* |P=0.300N P=0.019 * (e) P=0.232 |
|POLY 1.5 | P=0.041N* P=0.419N P=0.447N P=0.038N* |P=0.302N P=0.017 * (e) P=0.235 |
|POLY 6 | P=0.053N P=0.476N P=0.488N P=0.053N |P=0.296N P=0.021 * (e) P=0.230 |
|LOGISTIC REGRESSION| P=0.025N* P=0.388N P=0.326N P=0.023N* |P=0.312N P=0.017 * (e) P=0.235 |
|COCH-ARM / FISHERS | P=0.034N* P=0.394N P=0.394N P=0.030N* |P=0.311N P=0.013 * (e) P=0.247 |
|ORDER RESTRICTED | P=0.035N* (e) (e) (e) |P=0.135 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 5/48 (10%) 3/48 (6%) 1/50 (2%) |1/49 (2%) 2/50 (4%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/43.34 5/42.40 3/39.85 1/40.35 |1/43.45 2/46.25 0/44.36 2/42.76 |
|POLY-3 PERCENT (g) | 0.0% 11.8% 7.5% 2.5% |2.3% 4.3% 0.0% 4.7% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 1/28 (4%) |1/35 (3%) 2/39 (5%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 446 560 729 (T) |729 (T) 729 (T) --- 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.375N P=0.031 * P=0.111 P=0.461 |P=0.496 P=0.538 P=0.500N P=0.489 |
|POLY 3 | P=0.371N P=0.028 * P=0.104 P=0.486 |P=0.529 P=0.522 P=0.496N P=0.494 |
|POLY 1.5 | P=0.353N P=0.029 * P=0.105 P=0.492 |P=0.532 P=0.516 P=0.495N P=0.497 |
|POLY 6 | P=0.396N P=0.027 * P=0.103 P=0.477 |P=0.525 P=0.532 P=0.495N P=0.492 |
|LOGISTIC REGRESSION| P=0.291N P=0.017 * P=0.131 P=0.461 |P=0.528 P=0.538 (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.335N P=0.025 * P=0.114 P=0.500 |P=0.537 P=0.508 P=0.495N P=0.500 |
|ORDER RESTRICTED | P=0.101 (e) (e) (e) |P=0.397 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 6/48 (13%) 4/48 (8%) 1/50 (2%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/43.34 6/41.09 4/40.45 1/40.72 |0/43.45 1/46.91 0/44.36 2/42.47 |
|POLY-3 PERCENT (g) | 0.0% 14.6% 9.9% 2.5% |0.0% 2.1% 0.0% 4.7% |
|TERMINAL (d) | 0/34 (0%) 2/24 (8%) 1/30 (3%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | --- 446 437 624 |--- 509 --- 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326N P=0.010 * P=0.059 P=0.485 |P=0.161 P=0.500 (e) P=0.227 |
|POLY 3 | P=0.319N P=0.012 * P=0.051 P=0.488 |P=0.172 P=0.515 (e) P=0.232 |
|POLY 1.5 | P=0.303N P=0.013 * P=0.052 P=0.493 |P=0.175 P=0.511 (e) P=0.234 |
|POLY 6 | P=0.341N P=0.011 * P=0.051 P=0.480 |P=0.170 P=0.522 (e) P=0.229 |
|LOGISTIC REGRESSION| P=0.260N P=0.016 * P=0.076 P=0.509 |P=0.190 P=0.397 (e) P=0.233 |
|COCH-ARM / FISHERS | P=0.286N P=0.012 * P=0.054 P=0.500 |P=0.177 P=0.505 (e) P=0.247 |
|ORDER RESTRICTED | P=0.066 (e) (e) (e) |P=0.071 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/48 (6%) 4/48 (8%) 2/50 (4%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/43.34 3/40.62 4/39.85 2/40.69 |0/43.45 1/46.25 0/44.36 2/42.76 |
|POLY-3 PERCENT (g) | 0.0% 7.4% 10.0% 4.9% |0.0% 2.2% 0.0% 4.7% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 1/30 (3%) 0/28 (0%) |0/35 (0%) 1/39 (3%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 641 560 644 |--- 729 (T) --- 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.323 P=0.106 P=0.055 P=0.211 |P=0.158 P=0.522 (e) P=0.240 |
|POLY 3 | P=0.331 P=0.107 P=0.050 P=0.223 |P=0.174 P=0.512 (e) P=0.233 |
|POLY 1.5 | P=0.349 P=0.110 P=0.051 P=0.230 |P=0.175 P=0.509 (e) P=0.235 |
|POLY 6 | P=0.309 P=0.103 P=0.049 * P=0.215 |P=0.172 P=0.518 (e) P=0.232 |
|LOGISTIC REGRESSION| P=0.378 P=0.114 P=0.063 P=0.233 |P=0.179 P=0.522 (e) P=0.240 |
|COCH-ARM / FISHERS | P=0.371 P=0.114 P=0.054 P=0.247 |P=0.177 P=0.505 (e) P=0.247 |
|ORDER RESTRICTED | P=0.098 (e) (e) (e) |P=0.073 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 24/50 (48%) 13/49 (27%) 10/50 (20%) | |
|POLY-3 RATE (b) | 11/44.52 24/43.08 13/41.85 10/42.31 | |
|POLY-3 PERCENT (g) | 24.7% 55.7% 31.1% 23.6% | |
|TERMINAL (d) | 9/34 (27%) 15/24 (63%) 6/30 (20%) 6/28 (21%) | |
|FIRST INCIDENCE | 433 615 402 512 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075N P<0.001 ** P=0.293 P=0.538 | |
|POLY 3 | P=0.046N* P=0.002 ** P=0.337 P=0.553N | |
|POLY 1.5 | P=0.043N* P=0.003 ** P=0.346 P=0.529N | |
|POLY 6 | P=0.051N P<0.001 ** P=0.336 P=0.583N | |
|LOGISTIC REGRESSION| P=0.052N P=0.003 ** P=0.367 P=0.512N | |
|COCH-ARM / FISHERS | P=0.042N* P=0.006 ** P=0.385 P=0.500N | |
|ORDER RESTRICTED | P=0.068N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 4/49 (8%) 4/50 (8%) | |
|POLY-3 RATE (b) | 1/43.52 5/43.84 4/40.23 4/43.24 | |
|POLY-3 PERCENT (g) | 2.3% 11.4% 9.9% 9.3% | |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 2/30 (7%) 0/28 (0%) | |
|FIRST INCIDENCE | 682 471 560 356 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.318 P=0.102 P=0.154 P=0.167 | |
|POLY 3 | P=0.335 P=0.102 P=0.155 P=0.176 | |
|POLY 1.5 | P=0.343 P=0.104 P=0.160 P=0.180 | |
|POLY 6 | P=0.319 P=0.098 P=0.151 P=0.168 | |
|LOGISTIC REGRESSION| P=0.413 P=0.084 P=0.178 P=0.170 | |
|COCH-ARM / FISHERS | P=0.345 P=0.102 P=0.175 P=0.181 | |
|ORDER RESTRICTED | P=0.136 (e) (e) (e) | |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/48 (0%) 2/50 (4%) |0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.34 0/39.44 0/38.63 2/40.35 |0/43.55 0/45.89 0/44.36 0/42.95 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/23 (0%) 0/30 (0%) 2/28 (7%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.043 * (e) (e) P=0.202 |(e) (e) (e) (e) |
|POLY 3 | P=0.042 * (e) (e) P=0.226 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.043 * (e) (e) P=0.234 |(e) (e) (e) (e) |
|POLY 6 | P=0.041 * (e) (e) P=0.217 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.202 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.253 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.026 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Thymus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/48 (4%) 3/48 (6%) 2/50 (4%) |2/49 (4%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.70 2/40.64 3/40.69 2/41.85 |2/44.35 0/45.89 1/45.16 0/42.95 |
|POLY-3 PERCENT (g) | 2.3% 4.9% 7.4% 4.8% |4.5% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/23 (0%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 629 437 423 386 |595 --- 430 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.387 P=0.494 P=0.273 P=0.486 |P=0.287N P=0.234N P=0.503N P=0.250N |
|POLY 3 | P=0.406 P=0.483 P=0.288 P=0.493 |P=0.290N P=0.230N P=0.494N P=0.244N |
|POLY 1.5 | P=0.415 P=0.490 P=0.289 P=0.501 |P=0.282N P=0.232N P=0.492N P=0.239N |
|POLY 6 | P=0.392 P=0.469 P=0.286 P=0.480 |P=0.307N P=0.225N P=0.496N P=0.252N |
|LOGISTIC REGRESSION| P=0.493 P=0.444 P=0.401 P=0.502 |P=0.248N P=0.279N P=0.573N P=0.229N |
|COCH-ARM / FISHERS | P=0.424 P=0.492 P=0.301 P=0.508 |P=0.271N P=0.247N P=0.492N P=0.242N |
|ORDER RESTRICTED | P=0.336 (e) (e) (e) |P=0.079N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Ultimobranchial Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) 2/49 (4%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 5/43.34 0/41.42 2/39.63 3/40.77 |1/44.12 0/46.25 0/44.36 0/42.28 |
|POLY-3 PERCENT (g) | 11.5% 0.0% 5.1% 7.4% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 5/34 (15%) 0/24 (0%) 1/30 (3%) 2/28 (7%) |1/35 (3%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) --- 602 610 |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.513 P=0.070N P=0.271N P=0.458N |P=0.386N P=0.478N P=0.500N P=0.518N |
|POLY 3 | P=0.527 P=0.034N* P=0.253N P=0.390N |P=0.375N P=0.491N P=0.499N P=0.509N |
|POLY 1.5 | P=0.529 P=0.032N* P=0.245N P=0.374N |P=0.373N P=0.494N P=0.499N P=0.507N |
|POLY 6 | P=0.531 P=0.038N* P=0.260N P=0.411N |P=0.380N P=0.484N P=0.498N P=0.511N |
|LOGISTIC REGRESSION| P=0.505 (e) P=0.262N P=0.422N |P=0.386N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.538 P=0.028N* P=0.226N P=0.357N |P=0.369N P=0.500N P=0.500N P=0.505N |
|ORDER RESTRICTED | P=0.111N (e) (e) (e) |P=0.129N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 13/50 (26%) 15/49 (31%) 4/50 (8%) |23/50 (46%) 6/50 (12%) 18/50 (36%) 18/49 (37%) |
|POLY-3 RATE (b) | 9/43.34 13/43.72 15/41.29 4/40.89 |23/44.47 6/46.44 18/45.61 18/43.58 |
|POLY-3 PERCENT (g) | 20.8% 29.7% 36.3% 9.8% |51.7% 12.9% 39.5% 41.3% |
|TERMINAL (d) | 9/34 (27%) 7/24 (29%) 10/30 (33%) 2/28 (7%) |22/35 (63%) 5/39 (13%) 14/35 (40%) 14/32 (44%) |
|FIRST INCIDENCE | 729 (T) 446 402 633 |632 682 622 580 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.095N P=0.079 P=0.067 P=0.202N |P=0.107 P<0.001N** P=0.198N P=0.311N |
|POLY 3 | P=0.089N P=0.236 P=0.086 P=0.136N |P=0.166 P<0.001N** P=0.165N P=0.217N |
|POLY 1.5 | P=0.077N P=0.240 P=0.090 P=0.126N |P=0.183 P<0.001N** P=0.181N P=0.224N |
|POLY 6 | P=0.104N P=0.225 P=0.084 P=0.149N |P=0.144 P<0.001N** P=0.137N P=0.202N |
|LOGISTIC REGRESSION| P=0.080N P=0.211 P=0.075 P=0.171N |P=0.149 P<0.001N** P=0.180N P=0.267N |
|COCH-ARM / FISHERS | P=0.067N P=0.235 P=0.109 P=0.117N |P=0.219 P<0.001N** P=0.208N P=0.232N |
|ORDER RESTRICTED | P=0.025N* (e) (e) (e) |P=0.024N* (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 2/49 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 4/43.41 2/41.57 2/39.19 2/40.38 |0/44.12 0/46.25 0/44.36 0/42.28 |
|POLY-3 PERCENT (g) | 9.2% 4.8% 5.1% 5.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/34 (9%) 0/24 (0%) 2/30 (7%) 1/28 (4%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 711 701 729 (T) 723 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.361N P=0.482N P=0.399N P=0.427N |(e) (e) (e) (e) |
|POLY 3 | P=0.361N P=0.357N P=0.385N P=0.371N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.354N P=0.345N P=0.373N P=0.355N |(e) (e) (e) (e) |
|POLY 6 | P=0.369N P=0.377N P=0.398N P=0.393N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.384N P=0.401N P=0.401N P=0.419N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.339N P=0.339N P=0.349N P=0.339N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.328N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.34 2/42.52 0/39.73 0/40.35 |0/44.12 0/46.25 1/44.69 0/42.95 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 0.0% 0.0% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 446 --- --- |--- --- 640 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.241N P=0.242 (e) (e) |P=0.623 (e) P=0.505 (e) |
|POLY 3 | P=0.239N P=0.233 (e) (e) |P=0.609 (e) P=0.503 (e) |
|POLY 1.5 | P=0.233N P=0.236 (e) (e) |P=0.620 (e) P=0.502 (e) |
|POLY 6 | P=0.248N P=0.225 (e) (e) |P=0.598 (e) P=0.505 (e) |
|LOGISTIC REGRESSION| P=0.193N P=0.180 (e) (e) |P=0.640 (e) P=0.486 (e) |
|COCH-ARM / FISHERS | P=0.227N P=0.247 (e) (e) |P=0.634 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.257N (e) (e) (e) |P=0.383 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Uterus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | |3/44.12 0/46.25 1/44.36 3/43.24 |
|POLY-3 PERCENT (g) | |6.8% 0.0% 2.3% 6.9% |
|TERMINAL (d) | |3/35 (9%) 0/39 (0%) 1/35 (3%) 2/32 (6%) |
|FIRST INCIDENCE | |729 (T) --- 729 (T) 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.254 P=0.102N P=0.305N P=0.630 |
|POLY 3 | |P=0.281 P=0.110N P=0.303N P=0.653 |
|POLY 1.5 | |P=0.291 P=0.114N P=0.303N P=0.657 |
|POLY 6 | |P=0.267 P=0.105N P=0.300N P=0.649 |
|LOGISTIC REGRESSION| |P=0.271 (e) P=0.305N P=0.643 |
|COCH-ARM / FISHERS | |P=0.304 P=0.121N P=0.309N P=0.661N |
|ORDER RESTRICTED | |P=0.273 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | |1/44.12 2/46.25 1/44.36 0/42.95 |
|POLY-3 PERCENT (g) | |2.3% 4.3% 2.3% 0.0% |
|TERMINAL (d) | |1/35 (3%) 2/39 (5%) 1/35 (3%) 0/32 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.218N P=0.538 P=0.762 P=0.518N |
|POLY 3 | |P=0.198N P=0.516 P=0.760N P=0.505N |
|POLY 1.5 | |P=0.195N P=0.510 P=0.759N P=0.503N |
|POLY 6 | |P=0.203N P=0.528 P=0.758N P=0.509N |
|LOGISTIC REGRESSION| |P=0.218N P=0.538 P=0.762 (e) |
|COCH-ARM / FISHERS | |P=0.191N P=0.500 P=0.753N P=0.500N |
|ORDER RESTRICTED | |P=0.241N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | |0/44.12 0/46.25 1/44.36 2/42.95 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 2.3% 4.7% |
|TERMINAL (d) | |0/35 (0%) 0/39 (0%) 1/35 (3%) 2/32 (6%) |
|FIRST INCIDENCE | |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.045 * (e) P=0.500 P=0.219 |
|POLY 3 | |P=0.053 (e) P=0.501 P=0.231 |
|POLY 1.5 | |P=0.055 (e) P=0.501 P=0.234 |
|POLY 6 | |P=0.050 (e) P=0.502 P=0.227 |
|LOGISTIC REGRESSION| |(e) (e) P=0.500 P=0.219 |
|COCH-ARM / FISHERS | |P=0.059 (e) P=0.500 P=0.247 |
|ORDER RESTRICTED | |P=0.070 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | |2/44.12 1/46.25 0/44.36 0/42.95 |
|POLY-3 PERCENT (g) | |4.5% 2.2% 0.0% 0.0% |
|TERMINAL (d) | |2/35 (6%) 1/39 (3%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.121N P=0.462N P=0.238N P=0.258N |
|POLY 3 | |P=0.111N P=0.484N P=0.236N P=0.243N |
|POLY 1.5 | |P=0.110N P=0.490N P=0.236N P=0.240N |
|POLY 6 | |P=0.115N P=0.472N P=0.234N P=0.246N |
|LOGISTIC REGRESSION| |P=0.121N P=0.462N (e) (e) |
|COCH-ARM / FISHERS | |P=0.107N P=0.500N P=0.247N P=0.247N |
|ORDER RESTRICTED | |P=0.078N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Vagina |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/1 (0%) 0/4 (0%) 3/6 (50%) 10/20 (50%) |
|POLY-3 RATE (b) | |0/0.66 0/2.07 3/5.36 10/18.85 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 56.0% 53.1% |
|TERMINAL (d) | |0/0 (0%) 0/1 (0%) 2/4 (50%) 8/14 (57%) |
|FIRST INCIDENCE | |--- --- 657 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.035 * (e) P=0.510 P=0.236 |
|POLY 3 | |P=0.288 (e) P=0.645 P=0.635 |
|POLY 1.5 | |P=0.165 (e) P=0.600 P=0.581 |
|POLY 6 | |P=0.471 (e) P=0.719 P=0.720 |
|LOGISTIC REGRESSION| |P=0.229 (e) P=0.711 P=0.655 |
|COCH-ARM / FISHERS | |P=0.065 (e) P=0.571 P=0.524 |
|ORDER RESTRICTED | |P=0.609 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Vagina |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/1 (0%) 1/4 (25%) 1/6 (17%) 9/20 (45%) |
|POLY-3 RATE (b) | |0/0.66 1/2.70 1/5.09 9/19.32 |
|POLY-3 PERCENT (g) | |0.0% 37.0% 19.6% 46.6% |
|TERMINAL (d) | |0/0 (0%) 0/1 (0%) 1/4 (25%) 5/14 (36%) |
|FIRST INCIDENCE | |--- 521 729 (T) 622 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.013 * P=0.496 P=1.000 P=0.065 |
|POLY 3 | |P=0.265 P=0.778 P=0.852 P=0.663 |
|POLY 1.5 | |P=0.207 P=0.761 P=0.840 P=0.615 |
|POLY 6 | |P=0.349 P=0.816 P=0.870 P=0.732 |
|LOGISTIC REGRESSION| |P=0.107 (e) P=1.000 P=0.489 |
|COCH-ARM / FISHERS | |P=0.137 P=0.800 P=0.857 P=0.571 |
|ORDER RESTRICTED | |P=0.631 (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).