TDMS Study 96010-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) DATE: 05/27/03
EXPERIMENT: 96010 TEST: 03 TIME: 13:32:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: 96010A
PATHOLOGIST: FARNELL, DANIEL R. CAS: 7775-09-9
------------------------------------------------------------------------------------------------------------------------------------
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 (SODIUM CHLORATE) DATE: 05/27/03
EXPERIMENT: 96010 TEST: 03 TIME: 13:32:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: 96010A
PATHOLOGIST: FARNELL, DANIEL R. CAS: 7775-09-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF WATER DISINFECTION BYPRODUCTS (SODIUM
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
Adrenal Medulla Hyperplasia Focal
Bone Marrow Fibrosis
Hyperplasia
Bone Marrow: Myeloid Cell, Erythroid Cell
Hyperplasia
Brain Hemorrhage Focal
Eye Atrophy
Heart Cardiomyopathy
Intestine Large, Colon Edema
Kidney Nephropathy
Liver Basophilic Focus
Clear Cell Focus
Mixed Cell Focus
Liver: Hepatocyte Vacuolization Cytoplasmic Focal
Liver: Hepatocyte, Centrilobular Necrosis
Vacuolization Cytoplasmic
Liver: Hepatocyte, Midzonal Vacuolization Cytoplasmic
Lymph Node: Pancreatic Angiectasis
Hemorrhage
Mesentery: Fat Necrosis Focal
Nose Inflammation
Pancreas: Acinus Atrophy Focal
Pituitary Gland: Pars Distalis Cytoplasmic Alteration Focal
Preputial Gland Inflammation Chronic
Prostate Inflammation Chronic
Prostate: Epithelium Hyperplasia Focal
Spleen Fibrosis Focal
Hematopoietic Cell Proliferation
Stomach, Forestomach Edema
Stomach, Forestomach: Epithelium Hyperplasia
Stomach, Glandular Ulcer
Testes Atrophy
Thyroid Gland: Follicle Degeneration Cystic Focal
Thyroid Gland: Follicular Cell Hypertrophy
Urinary Bladder Edema
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Heart Infiltration Cellular Mixed Cell
Kidney Nephropathy
Kidney: Renal Tubule Accumulation, Hyaline Droplet
Pigmentation
Liver Clear Cell Focus
Congestion
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) DATE: 05/27/03
EXPERIMENT: 96010 TEST: 03 TIME: 13:32:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: 96010A
PATHOLOGIST: FARNELL, DANIEL R. CAS: 7775-09-9
Hyperplasia Regenerative
Lymph Node: Pancreatic Hemorrhage
Hyperplasia
Pigmentation
Mesentery: Fat Necrosis
Pituitary Gland Angiectasis
Pituitary Gland: Pars Distalis Degeneration Cystic Focal
Hemorrhage Focal
Pituitary Gland: Rathke's Cleft Hemorrhage
Salivary Glands Atrophy Focal
Spleen Hematopoietic Cell Proliferation
Stomach, Forestomach Ulcer
Thyroid Gland: Follicle Mineralization Focal
Thyroid Gland: Follicular Cell Hypertrophy
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 7/49 (14%) 4/50 (8%) 3/50 (6%) |2/50 (4%) 3/50 (6%) 5/50 (10%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/43.39 7/43.91 4/44.29 3/43.62 |2/44.75 3/44.07 5/43.75 2/47.00 |
|POLY-3 PERCENT (g) | 2.3% 15.9% 9.0% 6.9% |4.5% 6.8% 11.4% 4.3% |
|TERMINAL (d) | 1/36 (3%) 3/27 (11%) 2/31 (7%) 2/28 (7%) |2/37 (5%) 2/36 (6%) 2/33 (6%) 2/41 (5%) |
|FIRST INCIDENCE | 729 (T) 638 647 681 |729 (T) 623 651 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.504N P=0.021 * P=0.161 P=0.236 |P=0.521N P=0.492 P=0.182 P=0.658N |
|POLY 3 | P=0.449N P=0.031 * P=0.185 P=0.307 |P=0.537N P=0.493 P=0.207 P=0.676N |
|POLY 1.5 | P=0.443N P=0.031 * P=0.185 P=0.311 |P=0.550N P=0.495 P=0.211 P=0.683N |
|POLY 6 | P=0.465N P=0.028 * P=0.181 P=0.298 |P=0.526N P=0.493 P=0.199 P=0.670N |
|LOGISTIC REGRESSION| P=0.447N P=0.032 * P=0.184 P=0.292 |P=0.549N P=0.491 P=0.201 P=0.658N |
|COCH-ARM / FISHERS | P=0.440N P=0.030 * P=0.187 P=0.316 |P=0.574 P=0.500 P=0.218 P=0.691N |
|ORDER RESTRICTED | P=0.127 (e) (e) (e) |P=0.415N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.39 0/43.20 0/43.73 0/43.44 |2/45.21 1/43.69 1/43.90 2/47.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 2.3% 2.3% 4.3% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |1/37 (3%) 1/36 (3%) 0/33 (0%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- --- --- |594 729 (T) 511 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.544 P=0.509N P=0.516N P=0.660N |
|POLY 3 | (e) (e) (e) (e) |P=0.535 P=0.512N P=0.510N P=0.680N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.527 P=0.508N P=0.505N P=0.685N |
|POLY 6 | (e) (e) (e) (e) |P=0.541 P=0.517N P=0.520N P=0.676N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.477 P=0.497N P=0.480N P=0.685 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.513 P=0.500N P=0.500N P=0.691N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.546N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 3/49 (6%) 2/50 (4%) 4/50 (8%) |1/50 (2%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/44.25 3/44.27 2/43.73 4/44.01 |1/45.21 2/43.69 3/43.24 2/47.00 |
|POLY-3 PERCENT (g) | 6.8% 6.8% 4.6% 9.1% |2.2% 4.6% 6.9% 4.3% |
|TERMINAL (d) | 2/36 (6%) 1/27 (4%) 2/31 (7%) 2/28 (7%) |0/37 (0%) 2/36 (6%) 3/33 (9%) 2/41 (5%) |
|FIRST INCIDENCE | 381 555 729 (T) 590 |594 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.384 P=0.607 P=0.556N P=0.416 |P=0.455 P=0.491 P=0.273 P=0.531 |
|POLY 3 | P=0.423 P=0.662N P=0.505N P=0.497 |P=0.441 P=0.488 P=0.289 P=0.514 |
|POLY 1.5 | P=0.429 P=0.660N P=0.500N P=0.504 |P=0.431 P=0.492 P=0.297 P=0.509 |
|POLY 6 | P=0.414 P=0.653 P=0.516N P=0.484 |P=0.450 P=0.483 P=0.277 P=0.517 |
|LOGISTIC REGRESSION| P=0.450 P=0.549 P=0.484N P=0.505 |P=0.435 P=0.503 P=0.302 P=0.472 |
|COCH-ARM / FISHERS | P=0.439 P=0.661N P=0.490N P=0.511 |P=0.411 P=0.500 P=0.309 P=0.500 |
|ORDER RESTRICTED | P=0.453 (e) (e) (e) |P=0.346 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.39 0/43.20 2/43.73 0/43.44 |0/44.75 1/43.69 0/43.24 1/47.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.6% 0.0% |0.0% 2.3% 0.0% 2.1% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 2/31 (7%) 0/28 (0%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.493 (e) P=0.206 (e) |P=0.500 P=0.495 (e) P=0.520 |
|POLY 3 | P=0.518 (e) P=0.239 (e) |P=0.488 P=0.495 (e) P=0.510 |
|POLY 1.5 | P=0.523 (e) P=0.240 (e) |P=0.484 P=0.497 (e) P=0.506 |
|POLY 6 | P=0.509 (e) P=0.234 (e) |P=0.491 P=0.494 (e) P=0.513 |
|LOGISTIC REGRESSION| (e) (e) P=0.206 (e) |(e) P=0.495 (e) P=0.520 |
|COCH-ARM / FISHERS | P=0.527 (e) P=0.253 (e) |P=0.478 P=0.500 (e) P=0.500 |
|ORDER RESTRICTED | P=0.249 (e) (e) (e) |P=0.261 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.39 0/43.20 0/43.73 0/43.44 |1/45.20 1/43.69 0/43.24 2/47.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 2.3% 0.0% 4.3% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- --- --- |595 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.409 P=0.757 P=0.505N P=0.534 |
|POLY 3 | (e) (e) (e) (e) |P=0.387 P=0.753 P=0.509N P=0.514 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.384 P=0.756 P=0.505N P=0.509 |
|POLY 6 | (e) (e) (e) (e) |P=0.390 P=0.750 P=0.516N P=0.517 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.376 P=0.754N P=0.488N P=0.472 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.376 P=0.753N P=0.500N P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.293 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/49 (24%) 8/49 (16%) 7/50 (14%) 6/50 (12%) |7/50 (14%) 13/50 (26%) 7/50 (14%) 8/50 (16%) |
|POLY-3 RATE (b) | 12/43.86 8/43.98 7/44.37 6/44.12 |7/44.75 13/43.70 7/43.24 8/47.42 |
|POLY-3 PERCENT (g) | 27.4% 18.2% 15.8% 13.6% |15.6% 29.8% 16.2% 16.9% |
|TERMINAL (d) | 10/36 (28%) 4/27 (15%) 5/31 (16%) 2/28 (7%) |7/37 (19%) 12/36 (33%) 7/33 (21%) 6/41 (15%) |
|FIRST INCIDENCE | 630 582 605 651 |729 (T) 727 729 (T) 644 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.159N P=0.429N P=0.238N P=0.201N |P=0.226N P=0.088 P=0.524 P=0.581 |
|POLY 3 | P=0.098N P=0.220N P=0.142N P=0.089N |P=0.253N P=0.089 P=0.587 P=0.549 |
|POLY 1.5 | P=0.097N P=0.217N P=0.141N P=0.086N |P=0.272N P=0.094 P=0.600 P=0.530 |
|POLY 6 | P=0.099N P=0.238N P=0.150N P=0.096N |P=0.234N P=0.085 P=0.566 P=0.568 |
|LOGISTIC REGRESSION| P=0.101N P=0.234N P=0.150N P=0.097N |P=0.240N P=0.082 P=0.524 P=0.555 |
|COCH-ARM / FISHERS | P=0.095N P=0.226N P=0.142N P=0.088N |P=0.303N P=0.105 P=0.613N P=0.500 |
|ORDER RESTRICTED | P=0.072N (e) (e) (e) |P=0.361N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 12/49 (24%) 9/50 (18%) 13/50 (26%) |3/50 (6%) 4/50 (8%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/44.37 12/45.22 9/44.62 13/45.65 |3/44.75 4/44.03 1/43.35 1/47.00 |
|POLY-3 PERCENT (g) | 11.3% 26.5% 20.2% 28.5% |6.7% 9.1% 2.3% 2.1% |
|TERMINAL (d) | 2/36 (6%) 5/27 (19%) 5/31 (16%) 5/28 (18%) |3/37 (8%) 3/36 (8%) 0/33 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 574 542 561 562 |729 (T) 636 703 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.093 P=0.037 * P=0.159 P=0.028 * |P=0.088N P=0.487 P=0.350N P=0.269N |
|POLY 3 | P=0.116 P=0.055 P=0.194 P=0.035 * |P=0.092N P=0.491 P=0.317N P=0.288N |
|POLY 1.5 | P=0.118 P=0.056 P=0.199 P=0.036 * |P=0.094N P=0.493 P=0.311N P=0.294N |
|POLY 6 | P=0.111 P=0.050 P=0.181 P=0.033 * |P=0.090N P=0.491 P=0.326N P=0.282N |
|LOGISTIC REGRESSION| P=0.124 P=0.048 * P=0.204 P=0.038 * |P=0.089N P=0.485 P=0.335N P=0.269N |
|COCH-ARM / FISHERS | P=0.121 P=0.054 P=0.205 P=0.037 * |P=0.099N P=0.500 P=0.309N P=0.309N |
|ORDER RESTRICTED | P=0.031 * (e) (e) (e) |P=0.156N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.25 0/42.38 0/43.73 0/43.02 |0/44.75 0/43.02 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/36 (6%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.189N P=0.303N P=0.272N P=0.295N |(e) (e) (e) (e) |
|POLY 3 | P=0.166N P=0.241N P=0.234N P=0.238N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.168N P=0.239N P=0.232N P=0.235N |(e) (e) (e) (e) |
|POLY 6 | P=0.162N P=0.249N P=0.239N P=0.244N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.189N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.169N P=0.247N P=0.237N P=0.242N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.030N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 28/48 (58%) 35/48 (73%) 41/50 (82%) 40/49 (82%) |2/50 (4%) 1/49 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 28/45.07 35/45.91 41/47.90 40/46.97 |2/44.75 1/43.02 1/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 62.1% 76.2% 85.6% 85.2% |4.5% 2.3% 2.3% 0.0% |
|TERMINAL (d) | 24/36 (67%) 24/27 (89%) 30/31 (97%) 25/28 (89%) |2/37 (5%) 1/36 (3%) 1/33 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 469 542 209 443 |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.006 ** P<0.001 ** P<0.001 ** |P=0.160N P=0.510N P=0.540N P=0.216N |
|POLY 3 | P=0.007 ** P=0.101 P=0.006 ** P=0.008 ** |P=0.162N P=0.514N P=0.512N P=0.226N |
|POLY 1.5 | P=0.008 ** P=0.102 P=0.007 ** P=0.008 ** |P=0.165N P=0.512N P=0.506N P=0.230N |
|POLY 6 | P=0.007 ** P=0.094 P=0.004 ** P=0.008 ** |P=0.160N P=0.515N P=0.522N P=0.223N |
|LOGISTIC REGRESSION| P=0.009 ** P=0.093 P=0.007 ** P=0.008 ** |P=0.160N P=0.510N P=0.540N (e) |
|COCH-ARM / FISHERS | P=0.012 * P=0.098 P=0.009 ** P=0.011 * |P=0.171N P=0.508N P=0.500N P=0.247N |
|ORDER RESTRICTED | P=0.003 ** (e) (e) (e) |P=0.109N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia Focal Histiocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/49 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.25 0/42.38 0/43.73 0/43.02 |0/44.75 0/43.02 2/43.24 2/47.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.6% 4.3% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 2/33 (6%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.085 (e) P=0.213 P=0.261 |
|POLY 3 | (e) (e) (e) (e) |P=0.079 (e) P=0.229 P=0.248 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.075 (e) P=0.233 P=0.244 |
|POLY 6 | (e) (e) (e) (e) |P=0.082 (e) P=0.223 P=0.252 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.213 P=0.261 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.069 (e) P=0.247 P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.111 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow: Myeloid Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |7/50 (14%) 3/49 (6%) 2/50 (4%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/43.25 0/42.38 0/43.73 0/43.02 |7/45.28 3/43.56 2/43.72 6/47.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |15.5% 6.9% 4.6% 12.7% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |6/37 (16%) 2/36 (6%) 1/33 (3%) 4/41 (10%) |
|FIRST INCIDENCE | --- --- --- --- |566 563 587 670 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.534N P=0.173N P=0.107N P=0.430N |
|POLY 3 | (e) (e) (e) (e) |P=0.558 P=0.173N P=0.087N P=0.466N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.549 P=0.171N P=0.083N P=0.479N |
|POLY 6 | (e) (e) (e) (e) |P=0.565N P=0.173N P=0.093N P=0.453N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.536 P=0.169N P=0.082N P=0.480N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.530 P=0.167N P=0.080N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.182N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow: Myeloid Cell, Erythroid Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 2/49 (4%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/43.25 0/42.38 0/43.73 0/43.02 |0/44.75 2/43.03 2/43.47 3/47.34 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 0.0% 0.0% |0.0% 4.7% 4.6% 6.3% |
|TERMINAL (d) | 2/36 (6%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 2/41 (5%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- 727 699 635 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.189N P=0.303N P=0.272N P=0.295N |P=0.168 P=0.234 P=0.217 P=0.144 |
|POLY 3 | P=0.166N P=0.241N P=0.234N P=0.238N |P=0.156 P=0.228 P=0.231 P=0.129 |
|POLY 1.5 | P=0.168N P=0.239N P=0.232N P=0.235N |P=0.150 P=0.230 P=0.234 P=0.125 |
|POLY 6 | P=0.162N P=0.249N P=0.239N P=0.244N |P=0.163 P=0.228 P=0.226 P=0.133 |
|LOGISTIC REGRESSION| P=0.189N (e) (e) (e) |P=0.150 P=0.227 P=0.233 P=0.114 |
|COCH-ARM / FISHERS | P=0.169N P=0.247N P=0.237N P=0.242N |P=0.140 P=0.242 P=0.247 P=0.121 |
|ORDER RESTRICTED | P=0.030N* (e) (e) (e) |P=0.085 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Compression Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 6/50 (12%) 7/50 (14%) 6/50 (12%) |9/49 (18%) 9/50 (18%) 10/50 (20%) 9/50 (18%) |
|POLY-3 RATE (b) | 6/44.21 6/44.13 7/45.18 6/44.06 |9/44.99 9/44.67 10/45.11 9/48.06 |
|POLY-3 PERCENT (g) | 13.6% 13.6% 15.5% 13.6% |20.0% 20.2% 22.2% 18.7% |
|TERMINAL (d) | 4/36 (11%) 3/27 (11%) 2/31 (7%) 2/28 (7%) |4/37 (11%) 5/36 (14%) 5/33 (15%) 6/41 (15%) |
|FIRST INCIDENCE | 630 672 566 671 |595 636 547 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.468 P=0.463 P=0.442 P=0.505 |P=0.471N P=0.573 P=0.420 P=0.517N |
|POLY 3 | P=0.530 P=0.620 P=0.517 P=0.619 |P=0.491N P=0.597 P=0.503 P=0.542N |
|POLY 1.5 | P=0.530 P=0.615N P=0.510 P=0.619N |P=0.511N P=0.601N P=0.512 P=0.556N |
|POLY 6 | P=0.528 P=0.597 P=0.516 P=0.606 |P=0.479N P=0.590 P=0.485 P=0.534N |
|LOGISTIC REGRESSION| P=0.528 P=0.614 P=0.500 P=0.618 |P=0.515 P=0.589N P=0.530 P=0.578 |
|COCH-ARM / FISHERS | P=0.530 P=0.620N P=0.500 P=0.620N |P=0.539 P=0.584N P=0.520 P=0.584N |
|ORDER RESTRICTED | P=0.684 (e) (e) (e) |P=0.625N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 4/50 (8%) 6/50 (12%) |0/49 (0%) 4/50 (8%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/44.42 2/44.69 4/44.88 6/44.81 |0/43.79 4/44.02 3/44.15 2/47.14 |
|POLY-3 PERCENT (g) | 4.5% 4.5% 8.9% 13.4% |0.0% 9.1% 6.8% 4.2% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 1/28 (4%) |0/37 (0%) 3/36 (8%) 0/33 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 545 582 605 465 |--- 639 615 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.052 P=0.688N P=0.336 P=0.122 |P=0.547 P=0.061 P=0.115 P=0.259 |
|POLY 3 | P=0.048 * P=0.692N P=0.342 P=0.135 |P=0.545 P=0.061 P=0.120 P=0.254 |
|POLY 1.5 | P=0.049 * P=0.690N P=0.340 P=0.136 |P=0.532 P=0.061 P=0.121 P=0.249 |
|POLY 6 | P=0.048 * P=0.687 P=0.340 P=0.130 |P=0.557 P=0.060 P=0.117 P=0.258 |
|LOGISTIC REGRESSION| P=0.047 * P=0.588 P=0.339 P=0.120 |P=0.497 P=0.063 P=0.129 P=0.248 |
|COCH-ARM / FISHERS | P=0.048 * P=0.691N P=0.339 P=0.134 |P=0.511 P=0.061 P=0.125 P=0.253 |
|ORDER RESTRICTED | P=0.089 (e) (e) (e) |P=0.108 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |5/49 (10%) 2/50 (4%) 6/50 (12%) 1/49 (2%) |
|POLY-3 RATE (b) | |5/43.75 2/44.38 6/43.76 1/46.00 |
|POLY-3 PERCENT (g) | |11.4% 4.5% 13.7% 2.2% |
|TERMINAL (d) | |5/36 (14%) 0/36 (0%) 5/33 (15%) 1/40 (3%) |
|FIRST INCIDENCE | |729 (T) 623 573 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.193N P=0.222N P=0.446 P=0.080N |
|POLY 3 | |P=0.196N P=0.210N P=0.500 P=0.090N |
|POLY 1.5 | |P=0.206N P=0.211N P=0.507 P=0.094N |
|POLY 6 | |P=0.188N P=0.207N P=0.487 P=0.086N |
|LOGISTIC REGRESSION| |P=0.214N P=0.213N P=0.480 P=0.080N |
|COCH-ARM / FISHERS | |P=0.227N P=0.210N P=0.514 P=0.102N |
|ORDER RESTRICTED | |P=0.074N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 4/50 (8%) 3/50 (6%) 1/49 (2%) |
|POLY-3 RATE (b) | |1/44.12 4/44.07 3/43.24 1/46.00 |
|POLY-3 PERCENT (g) | |2.3% 9.1% 6.9% 2.2% |
|TERMINAL (d) | |0/36 (0%) 2/36 (6%) 3/33 (9%) 1/40 (3%) |
|FIRST INCIDENCE | |623 626 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.298N P=0.186 P=0.280 P=0.736N |
|POLY 3 | |P=0.314N P=0.178 P=0.298 P=0.751N |
|POLY 1.5 | |P=0.320N P=0.180 P=0.305 P=0.754N |
|POLY 6 | |P=0.309N P=0.176 P=0.286 P=0.749N |
|LOGISTIC REGRESSION| |P=0.319N P=0.187 P=0.305 P=0.742 |
|COCH-ARM / FISHERS | |P=0.333N P=0.187 P=0.316 P=0.753N |
|ORDER RESTRICTED | |P=0.312N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |6/49 (12%) 2/50 (4%) 1/50 (2%) 3/49 (6%) |
|POLY-3 RATE (b) | |6/43.79 2/43.69 1/43.24 3/46.00 |
|POLY-3 PERCENT (g) | |13.7% 4.6% 2.3% 6.5% |
|TERMINAL (d) | |5/36 (14%) 2/36 (6%) 1/33 (3%) 3/40 (8%) |
|FIRST INCIDENCE | |718 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.239N P=0.137N P=0.076N P=0.197N |
|POLY 3 | |P=0.257N P=0.133N P=0.057N P=0.218N |
|POLY 1.5 | |P=0.263N P=0.131N P=0.055N P=0.227N |
|POLY 6 | |P=0.252N P=0.134N P=0.061N P=0.210N |
|LOGISTIC REGRESSION| |P=0.250N P=0.137N P=0.073N P=0.208N |
|COCH-ARM / FISHERS | |P=0.276N P=0.128N P=0.053N P=0.243N |
|ORDER RESTRICTED | |P=0.057N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 RATE (b) | 1/44.37 1/44.23 0/43.73 2/43.91 | |
|POLY-3 PERCENT (g) | 2.3% 2.3% 0.0% 4.6% | |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 1/28 (4%) | |
|FIRST INCIDENCE | 511 605 --- 590 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.369 P=0.746N P=0.492N P=0.479 | |
|POLY 3 | P=0.374 P=0.760 P=0.503N P=0.496 | |
|POLY 1.5 | P=0.375 P=0.759N P=0.501N P=0.499 | |
|POLY 6 | P=0.371 P=0.753 P=0.507N P=0.488 | |
|LOGISTIC REGRESSION| P=0.380 P=0.625 P=0.454N P=0.461 | |
|COCH-ARM / FISHERS | P=0.376 P=0.753N P=0.500N P=0.500 | |
|ORDER RESTRICTED | P=0.269 (e) (e) (e) | |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/46 (0%) 2/50 (4%) |1/50 (2%) 0/49 (0%) 0/47 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.72 0/42.69 0/41.78 2/43.44 |1/44.75 0/43.02 0/40.76 1/47.34 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.6% |2.2% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 2/28 (7%) |1/37 (3%) 0/36 (0%) 0/32 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |729 (T) --- --- 635 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035 * (e) (e) P=0.185 |P=0.545 P=0.505N P=0.529N P=0.734N |
|POLY 3 | P=0.044 * (e) (e) P=0.236 |P=0.538 P=0.508N P=0.519N P=0.748N |
|POLY 1.5 | P=0.044 * (e) (e) P=0.237 |P=0.532 P=0.507N P=0.516N P=0.753N |
|POLY 6 | P=0.043 * (e) (e) P=0.230 |P=0.542 P=0.508N P=0.523N P=0.743N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.185 |P=0.512 (e) (e) P=0.747 |
|COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.247 |P=0.522 P=0.505N P=0.515N P=0.753N |
|ORDER RESTRICTED | P=0.029 * (e) (e) (e) |P=0.395N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/48 (4%) 1/46 (2%) 2/50 (4%) |2/50 (4%) 3/49 (6%) 1/47 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.72 2/42.69 1/41.99 2/43.48 |2/44.75 3/43.02 1/40.76 2/47.00 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 2.4% 4.6% |4.5% 7.0% 2.5% 4.3% |
|TERMINAL (d) | 0/36 (0%) 2/27 (7%) 0/31 (0%) 1/28 (4%) |2/37 (5%) 3/36 (8%) 1/32 (3%) 2/41 (5%) |
|FIRST INCIDENCE | --- 729 (T) 673 718 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.287 P=0.177 P=0.495 P=0.194 |P=0.394N P=0.487 P=0.551N P=0.658N |
|POLY 3 | P=0.321 P=0.232 P=0.492 P=0.236 |P=0.419N P=0.482 P=0.532N P=0.676N |
|POLY 1.5 | P=0.323 P=0.232 P=0.488 P=0.238 |P=0.424N P=0.484 P=0.527N P=0.683N |
|POLY 6 | P=0.314 P=0.227 P=0.494 P=0.230 |P=0.415N P=0.481 P=0.541N P=0.670N |
|LOGISTIC REGRESSION| P=0.313 P=0.177 P=0.479 P=0.216 |P=0.394N P=0.487 P=0.551N P=0.658N |
|COCH-ARM / FISHERS | P=0.321 P=0.237 P=0.479 P=0.247 |P=0.434N P=0.490 P=0.523N P=0.691N |
|ORDER RESTRICTED | P=0.153 (e) (e) (e) |P=0.469N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/48 (4%) 1/46 (2%) 2/50 (4%) |1/50 (2%) 2/49 (4%) 1/47 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.72 2/42.69 1/41.99 2/43.48 |1/44.75 2/43.02 1/40.76 2/47.00 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 2.4% 4.6% |2.2% 4.7% 2.5% 4.3% |
|TERMINAL (d) | 0/36 (0%) 2/27 (7%) 0/31 (0%) 1/28 (4%) |1/37 (3%) 2/36 (6%) 1/32 (3%) 2/41 (5%) |
|FIRST INCIDENCE | --- 729 (T) 673 718 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.287 P=0.177 P=0.495 P=0.194 |P=0.524 P=0.490 P=0.729 P=0.536 |
|POLY 3 | P=0.321 P=0.232 P=0.492 P=0.236 |P=0.508 P=0.486 P=0.740 P=0.517 |
|POLY 1.5 | P=0.323 P=0.232 P=0.488 P=0.238 |P=0.501 P=0.488 P=0.743 P=0.511 |
|POLY 6 | P=0.314 P=0.227 P=0.494 P=0.230 |P=0.514 P=0.485 P=0.735 P=0.523 |
|LOGISTIC REGRESSION| P=0.313 P=0.177 P=0.479 P=0.216 |P=0.524 P=0.490 P=0.729 P=0.536 |
|COCH-ARM / FISHERS | P=0.321 P=0.237 P=0.479 P=0.247 |P=0.487 P=0.492 P=0.737 P=0.500 |
|ORDER RESTRICTED | P=0.153 (e) (e) (e) |P=0.465 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Hyperplasia Focal Histiocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 1/49 (2%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.39 1/43.21 1/43.46 1/43.44 |2/44.75 0/43.69 1/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 2.3% 2.3% |4.5% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/31 (3%) 1/28 (4%) |2/37 (5%) 0/36 (0%) 1/33 (3%) 0/41 (0%) |
|FIRST INCIDENCE | --- 726 729 (T) 729 (T) |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.383 P=0.450 P=0.470 P=0.450 |P=0.255N P=0.244N P=0.540N P=0.216N |
|POLY 3 | P=0.418 P=0.499 P=0.500 P=0.500 |P=0.256N P=0.242N P=0.512N P=0.226N |
|POLY 1.5 | P=0.422 P=0.501 P=0.501 P=0.503 |P=0.261N P=0.241N P=0.506N P=0.230N |
|POLY 6 | P=0.409 P=0.493 P=0.497 P=0.494 |P=0.252N P=0.244N P=0.522N P=0.223N |
|LOGISTIC REGRESSION| P=0.388 P=0.472 P=0.470 P=0.450 |P=0.255N (e) P=0.540N (e) |
|COCH-ARM / FISHERS | P=0.425 P=0.500 P=0.500 P=0.505 |P=0.270N P=0.247N P=0.500N P=0.247N |
|ORDER RESTRICTED | P=0.327 (e) (e) (e) |P=0.067N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 1/49 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.39 1/43.32 1/43.46 1/43.44 |0/44.75 1/43.69 1/43.24 2/47.00 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 2.3% 2.3% |0.0% 2.3% 2.3% 4.3% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/31 (3%) 1/28 (4%) |0/37 (0%) 1/36 (3%) 1/33 (3%) 2/41 (5%) |
|FIRST INCIDENCE | --- 699 729 (T) 729 (T) |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.394 P=0.473 P=0.470 P=0.450 |P=0.201 P=0.495 P=0.477 P=0.261 |
|POLY 3 | P=0.418 P=0.500 P=0.500 P=0.500 |P=0.186 P=0.495 P=0.493 P=0.248 |
|POLY 1.5 | P=0.422 P=0.501 P=0.501 P=0.503 |P=0.182 P=0.497 P=0.496 P=0.244 |
|POLY 6 | P=0.409 P=0.494 P=0.497 P=0.494 |P=0.191 P=0.494 P=0.488 P=0.252 |
|LOGISTIC REGRESSION| P=0.412 P=0.500 P=0.470 P=0.450 |(e) P=0.495 P=0.477 P=0.261 |
|COCH-ARM / FISHERS | P=0.425 P=0.500 P=0.500 P=0.505 |P=0.172 P=0.500 P=0.500 P=0.247 |
|ORDER RESTRICTED | P=0.328 (e) (e) (e) |P=0.127 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 7/50 (14%) 10/50 (20%) |4/50 (8%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 6/44.93 3/44.76 7/44.56 10/44.68 |4/45.84 2/44.23 0/43.24 2/47.23 |
|POLY-3 PERCENT (g) | 13.4% 6.7% 15.7% 22.4% |8.7% 4.5% 0.0% 4.2% |
|TERMINAL (d) | 4/36 (11%) 1/27 (4%) 5/31 (16%) 8/28 (29%) |2/37 (5%) 1/36 (3%) 0/33 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 381 555 475 443 |555 563 --- 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029 * P=0.324N P=0.418 P=0.115 |P=0.228N P=0.355N P=0.074N P=0.304N |
|POLY 3 | P=0.040 * P=0.243N P=0.494 P=0.200 |P=0.244N P=0.354N P=0.068N P=0.324N |
|POLY 1.5 | P=0.041 * P=0.240N P=0.496 P=0.206 |P=0.245N P=0.348N P=0.064N P=0.328N |
|POLY 6 | P=0.037 * P=0.256N P=0.481 P=0.185 |P=0.243N P=0.360N P=0.074N P=0.320N |
|LOGISTIC REGRESSION| P=0.043 * P=0.296N P=0.500 P=0.202 |P=0.293N P=0.302N P=0.056N P=0.416N |
|COCH-ARM / FISHERS | P=0.043 * P=0.243N P=0.500 P=0.207 |P=0.250N P=0.339N P=0.059N P=0.339N |
|ORDER RESTRICTED | P=0.070 (e) (e) (e) |P=0.092N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/44.52 1/44.34 0/43.73 2/43.44 |0/44.75 1/43.69 1/44.08 4/47.00 |
|POLY-3 PERCENT (g) | 4.5% 2.3% 0.0% 4.6% |0.0% 2.3% 2.3% 8.5% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/31 (0%) 2/28 (7%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 4/41 (10%) |
|FIRST INCIDENCE | 423 562 --- 729 (T) |--- 729 (T) 401 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.537 P=0.521N P=0.256N P=0.627 |P=0.029 * P=0.495 P=0.500 P=0.077 |
|POLY 3 | P=0.556 P=0.501N P=0.241N P=0.685 |P=0.023 * P=0.495 P=0.497 P=0.067 |
|POLY 1.5 | P=0.558 P=0.498N P=0.240N P=0.690 |P=0.022 * P=0.497 P=0.499 P=0.065 |
|POLY 6 | P=0.554 P=0.512N P=0.245N P=0.675 |P=0.023 * P=0.494 P=0.492 P=0.069 |
|LOGISTIC REGRESSION| P=0.569 P=0.707N P=0.215N P=0.685 |P=0.015 * P=0.495 (e) P=0.077 |
|COCH-ARM / FISHERS | P=0.563 P=0.500N P=0.247N P=0.691N |P=0.021 * P=0.500 P=0.500 P=0.059 |
|ORDER RESTRICTED | P=0.404 (e) (e) (e) |P=0.014 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.05 1/43.83 2/43.84 2/43.48 |1/45.12 0/43.69 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 2.3% 2.3% 4.6% 4.6% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/31 (3%) 1/28 (4%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 636 721 703 718 |623 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.285 P=0.737 P=0.473 P=0.456 |P=0.353N P=0.495N P=0.510N P=0.478N |
|POLY 3 | P=0.310 P=0.760 P=0.498 P=0.495 |P=0.364N P=0.506N P=0.508N P=0.492N |
|POLY 1.5 | P=0.313 P=0.759N P=0.500 P=0.499 |P=0.363N P=0.504N P=0.504N P=0.495N |
|POLY 6 | P=0.304 P=0.752 P=0.492 P=0.485 |P=0.364N P=0.509N P=0.515N P=0.490N |
|LOGISTIC REGRESSION| P=0.311 P=0.759 P=0.500 P=0.500 |P=0.397N P=0.476N P=0.489N P=0.575N |
|COCH-ARM / FISHERS | P=0.314 P=0.753N P=0.500 P=0.500 |P=0.363N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.437 (e) (e) (e) |P=0.113N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/44 (0%) 2/49 (4%) |0/50 (0%) 0/48 (0%) 0/46 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/43.19 0/42.02 0/40.50 2/43.64 |0/44.75 0/42.56 0/40.74 0/46.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- 644 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.045 * (e) (e) P=0.239 |(e) (e) (e) (e) |
|POLY 3 | P=0.045 * (e) (e) P=0.239 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.045 * (e) (e) P=0.241 |(e) (e) (e) (e) |
|POLY 6 | P=0.045 * (e) (e) P=0.235 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.047 * (e) (e) P=0.240 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.253 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.030 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.72 2/43.38 0/43.46 0/43.44 |0/44.75 0/43.02 0/42.24 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/32 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 693 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.253N P=0.205 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.231N P=0.235 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.231N P=0.236 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.236N P=0.230 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.236N P=0.234 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.235N P=0.242 (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.247N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/46 (0%) 0/49 (0%) 0/49 (0%) |1/50 (2%) 0/49 (0%) 0/47 (0%) 2/47 (4%) |
|POLY-3 RATE (b) | 0/42.29 0/40.79 0/43.46 0/43.02 |1/44.75 0/43.02 0/41.16 2/45.24 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |1/37 (3%) 0/36 (0%) 0/32 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.221 P=0.505N P=0.529N P=0.523 |
|POLY 3 | (e) (e) (e) (e) |P=0.201 P=0.508N P=0.517N P=0.504 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.197 P=0.507N P=0.515N P=0.494 |
|POLY 6 | (e) (e) (e) (e) |P=0.206 P=0.508N P=0.520N P=0.515 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.159 (e) (e) P=0.416 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.189 P=0.505N P=0.515N P=0.477 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.137 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/46 (0%) 0/49 (0%) 0/49 (0%) |1/50 (2%) 2/49 (4%) 0/47 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 0/42.29 0/40.79 0/43.46 0/43.02 |1/44.75 2/43.81 0/41.16 0/44.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |1/37 (3%) 1/36 (3%) 0/32 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 433 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.122N P=0.491 P=0.529N P=0.484N |
|POLY 3 | (e) (e) (e) (e) |P=0.130N P=0.493 P=0.517N P=0.500N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.131N P=0.492 P=0.515N P=0.505N |
|POLY 6 | (e) (e) (e) (e) |P=0.129N P=0.493 P=0.520N P=0.495N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.156N P=0.528 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.132N P=0.492 P=0.515N P=0.515N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.164N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/47 (96%) 44/46 (96%) 48/49 (98%) 47/49 (96%) |43/50 (86%) 41/49 (84%) 37/47 (79%) 38/47 (81%) |
|POLY-3 RATE (b) | 45/46.15 44/45.61 48/48.63 47/48.25 |43/46.87 41/45.73 37/45.01 38/46.14 |
|POLY-3 PERCENT (g) | 97.5% 96.5% 98.7% 97.4% |91.7% 89.7% 82.2% 82.4% |
|TERMINAL (d) | 36/36 (100%) 26/27 (96%) 31/31 (100%) 28/28 (100%)|36/37 (97%) 34/36 (94%) 27/32 (84%) 33/40 (83%) |
|FIRST INCIDENCE | 381 542 209 443 |423 433 401 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.090 P=0.082 P=0.079 P=0.037 * |P=0.044N* P=0.518N P=0.513N P=0.054N |
|POLY 3 | P=0.531 P=0.643N P=0.661 P=0.768N |P=0.071N P=0.506N P=0.122N P=0.133N |
|POLY 1.5 | P=0.516 P=0.665N P=0.567 P=0.729 |P=0.134N P=0.517N P=0.171N P=0.214N |
|POLY 6 | P=0.599 P=0.599N P=0.856 P=0.748N |P=0.030N* P=0.442N P=0.079N P=0.063N |
|LOGISTIC REGRESSION| P=0.506 P=0.647N P=0.453 P=0.698 |P=0.100N P=0.594N P=0.262N P=0.145N |
|COCH-ARM / FISHERS | P=0.529 P=0.683N P=0.484 P=0.676 |P=0.271N P=0.483N P=0.250N P=0.341N |
|ORDER RESTRICTED | P=0.551 (e) (e) (e) |P=0.114N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 1/46 (2%) 4/49 (8%) 2/49 (4%) |5/50 (10%) 12/49 (24%) 11/47 (23%) 5/47 (11%) |
|POLY-3 RATE (b) | 0/42.29 1/40.93 4/44.47 2/43.78 |5/44.75 12/43.39 11/42.87 5/44.99 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 9.0% 4.6% |11.2% 27.7% 25.7% 11.1% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |5/37 (14%) 10/36 (28%) 7/32 (22%) 4/40 (10%) |
|FIRST INCIDENCE | --- 695 561 590 |729 (T) 644 511 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.151 P=0.473 P=0.064 P=0.250 |P=0.213N P=0.048 * P=0.056 P=0.578N |
|POLY 3 | P=0.163 P=0.493 P=0.066 P=0.245 |P=0.230N P=0.043 * P=0.067 P=0.627N |
|POLY 1.5 | P=0.164 P=0.496 P=0.066 P=0.246 |P=0.257N P=0.044 * P=0.067 P=0.617 |
|POLY 6 | P=0.160 P=0.488 P=0.066 P=0.241 |P=0.203N P=0.043 * P=0.068 P=0.608N |
|LOGISTIC REGRESSION| P=0.173 P=0.496 P=0.071 P=0.238 |P=0.270N P=0.042 * P=0.065 P=0.626N |
|COCH-ARM / FISHERS | P=0.166 P=0.495 P=0.064 P=0.258 |P=0.303N P=0.049 * P=0.066 P=0.590 |
|ORDER RESTRICTED | P=0.082 (e) (e) (e) |P=0.156N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/47 (9%) 4/46 (9%) 1/49 (2%) 4/49 (8%) |2/50 (4%) 1/49 (2%) 4/47 (9%) 4/47 (9%) |
|POLY-3 RATE (b) | 4/44.87 4/42.55 1/44.00 4/44.46 |2/45.84 1/43.82 4/43.35 4/46.30 |
|POLY-3 PERCENT (g) | 8.9% 9.4% 2.3% 9.0% |4.4% 2.3% 9.2% 8.6% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/32 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 381 542 561 562 |555 423 511 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.475N P=0.622N P=0.178N P=0.627N |P=0.146 P=0.512N P=0.340 P=0.367 |
|POLY 3 | P=0.465N P=0.614 P=0.185N P=0.638 |P=0.133 P=0.516N P=0.312 P=0.342 |
|POLY 1.5 | P=0.457N P=0.622 P=0.178N P=0.637N |P=0.122 P=0.512N P=0.311 P=0.330 |
|POLY 6 | P=0.475N P=0.599 P=0.195N P=0.624 |P=0.145 P=0.519N P=0.309 P=0.355 |
|LOGISTIC REGRESSION| P=0.378N P=0.494 P=0.128N P=0.654N |P=0.006 ** P=0.361N P=0.293 P=0.078 |
|COCH-ARM / FISHERS | P=0.444N P=0.631 P=0.168N P=0.619N |P=0.104 P=0.508N P=0.310 P=0.310 |
|ORDER RESTRICTED | P=0.415N (e) (e) (e) |P=0.203 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/48 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/43.72 1/44.06 1/42.98 3/43.51 |0/44.75 0/43.69 2/43.36 0/47.00 |
|POLY-3 PERCENT (g) | 4.6% 2.3% 2.3% 6.9% |0.0% 0.0% 4.6% 0.0% |
|TERMINAL (d) | 2/36 (6%) 0/27 (0%) 0/31 (0%) 2/28 (7%) |0/37 (0%) 0/36 (0%) 1/33 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 660 703 710 |--- --- 699 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.255 P=0.566N P=0.544N P=0.396 |P=0.539 (e) P=0.219 (e) |
|POLY 3 | P=0.287 P=0.497N P=0.506N P=0.498 |P=0.562 (e) P=0.230 (e) |
|POLY 1.5 | P=0.287 P=0.496N P=0.509N P=0.501 |P=0.547 (e) P=0.234 (e) |
|POLY 6 | P=0.285 P=0.506N P=0.507N P=0.488 |P=0.575 (e) P=0.225 (e) |
|LOGISTIC REGRESSION| P=0.283 P=0.500N P=0.512N P=0.447 |P=0.534 (e) P=0.226 (e) |
|COCH-ARM / FISHERS | P=0.288 P=0.500N P=0.515N P=0.500 |P=0.522 (e) P=0.247 (e) |
|ORDER RESTRICTED | P=0.288 (e) (e) (e) |P=0.241 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 30/50 (60%) 33/48 (69%) 29/50 (58%) |42/50 (84%) 44/50 (88%) 41/50 (82%) 42/50 (84%) |
|POLY-3 RATE (b) | 27/43.72 30/45.40 33/43.75 29/45.12 |42/48.62 44/48.60 41/47.28 42/48.90 |
|POLY-3 PERCENT (g) | 61.8% 66.1% 75.4% 64.3% |86.4% 90.5% 86.7% 85.9% |
|TERMINAL (d) | 27/36 (75%) 24/27 (89%) 30/31 (97%) 23/28 (82%) |34/37 (92%) 33/36 (92%) 32/33 (97%) 37/41 (90%) |
|FIRST INCIDENCE | 729 (T) 542 576 443 |423 365 401 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.100 P=0.009 ** P=0.003 ** P=0.037 * |P=0.132N P=0.331 P=0.326 P=0.249N |
|POLY 3 | P=0.431 P=0.416 P=0.111 P=0.490 |P=0.378N P=0.368 P=0.607 P=0.592N |
|POLY 1.5 | P=0.416 P=0.399 P=0.104 P=0.469 |P=0.381N P=0.366 P=0.576N P=0.596N |
|POLY 6 | P=0.441 P=0.393 P=0.105 P=0.490 |P=0.397N P=0.389 P=0.519 P=0.595N |
|LOGISTIC REGRESSION| P=0.359 P=0.207 P=0.042 * P=0.339 |P=0.302N P=0.360 P=0.534N P=0.546N |
|COCH-ARM / FISHERS | P=0.390 P=0.343 P=0.098 P=0.420 |P=0.401N P=0.387 P=0.500N P=0.607N |
|ORDER RESTRICTED | P=0.315 (e) (e) (e) |P=0.535N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Cholangiofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/48 (2%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/43.72 1/43.80 1/43.39 1/43.44 |1/44.75 0/43.69 1/43.58 3/47.23 |
|POLY-3 PERCENT (g) | 4.6% 2.3% 2.3% 2.3% |2.2% 0.0% 2.3% 6.4% |
|TERMINAL (d) | 2/36 (6%) 1/27 (4%) 0/31 (0%) 1/28 (4%) |1/37 (3%) 0/36 (0%) 0/33 (0%) 2/41 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 576 729 (T) |729 (T) --- 636 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.471N P=0.600N P=0.527N P=0.588N |P=0.094 P=0.505N P=0.742 P=0.345 |
|POLY 3 | P=0.439N P=0.499N P=0.503N P=0.502N |P=0.080 P=0.505N P=0.755 P=0.325 |
|POLY 1.5 | P=0.440N P=0.497N P=0.507N P=0.500N |P=0.077 P=0.503N P=0.758 P=0.318 |
|POLY 6 | P=0.437N P=0.510N P=0.502N P=0.511N |P=0.083 P=0.506N P=0.750 P=0.333 |
|LOGISTIC REGRESSION| P=0.440N P=0.600N P=0.518N P=0.588N |P=0.072 (e) P=0.760N P=0.319 |
|COCH-ARM / FISHERS | P=0.440N P=0.500N P=0.515N P=0.500N |P=0.072 P=0.500N P=0.753N P=0.309 |
|ORDER RESTRICTED | P=0.417N (e) (e) (e) |P=0.094 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 18/50 (36%) 29/48 (60%) 15/50 (30%) |6/50 (12%) 16/50 (32%) 18/50 (36%) 10/50 (20%) |
|POLY-3 RATE (b) | 21/43.72 18/43.86 29/43.27 15/43.44 |6/45.28 16/44.71 18/43.24 10/47.00 |
|POLY-3 PERCENT (g) | 48.0% 41.0% 67.0% 34.5% |13.3% 35.8% 41.6% 21.3% |
|TERMINAL (d) | 21/36 (58%) 17/27 (63%) 27/31 (87%) 15/28 (54%) |5/37 (14%) 14/36 (39%) 18/33 (55%) 10/41 (24%) |
|FIRST INCIDENCE | 729 (T) 714 660 729 (T) |566 511 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.518N P=0.355 P=0.004 ** P=0.450N |P=0.490N P=0.013 * P<0.001 ** P=0.272 |
|POLY 3 | P=0.293N P=0.325N P=0.050 P=0.138N |P=0.526 P=0.010 * P=0.002 ** P=0.229 |
|POLY 1.5 | P=0.294N P=0.320N P=0.050 P=0.138N |P=0.505 P=0.011 * P=0.003 ** P=0.221 |
|POLY 6 | P=0.303N P=0.368N P=0.043 * P=0.154N |P=0.542 P=0.010 * P<0.001 ** P=0.235 |
|LOGISTIC REGRESSION| P=0.456N P=0.479 P=0.012 * P=0.450N |P=0.526N P=0.013 * P=0.002 ** P=0.242 |
|COCH-ARM / FISHERS | P=0.302N P=0.341N P=0.052 P=0.149N |P=0.465 P=0.014 * P=0.005 ** P=0.207 |
|ORDER RESTRICTED | P=0.063N (e) (e) (e) |P=0.020 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/48 (0%) 0/50 (0%) |6/50 (12%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.72 2/44.50 0/42.88 0/43.44 |6/44.75 2/44.07 2/43.82 1/47.00 |
|POLY-3 PERCENT (g) | 0.0% 4.5% 0.0% 0.0% |13.4% 4.5% 4.6% 2.1% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |6/37 (16%) 1/36 (3%) 1/33 (3%) 1/41 (2%) |
|FIRST INCIDENCE | --- 555 --- --- |729 (T) 623 547 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.241N P=0.240 (e) (e) |P=0.059N P=0.142N P=0.169N P=0.043N* |
|POLY 3 | P=0.233N P=0.241 (e) (e) |P=0.059N P=0.137N P=0.139N P=0.048N* |
|POLY 1.5 | P=0.233N P=0.241 (e) (e) |P=0.062N P=0.137N P=0.136N P=0.051N |
|POLY 6 | P=0.237N P=0.236 (e) (e) |P=0.057N P=0.137N P=0.145N P=0.046N* |
|LOGISTIC REGRESSION| P=0.234N P=0.174 (e) (e) |P=0.065N P=0.142N P=0.142N P=0.043N* |
|COCH-ARM / FISHERS | P=0.238N P=0.247 (e) (e) |P=0.069N P=0.134N P=0.134N P=0.056N |
|ORDER RESTRICTED | P=0.252N (e) (e) (e) |P=0.014N* (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 9/50 (18%) 12/48 (25%) 14/50 (28%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 13/44.15 9/44.18 12/43.41 14/44.44 |1/44.75 0/43.69 1/43.24 3/47.00 |
|POLY-3 PERCENT (g) | 29.5% 20.4% 27.6% 31.5% |2.2% 0.0% 2.3% 6.4% |
|TERMINAL (d) | 11/36 (31%) 6/27 (22%) 8/31 (26%) 11/28 (39%) |1/37 (3%) 0/36 (0%) 1/33 (3%) 3/41 (7%) |
|FIRST INCIDENCE | 636 660 675 482 |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.163 P=0.463N P=0.534 P=0.256 |P=0.091 P=0.505N P=0.736 P=0.342 |
|POLY 3 | P=0.258 P=0.228N P=0.520N P=0.508 |P=0.079 P=0.505N P=0.753 P=0.323 |
|POLY 1.5 | P=0.257 P=0.224N P=0.530N P=0.512 |P=0.076 P=0.503N P=0.757 P=0.317 |
|POLY 6 | P=0.254 P=0.252N P=0.522N P=0.484 |P=0.082 P=0.506N P=0.747 P=0.329 |
|LOGISTIC REGRESSION| P=0.238 P=0.271N P=0.531N P=0.481 |P=0.091 (e) P=0.736 P=0.342 |
|COCH-ARM / FISHERS | P=0.253 P=0.235N P=0.547N P=0.500 |P=0.072 P=0.500N P=0.753N P=0.309 |
|ORDER RESTRICTED | P=0.383 (e) (e) (e) |P=0.093 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/48 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/43.72 3/44.00 0/42.88 2/43.44 |0/44.75 1/43.69 1/43.24 2/47.38 |
|POLY-3 PERCENT (g) | 4.6% 6.8% 0.0% 4.6% |0.0% 2.3% 2.3% 4.2% |
|TERMINAL (d) | 2/36 (6%) 1/27 (4%) 0/31 (0%) 2/28 (7%) |0/37 (0%) 1/36 (3%) 1/33 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 693 --- 729 (T) |--- 729 (T) 729 (T) 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.437N P=0.403 P=0.272N P=0.602 |P=0.203 P=0.495 P=0.477 P=0.261 |
|POLY 3 | P=0.389N P=0.503 P=0.241N P=0.692 |P=0.189 P=0.495 P=0.493 P=0.250 |
|POLY 1.5 | P=0.390N P=0.505 P=0.243N P=0.693N |P=0.183 P=0.497 P=0.496 P=0.245 |
|POLY 6 | P=0.392N P=0.491 P=0.242N P=0.683 |P=0.195 P=0.494 P=0.488 P=0.256 |
|LOGISTIC REGRESSION| P=0.403N P=0.476 (e) P=0.602 |P=0.180 P=0.495 P=0.477 P=0.213 |
|COCH-ARM / FISHERS | P=0.391N P=0.500 P=0.258N P=0.691N |P=0.172 P=0.500 P=0.500 P=0.247 |
|ORDER RESTRICTED | P=0.334N (e) (e) (e) |P=0.129 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 3/48 (6%) 5/50 (10%) |7/50 (14%) 4/50 (8%) 8/50 (16%) 3/50 (6%) |
|POLY-3 RATE (b) | 6/43.72 2/43.80 3/43.39 5/43.62 |7/46.54 4/44.28 8/44.08 3/47.00 |
|POLY-3 PERCENT (g) | 13.7% 4.6% 6.9% 11.5% |15.0% 9.0% 18.2% 6.4% |
|TERMINAL (d) | 6/36 (17%) 2/27 (7%) 2/31 (7%) 3/28 (11%) |4/37 (11%) 3/36 (8%) 5/33 (15%) 3/41 (7%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 576 701 |423 541 615 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.394 P=0.241N P=0.307N P=0.594 |P=0.226N P=0.282N P=0.433 P=0.133N |
|POLY 3 | P=0.465 P=0.131N P=0.245N P=0.502N |P=0.241N P=0.290N P=0.454 P=0.153N |
|POLY 1.5 | P=0.463 P=0.130N P=0.252N P=0.498N |P=0.250N P=0.280N P=0.474 P=0.155N |
|POLY 6 | P=0.469 P=0.140N P=0.243N P=0.515N |P=0.235N P=0.300N P=0.430 P=0.153N |
|LOGISTIC REGRESSION| P=0.453 P=0.241N P=0.253N P=0.575N |P=0.295N P=0.231N P=0.519 P=0.215N |
|COCH-ARM / FISHERS | P=0.463 P=0.134N P=0.264N P=0.500N |P=0.269N P=0.262N P=0.500 P=0.159N |
|ORDER RESTRICTED | P=0.257N (e) (e) (e) |P=0.148N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hyperplasia Focal Histiocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 8/48 (17%) 5/50 (10%) |20/50 (40%) 19/50 (38%) 16/50 (32%) 23/50 (46%) |
|POLY-3 RATE (b) | 6/44.59 2/43.80 8/43.98 5/43.91 |20/46.21 19/46.50 16/45.22 23/48.32 |
|POLY-3 PERCENT (g) | 13.5% 4.6% 18.2% 11.4% |43.3% 40.9% 35.4% 47.6% |
|TERMINAL (d) | 4/36 (11%) 2/27 (7%) 4/31 (13%) 4/28 (14%) |18/37 (49%) 12/36 (33%) 11/33 (33%) 21/41 (51%) |
|FIRST INCIDENCE | 469 729 (T) 576 590 |423 365 547 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.291 P=0.220N P=0.324 P=0.621 |P=0.456 P=0.539N P=0.399N P=0.504 |
|POLY 3 | P=0.342 P=0.138N P=0.375 P=0.511N |P=0.347 P=0.490N P=0.287N P=0.415 |
|POLY 1.5 | P=0.342 P=0.134N P=0.367 P=0.503N |P=0.330 P=0.500N P=0.279N P=0.387 |
|POLY 6 | P=0.341 P=0.151N P=0.379 P=0.529N |P=0.356 P=0.465N P=0.296N P=0.443 |
|LOGISTIC REGRESSION| P=0.345 P=0.134N P=0.352 P=0.500N |P=0.308 P=0.502N P=0.279N P=0.363 |
|COCH-ARM / FISHERS | P=0.345 P=0.134N P=0.355 P=0.500N |P=0.298 P=0.500N P=0.266N P=0.343 |
|ORDER RESTRICTED | P=0.318 (e) (e) (e) |P=0.350 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hyperplasia Regenerative |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.72 0/43.80 0/42.88 0/43.44 |0/44.75 0/43.69 0/43.24 2/47.11 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.3% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 703 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.053 (e) (e) P=0.257 |
|POLY 3 | (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.249 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.245 |
|POLY 6 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.253 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.049 * (e) (e) P=0.247 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.034 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 29/50 (58%) 33/48 (69%) 28/50 (56%) |39/50 (78%) 38/50 (76%) 35/50 (70%) 41/50 (82%) |
|POLY-3 RATE (b) | 36/46.64 29/46.20 33/46.07 28/45.77 |39/48.99 38/47.60 35/47.78 41/49.21 |
|POLY-3 PERCENT (g) | 77.2% 62.8% 71.6% 61.2% |79.6% 79.8% 73.3% 83.3% |
|TERMINAL (d) | 29/36 (81%) 21/27 (78%) 24/31 (77%) 20/28 (71%) |30/37 (81%) 29/36 (81%) 25/33 (76%) 35/41 (85%) |
|FIRST INCIDENCE | 381 542 209 443 |423 365 401 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.414N P=0.548 P=0.489 P=0.459N |P=0.387N P=0.568 P=0.533N P=0.437N |
|POLY 3 | P=0.168N P=0.087N P=0.349N P=0.065N |P=0.408 P=0.591 P=0.305N P=0.414 |
|POLY 1.5 | P=0.172N P=0.088N P=0.383N P=0.065N |P=0.391 P=0.569N P=0.277N P=0.410 |
|POLY 6 | P=0.163N P=0.103N P=0.329N P=0.073N |P=0.420 P=0.549 P=0.355N P=0.414 |
|LOGISTIC REGRESSION| P=0.175N P=0.081N P=0.426N P=0.063N |P=0.386 P=0.511N P=0.244N P=0.399 |
|COCH-ARM / FISHERS | P=0.178N P=0.104N P=0.448N P=0.072N |P=0.360 P=0.500N P=0.247N P=0.402 |
|ORDER RESTRICTED | P=0.061N (e) (e) (e) |P=0.372 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 11/50 (22%) 3/48 (6%) 8/50 (16%) |12/50 (24%) 6/50 (12%) 7/50 (14%) 8/50 (16%) |
|POLY-3 RATE (b) | 13/43.85 11/44.49 3/42.98 8/43.44 |12/44.75 6/44.28 7/43.24 8/47.14 |
|POLY-3 PERCENT (g) | 29.7% 24.7% 7.0% 18.4% |26.8% 13.6% 16.2% 17.0% |
|TERMINAL (d) | 12/36 (33%) 9/27 (33%) 2/31 (7%) 8/28 (29%) |12/37 (32%) 5/36 (14%) 7/33 (21%) 7/41 (17%) |
|FIRST INCIDENCE | 695 605 703 729 (T) |729 (T) 541 729 (T) 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.106N P=0.496 P=0.015N* P=0.353N |P=0.274N P=0.104N P=0.218N P=0.154N |
|POLY 3 | P=0.066N P=0.389N P=0.006N** P=0.162N |P=0.313N P=0.096N P=0.169N P=0.186N |
|POLY 1.5 | P=0.067N P=0.389N P=0.006N** P=0.159N |P=0.329N P=0.096N P=0.161N P=0.201N |
|POLY 6 | P=0.066N P=0.413N P=0.006N** P=0.178N |P=0.299N P=0.094N P=0.185N P=0.172N |
|LOGISTIC REGRESSION| P=0.074N P=0.464N P=0.009N** P=0.277N |P=0.293N P=0.106N P=0.218N P=0.173N |
|COCH-ARM / FISHERS | P=0.070N P=0.408N P=0.008N** P=0.163N |P=0.358N P=0.096N P=0.154N P=0.227N |
|ORDER RESTRICTED | P=0.030N* (e) (e) (e) |P=0.122N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 49/50 (98%) 46/48 (96%) 50/50 (100%)|29/50 (58%) 24/50 (48%) 34/50 (68%) 26/50 (52%) |
|POLY-3 RATE (b) | 48/48.47 49/49.88 46/47.02 50/50.00 |29/46.88 24/46.28 34/47.15 26/48.71 |
|POLY-3 PERCENT (g) | 99.0% 98.2% 97.8% 100.0% |61.9% 51.9% 72.1% 53.4% |
|TERMINAL (d) | 36/36 (100%) 27/27 (100%) 30/31 (97%) 28/28 (100%)|22/37 (60%) 16/36 (44%) 23/33 (70%) 20/41 (49%) |
|FIRST INCIDENCE | 423 542 561 443 |566 563 511 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.180 P=0.050 P=0.339 P=0.050 |P=0.376N P=0.285N P=0.113 P=0.208N |
|POLY 3 | P=0.417 P=0.738N P=0.655N P=0.926 |P=0.460N P=0.220N P=0.196 P=0.263N |
|POLY 1.5 | P=0.312 P=0.797 P=0.732N P=0.523 |P=0.502N P=0.220N P=0.200 P=0.291N |
|POLY 6 | P=0.535 P=0.679N P=0.545N P=1.000 |P=0.435N P=0.213N P=0.187 P=0.240N |
|LOGISTIC REGRESSION| P=0.220 P=0.718N P=0.616N P=0.398 |P=0.524N P=0.232N P=0.175 P=0.297N |
|COCH-ARM / FISHERS | P=0.238 P=0.500 P=0.676N P=0.247 |P=0.484 P=0.212N P=0.204 P=0.344N |
|ORDER RESTRICTED | P=0.325 (e) (e) (e) |P=0.299N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/48 (0%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.72 1/44.05 0/42.88 2/44.33 |0/44.75 2/44.48 0/43.24 1/47.11 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 4.5% |0.0% 4.5% 0.0% 2.1% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 663 --- 545 |--- 433 --- 703 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.184 P=0.495 (e) P=0.253 |P=0.597N P=0.234 (e) P=0.510 |
|POLY 3 | P=0.179 P=0.501 (e) P=0.240 |P=0.616N P=0.236 (e) P=0.510 |
|POLY 1.5 | P=0.178 P=0.502 (e) P=0.240 |P=0.616N P=0.236 (e) P=0.506 |
|POLY 6 | P=0.177 P=0.496 (e) P=0.237 |P=0.617N P=0.235 (e) P=0.514 |
|LOGISTIC REGRESSION| P=0.175 P=0.486 (e) P=0.200 |P=0.601 P=0.279 (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.176 P=0.500 (e) P=0.247 |P=0.616N P=0.247 (e) P=0.500 |
|ORDER RESTRICTED | P=0.076 (e) (e) (e) |P=0.317 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.72 0/43.80 0/42.88 0/43.44 |0/44.75 0/43.69 2/44.06 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 587 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.541 (e) P=0.234 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.560 (e) P=0.234 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.546 (e) P=0.235 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.573 (e) P=0.230 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.444 (e) P=0.247 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.522 (e) P=0.247 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.244 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 0/48 (0%) 4/50 (8%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/44.67 3/44.32 0/42.88 4/43.80 |1/45.00 2/43.96 1/43.61 2/47.65 |
|POLY-3 PERCENT (g) | 6.7% 6.8% 0.0% 9.1% |2.2% 4.6% 2.3% 4.2% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/31 (0%) 1/28 (4%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 381 663 --- 681 |661 657 626 635 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.455 P=0.609 P=0.141N P=0.421 |P=0.529 P=0.482 P=0.746 P=0.537 |
|POLY 3 | P=0.482 P=0.659 P=0.126N P=0.489 |P=0.511 P=0.492 P=0.754 P=0.520 |
|POLY 1.5 | P=0.483 P=0.662N P=0.126N P=0.495 |P=0.502 P=0.494 P=0.757 P=0.512 |
|POLY 6 | P=0.479 P=0.647 P=0.128N P=0.477 |P=0.520 P=0.490 P=0.748 P=0.528 |
|LOGISTIC REGRESSION| P=0.487 P=0.604 P=0.124N P=0.490 |P=0.432 P=0.504 P=0.754N P=0.411 |
|COCH-ARM / FISHERS | P=0.486 P=0.661N P=0.129N P=0.500 |P=0.487 P=0.500 P=0.753N P=0.500 |
|ORDER RESTRICTED | P=0.278 (e) (e) (e) |P=0.468 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 15/50 (30%) 14/48 (29%) 18/50 (36%) |17/50 (34%) 10/50 (20%) 10/50 (20%) 10/50 (20%) |
|POLY-3 RATE (b) | 26/44.17 15/43.81 14/43.39 18/44.52 |17/46.12 10/44.93 10/43.94 10/47.11 |
|POLY-3 PERCENT (g) | 58.9% 34.2% 32.3% 40.4% |36.9% 22.3% 22.8% 21.2% |
|TERMINAL (d) | 24/36 (67%) 14/27 (52%) 13/31 (42%) 16/28 (57%) |14/37 (38%) 7/36 (19%) 7/33 (21%) 9/41 (22%) |
|FIRST INCIDENCE | 630 726 576 443 |423 541 587 703 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.346N P=0.153N P=0.033N* P=0.326N |P=0.106N P=0.110N P=0.157N P=0.054N |
|POLY 3 | P=0.169N P=0.014N* P=0.008N** P=0.057N |P=0.126N P=0.095N P=0.107N P=0.073N |
|POLY 1.5 | P=0.183N P=0.014N* P=0.011N* P=0.061N |P=0.134N P=0.094N P=0.098N P=0.079N |
|POLY 6 | P=0.155N P=0.018N* P=0.008N** P=0.063N |P=0.122N P=0.093N P=0.120N P=0.068N |
|LOGISTIC REGRESSION| P=0.214N P=0.042N* P=0.012N* P=0.083N |P=0.126N P=0.092N P=0.098N P=0.074N |
|COCH-ARM / FISHERS | P=0.206N P=0.021N* P=0.018N* P=0.079N |P=0.151N P=0.088N P=0.088N P=0.088N |
|ORDER RESTRICTED | P=0.014N* (e) (e) (e) |P=0.057N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte, Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 6/48 (13%) 4/50 (8%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/44.39 3/44.91 6/44.59 4/44.35 |2/45.68 1/44.02 1/43.76 2/47.57 |
|POLY-3 PERCENT (g) | 2.3% 6.7% 13.5% 9.0% |4.4% 2.3% 2.3% 4.2% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 503 562 561 562 |555 639 573 635 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.151 P=0.317 P=0.064 P=0.169 |P=0.546 P=0.505N P=0.505N P=0.659N |
|POLY 3 | P=0.150 P=0.309 P=0.056 P=0.178 |P=0.536 P=0.513N P=0.515N P=0.679N |
|POLY 1.5 | P=0.152 P=0.311 P=0.053 P=0.180 |P=0.527 P=0.508N P=0.508N P=0.684N |
|POLY 6 | P=0.146 P=0.301 P=0.058 P=0.173 |P=0.543 P=0.518N P=0.526N P=0.674N |
|LOGISTIC REGRESSION| P=0.150 P=0.145 P=0.043 * P=0.156 |P=0.384 P=0.445N P=0.479N P=0.563 |
|COCH-ARM / FISHERS | P=0.154 P=0.309 P=0.050 P=0.181 |P=0.513 P=0.500N P=0.500N P=0.691N |
|ORDER RESTRICTED | P=0.087 (e) (e) (e) |P=0.549N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte, Centrilobular |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 9/50 (18%) 12/48 (25%) 11/50 (22%) |5/50 (10%) 3/50 (6%) 8/50 (16%) 3/50 (6%) |
|POLY-3 RATE (b) | 4/45.88 9/46.46 12/45.07 11/44.79 |5/46.13 3/44.02 8/45.40 3/47.46 |
|POLY-3 PERCENT (g) | 8.7% 19.4% 26.6% 24.6% |10.8% 6.8% 17.6% 6.3% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 3/31 (10%) 4/28 (14%) |0/37 (0%) 2/36 (6%) 1/33 (3%) 1/41 (2%) |
|FIRST INCIDENCE | 469 562 561 562 |594 639 573 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.069 P=0.128 P=0.034 * P=0.040 * |P=0.445N P=0.376N P=0.248 P=0.319N |
|POLY 3 | P=0.053 P=0.120 P=0.022 * P=0.038 * |P=0.456N P=0.382N P=0.265 P=0.341N |
|POLY 1.5 | P=0.058 P=0.121 P=0.022 * P=0.041 * |P=0.472N P=0.373N P=0.270 P=0.346N |
|POLY 6 | P=0.047 * P=0.113 P=0.023 * P=0.033 * |P=0.442N P=0.394N P=0.257 P=0.339N |
|LOGISTIC REGRESSION| P=0.064 P=0.041 * P=0.016 * P=0.040 * |P=0.539 P=0.337N P=0.300 P=0.447N |
|COCH-ARM / FISHERS | P=0.066 P=0.117 P=0.022 * P=0.045 * |P=0.504N P=0.357N P=0.277 P=0.357N |
|ORDER RESTRICTED | P=0.029 * (e) (e) (e) |P=0.299N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte, Midzonal |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 1/50 (2%) 0/48 (0%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/45.11 1/43.92 0/42.88 1/43.63 |0/44.75 2/44.48 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 13.3% 2.3% 0.0% 2.3% |0.0% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 2/36 (6%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 423 699 --- 678 |--- 433 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060N P=0.090N P=0.026N* P=0.082N |P=0.230N P=0.234 (e) (e) |
|POLY 3 | P=0.048N* P=0.060N P=0.018N* P=0.061N |P=0.236N P=0.236 (e) (e) |
|POLY 1.5 | P=0.049N* P=0.057N P=0.018N* P=0.058N |P=0.235N P=0.236 (e) (e) |
|POLY 6 | P=0.045N* P=0.067N P=0.019N* P=0.067N |P=0.236N P=0.235 (e) (e) |
|LOGISTIC REGRESSION| P=0.052N P=0.068N P=0.020N* P=0.061N |P=0.298N P=0.279 (e) (e) |
|COCH-ARM / FISHERS | P=0.053N P=0.056N P=0.015N* P=0.056N |P=0.236N P=0.247 (e) (e) |
|ORDER RESTRICTED | P=0.003N** (e) (e) (e) |P=0.237N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte, Periportal |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/48 (2%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.72 1/43.94 1/43.14 0/43.44 |0/44.75 2/45.15 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 2.3% 0.0% |0.0% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 693 660 --- |--- 423 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.528N P=0.479 P=0.505 (e) |P=0.234N P=0.235 (e) (e) |
|POLY 3 | P=0.524N P=0.501 P=0.497 (e) |P=0.233N P=0.239 (e) (e) |
|POLY 1.5 | P=0.522N P=0.502 P=0.495 (e) |P=0.234N P=0.238 (e) (e) |
|POLY 6 | P=0.529N P=0.495 P=0.497 (e) |P=0.234N P=0.240 (e) (e) |
|LOGISTIC REGRESSION| P=0.523N P=0.501 P=0.489 (e) |P=0.409N P=0.356 (e) (e) |
|COCH-ARM / FISHERS | P=0.524N P=0.500 P=0.490 (e) |P=0.236N P=0.247 (e) (e) |
|ORDER RESTRICTED | P=0.399 (e) (e) (e) |P=0.240N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.18 1/44.08 3/44.90 0/43.44 |0/44.75 0/43.69 2/44.47 1/47.14 |
|POLY-3 PERCENT (g) | 4.4% 2.3% 6.7% 0.0% |0.0% 0.0% 4.5% 2.1% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 423 652 566 --- |--- --- 514 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.294N P=0.485N P=0.509 P=0.235N |P=0.217 (e) P=0.242 P=0.514 |
|POLY 3 | P=0.302N P=0.509N P=0.497 P=0.246N |P=0.226 (e) P=0.236 P=0.510 |
|POLY 1.5 | P=0.298N P=0.503N P=0.498 P=0.242N |P=0.216 (e) P=0.237 P=0.506 |
|POLY 6 | P=0.308N P=0.521N P=0.493 P=0.254N |P=0.235 (e) P=0.232 P=0.514 |
|LOGISTIC REGRESSION| P=0.274N P=0.721 P=0.509 P=0.356N |P=0.095 (e) P=0.233 P=0.492 |
|COCH-ARM / FISHERS | P=0.292N P=0.500N P=0.500 P=0.247N |P=0.201 (e) P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.191N (e) (e) (e) |P=0.167 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/43.72 1/43.80 2/43.73 2/43.76 |1/44.79 0/43.69 1/43.24 2/47.37 |
|POLY-3 PERCENT (g) | 6.9% 2.3% 4.6% 4.6% |2.2% 0.0% 2.3% 4.2% |
|TERMINAL (d) | 3/36 (8%) 1/27 (4%) 2/31 (7%) 1/28 (4%) |0/37 (0%) 0/36 (0%) 1/33 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 639 |717 --- 729 (T) 670 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.567 P=0.412N P=0.569N P=0.582N |P=0.220 P=0.516N P=0.726 P=0.522 |
|POLY 3 | P=0.567N P=0.304N P=0.500N P=0.500N |P=0.213 P=0.505N P=0.753 P=0.519 |
|POLY 1.5 | P=0.568N P=0.302N P=0.499N P=0.498N |P=0.206 P=0.503N P=0.757 P=0.512 |
|POLY 6 | P=0.565N P=0.315N P=0.507N P=0.508N |P=0.220 P=0.507N P=0.746 P=0.527 |
|LOGISTIC REGRESSION| P=0.578N P=0.412N P=0.569N P=0.507N |P=0.199 P=0.506N P=0.744 P=0.486 |
|COCH-ARM / FISHERS | P=0.567N P=0.309N P=0.500N P=0.500N |P=0.193 P=0.500N P=0.753N P=0.500 |
|ORDER RESTRICTED | P=0.394N (e) (e) (e) |P=0.247 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |4/50 (8%) 6/50 (12%) 5/50 (10%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/45.11 1/44.39 1/44.46 2/44.76 |4/47.30 6/47.95 5/46.34 2/48.32 |
|POLY-3 PERCENT (g) | 4.4% 2.3% 2.3% 4.5% |8.5% 12.5% 10.8% 4.1% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 469 542 475 443 |423 365 401 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.512 P=0.474N P=0.488N P=0.682N |P=0.164N P=0.362 P=0.501 P=0.329N |
|POLY 3 | P=0.513 P=0.506N P=0.505N P=0.691 |P=0.163N P=0.378 P=0.487 P=0.328N |
|POLY 1.5 | P=0.513 P=0.501N P=0.503N P=0.694N |P=0.166N P=0.376 P=0.494 P=0.331N |
|POLY 6 | P=0.513 P=0.518N P=0.512N P=0.683 |P=0.162N P=0.379 P=0.475 P=0.325N |
|LOGISTIC REGRESSION| P=0.515 P=0.663 P=0.458N P=0.560 |P=0.567 P=0.474 P=0.561 P=0.685 |
|COCH-ARM / FISHERS | P=0.513 P=0.500N P=0.500N P=0.691N |P=0.169N P=0.370 P=0.500 P=0.339N |
|ORDER RESTRICTED | P=0.547 (e) (e) (e) |P=0.211N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia Focal Histiocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.72 1/44.23 1/43.73 0/43.44 |1/45.49 1/43.69 0/43.24 2/47.00 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 2.3% 0.0% |2.2% 2.3% 0.0% 4.3% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/31 (3%) 0/28 (0%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 2/41 (5%) |
|FIRST INCIDENCE | --- 605 729 (T) --- |462 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.536N P=0.509 P=0.470 (e) |P=0.405 P=0.753 P=0.500N P=0.526 |
|POLY 3 | P=0.523N P=0.502 P=0.500 (e) |P=0.386 P=0.752 P=0.510N P=0.511 |
|POLY 1.5 | P=0.522N P=0.503 P=0.500 (e) |P=0.383 P=0.755 P=0.506N P=0.507 |
|POLY 6 | P=0.530N P=0.497 P=0.497 (e) |P=0.389 P=0.749 P=0.517N P=0.515 |
|LOGISTIC REGRESSION| P=0.521N P=0.425 P=0.470 (e) |P=0.335 P=0.728N P=0.483N P=0.400 |
|COCH-ARM / FISHERS | P=0.522N P=0.500 P=0.500 (e) |P=0.376 P=0.753N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.401 (e) (e) (e) |P=0.291 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |2/50 (4%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.52 3/43.80 1/44.16 2/43.56 |2/45.35 3/43.69 2/43.76 1/47.23 |
|POLY-3 PERCENT (g) | 2.3% 6.9% 2.3% 4.6% |4.4% 6.9% 4.6% 2.1% |
|TERMINAL (d) | 0/36 (0%) 3/27 (11%) 0/31 (0%) 1/28 (4%) |0/37 (0%) 3/36 (8%) 1/33 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 423 729 (T) 607 699 |555 729 (T) 573 670 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.581 P=0.235 P=0.758N P=0.464 |P=0.246N P=0.484 P=0.667 P=0.481N |
|POLY 3 | P=0.583N P=0.299 P=0.759 P=0.492 |P=0.253N P=0.483 P=0.681 P=0.486N |
|POLY 1.5 | P=0.580N P=0.304 P=0.759 P=0.497 |P=0.259N P=0.489 P=0.687 P=0.491N |
|POLY 6 | P=0.591N P=0.286 P=0.756 P=0.483 |P=0.248N P=0.476 P=0.671 P=0.481N |
|LOGISTIC REGRESSION| P=0.575N P=0.264 P=0.740N P=0.467 |P=0.286N P=0.500 P=0.681N P=0.587N |
|COCH-ARM / FISHERS | P=0.577N P=0.309 P=0.753N P=0.500 |P=0.268N P=0.500 P=0.691N P=0.500N |
|ORDER RESTRICTED | P=0.454 (e) (e) (e) |P=0.325N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 3/50 (6%) 3/50 (6%) |2/50 (4%) 0/50 (0%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 5/43.84 2/43.81 3/43.94 3/43.60 |2/45.00 0/43.69 4/43.24 2/47.00 |
|POLY-3 PERCENT (g) | 11.4% 4.6% 6.8% 6.9% |4.4% 0.0% 9.3% 4.3% |
|TERMINAL (d) | 4/36 (11%) 1/27 (4%) 2/31 (7%) 1/28 (4%) |1/37 (3%) 0/36 (0%) 4/33 (12%) 2/41 (5%) |
|FIRST INCIDENCE | 699 726 675 699 |661 --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.501N P=0.335N P=0.432N P=0.470N |P=0.333 P=0.251N P=0.288 P=0.657N |
|POLY 3 | P=0.444N P=0.216N P=0.355N P=0.359N |P=0.324 P=0.244N P=0.319 P=0.678N |
|POLY 1.5 | P=0.445N P=0.213N P=0.355N P=0.355N |P=0.311 P=0.242N P=0.328 P=0.684N |
|POLY 6 | P=0.443N P=0.229N P=0.362N P=0.371N |P=0.336 P=0.246N P=0.304 P=0.674N |
|LOGISTIC REGRESSION| P=0.458N P=0.259N P=0.367N P=0.384N |P=0.318 P=0.238N P=0.307 P=0.684N |
|COCH-ARM / FISHERS | P=0.442N P=0.218N P=0.357N P=0.357N |P=0.287 P=0.247N P=0.339 P=0.691N |
|ORDER RESTRICTED | P=0.274N (e) (e) (e) |P=0.238 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 5/50 (10%) 3/50 (6%) 4/50 (8%) |4/50 (8%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 8/44.07 5/44.19 3/43.73 4/43.77 |4/44.75 2/43.69 3/43.24 2/47.00 |
|POLY-3 PERCENT (g) | 18.2% 11.3% 6.9% 9.1% |8.9% 4.6% 6.9% 4.3% |
|TERMINAL (d) | 7/36 (19%) 3/27 (11%) 3/31 (10%) 2/28 (7%) |4/37 (11%) 2/36 (6%) 3/33 (9%) 2/41 (5%) |
|FIRST INCIDENCE | 630 638 729 (T) 672 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.198N P=0.438N P=0.148N P=0.288N |P=0.326N P=0.349N P=0.563N P=0.290N |
|POLY 3 | P=0.153N P=0.272N P=0.099N P=0.178N |P=0.344N P=0.348N P=0.519N P=0.315N |
|POLY 1.5 | P=0.153N P=0.269N P=0.099N P=0.176N |P=0.354N P=0.345N P=0.510N P=0.323N |
|POLY 6 | P=0.154N P=0.291N P=0.105N P=0.188N |P=0.334N P=0.351N P=0.534N P=0.307N |
|LOGISTIC REGRESSION| P=0.157N P=0.286N P=0.106N P=0.186N |P=0.326N P=0.349N P=0.563N P=0.290N |
|COCH-ARM / FISHERS | P=0.152N P=0.277N P=0.100N P=0.178N |P=0.372N P=0.339N P=0.500N P=0.339N |
|ORDER RESTRICTED | P=0.101N (e) (e) (e) |P=0.275N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 1/49 (2%) 3/50 (6%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.39 1/44.06 1/42.87 3/43.54 |0/44.75 0/43.02 0/42.64 0/47.00 |
|POLY-3 PERCENT (g) | 2.3% 2.3% 2.3% 6.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/30 (0%) 2/28 (7%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 660 695 703 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.139 P=0.729 P=0.731 P=0.231 |(e) (e) (e) (e) |
|POLY 3 | P=0.158 P=0.757N P=0.758 P=0.306 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.160 P=0.755N P=0.759 P=0.311 |(e) (e) (e) (e) |
|POLY 6 | P=0.155 P=0.757 P=0.754 P=0.296 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.157 P=0.758N P=0.758 P=0.276 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.161 P=0.747N P=0.753N P=0.316 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.188 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 3/49 (6%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.39 2/44.57 3/43.05 0/43.44 |0/44.75 0/43.02 0/42.64 1/47.00 |
|POLY-3 PERCENT (g) | 0.0% 4.5% 7.0% 0.0% |0.0% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/30 (3%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- 574 660 --- |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.483N P=0.247 P=0.110 (e) |P=0.203 (e) (e) P=0.520 |
|POLY 3 | P=0.472N P=0.243 P=0.117 (e) |P=0.195 (e) (e) P=0.510 |
|POLY 1.5 | P=0.466N P=0.244 P=0.118 (e) |P=0.192 (e) (e) P=0.506 |
|POLY 6 | P=0.486N P=0.237 P=0.114 (e) |P=0.198 (e) (e) P=0.513 |
|LOGISTIC REGRESSION| P=0.457N P=0.174 P=0.119 (e) |(e) (e) (e) P=0.520 |
|COCH-ARM / FISHERS | P=0.462N P=0.253 P=0.121 (e) |P=0.186 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.224N (e) (e) (e) |P=0.130 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 3/50 (6%) 0/49 (0%) 1/50 (2%) |2/50 (4%) 4/49 (8%) 0/49 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 3/44.12 3/45.18 0/42.73 1/43.73 |2/44.75 4/43.61 0/42.64 4/47.11 |
|POLY-3 PERCENT (g) | 6.8% 6.6% 0.0% 2.3% |4.5% 9.2% 0.0% 8.5% |
|TERMINAL (d) | 2/36 (6%) 0/27 (0%) 0/30 (0%) 0/28 (0%) |2/37 (5%) 3/36 (8%) 0/33 (0%) 3/41 (7%) |
|FIRST INCIDENCE | 469 542 --- 651 |729 (T) 541 --- 703 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.116N P=0.631 P=0.144N P=0.348N |P=0.516 P=0.326 P=0.264N P=0.382 |
|POLY 3 | P=0.110N P=0.652N P=0.124N P=0.308N |P=0.488 P=0.325 P=0.248N P=0.361 |
|POLY 1.5 | P=0.108N P=0.649N P=0.122N P=0.303N |P=0.482 P=0.325 P=0.245N P=0.352 |
|POLY 6 | P=0.113N P=0.663N P=0.129N P=0.319N |P=0.492 P=0.327 P=0.253N P=0.370 |
|LOGISTIC REGRESSION| P=0.093N P=0.565 P=0.113N P=0.304N |P=0.492 P=0.324 (e) P=0.369 |
|COCH-ARM / FISHERS | P=0.106N P=0.651N P=0.121N P=0.301N |P=0.473 P=0.329 P=0.253N P=0.339 |
|ORDER RESTRICTED | P=0.136N (e) (e) (e) |P=0.312 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 0/49 (0%) 1/50 (2%) |1/50 (2%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.12 1/44.36 0/42.73 1/43.51 |1/44.75 0/43.02 0/42.64 0/47.00 |
|POLY-3 PERCENT (g) | 4.5% 2.3% 0.0% 2.3% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/30 (0%) 0/28 (0%) |1/37 (3%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 469 555 --- 710 |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.396N P=0.516N P=0.257N P=0.546N |P=0.352N P=0.505N P=0.523N P=0.480N |
|POLY 3 | P=0.379N P=0.498N P=0.244N P=0.505N |P=0.364N P=0.508N P=0.510N P=0.490N |
|POLY 1.5 | P=0.378N P=0.493N P=0.241N P=0.499N |P=0.363N P=0.507N P=0.507N P=0.494N |
|POLY 6 | P=0.379N P=0.510N P=0.250N P=0.516N |P=0.366N P=0.508N P=0.514N P=0.487N |
|LOGISTIC REGRESSION| P=0.358N P=0.654N P=0.214N P=0.505N |P=0.352N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.374N P=0.492N P=0.247N P=0.492N |P=0.362N P=0.505N P=0.505N P=0.500N |
|ORDER RESTRICTED | P=0.232N (e) (e) (e) |P=0.111N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/34 (15%) 7/24 (29%) 5/26 (19%) 3/34 (9%) |2/36 (6%) 4/34 (12%) 2/30 (7%) 4/39 (10%) |
|POLY-3 RATE (b) | 5/29.59 7/21.25 5/22.73 3/29.34 |2/32.62 4/29.78 2/24.90 4/36.23 |
|POLY-3 PERCENT (g) | 16.9% 32.9% 22.0% 10.2% |6.1% 13.4% 8.0% 11.0% |
|TERMINAL (d) | 4/23 (17%) 4/12 (33%) 2/13 (15%) 1/16 (6%) |2/27 (7%) 4/24 (17%) 2/17 (12%) 3/30 (10%) |
|FIRST INCIDENCE | 706 663 660 681 |729 (T) 729 (T) 729 (T) 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.235N P=0.117 P=0.396 P=0.515N |P=0.472 P=0.280 P=0.519 P=0.388 |
|POLY 3 | P=0.115N P=0.158 P=0.456 P=0.357N |P=0.471 P=0.293 P=0.594 P=0.386 |
|POLY 1.5 | P=0.115N P=0.158 P=0.451 P=0.355N |P=0.466 P=0.299 P=0.610 P=0.382 |
|POLY 6 | P=0.121N P=0.154 P=0.458 P=0.367N |P=0.472 P=0.287 P=0.568 P=0.387 |
|LOGISTIC REGRESSION| P=0.125N P=0.137 P=0.433 P=0.388N |P=0.461 P=0.280 P=0.519 P=0.381 |
|COCH-ARM / FISHERS | P=0.117N P=0.156 P=0.450 P=0.355N |P=0.455 P=0.309 P=0.621 P=0.376 |
|ORDER RESTRICTED | P=0.124N (e) (e) (e) |P=0.375 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/34 (9%) 2/24 (8%) 2/26 (8%) 1/34 (3%) |6/36 (17%) 6/34 (18%) 5/30 (17%) 3/39 (8%) |
|POLY-3 RATE (b) | 3/29.59 2/20.94 2/22.44 1/29.29 |6/32.66 6/31.23 5/26.28 3/36.00 |
|POLY-3 PERCENT (g) | 10.1% 9.6% 8.9% 3.4% |18.4% 19.2% 19.0% 8.3% |
|TERMINAL (d) | 2/23 (9%) 1/12 (8%) 1/13 (8%) 0/16 (0%) |5/27 (19%) 3/24 (13%) 1/17 (6%) 3/30 (10%) |
|FIRST INCIDENCE | 706 693 647 672 |717 433 573 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.292N P=0.669 P=0.657N P=0.392N |P=0.138N P=0.555 P=0.556 P=0.195N |
|POLY 3 | P=0.217N P=0.657N P=0.626N P=0.307N |P=0.123N P=0.592 P=0.606 P=0.191N |
|POLY 1.5 | P=0.216N P=0.655N P=0.627N P=0.305N |P=0.125N P=0.588 P=0.618 P=0.194N |
|POLY 6 | P=0.221N P=0.664N P=0.631N P=0.314N |P=0.125N P=0.594 P=0.587 P=0.192N |
|LOGISTIC REGRESSION| P=0.218N P=0.674N P=0.635N P=0.312N |P=0.135N P=0.592 P=0.625 P=0.206N |
|COCH-ARM / FISHERS | P=0.212N P=0.696 P=0.628N P=0.307N |P=0.128N P=0.581 P=0.627 P=0.201N |
|ORDER RESTRICTED | P=0.242N (e) (e) (e) |P=0.166N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/34 (3%) 3/24 (13%) 4/26 (15%) 1/34 (3%) |1/36 (3%) 4/34 (12%) 2/30 (7%) 3/39 (8%) |
|POLY-3 RATE (b) | 1/29.50 3/20.94 4/22.56 1/29.07 |1/32.99 4/29.79 2/24.90 3/36.00 |
|POLY-3 PERCENT (g) | 3.4% 14.3% 17.7% 3.4% |3.0% 13.4% 8.0% 8.3% |
|TERMINAL (d) | 1/23 (4%) 2/12 (17%) 3/13 (23%) 1/16 (6%) |0/27 (0%) 3/24 (13%) 2/17 (12%) 3/30 (10%) |
|FIRST INCIDENCE | 729 (T) 693 607 729 (T) |623 727 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.540N P=0.145 P=0.069 P=0.680 |P=0.522 P=0.161 P=0.386 P=0.345 |
|POLY 3 | P=0.423N P=0.186 P=0.100 P=0.758 |P=0.516 P=0.146 P=0.402 P=0.336 |
|POLY 1.5 | P=0.417N P=0.188 P=0.100 P=0.760 |P=0.516 P=0.151 P=0.418 P=0.336 |
|POLY 6 | P=0.438N P=0.182 P=0.098 P=0.753 |P=0.509 P=0.139 P=0.378 P=0.332 |
|LOGISTIC REGRESSION| P=0.431N P=0.172 P=0.099 P=0.680 |P=0.523 P=0.153 P=0.428 P=0.333 |
|COCH-ARM / FISHERS | P=0.414N P=0.187 P=0.105 P=0.754N |P=0.512 P=0.161 P=0.431 P=0.338 |
|ORDER RESTRICTED | P=0.209 (e) (e) (e) |P=0.211 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/34 (3%) 0/24 (0%) 1/26 (4%) 3/34 (9%) |1/36 (3%) 2/34 (6%) 2/30 (7%) 3/39 (8%) |
|POLY-3 RATE (b) | 1/29.50 0/20.80 1/22.13 3/29.07 |1/32.62 2/29.78 2/25.38 3/36.00 |
|POLY-3 PERCENT (g) | 3.4% 0.0% 4.5% 10.3% |3.1% 6.7% 7.9% 8.3% |
|TERMINAL (d) | 1/23 (4%) 0/12 (0%) 1/13 (8%) 3/16 (19%) |1/27 (4%) 2/24 (8%) 1/17 (6%) 3/30 (10%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |729 (T) 729 (T) 587 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054 P=0.630N P=0.630 P=0.181 |P=0.300 P=0.459 P=0.394 P=0.342 |
|POLY 3 | P=0.093 P=0.570N P=0.696 P=0.298 |P=0.300 P=0.468 P=0.413 P=0.340 |
|POLY 1.5 | P=0.095 P=0.569N P=0.696 P=0.302 |P=0.296 P=0.473 P=0.424 P=0.339 |
|POLY 6 | P=0.090 P=0.573N P=0.692 P=0.288 |P=0.300 P=0.463 P=0.395 P=0.340 |
|LOGISTIC REGRESSION| P=0.054 (e) P=0.630 P=0.181 |P=0.297 P=0.459 P=0.445 P=0.342 |
|COCH-ARM / FISHERS | P=0.096 P=0.586N P=0.683 P=0.307 |P=0.286 P=0.478 P=0.431 P=0.338 |
|ORDER RESTRICTED | P=0.086 (e) (e) (e) |P=0.282 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/34 (6%) 0/24 (0%) 0/26 (0%) 0/34 (0%) |0/36 (0%) 1/34 (3%) 0/30 (0%) 0/39 (0%) |
|POLY-3 RATE (b) | 2/30.89 0/20.80 0/22.13 0/29.07 |0/32.62 1/30.44 0/24.90 0/36.00 |
|POLY-3 PERCENT (g) | 6.5% 0.0% 0.0% 0.0% |0.0% 3.3% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/12 (0%) 0/13 (0%) 0/16 (0%) |0/27 (0%) 0/24 (0%) 0/17 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 469 --- --- --- |--- 511 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.176N P=0.226N P=0.235N P=0.237N |P=0.418N P=0.496 (e) (e) |
|POLY 3 | P=0.161N P=0.328N P=0.314N P=0.250N |P=0.421N P=0.486 (e) (e) |
|POLY 1.5 | P=0.163N P=0.323N P=0.309N P=0.244N |P=0.418N P=0.487 (e) (e) |
|POLY 6 | P=0.159N P=0.338N P=0.323N P=0.259N |P=0.427N P=0.485 (e) (e) |
|LOGISTIC REGRESSION| P=0.107N P=0.996N P=0.144N P=0.185N |P=0.559N P=0.569 (e) (e) |
|COCH-ARM / FISHERS | P=0.165N P=0.339N P=0.317N P=0.246N |P=0.413N P=0.486 (e) (e) |
|ORDER RESTRICTED | P=0.033N* (e) (e) (e) |P=0.352N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/34 (9%) 3/24 (13%) 3/26 (12%) 6/34 (18%) |1/36 (3%) 0/34 (0%) 0/30 (0%) 1/39 (3%) |
|POLY-3 RATE (b) | 3/29.50 3/20.86 3/22.24 6/29.81 |1/32.62 0/29.78 0/24.90 1/36.00 |
|POLY-3 PERCENT (g) | 10.2% 14.4% 13.5% 20.1% |3.1% 0.0% 0.0% 2.8% |
|TERMINAL (d) | 3/23 (13%) 2/12 (17%) 2/13 (15%) 2/16 (13%) |1/27 (4%) 0/24 (0%) 0/17 (0%) 1/30 (3%) |
|FIRST INCIDENCE | 729 (T) 714 703 651 |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.109 P=0.389 P=0.424 P=0.151 |P=0.544 P=0.523N P=0.592N P=0.739N |
|POLY 3 | P=0.203 P=0.495 P=0.527 P=0.240 |P=0.549 P=0.518N P=0.554N P=0.739N |
|POLY 1.5 | P=0.202 P=0.497 P=0.528 P=0.240 |P=0.546 P=0.516N P=0.545N P=0.740N |
|POLY 6 | P=0.202 P=0.487 P=0.521 P=0.238 |P=0.551 P=0.521N P=0.566N P=0.739N |
|LOGISTIC REGRESSION| P=0.179 P=0.433 P=0.462 P=0.224 |P=0.544 (e) (e) P=0.739N |
|COCH-ARM / FISHERS | P=0.200 P=0.486 P=0.528 P=0.238 |P=0.539 P=0.514N P=0.545N P=0.733N |
|ORDER RESTRICTED | P=0.190 (e) (e) (e) |P=0.398N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/34 (15%) 3/24 (13%) 1/26 (4%) 1/34 (3%) |5/36 (14%) 3/34 (9%) 0/30 (0%) 5/39 (13%) |
|POLY-3 RATE (b) | 5/30.68 3/21.57 1/22.68 1/29.07 |5/32.62 3/30.44 0/24.90 5/36.73 |
|POLY-3 PERCENT (g) | 16.3% 13.9% 4.4% 3.4% |15.3% 9.9% 0.0% 13.6% |
|TERMINAL (d) | 2/23 (9%) 0/12 (0%) 0/13 (0%) 1/16 (6%) |5/27 (19%) 2/24 (8%) 0/17 (0%) 4/30 (13%) |
|FIRST INCIDENCE | 469 574 561 729 (T) |729 (T) 511 --- 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.072N P=0.470N P=0.159N P=0.161N |P=0.542N P=0.414N P=0.084N P=0.568N |
|POLY 3 | P=0.047N* P=0.560N P=0.179N P=0.109N |P=0.547N P=0.393N P=0.055N P=0.555N |
|POLY 1.5 | P=0.045N* P=0.558N P=0.177N P=0.103N |P=0.548N P=0.391N P=0.050N P=0.563N |
|POLY 6 | P=0.051N P=0.568N P=0.186N P=0.119N |P=0.551N P=0.395N P=0.065N P=0.552N |
|LOGISTIC REGRESSION| P=0.039N* P=0.586N P=0.141N P=0.098N |P=0.554N P=0.394N (e) P=0.580N |
|COCH-ARM / FISHERS | P=0.043N* P=0.564N P=0.171N P=0.099N |P=0.553N P=0.388N P=0.042N* P=0.579N |
|ORDER RESTRICTED | P=0.049N* (e) (e) (e) |P=0.239N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/34 (24%) 5/24 (21%) 9/26 (35%) 6/34 (18%) |31/36 (86%) 22/34 (65%) 15/30 (50%) 25/39 (64%) |
|POLY-3 RATE (b) | 8/29.63 5/22.01 9/22.50 6/29.36 |31/35.50 22/32.41 15/27.66 25/37.87 |
|POLY-3 PERCENT (g) | 27.0% 22.7% 40.0% 20.4% |87.3% 67.9% 54.2% 66.0% |
|TERMINAL (d) | 7/23 (30%) 2/12 (17%) 7/13 (54%) 5/16 (31%) |24/27 (89%) 14/24 (58%) 10/17 (59%) 20/30 (67%) |
|FIRST INCIDENCE | 695 542 660 651 |423 511 511 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.451 P=0.606N P=0.118 P=0.599 |P=0.098N P=0.131N P=0.054N P=0.052N |
|POLY 3 | P=0.442N P=0.489N P=0.242 P=0.387N |P=0.057N P=0.046N* P=0.002N** P=0.025N* |
|POLY 1.5 | P=0.427N P=0.504N P=0.244 P=0.383N |P=0.056N P=0.041N* P<0.001N** P=0.025N* |
|POLY 6 | P=0.470N P=0.482N P=0.231 P=0.403N |P=0.068N P=0.045N* P=0.004N** P=0.028N* |
|LOGISTIC REGRESSION| P=0.429N P=0.529N P=0.180 P=0.454N |P=0.066N P=0.037N* P=0.002N** P=0.028N* |
|COCH-ARM / FISHERS | P=0.409N P=0.535N P=0.255 P=0.383N |P=0.068N P=0.035N* P=0.002N** P=0.026N* |
|ORDER RESTRICTED | P=0.308N (e) (e) (e) |P=0.005N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/34 (3%) 1/24 (4%) 1/26 (4%) 0/34 (0%) |1/36 (3%) 7/34 (21%) 3/30 (10%) 6/39 (15%) |
|POLY-3 RATE (b) | 1/30.23 1/21.39 1/22.68 0/29.07 |1/32.62 7/31.24 3/25.38 6/37.06 |
|POLY-3 PERCENT (g) | 3.3% 4.7% 4.4% 0.0% |3.1% 22.4% 11.8% 16.2% |
|TERMINAL (d) | 0/23 (0%) 0/12 (0%) 0/13 (0%) 0/16 (0%) |1/27 (4%) 5/24 (21%) 2/17 (12%) 4/30 (13%) |
|FIRST INCIDENCE | 469 542 561 --- |729 (T) 423 587 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.303N P=0.744N P=0.751N P=0.500N |P=0.317 P=0.024 * P=0.191 P=0.078 |
|POLY 3 | P=0.290N P=0.682 P=0.696 P=0.508N |P=0.327 P=0.022 * P=0.218 P=0.076 |
|POLY 1.5 | P=0.286N P=0.682 P=0.696 P=0.504N |P=0.319 P=0.022 * P=0.229 P=0.073 |
|POLY 6 | P=0.297N P=0.679 P=0.693 P=0.514N |P=0.332 P=0.022 * P=0.201 P=0.078 |
|LOGISTIC REGRESSION| P=0.225N P=0.297 P=0.749N P=0.388N |P=0.264 P=0.028 * P=0.232 P=0.058 |
|COCH-ARM / FISHERS | P=0.278N P=0.661 P=0.683 P=0.500N |P=0.304 P=0.022 * P=0.241 P=0.067 |
|ORDER RESTRICTED | P=0.258N (e) (e) (e) |P=0.050 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/45 (16%) 7/43 (16%) 7/47 (15%) 2/44 (5%) |37/50 (74%) 39/50 (78%) 34/50 (68%) 38/50 (76%) |
|POLY-3 RATE (b) | 7/41.07 7/39.83 7/41.36 2/38.50 |37/45.79 39/45.03 34/45.02 38/48.58 |
|POLY-3 PERCENT (g) | 17.0% 17.6% 16.9% 5.2% |80.8% 86.6% 75.5% 78.2% |
|TERMINAL (d) | 5/34 (15%) 4/27 (15%) 4/30 (13%) 1/27 (4%) |31/37 (84%) 34/36 (94%) 27/33 (82%) 32/41 (78%) |
|FIRST INCIDENCE | 630 672 703 671 |623 626 615 635 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.094N P=0.461 P=0.526 P=0.130N |P=0.185N P=0.313 P=0.509 P=0.360N |
|POLY 3 | P=0.068N P=0.591 P=0.609N P=0.093N |P=0.220N P=0.306 P=0.351N P=0.477N |
|POLY 1.5 | P=0.063N P=0.589 P=0.598N P=0.088N |P=0.318N P=0.339 P=0.335N P=0.563N |
|POLY 6 | P=0.076N P=0.581 P=0.601 P=0.101N |P=0.136N P=0.283 P=0.394N P=0.381N |
|LOGISTIC REGRESSION| P=0.069N P=0.592 P=0.614N P=0.092N |P=0.176N P=0.273 P=0.474N P=0.449N |
|COCH-ARM / FISHERS | P=0.056N P=0.578 P=0.579N P=0.084N |P=0.480N P=0.408 P=0.330N P=0.500 |
|ORDER RESTRICTED | P=0.094N (e) (e) (e) |P=0.297N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/45 (0%) 0/43 (0%) 0/47 (0%) 0/44 (0%) |4/50 (8%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/40.58 0/39.50 0/41.17 0/38.28 |4/46.88 1/44.23 3/45.21 2/48.32 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |8.5% 2.3% 6.6% 4.1% |
|TERMINAL (d) | 0/34 (0%) 0/27 (0%) 0/30 (0%) 0/27 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- --- |511 563 401 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.446N P=0.192N P=0.504N P=0.321N |
|POLY 3 | (e) (e) (e) (e) |P=0.434N P=0.197N P=0.520N P=0.324N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.446N P=0.190N P=0.509N P=0.328N |
|POLY 6 | (e) (e) (e) (e) |P=0.425N P=0.205N P=0.538N P=0.322N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.325 P=0.098N P=0.474N P=0.723 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.470N P=0.181N P=0.500N P=0.339N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.269N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/45 (0%) 0/43 (0%) 0/47 (0%) 0/44 (0%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/40.58 0/39.50 0/41.17 0/38.28 |2/44.75 1/44.02 1/43.24 4/47.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 2.3% 2.3% 8.5% |
|TERMINAL (d) | 0/34 (0%) 0/27 (0%) 0/30 (0%) 0/27 (0%) |2/37 (5%) 0/36 (0%) 1/33 (3%) 4/41 (10%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 639 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.177 P=0.509N P=0.540N P=0.385 |
|POLY 3 | (e) (e) (e) (e) |P=0.154 P=0.506N P=0.512N P=0.360 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.150 P=0.504N P=0.506N P=0.352 |
|POLY 6 | (e) (e) (e) (e) |P=0.157 P=0.506N P=0.522N P=0.368 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.164 P=0.503N P=0.540N P=0.385 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.143 P=0.500N P=0.500N P=0.339 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.154 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/45 (0%) 1/43 (2%) 2/47 (4%) 2/44 (5%) |7/50 (14%) 11/50 (22%) 10/50 (20%) 9/50 (18%) |
|POLY-3 RATE (b) | 0/40.58 1/39.50 2/41.82 2/38.33 |7/44.75 11/44.41 10/44.16 9/47.00 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 4.8% 5.2% |15.6% 24.8% 22.7% 19.2% |
|TERMINAL (d) | 0/34 (0%) 1/27 (4%) 0/30 (0%) 1/27 (4%) |7/37 (19%) 8/36 (22%) 8/33 (24%) 9/41 (22%) |
|FIRST INCIDENCE | --- 729 (T) 566 718 |729 (T) 623 547 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.151 P=0.454 P=0.238 P=0.196 |P=0.485N P=0.204 P=0.220 P=0.480 |
|POLY 3 | P=0.155 P=0.495 P=0.244 P=0.224 |P=0.534N P=0.209 P=0.284 P=0.434 |
|POLY 1.5 | P=0.160 P=0.494 P=0.245 P=0.228 |P=0.540 P=0.210 P=0.291 P=0.419 |
|POLY 6 | P=0.148 P=0.492 P=0.241 P=0.218 |P=0.520N P=0.211 P=0.272 P=0.448 |
|LOGISTIC REGRESSION| P=0.169 P=0.454 P=0.268 P=0.210 |P=0.521N P=0.195 P=0.261 P=0.480 |
|COCH-ARM / FISHERS | P=0.166 P=0.489 P=0.258 P=0.242 |P=0.503 P=0.218 P=0.298 P=0.393 |
|ORDER RESTRICTED | P=0.146 (e) (e) (e) |P=0.348 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/19 (11%) 0/20 (0%) 2/19 (11%) 2/23 (9%) |4/18 (22%) 2/10 (20%) 1/13 (8%) 0/16 (0%) |
|POLY-3 RATE (b) | 2/16.43 0/18.04 2/17.18 2/19.70 |4/17.60 2/9.29 1/11.52 0/15.47 |
|POLY-3 PERCENT (g) | 12.2% 0.0% 11.6% 10.2% |22.7% 21.5% 8.7% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |0/11 (0%) 0/6 (0%) 0/6 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 469 --- 475 465 |423 511 511 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.340 P=0.228N P=0.676N P=0.684N |P=0.037N* P=0.353N P=0.189N P=0.062N |
|POLY 3 | P=0.378 P=0.211N P=0.682N P=0.631N |P=0.028N* P=0.655N P=0.319N P=0.065N |
|POLY 1.5 | P=0.387 P=0.213N P=0.685N P=0.625N |P=0.028N* P=0.644N P=0.301N P=0.064N |
|POLY 6 | P=0.366 P=0.216N P=0.691N P=0.648N |P=0.028N* P=0.671N P=0.349N P=0.066N |
|LOGISTIC REGRESSION| P=0.349 P=0.879N P=0.289 P=0.599 |P=0.258N (e) P=0.257N (e) |
|COCH-ARM / FISHERS | P=0.398 P=0.231N P=0.698N P=0.620N |P=0.029N* P=0.642N P=0.285N P=0.066N |
|ORDER RESTRICTED | P=0.465 (e) (e) (e) |P=0.020N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/19 (63%) 10/20 (50%) 13/19 (68%) 14/23 (61%) |12/18 (67%) 5/10 (50%) 9/13 (69%) 13/16 (81%) |
|POLY-3 RATE (b) | 12/15.04 10/18.70 13/16.91 14/19.51 |12/15.50 5/8.04 9/11.21 13/15.78 |
|POLY-3 PERCENT (g) | 79.8% 53.5% 76.9% 71.8% |77.4% 62.2% 80.3% 82.4% |
|TERMINAL (d) | 12/13 (92%) 5/10 (50%) 10/10 (100%) 8/9 (89%) |10/11 (91%) 5/6 (83%) 6/6 (100%) 12/14 (86%) |
|FIRST INCIDENCE | 729 (T) 663 607 639 |644 729 (T) 699 644 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.032 * P=0.559 P=0.079 P=0.042 * |P=0.544N P=0.214N P=0.342 P=0.374N |
|POLY 3 | P=0.319 P=0.095N P=0.604N P=0.436N |P=0.293 P=0.374N P=0.631 P=0.541 |
|POLY 1.5 | P=0.362 P=0.164N P=0.652 P=0.490N |P=0.198 P=0.339N P=0.623 P=0.427 |
|POLY 6 | P=0.255 P=0.052N P=0.553N P=0.399N |P=0.457 P=0.463N P=0.601 P=0.666 |
|LOGISTIC REGRESSION| P=0.202 P=0.090N P=0.713 P=0.595N |P=0.549 P=0.473N P=0.562 P=0.653N |
|COCH-ARM / FISHERS | P=0.400 P=0.307N P=0.500 P=0.567N |P=0.117 P=0.321N P=0.597 P=0.285 |
|ORDER RESTRICTED | P=0.312N (e) (e) (e) |P=0.324 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 2/49 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.39 1/43.53 2/43.26 1/43.44 |0/44.75 0/43.69 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 4.6% 2.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/31 (3%) 1/28 (4%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 638 703 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.357 P=0.510 P=0.215 P=0.450 |(e) (e) (e) (e) |
|POLY 3 | P=0.373 P=0.501 P=0.236 P=0.500 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.379 P=0.502 P=0.237 P=0.503 |(e) (e) (e) (e) |
|POLY 6 | P=0.362 P=0.496 P=0.233 P=0.494 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.380 P=0.465 P=0.233 P=0.450 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.383 P=0.500 P=0.247 P=0.505 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.224 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/49 (2%) 6/49 (12%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.39 1/43.53 6/43.46 1/43.44 |1/44.79 2/44.07 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 2.3% 2.3% 13.8% 2.3% |2.2% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 4/31 (13%) 1/28 (4%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 638 675 729 (T) |718 623 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.361 P=0.735 P=0.043 * P=0.705 |P=0.121N P=0.493 P=0.533N P=0.490N |
|POLY 3 | P=0.390 P=0.760N P=0.055 P=0.760N |P=0.123N P=0.494 P=0.507N P=0.490N |
|POLY 1.5 | P=0.399 P=0.758N P=0.056 P=0.757N |P=0.123N P=0.496 P=0.504N P=0.494N |
|POLY 6 | P=0.374 P=0.756 P=0.054 P=0.755 |P=0.124N P=0.494 P=0.513N P=0.487N |
|LOGISTIC REGRESSION| P=0.400 P=0.760 P=0.054 P=0.705 |P=0.124N P=0.501 P=0.513N P=0.489N |
|COCH-ARM / FISHERS | P=0.410 P=0.753N P=0.056 P=0.747N |P=0.124N P=0.500 P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.170 (e) (e) (e) |P=0.156N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 3/49 (6%) 0/49 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.39 3/43.59 0/43.16 1/43.44 |0/44.75 1/43.69 0/43.24 1/47.34 |
|POLY-3 PERCENT (g) | 2.3% 6.9% 0.0% 2.3% |0.0% 2.3% 0.0% 2.1% |
|TERMINAL (d) | 1/36 (3%) 2/27 (7%) 0/31 (0%) 1/28 (4%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 619 --- 729 (T) |--- 729 (T) --- 635 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309N P=0.233 P=0.530N P=0.705 |P=0.503 P=0.495 (e) P=0.527 |
|POLY 3 | P=0.277N P=0.307 P=0.501N P=0.760N |P=0.490 P=0.495 (e) P=0.511 |
|POLY 1.5 | P=0.275N P=0.309 P=0.501N P=0.757N |P=0.485 P=0.497 (e) P=0.507 |
|POLY 6 | P=0.283N P=0.297 P=0.504N P=0.755 |P=0.494 P=0.494 (e) P=0.516 |
|LOGISTIC REGRESSION| P=0.279N P=0.305 (e) P=0.705 |P=0.467 P=0.495 (e) P=0.438 |
|COCH-ARM / FISHERS | P=0.275N P=0.309 P=0.500N P=0.747N |P=0.478 P=0.500 (e) P=0.500 |
|ORDER RESTRICTED | P=0.268N (e) (e) (e) |P=0.262 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |5/50 (10%) 1/50 (2%) 1/49 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | |5/46.71 1/44.00 1/42.24 4/47.00 |
|POLY-3 PERCENT (g) | |10.7% 2.3% 2.4% 8.5% |
|TERMINAL (d) | |2/37 (5%) 0/36 (0%) 1/32 (3%) 4/41 (10%) |
|FIRST INCIDENCE | |462 644 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.537 P=0.118N P=0.126N P=0.454N |
|POLY 3 | |P=0.513 P=0.116N P=0.126N P=0.496N |
|POLY 1.5 | |P=0.507 P=0.111N P=0.117N P=0.497N |
|POLY 6 | |P=0.516 P=0.120N P=0.139N P=0.496N |
|LOGISTIC REGRESSION| |P=0.425 P=0.065N P=0.086N P=0.630N |
|COCH-ARM / FISHERS | |P=0.493 P=0.102N P=0.107N P=0.500N |
|ORDER RESTRICTED | |P=0.154N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Ovary: Periovarian Tissue |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 4/50 (8%) 2/49 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | |4/44.79 4/43.69 2/42.24 1/47.00 |
|POLY-3 PERCENT (g) | |8.9% 9.2% 4.7% 2.1% |
|TERMINAL (d) | |3/37 (8%) 4/36 (11%) 2/32 (6%) 1/41 (2%) |
|FIRST INCIDENCE | |718 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.071N P=0.626 P=0.408N P=0.155N |
|POLY 3 | |P=0.074N P=0.630 P=0.364N P=0.164N |
|POLY 1.5 | |P=0.078N P=0.634 P=0.356N P=0.170N |
|POLY 6 | |P=0.072N P=0.626 P=0.379N P=0.160N |
|LOGISTIC REGRESSION| |P=0.075N P=0.621 P=0.407N P=0.158N |
|COCH-ARM / FISHERS | |P=0.084N P=0.643N P=0.349N P=0.181N |
|ORDER RESTRICTED | |P=0.126N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/49 (47%) 23/49 (47%) 27/49 (55%) 15/50 (30%) |15/50 (30%) 8/49 (16%) 9/49 (18%) 16/49 (33%) |
|POLY-3 RATE (b) | 23/46.12 23/45.20 27/46.42 15/44.63 |15/45.64 8/43.61 9/43.02 16/46.90 |
|POLY-3 PERCENT (g) | 49.9% 50.9% 58.2% 33.6% |32.9% 18.3% 20.9% 34.1% |
|TERMINAL (d) | 16/36 (44%) 14/27 (52%) 15/31 (48%) 10/28 (36%) |12/37 (32%) 7/36 (19%) 6/32 (19%) 14/41 (34%) |
|FIRST INCIDENCE | 469 574 209 562 |423 541 636 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179N P=0.260 P=0.175 P=0.249N |P=0.304 P=0.093N P=0.221N P=0.544N |
|POLY 3 | P=0.074N P=0.545 P=0.275 P=0.084N |P=0.233 P=0.090N P=0.151N P=0.537 |
|POLY 1.5 | P=0.064N P=0.571 P=0.282 P=0.071N |P=0.217 P=0.089N P=0.142N P=0.510 |
|POLY 6 | P=0.094N P=0.486 P=0.255 P=0.110N |P=0.252 P=0.090N P=0.163N P=0.569 |
|LOGISTIC REGRESSION| P=0.058N P=0.573N P=0.272 P=0.065N |P=0.239 P=0.090N P=0.149N P=0.529 |
|COCH-ARM / FISHERS | P=0.056N P=0.580N P=0.272 P=0.063N |P=0.193 P=0.084N P=0.132N P=0.473 |
|ORDER RESTRICTED | P=0.041N* (e) (e) (e) |P=0.211 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Cyst Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/49 (31%) 13/49 (27%) 19/49 (39%) 16/50 (32%) |11/50 (22%) 16/49 (33%) 15/49 (31%) 19/49 (39%) |
|POLY-3 RATE (b) | 15/43.62 13/43.93 19/44.42 16/44.40 |11/45.18 16/45.09 15/43.41 19/46.45 |
|POLY-3 PERCENT (g) | 34.4% 29.6% 42.8% 36.0% |24.4% 35.5% 34.6% 40.9% |
|TERMINAL (d) | 13/36 (36%) 9/27 (33%) 14/31 (45%) 11/28 (39%) |8/37 (22%) 10/36 (28%) 13/32 (41%) 18/41 (44%) |
|FIRST INCIDENCE | 695 582 647 651 |623 433 401 703 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.172 P=0.457 P=0.141 P=0.242 |P=0.177 P=0.180 P=0.143 P=0.116 |
|POLY 3 | P=0.304 P=0.400N P=0.276 P=0.525 |P=0.103 P=0.176 P=0.204 P=0.069 |
|POLY 1.5 | P=0.308 P=0.396N P=0.271 P=0.530 |P=0.098 P=0.170 P=0.218 P=0.063 |
|POLY 6 | P=0.298 P=0.429N P=0.271 P=0.505 |P=0.105 P=0.186 P=0.180 P=0.074 |
|LOGISTIC REGRESSION| P=0.269 P=0.476N P=0.231 P=0.451 |P=0.115 P=0.160 P=0.195 P=0.087 |
|COCH-ARM / FISHERS | P=0.316 P=0.412N P=0.262 P=0.527 |P=0.087 P=0.168 P=0.228 P=0.055 |
|ORDER RESTRICTED | P=0.367 (e) (e) (e) |P=0.065 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 4/50 (8%) 1/49 (2%) 3/50 (6%) |10/49 (20%) 6/49 (12%) 2/50 (4%) 13/50 (26%) |
|POLY-3 RATE (b) | 2/42.47 4/43.94 1/43.56 3/43.56 |10/45.11 6/43.23 2/43.24 13/47.73 |
|POLY-3 PERCENT (g) | 4.7% 9.1% 2.3% 6.9% |22.2% 13.9% 4.6% 27.2% |
|TERMINAL (d) | 2/36 (6%) 3/27 (11%) 0/31 (0%) 2/28 (7%) |8/36 (22%) 6/36 (17%) 2/33 (6%) 11/41 (27%) |
|FIRST INCIDENCE | 729 (T) 693 703 699 |423 729 (T) 729 (T) 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.577 P=0.227 P=0.541N P=0.402 |P=0.241 P=0.210N P=0.023N* P=0.435 |
|POLY 3 | P=0.523N P=0.353 P=0.491N P=0.512 |P=0.191 P=0.231N P=0.016N* P=0.373 |
|POLY 1.5 | P=0.520N P=0.358 P=0.491N P=0.517 |P=0.184 P=0.223N P=0.014N* P=0.359 |
|POLY 6 | P=0.530N P=0.336 P=0.496N P=0.499 |P=0.197 P=0.238N P=0.019N* P=0.388 |
|LOGISTIC REGRESSION| P=0.540N P=0.301 P=0.503N P=0.472 |P=0.199 P=0.209N P=0.014N* P=0.317 |
|COCH-ARM / FISHERS | P=0.519N P=0.359 P=0.492N P=0.520 |P=0.177 P=0.207N P=0.013N* P=0.337 |
|ORDER RESTRICTED | P=0.504N (e) (e) (e) |P=0.052 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |1/49 (2%) 2/49 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.47 0/43.80 0/43.46 0/43.44 |1/43.75 2/44.04 2/43.64 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 4.5% 4.6% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |1/36 (3%) 1/36 (3%) 1/33 (3%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 423 615 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.238N P=0.498 P=0.480 P=0.474N |
|POLY 3 | (e) (e) (e) (e) |P=0.236N P=0.502 P=0.499 P=0.486N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.242N P=0.501 P=0.503 P=0.490N |
|POLY 6 | (e) (e) (e) (e) |P=0.231N P=0.504 P=0.492 P=0.482N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.296N P=0.531 P=0.507 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.251N P=0.500 P=0.508 P=0.495N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.212N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/50 (2%) 1/49 (2%) 1/50 (2%) |2/49 (4%) 2/49 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/42.47 1/43.80 1/43.46 1/43.44 |2/43.75 2/43.89 1/43.24 2/47.00 |
|POLY-3 PERCENT (g) | 4.7% 2.3% 2.3% 2.3% |4.6% 4.6% 2.3% 4.3% |
|TERMINAL (d) | 2/36 (6%) 1/27 (4%) 1/31 (3%) 1/28 (4%) |2/36 (6%) 1/36 (3%) 1/33 (3%) 2/41 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 511 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482N P=0.600N P=0.552N P=0.588N |P=0.509N P=0.691 P=0.530N P=0.647N |
|POLY 3 | P=0.432N P=0.489N P=0.492N P=0.492N |P=0.533N P=0.693N P=0.504N P=0.668N |
|POLY 1.5 | P=0.432N P=0.485N P=0.492N P=0.488N |P=0.537N P=0.694 P=0.499N P=0.675N |
|POLY 6 | P=0.432N P=0.502N P=0.498N P=0.503N |P=0.531N P=0.691N P=0.513N P=0.661N |
|LOGISTIC REGRESSION| P=0.482N P=0.600N P=0.552N P=0.588N |P=0.541N P=0.689N P=0.530N P=0.647N |
|COCH-ARM / FISHERS | P=0.430N P=0.485N P=0.492N P=0.485N |P=0.544N P=0.691N P=0.492N P=0.684N |
|ORDER RESTRICTED | P=0.403N (e) (e) (e) |P=0.593N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/48 (6%) 7/50 (14%) 3/49 (6%) 8/50 (16%) |3/49 (6%) 1/49 (2%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/42.47 7/45.14 3/43.46 8/43.63 |3/44.55 1/43.61 2/43.36 3/47.23 |
|POLY-3 PERCENT (g) | 7.1% 15.5% 6.9% 18.3% |6.7% 2.3% 4.6% 6.4% |
|TERMINAL (d) | 3/36 (8%) 2/27 (7%) 3/31 (10%) 7/28 (25%) |2/36 (6%) 0/36 (0%) 1/33 (3%) 2/41 (5%) |
|FIRST INCIDENCE | 729 (T) 542 729 (T) 678 |423 623 699 670 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.146 P=0.108 P=0.593 P=0.043 * |P=0.448 P=0.308N P=0.532N P=0.613N |
|POLY 3 | P=0.197 P=0.182 P=0.652N P=0.105 |P=0.434 P=0.313N P=0.512N P=0.635N |
|POLY 1.5 | P=0.203 P=0.183 P=0.651N P=0.110 |P=0.427 P=0.311N P=0.503N P=0.642N |
|POLY 6 | P=0.185 P=0.173 P=0.660N P=0.096 |P=0.441 P=0.312N P=0.525N P=0.627N |
|LOGISTIC REGRESSION| P=0.201 P=0.174 P=0.593 P=0.072 |P=0.372 P=0.270N P=0.478N P=0.605 |
|COCH-ARM / FISHERS | P=0.209 P=0.176 P=0.651N P=0.113 |P=0.411 P=0.309N P=0.490N P=0.651N |
|ORDER RESTRICTED | P=0.081 (e) (e) (e) |P=0.487N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 2/50 (4%) 0/49 (0%) 0/50 (0%) |11/49 (22%) 14/49 (29%) 11/50 (22%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/42.81 2/43.80 0/43.46 0/43.44 |11/45.28 14/45.01 11/44.74 3/47.59 |
|POLY-3 PERCENT (g) | 4.7% 4.6% 0.0% 0.0% |24.3% 31.1% 24.6% 6.3% |
|TERMINAL (d) | 1/36 (3%) 2/27 (7%) 0/31 (0%) 0/28 (0%) |8/36 (22%) 10/36 (28%) 6/33 (18%) 2/41 (5%) |
|FIRST INCIDENCE | 636 729 (T) --- --- |462 423 514 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.076N P=0.615 P=0.256N P=0.262N |P=0.005N** P=0.322 P=0.517 P=0.015N* |
|POLY 3 | P=0.066N P=0.686N P=0.234N P=0.234N |P=0.003N** P=0.313 P=0.584 P=0.015N* |
|POLY 1.5 | P=0.066N P=0.680N P=0.233N P=0.230N |P=0.004N** P=0.315 P=0.594N P=0.016N* |
|POLY 6 | P=0.066N P=0.687 P=0.238N P=0.242N |P=0.003N** P=0.312 P=0.564 P=0.014N* |
|LOGISTIC REGRESSION| P=0.066N P=0.684N P=0.233N P=0.228N |P=0.006N** P=0.327 P=0.568N P=0.028N* |
|COCH-ARM / FISHERS | P=0.066N P=0.676N P=0.242N P=0.237N |P=0.005N** P=0.322 P=0.574N P=0.018N* |
|ORDER RESTRICTED | P=0.113N (e) (e) (e) |P=0.006N** (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 47
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 2/50 (4%) 1/49 (2%) 3/50 (6%) |9/49 (18%) 6/49 (12%) 10/50 (20%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/43.05 2/43.80 1/43.46 3/44.03 |9/44.88 6/43.23 10/43.24 2/47.00 |
|POLY-3 PERCENT (g) | 4.7% 4.6% 2.3% 6.8% |20.1% 13.9% 23.1% 4.3% |
|TERMINAL (d) | 1/36 (3%) 2/27 (7%) 1/31 (3%) 1/28 (4%) |5/36 (14%) 6/36 (17%) 10/33 (30%) 2/41 (5%) |
|FIRST INCIDENCE | 545 729 (T) 729 (T) 590 |595 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.377 P=0.623 P=0.527N P=0.456 |P=0.045N* P=0.299N P=0.417 P=0.020N* |
|POLY 3 | P=0.418 P=0.688N P=0.497N P=0.510 |P=0.044N* P=0.314N P=0.464 P=0.020N* |
|POLY 1.5 | P=0.420 P=0.681N P=0.494N P=0.516 |P=0.048N* P=0.304N P=0.491 P=0.021N* |
|POLY 6 | P=0.415 P=0.685 P=0.505N P=0.498 |P=0.041N* P=0.327N P=0.420 P=0.020N* |
|LOGISTIC REGRESSION| P=0.422 P=0.685N P=0.493N P=0.513 |P=0.047N* P=0.294N P=0.481 P=0.026N* |
|COCH-ARM / FISHERS | P=0.421 P=0.676N P=0.492N P=0.520 |P=0.060N P=0.288N P=0.520 P=0.023N* |
|ORDER RESTRICTED | P=0.403 (e) (e) (e) |P=0.020N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 2/50 (4%) 3/49 (6%) 1/50 (2%) |7/49 (14%) 5/49 (10%) 10/50 (20%) 4/50 (8%) |
|POLY-3 RATE (b) | 4/43.17 2/43.94 3/43.46 1/43.44 |7/43.75 5/44.04 10/43.24 4/47.00 |
|POLY-3 PERCENT (g) | 9.3% 4.6% 6.9% 2.3% |16.0% 11.4% 23.1% 8.5% |
|TERMINAL (d) | 2/36 (6%) 1/27 (4%) 3/31 (10%) 1/28 (4%) |7/36 (19%) 4/36 (11%) 10/33 (30%) 4/41 (10%) |
|FIRST INCIDENCE | 545 693 729 (T) 729 (T) |729 (T) 423 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.239N P=0.419N P=0.561N P=0.233N |P=0.291N P=0.380N P=0.224 P=0.189N |
|POLY 3 | P=0.201N P=0.329N P=0.496N P=0.176N |P=0.314N P=0.374N P=0.285 P=0.221N |
|POLY 1.5 | P=0.199N P=0.321N P=0.492N P=0.171N |P=0.330N P=0.377N P=0.299 P=0.232N |
|POLY 6 | P=0.205N P=0.348N P=0.511N P=0.188N |P=0.299N P=0.370N P=0.263 P=0.211N |
|LOGISTIC REGRESSION| P=0.197N P=0.320N P=0.488N P=0.167N |P=0.313N P=0.384N P=0.224 P=0.189N |
|COCH-ARM / FISHERS | P=0.195N P=0.319N P=0.488N P=0.168N |P=0.359N P=0.380N P=0.314 P=0.251N |
|ORDER RESTRICTED | P=0.128N (e) (e) (e) |P=0.202N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 48
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Rathke's Cleft |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) |1/49 (2%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.47 0/43.80 0/43.46 1/44.02 |1/43.75 2/44.39 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.3% |2.3% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |1/36 (3%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- 545 |729 (T) 433 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.185 (e) (e) P=0.509 |P=0.118N P=0.500 P=0.517N P=0.474N |
|POLY 3 | P=0.188 (e) (e) P=0.507 |P=0.120N P=0.505 P=0.502N P=0.486N |
|POLY 1.5 | P=0.188 (e) (e) P=0.509 |P=0.120N P=0.502 P=0.499N P=0.490N |
|POLY 6 | P=0.187 (e) (e) P=0.503 |P=0.120N P=0.509 P=0.508N P=0.482N |
|LOGISTIC REGRESSION| P=0.181 (e) (e) P=0.454 |P=0.155N P=0.553 (e) (e) |
|COCH-ARM / FISHERS | P=0.187 (e) (e) P=0.510 |P=0.121N P=0.500 P=0.495N P=0.495N |
|ORDER RESTRICTED | P=0.127 (e) (e) (e) |P=0.157N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Rathke's Cleft |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/50 (0%) 2/49 (4%) 2/50 (4%) |1/49 (2%) 2/49 (4%) 2/50 (4%) 6/50 (12%) |
|POLY-3 RATE (b) | 1/42.47 0/43.80 2/43.88 2/43.66 |1/43.75 2/43.23 2/43.68 6/47.48 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 4.6% 4.6% |2.3% 4.6% 4.6% 12.6% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 1/31 (3%) 0/28 (0%) |1/36 (3%) 2/36 (6%) 0/33 (0%) 4/41 (10%) |
|FIRST INCIDENCE | 729 (T) --- 605 699 |729 (T) 729 (T) 636 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.170 P=0.557N P=0.471 P=0.449 |P=0.038 * P=0.500 P=0.469 P=0.083 |
|POLY 3 | P=0.188 P=0.494N P=0.511 P=0.510 |P=0.029 * P=0.496 P=0.500 P=0.070 |
|POLY 1.5 | P=0.189 P=0.491N P=0.510 P=0.513 |P=0.027 * P=0.497 P=0.503 P=0.066 |
|POLY 6 | P=0.187 P=0.501N P=0.508 P=0.501 |P=0.031 * P=0.496 P=0.493 P=0.075 |
|LOGISTIC REGRESSION| P=0.190 (e) P=0.507 P=0.505 |P=0.028 * P=0.500 P=0.508 P=0.066 |
|COCH-ARM / FISHERS | P=0.190 P=0.490N P=0.508 P=0.515 |P=0.025 * P=0.500 P=0.508 P=0.059 |
|ORDER RESTRICTED | P=0.274 (e) (e) (e) |P=0.025 * (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 49
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/49 (4%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 RATE (b) | 0/42.39 2/43.34 1/43.73 2/43.44 | |
|POLY-3 PERCENT (g) | 0.0% 4.6% 2.3% 4.6% | |
|TERMINAL (d) | 0/35 (0%) 1/27 (4%) 1/31 (3%) 2/28 (7%) | |
|FIRST INCIDENCE | --- 695 729 (T) 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.285 P=0.198 P=0.476 P=0.190 | |
|POLY 3 | P=0.323 P=0.242 P=0.506 P=0.242 | |
|POLY 1.5 | P=0.327 P=0.244 P=0.507 P=0.245 | |
|POLY 6 | P=0.313 P=0.236 P=0.502 P=0.236 | |
|LOGISTIC REGRESSION| P=0.308 P=0.238 P=0.476 P=0.190 | |
|COCH-ARM / FISHERS | P=0.328 P=0.253 P=0.510 P=0.258 | |
|ORDER RESTRICTED | P=0.159 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/48 (46%) 12/49 (24%) 18/50 (36%) 20/50 (40%) | |
|POLY-3 RATE (b) | 22/45.87 12/43.37 18/45.64 20/44.78 | |
|POLY-3 PERCENT (g) | 48.0% 27.7% 39.4% 44.7% | |
|TERMINAL (d) | 13/35 (37%) 9/27 (33%) 11/31 (36%) 16/28 (57%) | |
|FIRST INCIDENCE | 381 699 561 545 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.207 P=0.134N P=0.405N P=0.461 | |
|POLY 3 | P=0.323 P=0.036N* P=0.270N P=0.458N | |
|POLY 1.5 | P=0.336 P=0.028N* P=0.250N P=0.408N | |
|POLY 6 | P=0.304 P=0.057N P=0.301N P=0.539N | |
|LOGISTIC REGRESSION| P=0.349 P=0.023N* P=0.215N P=0.353N | |
|COCH-ARM / FISHERS | P=0.360 P=0.023N* P=0.216N P=0.352N | |
|ORDER RESTRICTED | P=0.232N (e) (e) (e) | |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 50
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 23/49 (47%) 29/50 (58%) 30/50 (60%) | |
|POLY-3 RATE (b) | 21/45.45 23/45.03 29/46.94 30/47.23 | |
|POLY-3 PERCENT (g) | 46.2% 51.1% 61.8% 63.5% | |
|TERMINAL (d) | 17/36 (47%) 14/27 (52%) 17/31 (55%) 20/28 (71%) | |
|FIRST INCIDENCE | 469 562 566 465 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.015 * P=0.137 P=0.046 * P=0.010 * | |
|POLY 3 | P=0.039 * P=0.399 P=0.094 P=0.066 | |
|POLY 1.5 | P=0.035 * P=0.404 P=0.084 P=0.063 | |
|POLY 6 | P=0.041 * P=0.367 P=0.105 P=0.062 | |
|LOGISTIC REGRESSION| P=0.029 * P=0.406 P=0.080 P=0.055 | |
|COCH-ARM / FISHERS | P=0.031 * P=0.385 P=0.081 P=0.055 | |
|ORDER RESTRICTED | P=0.062 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Mineralization Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/49 (4%) 3/50 (6%) 4/50 (8%) | |
|POLY-3 RATE (b) | 3/43.93 2/43.53 3/43.73 4/43.75 | |
|POLY-3 PERCENT (g) | 6.8% 4.6% 6.9% 9.1% | |
|TERMINAL (d) | 1/36 (3%) 1/27 (4%) 3/31 (10%) 3/28 (11%) | |
|FIRST INCIDENCE | 699 638 729 (T) 644 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.264 P=0.574N P=0.595 P=0.408 | |
|POLY 3 | P=0.305 P=0.504N P=0.661 P=0.498 | |
|POLY 1.5 | P=0.308 P=0.503N P=0.662 P=0.501 | |
|POLY 6 | P=0.299 P=0.516N P=0.652 P=0.485 | |
|LOGISTIC REGRESSION| P=0.302 P=0.506N P=0.651 P=0.494 | |
|COCH-ARM / FISHERS | P=0.310 P=0.510N P=0.661N P=0.500 | |
|ORDER RESTRICTED | P=0.417 (e) (e) (e) | |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 51
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Prostate: Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 4/49 (8%) 2/50 (4%) 11/50 (22%) | |
|POLY-3 RATE (b) | 11/44.07 4/43.20 2/43.85 11/43.76 | |
|POLY-3 PERCENT (g) | 25.0% 9.3% 4.6% 25.1% | |
|TERMINAL (d) | 10/36 (28%) 4/27 (15%) 1/31 (3%) 10/28 (36%) | |
|FIRST INCIDENCE | 630 729 (T) 698 639 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.207 P=0.123N P=0.017N* P=0.358 | |
|POLY 3 | P=0.291 P=0.046N* P=0.007N** P=0.590 | |
|POLY 1.5 | P=0.293 P=0.045N* P=0.007N** P=0.595N | |
|POLY 6 | P=0.291 P=0.052N P=0.007N** P=0.565 | |
|LOGISTIC REGRESSION| P=0.265 P=0.061N P=0.009N** P=0.544 | |
|COCH-ARM / FISHERS | P=0.303 P=0.049N* P=0.007N** P=0.595N | |
|ORDER RESTRICTED | P=0.082 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.39 0/43.80 0/43.73 0/43.44 |2/44.75 0/43.69 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |2/37 (5%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.167N P=0.244N P=0.264N P=0.216N |
|POLY 3 | (e) (e) (e) (e) |P=0.169N P=0.242N P=0.245N P=0.226N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.170N P=0.241N P=0.241N P=0.230N |
|POLY 6 | (e) (e) (e) (e) |P=0.169N P=0.244N P=0.251N P=0.223N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.167N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.173N P=0.247N P=0.247N P=0.247N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.026N* (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 52
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/43.72 1/43.80 3/43.73 1/43.54 |0/44.75 0/43.69 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 6.9% 2.3% 6.9% 2.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/36 (8%) 1/27 (4%) 3/31 (10%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 703 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.443N P=0.412N P=0.593 P=0.389N |(e) (e) (e) (e) |
|POLY 3 | P=0.392N P=0.304N P=0.663N P=0.306N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.392N P=0.302N P=0.662N P=0.304N |(e) (e) (e) (e) |
|POLY 6 | P=0.392N P=0.315N P=0.656 P=0.314N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.420N P=0.412N P=0.593 P=0.330N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.389N P=0.309N P=0.661N P=0.309N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.245N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.72 2/44.23 0/43.73 0/43.44 |0/44.75 0/43.69 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 4.5% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 1/27 (4%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 605 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.246N P=0.213 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.233N P=0.240 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.232N P=0.240 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.239N P=0.234 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.235N P=0.223 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.236N P=0.247 (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.251N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 53
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.72 2/43.80 0/43.73 0/43.44 |0/44.75 1/43.69 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 0.0% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 2/27 (7%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.256N P=0.177 (e) (e) |P=0.410N P=0.495 (e) (e) |
|POLY 3 | P=0.234N P=0.237 (e) (e) |P=0.431N P=0.495 (e) (e) |
|POLY 1.5 | P=0.233N P=0.239 (e) (e) |P=0.428N P=0.497 (e) (e) |
|POLY 6 | P=0.241N P=0.230 (e) (e) |P=0.434N P=0.494 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.177 (e) (e) |(e) P=0.495 (e) (e) |
|COCH-ARM / FISHERS | P=0.236N P=0.247 (e) (e) |P=0.423N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.249N (e) (e) (e) |P=0.367N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Angiectasis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/49 (4%) 1/49 (2%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/42.62 2/43.23 1/43.26 3/43.80 |0/44.75 1/43.69 0/43.24 1/47.34 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 2.3% 6.9% |0.0% 2.3% 0.0% 2.1% |
|TERMINAL (d) | 0/36 (0%) 1/27 (4%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 721 703 678 |--- 729 (T) --- 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.129 P=0.186 P=0.489 P=0.106 |P=0.501 P=0.495 (e) P=0.522 |
|POLY 3 | P=0.148 P=0.240 P=0.503 P=0.123 |P=0.490 P=0.495 (e) P=0.511 |
|POLY 1.5 | P=0.150 P=0.242 P=0.503 P=0.125 |P=0.485 P=0.497 (e) P=0.507 |
|POLY 6 | P=0.144 P=0.233 P=0.501 P=0.119 |P=0.494 P=0.494 (e) P=0.516 |
|LOGISTIC REGRESSION| P=0.146 P=0.212 P=0.503 P=0.126 |P=0.467 P=0.495 (e) P=0.439 |
|COCH-ARM / FISHERS | P=0.151 P=0.253 P=0.505 P=0.129 |P=0.478 P=0.500 (e) P=0.500 |
|ORDER RESTRICTED | P=0.060 (e) (e) (e) |P=0.262 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 54
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/49 (4%) 2/49 (4%) 4/50 (8%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/42.62 2/43.23 2/43.32 4/43.80 |0/44.75 1/43.69 0/43.24 1/47.34 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 4.6% 9.1% |0.0% 2.3% 0.0% 2.1% |
|TERMINAL (d) | 0/36 (0%) 1/27 (4%) 0/31 (0%) 1/28 (4%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 721 703 678 |--- 729 (T) --- 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.049 * P=0.186 P=0.224 P=0.050 |P=0.501 P=0.495 (e) P=0.522 |
|POLY 3 | P=0.060 P=0.240 P=0.241 P=0.063 |P=0.490 P=0.495 (e) P=0.511 |
|POLY 1.5 | P=0.061 P=0.242 P=0.241 P=0.065 |P=0.485 P=0.497 (e) P=0.507 |
|POLY 6 | P=0.058 P=0.233 P=0.238 P=0.060 |P=0.494 P=0.494 (e) P=0.516 |
|LOGISTIC REGRESSION| P=0.058 P=0.212 P=0.240 P=0.065 |P=0.467 P=0.495 (e) P=0.439 |
|COCH-ARM / FISHERS | P=0.063 P=0.253 P=0.253 P=0.064 |P=0.478 P=0.500 (e) P=0.500 |
|ORDER RESTRICTED | P=0.029 * (e) (e) (e) |P=0.262 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 6/49 (12%) 4/49 (8%) 11/50 (22%) |16/50 (32%) 21/50 (42%) 8/50 (16%) 17/50 (34%) |
|POLY-3 RATE (b) | 2/43.27 6/45.56 4/44.90 11/45.11 |16/47.24 21/47.38 8/45.69 17/48.26 |
|POLY-3 PERCENT (g) | 4.6% 13.2% 8.9% 24.4% |33.9% 44.3% 17.5% 35.2% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/31 (0%) 3/28 (11%) |12/37 (32%) 12/36 (33%) 3/33 (9%) 13/41 (32%) |
|FIRST INCIDENCE | 511 542 209 590 |462 365 401 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.013 * P=0.137 P=0.337 P=0.008 ** |P=0.197N P=0.203 P=0.092N P=0.540N |
|POLY 3 | P=0.011 * P=0.150 P=0.354 P=0.008 ** |P=0.249N P=0.202 P=0.056N P=0.530 |
|POLY 1.5 | P=0.012 * P=0.148 P=0.353 P=0.009 ** |P=0.252N P=0.201 P=0.052N P=0.518 |
|POLY 6 | P=0.011 * P=0.147 P=0.352 P=0.008 ** |P=0.248N P=0.210 P=0.064N P=0.545 |
|LOGISTIC REGRESSION| P=0.014 * P=0.061 P=0.364 P=0.011 * |P=0.342N P=0.225 P=0.036N* P=0.442 |
|COCH-ARM / FISHERS | P=0.013 * P=0.141 P=0.349 P=0.009 ** |P=0.264N P=0.204 P=0.050N P=0.500 |
|ORDER RESTRICTED | P=0.003 ** (e) (e) (e) |P=0.142N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 55
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 1/49 (2%) 0/49 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/43.13 1/43.45 0/43.16 0/43.44 |1/45.21 1/44.23 1/43.24 2/47.00 |
|POLY-3 PERCENT (g) | 2.3% 2.3% 0.0% 0.0% |2.2% 2.3% 2.3% 4.3% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 1/33 (3%) 2/41 (5%) |
|FIRST INCIDENCE | 574 663 --- --- |594 563 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.203N P=0.756N P=0.491N P=0.496N |P=0.374 P=0.755 P=0.743 P=0.531 |
|POLY 3 | P=0.201N P=0.759N P=0.500N P=0.499N |P=0.359 P=0.756 P=0.751 P=0.514 |
|POLY 1.5 | P=0.201N P=0.756N P=0.498N P=0.495N |P=0.354 P=0.757 P=0.755 P=0.509 |
|POLY 6 | P=0.202N P=0.755 P=0.504N P=0.506N |P=0.363 P=0.754 P=0.743 P=0.517 |
|LOGISTIC REGRESSION| P=0.184N P=0.721 P=0.462N P=0.514N |P=0.306 P=0.720N P=0.756N P=0.472 |
|COCH-ARM / FISHERS | P=0.199N P=0.747N P=0.495N P=0.490N |P=0.342 P=0.753N P=0.753N P=0.500 |
|ORDER RESTRICTED | P=0.250N (e) (e) (e) |P=0.435 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Focal Histiocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 1/49 (2%) 2/49 (4%) 1/50 (2%) |2/50 (4%) 4/50 (8%) 2/50 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 1/42.62 1/43.20 2/43.16 1/43.44 |2/44.75 4/43.69 2/43.24 5/47.00 |
|POLY-3 PERCENT (g) | 2.4% 2.3% 4.6% 2.3% |4.5% 9.2% 4.6% 10.6% |
|TERMINAL (d) | 1/36 (3%) 1/27 (4%) 2/31 (7%) 1/28 (4%) |2/37 (5%) 4/36 (11%) 2/33 (6%) 5/41 (12%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.518 P=0.697 P=0.448 P=0.705 |P=0.308 P=0.323 P=0.654 P=0.259 |
|POLY 3 | P=0.564 P=0.758N P=0.504 P=0.757N |P=0.276 P=0.326 P=0.682 P=0.237 |
|POLY 1.5 | P=0.569 P=0.755N P=0.505 P=0.753N |P=0.269 P=0.330 P=0.687 P=0.229 |
|POLY 6 | P=0.557 P=0.757 P=0.499 P=0.759 |P=0.283 P=0.322 P=0.672 P=0.243 |
|LOGISTIC REGRESSION| P=0.518 P=0.697 P=0.448 P=0.705 |P=0.308 P=0.323 P=0.654 P=0.259 |
|COCH-ARM / FISHERS | P=0.574 P=0.747N P=0.508 P=0.742N |P=0.255 P=0.339 P=0.691N P=0.218 |
|ORDER RESTRICTED | P=0.590 (e) (e) (e) |P=0.196 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 56
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 4/50 (8%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.72 1/44.02 0/43.73 4/44.26 |0/44.75 1/44.07 1/43.58 1/47.00 |
|POLY-3 PERCENT (g) | 2.3% 2.3% 0.0% 9.0% |0.0% 2.3% 2.3% 2.1% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 729 (T) 672 --- 644 |--- 623 636 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.064 P=0.720 P=0.530N P=0.162 |P=0.447 P=0.505 P=0.490 P=0.520 |
|POLY 3 | P=0.063 P=0.759N P=0.500N P=0.182 |P=0.440 P=0.497 P=0.495 P=0.510 |
|POLY 1.5 | P=0.063 P=0.758N P=0.500N P=0.182 |P=0.433 P=0.498 P=0.497 P=0.506 |
|POLY 6 | P=0.063 P=0.757 P=0.503N P=0.179 |P=0.447 P=0.497 P=0.490 P=0.513 |
|LOGISTIC REGRESSION| P=0.065 P=0.762N (e) P=0.179 |P=0.383 P=0.524 P=0.509 P=0.520 |
|COCH-ARM / FISHERS | P=0.065 P=0.753N P=0.500N P=0.181 |P=0.419 P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.035 * (e) (e) (e) |P=0.320 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.72 4/44.16 0/43.73 1/43.54 |0/44.75 2/44.75 1/44.08 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 9.1% 0.0% 2.3% |0.0% 4.5% 2.3% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 695 --- 703 |--- 433 401 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.334N P=0.051 (e) P=0.472 |P=0.325N P=0.232 P=0.500 (e) |
|POLY 3 | P=0.301N P=0.061 (e) P=0.499 |P=0.322N P=0.237 P=0.497 (e) |
|POLY 1.5 | P=0.299N P=0.062 (e) P=0.501 |P=0.326N P=0.237 P=0.499 (e) |
|POLY 6 | P=0.309N P=0.058 (e) P=0.495 |P=0.319N P=0.238 P=0.492 (e) |
|LOGISTIC REGRESSION| P=0.306N P=0.062 (e) P=0.499 |P=0.580N P=0.298 (e) (e) |
|COCH-ARM / FISHERS | P=0.304N P=0.059 (e) P=0.500 |P=0.333N P=0.247 P=0.500 (e) |
|ORDER RESTRICTED | P=0.220 (e) (e) (e) |P=0.314N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 57
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 2/50 (4%) 4/50 (8%) |2/50 (4%) 7/50 (14%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.81 5/44.72 2/44.40 4/44.24 |2/44.80 7/46.26 0/43.24 1/47.23 |
|POLY-3 PERCENT (g) | 2.3% 11.2% 4.5% 9.0% |4.5% 15.1% 0.0% 2.1% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 2/36 (6%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 706 619 561 644 |717 433 --- 670 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.379 P=0.088 P=0.488 P=0.166 |P=0.036N* P=0.084 P=0.277N P=0.477N |
|POLY 3 | P=0.395 P=0.106 P=0.505 P=0.181 |P=0.031N* P=0.086 P=0.245N P=0.482N |
|POLY 1.5 | P=0.394 P=0.106 P=0.503 P=0.182 |P=0.032N* P=0.083 P=0.241N P=0.489N |
|POLY 6 | P=0.390 P=0.101 P=0.502 P=0.178 |P=0.030N* P=0.091 P=0.252N P=0.475N |
|LOGISTIC REGRESSION| P=0.392 P=0.101 P=0.502 P=0.179 |P=0.051N P=0.097 P=0.255N P=0.498N |
|COCH-ARM / FISHERS | P=0.390 P=0.102 P=0.500 P=0.181 |P=0.036N* P=0.080 P=0.247N P=0.500N |
|ORDER RESTRICTED | P=0.160 (e) (e) (e) |P=0.040N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 8/50 (16%) 1/50 (2%) 7/50 (14%) |2/50 (4%) 4/50 (8%) 6/50 (12%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/44.39 8/45.06 1/43.94 7/45.27 |2/44.80 4/45.09 6/45.40 1/47.23 |
|POLY-3 PERCENT (g) | 4.5% 17.8% 2.3% 15.5% |4.5% 8.9% 13.2% 2.1% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 1/36 (3%) 1/33 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 545 574 675 465 |717 433 401 670 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309 P=0.042 * P=0.512N P=0.078 |P=0.308N P=0.326 P=0.120 P=0.477N |
|POLY 3 | P=0.332 P=0.047 * P=0.504N P=0.083 |P=0.303N P=0.340 P=0.137 P=0.482N |
|POLY 1.5 | P=0.331 P=0.048 * P=0.502N P=0.083 |P=0.316N P=0.338 P=0.136 P=0.489N |
|POLY 6 | P=0.326 P=0.044 * P=0.510N P=0.081 |P=0.291N P=0.343 P=0.135 P=0.475N |
|LOGISTIC REGRESSION| P=0.331 P=0.041 * P=0.496N P=0.069 |P=0.468N P=0.365 P=0.145 P=0.498N |
|COCH-ARM / FISHERS | P=0.329 P=0.046 * P=0.500N P=0.080 |P=0.340N P=0.339 P=0.134 P=0.500N |
|ORDER RESTRICTED | P=0.057 (e) (e) (e) |P=0.158N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 58
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 2/48 (4%) 4/48 (8%) 4/50 (8%) |2/50 (4%) 0/49 (0%) 2/49 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/44.40 2/43.81 4/43.68 4/44.51 |2/45.35 0/43.02 2/43.16 2/47.14 |
|POLY-3 PERCENT (g) | 6.8% 4.6% 9.2% 9.0% |4.4% 0.0% 4.6% 4.2% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 1/33 (3%) 1/41 (2%) |
|FIRST INCIDENCE | 545 555 561 465 |555 --- 615 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.271 P=0.490N P=0.482 P=0.464 |P=0.371 P=0.250N P=0.665 P=0.670N |
|POLY 3 | P=0.287 P=0.506N P=0.491 P=0.501 |P=0.369 P=0.249N P=0.676 P=0.680N |
|POLY 1.5 | P=0.293 P=0.504N P=0.491 P=0.508 |P=0.359 P=0.247N P=0.681 P=0.685N |
|POLY 6 | P=0.278 P=0.518N P=0.485 P=0.485 |P=0.378 P=0.251N P=0.668 P=0.676N |
|LOGISTIC REGRESSION| P=0.315 P=0.685N P=0.486 P=0.495 |P=0.306 P=0.220N P=0.694N P=0.653 |
|COCH-ARM / FISHERS | P=0.299 P=0.510N P=0.488 P=0.511 |P=0.340 P=0.253N P=0.684 P=0.691N |
|ORDER RESTRICTED | P=0.427 (e) (e) (e) |P=0.442 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/48 (0%) 0/48 (0%) 3/50 (6%) |0/50 (0%) 1/49 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.39 0/42.74 0/42.88 3/44.01 |0/44.75 1/43.02 0/42.76 0/47.00 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 6.8% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 1/36 (3%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 651 |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.063 P=0.557N P=0.530N P=0.272 |P=0.410N P=0.495 (e) (e) |
|POLY 3 | P=0.069 P=0.503N P=0.502N P=0.310 |P=0.429N P=0.492 (e) (e) |
|POLY 1.5 | P=0.070 P=0.502N P=0.503N P=0.313 |P=0.426N P=0.493 (e) (e) |
|POLY 6 | P=0.070 P=0.508N P=0.504N P=0.304 |P=0.431N P=0.492 (e) (e) |
|LOGISTIC REGRESSION| P=0.072 (e) (e) P=0.312 |(e) P=0.495 (e) (e) |
|COCH-ARM / FISHERS | P=0.071 P=0.505N P=0.505N P=0.316 |P=0.422N P=0.495 (e) (e) |
|ORDER RESTRICTED | P=0.039 * (e) (e) (e) |P=0.364N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 59
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 11/50 (22%) 9/50 (18%) 6/50 (12%) | |
|POLY-3 RATE (b) | 4/43.81 11/44.78 9/44.58 6/44.31 | |
|POLY-3 PERCENT (g) | 9.1% 24.6% 20.2% 13.5% | |
|TERMINAL (d) | 3/36 (8%) 5/27 (19%) 4/31 (13%) 2/28 (7%) | |
|FIRST INCIDENCE | 706 619 647 651 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.519N P=0.022 * P=0.091 P=0.285 | |
|POLY 3 | P=0.436N P=0.047 * P=0.120 P=0.376 | |
|POLY 1.5 | P=0.438N P=0.047 * P=0.119 P=0.376 | |
|POLY 6 | P=0.440N P=0.042 * P=0.119 P=0.370 | |
|LOGISTIC REGRESSION| P=0.450N P=0.044 * P=0.115 P=0.367 | |
|COCH-ARM / FISHERS | P=0.445N P=0.045 * P=0.117 P=0.370 | |
|ORDER RESTRICTED | P=0.150 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 3/50 (6%) | |
|POLY-3 RATE (b) | 1/43.72 1/44.36 1/44.26 3/44.48 | |
|POLY-3 PERCENT (g) | 2.3% 2.3% 2.3% 6.7% | |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/31 (0%) 0/28 (0%) | |
|FIRST INCIDENCE | 729 (T) 555 566 482 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.155 P=0.741 P=0.751 P=0.279 | |
|POLY 3 | P=0.161 P=0.758N P=0.758N P=0.311 | |
|POLY 1.5 | P=0.161 P=0.757N P=0.759N P=0.311 | |
|POLY 6 | P=0.161 P=0.759 P=0.760N P=0.307 | |
|LOGISTIC REGRESSION| P=0.157 P=0.736 P=0.761N P=0.288 | |
|COCH-ARM / FISHERS | P=0.158 P=0.753N P=0.753N P=0.309 | |
|ORDER RESTRICTED | P=0.193 (e) (e) (e) | |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 60
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 1/49 (2%) 0/47 (0%) |2/49 (4%) 1/48 (2%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/42.73 0/42.07 1/43.20 0/41.06 |2/44.66 1/42.82 0/41.58 0/45.23 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |4.5% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/27 (0%) |0/36 (0%) 0/35 (0%) 0/32 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 673 --- |594 423 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.637 (e) P=0.495 (e) |P=0.104N P=0.505N P=0.247N P=0.223N |
|POLY 3 | P=0.630 (e) P=0.502 (e) |P=0.107N P=0.515N P=0.253N P=0.234N |
|POLY 1.5 | P=0.633 (e) P=0.503 (e) |P=0.107N P=0.512N P=0.248N P=0.237N |
|POLY 6 | P=0.623 (e) P=0.499 (e) |P=0.108N P=0.518N P=0.262N P=0.233N |
|LOGISTIC REGRESSION| P=0.637 (e) P=0.506 (e) |P=0.163N P=0.388N P=0.225N P=0.346N |
|COCH-ARM / FISHERS | P=0.636 (e) P=0.505 (e) |P=0.108N P=0.508N P=0.253N P=0.253N |
|ORDER RESTRICTED | P=0.383 (e) (e) (e) |P=0.073N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 2/48 (4%) 3/49 (6%) 0/47 (0%) |1/49 (2%) 0/48 (0%) 2/48 (4%) 1/48 (2%) |
|POLY-3 RATE (b) | 1/43.31 2/42.96 3/44.50 0/41.06 |1/44.31 0/42.02 2/42.81 1/45.55 |
|POLY-3 PERCENT (g) | 2.3% 4.7% 6.7% 0.0% |2.3% 0.0% 4.7% 2.2% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/31 (3%) 0/27 (0%) |0/36 (0%) 0/35 (0%) 0/32 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 545 555 209 --- |555 --- 514 644 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.321N P=0.528 P=0.307 P=0.496N |P=0.427 P=0.509N P=0.500 P=0.748N |
|POLY 3 | P=0.332N P=0.497 P=0.315 P=0.511N |P=0.437 P=0.511N P=0.488 P=0.754N |
|POLY 1.5 | P=0.325N P=0.501 P=0.316 P=0.507N |P=0.425 P=0.508N P=0.491 P=0.758N |
|POLY 6 | P=0.345N P=0.486 P=0.308 P=0.518N |P=0.450 P=0.512N P=0.482 P=0.750N |
|LOGISTIC REGRESSION| P=0.291N P=0.334 P=0.320 P=0.558N |P=0.216 P=0.444N P=0.510 P=0.659 |
|COCH-ARM / FISHERS | P=0.319N P=0.500 P=0.316 P=0.505N |P=0.403 P=0.505N P=0.492 P=0.747 |
|ORDER RESTRICTED | P=0.200N (e) (e) (e) |P=0.376 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 61
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 2/49 (4%) 1/47 (2%) |1/49 (2%) 0/48 (0%) 0/48 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | 0/42.73 0/42.07 2/43.97 1/41.06 |1/44.49 0/42.02 0/41.58 1/45.34 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.6% 2.4% |2.3% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/31 (3%) 1/27 (4%) |0/36 (0%) 0/35 (0%) 0/32 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 209 729 (T) |462 --- --- 703 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179 (e) P=0.223 P=0.443 |P=0.532 P=0.508N P=0.500N P=0.753N |
|POLY 3 | P=0.191 (e) P=0.243 P=0.492 |P=0.534 P=0.511N P=0.513N P=0.756N |
|POLY 1.5 | P=0.194 (e) P=0.244 P=0.495 |P=0.529 P=0.509N P=0.509N P=0.760N |
|POLY 6 | P=0.186 (e) P=0.239 P=0.486 |P=0.539 P=0.513N P=0.519N P=0.753N |
|LOGISTIC REGRESSION| P=0.194 (e) P=0.283 P=0.443 |P=0.408 P=0.359N P=0.485N P=0.640 |
|COCH-ARM / FISHERS | P=0.196 (e) P=0.253 P=0.495 |P=0.519 P=0.505N P=0.505N P=0.747 |
|ORDER RESTRICTED | P=0.172 (e) (e) (e) |P=0.402N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/47 (96%) 42/44 (95%) 41/43 (95%) 44/47 (94%) |43/47 (91%) 44/47 (94%) 43/43 (100%) 44/46 (96%) |
|POLY-3 RATE (b) | 45/47.00 42/43.44 41/42.02 44/46.69 |43/47.00 44/46.13 43/43.00 44/46.00 |
|POLY-3 PERCENT (g) | 95.7% 96.7% 97.6% 94.2% |91.5% 95.4% 100.0% 95.7% |
|TERMINAL (d) | 34/36 (94%) 26/27 (96%) 30/31 (97%) 26/28 (93%) |32/36 (89%) 34/36 (94%) 32/32 (100%) 38/40 (95%) |
|FIRST INCIDENCE | 381 542 576 443 |423 423 401 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.236 P=0.170 P=0.496 P=0.149 |P=0.260N P=0.471 P=0.248 P=0.324N |
|POLY 3 | P=0.413N P=0.627 P=0.545 P=0.556N |P=0.249 P=0.366 P=0.072 P=0.348 |
|POLY 1.5 | P=0.407N P=0.668 P=0.575 P=0.530N |P=0.231 P=0.402 P=0.072 P=0.348 |
|POLY 6 | P=0.430N P=0.576 P=0.539 P=0.597N |P=0.258 P=0.350 P=0.072 P=0.348 |
|LOGISTIC REGRESSION| P=0.401N P=0.662N P=0.685N P=0.492N |P=0.204 P=0.487 (e) (e) |
|COCH-ARM / FISHERS | P=0.390N P=0.666N P=0.657N P=0.500N |P=0.192 P=0.500 P=0.070 P=0.349 |
|ORDER RESTRICTED | P=0.424N (e) (e) (e) |P=0.104 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 62
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 0/44 (0%) 1/43 (2%) 2/47 (4%) |0/47 (0%) 0/47 (0%) 0/43 (0%) 0/46 (0%) |
|POLY-3 RATE (b) | 1/42.29 0/39.82 1/39.66 2/41.73 |0/42.66 0/41.93 0/38.90 0/43.71 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 2.5% 4.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 1/31 (3%) 2/28 (7%) |0/36 (0%) 0/36 (0%) 0/32 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.163 P=0.557N P=0.728 P=0.412 |(e) (e) (e) (e) |
|POLY 3 | P=0.197 P=0.512N P=0.746 P=0.495 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.199 P=0.511N P=0.744 P=0.499 |(e) (e) (e) (e) |
|POLY 6 | P=0.194 P=0.516N P=0.748 P=0.487 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.163 (e) P=0.728 P=0.412 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.200 P=0.516N P=0.730 P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.224 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/47 (4%) 0/44 (0%) 0/43 (0%) 0/47 (0%) |0/47 (0%) 0/47 (0%) 0/43 (0%) 0/46 (0%) |
|POLY-3 RATE (b) | 2/42.29 0/39.82 0/39.66 0/41.73 |0/42.66 0/41.93 0/38.90 0/43.71 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/36 (6%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/36 (0%) 0/36 (0%) 0/32 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.189N P=0.303N P=0.272N P=0.295N |(e) (e) (e) (e) |
|POLY 3 | P=0.172N P=0.250N P=0.251N P=0.240N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.173N P=0.250N P=0.254N P=0.238N |(e) (e) (e) (e) |
|POLY 6 | P=0.168N P=0.254N P=0.250N P=0.245N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.189N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.174N P=0.264N P=0.270N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.030N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 63
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Mineralization Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/47 (96%) 43/44 (98%) 42/43 (98%) 42/47 (89%) |25/47 (53%) 26/47 (55%) 40/43 (93%) 44/46 (96%) |
|POLY-3 RATE (b) | 45/45.81 43/44.00 42/42.79 42/45.35 |25/42.75 26/43.33 40/41.69 44/45.28 |
|POLY-3 PERCENT (g) | 98.2% 97.7% 98.1% 92.6% |58.5% 60.0% 96.0% 97.2% |
|TERMINAL (d) | 36/36 (100%) 26/27 (96%) 31/31 (100%) 27/28 (96%) |23/36 (64%) 23/36 (64%) 31/32 (97%) 39/40 (98%) |
|FIRST INCIDENCE | 469 542 209 443 |717 433 511 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.377 P=0.107 P=0.390 P=0.188 |P<0.001 ** P=0.490 P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.075N P=0.737N P=0.819N P=0.176N |P<0.001 ** P=0.530 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.061N P=0.739 P=0.730 P=0.175N |P<0.001 ** P=0.513 P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.133N P=0.655N P=0.847N P=0.223N |P<0.001 ** P=0.558 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.068N P=0.712 P=0.498 P=0.159N |P<0.001 ** P=0.460 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.068N P=0.525 P=0.534 P=0.217N |P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P=0.062N (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/47 (9%) 13/44 (30%) 33/43 (77%) 40/47 (85%) |3/47 (6%) 7/47 (15%) 27/43 (63%) 42/46 (91%) |
|POLY-3 RATE (b) | 4/42.29 13/41.13 33/42.30 40/45.49 |3/43.47 7/42.78 27/40.15 42/45.28 |
|POLY-3 PERCENT (g) | 9.5% 31.6% 78.0% 87.9% |6.9% 16.4% 67.3% 92.8% |
|TERMINAL (d) | 4/36 (11%) 9/27 (33%) 25/31 (81%) 27/28 (96%) |2/36 (6%) 5/36 (14%) 23/32 (72%) 37/40 (93%) |
|FIRST INCIDENCE | 729 (T) 555 209 443 |423 433 511 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.160 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.010 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.150 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.010 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.152 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.010 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.149 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.170 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.010 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.158 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 64
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) |0/0 (0%) 1/2 (50%) 2/2 (100%) 0/1 (0%) |
|POLY-3 RATE (b) | 0/0.00 0/0.44 0/1.00 0/0.00 |0/0.00 1/2.00 2/2.00 0/0.66 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 50.0% 100.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 423 587 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.550N P=0.500 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.539N P=1.000 (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/47 (0%) 2/50 (4%) |0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.19 0/43.20 0/42.25 2/44.29 |0/44.75 0/42.02 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/35 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- 562 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.046 * (e) (e) P=0.253 |(e) (e) (e) (e) |
|POLY 3 | P=0.045 * (e) (e) P=0.243 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.045 * (e) (e) P=0.245 |(e) (e) (e) (e) |
|POLY 6 | P=0.044 * (e) (e) P=0.238 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.047 * (e) (e) P=0.242 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.258 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.031 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 65
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 2/47 (4%) 0/50 (0%) |0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.19 0/43.20 2/42.84 0/43.44 |0/44.75 0/42.02 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 0/35 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- 566 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.508 (e) P=0.237 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.508 (e) P=0.235 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.517 (e) P=0.234 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.495 (e) P=0.235 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.542 (e) P=0.241 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.528 (e) P=0.242 (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.245 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |16/50 (32%) 7/50 (14%) 16/49 (33%) 11/50 (22%) |
|POLY-3 RATE (b) | |16/46.01 7/44.04 16/43.88 11/47.59 |
|POLY-3 PERCENT (g) | |34.8% 15.9% 36.5% 23.1% |
|TERMINAL (d) | |12/37 (32%) 5/36 (14%) 12/32 (38%) 10/41 (24%) |
|FIRST INCIDENCE | |566 636 401 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.414N P=0.040N* P=0.420 P=0.124N |
|POLY 3 | |P=0.444N P=0.032N* P=0.521 P=0.154N |
|POLY 1.5 | |P=0.473N P=0.030N* P=0.542 P=0.163N |
|POLY 6 | |P=0.423N P=0.036N* P=0.482 P=0.149N |
|LOGISTIC REGRESSION| |P=0.488N P=0.031N* P=0.535 P=0.166N |
|COCH-ARM / FISHERS | |P=0.530N P=0.028N* P=0.558 P=0.184N |
|ORDER RESTRICTED | |P=0.149N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 66
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (SODIUM
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 125 MG/L 1000MG/L 2000MG/L |0 MG/L 125 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Vagina |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/6 (33%) 1/3 (33%) 1/3 (33%) 1/1 (100%) |
|POLY-3 RATE (b) | |2/5.07 1/2.46 1/2.23 1/1.00 |
|POLY-3 PERCENT (g) | |39.4% 40.6% 44.9% 100.0% |
|TERMINAL (d) | |2/2 (100%) 1/2 (50%) 1/1 (100%) 1/1 (100%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.545 P=0.500N P=1.000N P=1.000N |
|POLY 3 | |P=0.333 P=0.755 P=0.729 P=0.494 |
|POLY 1.5 | |P=0.322 P=0.751 P=0.735 P=0.468 |
|POLY 6 | |P=0.361 P=0.766 P=0.724 P=0.538 |
|LOGISTIC REGRESSION| |P=0.545 P=0.500N P=1.000N P=1.000N |
|COCH-ARM / FISHERS | |P=0.301 P=0.762 P=0.762 P=0.429 |
|ORDER RESTRICTED | |P=0.382 (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).
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