TDMS Study 96010-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) DATE: 05/27/03
EXPERIMENT: 96010 TEST: 03 TIME: 13:29:04
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 PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) DATE: 05/27/03
EXPERIMENT: 96010 TEST: 03 TIME: 13:29:04
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
Rats(FISCHER 344)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Brain
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pancreas
Pituitary Gland
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (SODIUM CHLORATE) DATE: 05/27/03
EXPERIMENT: 96010 TEST: 03 TIME: 13:29:04
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
----- ----------
Clitoral/Preputial Gland Adenoma
Pancreas Carcinoma or Adenoma
Testes Adenoma
Thyroid Gland: Follicular Cell Carcinoma
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Osteosarcoma
Osteosarcoma or Osteoma
Benign Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Clitoral/Preputial Gland Adenoma
Carcinoma
Carcinoma or Adenoma
Mammary Gland Carcinoma or Adenoma
Pancreas Adenoma
Carcinoma or Adenoma
Skin
Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, malignant or NOS), or Trichoepithelioma
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom
Trichoepithelioma
Thyroid Gland: Follicular Cell Adenoma
Carcinoma or Adenoma
===============================================================
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 1
Statistical Analysis of Primary Tumors 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 |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 4/49 (8%) 3/50 (6%) 8/50 (16%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/43.39 4/43.76 3/43.85 8/43.70 |2/44.75 1/43.69 1/43.24 1/47.00 |
|POLY-3 PERCENT (g) | 13.8% 9.1% 6.8% 18.3% |4.5% 2.3% 2.3% 2.1% |
|TERMINAL (d) | 6/36 (17%) 3/27 (11%) 2/31 (7%) 5/28 (18%) |2/37 (5%) 1/36 (3%) 1/33 (3%) 1/41 (2%) |
|FIRST INCIDENCE | 729 (T) 555 698 699 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.169 P=0.531N P=0.316N P=0.229 |P=0.405N P=0.510N P=0.540N P=0.464N |
|POLY 3 | P=0.229 P=0.364N P=0.236N P=0.391 |P=0.423N P=0.508N P=0.512N P=0.483N |
|POLY 1.5 | P=0.234 P=0.361N P=0.234N P=0.399 |P=0.428N P=0.506N P=0.506N P=0.489N |
|POLY 6 | P=0.223 P=0.378N P=0.243N P=0.373 |P=0.418N P=0.511N P=0.522N P=0.477N |
|LOGISTIC REGRESSION| P=0.218 P=0.378N P=0.274N P=0.310 |P=0.405N P=0.510N P=0.540N P=0.464N |
|COCH-ARM / FISHERS | P=0.241 P=0.370N P=0.233N P=0.403 |P=0.437N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.177 (e) (e) (e) |P=0.393N (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 Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 0/49 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/43.39 0/43.20 1/43.97 1/43.44 |0/44.75 1/44.28 0/43.24 1/47.00 |
|POLY-3 PERCENT (g) | 6.9% 0.0% 2.3% 2.3% |0.0% 2.3% 0.0% 2.1% |
|TERMINAL (d) | 3/36 (8%) 0/27 (0%) 0/31 (0%) 1/28 (4%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 729 (T) --- 667 729 (T) |--- 541 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.443N P=0.176N P=0.347N P=0.398N |P=0.495 P=0.496 (e) P=0.520 |
|POLY 3 | P=0.404N P=0.119N P=0.300N P=0.305N |P=0.488 P=0.498 (e) P=0.510 |
|POLY 1.5 | P=0.405N P=0.118N P=0.299N P=0.300N |P=0.484 P=0.498 (e) P=0.506 |
|POLY 6 | P=0.400N P=0.125N P=0.305N P=0.315N |P=0.492 P=0.498 (e) P=0.513 |
|LOGISTIC REGRESSION| P=0.414N (e) P=0.305N P=0.398N |P=0.422 P=0.570 (e) P=0.520 |
|COCH-ARM / FISHERS | P=0.401N P=0.121N P=0.301N P=0.301N |P=0.478 P=0.500 (e) P=0.500 |
|ORDER RESTRICTED | P=0.101N (e) (e) (e) |P=0.261 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 2
Statistical Analysis of Primary Tumors 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 |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/49 (18%) 4/49 (8%) 4/50 (8%) 9/50 (18%) |2/50 (4%) 2/50 (4%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 9/43.39 4/43.76 4/44.09 9/43.70 |2/44.75 2/44.28 1/43.24 3/47.00 |
|POLY-3 PERCENT (g) | 20.7% 9.1% 9.1% 20.6% |4.5% 4.5% 2.3% 6.4% |
|TERMINAL (d) | 9/36 (25%) 3/27 (11%) 2/31 (7%) 6/28 (21%) |2/37 (5%) 1/36 (3%) 1/33 (3%) 3/41 (7%) |
|FIRST INCIDENCE | 729 (T) 555 667 699 |729 (T) 541 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.250 P=0.237N P=0.175N P=0.389 |P=0.454 P=0.684 P=0.540N P=0.547 |
|POLY 3 | P=0.331 P=0.110N P=0.107N P=0.598N |P=0.430 P=0.690 P=0.512N P=0.522 |
|POLY 1.5 | P=0.336 P=0.109N P=0.108N P=0.588N |P=0.423 P=0.691 P=0.506N P=0.514 |
|POLY 6 | P=0.327 P=0.117N P=0.110N P=0.591 |P=0.435 P=0.690 P=0.522N P=0.530 |
|LOGISTIC REGRESSION| P=0.317 P=0.126N P=0.126N P=0.498 |P=0.426 P=0.691N P=0.540N P=0.547 |
|COCH-ARM / FISHERS | P=0.347 P=0.116N P=0.109N P=0.584N |P=0.411 P=0.691N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.240N (e) (e) (e) |P=0.430 (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/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 6/49 (12%) 5/50 (10%) 5/50 (10%) |11/49 (22%) 5/50 (10%) 12/50 (24%) 4/49 (8%) |
|POLY-3 RATE (b) | 1/42.39 6/43.79 5/44.22 5/44.37 |11/44.20 5/43.69 12/44.69 4/46.00 |
|POLY-3 PERCENT (g) | 2.4% 13.7% 11.3% 11.3% |24.9% 11.4% 26.9% 8.7% |
|TERMINAL (d) | 1/35 (3%) 5/27 (19%) 3/31 (10%) 3/28 (11%) |10/36 (28%) 5/36 (14%) 8/33 (24%) 4/40 (10%) |
|FIRST INCIDENCE | 729 (T) 542 626 465 |595 729 (T) 511 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.227 P=0.031 * P=0.086 P=0.075 |P=0.132N P=0.083N P=0.418 P=0.028N* |
|POLY 3 | P=0.287 P=0.060 P=0.111 P=0.111 |P=0.131N P=0.085N P=0.512 P=0.035N* |
|POLY 1.5 | P=0.289 P=0.062 P=0.111 P=0.113 |P=0.147N P=0.083N P=0.518 P=0.038N* |
|POLY 6 | P=0.277 P=0.056 P=0.108 P=0.107 |P=0.119N P=0.089N P=0.499 P=0.033N* |
|LOGISTIC REGRESSION| P=0.287 P=0.062 P=0.110 P=0.112 |P=0.150N P=0.086N P=0.499 P=0.034N* |
|COCH-ARM / FISHERS | P=0.287 P=0.059 P=0.112 P=0.112 |P=0.179N P=0.079N P=0.522 P=0.045N* |
|ORDER RESTRICTED | P=0.096 (e) (e) (e) |P=0.028N* (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 3
Statistical Analysis of Primary Tumors 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/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/48 (6%) 1/49 (2%) 2/50 (4%) 2/50 (4%) |3/49 (6%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/43.05 1/43.20 2/43.76 2/43.91 |3/43.75 1/43.69 0/43.24 0/46.00 |
|POLY-3 PERCENT (g) | 7.0% 2.3% 4.6% 4.6% |6.9% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 2/35 (6%) 1/27 (4%) 1/31 (3%) 1/28 (4%) |3/36 (8%) 1/36 (3%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 511 729 (T) 721 590 |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.573 P=0.369N P=0.539N P=0.554N |P=0.054N P=0.305N P=0.136N P=0.103N |
|POLY 3 | P=0.555N P=0.304N P=0.492N P=0.491N |P=0.054N P=0.305N P=0.120N P=0.110N |
|POLY 1.5 | P=0.554N P=0.299N P=0.488N P=0.485N |P=0.055N P=0.303N P=0.118N P=0.113N |
|POLY 6 | P=0.555N P=0.317N P=0.504N P=0.503N |P=0.054N P=0.307N P=0.125N P=0.107N |
|LOGISTIC REGRESSION| P=0.549N P=0.308N P=0.481N P=0.488N |P=0.054N P=0.305N (e) (e) |
|COCH-ARM / FISHERS | P=0.551N P=0.301N P=0.480N P=0.480N |P=0.058N P=0.301N P=0.117N P=0.121N |
|ORDER RESTRICTED | P=0.386N (e) (e) (e) |P=0.018N* (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/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 7/49 (14%) 7/50 (14%) 6/50 (12%) |14/49 (29%) 6/50 (12%) 12/50 (24%) 4/49 (8%) |
|POLY-3 RATE (b) | 4/43.05 7/43.79 7/44.25 6/44.84 |14/44.20 6/43.69 12/44.69 4/46.00 |
|POLY-3 PERCENT (g) | 9.3% 16.0% 15.8% 13.4% |31.7% 13.7% 26.9% 8.7% |
|TERMINAL (d) | 3/35 (9%) 6/27 (22%) 4/31 (13%) 3/28 (11%) |13/36 (36%) 6/36 (17%) 8/33 (24%) 4/40 (10%) |
|FIRST INCIDENCE | 511 542 626 465 |595 729 (T) 511 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.372 P=0.162 P=0.218 P=0.296 |P=0.039N* P=0.036N* P=0.502N P=0.004N** |
|POLY 3 | P=0.461 P=0.270 P=0.276 P=0.395 |P=0.036N* P=0.037N* P=0.395N P=0.005N** |
|POLY 1.5 | P=0.463 P=0.276 P=0.280 P=0.398 |P=0.042N* P=0.036N* P=0.389N P=0.006N** |
|POLY 6 | P=0.454 P=0.251 P=0.266 P=0.384 |P=0.031N* P=0.039N* P=0.408N P=0.005N** |
|LOGISTIC REGRESSION| P=0.463 P=0.273 P=0.283 P=0.389 |P=0.044N* P=0.039N* P=0.417N P=0.006N** |
|COCH-ARM / FISHERS | P=0.462 P=0.274 P=0.286 P=0.397 |P=0.059N P=0.035N* P=0.387N P=0.009N** |
|ORDER RESTRICTED | P=0.344 (e) (e) (e) |P=0.003N** (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 4
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/49 (8%) 3/49 (6%) 5/50 (10%) |2/50 (4%) 1/49 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/43.72 4/43.59 3/43.52 5/43.62 |2/44.75 1/43.02 0/42.24 0/47.00 |
|POLY-3 PERCENT (g) | 6.9% 9.2% 6.9% 11.5% |4.5% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 3/36 (8%) 2/27 (7%) 2/31 (7%) 4/28 (14%) |2/37 (5%) 1/36 (3%) 0/32 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 663 714 681 |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.274 P=0.381 P=0.597 P=0.238 |P=0.102N P=0.510N P=0.271N P=0.216N |
|POLY 3 | P=0.335 P=0.498 P=0.661 P=0.355 |P=0.104N P=0.514N P=0.250N P=0.226N |
|POLY 1.5 | P=0.338 P=0.499 P=0.658 P=0.358 |P=0.105N P=0.512N P=0.246N P=0.230N |
|POLY 6 | P=0.327 P=0.488 P=0.657 P=0.343 |P=0.104N P=0.515N P=0.257N P=0.223N |
|LOGISTIC REGRESSION| P=0.321 P=0.482 P=0.626 P=0.310 |P=0.102N P=0.510N (e) (e) |
|COCH-ARM / FISHERS | P=0.339 P=0.489 P=0.651 P=0.357 |P=0.106N P=0.508N P=0.253N P=0.247N |
|ORDER RESTRICTED | P=0.355 (e) (e) (e) |P=0.067N (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 |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 0/49 (0%) 2/50 (4%) |1/50 (2%) 1/49 (2%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.72 1/43.20 0/43.46 2/43.55 |1/44.75 1/43.02 0/42.24 1/47.00 |
|POLY-3 PERCENT (g) | 4.6% 2.3% 0.0% 4.6% |2.2% 2.3% 0.0% 2.1% |
|TERMINAL (d) | 2/36 (6%) 1/27 (4%) 0/31 (0%) 1/28 (4%) |1/37 (3%) 1/36 (3%) 0/32 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 701 |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523 P=0.600N P=0.272N P=0.614 |P=0.553N P=0.756 P=0.529N P=0.739N |
|POLY 3 | P=0.564 P=0.504N P=0.238N P=0.693 |P=0.577N P=0.752 P=0.511N P=0.750N |
|POLY 1.5 | P=0.564 P=0.503N P=0.239N P=0.693N |P=0.577N P=0.753 P=0.508N P=0.754N |
|POLY 6 | P=0.564 P=0.513N P=0.241N P=0.685 |P=0.578N P=0.751 P=0.517N P=0.746N |
|LOGISTIC REGRESSION| P=0.546 P=0.600N (e) P=0.671 |P=0.553N P=0.756 (e) P=0.739N |
|COCH-ARM / FISHERS | P=0.565 P=0.508N P=0.253N P=0.691N |P=0.579N P=0.747 P=0.505N P=0.753N |
|ORDER RESTRICTED | P=0.413 (e) (e) (e) |P=0.522N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 5
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/49 (10%) 3/49 (6%) 7/50 (14%) |3/50 (6%) 2/49 (4%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/43.72 5/43.59 3/43.52 7/43.73 |3/44.75 2/43.02 0/42.24 1/47.00 |
|POLY-3 PERCENT (g) | 11.4% 11.5% 6.9% 16.0% |6.7% 4.7% 0.0% 2.1% |
|TERMINAL (d) | 5/36 (14%) 3/27 (11%) 2/31 (7%) 5/28 (18%) |3/37 (8%) 2/36 (6%) 0/32 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 729 (T) 663 714 681 |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.259 P=0.472 P=0.436N P=0.234 |P=0.144N P=0.513N P=0.147N P=0.269N |
|POLY 3 | P=0.331 P=0.629 P=0.358N P=0.379 |P=0.153N P=0.518N P=0.129N P=0.288N |
|POLY 1.5 | P=0.333 P=0.629 P=0.361N P=0.382 |P=0.154N P=0.516N P=0.126N P=0.294N |
|POLY 6 | P=0.325 P=0.618 P=0.363N P=0.365 |P=0.152N P=0.519N P=0.135N P=0.282N |
|LOGISTIC REGRESSION| P=0.311 P=0.597 P=0.407N P=0.324 |P=0.144N P=0.513N (e) P=0.269N |
|COCH-ARM / FISHERS | P=0.335 P=0.617 P=0.369N P=0.380 |P=0.157N P=0.510N P=0.125N P=0.309N |
|ORDER RESTRICTED | P=0.296 (e) (e) (e) |P=0.101N (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 |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/48 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.72 3/43.80 0/42.88 0/43.44 |0/44.75 0/43.69 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 6.9% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 3/27 (11%) 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=0.161N P=0.075 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.141N P=0.119 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.140N P=0.120 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.146N P=0.113 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.075 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.146N P=0.121 (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.164N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 6
Statistical Analysis of Primary Tumors 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/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.72 1/43.80 2/43.73 0/43.44 |1/44.75 1/43.69 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 2.3% 2.3% 4.6% 0.0% |2.2% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/36 (3%) 1/27 (4%) 2/31 (7%) 0/28 (0%) |1/37 (3%) 1/36 (3%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.414N P=0.697 P=0.448 P=0.550N |P=0.195N P=0.756 P=0.523N P=0.480N |
|POLY 3 | P=0.379N P=0.760N P=0.500 P=0.501N |P=0.204N P=0.755 P=0.507N P=0.490N |
|POLY 1.5 | P=0.378N P=0.758N P=0.501 P=0.500N |P=0.204N P=0.757 P=0.504N P=0.494N |
|POLY 6 | P=0.383N P=0.754 P=0.495 P=0.506N |P=0.205N P=0.754 P=0.512N P=0.487N |
|LOGISTIC REGRESSION| P=0.414N P=0.697 P=0.448 (e) |P=0.195N P=0.756 (e) (e) |
|COCH-ARM / FISHERS | P=0.376N P=0.753N P=0.500 P=0.500N |P=0.203N P=0.753N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.273N (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 |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/43.72 2/43.80 0/43.73 1/43.44 |1/44.75 0/43.69 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 6.9% 4.6% 0.0% 2.3% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/36 (8%) 2/27 (7%) 0/31 (0%) 1/28 (4%) |1/37 (3%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.186N P=0.631N P=0.148N P=0.398N |P=0.352N P=0.505N P=0.523N P=0.480N |
|POLY 3 | P=0.159N P=0.499N P=0.118N P=0.307N |P=0.365N P=0.505N P=0.507N P=0.490N |
|POLY 1.5 | P=0.159N P=0.496N P=0.118N P=0.305N |P=0.364N P=0.503N P=0.504N P=0.494N |
|POLY 6 | P=0.158N P=0.513N P=0.121N P=0.316N |P=0.366N P=0.506N P=0.512N P=0.487N |
|LOGISTIC REGRESSION| P=0.186N P=0.631N (e) P=0.398N |P=0.352N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.158N P=0.500N P=0.121N P=0.309N |P=0.363N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.108N (e) (e) (e) |P=0.111N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 7
Statistical Analysis of Primary Tumors 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/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/43.72 3/43.80 2/43.73 1/43.44 |2/44.75 1/43.69 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 9.2% 6.9% 4.6% 2.3% |4.5% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 4/36 (11%) 3/27 (11%) 2/31 (7%) 1/28 (4%) |2/37 (5%) 1/36 (3%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.147N P=0.656 P=0.407N P=0.261N |P=0.101N P=0.510N P=0.264N P=0.216N |
|POLY 3 | P=0.119N P=0.499N P=0.337N P=0.180N |P=0.104N P=0.508N P=0.245N P=0.226N |
|POLY 1.5 | P=0.119N P=0.495N P=0.336N P=0.178N |P=0.105N P=0.506N P=0.241N P=0.230N |
|POLY 6 | P=0.119N P=0.516N P=0.343N P=0.187N |P=0.104N P=0.511N P=0.251N P=0.223N |
|LOGISTIC REGRESSION| P=0.147N P=0.656 P=0.407N P=0.261N |P=0.101N P=0.510N (e) (e) |
|COCH-ARM / FISHERS | P=0.117N P=0.500N P=0.339N P=0.181N |P=0.106N P=0.500N P=0.247N P=0.247N |
|ORDER RESTRICTED | P=0.131N (e) (e) (e) |P=0.067N (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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.72 0/43.80 0/43.73 0/43.44 |3/44.75 0/43.69 0/43.24 2/47.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.7% 0.0% 0.0% 4.3% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |3/37 (8%) 0/36 (0%) 0/33 (0%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.594N P=0.126N P=0.142N P=0.453N |
|POLY 3 | (e) (e) (e) (e) |P=0.609 P=0.123N P=0.125N P=0.478N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.603 P=0.122N P=0.122N P=0.486N |
|POLY 6 | (e) (e) (e) (e) |P=0.614 P=0.124N P=0.130N P=0.470N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.594N (e) (e) P=0.453N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.591 P=0.121N P=0.121N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.094N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 8
Statistical Analysis of Primary Tumors 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 |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.72 1/43.81 1/43.73 0/43.44 |3/46.46 1/44.28 0/43.24 2/47.00 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 2.3% 0.0% |6.5% 2.3% 0.0% 4.3% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/31 (3%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 2/41 (5%) |
|FIRST INCIDENCE | --- 726 729 (T) --- |462 541 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.553N P=0.450 P=0.470 (e) |P=0.460N P=0.320N P=0.129N P=0.470N |
|POLY 3 | P=0.523N P=0.500 P=0.500 (e) |P=0.483N P=0.323N P=0.132N P=0.495N |
|POLY 1.5 | P=0.522N P=0.502 P=0.500 (e) |P=0.484N P=0.317N P=0.126N P=0.496N |
|POLY 6 | P=0.530N P=0.494 P=0.497 (e) |P=0.484N P=0.329N P=0.141N P=0.494N |
|LOGISTIC REGRESSION| P=0.545N P=0.472 P=0.470 (e) |P=0.587 P=0.183N P=0.091N P=0.685N |
|COCH-ARM / FISHERS | P=0.522N P=0.500 P=0.500 (e) |P=0.487N P=0.309N P=0.121N P=0.500N |
|ORDER RESTRICTED | P=0.400 (e) (e) (e) |P=0.191N (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 |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |6/50 (12%) 1/50 (2%) 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/43.72 1/43.81 1/43.73 0/43.44 |6/46.46 1/44.28 0/43.24 4/47.00 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 2.3% 0.0% |12.9% 2.3% 0.0% 8.5% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/31 (3%) 0/28 (0%) |3/37 (8%) 0/36 (0%) 0/33 (0%) 4/41 (10%) |
|FIRST INCIDENCE | --- 726 729 (T) --- |462 541 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.553N P=0.450 P=0.470 (e) |P=0.461N P=0.069N P=0.024N* P=0.321N |
|POLY 3 | P=0.523N P=0.500 P=0.500 (e) |P=0.494N P=0.064N P=0.019N* P=0.362N |
|POLY 1.5 | P=0.522N P=0.502 P=0.500 (e) |P=0.497N P=0.061N P=0.018N* P=0.365N |
|POLY 6 | P=0.530N P=0.494 P=0.497 (e) |P=0.494N P=0.067N P=0.022N* P=0.362N |
|LOGISTIC REGRESSION| P=0.545N P=0.472 P=0.470 (e) |P=0.576N P=0.037N* P=0.013N* P=0.452N |
|COCH-ARM / FISHERS | P=0.522N P=0.500 P=0.500 (e) |P=0.505N P=0.056N P=0.013N* P=0.370N |
|ORDER RESTRICTED | P=0.400 (e) (e) (e) |P=0.038N* (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 9
Statistical Analysis of Primary Tumors 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 |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 4/50 (8%) |33/50 (66%) 29/50 (58%) 31/50 (62%) 33/50 (66%) |
|POLY-3 RATE (b) | 2/43.72 1/43.80 4/44.26 4/43.48 |33/47.28 29/45.65 31/45.14 33/47.81 |
|POLY-3 PERCENT (g) | 4.6% 2.3% 9.0% 9.2% |69.8% 63.5% 68.7% 69.0% |
|TERMINAL (d) | 2/36 (6%) 1/27 (4%) 3/31 (10%) 3/28 (11%) |26/37 (70%) 25/36 (69%) 24/33 (73%) 29/41 (71%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 566 718 |423 365 547 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.090 P=0.600N P=0.287 P=0.234 |P=0.429N P=0.335N P=0.476 P=0.335N |
|POLY 3 | P=0.118 P=0.499N P=0.343 P=0.334 |P=0.437 P=0.333N P=0.544N P=0.557N |
|POLY 1.5 | P=0.119 P=0.497N P=0.341 P=0.338 |P=0.414 P=0.304N P=0.487N P=0.566N |
|POLY 6 | P=0.116 P=0.510N P=0.338 P=0.323 |P=0.462 P=0.376N P=0.567 P=0.551N |
|LOGISTIC REGRESSION| P=0.115 P=0.600N P=0.337 P=0.261 |P=0.531 P=0.300N P=0.483N P=0.469N |
|COCH-ARM / FISHERS | P=0.121 P=0.500N P=0.339 P=0.339 |P=0.379 P=0.268N P=0.418N P=0.583N |
|ORDER RESTRICTED | P=0.210 (e) (e) (e) |P=0.599N (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 |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 4/50 (8%) |35/50 (70%) 29/50 (58%) 31/50 (62%) 34/50 (68%) |
|POLY-3 RATE (b) | 2/43.72 1/43.80 4/44.26 4/43.48 |35/47.28 29/45.65 31/45.14 34/47.81 |
|POLY-3 PERCENT (g) | 4.6% 2.3% 9.0% 9.2% |74.0% 63.5% 68.7% 71.1% |
|TERMINAL (d) | 2/36 (6%) 1/27 (4%) 3/31 (10%) 3/28 (11%) |28/37 (76%) 25/36 (69%) 24/33 (73%) 30/41 (73%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 566 718 |423 365 547 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.090 P=0.600N P=0.287 P=0.234 |P=0.399N P=0.206N P=0.533N P=0.254N |
|POLY 3 | P=0.118 P=0.499N P=0.343 P=0.334 |P=0.466 P=0.184N P=0.362N P=0.464N |
|POLY 1.5 | P=0.119 P=0.497N P=0.341 P=0.338 |P=0.441 P=0.167N P=0.315N P=0.477N |
|POLY 6 | P=0.116 P=0.510N P=0.338 P=0.323 |P=0.494 P=0.214N P=0.438N P=0.455N |
|LOGISTIC REGRESSION| P=0.115 P=0.600N P=0.337 P=0.261 |P=0.510N P=0.170N P=0.316N P=0.366N |
|COCH-ARM / FISHERS | P=0.121 P=0.500N P=0.339 P=0.339 |P=0.402 P=0.149N P=0.263N P=0.500N |
|ORDER RESTRICTED | P=0.210 (e) (e) (e) |P=0.391N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 10
Statistical Analysis of Primary Tumors 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 |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 5/50 (10%) 4/50 (8%) |37/50 (74%) 30/50 (60%) 31/50 (62%) 35/50 (70%) |
|POLY-3 RATE (b) | 2/43.72 2/43.81 5/44.26 4/43.48 |37/48.68 30/46.24 31/45.14 35/47.81 |
|POLY-3 PERCENT (g) | 4.6% 4.6% 11.3% 9.2% |76.0% 64.9% 68.7% 73.2% |
|TERMINAL (d) | 2/36 (6%) 1/27 (4%) 4/31 (13%) 3/28 (11%) |28/37 (76%) 25/36 (69%) 24/33 (73%) 31/41 (76%) |
|FIRST INCIDENCE | 729 (T) 726 566 718 |423 365 547 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.134 P=0.590 P=0.172 P=0.234 |P=0.334N P=0.169N P=0.386N P=0.198N |
|POLY 3 | P=0.173 P=0.693N P=0.221 P=0.334 |P=0.466 P=0.161N P=0.280N P=0.466N |
|POLY 1.5 | P=0.176 P=0.690N P=0.220 P=0.338 |P=0.470 P=0.134N P=0.214N P=0.445N |
|POLY 6 | P=0.168 P=0.684 P=0.216 P=0.323 |P=0.460 P=0.198N P=0.378N P=0.491N |
|LOGISTIC REGRESSION| P=0.168 P=0.621 P=0.216 P=0.261 |P=0.474N P=0.109N P=0.162N P=0.350N |
|COCH-ARM / FISHERS | P=0.177 P=0.691N P=0.218 P=0.339 |P=0.474 P=0.101N P=0.142N P=0.412N |
|ORDER RESTRICTED | P=0.248 (e) (e) (e) |P=0.338N (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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 3/49 (6%) 1/49 (2%) 0/50 (0%) |2/50 (4%) 0/49 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/43.39 3/43.20 1/43.46 0/43.44 |2/44.75 0/43.02 0/42.24 0/46.34 |
|POLY-3 PERCENT (g) | 0.0% 6.9% 2.3% 0.0% |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 3/27 (11%) 1/31 (3%) 0/28 (0%) |2/37 (5%) 0/36 (0%) 0/32 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.243N P=0.075 P=0.470 (e) |P=0.168N P=0.244N P=0.271N P=0.216N |
|POLY 3 | P=0.214N P=0.118 P=0.500 (e) |P=0.172N P=0.246N P=0.250N P=0.229N |
|POLY 1.5 | P=0.211N P=0.120 P=0.501 (e) |P=0.172N P=0.245N P=0.246N P=0.234N |
|POLY 6 | P=0.224N P=0.112 P=0.497 (e) |P=0.172N P=0.246N P=0.257N P=0.225N |
|LOGISTIC REGRESSION| (e) P=0.075 P=0.470 (e) |P=0.168N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.212N P=0.121 P=0.500 (e) |P=0.175N P=0.253N P=0.253N P=0.253N |
|ORDER RESTRICTED | P=0.218N (e) (e) (e) |P=0.027N* (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 11
Statistical Analysis of Primary Tumors 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 |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 4/49 (8%) 1/49 (2%) 0/50 (0%) |2/50 (4%) 0/49 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/43.39 4/43.20 1/43.46 0/43.44 |2/44.75 0/43.02 0/42.24 0/46.34 |
|POLY-3 PERCENT (g) | 0.0% 9.3% 2.3% 0.0% |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 4/27 (15%) 1/31 (3%) 0/28 (0%) |2/37 (5%) 0/36 (0%) 0/32 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.164N P=0.032 * P=0.470 (e) |P=0.168N P=0.244N P=0.271N P=0.216N |
|POLY 3 | P=0.138N P=0.059 P=0.500 (e) |P=0.172N P=0.246N P=0.250N P=0.229N |
|POLY 1.5 | P=0.135N P=0.061 P=0.501 (e) |P=0.172N P=0.245N P=0.246N P=0.234N |
|POLY 6 | P=0.146N P=0.055 P=0.497 (e) |P=0.172N P=0.246N P=0.257N P=0.225N |
|LOGISTIC REGRESSION| (e) P=0.032 * P=0.470 (e) |P=0.168N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.138N P=0.059 P=0.500 (e) |P=0.175N P=0.253N P=0.253N P=0.253N |
|ORDER RESTRICTED | P=0.148N (e) (e) (e) |P=0.027N* (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 or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/48 (33%) 15/50 (30%) 20/49 (41%) 15/50 (30%) |23/49 (47%) 18/49 (37%) 17/50 (34%) 25/50 (50%) |
|POLY-3 RATE (b) | 16/43.05 15/44.42 20/45.67 15/44.68 |23/46.10 18/43.93 17/46.64 25/48.71 |
|POLY-3 PERCENT (g) | 37.2% 33.8% 43.8% 33.6% |49.9% 41.0% 36.5% 51.3% |
|TERMINAL (d) | 13/36 (36%) 11/27 (41%) 12/31 (39%) 8/28 (29%) |16/36 (44%) 15/36 (42%) 9/33 (27%) 20/41 (49%) |
|FIRST INCIDENCE | 630 652 561 651 |511 626 511 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.375 P=0.351 P=0.166 P=0.423 |P=0.430 P=0.233N P=0.260N P=0.516N |
|POLY 3 | P=0.516N P=0.457N P=0.337 P=0.449N |P=0.367 P=0.261N P=0.134N P=0.526 |
|POLY 1.5 | P=0.522N P=0.441N P=0.318 P=0.442N |P=0.334 P=0.240N P=0.132N P=0.503 |
|POLY 6 | P=0.510N P=0.506N P=0.344 P=0.470N |P=0.395 P=0.284N P=0.141N P=0.543 |
|LOGISTIC REGRESSION| P=0.528 P=0.528N P=0.293 P=0.484N |P=0.296 P=0.215N P=0.127N P=0.461 |
|COCH-ARM / FISHERS | P=0.527N P=0.445N P=0.290 P=0.445N |P=0.277 P=0.206N P=0.134N P=0.459 |
|ORDER RESTRICTED | P=0.507N (e) (e) (e) |P=0.297 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 12
Statistical Analysis of Primary Tumors 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 or Unspecified Site |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |1/49 (2%) 3/49 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.47 0/43.80 0/43.46 0/43.44 |1/44.06 3/43.88 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 6.8% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |0/36 (0%) 1/36 (3%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- --- |644 636 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.074N P=0.299 P=0.520N P=0.482N |
|POLY 3 | (e) (e) (e) (e) |P=0.074N P=0.304 P=0.504N P=0.487N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.074N P=0.303 P=0.500N P=0.490N |
|POLY 6 | (e) (e) (e) (e) |P=0.074N P=0.305 P=0.510N P=0.485N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.082N P=0.315 P=0.488N P=0.550N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.076N P=0.309 P=0.495N P=0.495N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.104N (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 or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/48 (33%) 15/50 (30%) 20/49 (41%) 15/50 (30%) |24/49 (49%) 21/49 (43%) 17/50 (34%) 25/50 (50%) |
|POLY-3 RATE (b) | 16/43.05 15/44.42 20/45.67 15/44.68 |24/46.41 21/44.57 17/46.64 25/48.71 |
|POLY-3 PERCENT (g) | 37.2% 33.8% 43.8% 33.6% |51.7% 47.1% 36.5% 51.3% |
|TERMINAL (d) | 13/36 (36%) 11/27 (41%) 12/31 (39%) 8/28 (29%) |16/36 (44%) 16/36 (44%) 9/33 (27%) 20/41 (49%) |
|FIRST INCIDENCE | 630 652 561 651 |511 626 511 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.375 P=0.351 P=0.166 P=0.423 |P=0.452N P=0.373N P=0.212N P=0.443N |
|POLY 3 | P=0.516N P=0.457N P=0.337 P=0.449N |P=0.527N P=0.409N P=0.099N P=0.566N |
|POLY 1.5 | P=0.522N P=0.441N P=0.318 P=0.442N |P=0.521 P=0.386N P=0.095N P=0.578 |
|POLY 6 | P=0.510N P=0.506N P=0.344 P=0.470N |P=0.515N P=0.430N P=0.109N P=0.560N |
|LOGISTIC REGRESSION| P=0.528 P=0.528N P=0.293 P=0.484N |P=0.477 P=0.355N P=0.089N P=0.533 |
|COCH-ARM / FISHERS | P=0.527N P=0.445N P=0.290 P=0.445N |P=0.463 P=0.343N P=0.095N P=0.540 |
|ORDER RESTRICTED | P=0.507N (e) (e) (e) |P=0.355N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 13
Statistical Analysis of Primary Tumors 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 |
| Basal Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.72 2/43.80 0/43.73 2/43.44 |1/44.75 0/43.69 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 4.6% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 2/27 (7%) 0/31 (0%) 2/28 (7%) |1/37 (3%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.307 P=0.177 (e) P=0.185 |P=0.352N P=0.505N P=0.523N P=0.480N |
|POLY 3 | P=0.345 P=0.237 (e) P=0.236 |P=0.365N P=0.505N P=0.507N P=0.490N |
|POLY 1.5 | P=0.347 P=0.239 (e) P=0.237 |P=0.364N P=0.503N P=0.504N P=0.494N |
|POLY 6 | P=0.338 P=0.230 (e) P=0.230 |P=0.366N P=0.506N P=0.512N P=0.487N |
|LOGISTIC REGRESSION| (e) P=0.177 (e) P=0.185 |P=0.352N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.347 P=0.247 (e) P=0.247 |P=0.363N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.115 (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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.72 2/43.80 0/43.73 2/43.44 |3/44.75 0/43.69 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 2.3% 4.6% 0.0% 4.6% |6.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/36 (3%) 2/27 (7%) 0/31 (0%) 2/28 (7%) |3/37 (8%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.489 P=0.400 P=0.530N P=0.412 |P=0.086N P=0.126N P=0.142N P=0.104N |
|POLY 3 | P=0.533 P=0.501 P=0.500N P=0.498 |P=0.084N P=0.123N P=0.125N P=0.110N |
|POLY 1.5 | P=0.535 P=0.503 P=0.500N P=0.500 |P=0.085N P=0.122N P=0.122N P=0.113N |
|POLY 6 | P=0.528 P=0.490 P=0.503N P=0.489 |P=0.083N P=0.124N P=0.130N P=0.107N |
|LOGISTIC REGRESSION| P=0.489 P=0.400 (e) P=0.412 |P=0.086N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.535 P=0.500 P=0.500N P=0.500 |P=0.091N P=0.121N P=0.121N P=0.121N |
|ORDER RESTRICTED | P=0.410 (e) (e) (e) |P=0.006N** (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 14
Statistical Analysis of Primary Tumors 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 |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 1/50 (2%) 3/50 (6%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/44.15 4/43.99 1/43.73 3/43.48 |3/44.75 0/43.69 0/43.24 1/47.34 |
|POLY-3 PERCENT (g) | 11.3% 9.1% 2.3% 6.9% |6.7% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 3/36 (8%) 2/27 (7%) 1/31 (3%) 2/28 (7%) |3/37 (8%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 636 695 729 (T) 718 |729 (T) --- --- 635 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.270N P=0.624N P=0.137N P=0.470N |P=0.322N P=0.126N P=0.142N P=0.269N |
|POLY 3 | P=0.224N P=0.502N P=0.103N P=0.364N |P=0.337N P=0.123N P=0.125N P=0.285N |
|POLY 1.5 | P=0.223N P=0.496N P=0.102N P=0.358N |P=0.340N P=0.122N P=0.122N P=0.293N |
|POLY 6 | P=0.227N P=0.524N P=0.108N P=0.381N |P=0.335N P=0.124N P=0.130N P=0.278N |
|LOGISTIC REGRESSION| P=0.227N P=0.507N P=0.103N P=0.367N |P=0.338N (e) (e) P=0.300N |
|COCH-ARM / FISHERS | P=0.220N P=0.500N P=0.102N P=0.357N |P=0.347N P=0.121N P=0.121N P=0.309N |
|ORDER RESTRICTED | P=0.177N (e) (e) (e) |P=0.033N* (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 |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 10/50 (20%) 5/50 (10%) 8/50 (16%) |4/50 (8%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 9/43.97 10/45.25 5/44.26 8/44.06 |4/45.12 1/43.75 1/43.24 1/47.00 |
|POLY-3 PERCENT (g) | 20.5% 22.1% 11.3% 18.2% |8.9% 2.3% 2.3% 2.1% |
|TERMINAL (d) | 7/36 (19%) 6/27 (22%) 3/31 (10%) 5/28 (18%) |3/37 (8%) 0/36 (0%) 1/33 (3%) 1/41 (2%) |
|FIRST INCIDENCE | 695 555 607 651 |623 714 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.377N P=0.313 P=0.274N P=0.539 |P=0.173N P=0.190N P=0.213N P=0.152N |
|POLY 3 | P=0.300N P=0.528 P=0.187N P=0.498N |P=0.175N P=0.188N P=0.191N P=0.167N |
|POLY 1.5 | P=0.297N P=0.524 P=0.189N P=0.495N |P=0.180N P=0.185N P=0.186N P=0.171N |
|POLY 6 | P=0.306N P=0.513 P=0.192N P=0.514N |P=0.172N P=0.191N P=0.202N P=0.163N |
|LOGISTIC REGRESSION| P=0.298N P=0.504 P=0.196N P=0.524N |P=0.176N P=0.184N P=0.188N P=0.173N |
|COCH-ARM / FISHERS | P=0.294N P=0.500 P=0.194N P=0.500N |P=0.188N P=0.181N P=0.181N P=0.181N |
|ORDER RESTRICTED | P=0.335N (e) (e) (e) |P=0.066N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 15
Statistical Analysis of Primary Tumors 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 |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 12/50 (24%) 6/50 (12%) 8/50 (16%) |4/50 (8%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 10/44.83 12/45.53 6/45.23 8/44.06 |4/45.12 2/43.76 1/43.24 2/47.23 |
|POLY-3 PERCENT (g) | 22.3% 26.4% 13.3% 18.2% |8.9% 4.6% 2.3% 4.2% |
|TERMINAL (d) | 7/36 (19%) 7/27 (26%) 3/31 (10%) 5/28 (18%) |3/37 (8%) 0/36 (0%) 1/33 (3%) 1/41 (2%) |
|FIRST INCIDENCE | 381 555 209 651 |623 714 729 (T) 670 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.242N P=0.238 P=0.289N P=0.562N |P=0.267N P=0.351N P=0.213N P=0.294N |
|POLY 3 | P=0.180N P=0.420 P=0.198N P=0.412N |P=0.277N P=0.351N P=0.191N P=0.316N |
|POLY 1.5 | P=0.176N P=0.419 P=0.199N P=0.404N |P=0.283N P=0.347N P=0.186N P=0.324N |
|POLY 6 | P=0.188N P=0.404 P=0.205N P=0.431N |P=0.273N P=0.356N P=0.202N P=0.310N |
|LOGISTIC REGRESSION| P=0.170N P=0.401 P=0.205N P=0.397N |P=0.277N P=0.346N P=0.188N P=0.339N |
|COCH-ARM / FISHERS | P=0.172N P=0.405 P=0.207N P=0.398N |P=0.293N P=0.339N P=0.181N P=0.339N |
|ORDER RESTRICTED | P=0.243N (e) (e) (e) |P=0.168N (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 |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 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) | 1/44.58 2/44.08 0/43.73 0/43.44 |0/44.75 1/43.70 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 2.2% 4.5% 0.0% 0.0% |0.0% 2.3% 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 | 381 652 --- --- |--- 727 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.131N P=0.470 P=0.504N P=0.500N |P=0.415N P=0.495 (e) (e) |
|POLY 3 | P=0.126N P=0.496 P=0.504N P=0.505N |P=0.431N P=0.495 (e) (e) |
|POLY 1.5 | P=0.125N P=0.500 P=0.502N P=0.502N |P=0.428N P=0.497 (e) (e) |
|POLY 6 | P=0.129N P=0.486 P=0.508N P=0.511N |P=0.434N P=0.494 (e) (e) |
|LOGISTIC REGRESSION| P=0.111N P=0.334 P=0.358N (e) |P=0.414N P=0.492 (e) (e) |
|COCH-ARM / FISHERS | P=0.124N P=0.500 P=0.500N P=0.500N |P=0.423N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.170N (e) (e) (e) |P=0.367N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 16
Statistical Analysis of Primary Tumors 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 |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.58 2/44.08 1/44.71 0/43.44 |0/44.75 1/43.70 0/43.24 1/47.23 |
|POLY-3 PERCENT (g) | 2.2% 4.5% 2.2% 0.0% |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%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 381 652 209 --- |--- 727 --- 670 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.203N P=0.470 P=0.758 P=0.500N |P=0.498 P=0.495 (e) P=0.519 |
|POLY 3 | P=0.198N P=0.496 P=0.760N P=0.505N |P=0.489 P=0.495 (e) P=0.511 |
|POLY 1.5 | P=0.196N P=0.500 P=0.759N P=0.502N |P=0.485 P=0.497 (e) P=0.507 |
|POLY 6 | P=0.203N P=0.486 P=0.758 P=0.511N |P=0.494 P=0.494 (e) P=0.515 |
|LOGISTIC REGRESSION| P=0.161N P=0.334 (e) (e) |P=0.480 P=0.492 (e) P=0.471 |
|COCH-ARM / FISHERS | P=0.193N P=0.500 P=0.753N P=0.500N |P=0.478 P=0.500 (e) P=0.500 |
|ORDER RESTRICTED | P=0.228N (e) (e) (e) |P=0.261 (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 |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/44.15 2/43.99 1/43.73 1/43.48 |0/44.75 0/43.69 0/43.24 1/47.34 |
|POLY-3 PERCENT (g) | 9.1% 4.6% 2.3% 2.3% |0.0% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 2/36 (6%) 0/27 (0%) 1/31 (3%) 0/28 (0%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 636 695 729 (T) 718 |--- --- --- 635 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.156N P=0.418N P=0.220N P=0.238N |P=0.205 (e) (e) P=0.527 |
|POLY 3 | P=0.132N P=0.338N P=0.181N P=0.183N |P=0.195 (e) (e) P=0.511 |
|POLY 1.5 | P=0.132N P=0.334N P=0.180N P=0.180N |P=0.191 (e) (e) P=0.507 |
|POLY 6 | P=0.133N P=0.354N P=0.188N P=0.192N |P=0.199 (e) (e) P=0.516 |
|LOGISTIC REGRESSION| P=0.132N P=0.335N P=0.179N P=0.180N |P=0.145 (e) (e) P=0.438 |
|COCH-ARM / FISHERS | P=0.130N P=0.339N P=0.181N P=0.181N |P=0.185 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.098N (e) (e) (e) |P=0.131 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 17
Statistical Analysis of Primary Tumors 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 |
| Trichoepithelioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 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) | 1/43.72 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) | 2.3% 0.0% 0.0% 0.0% |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/36 (3%) 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) --- --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.381N P=0.557N P=0.530N P=0.550N |P=0.167N P=0.244N P=0.264N P=0.216N |
|POLY 3 | P=0.363N P=0.500N P=0.500N P=0.501N |P=0.169N P=0.242N P=0.245N P=0.226N |
|POLY 1.5 | P=0.365N P=0.498N P=0.500N P=0.500N |P=0.170N P=0.241N P=0.241N P=0.230N |
|POLY 6 | P=0.357N P=0.506N P=0.503N P=0.506N |P=0.169N P=0.244N P=0.251N P=0.223N |
|LOGISTIC REGRESSION| P=0.381N (e) (e) (e) |P=0.167N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.363N P=0.500N P=0.500N P=0.500N |P=0.173N P=0.247N P=0.247N P=0.247N |
|ORDER RESTRICTED | P=0.121N (e) (e) (e) |P=0.026N* (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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 49/50 (98%) 44/50 (88%) 45/50 (90%) | |
|POLY-3 RATE (b) | 45/47.98 49/49.46 44/47.14 45/48.49 | |
|POLY-3 PERCENT (g) | 93.8% 99.1% 93.3% 92.8% | |
|TERMINAL (d) | 34/36 (94%) 27/27 (100%) 30/31 (97%) 27/28 (96%) | |
|FIRST INCIDENCE | 469 542 561 443 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.383 P=0.018 * P=0.282 P=0.101 | |
|POLY 3 | P=0.198N P=0.164 P=0.644N P=0.593N | |
|POLY 1.5 | P=0.196N P=0.137 P=0.592N P=0.590N | |
|POLY 6 | P=0.239N P=0.186 P=0.671 P=0.639N | |
|LOGISTIC REGRESSION| P=0.208N P=0.215 P=0.391N P=0.576N | |
|COCH-ARM / FISHERS | P=0.229N P=0.102 P=0.500N P=0.630N | |
|ORDER RESTRICTED | P=0.285N (e) (e) (e) | |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 18
Statistical Analysis of Primary Tumors 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: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/47 (19%) 9/44 (20%) 6/43 (14%) 9/47 (19%) |12/47 (26%) 9/47 (19%) 11/43 (26%) 9/46 (20%) |
|POLY-3 RATE (b) | 9/42.76 9/40.47 6/40.05 9/41.77 |12/42.92 9/42.52 11/38.90 9/43.71 |
|POLY-3 PERCENT (g) | 21.1% 22.2% 15.0% 21.6% |28.0% 21.2% 28.3% 20.6% |
|TERMINAL (d) | 7/36 (19%) 7/27 (26%) 4/31 (13%) 8/28 (29%) |10/36 (28%) 6/36 (17%) 11/32 (34%) 9/40 (23%) |
|FIRST INCIDENCE | 636 619 660 718 |661 644 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.506 P=0.388 P=0.383N P=0.395 |P=0.293N P=0.326N P=0.563 P=0.223N |
|POLY 3 | P=0.485N P=0.553 P=0.334N P=0.583 |P=0.368N P=0.317N P=0.585 P=0.292N |
|POLY 1.5 | P=0.477N P=0.554 P=0.343N P=0.595 |P=0.384N P=0.317N P=0.591 P=0.306N |
|POLY 6 | P=0.503N P=0.539 P=0.329N P=0.553 |P=0.359N P=0.312N P=0.568 P=0.281N |
|LOGISTIC REGRESSION| P=0.486N P=0.547 P=0.336N P=0.548 |P=0.340N P=0.324N P=0.557 P=0.265N |
|COCH-ARM / FISHERS | P=0.466N P=0.542 P=0.354N P=0.603N |P=0.418N P=0.311N P=0.593 P=0.330N |
|ORDER RESTRICTED | P=0.550N (e) (e) (e) |P=0.331N (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 |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/47 (4%) 2/44 (5%) 0/43 (0%) 1/47 (2%) |1/47 (2%) 3/47 (6%) 1/43 (2%) 3/46 (7%) |
|POLY-3 RATE (b) | 2/42.29 2/39.82 0/39.66 1/41.73 |1/42.66 3/42.30 1/39.38 3/43.71 |
|POLY-3 PERCENT (g) | 4.7% 5.0% 0.0% 2.4% |2.3% 7.1% 2.5% 6.9% |
|TERMINAL (d) | 2/36 (6%) 2/27 (7%) 0/31 (0%) 1/28 (4%) |1/36 (3%) 2/36 (6%) 0/32 (0%) 3/40 (8%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |729 (T) 626 587 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.292N P=0.588 P=0.272N P=0.588N |P=0.431 P=0.309 P=0.747 P=0.343 |
|POLY 3 | P=0.254N P=0.673 P=0.251N P=0.505N |P=0.394 P=0.302 P=0.743 P=0.314 |
|POLY 1.5 | P=0.254N P=0.674 P=0.254N P=0.501N |P=0.387 P=0.302 P=0.742 P=0.308 |
|POLY 6 | P=0.253N P=0.666 P=0.250N P=0.513N |P=0.400 P=0.303 P=0.742 P=0.320 |
|LOGISTIC REGRESSION| P=0.292N P=0.588 (e) P=0.588N |P=0.369 P=0.302 P=0.740 P=0.343 |
|COCH-ARM / FISHERS | P=0.254N P=0.666 P=0.270N P=0.500N |P=0.374 P=0.308 P=0.730 P=0.300 |
|ORDER RESTRICTED | P=0.259N (e) (e) (e) |P=0.254 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 19
Statistical Analysis of Primary Tumors 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: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/47 (23%) 11/44 (25%) 6/43 (14%) 10/47 (21%) |13/47 (28%) 11/47 (23%) 12/43 (28%) 12/46 (26%) |
|POLY-3 RATE (b) | 11/42.76 11/40.47 6/40.05 10/41.77 |13/42.92 11/42.89 12/39.38 12/43.71 |
|POLY-3 PERCENT (g) | 25.7% 27.2% 15.0% 23.9% |30.3% 25.7% 30.5% 27.5% |
|TERMINAL (d) | 9/36 (25%) 9/27 (33%) 4/31 (13%) 9/28 (32%) |11/36 (31%) 7/36 (19%) 11/32 (34%) 12/40 (30%) |
|FIRST INCIDENCE | 636 619 660 718 |661 626 587 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.453N P=0.342 P=0.221N P=0.461 |P=0.423N P=0.420N P=0.555 P=0.381N |
|POLY 3 | P=0.339N P=0.539 P=0.174N P=0.524N |P=0.526N P=0.406N P=0.588 P=0.479N |
|POLY 1.5 | P=0.332N P=0.540 P=0.182N P=0.509N |P=0.541N P=0.411N P=0.588 P=0.495N |
|POLY 6 | P=0.354N P=0.523 P=0.169N P=0.559N |P=0.521N P=0.394N P=0.579 P=0.465N |
|LOGISTIC REGRESSION| P=0.344N P=0.527 P=0.175N P=0.577N |P=0.500N P=0.424N P=0.570 P=0.442N |
|COCH-ARM / FISHERS | P=0.323N P=0.526 P=0.191N P=0.500N |P=0.506 P=0.407N P=0.582 P=0.525N |
|ORDER RESTRICTED | P=0.355N (e) (e) (e) |P=0.598N (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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 0/44 (0%) 0/43 (0%) 2/47 (4%) |0/47 (0%) 0/47 (0%) 0/43 (0%) 2/46 (4%) |
|POLY-3 RATE (b) | 1/42.38 0/39.82 0/39.66 2/41.73 |0/42.66 0/41.93 0/38.90 2/44.12 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 4.8% |0.0% 0.0% 0.0% 4.5% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 2/28 (7%) |0/36 (0%) 0/36 (0%) 0/32 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 705 --- --- 729 (T) |--- --- --- 644 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.176 P=0.529N P=0.523N P=0.422 |P=0.052 (e) (e) P=0.255 |
|POLY 3 | P=0.206 P=0.512N P=0.513N P=0.495 |P=0.044 * (e) (e) P=0.245 |
|POLY 1.5 | P=0.206 P=0.512N P=0.515N P=0.498 |P=0.043 * (e) (e) P=0.240 |
|POLY 6 | P=0.205 P=0.517N P=0.512N P=0.485 |P=0.045 * (e) (e) P=0.250 |
|LOGISTIC REGRESSION| P=0.196 P=0.512N P=0.517N P=0.478 |P=0.033 * (e) (e) P=0.200 |
|COCH-ARM / FISHERS | P=0.207 P=0.516N P=0.522N P=0.500 |P=0.042 * (e) (e) P=0.242 |
|ORDER RESTRICTED | P=0.130 (e) (e) (e) |P=0.032 * (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 20
Statistical Analysis of Primary Tumors 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: Follicular Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/44 (0%) 0/43 (0%) 4/47 (9%) |1/47 (2%) 0/47 (0%) 1/43 (2%) 2/46 (4%) |
|POLY-3 RATE (b) | 0/42.29 0/39.82 0/39.66 4/41.73 |1/42.66 0/41.93 1/39.01 2/43.71 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 9.6% |2.3% 0.0% 2.6% 4.6% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 4/28 (14%) |1/36 (3%) 0/36 (0%) 0/32 (0%) 2/40 (5%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |729 (T) --- 703 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** (e) (e) P=0.035 * |P=0.219 P=0.500N P=0.732 P=0.537 |
|POLY 3 | P=0.003 ** (e) (e) P=0.058 |P=0.203 P=0.503N P=0.741 P=0.508 |
|POLY 1.5 | P=0.003 ** (e) (e) P=0.059 |P=0.198 P=0.503N P=0.741 P=0.503 |
|POLY 6 | P=0.003 ** (e) (e) P=0.055 |P=0.207 P=0.504N P=0.739 P=0.514 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.035 * |P=0.204 (e) P=0.742 P=0.537 |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) P=0.058 |P=0.187 P=0.500N P=0.730 P=0.492 |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) |P=0.236 (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 |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 0/44 (0%) 0/43 (0%) 6/47 (13%) |1/47 (2%) 0/47 (0%) 1/43 (2%) 4/46 (9%) |
|POLY-3 RATE (b) | 1/42.38 0/39.82 0/39.66 6/41.73 |1/42.66 0/41.93 1/39.01 4/44.12 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 14.4% |2.3% 0.0% 2.6% 9.1% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 6/28 (21%) |1/36 (3%) 0/36 (0%) 0/32 (0%) 2/40 (5%) |
|FIRST INCIDENCE | 705 --- --- 729 (T) |729 (T) --- 703 644 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.529N P=0.523N P=0.028 * |P=0.034 * P=0.500N P=0.732 P=0.212 |
|POLY 3 | P=0.002 ** P=0.512N P=0.513N P=0.052 |P=0.026 * P=0.503N P=0.741 P=0.189 |
|POLY 1.5 | P=0.002 ** P=0.512N P=0.515N P=0.055 |P=0.024 * P=0.503N P=0.741 P=0.182 |
|POLY 6 | P=0.002 ** P=0.517N P=0.512N P=0.048 * |P=0.027 * P=0.504N P=0.739 P=0.196 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.512N P=0.517N P=0.037 * |P=0.024 * (e) P=0.742 P=0.172 |
|COCH-ARM / FISHERS | P=0.002 ** P=0.516N P=0.522N P=0.055 |P=0.023 * P=0.500N P=0.730 P=0.174 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.029 * (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 21
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |9/50 (18%) 8/50 (16%) 9/50 (18%) 7/50 (14%) |
|POLY-3 RATE (b) | |9/45.06 8/44.03 9/45.03 7/47.57 |
|POLY-3 PERCENT (g) | |20.0% 18.2% 20.0% 14.7% |
|TERMINAL (d) | |8/37 (22%) 7/36 (19%) 4/33 (12%) 5/41 (12%) |
|FIRST INCIDENCE | |644 636 514 635 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.303N P=0.524N P=0.518 P=0.312N |
|POLY 3 | |P=0.318N P=0.521N P=0.603 P=0.347N |
|POLY 1.5 | |P=0.341N P=0.514N P=0.602N P=0.365N |
|POLY 6 | |P=0.297N P=0.527N P=0.596 P=0.331N |
|LOGISTIC REGRESSION| |P=0.358N P=0.527N P=0.599 P=0.357N |
|COCH-ARM / FISHERS | |P=0.380N P=0.500N P=0.602N P=0.393N |
|ORDER RESTRICTED | |P=0.403N (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 |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |10/50 (20%) 8/50 (16%) 9/50 (18%) 7/50 (14%) |
|POLY-3 RATE (b) | |10/45.06 8/44.03 9/45.03 7/47.57 |
|POLY-3 PERCENT (g) | |22.2% 18.2% 20.0% 14.7% |
|TERMINAL (d) | |9/37 (24%) 7/36 (19%) 4/33 (12%) 5/41 (12%) |
|FIRST INCIDENCE | |644 636 514 635 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.245N P=0.422N P=0.585N P=0.226N |
|POLY 3 | |P=0.255N P=0.417N P=0.501N P=0.255N |
|POLY 1.5 | |P=0.277N P=0.411N P=0.499N P=0.271N |
|POLY 6 | |P=0.236N P=0.423N P=0.508N P=0.239N |
|LOGISTIC REGRESSION| |P=0.291N P=0.423N P=0.507N P=0.262N |
|COCH-ARM / FISHERS | |P=0.314N P=0.398N P=0.500N P=0.298N |
|ORDER RESTRICTED | |P=0.280N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 22
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.39 1/43.80 0/43.73 0/43.44 |0/44.75 2/44.02 1/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 2.3% 2.3% 0.0% 0.0% |0.0% 4.5% 2.3% 0.0% |
|TERMINAL (d) | 0/36 (0%) 1/27 (4%) 0/31 (0%) 0/28 (0%) |0/37 (0%) 1/36 (3%) 1/33 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 503 729 (T) --- --- |--- 639 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.215N P=0.736 P=0.496N P=0.500N |P=0.316N P=0.234 P=0.477 (e) |
|POLY 3 | P=0.205N P=0.758 P=0.503N P=0.504N |P=0.324N P=0.233 P=0.493 (e) |
|POLY 1.5 | P=0.205N P=0.760N P=0.502N P=0.502N |P=0.328N P=0.234 P=0.496 (e) |
|POLY 6 | P=0.206N P=0.750 P=0.507N P=0.510N |P=0.321N P=0.233 P=0.488 (e) |
|LOGISTIC REGRESSION| P=0.195N P=0.710 P=0.450N P=0.597N |P=0.330N P=0.239 P=0.477 (e) |
|COCH-ARM / FISHERS | P=0.203N P=0.753N P=0.500N P=0.500N |P=0.333N P=0.247 P=0.500 (e) |
|ORDER RESTRICTED | P=0.253N (e) (e) (e) |P=0.309N (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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 21/50 (42%) 16/50 (32%) 23/50 (46%) |11/50 (22%) 9/50 (18%) 13/50 (26%) 9/50 (18%) |
|POLY-3 RATE (b) | 13/45.60 21/46.69 16/45.67 23/47.49 |11/45.75 9/44.07 13/44.89 9/47.79 |
|POLY-3 PERCENT (g) | 28.5% 45.0% 35.0% 48.4% |24.0% 20.4% 29.0% 18.8% |
|TERMINAL (d) | 8/36 (22%) 8/27 (30%) 8/31 (26%) 10/28 (36%) |7/37 (19%) 8/36 (22%) 7/33 (21%) 6/41 (15%) |
|FIRST INCIDENCE | 545 574 561 465 |594 623 615 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.084 P=0.037 * P=0.255 P=0.020 * |P=0.387N P=0.430N P=0.318 P=0.325N |
|POLY 3 | P=0.111 P=0.074 P=0.328 P=0.036 * |P=0.408N P=0.437N P=0.385 P=0.359N |
|POLY 1.5 | P=0.106 P=0.075 P=0.329 P=0.034 * |P=0.436N P=0.424N P=0.395 P=0.375N |
|POLY 6 | P=0.111 P=0.067 P=0.315 P=0.035 * |P=0.381N P=0.452N P=0.370 P=0.345N |
|LOGISTIC REGRESSION| P=0.098 P=0.069 P=0.330 P=0.029 * |P=0.452N P=0.421N P=0.396 P=0.399N |
|COCH-ARM / FISHERS | P=0.097 P=0.069 P=0.330 P=0.030 * |P=0.484N P=0.402N P=0.408 P=0.402N |
|ORDER RESTRICTED | P=0.031 * (e) (e) (e) |P=0.404N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 23
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.72 1/44.06 2/44.36 2/43.44 |0/44.75 0/43.69 1/43.76 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 4.5% 4.6% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 2/28 (7%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 660 607 729 (T) |--- --- 573 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.157 P=0.500 P=0.237 P=0.185 |P=0.647 (e) P=0.504 (e) |
|POLY 3 | P=0.164 P=0.502 P=0.240 P=0.236 |P=0.667 (e) P=0.496 (e) |
|POLY 1.5 | P=0.166 P=0.503 P=0.239 P=0.237 |P=0.656 (e) P=0.498 (e) |
|POLY 6 | P=0.158 P=0.496 P=0.239 P=0.230 |P=0.677 (e) P=0.491 (e) |
|LOGISTIC REGRESSION| P=0.166 P=0.484 P=0.239 P=0.185 |P=0.571 (e) P=0.513 (e) |
|COCH-ARM / FISHERS | P=0.166 P=0.500 P=0.247 P=0.247 |P=0.637 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.153 (e) (e) (e) |P=0.377 (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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.72 1/44.06 2/44.36 2/43.44 |0/44.75 0/43.69 1/43.76 0/47.00 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 4.5% 4.6% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 2/28 (7%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 660 607 729 (T) |--- --- 573 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.157 P=0.500 P=0.237 P=0.185 |P=0.647 (e) P=0.504 (e) |
|POLY 3 | P=0.164 P=0.502 P=0.240 P=0.236 |P=0.667 (e) P=0.496 (e) |
|POLY 1.5 | P=0.166 P=0.503 P=0.239 P=0.237 |P=0.656 (e) P=0.498 (e) |
|POLY 6 | P=0.158 P=0.496 P=0.239 P=0.230 |P=0.677 (e) P=0.491 (e) |
|LOGISTIC REGRESSION| P=0.166 P=0.484 P=0.239 P=0.185 |P=0.571 (e) P=0.513 (e) |
|COCH-ARM / FISHERS | P=0.166 P=0.500 P=0.247 P=0.247 |P=0.637 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.153 (e) (e) (e) |P=0.377 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 24
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.64 0/43.80 0/43.73 1/43.44 |0/44.75 1/44.23 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 0.0% 2.3% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 1/28 (4%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 469 --- --- 729 (T) |--- 563 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.377N P=0.141N P=0.138N P=0.365N |P=0.415N P=0.496 (e) (e) |
|POLY 3 | P=0.344N P=0.122N P=0.122N P=0.315N |P=0.429N P=0.498 (e) (e) |
|POLY 1.5 | P=0.347N P=0.119N P=0.121N P=0.309N |P=0.427N P=0.498 (e) (e) |
|POLY 6 | P=0.336N P=0.129N P=0.127N P=0.327N |P=0.432N P=0.498 (e) (e) |
|LOGISTIC REGRESSION| P=0.344N P=0.150N P=0.115N P=0.315N |P=0.509N P=0.556 (e) (e) |
|COCH-ARM / FISHERS | P=0.347N P=0.121N P=0.121N P=0.309N |P=0.423N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.041N* (e) (e) (e) |P=0.370N (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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.64 0/43.80 0/43.73 1/43.44 |0/44.75 1/44.23 0/43.24 0/47.00 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 0.0% 2.3% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/31 (0%) 1/28 (4%) |0/37 (0%) 0/36 (0%) 0/33 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 469 --- --- 729 (T) |--- 563 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.377N P=0.141N P=0.138N P=0.365N |P=0.415N P=0.496 (e) (e) |
|POLY 3 | P=0.344N P=0.122N P=0.122N P=0.315N |P=0.429N P=0.498 (e) (e) |
|POLY 1.5 | P=0.347N P=0.119N P=0.121N P=0.309N |P=0.427N P=0.498 (e) (e) |
|POLY 6 | P=0.336N P=0.129N P=0.127N P=0.327N |P=0.432N P=0.498 (e) (e) |
|LOGISTIC REGRESSION| P=0.344N P=0.150N P=0.115N P=0.315N |P=0.509N P=0.556 (e) (e) |
|COCH-ARM / FISHERS | P=0.347N P=0.121N P=0.121N P=0.309N |P=0.423N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.041N* (e) (e) (e) |P=0.370N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 25
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 49/50 (98%) 47/50 (94%) 47/50 (94%) |46/50 (92%) 42/50 (84%) 44/50 (88%) 47/50 (94%) |
|POLY-3 RATE (b) | 48/48.34 49/49.46 47/48.09 47/48.82 |46/48.80 42/47.38 44/48.83 47/49.41 |
|POLY-3 PERCENT (g) | 99.3% 99.1% 97.7% 96.3% |94.3% 88.7% 90.1% 95.1% |
|TERMINAL (d) | 36/36 (100%) 27/27 (100%) 31/31 (100%) 27/28 (96%) |35/37 (95%) 33/36 (92%) 29/33 (88%) 39/41 (95%) |
|FIRST INCIDENCE | 469 542 561 443 |423 365 511 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.337 P=0.048 * P=0.270 P=0.129 |P=0.408N P=0.360N P=0.408 P=0.303N |
|POLY 3 | P=0.128N P=0.955N P=0.608N P=0.346N |P=0.319 P=0.248N P=0.342N P=0.609 |
|POLY 1.5 | P=0.162N P=0.826 P=0.580N P=0.384N |P=0.261 P=0.208N P=0.356N P=0.567 |
|POLY 6 | P=0.126N P=1.000N P=0.707N P=0.386N |P=0.402 P=0.323N P=0.326N P=0.650 |
|LOGISTIC REGRESSION| P=0.210N P=0.355N P=0.240N P=0.346N |P=0.313 P=0.216N P=0.396N P=0.641 |
|COCH-ARM / FISHERS | P=0.249N P=0.500 P=0.500N P=0.500N |P=0.202 P=0.178N P=0.370N P=0.500 |
|ORDER RESTRICTED | P=0.135N (e) (e) (e) |P=0.334 (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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 32/50 (64%) 24/50 (48%) 32/50 (64%) |21/50 (42%) 22/50 (44%) 19/50 (38%) 22/50 (44%) |
|POLY-3 RATE (b) | 27/48.71 32/47.98 24/48.25 32/48.14 |21/47.47 22/46.55 19/47.04 22/48.35 |
|POLY-3 PERCENT (g) | 55.4% 66.7% 49.7% 66.5% |44.2% 47.3% 40.4% 45.5% |
|TERMINAL (d) | 16/36 (44%) 14/27 (52%) 11/31 (36%) 16/28 (57%) |14/37 (38%) 14/36 (39%) 8/33 (24%) 17/41 (42%) |
|FIRST INCIDENCE | 381 562 209 465 |462 541 547 635 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.276 P=0.092 P=0.513N P=0.098 |P=0.391N P=0.461 P=0.551N P=0.499N |
|POLY 3 | P=0.365 P=0.175 P=0.360N P=0.181 |P=0.497N P=0.465 P=0.432N P=0.533 |
|POLY 1.5 | P=0.375 P=0.191 P=0.350N P=0.194 |P=0.513N P=0.472 P=0.428N P=0.520 |
|POLY 6 | P=0.347 P=0.152 P=0.382N P=0.160 |P=0.486N P=0.471 P=0.435N P=0.547 |
|LOGISTIC REGRESSION| P=0.390 P=0.196 P=0.346N P=0.206 |P=0.502 P=0.503 P=0.392N P=0.480 |
|COCH-ARM / FISHERS | P=0.384 P=0.208 P=0.345N P=0.208 |P=0.527 P=0.500 P=0.419N P=0.500 |
|ORDER RESTRICTED | P=0.204 (e) (e) (e) |P=0.610N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/27/03 EXPERIMENT: 96010 TEST: 03 Page 26
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 50/50 (100%) 50/50 (100%)|49/50 (98%) 48/50 (96%) 46/50 (92%) 48/50 (96%) |
|POLY-3 RATE (b) | 49/49.20 50/50.00 50/50.00 50/50.00 |49/50.00 48/49.21 46/49.17 48/49.41 |
|POLY-3 PERCENT (g) | 99.6% 100.0% 100.0% 100.0% |98.0% 97.5% 93.6% 97.1% |
|TERMINAL (d) | 36/36 (100%) 27/27 (100%) 31/31 (100%) 28/28 (100%)|36/37 (97%) 35/36 (97%) 30/33 (91%) 40/41 (98%) |
|FIRST INCIDENCE | 381 542 209 443 |423 365 511 475 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.206 P=0.054 P=0.176 P=0.073 |P=0.149N P=0.551 P=0.467 P=0.168N |
|POLY 3 | P=0.987 P=1.000 P=1.000 P=1.000 |P=0.429N P=0.706N P=0.271N P=0.652N |
|POLY 1.5 | P=0.671 P=0.894 P=0.894 P=0.894 |P=0.401N P=0.639N P=0.237N P=0.589N |
|POLY 6 | P=1.000 P=1.000 P=1.000 P=1.000 |P=0.470N P=0.746N P=0.294N P=0.716N |
|LOGISTIC REGRESSION| P=0.306 P=0.995 P=0.398 P=0.764 |P=0.274N P=0.536N P=0.188N P=0.444N |
|COCH-ARM / FISHERS | P=0.363 P=0.500 P=0.500 P=0.500 |P=0.380N P=0.500N P=0.181N P=0.500N |
|ORDER RESTRICTED | P=0.119 (e) (e) (e) |P=0.359N (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).
--multipart-boundary
Content-type: text/plain
Range: bytes 231926-231926/231926
--multipart-boundary--