TDMS Study 96018-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (BROMODICHLOROMETHANE) DATE: 04/15/03
EXPERIMENT: 96018 TEST: 03 TIME: 15:28:34
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96018
PATHOLOGIST: FARNELL, DANIEL R. CAS: 75-27-4
------------------------------------------------------------------------------------------------------------------------------------
FINAL#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 (BROMODICHLOROMETHANE) DATE: 04/15/03
EXPERIMENT: 96018 TEST: 03 TIME: 15:28:34
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96018
PATHOLOGIST: FARNELL, DANIEL R. CAS: 75-27-4
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
Liver
Lung
Nose
Pancreas
Pituitary Gland
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 9/50 (18%) 12/50 (24%) 8/49 (16%) |
|POLY-3 RATE (b) | 8/42.82 9/43.30 12/45.17 8/42.20 |
|POLY-3 PERCENT (g) | 18.7% 20.8% 26.6% 19.0% |
|TERMINAL (d) | 7/29 (24%) 6/28 (21%) 5/29 (17%) 5/26 (19%) |
|FIRST INCIDENCE | 722 683 649 693 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.439 P=0.456 P=0.240 P=0.511 |
|POLY 3 | P=0.524 P=0.510 P=0.265 P=0.597 |
|POLY 1.5 | P=0.526 P=0.510 P=0.251 P=0.598 |
|POLY 6 | P=0.511 P=0.504 P=0.278 P=0.585 |
|LOGISTIC REGRESSION| P=0.485 P=0.454 P=0.245 P=0.525 |
|COCH-ARM / FISHERS | P=0.516 P=0.500 P=0.227 P=0.590 |
|ORDER RESTRICTED | P=0.502 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Complex |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/43.15 1/43.15 0/44.15 0/41.84 |
|POLY-3 PERCENT (g) | 4.6% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/28 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 655 681 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.111N P=0.511N P=0.241N P=0.269N |
|POLY 3 | P=0.101N P=0.500N P=0.232N P=0.244N |
|POLY 1.5 | P=0.102N P=0.498N P=0.233N P=0.241N |
|POLY 6 | P=0.101N P=0.506N P=0.234N P=0.250N |
|LOGISTIC REGRESSION| P=0.103N P=0.501N P=0.239N P=0.242N |
|COCH-ARM / FISHERS | P=0.102N P=0.500N P=0.247N P=0.253N |
|ORDER RESTRICTED | P=0.078N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 1/42.84 0/42.97 1/44.15 2/41.87 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.3% 4.8% |
|TERMINAL (d) | 0/29 (0%) 0/28 (0%) 1/29 (3%) 1/26 (4%) |
|FIRST INCIDENCE | 718 --- 729 (T) 722 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.221 P=0.527N P=0.760 P=0.452 |
|POLY 3 | P=0.242 P=0.499N P=0.754N P=0.492 |
|POLY 1.5 | P=0.243 P=0.499N P=0.755N P=0.495 |
|POLY 6 | P=0.238 P=0.502N P=0.755N P=0.484 |
|LOGISTIC REGRESSION| P=0.222 P=0.505N P=0.760N P=0.465 |
|COCH-ARM / FISHERS | P=0.242 P=0.500N P=0.753N P=0.492 |
|ORDER RESTRICTED | P=0.216 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 11/50 (22%) 10/50 (20%) 13/50 (26%) 9/49 (18%) |
|POLY-3 RATE (b) | 11/43.22 10/43.49 13/45.17 9/42.22 |
|POLY-3 PERCENT (g) | 25.5% 23.0% 28.8% 21.3% |
|TERMINAL (d) | 7/29 (24%) 6/28 (21%) 6/29 (21%) 5/26 (19%) |
|FIRST INCIDENCE | 655 681 649 693 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.505N P=0.549N P=0.417 P=0.518N |
|POLY 3 | P=0.417N P=0.494N P=0.455 P=0.422N |
|POLY 1.5 | P=0.412N P=0.492N P=0.440 P=0.416N |
|POLY 6 | P=0.436N P=0.505N P=0.466 P=0.444N |
|LOGISTIC REGRESSION| P=0.442N P=0.520N P=0.440 P=0.469N |
|COCH-ARM / FISHERS | P=0.418N P=0.500N P=0.408 P=0.421N |
|ORDER RESTRICTED | P=0.499N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.79 1/43.34 0/44.15 0/42.45 |
|POLY-3 PERCENT (g) | 4.7% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 0/28 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 729 (T) 624 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.105N P=0.503N P=0.238N P=0.262N |
|POLY 3 | P=0.100N P=0.496N P=0.230N P=0.239N |
|POLY 1.5 | P=0.100N P=0.496N P=0.232N P=0.237N |
|POLY 6 | P=0.100N P=0.498N P=0.230N P=0.245N |
|LOGISTIC REGRESSION| P=0.100N P=0.499N (e) (e) |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |
|ORDER RESTRICTED | P=0.075N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/43.54 2/42.97 3/44.15 0/41.45 |
|POLY-3 PERCENT (g) | 4.6% 4.7% 6.8% 0.0% |
|TERMINAL (d) | 1/29 (3%) 2/28 (7%) 3/29 (10%) 0/25 (0%) |
|FIRST INCIDENCE | 459 729 (T) 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.227N P=0.686 P=0.502 P=0.254N |
|POLY 3 | P=0.213N P=0.689 P=0.506 P=0.248N |
|POLY 1.5 | P=0.207N P=0.692 P=0.506 P=0.244N |
|POLY 6 | P=0.224N P=0.683 P=0.503 P=0.256N |
|LOGISTIC REGRESSION| P=0.204N P=0.688 P=0.486 P=0.275N |
|COCH-ARM / FISHERS | P=0.204N P=0.691N P=0.500 P=0.253N |
|ORDER RESTRICTED | P=0.166N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/42.82 3/43.65 0/44.15 1/41.45 |
|POLY-3 PERCENT (g) | 2.3% 6.9% 0.0% 2.4% |
|TERMINAL (d) | 0/29 (0%) 1/28 (4%) 0/29 (0%) 1/25 (4%) |
|FIRST INCIDENCE | 722 556 --- 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.440N P=0.295 P=0.500N P=0.728 |
|POLY 3 | P=0.414N P=0.312 P=0.494N P=0.754 |
|POLY 1.5 | P=0.413N P=0.311 P=0.495N P=0.756 |
|POLY 6 | P=0.420N P=0.310 P=0.494N P=0.747 |
|LOGISTIC REGRESSION| P=0.416N P=0.303 P=0.497N P=0.730 |
|COCH-ARM / FISHERS | P=0.416N P=0.309 P=0.500N P=0.747 |
|ORDER RESTRICTED | P=0.277N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 3/50 (6%) 1/49 (2%) |
|POLY-3 RATE (b) | 3/43.57 5/43.65 3/44.15 1/41.45 |
|POLY-3 PERCENT (g) | 6.9% 11.5% 6.8% 2.4% |
|TERMINAL (d) | 1/29 (3%) 3/28 (11%) 3/29 (10%) 1/25 (4%) |
|FIRST INCIDENCE | 459 556 729 (T) 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.191N P=0.344 P=0.660N P=0.345N |
|POLY 3 | P=0.172N P=0.357 P=0.657N P=0.323N |
|POLY 1.5 | P=0.166N P=0.359 P=0.657N P=0.317N |
|POLY 6 | P=0.184N P=0.350 P=0.661N P=0.336N |
|LOGISTIC REGRESSION| P=0.163N P=0.348 P=0.659 P=0.318N |
|COCH-ARM / FISHERS | P=0.163N P=0.357 P=0.661N P=0.316N |
|ORDER RESTRICTED | P=0.173N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 1/50 (2%) 5/50 (10%) 3/49 (6%) |
|POLY-3 RATE (b) | 3/42.65 1/42.97 5/44.39 3/42.01 |
|POLY-3 PERCENT (g) | 7.0% 2.3% 11.3% 7.1% |
|TERMINAL (d) | 2/29 (7%) 1/28 (4%) 2/29 (7%) 2/26 (8%) |
|FIRST INCIDENCE | 722 729 (T) 697 686 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.372 P=0.325N P=0.360 P=0.612 |
|POLY 3 | P=0.411 P=0.302N P=0.378 P=0.656 |
|POLY 1.5 | P=0.416 P=0.299N P=0.376 P=0.660 |
|POLY 6 | P=0.401 P=0.308N P=0.378 P=0.646 |
|LOGISTIC REGRESSION| P=0.384 P=0.331N P=0.366 P=0.626 |
|COCH-ARM / FISHERS | P=0.417 P=0.301N P=0.369 P=0.661N |
|ORDER RESTRICTED | P=0.326 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 2/50 (4%) 6/50 (12%) 4/49 (8%) |
|POLY-3 RATE (b) | 3/42.65 2/43.20 6/44.62 4/42.23 |
|POLY-3 PERCENT (g) | 7.0% 4.6% 13.5% 9.5% |
|TERMINAL (d) | 2/29 (7%) 1/28 (4%) 2/29 (7%) 2/26 (8%) |
|FIRST INCIDENCE | 722 667 667 672 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.264 P=0.516N P=0.253 P=0.445 |
|POLY 3 | P=0.300 P=0.494N P=0.264 P=0.495 |
|POLY 1.5 | P=0.305 P=0.492N P=0.261 P=0.499 |
|POLY 6 | P=0.291 P=0.500N P=0.266 P=0.485 |
|LOGISTIC REGRESSION| P=0.291 P=0.506N P=0.256 P=0.474 |
|COCH-ARM / FISHERS | P=0.306 P=0.490N P=0.254 P=0.500 |
|ORDER RESTRICTED | P=0.282 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.62 2/43.14 3/44.15 0/42.45 |
|POLY-3 PERCENT (g) | 2.4% 4.6% 6.8% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/28 (4%) 3/29 (10%) 0/26 (0%) |
|FIRST INCIDENCE | 729 (T) 683 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.367N P=0.489 P=0.304 P=0.522N |
|POLY 3 | P=0.342N P=0.504 P=0.318 P=0.501N |
|POLY 1.5 | P=0.336N P=0.506 P=0.317 P=0.498N |
|POLY 6 | P=0.356N P=0.500 P=0.316 P=0.507N |
|LOGISTIC REGRESSION| P=0.359N P=0.497 P=0.304 (e) |
|COCH-ARM / FISHERS | P=0.332N P=0.508 P=0.316 P=0.495N |
|ORDER RESTRICTED | P=0.193N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.98 0/42.97 2/44.73 0/42.45 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/28 (0%) 1/29 (3%) 0/26 (0%) |
|FIRST INCIDENCE | 680 --- 548 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.474N P=0.505N P=0.504 P=0.522N |
|POLY 3 | P=0.465N P=0.500N P=0.514 P=0.503N |
|POLY 1.5 | P=0.462N P=0.499N P=0.510 P=0.500N |
|POLY 6 | P=0.472N P=0.504N P=0.514 P=0.509N |
|LOGISTIC REGRESSION| P=0.473N P=0.501N P=0.466 P=0.500N |
|COCH-ARM / FISHERS | P=0.461N P=0.500N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.328N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.98 1/42.97 2/44.73 0/42.45 |
|POLY-3 PERCENT (g) | 2.3% 2.3% 4.5% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/28 (4%) 1/29 (3%) 0/26 (0%) |
|FIRST INCIDENCE | 680 729 (T) 548 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.384N P=0.753 P=0.504 P=0.522N |
|POLY 3 | P=0.370N P=0.761 P=0.514 P=0.503N |
|POLY 1.5 | P=0.367N P=0.760N P=0.510 P=0.500N |
|POLY 6 | P=0.380N P=0.757 P=0.514 P=0.509N |
|LOGISTIC REGRESSION| P=0.370N P=0.762N P=0.466 P=0.500N |
|COCH-ARM / FISHERS | P=0.366N P=0.753N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.279N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/42.79 4/42.97 2/44.38 2/42.45 |
|POLY-3 PERCENT (g) | 2.3% 9.3% 4.5% 4.7% |
|TERMINAL (d) | 1/29 (3%) 4/28 (14%) 1/29 (3%) 2/26 (8%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 669 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.527 P=0.166 P=0.503 P=0.462 |
|POLY 3 | P=0.566 P=0.179 P=0.513 P=0.497 |
|POLY 1.5 | P=0.571 P=0.181 P=0.509 P=0.501 |
|POLY 6 | P=0.551 P=0.174 P=0.514 P=0.488 |
|LOGISTIC REGRESSION| P=0.535 P=0.166 P=0.510 P=0.462 |
|COCH-ARM / FISHERS | P=0.569 P=0.181 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.342 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/42.79 4/42.97 2/44.38 3/42.58 |
|POLY-3 PERCENT (g) | 4.7% 9.3% 4.5% 7.1% |
|TERMINAL (d) | 2/29 (7%) 4/28 (14%) 1/29 (3%) 2/26 (8%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 669 695 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.472 P=0.318 P=0.692N P=0.450 |
|POLY 3 | P=0.520 P=0.338 P=0.681N P=0.498 |
|POLY 1.5 | P=0.524 P=0.340 P=0.684N P=0.502 |
|POLY 6 | P=0.509 P=0.331 P=0.680N P=0.487 |
|LOGISTIC REGRESSION| P=0.488 P=0.318 P=0.685N P=0.458 |
|COCH-ARM / FISHERS | P=0.521 P=0.339 P=0.691N P=0.500 |
|ORDER RESTRICTED | P=0.517 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/42.79 4/42.97 2/44.38 3/42.58 |
|POLY-3 PERCENT (g) | 4.7% 9.3% 4.5% 7.1% |
|TERMINAL (d) | 2/29 (7%) 4/28 (14%) 1/29 (3%) 2/26 (8%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 669 695 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.472 P=0.318 P=0.692N P=0.450 |
|POLY 3 | P=0.520 P=0.338 P=0.681N P=0.498 |
|POLY 1.5 | P=0.524 P=0.340 P=0.684N P=0.502 |
|POLY 6 | P=0.509 P=0.331 P=0.680N P=0.487 |
|LOGISTIC REGRESSION| P=0.488 P=0.318 P=0.685N P=0.458 |
|COCH-ARM / FISHERS | P=0.521 P=0.339 P=0.691N P=0.500 |
|ORDER RESTRICTED | P=0.517 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 1/50 (2%) 4/50 (8%) 4/49 (8%) |
|POLY-3 RATE (b) | 3/42.67 1/42.97 4/44.16 4/42.02 |
|POLY-3 PERCENT (g) | 7.0% 2.3% 9.1% 9.5% |
|TERMINAL (d) | 2/29 (7%) 1/28 (4%) 3/29 (10%) 2/26 (8%) |
|FIRST INCIDENCE | 718 729 (T) 727 705 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.229 P=0.328N P=0.503 P=0.433 |
|POLY 3 | P=0.266 P=0.302N P=0.519 P=0.492 |
|POLY 1.5 | P=0.269 P=0.300N P=0.518 P=0.497 |
|POLY 6 | P=0.258 P=0.308N P=0.516 P=0.479 |
|LOGISTIC REGRESSION| P=0.229 P=0.329N P=0.502 P=0.452 |
|COCH-ARM / FISHERS | P=0.270 P=0.301N P=0.511 P=0.500 |
|ORDER RESTRICTED | P=0.305 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 22/49 (45%) 29/50 (58%) 28/50 (56%) 26/48 (54%) |
|POLY-3 RATE (b) | 22/44.57 29/46.34 28/47.16 26/44.23 |
|POLY-3 PERCENT (g) | 49.4% 62.6% 59.4% 58.8% |
|TERMINAL (d) | 13/29 (45%) 17/28 (61%) 17/29 (59%) 12/25 (48%) |
|FIRST INCIDENCE | 459 526 430 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.210 P=0.128 P=0.207 P=0.175 |
|POLY 3 | P=0.300 P=0.140 P=0.222 P=0.245 |
|POLY 1.5 | P=0.303 P=0.139 P=0.212 P=0.248 |
|POLY 6 | P=0.288 P=0.139 P=0.221 P=0.235 |
|LOGISTIC REGRESSION| P=0.293 P=0.139 P=0.199 P=0.240 |
|COCH-ARM / FISHERS | P=0.289 P=0.135 P=0.183 P=0.239 |
|ORDER RESTRICTED | P=0.234 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.82 0/42.97 1/44.15 1/42.45 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 2.3% 2.4% |
|TERMINAL (d) | 1/29 (3%) 0/28 (0%) 1/29 (3%) 1/26 (4%) |
|FIRST INCIDENCE | 722 --- 729 (T) 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.530N P=0.255N P=0.500N P=0.541N |
|POLY 3 | P=0.500N P=0.236N P=0.489N P=0.503N |
|POLY 1.5 | P=0.500N P=0.236N P=0.492N P=0.499N |
|POLY 6 | P=0.501N P=0.239N P=0.490N P=0.513N |
|LOGISTIC REGRESSION| P=0.531N P=0.251N P=0.498N P=0.544N |
|COCH-ARM / FISHERS | P=0.500N P=0.247N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.272N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/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) | 4/50 (8%) 1/50 (2%) 2/50 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 4/42.82 1/42.97 2/44.15 5/42.98 |
|POLY-3 PERCENT (g) | 9.3% 2.3% 4.5% 11.6% |
|TERMINAL (d) | 3/29 (10%) 1/28 (4%) 2/29 (7%) 3/26 (12%) |
|FIRST INCIDENCE | 722 729 (T) 729 (T) 642 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.231 P=0.195N P=0.337N P=0.437 |
|POLY 3 | P=0.274 P=0.177N P=0.323N P=0.502 |
|POLY 1.5 | P=0.275 P=0.176N P=0.326N P=0.505 |
|POLY 6 | P=0.271 P=0.181N P=0.323N P=0.492 |
|LOGISTIC REGRESSION| P=0.250 P=0.201N P=0.332N P=0.477 |
|COCH-ARM / FISHERS | P=0.273 P=0.181N P=0.339N P=0.500 |
|ORDER RESTRICTED | P=0.200 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 6/50 (12%) 8/50 (16%) 10/50 (20%) 6/50 (12%) |
|POLY-3 RATE (b) | 6/42.87 8/44.42 10/45.20 6/42.84 |
|POLY-3 PERCENT (g) | 14.0% 18.0% 22.1% 14.0% |
|TERMINAL (d) | 5/29 (17%) 5/28 (18%) 5/29 (17%) 3/26 (12%) |
|FIRST INCIDENCE | 709 526 642 686 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.501 P=0.366 P=0.214 P=0.541 |
|POLY 3 | P=0.534N P=0.413 P=0.238 P=0.621 |
|POLY 1.5 | P=0.526N P=0.406 P=0.227 P=0.617N |
|POLY 6 | P=0.553 P=0.416 P=0.248 P=0.608 |
|LOGISTIC REGRESSION| P=0.530N P=0.390 P=0.224 P=0.573 |
|COCH-ARM / FISHERS | P=0.527N P=0.387 P=0.207 P=0.620N |
|ORDER RESTRICTED | P=0.482 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 7/50 (14%) 9/50 (18%) 10/50 (20%) 7/50 (14%) |
|POLY-3 RATE (b) | 7/42.87 9/44.42 10/45.20 7/43.19 |
|POLY-3 PERCENT (g) | 16.3% 20.3% 22.1% 16.2% |
|TERMINAL (d) | 6/29 (21%) 6/28 (21%) 5/29 (17%) 3/26 (12%) |
|FIRST INCIDENCE | 709 526 642 633 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.509 P=0.369 P=0.302 P=0.535 |
|POLY 3 | P=0.511N P=0.422 P=0.338 P=0.609N |
|POLY 1.5 | P=0.507N P=0.413 P=0.324 P=0.606N |
|POLY 6 | P=0.524N P=0.424 P=0.351 P=0.611 |
|LOGISTIC REGRESSION| P=0.516N P=0.396 P=0.320 P=0.583 |
|COCH-ARM / FISHERS | P=0.513N P=0.393 P=0.298 P=0.613N |
|ORDER RESTRICTED | P=0.539N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/42.82 1/42.97 2/44.15 3/42.76 |
|POLY-3 PERCENT (g) | 7.0% 2.3% 4.5% 7.0% |
|TERMINAL (d) | 2/29 (7%) 1/28 (4%) 2/29 (7%) 2/26 (8%) |
|FIRST INCIDENCE | 722 729 (T) 729 (T) 642 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.434 P=0.325N P=0.500N P=0.613 |
|POLY 3 | P=0.477 P=0.304N P=0.486N P=0.662 |
|POLY 1.5 | P=0.479 P=0.303N P=0.489N P=0.660N |
|POLY 6 | P=0.471 P=0.308N P=0.487N P=0.653 |
|LOGISTIC REGRESSION| P=0.451 P=0.331N P=0.498N P=0.645 |
|COCH-ARM / FISHERS | P=0.477 P=0.309N P=0.500N P=0.661N |
|ORDER RESTRICTED | P=0.489 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 3/42.82 1/42.97 2/44.15 4/42.98 |
|POLY-3 PERCENT (g) | 7.0% 2.3% 4.5% 9.3% |
|TERMINAL (d) | 2/29 (7%) 1/28 (4%) 2/29 (7%) 2/26 (8%) |
|FIRST INCIDENCE | 722 729 (T) 729 (T) 642 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.253 P=0.325N P=0.500N P=0.446 |
|POLY 3 | P=0.293 P=0.304N P=0.486N P=0.502 |
|POLY 1.5 | P=0.294 P=0.303N P=0.489N P=0.504 |
|POLY 6 | P=0.290 P=0.308N P=0.487N P=0.493 |
|LOGISTIC REGRESSION| P=0.275 P=0.331N P=0.498N P=0.488 |
|COCH-ARM / FISHERS | P=0.292 P=0.309N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.281 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 3/42.82 1/42.97 2/44.15 4/42.98 |
|POLY-3 PERCENT (g) | 7.0% 2.3% 4.5% 9.3% |
|TERMINAL (d) | 2/29 (7%) 1/28 (4%) 2/29 (7%) 2/26 (8%) |
|FIRST INCIDENCE | 722 729 (T) 729 (T) 642 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.253 P=0.325N P=0.500N P=0.446 |
|POLY 3 | P=0.293 P=0.304N P=0.486N P=0.502 |
|POLY 1.5 | P=0.294 P=0.303N P=0.489N P=0.504 |
|POLY 6 | P=0.290 P=0.308N P=0.487N P=0.493 |
|LOGISTIC REGRESSION| P=0.275 P=0.331N P=0.498N P=0.488 |
|COCH-ARM / FISHERS | P=0.292 P=0.309N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.281 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 45/50 (90%) 47/50 (94%) 41/50 (82%) 47/50 (94%) |
|POLY-3 RATE (b) | 45/47.36 47/48.65 41/47.64 47/49.02 |
|POLY-3 PERCENT (g) | 95.0% 96.6% 86.1% 95.9% |
|TERMINAL (d) | 28/29 (97%) 28/28 (100%) 26/29 (90%) 25/26 (96%) |
|FIRST INCIDENCE | 405 498 526 448 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.240 P=0.343 P=0.294N P=0.212 |
|POLY 3 | P=0.538N P=0.559 P=0.102N P=0.629 |
|POLY 1.5 | P=0.565 P=0.469 P=0.124N P=0.518 |
|POLY 6 | P=0.494N P=0.647 P=0.100N P=0.728 |
|LOGISTIC REGRESSION| P=0.528 P=0.473 P=0.077N P=0.467 |
|COCH-ARM / FISHERS | P=0.437 P=0.357 P=0.194N P=0.357 |
|ORDER RESTRICTED | P=0.224N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/46 (17%) 6/48 (13%) 10/44 (23%) 7/42 (17%) |
|POLY-3 RATE (b) | 8/41.34 6/41.66 10/39.78 7/37.14 |
|POLY-3 PERCENT (g) | 19.4% 14.4% 25.1% 18.9% |
|TERMINAL (d) | 5/29 (17%) 5/28 (18%) 8/29 (28%) 7/26 (27%) |
|FIRST INCIDENCE | 526 624 709 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.487 P=0.401N P=0.400 P=0.579N |
|POLY 3 | P=0.462 P=0.379N P=0.360 P=0.591N |
|POLY 1.5 | P=0.467 P=0.366N P=0.362 P=0.581N |
|POLY 6 | P=0.447 P=0.403N P=0.350 P=0.612N |
|LOGISTIC REGRESSION| P=0.488 P=0.355N P=0.379 P=0.567N |
|COCH-ARM / FISHERS | P=0.465 P=0.354N P=0.356 P=0.577N |
|ORDER RESTRICTED | P=0.445 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/46 (2%) 1/48 (2%) 1/44 (2%) 4/42 (10%) |
|POLY-3 RATE (b) | 1/40.05 1/41.28 1/39.67 4/37.54 |
|POLY-3 PERCENT (g) | 2.5% 2.4% 2.5% 10.7% |
|TERMINAL (d) | 1/29 (3%) 1/28 (4%) 1/29 (3%) 2/26 (8%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 642 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.055 P=0.754 P=0.762 P=0.154 |
|POLY 3 | P=0.054 P=0.754N P=0.759 P=0.158 |
|POLY 1.5 | P=0.053 P=0.752N P=0.756 P=0.156 |
|POLY 6 | P=0.055 P=0.758N P=0.761 P=0.158 |
|LOGISTIC REGRESSION| P=0.054 P=0.754 P=0.762 P=0.156 |
|COCH-ARM / FISHERS | P=0.051 P=0.742N P=0.742 P=0.153 |
|ORDER RESTRICTED | P=0.059 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 9/46 (20%) 7/48 (15%) 11/44 (25%) 11/42 (26%) |
|POLY-3 RATE (b) | 9/41.34 7/41.66 11/39.78 11/37.54 |
|POLY-3 PERCENT (g) | 21.8% 16.8% 27.7% 29.3% |
|TERMINAL (d) | 6/29 (21%) 6/28 (21%) 9/29 (31%) 9/26 (35%) |
|FIRST INCIDENCE | 526 624 709 642 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.179 P=0.409N P=0.404 P=0.312 |
|POLY 3 | P=0.164 P=0.384N P=0.360 P=0.305 |
|POLY 1.5 | P=0.166 P=0.370N P=0.363 P=0.312 |
|POLY 6 | P=0.159 P=0.410N P=0.350 P=0.290 |
|LOGISTIC REGRESSION| P=0.178 P=0.360N P=0.385 P=0.324 |
|COCH-ARM / FISHERS | P=0.164 P=0.357N P=0.357 P=0.313 |
|ORDER RESTRICTED | P=0.237 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/46 (0%) 2/48 (4%) 0/44 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/40.05 2/41.36 0/39.67 0/37.14 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/28 (4%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- 709 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.425N P=0.226 (e) (e) |
|POLY 3 | P=0.423N P=0.244 (e) (e) |
|POLY 1.5 | P=0.423N P=0.246 (e) (e) |
|POLY 6 | P=0.424N P=0.240 (e) (e) |
|LOGISTIC REGRESSION| P=0.422N P=0.236 (e) (e) |
|COCH-ARM / FISHERS | P=0.427N P=0.258 (e) (e) |
|ORDER RESTRICTED | P=0.269N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/46 (0%) 2/48 (4%) 1/44 (2%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/40.05 2/41.36 1/39.67 0/37.14 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 2.5% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/28 (4%) 1/29 (3%) 0/26 (0%) |
|FIRST INCIDENCE | --- 709 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.486N P=0.226 P=0.500 (e) |
|POLY 3 | P=0.483N P=0.244 P=0.498 (e) |
|POLY 1.5 | P=0.484N P=0.246 P=0.496 (e) |
|POLY 6 | P=0.485N P=0.240 P=0.500 (e) |
|LOGISTIC REGRESSION| P=0.483N P=0.236 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.489N P=0.258 P=0.489 (e) |
|ORDER RESTRICTED | P=0.332 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 16/50 (32%) 18/50 (36%) 16/50 (32%) 15/50 (30%) |
|POLY-3 RATE (b) | 16/45.79 18/45.77 16/45.70 15/45.00 |
|POLY-3 PERCENT (g) | 34.9% 39.3% 35.0% 33.3% |
|TERMINAL (d) | 4/29 (14%) 7/28 (25%) 9/29 (31%) 7/26 (27%) |
|FIRST INCIDENCE | 479 405 561 616 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.501N P=0.385 P=0.568N P=0.558 |
|POLY 3 | P=0.413N P=0.413 P=0.584 P=0.524N |
|POLY 1.5 | P=0.397N P=0.424 P=0.579N P=0.507N |
|POLY 6 | P=0.446N P=0.386 P=0.556 P=0.560N |
|LOGISTIC REGRESSION| P=0.391N P=0.410 P=0.584 P=0.503N |
|COCH-ARM / FISHERS | P=0.389N P=0.417 P=0.585N P=0.500N |
|ORDER RESTRICTED | P=0.553N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/42.79 3/43.15 3/44.78 2/42.45 |
|POLY-3 PERCENT (g) | 7.0% 7.0% 6.7% 4.7% |
|TERMINAL (d) | 3/29 (10%) 2/28 (7%) 2/29 (7%) 2/26 (8%) |
|FIRST INCIDENCE | 729 (T) 681 526 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.438N P=0.650 P=0.658N P=0.551N |
|POLY 3 | P=0.399N P=0.659N P=0.642N P=0.504N |
|POLY 1.5 | P=0.396N P=0.658N P=0.648N P=0.499N |
|POLY 6 | P=0.410N P=0.663 P=0.639N P=0.516N |
|LOGISTIC REGRESSION| P=0.402N P=0.648 P=0.657N P=0.551N |
|COCH-ARM / FISHERS | P=0.397N P=0.661N P=0.661N P=0.500N |
|ORDER RESTRICTED | P=0.525N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/42.79 3/43.15 3/44.78 2/42.45 |
|POLY-3 PERCENT (g) | 7.0% 7.0% 6.7% 4.7% |
|TERMINAL (d) | 3/29 (10%) 2/28 (7%) 2/29 (7%) 2/26 (8%) |
|FIRST INCIDENCE | 729 (T) 681 526 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.438N P=0.650 P=0.658N P=0.551N |
|POLY 3 | P=0.399N P=0.659N P=0.642N P=0.504N |
|POLY 1.5 | P=0.396N P=0.658N P=0.648N P=0.499N |
|POLY 6 | P=0.410N P=0.663 P=0.639N P=0.516N |
|LOGISTIC REGRESSION| P=0.402N P=0.648 P=0.657N P=0.551N |
|COCH-ARM / FISHERS | P=0.397N P=0.661N P=0.661N P=0.500N |
|ORDER RESTRICTED | P=0.525N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 49/50 (98%) 49/50 (98%) 50/50 (100%) 49/50 (98%) |
|POLY-3 RATE (b) | 49/49.12 49/49.17 50/50.00 49/50.00 |
|POLY-3 PERCENT (g) | 99.8% 99.7% 100.0% 98.0% |
|TERMINAL (d) | 29/29 (100%) 28/28 (100%) 29/29 (100%) 25/26 (96%) |
|FIRST INCIDENCE | 405 498 430 448 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.287 P=0.474 P=0.526 P=0.318 |
|POLY 3 | P=0.275N P=1.000N P=1.000 P=0.549N |
|POLY 1.5 | P=0.422N P=0.956N P=0.974 P=0.629N |
|POLY 6 | P=0.211N P=1.000N P=1.000 P=0.509N |
|LOGISTIC REGRESSION| P=0.509N (e) (e) P=0.688N |
|COCH-ARM / FISHERS | P=0.616 P=0.753N P=0.500 P=0.753N |
|ORDER RESTRICTED | P=0.167N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 28/50 (56%) 27/50 (54%) 27/50 (54%) 27/50 (54%) |
|POLY-3 RATE (b) | 28/48.99 27/47.50 27/47.83 27/47.27 |
|POLY-3 PERCENT (g) | 57.2% 56.8% 56.5% 57.1% |
|TERMINAL (d) | 9/29 (31%) 11/28 (39%) 14/29 (48%) 12/26 (46%) |
|FIRST INCIDENCE | 354 405 526 485 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.458 P=0.546N P=0.484N P=0.496 |
|POLY 3 | P=0.538N P=0.569N P=0.554N P=0.581N |
|POLY 1.5 | P=0.511N P=0.541N P=0.531N P=0.548N |
|POLY 6 | P=0.502 P=0.560 P=0.577 P=0.542 |
|LOGISTIC REGRESSION| P=0.471N P=0.510N P=0.559N P=0.491N |
|COCH-ARM / FISHERS | P=0.471N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.732N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/15/03 EXPERIMENT: 96018 TEST: 03 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (BROMODICHL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) 49/50 (98%) |
|POLY-3 RATE (b) | 50/50.00 50/50.00 50/50.00 49/50.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 98.0% |
|TERMINAL (d) | 29/29 (100%) 28/28 (100%) 29/29 (100%) 25/26 (96%) |
|FIRST INCIDENCE | 354 405 430 448 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.355 (e) (e) P=0.375 |
|POLY 3 | P=0.199N (e) (e) P=0.500N |
|POLY 1.5 | P=0.199N (e) (e) P=0.500N |
|POLY 6 | P=0.199N (e) (e) P=0.500N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.198N (e) (e) P=0.500N |
|ORDER RESTRICTED | P=0.121N (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).