TDMS Study 96017-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID) DATE: 04/14/04
EXPERIMENT: 96017 TEST: 05 TIME: 09:21:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96017
PATHOLOGIST: HERSCHELL, GILES CAS: 631-64-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1 RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID) DATE: 04/14/04
EXPERIMENT: 96017 TEST: 05 TIME: 09:21:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96017
PATHOLOGIST: HERSCHELL, GILES CAS: 631-64-1
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
Islets, Pancreatic
Kidney
Liver
Lung
Pancreas
Parathyroid Gland
Pituitary Gland
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst WATER DISINFECTION BYPRODUCTS (DIBROMOACETIC ACID) DATE: 04/14/04
EXPERIMENT: 96017 TEST: 05 TIME: 09:21:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85420 ROUTE: DOSED WATER NTP C#: C96017
PATHOLOGIST: HERSCHELL, GILES CAS: 631-64-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF WATER DISINFECTION BYPRODUCTS (DIBROMOAC
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Mesothelioma: Benign, Malignant, NOS
Mesothelioma: Malignant
Benign Tumors
Malignant Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Clitoral/Preputial Gland Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Thyroid Gland: Follicular Cell Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 6/50 (12%) 8/49 (16%) 6/50 (12%) |1/49 (2%) 3/50 (6%) 2/50 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 7/42.66 6/42.27 8/39.97 6/41.42 |1/43.23 3/46.29 2/44.36 1/42.48 |
|POLY-3 PERCENT (g) | 16.4% 14.2% 20.0% 14.5% |2.3% 6.5% 4.5% 2.4% |
|TERMINAL (d) | 6/34 (18%) 1/24 (4%) 5/30 (17%) 3/28 (11%) |1/35 (3%) 2/39 (5%) 2/35 (6%) 1/32 (3%) |
|FIRST INCIDENCE | 711 618 560 624 |729 (T) 720 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.530 P=0.529 P=0.406 P=0.607 |P=0.441N P=0.348 P=0.500 P=0.742 |
|POLY 3 | P=0.549N P=0.507N P=0.445 P=0.523N |P=0.396N P=0.330 P=0.509 P=0.757 |
|POLY 1.5 | P=0.535N P=0.493N P=0.460 P=0.505N |P=0.391N P=0.323 P=0.509 P=0.759 |
|POLY 6 | P=0.538 P=0.532N P=0.430 P=0.547N |P=0.404N P=0.342 P=0.511 P=0.755 |
|LOGISTIC REGRESSION| P=0.541 P=0.544N P=0.415 P=0.546N |P=0.440N P=0.358 P=0.500 P=0.742 |
|COCH-ARM / FISHERS | P=0.510N P=0.484N P=0.500 P=0.484N |P=0.385N P=0.316 P=0.508 P=0.753N |
|ORDER RESTRICTED | P=0.601N (e) (e) (e) |P=0.481 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/42.59 2/42.35 0/39.19 1/40.64 |0/43.23 0/46.25 0/44.36 0/42.48 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 0.0% 2.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 437 --- 651 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.633N P=0.228 (e) P=0.478 |(e) (e) (e) (e) |
|POLY 3 | P=0.622N P=0.236 (e) P=0.491 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.614N P=0.240 (e) P=0.497 |(e) (e) (e) (e) |
|POLY 6 | P=0.633N P=0.227 (e) P=0.482 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.582N P=0.199 (e) P=0.510 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.604N P=0.253 (e) P=0.505 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.316 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 7/50 (14%) 8/49 (16%) 8/50 (16%) |1/49 (2%) 3/50 (6%) 2/50 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 7/42.66 7/43.05 8/39.97 8/41.71 |1/43.23 3/46.29 2/44.36 1/42.48 |
|POLY-3 PERCENT (g) | 16.4% 16.3% 20.0% 19.2% |2.3% 6.5% 4.5% 2.4% |
|TERMINAL (d) | 6/34 (18%) 1/24 (4%) 5/30 (17%) 4/28 (14%) |1/35 (3%) 2/39 (5%) 2/35 (6%) 1/32 (3%) |
|FIRST INCIDENCE | 711 437 560 624 |729 (T) 720 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.358 P=0.420 P=0.406 P=0.370 |P=0.441N P=0.348 P=0.500 P=0.742 |
|POLY 3 | P=0.371 P=0.607N P=0.445 P=0.481 |P=0.396N P=0.330 P=0.509 P=0.757 |
|POLY 1.5 | P=0.387 P=0.597N P=0.460 P=0.498 |P=0.391N P=0.323 P=0.509 P=0.759 |
|POLY 6 | P=0.358 P=0.603 P=0.430 P=0.460 |P=0.404N P=0.342 P=0.511 P=0.755 |
|LOGISTIC REGRESSION| P=0.381 P=0.610N P=0.415 P=0.456 |P=0.440N P=0.358 P=0.500 P=0.742 |
|COCH-ARM / FISHERS | P=0.416 P=0.597N P=0.500 P=0.517 |P=0.385N P=0.316 P=0.508 P=0.753N |
|ORDER RESTRICTED | P=0.546 (e) (e) (e) |P=0.481 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.13 0/41.42 2/40.20 0/40.35 |0/44.12 0/46.25 1/44.36 1/42.95 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 5.0% 0.0% |0.0% 0.0% 2.3% 2.3% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 1/30 (3%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 1/35 (3%) 1/32 (3%) |
|FIRST INCIDENCE | 433 --- 590 --- |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.568N P=0.496N P=0.465 P=0.508N |P=0.175 (e) P=0.500 P=0.482 |
|POLY 3 | P=0.567N P=0.513N P=0.468 P=0.518N |P=0.189 (e) P=0.501 P=0.495 |
|POLY 1.5 | P=0.560N P=0.506N P=0.478 P=0.510N |P=0.195 (e) P=0.501 P=0.497 |
|POLY 6 | P=0.574N P=0.523N P=0.458 P=0.528N |P=0.182 (e) P=0.502 P=0.491 |
|LOGISTIC REGRESSION| P=0.523N P=0.651N P=0.562 P=0.553N |(e) (e) P=0.500 P=0.482 |
|COCH-ARM / FISHERS | P=0.550N P=0.500N P=0.500 P=0.500N |P=0.202 (e) P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.323N (e) (e) (e) |P=0.246 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 8/50 (16%) 4/50 (8%) |8/50 (16%) 10/50 (20%) 5/48 (10%) 3/49 (6%) |
|POLY-3 RATE (b) | 3/43.34 5/41.62 8/39.85 4/41.16 |8/44.44 10/46.55 5/42.36 3/41.95 |
|POLY-3 PERCENT (g) | 6.9% 12.0% 20.1% 9.7% |18.0% 21.5% 11.8% 7.2% |
|TERMINAL (d) | 3/34 (9%) 4/24 (17%) 7/30 (23%) 2/28 (7%) |7/35 (20%) 8/39 (21%) 5/33 (15%) 3/31 (10%) |
|FIRST INCIDENCE | 729 (T) 679 700 610 |641 682 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.401 P=0.198 P=0.065 P=0.415 |P=0.050N P=0.505 P=0.309N P=0.136N |
|POLY 3 | P=0.403 P=0.333 P=0.072 P=0.472 |P=0.033N* P=0.439 P=0.306N P=0.116N |
|POLY 1.5 | P=0.419 P=0.347 P=0.080 P=0.485 |P=0.029N* P=0.423 P=0.303N P=0.111N |
|POLY 6 | P=0.386 P=0.311 P=0.064 P=0.455 |P=0.038N* P=0.470 P=0.306N P=0.123N |
|LOGISTIC REGRESSION| P=0.376 P=0.265 P=0.059 P=0.473 |P=0.042N* P=0.472 P=0.292N P=0.126N |
|COCH-ARM / FISHERS | P=0.442 P=0.357 P=0.100 P=0.500 |P=0.027N* P=0.398 P=0.304N P=0.106N |
|ORDER RESTRICTED | P=0.203 (e) (e) (e) |P=0.074N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 6/50 (12%) 1/48 (2%) 5/49 (10%) |
|POLY-3 RATE (b) | 0/43.34 0/41.42 0/39.73 0/40.35 |1/44.12 6/47.21 1/42.36 5/42.88 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 12.7% 2.4% 11.7% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |1/35 (3%) 4/39 (10%) 1/33 (3%) 2/31 (7%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 392 729 (T) 580 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.281 P=0.079 P=0.749 P=0.093 |
|POLY 3 | (e) (e) (e) (e) |P=0.335 P=0.068 P=0.752 P=0.094 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.339 P=0.063 P=0.752 P=0.095 |
|POLY 6 | (e) (e) (e) (e) |P=0.332 P=0.075 P=0.753 P=0.093 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.355 P=0.050 P=0.749 P=0.099 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.343 P=0.056 P=0.742 P=0.098 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.068 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 8/50 (16%) 4/50 (8%) |9/50 (18%) 15/50 (30%) 6/48 (13%) 8/49 (16%) |
|POLY-3 RATE (b) | 3/43.34 5/41.62 8/39.85 4/41.16 |9/44.44 15/47.51 6/42.36 8/42.88 |
|POLY-3 PERCENT (g) | 6.9% 12.0% 20.1% 9.7% |20.3% 31.6% 14.2% 18.7% |
|TERMINAL (d) | 3/34 (9%) 4/24 (17%) 7/30 (23%) 2/28 (7%) |8/35 (23%) 11/39 (28%) 6/33 (18%) 5/31 (16%) |
|FIRST INCIDENCE | 729 (T) 679 700 610 |641 392 729 (T) 580 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.401 P=0.198 P=0.065 P=0.415 |P=0.222N P=0.202 P=0.324N P=0.585N |
|POLY 3 | P=0.403 P=0.333 P=0.072 P=0.472 |P=0.143N P=0.158 P=0.321N P=0.533N |
|POLY 1.5 | P=0.419 P=0.347 P=0.080 P=0.485 |P=0.135N P=0.143 P=0.318N P=0.526N |
|POLY 6 | P=0.386 P=0.311 P=0.064 P=0.455 |P=0.155N P=0.185 P=0.321N P=0.539N |
|LOGISTIC REGRESSION| P=0.376 P=0.265 P=0.059 P=0.473 |P=0.150N P=0.134 P=0.304N P=0.548N |
|COCH-ARM / FISHERS | P=0.442 P=0.357 P=0.100 P=0.500 |P=0.126N P=0.121 P=0.318N P=0.518N |
|ORDER RESTRICTED | P=0.203 (e) (e) (e) |P=0.211N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/48 (10%) 3/50 (6%) 4/48 (8%) 1/50 (2%) |0/47 (0%) 0/49 (0%) 0/49 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 5/42.17 3/41.64 4/39.16 1/41.00 |0/41.84 0/45.91 0/43.63 0/41.81 |
|POLY-3 PERCENT (g) | 11.9% 7.2% 10.2% 2.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/34 (12%) 1/24 (4%) 3/30 (10%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 682 679 560 512 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.143N P=0.522N P=0.573N P=0.150N |(e) (e) (e) (e) |
|POLY 3 | P=0.130N P=0.363N P=0.547N P=0.107N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.125N P=0.346N P=0.533N P=0.099N |(e) (e) (e) (e) |
|POLY 6 | P=0.136N P=0.392N P=0.562N P=0.119N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.129N P=0.401N P=0.549N P=0.097N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.118N P=0.335N P=0.500N P=0.093N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.082N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/48 (10%) 3/50 (6%) 5/48 (10%) 1/50 (2%) |0/47 (0%) 0/49 (0%) 0/49 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 5/42.17 3/41.64 5/39.35 1/41.00 |0/41.84 0/45.91 0/43.63 0/41.81 |
|POLY-3 PERCENT (g) | 11.9% 7.2% 12.7% 2.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/34 (12%) 1/24 (4%) 3/30 (10%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 682 679 560 512 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.176N P=0.522N P=0.552 P=0.150N |(e) (e) (e) (e) |
|POLY 3 | P=0.157N P=0.363N P=0.587 P=0.107N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.151N P=0.346N P=0.599 P=0.099N |(e) (e) (e) (e) |
|POLY 6 | P=0.165N P=0.392N P=0.574 P=0.119N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.155N P=0.401N P=0.586 P=0.097N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.142N P=0.335N P=0.630N P=0.093N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.092N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.34 1/41.42 2/39.73 1/40.64 |2/44.12 0/46.25 0/44.36 1/42.95 |
|POLY-3 PERCENT (g) | 2.3% 2.4% 5.0% 2.5% |4.5% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 1/34 (3%) 1/24 (4%) 2/30 (7%) 0/28 (0%) |2/35 (6%) 0/39 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 651 |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.541 P=0.682 P=0.456 P=0.724 |P=0.590N P=0.215N P=0.238N P=0.531N |
|POLY 3 | P=0.539 P=0.751 P=0.470 P=0.746 |P=0.563N P=0.227N P=0.236N P=0.509N |
|POLY 1.5 | P=0.548 P=0.757 P=0.479 P=0.753 |P=0.558N P=0.231N P=0.236N P=0.505N |
|POLY 6 | P=0.529 P=0.741 P=0.459 P=0.737 |P=0.573N P=0.220N P=0.234N P=0.515N |
|LOGISTIC REGRESSION| P=0.531 P=0.682 P=0.456 P=0.756 |P=0.590N (e) (e) P=0.531N |
|COCH-ARM / FISHERS | P=0.561 P=0.753N P=0.500 P=0.753N |P=0.550N P=0.247N P=0.247N P=0.500N |
|ORDER RESTRICTED | P=0.551 (e) (e) (e) |P=0.135N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/43.34 1/41.42 3/39.73 1/40.64 |2/44.12 0/46.25 1/44.36 2/42.95 |
|POLY-3 PERCENT (g) | 2.3% 2.4% 7.6% 2.5% |4.5% 0.0% 2.3% 4.7% |
|TERMINAL (d) | 1/34 (3%) 1/24 (4%) 3/30 (10%) 0/28 (0%) |2/35 (6%) 0/39 (0%) 1/35 (3%) 2/32 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 651 |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.488 P=0.682 P=0.261 P=0.724 |P=0.313 P=0.215N P=0.500N P=0.663 |
|POLY 3 | P=0.485 P=0.751 P=0.274 P=0.746 |P=0.339 P=0.227N P=0.498N P=0.684 |
|POLY 1.5 | P=0.496 P=0.757 P=0.284 P=0.753 |P=0.349 P=0.231N P=0.498N P=0.689 |
|POLY 6 | P=0.473 P=0.741 P=0.263 P=0.737 |P=0.325 P=0.220N P=0.496N P=0.679 |
|LOGISTIC REGRESSION| P=0.474 P=0.682 P=0.261 P=0.756 |P=0.313 (e) P=0.500N P=0.663 |
|COCH-ARM / FISHERS | P=0.510 P=0.753N P=0.309 P=0.753N |P=0.363 P=0.247N P=0.500N P=0.691N |
|ORDER RESTRICTED | P=0.405 (e) (e) (e) |P=0.394 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/43.34 1/41.42 3/39.73 1/40.64 |2/44.12 0/46.25 1/44.36 2/42.95 |
|POLY-3 PERCENT (g) | 2.3% 2.4% 7.6% 2.5% |4.5% 0.0% 2.3% 4.7% |
|TERMINAL (d) | 1/34 (3%) 1/24 (4%) 3/30 (10%) 0/28 (0%) |2/35 (6%) 0/39 (0%) 1/35 (3%) 2/32 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 651 |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.488 P=0.682 P=0.261 P=0.724 |P=0.313 P=0.215N P=0.500N P=0.663 |
|POLY 3 | P=0.485 P=0.751 P=0.274 P=0.746 |P=0.339 P=0.227N P=0.498N P=0.684 |
|POLY 1.5 | P=0.496 P=0.757 P=0.284 P=0.753 |P=0.349 P=0.231N P=0.498N P=0.689 |
|POLY 6 | P=0.473 P=0.741 P=0.263 P=0.737 |P=0.325 P=0.220N P=0.496N P=0.679 |
|LOGISTIC REGRESSION| P=0.474 P=0.682 P=0.261 P=0.756 |P=0.313 (e) P=0.500N P=0.663 |
|COCH-ARM / FISHERS | P=0.510 P=0.753N P=0.309 P=0.753N |P=0.363 P=0.247N P=0.500N P=0.691N |
|ORDER RESTRICTED | P=0.405 (e) (e) (e) |P=0.394 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 4/50 (8%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/43.52 0/41.42 4/39.73 2/40.46 |1/44.12 1/46.25 2/44.36 3/42.95 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 10.1% 4.9% |2.3% 2.2% 4.5% 7.0% |
|TERMINAL (d) | 1/34 (3%) 0/24 (0%) 4/30 (13%) 1/28 (4%) |1/35 (3%) 1/39 (3%) 2/35 (6%) 3/32 (9%) |
|FIRST INCIDENCE | 682 --- 729 (T) 701 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.254 P=0.298N P=0.279 P=0.616 |P=0.112 P=0.738N P=0.500 P=0.273 |
|POLY 3 | P=0.257 P=0.248N P=0.295 P=0.668 |P=0.137 P=0.750N P=0.502 P=0.295 |
|POLY 1.5 | P=0.266 P=0.242N P=0.309 P=0.680 |P=0.143 P=0.754N P=0.502 P=0.300 |
|POLY 6 | P=0.247 P=0.259N P=0.280 P=0.651 |P=0.129 P=0.743N P=0.504 P=0.289 |
|LOGISTIC REGRESSION| P=0.241 P=0.249N P=0.276 P=0.660 |P=0.112 P=0.738N P=0.500 P=0.273 |
|COCH-ARM / FISHERS | P=0.281 P=0.247N P=0.339 P=0.691N |P=0.150 P=0.753N P=0.500 P=0.309 |
|ORDER RESTRICTED | P=0.211 (e) (e) (e) |P=0.203 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.34 1/41.71 1/39.73 0/40.35 |1/44.47 2/46.25 0/44.36 2/42.95 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 2.5% 0.0% |2.3% 4.3% 0.0% 4.7% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 1/30 (3%) 0/28 (0%) |0/35 (0%) 2/39 (5%) 0/35 (0%) 2/32 (6%) |
|FIRST INCIDENCE | --- 651 729 (T) --- |632 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.537N P=0.490 P=0.475 (e) |P=0.492 P=0.533 P=0.505N P=0.474 |
|POLY 3 | P=0.537N P=0.492 P=0.483 (e) |P=0.527 P=0.514 P=0.500N P=0.488 |
|POLY 1.5 | P=0.528N P=0.497 P=0.488 (e) |P=0.532 P=0.508 P=0.500N P=0.493 |
|POLY 6 | P=0.549N P=0.485 P=0.476 (e) |P=0.520 P=0.523 P=0.500N P=0.480 |
|LOGISTIC REGRESSION| P=0.526N P=0.500 P=0.475 (e) |P=0.523 P=0.500 P=0.517N P=0.496 |
|COCH-ARM / FISHERS | P=0.518N P=0.500 P=0.500 (e) |P=0.539 P=0.500 P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.391 (e) (e) (e) |P=0.394 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 5/50 (10%) 2/50 (4%) |2/50 (4%) 3/50 (6%) 2/50 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 2/43.52 1/41.71 5/39.73 2/40.46 |2/44.47 3/46.25 2/44.36 5/42.95 |
|POLY-3 PERCENT (g) | 4.6% 2.4% 12.6% 4.9% |4.5% 6.5% 4.5% 11.6% |
|TERMINAL (d) | 1/34 (3%) 0/24 (0%) 5/30 (17%) 1/28 (4%) |1/35 (3%) 3/39 (8%) 2/35 (6%) 5/32 (16%) |
|FIRST INCIDENCE | 682 651 729 (T) 701 |632 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.332 P=0.565N P=0.167 P=0.616 |P=0.127 P=0.545 P=0.691 P=0.185 |
|POLY 3 | P=0.331 P=0.515N P=0.180 P=0.668 |P=0.161 P=0.518 P=0.693 P=0.201 |
|POLY 1.5 | P=0.346 P=0.506N P=0.192 P=0.680 |P=0.169 P=0.511 P=0.693N P=0.209 |
|POLY 6 | P=0.313 P=0.530N P=0.166 P=0.651 |P=0.151 P=0.530 P=0.694 P=0.192 |
|LOGISTIC REGRESSION| P=0.323 P=0.503N P=0.163 P=0.660 |P=0.139 P=0.515 P=0.693N P=0.198 |
|COCH-ARM / FISHERS | P=0.366 P=0.500N P=0.218 P=0.691N |P=0.178 P=0.500 P=0.691N P=0.218 |
|ORDER RESTRICTED | P=0.247 (e) (e) (e) |P=0.145 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |3/50 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.34 0/41.42 1/39.73 1/40.35 |3/44.12 1/46.25 2/44.69 1/42.95 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.5% 2.5% |6.8% 2.2% 4.5% 2.3% |
|TERMINAL (d) | 1/34 (3%) 0/24 (0%) 1/30 (3%) 1/28 (4%) |3/35 (9%) 1/39 (3%) 1/35 (3%) 1/32 (3%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |729 (T) 729 (T) 640 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.438 P=0.569N P=0.734 P=0.718 |P=0.399N P=0.267N P=0.498N P=0.337N |
|POLY 3 | P=0.436 P=0.509N P=0.741 P=0.745 |P=0.371N P=0.289N P=0.494N P=0.315N |
|POLY 1.5 | P=0.441 P=0.504N P=0.747 P=0.752 |P=0.361N P=0.295N P=0.496N P=0.310N |
|POLY 6 | P=0.430 P=0.518N P=0.734 P=0.734 |P=0.389N P=0.277N P=0.489N P=0.320N |
|LOGISTIC REGRESSION| P=0.438 (e) P=0.734 P=0.718 |P=0.375N P=0.267N P=0.497N P=0.337N |
|COCH-ARM / FISHERS | P=0.450 P=0.500N P=0.753N P=0.753N |P=0.347N P=0.309N P=0.500N P=0.309N |
|ORDER RESTRICTED | P=0.513 (e) (e) (e) |P=0.230N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |3/50 (6%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.34 0/41.42 1/39.73 2/40.35 |3/44.12 2/46.25 2/44.69 1/42.95 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.5% 5.0% |6.8% 4.3% 4.5% 2.3% |
|TERMINAL (d) | 1/34 (3%) 0/24 (0%) 1/30 (3%) 2/28 (7%) |3/35 (9%) 2/39 (5%) 1/35 (3%) 1/32 (3%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |729 (T) 729 (T) 640 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.180 P=0.569N P=0.734 P=0.432 |P=0.299N P=0.450N P=0.498N P=0.337N |
|POLY 3 | P=0.180 P=0.509N P=0.741 P=0.475 |P=0.271N P=0.479N P=0.494N P=0.315N |
|POLY 1.5 | P=0.184 P=0.504N P=0.747 P=0.487 |P=0.263N P=0.487N P=0.496N P=0.310N |
|POLY 6 | P=0.176 P=0.518N P=0.734 P=0.459 |P=0.284N P=0.463N P=0.489N P=0.320N |
|LOGISTIC REGRESSION| P=0.180 (e) P=0.734 P=0.432 |P=0.279N P=0.450N P=0.497N P=0.337N |
|COCH-ARM / FISHERS | P=0.191 P=0.500N P=0.753N P=0.500 |P=0.251N P=0.500N P=0.500N P=0.309N |
|ORDER RESTRICTED | P=0.204 (e) (e) (e) |P=0.255N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 4/50 (8%) 5/50 (10%) |32/50 (64%) 33/50 (66%) 39/50 (78%) 36/50 (72%) |
|POLY-3 RATE (b) | 4/43.34 5/41.61 4/39.73 5/40.35 |32/45.65 33/47.34 39/46.55 36/44.88 |
|POLY-3 PERCENT (g) | 9.2% 12.0% 10.1% 12.4% |70.1% 69.7% 83.8% 80.2% |
|TERMINAL (d) | 4/34 (12%) 3/24 (13%) 4/30 (13%) 5/28 (18%) |27/35 (77%) 28/39 (72%) 31/35 (89%) 30/32 (94%) |
|FIRST INCIDENCE | 729 (T) 701 729 (T) 729 (T) |602 521 441 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.460 P=0.310 P=0.575 P=0.377 |P=0.016 * P=0.383N P=0.113 P=0.095 |
|POLY 3 | P=0.447 P=0.474 P=0.595 P=0.455 |P=0.061 P=0.576N P=0.079 P=0.175 |
|POLY 1.5 | P=0.466 P=0.490 P=0.611 P=0.476 |P=0.094 P=0.568 P=0.087 P=0.212 |
|POLY 6 | P=0.423 P=0.449 P=0.578 P=0.426 |P=0.030 * P=0.510N P=0.078 P=0.131 |
|LOGISTIC REGRESSION| P=0.426 P=0.387 P=0.575 P=0.377 |P=0.048 * P=0.511N P=0.072 P=0.145 |
|COCH-ARM / FISHERS | P=0.494 P=0.500 P=0.643N P=0.500 |P=0.156 P=0.500 P=0.093 P=0.260 |
|ORDER RESTRICTED | P=0.504 (e) (e) (e) |P=0.118 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 4/50 (8%) 6/50 (12%) |32/50 (64%) 33/50 (66%) 39/50 (78%) 36/50 (72%) |
|POLY-3 RATE (b) | 4/43.34 5/41.61 4/39.73 6/40.35 |32/45.65 33/47.34 39/46.55 36/44.88 |
|POLY-3 PERCENT (g) | 9.2% 12.0% 10.1% 14.9% |70.1% 69.7% 83.8% 80.2% |
|TERMINAL (d) | 4/34 (12%) 3/24 (13%) 4/30 (13%) 6/28 (21%) |27/35 (77%) 28/39 (72%) 31/35 (89%) 30/32 (94%) |
|FIRST INCIDENCE | 729 (T) 701 729 (T) 729 (T) |602 521 441 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.317 P=0.310 P=0.575 P=0.249 |P=0.016 * P=0.383N P=0.113 P=0.095 |
|POLY 3 | P=0.307 P=0.474 P=0.595 P=0.324 |P=0.061 P=0.576N P=0.079 P=0.175 |
|POLY 1.5 | P=0.326 P=0.490 P=0.611 P=0.346 |P=0.094 P=0.568 P=0.087 P=0.212 |
|POLY 6 | P=0.286 P=0.449 P=0.578 P=0.296 |P=0.030 * P=0.510N P=0.078 P=0.131 |
|LOGISTIC REGRESSION| P=0.285 P=0.387 P=0.575 P=0.249 |P=0.048 * P=0.511N P=0.072 P=0.145 |
|COCH-ARM / FISHERS | P=0.352 P=0.500 P=0.643N P=0.370 |P=0.156 P=0.500 P=0.093 P=0.260 |
|ORDER RESTRICTED | P=0.330 (e) (e) (e) |P=0.118 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 5/50 (10%) 7/50 (14%) |32/50 (64%) 34/50 (68%) 40/50 (80%) 36/50 (72%) |
|POLY-3 RATE (b) | 5/43.34 5/41.61 5/39.73 7/40.35 |32/45.65 34/47.34 40/46.87 36/44.88 |
|POLY-3 PERCENT (g) | 11.5% 12.0% 12.6% 17.4% |70.1% 71.8% 85.3% 80.2% |
|TERMINAL (d) | 5/34 (15%) 3/24 (13%) 5/30 (17%) 7/28 (25%) |27/35 (77%) 29/39 (74%) 31/35 (89%) 30/32 (94%) |
|FIRST INCIDENCE | 729 (T) 701 729 (T) 729 (T) |602 521 441 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.256 P=0.422 P=0.551 P=0.244 |P=0.020 * P=0.457N P=0.083 P=0.095 |
|POLY 3 | P=0.249 P=0.605 P=0.575 P=0.328 |P=0.073 P=0.519 P=0.052 P=0.175 |
|POLY 1.5 | P=0.267 P=0.620 P=0.593 P=0.352 |P=0.109 P=0.480 P=0.055 P=0.212 |
|POLY 6 | P=0.228 P=0.580 P=0.555 P=0.296 |P=0.038 * P=0.590 P=0.056 P=0.131 |
|LOGISTIC REGRESSION| P=0.225 P=0.511 P=0.551 P=0.244 |P=0.058 P=0.586 P=0.042 * P=0.145 |
|COCH-ARM / FISHERS | P=0.293 P=0.630N P=0.630N P=0.380 |P=0.175 P=0.417 P=0.059 P=0.260 |
|ORDER RESTRICTED | P=0.343 (e) (e) (e) |P=0.098 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.34 0/41.42 0/39.73 0/40.35 |0/44.12 1/46.25 0/44.36 2/43.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 0.0% 4.6% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 1/39 (3%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) --- 664 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.154 P=0.522 (e) P=0.230 |
|POLY 3 | (e) (e) (e) (e) |P=0.175 P=0.509 (e) P=0.232 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.177 P=0.506 (e) P=0.235 |
|POLY 6 | (e) (e) (e) (e) |P=0.173 P=0.516 (e) P=0.230 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.170 P=0.522 (e) P=0.235 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.179 P=0.500 (e) P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.072 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.34 0/41.42 1/40.15 0/40.35 |0/44.12 1/46.25 0/44.36 2/43.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.5% 0.0% |0.0% 2.2% 0.0% 4.6% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 1/39 (3%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | --- --- 607 --- |--- 729 (T) --- 664 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.619 (e) P=0.465 (e) |P=0.154 P=0.522 (e) P=0.230 |
|POLY 3 | P=0.614 (e) P=0.485 (e) |P=0.175 P=0.509 (e) P=0.232 |
|POLY 1.5 | P=0.624 (e) P=0.489 (e) |P=0.177 P=0.506 (e) P=0.235 |
|POLY 6 | P=0.601 (e) P=0.480 (e) |P=0.173 P=0.516 (e) P=0.230 |
|LOGISTIC REGRESSION| P=0.648 (e) P=0.526 (e) |P=0.170 P=0.522 (e) P=0.235 |
|COCH-ARM / FISHERS | P=0.634 (e) P=0.500 (e) |P=0.179 P=0.500 (e) P=0.247 |
|ORDER RESTRICTED | P=0.367 (e) (e) (e) |P=0.072 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/50 (4%) 2/48 (4%) 1/49 (2%) |0/47 (0%) 0/50 (0%) 0/49 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | 0/41.99 2/41.81 2/38.61 1/40.00 |0/41.84 0/46.25 0/43.63 1/41.81 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 5.2% 2.5% |0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 0/34 (0%) 1/24 (4%) 2/30 (7%) 1/28 (4%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | --- 618 729 (T) 729 (T) |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.521 P=0.197 P=0.211 P=0.461 |P=0.165 (e) (e) P=0.482 |
|POLY 3 | P=0.506 P=0.236 P=0.219 P=0.490 |P=0.177 (e) (e) P=0.500 |
|POLY 1.5 | P=0.522 P=0.242 P=0.224 P=0.497 |P=0.180 (e) (e) P=0.502 |
|POLY 6 | P=0.484 P=0.226 P=0.212 P=0.480 |P=0.174 (e) (e) P=0.497 |
|LOGISTIC REGRESSION| P=0.517 P=0.248 P=0.211 P=0.461 |(e) (e) (e) P=0.482 |
|COCH-ARM / FISHERS | P=0.538 P=0.258 P=0.247 P=0.505 |P=0.182 (e) (e) P=0.505 |
|ORDER RESTRICTED | P=0.216 (e) (e) (e) |P=0.120 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 21/49 (43%) 17/49 (35%) 8/50 (16%) |26/50 (52%) 30/50 (60%) 28/50 (56%) 22/49 (45%) |
|POLY-3 RATE (b) | 23/45.06 21/42.91 17/41.48 8/41.56 |26/46.51 30/47.54 28/45.71 22/44.19 |
|POLY-3 PERCENT (g) | 51.0% 48.9% 41.0% 19.3% |55.9% 63.1% 61.3% 49.8% |
|TERMINAL (d) | 16/34 (47%) 13/24 (54%) 11/30 (37%) 5/28 (18%) |20/35 (57%) 24/39 (62%) 22/35 (63%) 16/32 (50%) |
|FIRST INCIDENCE | 591 602 560 512 |519 509 622 602 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002N** P=0.300 P=0.330N P=0.011N* |P=0.362N P=0.496 P=0.435 P=0.411N |
|POLY 3 | P<0.001N** P=0.507N P=0.232N P<0.001N** |P=0.197N P=0.306 P=0.376 P=0.352N |
|POLY 1.5 | P<0.001N** P=0.474N P=0.215N P<0.001N** |P=0.173N P=0.295 P=0.399 P=0.332N |
|POLY 6 | P<0.001N** P=0.560N P=0.253N P=0.002N** |P=0.232N P=0.338 P=0.365 P=0.374N |
|LOGISTIC REGRESSION| P<0.001N** P=0.528N P=0.245N P=0.002N** |P=0.192N P=0.326 P=0.425 P=0.325N |
|COCH-ARM / FISHERS | P<0.001N** P=0.455N P=0.173N P<0.001N** |P=0.145N P=0.273 P=0.421 P=0.307N |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.249N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 21/49 (43%) 17/49 (35%) 8/50 (16%) |26/50 (52%) 31/50 (62%) 28/50 (56%) 23/49 (47%) |
|POLY-3 RATE (b) | 23/45.06 21/42.91 17/41.48 8/41.56 |26/46.51 31/47.54 28/45.71 23/44.52 |
|POLY-3 PERCENT (g) | 51.0% 48.9% 41.0% 19.3% |55.9% 65.2% 61.3% 51.7% |
|TERMINAL (d) | 16/34 (47%) 13/24 (54%) 11/30 (37%) 5/28 (18%) |20/35 (57%) 25/39 (64%) 22/35 (63%) 16/32 (50%) |
|FIRST INCIDENCE | 591 602 560 512 |519 509 622 602 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002N** P=0.300 P=0.330N P=0.011N* |P=0.401N P=0.427 P=0.435 P=0.485N |
|POLY 3 | P<0.001N** P=0.507N P=0.232N P<0.001N** |P=0.214N P=0.235 P=0.376 P=0.421N |
|POLY 1.5 | P<0.001N** P=0.474N P=0.215N P<0.001N** |P=0.194N P=0.226 P=0.399 P=0.404N |
|POLY 6 | P<0.001N** P=0.560N P=0.253N P=0.002N** |P=0.241N P=0.263 P=0.365 P=0.434N |
|LOGISTIC REGRESSION| P<0.001N** P=0.528N P=0.245N P=0.002N** |P=0.219N P=0.258 P=0.425 P=0.401N |
|COCH-ARM / FISHERS | P<0.001N** P=0.455N P=0.173N P<0.001N** |P=0.168N P=0.210 P=0.421 P=0.381N |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.293N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.34 1/41.42 0/39.73 0/40.35 |0/44.12 0/46.25 0/44.36 1/42.95 |
|POLY-3 PERCENT (g) | 4.6% 2.4% 0.0% 0.0% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 2/34 (6%) 1/24 (4%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.111N P=0.621N P=0.266N P=0.282N |P=0.165 (e) (e) P=0.482 |
|POLY 3 | P=0.110N P=0.516N P=0.257N P=0.253N |P=0.178 (e) (e) P=0.495 |
|POLY 1.5 | P=0.110N P=0.507N P=0.250N P=0.246N |P=0.181 (e) (e) P=0.497 |
|POLY 6 | P=0.110N P=0.531N P=0.264N P=0.264N |P=0.175 (e) (e) P=0.491 |
|LOGISTIC REGRESSION| P=0.111N P=0.621N (e) (e) |(e) (e) (e) P=0.482 |
|COCH-ARM / FISHERS | P=0.107N P=0.500N P=0.247N P=0.247N |P=0.184 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.085N (e) (e) (e) |P=0.115 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) 2/50 (4%) 5/50 (10%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 7/43.70 3/41.56 2/39.73 5/40.66 |1/44.12 1/46.25 1/44.36 2/43.13 |
|POLY-3 PERCENT (g) | 16.0% 7.2% 5.0% 12.3% |2.3% 2.2% 2.3% 4.6% |
|TERMINAL (d) | 6/34 (18%) 2/24 (8%) 2/30 (7%) 3/28 (11%) |1/35 (3%) 1/39 (3%) 1/35 (3%) 1/32 (3%) |
|FIRST INCIDENCE | 629 693 729 (T) 651 |729 (T) 729 (T) 729 (T) 682 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.490N P=0.305N P=0.116N P=0.508N |P=0.291 P=0.738N P=0.762 P=0.469 |
|POLY 3 | P=0.481N P=0.177N P=0.102N P=0.430N |P=0.327 P=0.750N P=0.760N P=0.492 |
|POLY 1.5 | P=0.472N P=0.166N P=0.094N P=0.406N |P=0.334 P=0.754N P=0.759N P=0.496 |
|POLY 6 | P=0.488N P=0.197N P=0.113N P=0.463N |P=0.317 P=0.743N P=0.758N P=0.488 |
|LOGISTIC REGRESSION| P=0.517N P=0.199N P=0.111N P=0.461N |P=0.309 P=0.738N P=0.762 P=0.486 |
|COCH-ARM / FISHERS | P=0.453N P=0.159N P=0.080N P=0.380N |P=0.342 P=0.753N P=0.753N P=0.500 |
|ORDER RESTRICTED | P=0.179N (e) (e) (e) |P=0.397 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/44.85 4/42.22 3/39.84 1/40.35 |1/44.12 0/46.25 0/44.36 0/42.95 |
|POLY-3 PERCENT (g) | 11.2% 9.5% 7.5% 2.5% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/34 (6%) 0/24 (0%) 2/30 (7%) 1/28 (4%) |1/35 (3%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 516 651 701 729 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.090N P=0.589N P=0.422N P=0.146N |P=0.386N P=0.478N P=0.500N P=0.518N |
|POLY 3 | P=0.086N P=0.538N P=0.423N P=0.127N |P=0.372N P=0.491N P=0.499N P=0.505N |
|POLY 1.5 | P=0.079N P=0.518N P=0.400N P=0.115N |P=0.370N P=0.494N P=0.499N P=0.503N |
|POLY 6 | P=0.097N P=0.566N P=0.449N P=0.145N |P=0.379N P=0.484N P=0.498N P=0.509N |
|LOGISTIC REGRESSION| P=0.070N P=0.497N P=0.353N P=0.095N |P=0.386N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.069N P=0.500N P=0.357N P=0.102N |P=0.366N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.101N (e) (e) (e) |P=0.125N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 6/50 (12%) 6/50 (12%) 4/50 (8%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/44.85 6/42.61 6/40.67 4/41.06 |1/44.12 0/46.25 0/44.36 0/42.95 |
|POLY-3 PERCENT (g) | 13.4% 14.1% 14.8% 9.7% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/34 (9%) 1/24 (4%) 4/30 (13%) 2/28 (7%) |1/35 (3%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 516 618 402 571 |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.349N P=0.496 P=0.542 P=0.473N |P=0.386N P=0.478N P=0.500N P=0.518N |
|POLY 3 | P=0.346N P=0.585 P=0.551 P=0.426N |P=0.372N P=0.491N P=0.499N P=0.505N |
|POLY 1.5 | P=0.324N P=0.604 P=0.575 P=0.400N |P=0.370N P=0.494N P=0.499N P=0.503N |
|POLY 6 | P=0.374N P=0.558 P=0.522 P=0.459N |P=0.379N P=0.484N P=0.498N P=0.509N |
|LOGISTIC REGRESSION| P=0.290N P=0.616N P=0.610N P=0.355N |P=0.386N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.293N P=0.620N P=0.620N P=0.370N |P=0.366N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.437N (e) (e) (e) |P=0.125N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.34 3/42.10 3/40.56 2/40.54 |0/44.12 0/46.25 0/44.36 0/42.95 |
|POLY-3 PERCENT (g) | 0.0% 7.1% 7.4% 4.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 1/24 (4%) 2/30 (7%) 1/28 (4%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 618 402 679 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.363 P=0.099 P=0.107 P=0.195 |(e) (e) (e) (e) |
|POLY 3 | P=0.357 P=0.113 P=0.107 P=0.222 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.374 P=0.117 P=0.111 P=0.229 |(e) (e) (e) (e) |
|POLY 6 | P=0.335 P=0.107 P=0.102 P=0.213 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.401 P=0.121 P=0.134 P=0.219 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.394 P=0.121 P=0.121 P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.126 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/43.34 3/42.10 3/40.56 3/41.06 |0/44.12 0/46.25 0/44.36 0/42.95 |
|POLY-3 PERCENT (g) | 2.3% 7.1% 7.4% 7.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/34 (3%) 1/24 (4%) 2/30 (7%) 1/28 (4%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) 618 402 571 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.307 P=0.240 P=0.272 P=0.249 |(e) (e) (e) (e) |
|POLY 3 | P=0.309 P=0.294 P=0.281 P=0.286 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.321 P=0.301 P=0.289 P=0.295 |(e) (e) (e) (e) |
|POLY 6 | P=0.295 P=0.283 P=0.272 P=0.274 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.345 P=0.304 P=0.318 P=0.303 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.337 P=0.309 P=0.309 P=0.309 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.260 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/43.34 1/41.56 1/39.73 2/40.64 |0/44.12 0/46.25 0/44.36 0/42.95 |
|POLY-3 PERCENT (g) | 6.9% 2.4% 2.5% 4.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/34 (9%) 0/24 (0%) 1/30 (3%) 1/28 (4%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) 693 729 (T) 651 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.562N P=0.417N P=0.350N P=0.582N |(e) (e) (e) (e) |
|POLY 3 | P=0.548N P=0.320N P=0.337N P=0.529N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.544N P=0.311N P=0.327N P=0.516N |(e) (e) (e) (e) |
|POLY 6 | P=0.551N P=0.335N P=0.348N P=0.547N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.570N P=0.354N P=0.350N P=0.553N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.533N P=0.309N P=0.309N P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.322N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.70 1/41.42 2/39.73 3/40.38 |1/44.12 1/46.25 1/44.36 1/43.13 |
|POLY-3 PERCENT (g) | 4.6% 2.4% 5.0% 7.4% |2.3% 2.2% 2.3% 2.3% |
|TERMINAL (d) | 1/34 (3%) 1/24 (4%) 2/30 (7%) 2/28 (7%) |1/35 (3%) 1/39 (3%) 1/35 (3%) 0/32 (0%) |
|FIRST INCIDENCE | 629 729 (T) 729 (T) 723 |729 (T) 729 (T) 729 (T) 682 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.249 P=0.589N P=0.640 P=0.425 |P=0.578 P=0.738N P=0.762 P=0.741 |
|POLY 3 | P=0.244 P=0.519N P=0.660 P=0.464 |P=0.605 P=0.750N P=0.760N P=0.756 |
|POLY 1.5 | P=0.253 P=0.508N P=0.671 P=0.481 |P=0.612 P=0.754N P=0.759N P=0.758 |
|POLY 6 | P=0.234 P=0.536N P=0.646 P=0.441 |P=0.594 P=0.743N P=0.758N P=0.753 |
|LOGISTIC REGRESSION| P=0.230 P=0.509N P=0.665 P=0.458 |P=0.600 P=0.738N P=0.762 P=0.758 |
|COCH-ARM / FISHERS | P=0.266 P=0.500N P=0.691N P=0.500 |P=0.623 P=0.753N P=0.753N P=0.753N |
|ORDER RESTRICTED | P=0.319 (e) (e) (e) |P=0.734 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 2/50 (4%) 5/50 (10%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/43.70 2/41.56 2/39.73 5/40.66 |1/44.12 1/46.25 1/44.36 1/43.13 |
|POLY-3 PERCENT (g) | 13.7% 4.8% 5.0% 12.3% |2.3% 2.2% 2.3% 2.3% |
|TERMINAL (d) | 5/34 (15%) 1/24 (4%) 2/30 (7%) 3/28 (11%) |1/35 (3%) 1/39 (3%) 1/35 (3%) 0/32 (0%) |
|FIRST INCIDENCE | 629 693 729 (T) 651 |729 (T) 729 (T) 729 (T) 682 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.455 P=0.246N P=0.182N P=0.620N |P=0.578 P=0.738N P=0.762 P=0.741 |
|POLY 3 | P=0.463 P=0.148N P=0.165N P=0.551N |P=0.605 P=0.750N P=0.760N P=0.756 |
|POLY 1.5 | P=0.472 P=0.139N P=0.154N P=0.527N |P=0.612 P=0.754N P=0.759N P=0.758 |
|POLY 6 | P=0.456 P=0.164N P=0.178N P=0.582N |P=0.594 P=0.743N P=0.758N P=0.753 |
|LOGISTIC REGRESSION| P=0.433 P=0.160N P=0.173N P=0.577N |P=0.600 P=0.738N P=0.762 P=0.758 |
|COCH-ARM / FISHERS | P=0.490 P=0.134N P=0.134N P=0.500N |P=0.623 P=0.753N P=0.753N P=0.753N |
|ORDER RESTRICTED | P=0.241N (e) (e) (e) |P=0.734 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 2/50 (4%) 5/50 (10%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/43.70 2/41.56 2/39.73 5/40.66 |1/44.12 1/46.25 1/44.36 1/43.13 |
|POLY-3 PERCENT (g) | 11.4% 4.8% 5.0% 12.3% |2.3% 2.2% 2.3% 2.3% |
|TERMINAL (d) | 4/34 (12%) 1/24 (4%) 2/30 (7%) 3/28 (11%) |1/35 (3%) 1/39 (3%) 1/35 (3%) 0/32 (0%) |
|FIRST INCIDENCE | 629 693 729 (T) 651 |729 (T) 729 (T) 729 (T) 682 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.353 P=0.343N P=0.275N P=0.517 |P=0.578 P=0.738N P=0.762 P=0.741 |
|POLY 3 | P=0.358 P=0.236N P=0.256N P=0.585 |P=0.605 P=0.750N P=0.760N P=0.756 |
|POLY 1.5 | P=0.367 P=0.225N P=0.242N P=0.606 |P=0.612 P=0.754N P=0.759N P=0.758 |
|POLY 6 | P=0.349 P=0.256N P=0.272N P=0.556 |P=0.594 P=0.743N P=0.758N P=0.753 |
|LOGISTIC REGRESSION| P=0.333 P=0.244N P=0.263N P=0.566 |P=0.600 P=0.738N P=0.762 P=0.758 |
|COCH-ARM / FISHERS | P=0.385 P=0.218N P=0.218N P=0.630N |P=0.623 P=0.753N P=0.753N P=0.753N |
|ORDER RESTRICTED | P=0.314 (e) (e) (e) |P=0.734 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 46/50 (92%) 41/49 (84%) 46/50 (92%) | |
|POLY-3 RATE (b) | 41/45.62 46/48.00 41/44.36 46/47.61 | |
|POLY-3 PERCENT (g) | 89.9% 95.8% 92.4% 96.6% | |
|TERMINAL (d) | 33/34 (97%) 24/24 (100%) 28/30 (93%) 27/28 (96%) | |
|FIRST INCIDENCE | 530 437 437 423 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199 P=0.003 ** P=0.194 P=0.017 * | |
|POLY 3 | P=0.228 P=0.194 P=0.475 P=0.149 | |
|POLY 1.5 | P=0.210 P=0.166 P=0.442 P=0.121 | |
|POLY 6 | P=0.330 P=0.227 P=0.560 P=0.240 | |
|LOGISTIC REGRESSION| P=0.084 P=0.055 P=0.191 P=0.023 * | |
|COCH-ARM / FISHERS | P=0.259 P=0.117 P=0.518 P=0.117 | |
|ORDER RESTRICTED | P=0.086 (e) (e) (e) | |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 5/49 (10%) 7/50 (14%) |6/50 (12%) 11/50 (22%) 5/50 (10%) 5/49 (10%) |
|POLY-3 RATE (b) | 6/43.34 5/42.84 5/39.30 7/40.35 |6/44.58 11/46.25 5/44.36 5/43.29 |
|POLY-3 PERCENT (g) | 13.8% 11.7% 12.7% 17.4% |13.5% 23.8% 11.3% 11.6% |
|TERMINAL (d) | 6/34 (18%) 2/24 (8%) 4/30 (13%) 7/28 (25%) |5/35 (14%) 11/39 (28%) 5/35 (14%) 2/32 (6%) |
|FIRST INCIDENCE | 729 (T) 471 701 729 (T) |595 729 (T) 729 (T) 602 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.341 P=0.563 P=0.590N P=0.348 |P=0.200N P=0.197 P=0.503N P=0.542N |
|POLY 3 | P=0.314 P=0.508N P=0.569N P=0.444 |P=0.149N P=0.160 P=0.503N P=0.521N |
|POLY 1.5 | P=0.336 P=0.499N P=0.552N P=0.471 |P=0.146N P=0.153 P=0.500N P=0.518N |
|POLY 6 | P=0.290 P=0.529N P=0.585N P=0.408 |P=0.153N P=0.174 P=0.503N P=0.521N |
|LOGISTIC REGRESSION| P=0.317 P=0.504N P=0.598N P=0.348 |P=0.167N P=0.190 P=0.491N P=0.516N |
|COCH-ARM / FISHERS | P=0.371 P=0.500N P=0.514N P=0.500 |P=0.142N P=0.143 P=0.500N P=0.514N |
|ORDER RESTRICTED | P=0.429 (e) (e) (e) |P=0.271N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/49 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/43.34 2/41.44 1/39.19 1/40.35 |0/44.12 1/46.25 0/44.36 0/42.28 |
|POLY-3 PERCENT (g) | 2.3% 4.8% 2.6% 2.5% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 1/34 (3%) 1/24 (4%) 1/30 (3%) 1/28 (4%) |0/35 (0%) 1/39 (3%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) 724 729 (T) 729 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.477N P=0.385 P=0.734 P=0.718 |P=0.435N P=0.522 (e) (e) |
|POLY 3 | P=0.485N P=0.484 P=0.738 P=0.745 |P=0.408N P=0.509 (e) (e) |
|POLY 1.5 | P=0.476N P=0.494 P=0.744 P=0.752 |P=0.411N P=0.506 (e) (e) |
|POLY 6 | P=0.496N P=0.469 P=0.732 P=0.734 |P=0.403N P=0.516 (e) (e) |
|LOGISTIC REGRESSION| P=0.486N P=0.413 P=0.734 P=0.718 |(e) P=0.522 (e) (e) |
|COCH-ARM / FISHERS | P=0.462N P=0.500 P=0.747 P=0.753N |P=0.417N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.606N (e) (e) (e) |P=0.396N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) 6/49 (12%) 8/50 (16%) |6/50 (12%) 12/50 (24%) 5/50 (10%) 5/49 (10%) |
|POLY-3 RATE (b) | 7/43.34 7/42.86 6/39.30 8/40.35 |6/44.58 12/46.25 5/44.36 5/43.29 |
|POLY-3 PERCENT (g) | 16.2% 16.3% 15.3% 19.8% |13.5% 25.9% 11.3% 11.6% |
|TERMINAL (d) | 7/34 (21%) 3/24 (13%) 5/30 (17%) 8/28 (29%) |5/35 (14%) 12/39 (31%) 5/35 (14%) 2/32 (6%) |
|FIRST INCIDENCE | 729 (T) 471 701 729 (T) |595 729 (T) 729 (T) 602 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.412 P=0.387 P=0.599N P=0.334 |P=0.161N P=0.138 P=0.503N P=0.542N |
|POLY 3 | P=0.378 P=0.606 P=0.576N P=0.439 |P=0.115N P=0.108 P=0.503N P=0.521N |
|POLY 1.5 | P=0.405 P=0.612N P=0.558N P=0.468 |P=0.112N P=0.103 P=0.500N P=0.518N |
|POLY 6 | P=0.349 P=0.584 P=0.594N P=0.400 |P=0.117N P=0.119 P=0.503N P=0.521N |
|LOGISTIC REGRESSION| P=0.375 P=0.598 P=0.608N P=0.334 |P=0.133N P=0.135 P=0.491N P=0.516N |
|COCH-ARM / FISHERS | P=0.447 P=0.613N P=0.516N P=0.500 |P=0.111N P=0.096 P=0.500N P=0.514N |
|ORDER RESTRICTED | P=0.499 (e) (e) (e) |P=0.218N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 1/43.34 0/41.42 1/39.19 2/40.56 |0/44.12 0/46.25 0/44.36 2/42.28 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.6% 4.9% |0.0% 0.0% 0.0% 4.7% |
|TERMINAL (d) | 1/34 (3%) 0/24 (0%) 1/30 (3%) 1/28 (4%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 2/32 (6%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 674 |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.175 P=0.569N P=0.734 P=0.432 |P=0.034 * (e) (e) P=0.219 |
|POLY 3 | P=0.181 P=0.509N P=0.738 P=0.477 |P=0.039 * (e) (e) P=0.228 |
|POLY 1.5 | P=0.185 P=0.504N P=0.744 P=0.488 |P=0.039 * (e) (e) P=0.230 |
|POLY 6 | P=0.178 P=0.518N P=0.732 P=0.463 |P=0.037 * (e) (e) P=0.225 |
|LOGISTIC REGRESSION| P=0.170 (e) P=0.734 P=0.464 |(e) (e) (e) P=0.219 |
|COCH-ARM / FISHERS | P=0.190 P=0.500N P=0.747 P=0.500 |P=0.042 * (e) (e) P=0.242 |
|ORDER RESTRICTED | P=0.206 (e) (e) (e) |P=0.026 * (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 1/43.34 0/41.42 1/39.19 2/40.56 |0/44.12 1/46.25 1/44.36 2/42.28 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.6% 4.9% |0.0% 2.2% 2.3% 4.7% |
|TERMINAL (d) | 1/34 (3%) 0/24 (0%) 1/30 (3%) 1/28 (4%) |0/35 (0%) 1/39 (3%) 1/35 (3%) 2/32 (6%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 674 |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.175 P=0.569N P=0.734 P=0.432 |P=0.141 P=0.522 P=0.500 P=0.219 |
|POLY 3 | P=0.181 P=0.509N P=0.738 P=0.477 |P=0.162 P=0.509 P=0.501 P=0.228 |
|POLY 1.5 | P=0.185 P=0.504N P=0.744 P=0.488 |P=0.166 P=0.506 P=0.501 P=0.230 |
|POLY 6 | P=0.178 P=0.518N P=0.732 P=0.463 |P=0.157 P=0.516 P=0.502 P=0.225 |
|LOGISTIC REGRESSION| P=0.170 (e) P=0.734 P=0.464 |(e) P=0.522 P=0.500 P=0.219 |
|COCH-ARM / FISHERS | P=0.190 P=0.500N P=0.747 P=0.500 |P=0.169 P=0.500 P=0.500 P=0.242 |
|ORDER RESTRICTED | P=0.206 (e) (e) (e) |P=0.110 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 10/50 (20%) 7/50 (14%) 5/50 (10%) |
|POLY-3 RATE (b) | |4/44.67 10/47.12 7/44.48 5/43.14 |
|POLY-3 PERCENT (g) | |9.0% 21.2% 15.7% 11.6% |
|TERMINAL (d) | |2/35 (6%) 8/39 (21%) 6/35 (17%) 4/32 (13%) |
|FIRST INCIDENCE | |602 521 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.444N P=0.113 P=0.267 P=0.449 |
|POLY 3 | |P=0.374N P=0.088 P=0.257 P=0.478 |
|POLY 1.5 | |P=0.355N P=0.082 P=0.261 P=0.488 |
|POLY 6 | |P=0.401N P=0.099 P=0.257 P=0.465 |
|LOGISTIC REGRESSION| |P=0.369N P=0.075 P=0.265 P=0.484 |
|COCH-ARM / FISHERS | |P=0.334N P=0.074 P=0.262 P=0.500 |
|ORDER RESTRICTED | |P=0.261 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 10/50 (20%) 8/50 (16%) 5/50 (10%) |
|POLY-3 RATE (b) | |4/44.67 10/47.12 8/45.11 5/43.14 |
|POLY-3 PERCENT (g) | |9.0% 21.2% 17.7% 11.6% |
|TERMINAL (d) | |2/35 (6%) 8/39 (21%) 6/35 (17%) 4/32 (13%) |
|FIRST INCIDENCE | |602 521 519 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.469N P=0.113 P=0.184 P=0.449 |
|POLY 3 | |P=0.400N P=0.088 P=0.180 P=0.478 |
|POLY 1.5 | |P=0.380N P=0.082 P=0.181 P=0.488 |
|POLY 6 | |P=0.429N P=0.099 P=0.182 P=0.465 |
|LOGISTIC REGRESSION| |P=0.376N P=0.075 P=0.179 P=0.484 |
|COCH-ARM / FISHERS | |P=0.357N P=0.074 P=0.178 P=0.500 |
|ORDER RESTRICTED | |P=0.235 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.34 0/41.42 0/39.73 1/40.35 |1/44.76 0/46.25 0/44.36 2/43.48 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.5% |2.2% 0.0% 0.0% 4.6% |
|TERMINAL (d) | 0/34 (0%) 0/24 (0%) 0/30 (0%) 1/28 (4%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |519 --- --- 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179 (e) (e) P=0.461 |P=0.188 P=0.504N P=0.508N P=0.501 |
|POLY 3 | P=0.177 (e) (e) P=0.486 |P=0.189 P=0.493N P=0.502N P=0.490 |
|POLY 1.5 | P=0.180 (e) (e) P=0.492 |P=0.193 P=0.496N P=0.501N P=0.494 |
|POLY 6 | P=0.174 (e) (e) P=0.477 |P=0.183 P=0.488N P=0.502N P=0.486 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.461 |P=0.214 P=0.600N P=0.581N P=0.502 |
|COCH-ARM / FISHERS | P=0.184 (e) (e) P=0.500 |P=0.199 P=0.500N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.108 (e) (e) (e) |P=0.123 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 23
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/43.34 0/41.42 0/39.73 2/40.35 |1/44.76 0/46.25 0/44.36 2/43.48 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 5.0% |2.2% 0.0% 0.0% 4.6% |
|TERMINAL (d) | 1/34 (3%) 0/24 (0%) 0/30 (0%) 2/28 (7%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 729 (T) |519 --- --- 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.189 P=0.569N P=0.525N P=0.432 |P=0.188 P=0.504N P=0.508N P=0.501 |
|POLY 3 | P=0.191 P=0.509N P=0.517N P=0.475 |P=0.189 P=0.493N P=0.502N P=0.490 |
|POLY 1.5 | P=0.193 P=0.504N P=0.512N P=0.487 |P=0.193 P=0.496N P=0.501N P=0.494 |
|POLY 6 | P=0.190 P=0.518N P=0.523N P=0.459 |P=0.183 P=0.488N P=0.502N P=0.486 |
|LOGISTIC REGRESSION| P=0.189 (e) (e) P=0.432 |P=0.214 P=0.600N P=0.581N P=0.502 |
|COCH-ARM / FISHERS | P=0.199 P=0.500N P=0.500N P=0.500 |P=0.199 P=0.500N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.116 (e) (e) (e) |P=0.123 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.73 0/41.42 1/40.23 0/40.35 |0/44.12 0/46.25 1/44.36 1/42.95 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 2.5% 0.0% |0.0% 0.0% 2.3% 2.3% |
|TERMINAL (d) | 1/34 (3%) 0/24 (0%) 0/30 (0%) 0/28 (0%) |0/35 (0%) 0/39 (0%) 1/35 (3%) 1/32 (3%) |
|FIRST INCIDENCE | 616 --- 578 --- |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.296N P=0.286N P=0.552N P=0.272N |P=0.175 (e) P=0.500 P=0.482 |
|POLY 3 | P=0.280N P=0.249N P=0.529N P=0.255N |P=0.189 (e) P=0.501 P=0.495 |
|POLY 1.5 | P=0.280N P=0.242N P=0.520N P=0.247N |P=0.195 (e) P=0.501 P=0.497 |
|POLY 6 | P=0.278N P=0.261N P=0.539N P=0.268N |P=0.182 (e) P=0.502 P=0.491 |
|LOGISTIC REGRESSION| P=0.265N P=0.236N P=0.480N P=0.236N |(e) (e) P=0.500 P=0.482 |
|COCH-ARM / FISHERS | P=0.276N P=0.247N P=0.500N P=0.247N |P=0.202 (e) P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.086N (e) (e) (e) |P=0.246 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 24
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 31/50 (62%) 24/50 (48%) 13/50 (26%) |11/50 (22%) 13/50 (26%) 16/50 (32%) 22/50 (44%) |
|POLY-3 RATE (b) | 17/45.90 31/46.84 24/42.73 13/42.99 |11/45.22 13/48.01 16/46.15 22/46.39 |
|POLY-3 PERCENT (g) | 37.0% 66.2% 56.2% 30.2% |24.3% 27.1% 34.7% 47.4% |
|TERMINAL (d) | 11/34 (32%) 15/24 (63%) 16/30 (53%) 5/28 (18%) |8/35 (23%) 8/39 (21%) 11/35 (31%) 12/32 (38%) |
|FIRST INCIDENCE | 437 446 423 386 |605 509 519 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.053N P<0.001 ** P=0.059 P=0.446N |P=0.004 ** P=0.521 P=0.202 P=0.017 * |
|POLY 3 | P=0.026N* P=0.003 ** P=0.051 P=0.325N |P=0.006 ** P=0.474 P=0.195 P=0.016 * |
|POLY 1.5 | P=0.019N* P=0.004 ** P=0.066 P=0.291N |P=0.007 ** P=0.448 P=0.192 P=0.016 * |
|POLY 6 | P=0.038N* P=0.002 ** P=0.040 * P=0.367N |P=0.006 ** P=0.512 P=0.205 P=0.017 * |
|LOGISTIC REGRESSION| P=0.017N* P=0.005 ** P=0.080 P=0.254N |P=0.008 ** P=0.398 P=0.186 P=0.017 * |
|COCH-ARM / FISHERS | P=0.015N* P=0.004 ** P=0.111 P=0.257N |P=0.008 ** P=0.408 P=0.184 P=0.016 * |
|ORDER RESTRICTED | P=0.015N* (e) (e) (e) |P=0.012 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 10/50 (20%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/43.80 1/41.42 0/39.73 10/44.35 |0/44.12 0/46.25 1/44.48 0/42.95 |
|POLY-3 PERCENT (g) | 6.9% 2.4% 0.0% 22.6% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 2/34 (6%) 1/24 (4%) 0/30 (0%) 2/28 (7%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 591 729 (T) --- 512 |--- --- 701 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.405N P=0.147N P=0.031 * |P=0.609 (e) P=0.505 (e) |
|POLY 3 | P<0.001 ** P=0.325N P=0.137N P=0.035 * |P=0.610 (e) P=0.502 (e) |
|POLY 1.5 | P<0.001 ** P=0.314N P=0.131N P=0.036 * |P=0.620 (e) P=0.501 (e) |
|POLY 6 | P<0.001 ** P=0.344N P=0.144N P=0.035 * |P=0.598 (e) P=0.503 (e) |
|LOGISTIC REGRESSION| P=0.002 ** P=0.312N P=0.125N P=0.044 * |P=0.631 (e) P=0.501 (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.309N P=0.121N P=0.036 * |P=0.634 (e) P=0.500 (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.382 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 25
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 10/50 (20%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/43.80 1/41.42 0/39.73 10/44.35 |0/44.12 0/46.25 1/44.48 0/42.95 |
|POLY-3 PERCENT (g) | 6.9% 2.4% 0.0% 22.6% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 2/34 (6%) 1/24 (4%) 0/30 (0%) 2/28 (7%) |0/35 (0%) 0/39 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 591 729 (T) --- 512 |--- --- 701 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.405N P=0.147N P=0.031 * |P=0.609 (e) P=0.505 (e) |
|POLY 3 | P<0.001 ** P=0.325N P=0.137N P=0.035 * |P=0.610 (e) P=0.502 (e) |
|POLY 1.5 | P<0.001 ** P=0.314N P=0.131N P=0.036 * |P=0.620 (e) P=0.501 (e) |
|POLY 6 | P<0.001 ** P=0.344N P=0.144N P=0.035 * |P=0.598 (e) P=0.503 (e) |
|LOGISTIC REGRESSION| P=0.002 ** P=0.312N P=0.125N P=0.044 * |P=0.631 (e) P=0.501 (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.309N P=0.121N P=0.036 * |P=0.634 (e) P=0.500 (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.382 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 48/50 (96%) 45/50 (90%) 48/50 (96%) |42/50 (84%) 47/50 (94%) 43/50 (86%) 43/50 (86%) |
|POLY-3 RATE (b) | 47/47.45 48/49.17 45/45.95 48/48.27 |42/47.70 47/48.52 43/46.55 43/46.42 |
|POLY-3 PERCENT (g) | 99.0% 97.6% 97.9% 99.5% |88.1% 96.9% 92.4% 92.6% |
|TERMINAL (d) | 34/34 (100%) 24/24 (100%) 30/30 (100%) 28/28 (100%)|32/35 (91%) 38/39 (97%) 35/35 (100%) 32/32 (100%) |
|FIRST INCIDENCE | 516 437 437 423 |519 509 441 566 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.320 P=0.025 * P=0.297 P=0.085 |P=0.168 P=0.559 P=0.516 P=0.258 |
|POLY 3 | P=0.456 P=0.630N P=0.761N P=0.987 |P=0.538 P=0.085 P=0.342 P=0.327 |
|POLY 1.5 | P=0.484 P=0.688N P=0.584N P=0.766 |P=0.484N P=0.092 P=0.442 P=0.408 |
|POLY 6 | P=0.517 P=0.685N P=0.991N P=1.000 |P=0.356 P=0.099 P=0.216 P=0.233 |
|LOGISTIC REGRESSION| P=0.287 P=0.608 P=0.756 P=0.270 |P=0.528N P=0.112 P=0.454 P=0.386 |
|COCH-ARM / FISHERS | P=0.559 P=0.500 P=0.357N P=0.500 |P=0.353N P=0.100 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.362 (e) (e) (e) |P=0.158 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 96017 TEST: 05 Page 26
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - WATER DISINFECTION BYPRODUCTS (DIBROMOAC
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 38/50 (76%) 35/50 (70%) 26/50 (52%) |16/50 (32%) 24/50 (48%) 20/50 (40%) 32/50 (64%) |
|POLY-3 RATE (b) | 29/49.14 38/48.48 35/46.32 26/48.25 |16/46.21 24/49.04 20/46.47 32/48.13 |
|POLY-3 PERCENT (g) | 59.0% 78.4% 75.6% 53.9% |34.6% 48.9% 43.0% 66.5% |
|TERMINAL (d) | 18/34 (53%) 17/24 (71%) 21/30 (70%) 8/28 (29%) |11/35 (31%) 17/39 (44%) 14/35 (40%) 17/32 (53%) |
|FIRST INCIDENCE | 222 437 253 356 |519 392 519 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.241N P=0.012 * P=0.085 P=0.517 |P=0.003 ** P=0.180 P=0.286 P=0.003 ** |
|POLY 3 | P=0.084N P=0.028 * P=0.062 P=0.380N |P=0.004 ** P=0.112 P=0.267 P<0.001 ** |
|POLY 1.5 | P=0.082N P=0.034 * P=0.080 P=0.369N |P=0.004 ** P=0.098 P=0.269 P<0.001 ** |
|POLY 6 | P=0.081N P=0.022 * P=0.048 * P=0.385N |P=0.005 ** P=0.135 P=0.275 P=0.002 ** |
|LOGISTIC REGRESSION| P=0.053N P=0.063 P=0.169 P=0.176N |P=0.006 ** P=0.067 P=0.268 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.075N P=0.044 * P=0.149 P=0.344N |P=0.005 ** P=0.076 P=0.266 P<0.001 ** |
|ORDER RESTRICTED | P=0.045N* (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 50 MG/L 500 MG/L 1000 |0 MG/L 50 MG/L 500 MG/L 1000 |
| | MG/L | MG/L |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 49/50 (98%) 50/50 (100%)|45/50 (90%) 49/50 (98%) 48/50 (96%) 49/50 (98%) |
|POLY-3 RATE (b) | 50/50.00 50/50.00 49/49.00 50/50.00 |45/48.47 49/50.00 48/48.54 49/49.04 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% |92.8% 98.0% 98.9% 99.9% |
|TERMINAL (d) | 34/34 (100%) 24/24 (100%) 30/30 (100%) 28/28 (100%)|33/35 (94%) 38/39 (97%) 35/35 (100%) 32/32 (100%) |
|FIRST INCIDENCE | 222 437 253 356 |519 392 441 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.340 (e) P=0.250 (e) |P=0.047 * P=0.514N P=0.368 P=0.130 |
|POLY 3 | P=1.000N (e) P=1.000N (e) |P=0.053 P=0.219 P=0.138 P=0.077 |
|POLY 1.5 | P=1.000N (e) P=1.000N (e) |P=0.072 P=0.184 P=0.182 P=0.076 |
|POLY 6 | P=1.000N (e) P=1.000N (e) |P=0.051 P=0.264 P=0.113 P=0.092 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.081 P=0.136 P=0.180 P=0.060 |
|COCH-ARM / FISHERS | P=0.634N (e) P=0.500N (e) |P=0.158 P=0.102 P=0.218 P=0.102 |
|ORDER RESTRICTED | P=0.379N (e) (e) (e) |P=0.011 * (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).