TDMS Study 97013-13 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (DICHLOROACETIC ACID) DATE: 01/27/05
EXPERIMENT: 97013 TEST: 13 TIME: 10:04:04
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: DOSED WATER NTP C#: 97013C
PATHOLOGIST: MISSING CAS: 79-43-6
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1/TGAC MICE
REASONS FOR REMOVAL: 25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/L
INCLUDE 002 0 MG/L
INCLUDE 003 500 MG/L
INCLUDE 004 500 MG/L
INCLUDE 005 1000MG/L
INCLUDE 006 1000MG/L
INCLUDE 007 2000MG/L
INCLUDE 008 2000MG/L
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (DICHLOROACETIC ACID) DATE: 01/27/05
EXPERIMENT: 97013 TEST: 13 TIME: 10:04:04
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: DOSED WATER NTP C#: 97013C
PATHOLOGIST: MISSING CAS: 79-43-6
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF WATER DISINFECTION MODEL (DICHLOROACET
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Kidney Nephropathy
Liver Inflammation Chronic
Liver: Hepatocyte Vacuolization Cytoplasmic
Lung Inflammation Chronic
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
Adrenal Cortex: Subcapsular Hyperplasia
Liver: Hepatocyte Necrosis
Vacuolization Cytoplasmic
Pituitary Gland: Pars Distalis Cyst
Skin: Epidermis Hyperplasia
Stomach, Forestomach: Epithelium Hyperkeratosis
===============================================================
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHL
OROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 1/15 (7%) 2/15 (13%) |2/15 (13%) 5/15 (33%) 4/15 (27%) 7/15 (47%) |
|POLY-3 RATE (b) | 1/14.05 0/13.10 1/13.54 2/14.38 |2/15.00 5/12.12 4/14.05 7/12.90 |
|POLY-3 PERCENT (g) | 7.1% 0.0% 7.4% 13.9% |13.3% 41.3% 28.5% 54.3% |
|TERMINAL (d) | 1/14 (7%) 0/13 (0%) 0/11 (0%) 2/14 (14%) |2/15 (13%) 3/8 (38%) 3/13 (23%) 5/10 (50%) |
|FIRST INCIDENCE | 176 (T) --- 141 176 (T) |177 (T) 36 127 115 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.254 P=0.515N P=0.742 P=0.500 |P=0.030 * P=0.062 P=0.272 P=0.018 * |
|POLY 3 | P=0.261 P=0.514N P=0.753 P=0.508 |P=0.026 * P=0.111 P=0.295 P=0.022 * |
|POLY 1.5 | P=0.261 P=0.511N P=0.760 P=0.510 |P=0.030 * P=0.138 P=0.301 P=0.026 * |
|POLY 6 | P=0.257 P=0.515N P=0.741 P=0.504 |P=0.023 * P=0.088 P=0.293 P=0.019 * |
|LOGISTIC REGRESSION| P=0.241 (e) P=0.765 P=0.500 |P=0.058 P=0.331 P=0.350 P=0.042 * |
|COCH-ARM / FISHERS | P=0.242 P=0.500N P=0.759N P=0.500 |P=0.053 P=0.195 P=0.326 P=0.054 |
|ORDER RESTRICTED | P=0.233 (e) (e) (e) |P=0.012 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/15 (53%) 9/15 (60%) 8/15 (53%) 8/15 (53%) |0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 8/14.05 9/13.10 8/13.06 8/14.38 |0/15.00 0/10.53 0/13.41 0/11.68 |
|POLY-3 PERCENT (g) | 57.0% 68.7% 61.3% 55.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 8/14 (57%) 9/13 (69%) 8/11 (73%) 8/14 (57%) |0/15 (0%) 0/8 (0%) 0/13 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 176 (T) 176 (T) 176 (T) 176 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.519N P=0.403 P=0.353 P=0.646 |(e) (e) (e) (e) |
|POLY 3 | P=0.469N P=0.409 P=0.564 P=0.618N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.463N P=0.427 P=0.619 P=0.612N |(e) (e) (e) (e) |
|POLY 6 | P=0.495N P=0.404 P=0.469 P=0.633N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.519N P=0.403 P=0.353 P=0.646 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.517N P=0.500 P=0.642N P=0.642N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.549N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 0/15 (0%) 2/15 (13%) 0/15 (0%) |10/15 (67%) 7/15 (47%) 3/15 (20%) 9/15 (60%) |
|POLY-3 RATE (b) | 2/14.05 0/13.10 2/13.06 0/14.38 |10/15.00 7/11.52 3/13.41 9/14.05 |
|POLY-3 PERCENT (g) | 14.2% 0.0% 15.3% 0.0% |66.7% 60.8% 22.4% 64.1% |
|TERMINAL (d) | 2/14 (14%) 0/13 (0%) 2/11 (18%) 0/14 (0%) |10/15 (67%) 5/8 (63%) 3/13 (23%) 5/10 (50%) |
|FIRST INCIDENCE | 176 (T) --- 176 (T) --- |177 (T) 131 177 (T) 66 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.250N P=0.252N P=0.610 P=0.236N |P=0.442 P=0.363 P=0.029N* P=0.336 |
|POLY 3 | P=0.223N P=0.247N P=0.673 P=0.226N |P=0.435N P=0.537N P=0.016N* P=0.593N |
|POLY 1.5 | P=0.224N P=0.244N P=0.690 P=0.225N |P=0.439N P=0.437N P=0.013N* P=0.575N |
|POLY 6 | P=0.226N P=0.248N P=0.644 P=0.229N |P=0.428N P=0.619N P=0.019N* P=0.597N |
|LOGISTIC REGRESSION| P=0.250N (e) P=0.610 (e) |P=0.523N P=0.621N P=0.029N* P=0.477N |
|COCH-ARM / FISHERS | P=0.242N P=0.241N P=0.701N P=0.241N |P=0.448N P=0.231N P=0.013N* P=0.500N |
|ORDER RESTRICTED | P=0.103N (e) (e) (e) |P=0.139N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 2/15 (13%) 2/15 (13%) 2/15 (13%) | |
|POLY-3 RATE (b) | 2/14.05 2/13.10 2/13.54 2/14.38 | |
|POLY-3 PERCENT (g) | 14.2% 15.3% 14.8% 13.9% | |
|TERMINAL (d) | 2/14 (14%) 2/13 (15%) 1/11 (9%) 2/14 (14%) | |
|FIRST INCIDENCE | 176 (T) 176 (T) 141 176 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.595N P=0.675 P=0.637 P=0.702 | |
|POLY 3 | P=0.582N P=0.674 P=0.686 P=0.691N | |
|POLY 1.5 | P=0.581N P=0.679 P=0.698 P=0.689N | |
|POLY 6 | P=0.590N P=0.672 P=0.666 P=0.695N | |
|LOGISTIC REGRESSION| P=0.586N P=0.675 P=0.704N P=0.702 | |
|COCH-ARM / FISHERS | P=0.601 P=0.701N P=0.701N P=0.701N | |
|ORDER RESTRICTED | P=0.720N (e) (e) (e) | |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/15 (67%) 9/15 (60%) 12/15 (80%) 14/15 (93%) |5/15 (33%) 6/15 (40%) 5/15 (33%) 7/15 (47%) |
|POLY-3 RATE (b) | 10/14.05 9/14.03 12/14.03 14/15.00 |5/15.00 6/12.71 5/14.37 7/14.05 |
|POLY-3 PERCENT (g) | 71.2% 64.1% 85.5% 93.3% |33.3% 47.2% 34.8% 49.8% |
|TERMINAL (d) | 10/14 (71%) 8/13 (62%) 10/11 (91%) 13/14 (93%) |5/15 (33%) 2/8 (25%) 4/13 (31%) 3/10 (30%) |
|FIRST INCIDENCE | 176 (T) 71 141 127 |177 (T) 36 63 66 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.046 * P=0.598N P=0.088 P=0.098 |P=0.209 P=0.174 P=0.553 P=0.169 |
|POLY 3 | P=0.046 * P=0.501N P=0.318 P=0.136 |P=0.287 P=0.365 P=0.616 P=0.304 |
|POLY 1.5 | P=0.043 * P=0.504N P=0.354 P=0.121 |P=0.290 P=0.410 P=0.628 P=0.314 |
|POLY 6 | P=0.043 * P=0.500N P=0.252 P=0.141 |P=0.289 P=0.332 P=0.605 P=0.301 |
|LOGISTIC REGRESSION| P=0.041 * P=0.555N P=0.230 P=0.104 |P=0.402 P=0.657 P=0.553N P=0.522 |
|COCH-ARM / FISHERS | P=0.031 * P=0.500N P=0.341 P=0.084 |P=0.311 P=0.500 P=0.650N P=0.355 |
|ORDER RESTRICTED | P=0.058 (e) (e) (e) |P=0.292 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |3/15 (20%) 1/15 (7%) 1/15 (7%) 0/15 (0%) |
|POLY-3 RATE (b) | 1/14.05 0/13.10 0/13.06 2/15.00 |3/15.00 1/10.53 1/13.41 0/11.68 |
|POLY-3 PERCENT (g) | 7.1% 0.0% 0.0% 13.3% |20.0% 9.5% 7.5% 0.0% |
|TERMINAL (d) | 1/14 (7%) 0/13 (0%) 0/11 (0%) 1/14 (7%) |3/15 (20%) 1/8 (13%) 1/13 (8%) 0/10 (0%) |
|FIRST INCIDENCE | 176 (T) --- --- 127 |177 (T) 177 (T) 177 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.258 P=0.515N P=0.548N P=0.508 |P=0.100N P=0.549N P=0.352N P=0.194N |
|POLY 3 | P=0.259 P=0.514N P=0.515N P=0.523 |P=0.072N P=0.438N P=0.341N P=0.158N |
|POLY 1.5 | P=0.256 P=0.511N P=0.505N P=0.519 |P=0.070N P=0.390N P=0.329N P=0.141N |
|POLY 6 | P=0.259 P=0.515N P=0.530N P=0.524 |P=0.075N P=0.485N P=0.349N P=0.174N |
|LOGISTIC REGRESSION| P=0.216 (e) (e) P=0.453 |P=0.100N P=0.549N P=0.352N (e) |
|COCH-ARM / FISHERS | P=0.242 P=0.500N P=0.500N P=0.500 |P=0.067N P=0.299N P=0.299N P=0.112N |
|ORDER RESTRICTED | P=0.146 (e) (e) (e) |P=0.061N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 3/15 (20%) 2/15 (13%) 1/15 (7%) |2/15 (13%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/14.05 3/14.07 2/13.06 1/15.00 |2/15.00 0/10.53 0/13.41 0/11.68 |
|POLY-3 PERCENT (g) | 0.0% 21.3% 15.3% 6.7% |13.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 2/13 (15%) 2/11 (18%) 0/14 (0%) |2/15 (13%) 0/8 (0%) 0/13 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- 57 176 (T) 127 |177 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.561 P=0.112 P=0.183 P=0.514 |P=0.142N P=0.383N P=0.268N P=0.329N |
|POLY 3 | P=0.598 P=0.105 P=0.214 P=0.513 |P=0.085N P=0.320N P=0.258N P=0.293N |
|POLY 1.5 | P=0.590 P=0.106 P=0.225 P=0.511 |P=0.090N P=0.289N P=0.251N P=0.274N |
|POLY 6 | P=0.600 P=0.105 P=0.197 P=0.514 |P=0.081N P=0.352N P=0.263N P=0.309N |
|LOGISTIC REGRESSION| P=0.461 P=0.134 P=0.183 P=0.346 |P=0.142N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.558 P=0.112 P=0.241 P=0.500 |P=0.112N P=0.241N P=0.241N P=0.241N |
|ORDER RESTRICTED | P=0.159 (e) (e) (e) |P=0.051N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/15 (60%) 13/15 (87%) 12/15 (80%) 11/15 (73%) |14/15 (93%) 10/15 (67%) 12/15 (80%) 12/15 (80%) |
|POLY-3 RATE (b) | 9/15.00 13/14.07 12/15.00 11/14.38 |14/15.00 10/11.13 12/14.05 12/13.33 |
|POLY-3 PERCENT (g) | 60.0% 92.4% 80.0% 76.5% |93.3% 89.9% 85.4% 90.1% |
|TERMINAL (d) | 8/14 (57%) 12/13 (92%) 8/11 (73%) 11/14 (79%) |14/15 (93%) 8/8 (100%) 11/13 (85%) 9/10 (90%) |
|FIRST INCIDENCE | 64 57 141 176 (T) |177 (T) 150 127 66 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.423 P=0.082 P=0.121 P=0.356 |P=0.231 P=0.100 P=0.664N P=0.197 |
|POLY 3 | P=0.335 P=0.047 * P=0.215 P=0.288 |P=0.482N P=0.681N P=0.466N P=0.646N |
|POLY 1.5 | P=0.365 P=0.056 P=0.215 P=0.312 |P=0.450N P=0.364N P=0.430N P=0.534N |
|POLY 6 | P=0.302 P=0.045 * P=0.215 P=0.265 |P=0.497N P=0.715 P=0.475N P=0.709N |
|LOGISTIC REGRESSION| P=0.410 P=0.102 (e) P=0.346 |P=0.447 P=0.476 P=0.502N P=0.642N |
|COCH-ARM / FISHERS | P=0.401 P=0.107 P=0.213 P=0.350 |P=0.414N P=0.084N P=0.299N P=0.299N |
|ORDER RESTRICTED | P=0.102 (e) (e) (e) |P=0.464N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 3/15 (20%) 1/15 (7%) 0/15 (0%) |2/15 (13%) 3/15 (20%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/14.05 3/13.10 1/13.06 0/14.38 |2/15.00 3/11.52 0/13.41 0/11.68 |
|POLY-3 PERCENT (g) | 0.0% 22.9% 7.7% 0.0% |13.3% 26.1% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 3/13 (23%) 1/11 (9%) 0/14 (0%) |2/15 (13%) 1/8 (13%) 0/13 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- 176 (T) 176 (T) --- |177 (T) 131 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.368N P=0.102 P=0.452 (e) |P=0.104N P=0.273 P=0.268N P=0.329N |
|POLY 3 | P=0.360N P=0.092 P=0.485 (e) |P=0.087N P=0.376 P=0.258N P=0.293N |
|POLY 1.5 | P=0.356N P=0.095 P=0.495 (e) |P=0.079N P=0.411 P=0.251N P=0.274N |
|POLY 6 | P=0.368N P=0.092 P=0.470 (e) |P=0.094N P=0.348 P=0.263N P=0.309N |
|LOGISTIC REGRESSION| (e) P=0.102 P=0.452 (e) |P=0.066N P=0.503 (e) (e) |
|COCH-ARM / FISHERS | P=0.363N P=0.112 P=0.500 (e) |P=0.067N P=0.500 P=0.241N P=0.241N |
|ORDER RESTRICTED | P=0.183N (e) (e) (e) |P=0.070N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 0/15 (0%) |1/15 (7%) 5/15 (33%) 1/15 (7%) 3/15 (20%) |
|POLY-3 RATE (b) | 0/14.05 1/13.10 1/13.06 0/14.38 |1/15.00 5/11.91 1/14.37 3/11.68 |
|POLY-3 PERCENT (g) | 0.0% 7.6% 7.7% 0.0% |6.7% 42.0% 7.0% 25.7% |
|TERMINAL (d) | 0/14 (0%) 1/13 (8%) 1/11 (9%) 0/14 (0%) |1/15 (7%) 3/8 (38%) 0/13 (0%) 3/10 (30%) |
|FIRST INCIDENCE | --- 176 (T) 176 (T) --- |177 (T) 36 63 177 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.592N P=0.485 P=0.452 (e) |P=0.360 P=0.025 * P=0.745 P=0.163 |
|POLY 3 | P=0.591N P=0.486 P=0.485 (e) |P=0.315 P=0.036 * P=0.751 P=0.210 |
|POLY 1.5 | P=0.589N P=0.489 P=0.495 (e) |P=0.355 P=0.049 * P=0.755 P=0.234 |
|POLY 6 | P=0.596N P=0.485 P=0.470 (e) |P=0.283 P=0.027 * P=0.747 P=0.191 |
|LOGISTIC REGRESSION| (e) P=0.485 P=0.452 (e) |P=0.532 P=0.148 P=0.464N P=0.163 |
|COCH-ARM / FISHERS | P=0.596N P=0.500 P=0.500 (e) |P=0.453 P=0.084 P=0.759N P=0.299 |
|ORDER RESTRICTED | P=0.380N (e) (e) (e) |P=0.156 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/15 (47%) 13/15 (87%) 15/15 (100%) 15/15 (100%)|6/15 (40%) 10/15 (67%) 14/15 (93%) 14/15 (93%) |
|POLY-3 RATE (b) | 7/14.05 13/13.10 15/15.00 15/15.00 |6/15.00 10/11.73 14/14.05 14/14.05 |
|POLY-3 PERCENT (g) | 49.8% 99.2% 100.0% 100.0% |40.0% 85.3% 99.7% 99.6% |
|TERMINAL (d) | 7/14 (50%) 13/13 (100%) 11/11 (100%) 14/14 (100%)|6/15 (40%) 8/8 (100%) 13/13 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 176 (T) 176 (T) 141 127 |177 (T) 36 127 66 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.007 ** P<0.001 ** P=0.003 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.042 * P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.007 ** P=0.002 ** P=0.002 ** |P<0.001 ** P=0.045 * P<0.001 ** P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.025 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.136 P=0.003 ** P=0.003 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 4/15 (27%) 2/15 (13%) 1/15 (7%) |0/15 (0%) 1/15 (7%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/14.05 4/13.10 2/13.54 1/14.38 |0/15.00 1/10.53 0/13.41 0/11.68 |
|POLY-3 PERCENT (g) | 0.0% 30.5% 14.8% 7.0% |0.0% 9.5% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 4/13 (31%) 1/11 (9%) 1/14 (7%) |0/15 (0%) 1/8 (13%) 0/13 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- 176 (T) 141 176 (T) |--- 177 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.575N P=0.047 * P=0.220 P=0.500 |P=0.604N P=0.375 (e) (e) |
|POLY 3 | P=0.576N P=0.036 * P=0.222 P=0.505 |P=0.613N P=0.431 (e) (e) |
|POLY 1.5 | P=0.571N P=0.037 * P=0.230 P=0.505 |P=0.601N P=0.453 (e) (e) |
|POLY 6 | P=0.586N P=0.036 * P=0.210 P=0.502 |P=0.623N P=0.409 (e) (e) |
|LOGISTIC REGRESSION| P=0.568N P=0.047 * P=0.223 P=0.500 |(e) P=0.375 (e) (e) |
|COCH-ARM / FISHERS | P=0.581N P=0.050 P=0.241 P=0.500 |P=0.568N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.119 (e) (e) (e) |P=0.371N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 3/14 (21%) 2/15 (13%) 0/14 (0%) |3/15 (20%) 2/14 (14%) 3/15 (20%) 2/15 (13%) |
|POLY-3 RATE (b) | 1/15.00 3/12.10 2/13.54 0/14.00 |3/15.00 2/10.73 3/14.05 2/12.38 |
|POLY-3 PERCENT (g) | 6.7% 24.8% 14.8% 0.0% |20.0% 18.7% 21.4% 16.2% |
|TERMINAL (d) | 0/14 (0%) 3/12 (25%) 1/11 (9%) 0/14 (0%) |3/15 (20%) 1/8 (13%) 2/13 (15%) 0/10 (0%) |
|FIRST INCIDENCE | 64 176 (T) 141 --- |177 (T) 164 127 141 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.239N P=0.257 P=0.480 P=0.500N |P=0.562N P=0.604 P=0.605 P=0.657N |
|POLY 3 | P=0.248N P=0.221 P=0.464 P=0.514N |P=0.501N P=0.655N P=0.639 P=0.590N |
|POLY 1.5 | P=0.247N P=0.230 P=0.479 P=0.514N |P=0.489N P=0.610N P=0.645 P=0.568N |
|POLY 6 | P=0.249N P=0.219 P=0.444 P=0.514N |P=0.503N P=0.672 P=0.637 P=0.601N |
|LOGISTIC REGRESSION| P=0.317N P=0.309 P=0.490 (e) |P=0.462N P=0.701 P=0.650N P=0.517N |
|COCH-ARM / FISHERS | P=0.246N P=0.272 P=0.500 P=0.517N |P=0.442N P=0.535N P=0.674N P=0.500N |
|ORDER RESTRICTED | P=0.146N (e) (e) (e) |P=0.619N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 1/1 (100%) 2/2 (100%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 1/1.00 1/1.00 2/2.00 0/0.00 |0/0.00 0/0.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/1 (100%) 1/1 (100%) 2/2 (100%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 176 (T) 176 (T) 176 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 1/1 (100%) 2/2 (100%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 1/1.00 1/1.00 2/2.00 0/0.00 |0/0.00 0/0.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/1 (100%) 1/1 (100%) 2/2 (100%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 176 (T) 176 (T) 176 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 1/1 (100%) 2/2 (100%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 1/1.00 1/1.00 2/2.00 0/0.00 |0/0.00 0/0.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/1 (100%) 1/1 (100%) 2/2 (100%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 176 (T) 176 (T) 176 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/15 (7%) 1/15 (7%) 1/15 (7%) 2/15 (13%) |
|POLY-3 RATE (b) | |1/15.00 1/10.53 1/13.41 2/11.68 |
|POLY-3 PERCENT (g) | |6.7% 9.5% 7.5% 17.1% |
|TERMINAL (d) | |1/15 (7%) 1/8 (13%) 1/13 (8%) 2/10 (20%) |
|FIRST INCIDENCE | |177 (T) 177 (T) 177 (T) 177 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.268 P=0.617 P=0.732 P=0.356 |
|POLY 3 | |P=0.293 P=0.676 P=0.735 P=0.412 |
|POLY 1.5 | |P=0.311 P=0.706 P=0.742 P=0.438 |
|POLY 6 | |P=0.278 P=0.646 P=0.730 P=0.391 |
|LOGISTIC REGRESSION| |P=0.268 P=0.617 P=0.732 P=0.356 |
|COCH-ARM / FISHERS | |P=0.347 P=0.759N P=0.759N P=0.500 |
|ORDER RESTRICTED | |P=0.297 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/14 (7%) 1/15 (7%) 1/15 (7%) 1/15 (7%) |1/15 (7%) 0/14 (0%) 3/15 (20%) 4/15 (27%) |
|POLY-3 RATE (b) | 1/13.05 1/14.03 1/13.06 1/14.38 |1/15.00 0/10.22 3/13.41 4/12.41 |
|POLY-3 PERCENT (g) | 7.7% 7.1% 7.7% 7.0% |6.7% 0.0% 22.4% 32.3% |
|TERMINAL (d) | 1/13 (8%) 0/13 (0%) 1/11 (9%) 1/14 (7%) |1/15 (7%) 0/8 (0%) 3/13 (23%) 3/10 (30%) |
|FIRST INCIDENCE | 176 (T) 71 176 (T) 176 (T) |177 (T) --- 177 (T) 115 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.613N P=0.760 P=0.727 P=0.748N |P=0.021 * P=0.625N P=0.247 P=0.084 |
|POLY 3 | P=0.615N P=0.745N P=0.761N P=0.739N |P=0.027 * P=0.574N P=0.257 P=0.107 |
|POLY 1.5 | P=0.612N P=0.745N P=0.751N P=0.738N |P=0.030 * P=0.556N P=0.268 P=0.120 |
|POLY 6 | P=0.621N P=0.744N P=0.744 P=0.742N |P=0.026 * P=0.592N P=0.250 P=0.097 |
|LOGISTIC REGRESSION| P=0.590 P=0.707N P=0.727 P=0.748N |P=0.029 * (e) P=0.247 P=0.154 |
|COCH-ARM / FISHERS | P=0.622N P=0.741N P=0.741N P=0.741N |P=0.039 * P=0.517N P=0.299 P=0.165 |
|ORDER RESTRICTED | P=0.716N (e) (e) (e) |P=0.023 * (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland: Duct |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 2/2 (100%) 1/1 (100%) 0/0 (0%) | |
|POLY-3 RATE (b) | 0/0.00 2/2.00 1/1.00 0/0.00 | |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 0.0% | |
|TERMINAL (d) | 0/0 (0%) 2/2 (100%) 1/1 (100%) 0/0 (0%) | |
|FIRST INCIDENCE | --- 176 (T) 176 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | |
|POLY 3 | (e) (e) (e) (e) | |
|POLY 1.5 | (e) (e) (e) (e) | |
|POLY 6 | (e) (e) (e) (e) | |
|LOGISTIC REGRESSION| (e) (e) (e) (e) | |
|COCH-ARM / FISHERS | (e) (e) (e) (e) | |
|ORDER RESTRICTED | (e) (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Skin: Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/6 (0%) |0/4 (0%) 0/4 (0%) 1/2 (50%) 4/8 (50%) |
|POLY-3 RATE (b) | 1/4.00 0/4.00 0/4.00 0/5.38 |0/4.00 0/3.80 1/2.00 4/8.00 |
|POLY-3 PERCENT (g) | 25.0% 0.0% 0.0% 0.0% |0.0% 0.0% 50.0% 50.0% |
|TERMINAL (d) | 1/4 (25%) 0/4 (0%) 0/4 (0%) 0/5 (0%) |0/4 (0%) 0/3 (0%) 1/2 (50%) 2/6 (33%) |
|FIRST INCIDENCE | 176 (T) --- --- --- |--- --- 177 (T) 141 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.282N P=0.500N P=0.500N P=0.455N |P=0.015 * (e) P=0.362 P=0.067 |
|POLY 3 | P=0.251N P=0.500N P=0.500N P=0.439N |P=0.028 * (e) P=0.342 P=0.127 |
|POLY 1.5 | P=0.254N P=0.500N P=0.500N P=0.430N |P=0.027 * (e) P=0.342 P=0.127 |
|POLY 6 | P=0.247N P=0.500N P=0.500N P=0.448N |P=0.030 * (e) P=0.342 P=0.127 |
|LOGISTIC REGRESSION| P=0.282N (e) (e) (e) |P=0.061 (e) P=0.362 (e) |
|COCH-ARM / FISHERS | P=0.255N P=0.500N P=0.500N P=0.400N |P=0.033 * (e) P=0.333 P=0.141 |
|ORDER RESTRICTED | P=0.077N (e) (e) (e) |P=0.033 * (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 2/15 (13%) 1/15 (7%) |1/15 (7%) 1/15 (7%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/14.05 0/13.10 2/13.54 1/15.00 |1/15.00 1/10.53 0/13.41 0/11.68 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 14.8% 6.7% |6.7% 9.5% 0.0% 0.0% |
|TERMINAL (d) | 0/14 (0%) 0/13 (0%) 1/11 (9%) 0/14 (0%) |1/15 (7%) 1/8 (13%) 0/13 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- 141 127 |177 (T) 177 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.259 (e) P=0.220 P=0.514 |P=0.278N P=0.617 P=0.529N P=0.581N |
|POLY 3 | P=0.279 (e) P=0.222 P=0.513 |P=0.250N P=0.676 P=0.522N P=0.549N |
|POLY 1.5 | P=0.272 (e) P=0.230 P=0.511 |P=0.246N P=0.706 P=0.516N P=0.535N |
|POLY 6 | P=0.282 (e) P=0.210 P=0.514 |P=0.254N P=0.646 P=0.526N P=0.561N |
|LOGISTIC REGRESSION| P=0.172 (e) P=0.223 P=0.346 |P=0.278N P=0.617 (e) (e) |
|COCH-ARM / FISHERS | P=0.242 (e) P=0.241 P=0.500 |P=0.233N P=0.759N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.155 (e) (e) (e) |P=0.242N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 1/15 (7%) |0/15 (0%) 5/15 (33%) 1/15 (7%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/14.05 0/13.10 1/13.54 1/14.38 |0/15.00 5/13.37 1/14.37 1/12.63 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.4% 7.0% |0.0% 37.4% 7.0% 7.9% |
|TERMINAL (d) | 0/14 (0%) 0/13 (0%) 0/11 (0%) 1/14 (7%) |0/15 (0%) 1/8 (13%) 0/13 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- 141 176 (T) |--- 36 63 66 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.243 (e) P=0.514 P=0.500 |P=0.514N P=0.016 * P=0.500 P=0.500 |
|POLY 3 | P=0.250 (e) P=0.493 P=0.505 |P=0.572N P=0.010 * P=0.491 P=0.466 |
|POLY 1.5 | P=0.250 (e) P=0.499 P=0.505 |P=0.539N P=0.012 * P=0.495 P=0.477 |
|POLY 6 | P=0.247 (e) P=0.482 P=0.502 |P=0.599 P=0.008 ** P=0.488 P=0.455 |
|LOGISTIC REGRESSION| P=0.207 (e) P=0.448 P=0.500 |P=0.120N P=0.243 (e) (e) |
|COCH-ARM / FISHERS | P=0.233 (e) P=0.500 P=0.500 |P=0.473N P=0.021 * P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.244 (e) (e) (e) |P=0.114 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 4/15 (27%) 3/15 (20%) 6/15 (40%) |2/15 (13%) 5/15 (33%) 2/15 (13%) 2/15 (13%) |
|POLY-3 RATE (b) | 2/15.00 4/13.10 3/14.03 6/15.00 |2/15.00 5/13.37 2/14.37 2/12.63 |
|POLY-3 PERCENT (g) | 13.3% 30.5% 21.4% 40.0% |13.3% 37.4% 13.9% 15.8% |
|TERMINAL (d) | 1/14 (7%) 4/13 (31%) 1/11 (9%) 5/14 (36%) |2/15 (13%) 1/8 (13%) 1/13 (8%) 1/10 (10%) |
|FIRST INCIDENCE | 64 176 (T) 141 127 |177 (T) 36 63 66 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.110 P=0.297 P=0.469 P=0.129 |P=0.476N P=0.096 P=0.657 P=0.583 |
|POLY 3 | P=0.093 P=0.262 P=0.468 P=0.105 |P=0.478N P=0.146 P=0.683 P=0.634 |
|POLY 1.5 | P=0.092 P=0.274 P=0.482 P=0.105 |P=0.449N P=0.164 P=0.689 P=0.656 |
|POLY 6 | P=0.092 P=0.259 P=0.451 P=0.105 |P=0.505N P=0.131 P=0.677 P=0.613 |
|LOGISTIC REGRESSION| P=0.065 P=0.347 P=0.715 (e) |P=0.170N P=0.682 P=0.498N P=0.550N |
|COCH-ARM / FISHERS | P=0.087 P=0.326 P=0.500 P=0.107 |P=0.389N P=0.195 P=0.701N P=0.701N |
|ORDER RESTRICTED | P=0.066 (e) (e) (e) |P=0.413N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 2/15 (13%) 1/15 (7%) 2/15 (13%) | |
|POLY-3 RATE (b) | 2/14.05 2/13.10 1/13.54 2/14.38 | |
|POLY-3 PERCENT (g) | 14.2% 15.3% 7.4% 13.9% | |
|TERMINAL (d) | 2/14 (14%) 2/13 (15%) 0/11 (0%) 2/14 (14%) | |
|FIRST INCIDENCE | 176 (T) 176 (T) 141 176 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.575N P=0.675 P=0.548N P=0.702 | |
|POLY 3 | P=0.567N P=0.674 P=0.513N P=0.691N | |
|POLY 1.5 | P=0.565N P=0.679 P=0.502N P=0.689N | |
|POLY 6 | P=0.574N P=0.672 P=0.532N P=0.695N | |
|LOGISTIC REGRESSION| P=0.568N P=0.675 P=0.499N P=0.702 | |
|COCH-ARM / FISHERS | P=0.581N P=0.701N P=0.500N P=0.701N | |
|ORDER RESTRICTED | P=0.588N (e) (e) (e) | |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 3/15 (20%) 4/14 (29%) 0/14 (0%) |1/15 (7%) 4/15 (27%) 3/15 (20%) 3/15 (20%) |
|POLY-3 RATE (b) | 1/15.00 3/15.00 4/14.00 0/14.00 |1/15.00 4/13.33 3/15.00 3/14.30 |
|POLY-3 PERCENT (g) | 6.7% 20.0% 28.6% 0.0% |6.7% 30.0% 20.0% 21.0% |
|TERMINAL (d) | 0/14 (0%) 1/13 (8%) 0/10 (0%) 0/14 (0%) |1/15 (7%) 0/8 (0%) 1/13 (8%) 0/10 (0%) |
|FIRST INCIDENCE | 64 57 141 --- |177 (T) 36 63 66 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.308N P=0.296 P=0.192 P=0.500N |P=0.315 P=0.113 P=0.276 P=0.259 |
|POLY 3 | P=0.332N P=0.298 P=0.141 P=0.514N |P=0.325 P=0.126 P=0.298 P=0.280 |
|POLY 1.5 | P=0.332N P=0.298 P=0.141 P=0.514N |P=0.336 P=0.140 P=0.298 P=0.288 |
|POLY 6 | P=0.332N P=0.298 P=0.141 P=0.514N |P=0.309 P=0.112 P=0.298 P=0.269 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.462N P=0.741N (e) P=0.473N |
|COCH-ARM / FISHERS | P=0.334N P=0.299 P=0.143 P=0.517N |P=0.347 P=0.165 P=0.299 P=0.299 |
|ORDER RESTRICTED | P=0.114N (e) (e) (e) |P=0.193 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 2/15 (13%) 1/14 (7%) 2/14 (14%) |4/15 (27%) 3/15 (20%) 4/15 (27%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/14.05 2/13.10 1/12.06 2/14.00 |4/15.00 3/10.53 4/13.41 1/11.68 |
|POLY-3 PERCENT (g) | 7.1% 15.3% 8.3% 14.3% |26.7% 28.5% 29.8% 8.6% |
|TERMINAL (d) | 1/14 (7%) 2/13 (15%) 1/10 (10%) 2/14 (14%) |4/15 (27%) 3/8 (38%) 4/13 (31%) 1/10 (10%) |
|FIRST INCIDENCE | 176 (T) 176 (T) 176 (T) 176 (T) |177 (T) 177 (T) 177 (T) 177 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.441 P=0.473 P=0.688 P=0.500 |P=0.229N P=0.476 P=0.570 P=0.309N |
|POLY 3 | P=0.445 P=0.475 P=0.727 P=0.499 |P=0.205N P=0.629 P=0.588 P=0.250N |
|POLY 1.5 | P=0.440 P=0.480 P=0.739 P=0.494 |P=0.182N P=0.637N P=0.607 P=0.222N |
|POLY 6 | P=0.445 P=0.474 P=0.707 P=0.500 |P=0.228N P=0.564 P=0.575 P=0.276N |
|LOGISTIC REGRESSION| P=0.441 P=0.473 P=0.688 P=0.500 |P=0.229N P=0.476 P=0.570 P=0.309N |
|COCH-ARM / FISHERS | P=0.412 P=0.500 P=0.741 P=0.473 |P=0.138N P=0.500N P=0.659N P=0.165N |
|ORDER RESTRICTED | P=0.434 (e) (e) (e) |P=0.183N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 13 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/15 (47%) 8/15 (53%) 5/15 (33%) 5/15 (33%) |4/15 (27%) 4/15 (27%) 4/15 (27%) 3/15 (20%) |
|POLY-3 RATE (b) | 7/15.00 8/15.00 5/14.03 5/14.38 |4/15.00 4/10.53 4/14.37 3/13.12 |
|POLY-3 PERCENT (g) | 46.7% 53.3% 35.6% 34.8% |26.7% 38.0% 27.8% 22.9% |
|TERMINAL (d) | 6/14 (43%) 6/13 (46%) 3/11 (27%) 5/14 (36%) |4/15 (27%) 4/8 (50%) 3/13 (23%) 1/10 (10%) |
|FIRST INCIDENCE | 64 57 141 176 (T) |177 (T) 177 (T) 63 66 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223N P=0.440 P=0.501N P=0.361N |P=0.538N P=0.259 P=0.578 P=0.642 |
|POLY 3 | P=0.238N P=0.500 P=0.413N P=0.393N |P=0.440N P=0.434 P=0.630 P=0.578N |
|POLY 1.5 | P=0.224N P=0.500 P=0.389N P=0.379N |P=0.426N P=0.510 P=0.640 P=0.556N |
|POLY 6 | P=0.254N P=0.500 P=0.444N P=0.406N |P=0.454N P=0.362 P=0.620 P=0.596N |
|LOGISTIC REGRESSION| P=0.239N (e) P=0.301N P=0.381N |P=0.384N P=0.259 P=0.537N P=0.339N |
|COCH-ARM / FISHERS | P=0.200N P=0.500 P=0.355N P=0.355N |P=0.401N P=0.659N P=0.659N P=0.500N |
|ORDER RESTRICTED | P=0.326N (e) (e) (e) |P=0.487N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |9/15 (60%) 8/15 (53%) 10/15 (67%) 5/15 (33%) |
|POLY-3 RATE (b) | |9/15.00 8/10.74 10/13.41 5/11.68 |
|POLY-3 PERCENT (g) | |60.0% 74.5% 74.6% 42.8% |
|TERMINAL (d) | |9/15 (60%) 7/8 (88%) 10/13 (77%) 5/10 (50%) |
|FIRST INCIDENCE | |177 (T) 164 177 (T) 177 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.307N P=0.093 P=0.294 P=0.468N |
|POLY 3 | |P=0.245N P=0.366 P=0.339 P=0.315N |
|POLY 1.5 | |P=0.187N P=0.512 P=0.381 P=0.250N |
|POLY 6 | |P=0.308N P=0.241 P=0.310 P=0.376N |
|LOGISTIC REGRESSION| |P=0.263N P=0.136 P=0.294 P=0.468N |
|COCH-ARM / FISHERS | |P=0.110N P=0.500N P=0.500 P=0.136N |
|ORDER RESTRICTED | |P=0.113N (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).