TDMS Study 97013-97 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 11/04/03
EXPERIMENT: 97013 TEST: 97 TIME: 12:03:40
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: 97013K
PATHOLOGIST: MISSING CAS: 75-27-4
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 11/04/03
EXPERIMENT: 97013 TEST: 97 TIME: 12:03:40
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: 97013K
PATHOLOGIST: MISSING CAS: 75-27-4
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF WATER DISINFECTION MODEL (BROMODICHLOR
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Kidney: Renal Tubule Degeneration
Dilatation
Skin Hyperplasia
Spleen Hematopoietic Cell Proliferation
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Kidney Casts Protein
Liver Inflammation
Liver: Hepatocyte Fatty Change
Vacuolization Cytoplasmic
Spleen Hematopoietic Cell Proliferation
Thymus Atrophy
===============================================================
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMO
DICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/10 (70%) 3/10 (30%) 6/10 (60%) 7/10 (70%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 7/8.57 3/6.13 6/7.52 7/8.24 |0/7.66 0/9.86 0/9.08 0/8.21 |
|POLY-3 PERCENT (g) | 81.7% 48.9% 79.8% 85.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 5/6 (83%) 3/6 (50%) 6/6 (100%) 7/8 (88%) |0/7 (0%) 0/9 (0%) 0/9 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 128 288 (T) 288 (T) 288 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.503N P=0.108N P=0.514N P=0.357N |(e) (e) (e) (e) |
|POLY 3 | P=0.411 P=0.223N P=0.719N P=0.687 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.419 P=0.229N P=0.637N P=0.671 |(e) (e) (e) (e) |
|POLY 6 | P=0.420 P=0.201N P=0.765 P=0.721 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.578 P=0.135N P=0.426N P=0.595N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.353 P=0.089N P=0.500N P=0.686N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.296 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |5/10 (50%) 6/10 (60%) 4/10 (40%) 7/10 (70%) |
|POLY-3 RATE (b) | 0/6.94 1/6.13 2/7.52 0/8.24 |5/9.04 6/9.86 4/9.08 7/9.20 |
|POLY-3 PERCENT (g) | 0.0% 16.3% 26.6% 0.0% |55.3% 60.8% 44.0% 76.1% |
|TERMINAL (d) | 0/6 (0%) 1/6 (17%) 2/6 (33%) 0/8 (0%) |3/7 (43%) 6/9 (67%) 4/9 (44%) 5/7 (71%) |
|FIRST INCIDENCE | --- 288 (T) 288 (T) --- |126 288 (T) 288 (T) 185 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.536N P=0.500 P=0.229 (e) |P=0.270 P=0.613N P=0.353N P=0.383 |
|POLY 3 | P=0.542N P=0.475 P=0.239 (e) |P=0.280 P=0.584 P=0.497N P=0.332 |
|POLY 1.5 | P=0.572N P=0.461 P=0.233 (e) |P=0.293 P=0.572 P=0.493N P=0.342 |
|POLY 6 | P=0.514N P=0.490 P=0.243 (e) |P=0.269 P=0.577 P=0.500N P=0.318 |
|LOGISTIC REGRESSION| (e) P=0.500 P=0.229 (e) |P=0.303 P=0.517 P=0.478N P=0.339 |
|COCH-ARM / FISHERS | P=0.620N P=0.500 P=0.237 (e) |P=0.296 P=0.500 P=0.500N P=0.325 |
|ORDER RESTRICTED | P=0.272N (e) (e) (e) |P=0.272 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 1/10 (10%) 0/10 (0%) 1/10 (10%) |1/10 (10%) 2/10 (20%) 6/10 (60%) 0/10 (0%) |
|POLY-3 RATE (b) | 3/7.85 1/6.13 0/7.52 1/8.24 |1/7.66 2/9.86 6/10.00 0/8.21 |
|POLY-3 PERCENT (g) | 38.2% 16.3% 0.0% 12.1% |13.1% 20.3% 60.0% 0.0% |
|TERMINAL (d) | 2/6 (33%) 1/6 (17%) 0/6 (0%) 1/8 (13%) |1/7 (14%) 2/9 (22%) 5/9 (56%) 0/7 (0%) |
|FIRST INCIDENCE | 128 288 (T) --- 288 (T) |288 (T) 288 (T) 125 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.144N P=0.319N P=0.124N P=0.222N |P=0.443N P=0.593 P=0.075 P=0.500N |
|POLY 3 | P=0.154N P=0.385N P=0.094N P=0.265N |P=0.423N P=0.590 P=0.057 P=0.486N |
|POLY 1.5 | P=0.156N P=0.400N P=0.095N P=0.280N |P=0.400N P=0.567 P=0.042 * P=0.486N |
|POLY 6 | P=0.152N P=0.362N P=0.093N P=0.247N |P=0.455N P=0.602 P=0.069 P=0.490N |
|LOGISTIC REGRESSION| P=0.165N P=0.330N P=0.107N P=0.287N |P=0.421N P=0.593 P=0.031 * (e) |
|COCH-ARM / FISHERS | P=0.187N P=0.291N P=0.105N P=0.291N |P=0.424N P=0.500 P=0.029 * P=0.500N |
|ORDER RESTRICTED | P=0.051N (e) (e) (e) |P=0.089N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/6.94 1/6.13 2/8.57 0/8.24 |0/7.66 0/9.86 1/9.08 0/8.21 |
|POLY-3 PERCENT (g) | 0.0% 16.3% 23.3% 0.0% |0.0% 0.0% 11.0% 0.0% |
|TERMINAL (d) | 0/6 (0%) 1/6 (17%) 0/6 (0%) 0/8 (0%) |0/7 (0%) 0/9 (0%) 1/9 (11%) 0/7 (0%) |
|FIRST INCIDENCE | --- 288 (T) 127 --- |--- --- 288 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.561N P=0.500 P=0.257 (e) |P=0.697 (e) P=0.550 (e) |
|POLY 3 | P=0.542N P=0.475 P=0.276 (e) |P=0.683 (e) P=0.534 (e) |
|POLY 1.5 | P=0.571N P=0.461 P=0.258 (e) |P=0.695 (e) P=0.524 (e) |
|POLY 6 | P=0.514N P=0.490 P=0.290 (e) |P=0.665 (e) P=0.542 (e) |
|LOGISTIC REGRESSION| P=0.628N P=0.500 P=0.205 (e) |(e) (e) P=0.550 (e) |
|COCH-ARM / FISHERS | P=0.620N P=0.500 P=0.237 (e) |P=0.696 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.293N (e) (e) (e) |P=0.409 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 4/10 (40%) 6/10 (60%) 6/10 (60%) |3/10 (30%) 4/10 (40%) 0/10 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 3/6.94 4/6.13 6/8.17 6/8.24 |3/7.66 4/9.86 0/9.08 5/9.01 |
|POLY-3 PERCENT (g) | 43.2% 65.3% 73.4% 72.9% |39.2% 40.6% 0.0% 55.5% |
|TERMINAL (d) | 3/6 (50%) 4/6 (67%) 4/6 (67%) 6/8 (75%) |3/7 (43%) 4/9 (44%) 0/9 (0%) 4/7 (57%) |
|FIRST INCIDENCE | 288 (T) 288 (T) 226 288 (T) |288 (T) 288 (T) --- 168 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.282 P=0.500 P=0.207 P=0.349 |P=0.291 P=0.667 P=0.069N P=0.342 |
|POLY 3 | P=0.210 P=0.405 P=0.249 P=0.255 |P=0.349 P=0.658 P=0.062N P=0.433 |
|POLY 1.5 | P=0.166 P=0.361 P=0.207 P=0.211 |P=0.346 P=0.619 P=0.070N P=0.411 |
|POLY 6 | P=0.260 P=0.460 P=0.306 P=0.309 |P=0.345 P=0.678N P=0.056N P=0.436 |
|LOGISTIC REGRESSION| P=0.214 P=0.500 P=0.204 P=0.349 |P=0.322 P=0.667 (e) P=0.362 |
|COCH-ARM / FISHERS | P=0.109 P=0.500 P=0.185 P=0.185 |P=0.320 P=0.500 P=0.105N P=0.325 |
|ORDER RESTRICTED | P=0.169 (e) (e) (e) |P=0.157 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 6/10 (60%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/6.94 0/6.13 0/7.52 6/8.24 |0/7.66 0/9.86 0/9.08 0/8.21 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 72.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/6 (0%) 0/6 (0%) 0/6 (0%) 6/8 (75%) |0/7 (0%) 0/9 (0%) 0/9 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- 288 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.015 * |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** (e) (e) P=0.002 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.015 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.005 ** |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 2/10 (20%) 4/10 (40%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/6.94 2/7.01 2/7.66 4/8.24 |0/7.66 0/9.86 0/9.08 0/8.21 |
|POLY-3 PERCENT (g) | 0.0% 28.5% 26.1% 48.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/6 (0%) 1/6 (17%) 1/6 (17%) 4/8 (50%) |0/7 (0%) 0/9 (0%) 0/9 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 143 274 288 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.078 P=0.225 P=0.257 P=0.081 |(e) (e) (e) (e) |
|POLY 3 | P=0.043 * P=0.222 P=0.245 P=0.046 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.036 * P=0.198 P=0.236 P=0.038 * |(e) (e) (e) (e) |
|POLY 6 | P=0.051 P=0.244 P=0.254 P=0.056 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.045 * P=0.224 P=0.244 P=0.081 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.031 * P=0.237 P=0.237 P=0.043 * |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.020 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |1/10 (10%) 2/10 (20%) 0/10 (0%) 3/10 (30%) |
|POLY-3 RATE (b) | 2/8.37 0/6.13 1/7.52 1/9.03 |1/7.66 2/9.86 0/9.08 3/8.46 |
|POLY-3 PERCENT (g) | 23.9% 0.0% 13.3% 11.1% |13.1% 20.3% 0.0% 35.5% |
|TERMINAL (d) | 0/6 (0%) 0/6 (0%) 1/6 (17%) 0/8 (0%) |1/7 (14%) 2/9 (22%) 0/9 (0%) 2/7 (29%) |
|FIRST INCIDENCE | 127 --- 288 (T) 169 |288 (T) 288 (T) --- 261 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.447N P=0.297N P=0.485N P=0.483N |P=0.208 P=0.593 P=0.450N P=0.310 |
|POLY 3 | P=0.429N P=0.303N P=0.540N P=0.472N |P=0.237 P=0.590 P=0.466N P=0.325 |
|POLY 1.5 | P=0.437N P=0.304N P=0.527N P=0.486N |P=0.238 P=0.567 P=0.476N P=0.321 |
|POLY 6 | P=0.423N P=0.298N P=0.554N P=0.461N |P=0.237 P=0.602 P=0.458N P=0.327 |
|LOGISTIC REGRESSION| P=0.549N P=0.161N P=0.521N P=0.584N |P=0.214 P=0.593 (e) P=0.307 |
|COCH-ARM / FISHERS | P=0.500N P=0.237N P=0.500N P=0.500N |P=0.227 P=0.500 P=0.500N P=0.291 |
|ORDER RESTRICTED | P=0.266N (e) (e) (e) |P=0.167 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/10 (70%) 6/10 (60%) 8/10 (80%) 5/10 (50%) |8/10 (80%) 9/10 (90%) 10/10 (100%) 6/10 (60%) |
|POLY-3 RATE (b) | 7/9.09 6/7.01 8/9.09 5/9.03 |8/8.13 9/9.86 10/10.00 6/9.01 |
|POLY-3 PERCENT (g) | 77.0% 85.6% 88.1% 55.4% |98.4% 91.3% 100.0% 66.6% |
|TERMINAL (d) | 4/6 (67%) 5/6 (83%) 5/6 (83%) 4/8 (50%) |7/7 (100%) 9/9 (100%) 9/9 (100%) 5/7 (71%) |
|FIRST INCIDENCE | 128 143 127 169 |233 288 (T) 125 168 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.132N P=0.565N P=0.521 P=0.205N |P=0.181N P=0.455N P=0.735N P=0.285N |
|POLY 3 | P=0.171N P=0.577 P=0.500 P=0.319N |P=0.026N* P=0.659N P=1.000 P=0.116N |
|POLY 1.5 | P=0.178N P=0.563 P=0.500 P=0.327N |P=0.032N* P=0.747N P=0.895 P=0.142N |
|POLY 6 | P=0.167N P=0.589 P=0.500 P=0.314N |P=0.032N* P=0.673N P=1.000 P=0.133N |
|LOGISTIC REGRESSION| P=0.174N P=0.695 P=0.521 P=0.310N |P=0.097N P=0.436N P=0.466 P=0.186N |
|COCH-ARM / FISHERS | P=0.288N P=0.500N P=0.500 P=0.325N |P=0.146N P=0.500 P=0.237 P=0.314N |
|ORDER RESTRICTED | P=0.114N (e) (e) (e) |P=0.013N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |2/10 (20%) 2/10 (20%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/6.94 2/8.13 0/7.52 0/8.24 |2/7.66 2/9.86 1/9.08 1/8.21 |
|POLY-3 PERCENT (g) | 0.0% 24.6% 0.0% 0.0% |26.1% 20.3% 11.0% 12.2% |
|TERMINAL (d) | 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/8 (0%) |2/7 (29%) 2/9 (22%) 1/9 (11%) 1/7 (14%) |
|FIRST INCIDENCE | --- 13 --- --- |288 (T) 288 (T) 288 (T) 288 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.402N P=0.228 (e) (e) |P=0.338N P=0.611N P=0.407N P=0.500N |
|POLY 3 | P=0.342N P=0.261 (e) (e) |P=0.331N P=0.606N P=0.438N P=0.474N |
|POLY 1.5 | P=0.368N P=0.241 (e) (e) |P=0.326N P=0.632N P=0.456N P=0.474N |
|POLY 6 | P=0.319N P=0.282 (e) (e) |P=0.336N P=0.591N P=0.423N P=0.481N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.338N P=0.611N P=0.407N P=0.500N |
|COCH-ARM / FISHERS | P=0.403N P=0.237 (e) (e) |P=0.327N P=0.709N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.226N (e) (e) (e) |P=0.383N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) |0/10 (0%) 2/10 (20%) 8/10 (80%) 5/10 (50%) |
|POLY-3 RATE (b) | 0/6.94 0/6.13 2/7.66 0/8.24 |0/7.66 2/9.86 8/10.00 5/8.21 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 26.1% 0.0% |0.0% 20.3% 80.0% 60.9% |
|TERMINAL (d) | 0/6 (0%) 0/6 (0%) 1/6 (17%) 0/8 (0%) |0/7 (0%) 2/9 (22%) 7/9 (78%) 5/7 (71%) |
|FIRST INCIDENCE | --- --- 274 --- |--- 288 (T) 125 288 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.653 (e) P=0.257 (e) |P=0.004 ** P=0.290 P=0.004 ** P=0.016 * |
|POLY 3 | P=0.708N (e) P=0.245 (e) |P<0.001 ** P=0.290 P<0.001 ** P=0.007 ** |
|POLY 1.5 | P=0.684 (e) P=0.236 (e) |P=0.002 ** P=0.272 P<0.001 ** P=0.008 ** |
|POLY 6 | P=0.692N (e) P=0.254 (e) |P<0.001 ** P=0.299 P<0.001 ** P=0.005 ** |
|LOGISTIC REGRESSION| P=0.645 (e) P=0.244 (e) |P=0.008 ** P=0.290 P<0.001 ** P=0.016 * |
|COCH-ARM / FISHERS | P=0.597 (e) P=0.237 (e) |P=0.009 ** P=0.237 P<0.001 ** P=0.016 * |
|ORDER RESTRICTED | P=0.247 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/10 (60%) 3/10 (30%) 7/10 (70%) 7/10 (70%) |6/10 (60%) 9/10 (90%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 6/7.66 3/6.13 7/8.57 7/8.24 |6/9.08 9/9.86 10/10.00 9/9.27 |
|POLY-3 PERCENT (g) | 78.4% 48.9% 81.7% 85.0% |66.1% 91.3% 100.0% 97.1% |
|TERMINAL (d) | 5/6 (83%) 3/6 (50%) 5/6 (83%) 7/8 (88%) |4/7 (57%) 9/9 (100%) 9/9 (100%) 7/7 (100%) |
|FIRST INCIDENCE | 189 288 (T) 127 288 (T) |102 288 (T) 125 168 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.494 P=0.173N P=0.514 P=0.568N |P=0.093 P=0.451 P=0.296 P=0.238 |
|POLY 3 | P=0.334 P=0.282N P=0.683 P=0.626 |P=0.046 * P=0.213 P=0.068 P=0.115 |
|POLY 1.5 | P=0.309 P=0.315N P=0.622 P=0.565 |P=0.060 P=0.198 P=0.053 P=0.130 |
|POLY 6 | P=0.360 P=0.246N P=0.721 P=0.684 |P=0.033 * P=0.202 P=0.075 P=0.100 |
|LOGISTIC REGRESSION| P=0.367 P=0.223N P=0.568 P=0.739N |P=0.103 P=0.194 P=0.051 P=0.175 |
|COCH-ARM / FISHERS | P=0.209 P=0.185N P=0.500 P=0.500 |P=0.089 P=0.152 P=0.043 * P=0.152 |
|ORDER RESTRICTED | P=0.267 (e) (e) (e) |P=0.011 * (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/6.94 2/6.13 0/7.52 0/8.24 |0/7.66 0/9.86 0/9.08 0/8.21 |
|POLY-3 PERCENT (g) | 0.0% 32.6% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/6 (0%) 2/6 (33%) 0/6 (0%) 0/8 (0%) |0/7 (0%) 0/9 (0%) 0/9 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 288 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.346N P=0.229 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.388N P=0.189 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.412N P=0.176 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.363N P=0.205 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.229 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.403N P=0.237 (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.164N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/7.66 1/7.13 2/8.43 0/8.24 |0/7.66 0/9.86 0/9.08 1/8.46 |
|POLY-3 PERCENT (g) | 13.1% 14.0% 23.7% 0.0% |0.0% 0.0% 0.0% 11.8% |
|TERMINAL (d) | 0/6 (0%) 0/6 (0%) 1/6 (17%) 0/8 (0%) |0/7 (0%) 0/9 (0%) 0/9 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 189 13 127 --- |--- --- --- 261 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.343N P=0.729 P=0.500 P=0.500N |P=0.191 (e) (e) P=0.527 |
|POLY 3 | P=0.326N P=0.749 P=0.535 P=0.485N |P=0.196 (e) (e) P=0.520 |
|POLY 1.5 | P=0.335N P=0.740 P=0.527 P=0.492N |P=0.198 (e) (e) P=0.517 |
|POLY 6 | P=0.319N P=0.758 P=0.536 P=0.479N |P=0.194 (e) (e) P=0.521 |
|LOGISTIC REGRESSION| P=0.467N P=0.574N P=0.471 P=0.527N |P=0.196 (e) (e) P=0.505 |
|COCH-ARM / FISHERS | P=0.361N P=0.763N P=0.500 P=0.500N |P=0.196 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.247N (e) (e) (e) |P=0.138 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Perivascular |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) |2/10 (20%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/6.94 1/6.13 1/7.52 0/8.24 |2/7.66 0/9.86 0/9.08 1/8.21 |
|POLY-3 PERCENT (g) | 0.0% 16.3% 13.3% 0.0% |26.1% 0.0% 0.0% 12.2% |
|TERMINAL (d) | 0/6 (0%) 1/6 (17%) 1/6 (17%) 0/8 (0%) |2/7 (29%) 0/9 (0%) 0/9 (0%) 1/7 (14%) |
|FIRST INCIDENCE | --- 288 (T) 288 (T) --- |288 (T) --- --- 288 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.529N P=0.500 P=0.500 (e) |P=0.473N P=0.178N P=0.178N P=0.500N |
|POLY 3 | P=0.551N P=0.475 P=0.516 (e) |P=0.500N P=0.169N P=0.185N P=0.474N |
|POLY 1.5 | P=0.573N P=0.461 P=0.510 (e) |P=0.490N P=0.183N P=0.196N P=0.474N |
|POLY 6 | P=0.529N P=0.490 P=0.520 (e) |P=0.502N P=0.162N P=0.176N P=0.481N |
|LOGISTIC REGRESSION| (e) P=0.500 P=0.500 (e) |P=0.473N (e) (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.597N P=0.500 P=0.500 (e) |P=0.460N P=0.237N P=0.237N P=0.500N |
|ORDER RESTRICTED | P=0.364N (e) (e) (e) |P=0.094N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Infiltration Cellular Plasma Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/9 (0%) 2/9 (22%) 1/10 (10%) |2/10 (20%) 1/10 (10%) 0/10 (0%) 2/9 (22%) |
|POLY-3 RATE (b) | 1/6.94 0/6.12 2/7.95 1/8.24 |2/8.57 1/9.86 0/9.08 2/8.74 |
|POLY-3 PERCENT (g) | 14.4% 0.0% 25.2% 12.1% |23.3% 10.1% 0.0% 22.9% |
|TERMINAL (d) | 1/6 (17%) 0/6 (0%) 1/6 (17%) 1/8 (13%) |1/7 (14%) 1/9 (11%) 0/9 (0%) 1/7 (14%) |
|FIRST INCIDENCE | 288 (T) --- 226 288 (T) |126 288 (T) --- 185 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.584 P=0.500N P=0.516 P=0.702N |P=0.584 P=0.429N P=0.212N P=0.684N |
|POLY 3 | P=0.595 P=0.525N P=0.550 P=0.725N |P=0.568 P=0.449N P=0.211N P=0.698N |
|POLY 1.5 | P=0.575 P=0.541N P=0.519 P=0.741N |P=0.566 P=0.462N P=0.216N P=0.702 |
|POLY 6 | P=0.612 P=0.510N P=0.574 P=0.708N |P=0.568 P=0.441N P=0.205N P=0.694N |
|LOGISTIC REGRESSION| P=0.555 (e) P=0.500 P=0.702N |P=0.457 P=0.695N P=0.292N P=0.533 |
|COCH-ARM / FISHERS | P=0.507 P=0.526N P=0.458 P=0.763N |P=0.560 P=0.500N P=0.237N P=0.667 |
|ORDER RESTRICTED | P=0.431 (e) (e) (e) |P=0.371N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/10 (10%) 0/10 (0%) 3/10 (30%) 1/10 (10%) |
|POLY-3 RATE (b) | |1/7.66 0/9.86 3/9.08 1/8.46 |
|POLY-3 PERCENT (g) | |13.1% 0.0% 33.0% 11.8% |
|TERMINAL (d) | |1/7 (14%) 0/9 (0%) 3/9 (33%) 0/7 (0%) |
|FIRST INCIDENCE | |288 (T) --- 288 (T) 261 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.452 P=0.450N P=0.389 P=0.746N |
|POLY 3 | |P=0.450 P=0.450N P=0.357 P=0.741N |
|POLY 1.5 | |P=0.463 P=0.463N P=0.336 P=0.744N |
|POLY 6 | |P=0.440 P=0.443N P=0.374 P=0.740N |
|LOGISTIC REGRESSION| |P=0.465 (e) P=0.389 P=0.760N |
|COCH-ARM / FISHERS | |P=0.468 P=0.500N P=0.291 P=0.763N |
|ORDER RESTRICTED | |P=0.273 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 0/10 (0%) 1/10 (10%) |2/10 (20%) 1/10 (10%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/6.94 1/6.13 0/7.52 1/9.03 |2/8.13 1/9.86 1/9.08 0/8.21 |
|POLY-3 PERCENT (g) | 14.4% 16.3% 0.0% 11.1% |24.6% 10.1% 11.0% 0.0% |
|TERMINAL (d) | 1/6 (17%) 1/6 (17%) 0/6 (0%) 0/8 (0%) |1/7 (14%) 1/9 (11%) 1/9 (11%) 0/7 (0%) |
|FIRST INCIDENCE | 288 (T) 288 (T) --- 169 |233 288 (T) 288 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.543N P=0.771 P=0.500N P=0.715N |P=0.147N P=0.415N P=0.427N P=0.240N |
|POLY 3 | P=0.581N P=0.739 P=0.484N P=0.701N |P=0.158N P=0.430N P=0.460N P=0.220N |
|POLY 1.5 | P=0.593N P=0.721 P=0.490N P=0.726N |P=0.152N P=0.444N P=0.468N P=0.215N |
|POLY 6 | P=0.570N P=0.757 P=0.480N P=0.678N |P=0.164N P=0.429N P=0.457N P=0.233N |
|LOGISTIC REGRESSION| P=0.603N P=0.771 (e) P=0.759 |P=0.138N P=0.486N P=0.475N P=0.222N |
|COCH-ARM / FISHERS | P=0.620N P=0.763N P=0.500N P=0.763N |P=0.143N P=0.500N P=0.500N P=0.237N |
|ORDER RESTRICTED | P=0.434N (e) (e) (e) |P=0.106N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pleura |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 3/3 (100%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 0/0.00 3/3.00 0/0.00 0/0.00 |0/0.00 0/0.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 13 --- --- |--- --- --- --- |
|-------------------| | |
|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/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/5 (0%) 1/6 (17%) 2/5 (40%) 4/7 (57%) |1/6 (17%) 3/5 (60%) 0/7 (0%) 2/7 (29%) |
|POLY-3 RATE (b) | 0/5.00 1/6.00 2/4.34 4/7.00 |1/6.00 3/5.00 0/6.08 2/6.74 |
|POLY-3 PERCENT (g) | 0.0% 16.7% 46.0% 57.1% |16.7% 60.0% 0.0% 29.7% |
|TERMINAL (d) | 0/5 (0%) 1/6 (17%) 2/3 (67%) 4/7 (57%) |1/6 (17%) 3/5 (60%) 0/6 (0%) 2/6 (33%) |
|FIRST INCIDENCE | --- 288 (T) 288 (T) 288 (T) |288 (T) 288 (T) --- 288 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030 * P=0.536 P=0.118 P=0.083 |P=0.585 P=0.207 P=0.500N P=0.500 |
|POLY 3 | P=0.019 * P=0.536 P=0.166 P=0.049 * |P=0.614N P=0.193 P=0.497N P=0.543 |
|POLY 1.5 | P=0.020 * P=0.536 P=0.183 P=0.049 * |P=0.606N P=0.193 P=0.491N P=0.549 |
|POLY 6 | P=0.018 * P=0.536 P=0.142 P=0.049 * |P=0.625N P=0.193 P=0.500N P=0.533 |
|LOGISTIC REGRESSION| (e) P=0.536 P=0.118 P=0.083 |P=0.585 P=0.207 (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.025 * P=0.545 P=0.222 P=0.071 |P=0.589N P=0.197 P=0.462N P=0.563 |
|ORDER RESTRICTED | P=0.018 * (e) (e) (e) |P=0.292N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |2/10 (20%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/6.94 1/7.13 0/7.52 0/8.24 |2/9.53 0/9.86 0/9.08 1/9.01 |
|POLY-3 PERCENT (g) | 0.0% 14.0% 0.0% 0.0% |21.0% 0.0% 0.0% 11.1% |
|TERMINAL (d) | 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/8 (0%) |0/7 (0%) 0/9 (0%) 0/9 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 14 --- --- |102 --- --- 168 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.561N P=0.479 (e) (e) |P=0.442N P=0.228N P=0.240N P=0.462N |
|POLY 3 | P=0.553N P=0.505 (e) (e) |P=0.468N P=0.218N P=0.237N P=0.520N |
|POLY 1.5 | P=0.567N P=0.490 (e) (e) |P=0.466N P=0.221N P=0.237N P=0.513N |
|POLY 6 | P=0.538N P=0.521 (e) (e) |P=0.468N P=0.214N P=0.232N P=0.527N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.659 (e) P=0.466N (e) |
|COCH-ARM / FISHERS | P=0.568N P=0.500 (e) (e) |P=0.460N P=0.237N P=0.237N P=0.500N |
|ORDER RESTRICTED | P=0.356N (e) (e) (e) |P=0.131N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/10 (40%) 0/10 (0%) 2/10 (20%) 1/10 (10%) |1/10 (10%) 2/10 (20%) 0/10 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 4/9.28 0/6.13 2/7.52 1/9.03 |1/7.66 2/9.86 0/9.08 5/9.20 |
|POLY-3 PERCENT (g) | 43.1% 0.0% 26.6% 11.1% |13.1% 20.3% 0.0% 54.4% |
|TERMINAL (d) | 1/6 (17%) 0/6 (0%) 2/6 (33%) 0/8 (0%) |1/7 (14%) 2/9 (22%) 0/9 (0%) 3/7 (43%) |
|FIRST INCIDENCE | 127 --- 288 (T) 169 |288 (T) 288 (T) --- 185 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.155N P=0.093N P=0.333N P=0.160N |P=0.028 * P=0.593 P=0.450N P=0.101 |
|POLY 3 | P=0.117N P=0.097N P=0.428N P=0.152N |P=0.026 * P=0.590 P=0.466N P=0.098 |
|POLY 1.5 | P=0.122N P=0.092N P=0.393N P=0.156N |P=0.025 * P=0.567 P=0.476N P=0.086 |
|POLY 6 | P=0.113N P=0.096N P=0.457N P=0.146N |P=0.027 * P=0.602 P=0.458N P=0.107 |
|LOGISTIC REGRESSION| P=0.199N P=0.027N* P=0.330N P=0.183N |P=0.030 * P=0.593 (e) P=0.078 |
|COCH-ARM / FISHERS | P=0.180N P=0.043N* P=0.314N P=0.152N |P=0.031 * P=0.500 P=0.500N P=0.070 |
|ORDER RESTRICTED | P=0.051N (e) (e) (e) |P=0.019 * (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 3/10 (30%) 2/10 (20%) |1/10 (10%) 2/10 (20%) 4/10 (40%) 4/10 (40%) |
|POLY-3 RATE (b) | 2/6.94 0/6.13 3/7.52 2/8.24 |1/8.57 2/9.86 4/9.08 4/8.94 |
|POLY-3 PERCENT (g) | 28.8% 0.0% 39.9% 24.3% |11.7% 20.3% 44.0% 44.7% |
|TERMINAL (d) | 2/6 (33%) 0/6 (0%) 3/6 (50%) 2/8 (25%) |0/7 (0%) 2/9 (22%) 4/9 (44%) 3/7 (43%) |
|FIRST INCIDENCE | 288 (T) --- 288 (T) 288 (T) |126 288 (T) 288 (T) 185 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.552 P=0.229N P=0.500 P=0.597N |P=0.076 P=0.571 P=0.231 P=0.188 |
|POLY 3 | P=0.553 P=0.249N P=0.543 P=0.643N |P=0.080 P=0.550 P=0.161 P=0.154 |
|POLY 1.5 | P=0.527 P=0.269N P=0.526 P=0.671N |P=0.084 P=0.538 P=0.155 P=0.155 |
|POLY 6 | P=0.574 P=0.230N P=0.554 P=0.615N |P=0.076 P=0.558 P=0.169 P=0.150 |
|LOGISTIC REGRESSION| P=0.552 (e) P=0.500 P=0.597N |P=0.083 P=0.305 P=0.138 P=0.114 |
|COCH-ARM / FISHERS | P=0.416 P=0.237N P=0.500 P=0.709N |P=0.084 P=0.500 P=0.152 P=0.152 |
|ORDER RESTRICTED | P=0.359 (e) (e) (e) |P=0.106 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 3/10 (30%) 2/10 (20%) |1/10 (10%) 2/10 (20%) 4/10 (40%) 4/10 (40%) |
|POLY-3 RATE (b) | 2/6.94 0/6.13 3/7.52 2/8.24 |1/7.66 2/9.86 4/9.08 4/8.94 |
|POLY-3 PERCENT (g) | 28.8% 0.0% 39.9% 24.3% |13.1% 20.3% 44.0% 44.7% |
|TERMINAL (d) | 2/6 (33%) 0/6 (0%) 3/6 (50%) 2/8 (25%) |1/7 (14%) 2/9 (22%) 4/9 (44%) 3/7 (43%) |
|FIRST INCIDENCE | 288 (T) --- 288 (T) 288 (T) |288 (T) 288 (T) 288 (T) 185 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.552 P=0.229N P=0.500 P=0.597N |P=0.066 P=0.593 P=0.235 P=0.168 |
|POLY 3 | P=0.553 P=0.249N P=0.543 P=0.643N |P=0.102 P=0.590 P=0.200 P=0.193 |
|POLY 1.5 | P=0.527 P=0.269N P=0.526 P=0.671N |P=0.101 P=0.567 P=0.182 P=0.183 |
|POLY 6 | P=0.574 P=0.230N P=0.554 P=0.615N |P=0.099 P=0.602 P=0.216 P=0.194 |
|LOGISTIC REGRESSION| P=0.552 (e) P=0.500 P=0.597N |P=0.081 P=0.593 P=0.235 P=0.163 |
|COCH-ARM / FISHERS | P=0.416 P=0.237N P=0.500 P=0.709N |P=0.084 P=0.500 P=0.152 P=0.152 |
|ORDER RESTRICTED | P=0.359 (e) (e) (e) |P=0.142 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 1/10 (10%) 0/10 (0%) 1/10 (10%) | |
|POLY-3 RATE (b) | 2/7.85 1/6.13 0/7.52 1/8.24 | |
|POLY-3 PERCENT (g) | 25.5% 16.3% 0.0% 12.1% | |
|TERMINAL (d) | 1/6 (17%) 1/6 (17%) 0/6 (0%) 1/8 (13%) | |
|FIRST INCIDENCE | 127 288 (T) --- 288 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.304N P=0.542N P=0.240N P=0.445N | |
|POLY 3 | P=0.337N P=0.591N P=0.232N P=0.482N | |
|POLY 1.5 | P=0.339N P=0.600N P=0.232N P=0.495N | |
|POLY 6 | P=0.334N P=0.573N P=0.231N P=0.465N | |
|LOGISTIC REGRESSION| P=0.343N P=0.527N P=0.238N P=0.519N | |
|COCH-ARM / FISHERS | P=0.361N P=0.500N P=0.237N P=0.500N | |
|ORDER RESTRICTED | P=0.197N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/9 (33%) 3/10 (30%) 3/10 (30%) 2/10 (20%) |2/10 (20%) 1/10 (10%) 0/10 (0%) 4/9 (44%) |
|POLY-3 RATE (b) | 3/6.46 3/9.12 3/8.03 2/9.20 |2/9.53 1/10.00 0/9.08 4/8.74 |
|POLY-3 PERCENT (g) | 46.5% 32.9% 37.4% 21.7% |21.0% 10.0% 0.0% 45.7% |
|TERMINAL (d) | 3/6 (50%) 0/6 (0%) 2/6 (33%) 1/8 (13%) |0/7 (0%) 0/9 (0%) 0/9 (0%) 2/6 (33%) |
|FIRST INCIDENCE | 288 (T) 13 226 93 |102 274 --- 168 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.293N P=0.640 P=0.663N P=0.388N |P=0.153 P=0.447N P=0.240N P=0.350 |
|POLY 3 | P=0.262N P=0.495N P=0.571N P=0.322N |P=0.101 P=0.483N P=0.237N P=0.268 |
|POLY 1.5 | P=0.281N P=0.537N P=0.593N P=0.357N |P=0.102 P=0.490N P=0.237N P=0.266 |
|POLY 6 | P=0.254N P=0.468N P=0.558N P=0.303N |P=0.099 P=0.473N P=0.232N P=0.269 |
|LOGISTIC REGRESSION| P=0.438N P=0.460N P=0.613N P=0.446N |P=0.071 P=0.436 P=0.466N P=0.135 |
|COCH-ARM / FISHERS | P=0.337N P=0.630N P=0.630N P=0.444N |P=0.116 P=0.500N P=0.237N P=0.259 |
|ORDER RESTRICTED | P=0.277N (e) (e) (e) |P=0.033 * (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/9 (44%) 2/10 (20%) 2/10 (20%) 3/10 (30%) |3/10 (30%) 2/10 (20%) 5/10 (50%) 3/9 (33%) |
|POLY-3 RATE (b) | 4/7.37 2/6.13 2/7.52 3/8.24 |3/8.13 2/9.86 5/10.00 3/7.21 |
|POLY-3 PERCENT (g) | 54.3% 32.6% 26.6% 36.4% |36.9% 20.3% 50.0% 41.6% |
|TERMINAL (d) | 3/6 (50%) 2/6 (33%) 2/6 (33%) 3/8 (38%) |2/7 (29%) 2/9 (22%) 4/9 (44%) 3/6 (50%) |
|FIRST INCIDENCE | 128 288 (T) 288 (T) 288 (T) |233 288 (T) 125 288 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.315N P=0.334N P=0.323N P=0.345N |P=0.370 P=0.382N P=0.477 P=0.616 |
|POLY 3 | P=0.359N P=0.406N P=0.288N P=0.424N |P=0.345 P=0.404N P=0.469 P=0.626 |
|POLY 1.5 | P=0.364N P=0.413N P=0.277N P=0.433N |P=0.382 P=0.423N P=0.437 P=0.645 |
|POLY 6 | P=0.356N P=0.393N P=0.305N P=0.413N |P=0.305 P=0.402N P=0.479 P=0.590 |
|LOGISTIC REGRESSION| P=0.329N P=0.330N P=0.242N P=0.390N |P=0.409 P=0.424N P=0.325 P=0.662 |
|COCH-ARM / FISHERS | P=0.429N P=0.259N P=0.259N P=0.430N |P=0.408 P=0.500N P=0.325 P=0.630 |
|ORDER RESTRICTED | P=0.282N (e) (e) (e) |P=0.389 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |2/10 (20%) 5/10 (50%) 2/10 (20%) 2/10 (20%) |
|POLY-3 RATE (b) | 2/7.46 0/6.13 1/7.52 1/8.24 |2/8.13 5/9.86 2/9.08 2/9.20 |
|POLY-3 PERCENT (g) | 26.8% 0.0% 13.3% 12.1% |24.6% 50.7% 22.0% 21.7% |
|TERMINAL (d) | 1/6 (17%) 0/6 (0%) 1/6 (17%) 1/8 (13%) |1/7 (14%) 5/9 (56%) 2/9 (22%) 0/7 (0%) |
|FIRST INCIDENCE | 226 --- 288 (T) 288 (T) |233 288 (T) 288 (T) 185 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.416N P=0.257N P=0.484N P=0.417N |P=0.407N P=0.304 P=0.618N P=0.669N |
|POLY 3 | P=0.441N P=0.270N P=0.497N P=0.463N |P=0.320N P=0.265 P=0.663N P=0.658N |
|POLY 1.5 | P=0.444N P=0.280N P=0.496N P=0.477N |P=0.328N P=0.245 P=0.672N P=0.665N |
|POLY 6 | P=0.441N P=0.261N P=0.506N P=0.454N |P=0.321N P=0.266 P=0.661N P=0.659N |
|LOGISTIC REGRESSION| P=0.442N P=0.255N P=0.480N P=0.466N |P=0.378N P=0.252 P=0.677N P=0.689 |
|COCH-ARM / FISHERS | P=0.500N P=0.237N P=0.500N P=0.500N |P=0.382N P=0.175 P=0.709N P=0.709N |
|ORDER RESTRICTED | P=0.241N (e) (e) (e) |P=0.362N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 97 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |7/10 (70%) 10/10 (100%) 9/10 (90%) 8/10 (80%) |
|POLY-3 RATE (b) | |7/7.66 10/10.00 9/9.08 8/8.46 |
|POLY-3 PERCENT (g) | |91.4% 100.0% 99.1% 94.5% |
|TERMINAL (d) | |7/7 (100%) 9/9 (100%) 9/9 (100%) 7/7 (100%) |
|FIRST INCIDENCE | |288 (T) 274 288 (T) 261 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.393 P=0.571 P=1.000 P=0.527 |
|POLY 3 | |P=0.851N P=0.680 P=0.740 P=0.865 |
|POLY 1.5 | |P=0.691N P=0.330 P=0.485 P=0.719 |
|POLY 6 | |P=0.963 P=0.988 P=0.990 P=0.994 |
|LOGISTIC REGRESSION| |P=0.393 (e) P=1.000 (e) |
|COCH-ARM / FISHERS | |P=0.559 P=0.105 P=0.291 P=0.500 |
|ORDER RESTRICTED | |P=0.194 (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).