TDMS Study 97013-99 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 11/05/03
EXPERIMENT: 97013 TEST: 99 TIME: 10:08:09
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013F
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: 11/05/03
EXPERIMENT: 97013 TEST: 99 TIME: 10:08:09
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013F
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 Casts Protein
Nephropathy
Lymph Node, Mandibular Infiltration Cellular Plasma Cell
Stomach, Forestomach: Epithelium Hyperplasia
Thyroid Gland Cyst
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Hematopoietic Cell Proliferation
Thymus Atrophy
===============================================================
Date: 11/05/03 EXPERIMENT: 97013 TEST: 99 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMO
DICHLOR
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/10 (50%) 3/10 (30%) 4/10 (40%) 4/10 (40%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 5/9.02 3/8.19 4/9.85 4/9.08 |0/5.97 0/4.87 0/8.76 0/5.96 |
|POLY-3 PERCENT (g) | 55.5% 36.7% 40.6% 44.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/6 (50%) 3/8 (38%) 4/9 (44%) 4/8 (50%) |0/5 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 153 274 (T) 274 (T) 274 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.345N P=0.230N P=0.266N P=0.329N |(e) (e) (e) (e) |
|POLY 3 | P=0.458N P=0.386N P=0.429N P=0.494N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.468N P=0.385N P=0.459N P=0.502N |(e) (e) (e) (e) |
|POLY 6 | P=0.449N P=0.359N P=0.394N P=0.477N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.433N P=0.323N P=0.619N P=0.495N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.325N P=0.500N P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.425N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |7/10 (70%) 5/10 (50%) 5/10 (50%) 7/10 (70%) |
|POLY-3 RATE (b) | 0/7.65 0/8.19 1/9.85 1/9.08 |7/8.09 5/7.42 5/9.58 7/7.55 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.2% 11.0% |86.5% 67.4% 52.2% 92.8% |
|TERMINAL (d) | 0/6 (0%) 0/8 (0%) 1/9 (11%) 1/8 (13%) |4/5 (80%) 2/4 (50%) 3/7 (43%) 5/5 (100%) |
|FIRST INCIDENCE | --- --- 274 (T) 274 (T) |51 83 226 133 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.264 (e) P=0.581 P=0.557 |P=0.549N P=0.497N P=0.160N P=0.637N |
|POLY 3 | P=0.281 (e) P=0.550 P=0.534 |P=0.500 P=0.384N P=0.145N P=0.676 |
|POLY 1.5 | P=0.265 (e) P=0.530 P=0.520 |P=0.494 P=0.344N P=0.168N P=0.684 |
|POLY 6 | P=0.296 (e) P=0.570 P=0.551 |P=0.475 P=0.428N P=0.153N P=0.616 |
|LOGISTIC REGRESSION| (e) (e) P=0.581 P=0.557 |P=0.543 P=0.341N P=0.260N P=0.669N |
|COCH-ARM / FISHERS | P=0.231 (e) P=0.500 P=0.500 |P=0.500 P=0.325N P=0.325N P=0.686N |
|ORDER RESTRICTED | P=0.287 (e) (e) (e) |P=0.191 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 97013 TEST: 99 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 4/10 (40%) 2/10 (20%) |2/10 (20%) 1/10 (10%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/8.47 2/8.19 4/10.00 2/10.00 |2/6.17 1/5.84 1/8.76 1/6.47 |
|POLY-3 PERCENT (g) | 11.8% 24.4% 40.0% 20.0% |32.4% 17.1% 11.4% 15.5% |
|TERMINAL (d) | 0/6 (0%) 2/8 (25%) 3/9 (33%) 0/8 (0%) |1/5 (20%) 0/4 (0%) 1/7 (14%) 0/5 (0%) |
|FIRST INCIDENCE | 153 274 (T) 260 166 |254 83 274 (T) 217 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.487 P=0.542 P=0.292 P=0.558 |P=0.385N P=0.560N P=0.403N P=0.521N |
|POLY 3 | P=0.507 P=0.487 P=0.203 P=0.559 |P=0.367N P=0.522N P=0.373N P=0.482N |
|POLY 1.5 | P=0.457 P=0.479 P=0.178 P=0.534 |P=0.376N P=0.498N P=0.386N P=0.480N |
|POLY 6 | P=0.563 P=0.513 P=0.239 P=0.590 |P=0.366N P=0.552N P=0.393N P=0.494N |
|LOGISTIC REGRESSION| P=0.317 P=0.506 P=0.047 * P=0.217 |P=0.396N P=0.508N P=0.363N P=0.497N |
|COCH-ARM / FISHERS | P=0.374 P=0.500 P=0.152 P=0.500 |P=0.404N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.297 (e) (e) (e) |P=0.324N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 2/10 (20%) 2/10 (20%) |1/10 (10%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 1/7.65 1/8.19 2/9.85 2/9.22 |1/5.97 0/4.87 0/8.76 2/6.47 |
|POLY-3 PERCENT (g) | 13.1% 12.2% 20.3% 21.7% |16.8% 0.0% 0.0% 30.9% |
|TERMINAL (d) | 1/6 (17%) 1/8 (13%) 2/9 (22%) 1/8 (13%) |1/5 (20%) 0/4 (0%) 0/7 (0%) 1/5 (20%) |
|FIRST INCIDENCE | 274 (T) 274 (T) 274 (T) 260 |274 (T) --- --- 217 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.415 P=0.702N P=0.649 P=0.615 |P=0.264 P=0.545N P=0.433N P=0.500 |
|POLY 3 | P=0.411 P=0.749N P=0.590 P=0.568 |P=0.276 P=0.541N P=0.424N P=0.531 |
|POLY 1.5 | P=0.382 P=0.762N P=0.555 P=0.539 |P=0.264 P=0.522N P=0.434N P=0.526 |
|POLY 6 | P=0.440 P=0.726N P=0.626 P=0.603 |P=0.282 P=0.557N P=0.430N P=0.530 |
|LOGISTIC REGRESSION| P=0.410 P=0.702N P=0.649 P=0.594 |P=0.248 (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.327 P=0.763N P=0.500 P=0.500 |P=0.239 P=0.500N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.509 (e) (e) (e) |P=0.122 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 97013 TEST: 99 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/7.65 2/8.19 0/9.85 0/9.08 |1/5.97 1/5.53 0/8.76 0/5.96 |
|POLY-3 PERCENT (g) | 0.0% 24.4% 0.0% 0.0% |16.8% 18.1% 0.0% 0.0% |
|TERMINAL (d) | 0/6 (0%) 2/8 (25%) 0/9 (0%) 0/8 (0%) |1/5 (20%) 0/4 (0%) 0/7 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 274 (T) --- --- |274 (T) 190 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355N P=0.298 (e) (e) |P=0.211N P=0.736 P=0.433N P=0.500N |
|POLY 3 | P=0.352N P=0.239 (e) (e) |P=0.210N P=0.754 P=0.424N P=0.500N |
|POLY 1.5 | P=0.375N P=0.225 (e) (e) |P=0.215N P=0.760 P=0.434N P=0.494N |
|POLY 6 | P=0.323N P=0.264 (e) (e) |P=0.208N P=0.750 P=0.430N P=0.511N |
|LOGISTIC REGRESSION| (e) P=0.298 (e) (e) |P=0.218N P=0.754 (e) (e) |
|COCH-ARM / FISHERS | P=0.403N P=0.237 (e) (e) |P=0.231N P=0.763N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.206N (e) (e) (e) |P=0.226N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/10 (60%) 5/10 (50%) 3/10 (30%) 6/10 (60%) |2/10 (20%) 1/10 (10%) 4/10 (40%) 1/10 (10%) |
|POLY-3 RATE (b) | 6/8.25 5/8.19 3/9.85 6/9.08 |2/6.96 1/5.50 4/9.15 1/6.66 |
|POLY-3 PERCENT (g) | 72.8% 61.1% 30.4% 66.1% |28.7% 18.2% 43.7% 15.0% |
|TERMINAL (d) | 5/6 (83%) 5/8 (63%) 3/9 (33%) 6/8 (75%) |1/5 (20%) 0/4 (0%) 3/7 (43%) 0/5 (0%) |
|FIRST INCIDENCE | 202 274 (T) 274 (T) 274 (T) |51 196 233 184 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.376N P=0.247N P=0.048N* P=0.380N |P=0.464N P=0.547N P=0.465 P=0.494N |
|POLY 3 | P=0.492N P=0.509N P=0.082N P=0.589N |P=0.468N P=0.588N P=0.463 P=0.517N |
|POLY 1.5 | P=0.520N P=0.538N P=0.116N P=0.627N |P=0.478N P=0.565N P=0.436 P=0.514N |
|POLY 6 | P=0.471N P=0.437N P=0.055N P=0.534N |P=0.473N P=0.598N P=0.457 P=0.522N |
|LOGISTIC REGRESSION| P=0.384N P=0.403N P=0.070N P=0.446N |P=0.490N P=0.490N P=0.297 P=0.511N |
|COCH-ARM / FISHERS | P=0.585 P=0.500N P=0.185N P=0.675N |P=0.500N P=0.500N P=0.314 P=0.500N |
|ORDER RESTRICTED | P=0.222N (e) (e) (e) |P=0.390N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 97013 TEST: 99 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Glomerulus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |1/10 (10%) 3/10 (30%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/7.65 0/8.19 0/9.85 0/9.08 |1/6.92 3/7.13 0/8.76 2/7.35 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |14.4% 42.1% 0.0% 27.2% |
|TERMINAL (d) | 0/6 (0%) 0/8 (0%) 0/9 (0%) 0/8 (0%) |0/5 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |98 94 --- 133 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.612 P=0.281 P=0.455N P=0.547 |
|POLY 3 | (e) (e) (e) (e) |P=0.601 P=0.291 P=0.453N P=0.522 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.595 P=0.289 P=0.456N P=0.517 |
|POLY 6 | (e) (e) (e) (e) |P=0.600 P=0.301 P=0.462N P=0.525 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.493 P=0.301 P=0.993N P=0.480 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.559 P=0.291 P=0.500N P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.358N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 1/10 (10%) 1/10 (10%) 1/10 (10%) |4/10 (40%) 2/10 (20%) 1/10 (10%) 4/10 (40%) |
|POLY-3 RATE (b) | 3/8.47 1/8.19 1/9.85 1/9.08 |4/6.17 2/4.87 1/8.76 4/6.96 |
|POLY-3 PERCENT (g) | 35.4% 12.2% 10.2% 11.0% |64.8% 41.1% 11.4% 57.5% |
|TERMINAL (d) | 2/6 (33%) 1/8 (13%) 1/9 (11%) 1/8 (13%) |3/5 (60%) 2/4 (50%) 1/7 (14%) 3/5 (60%) |
|FIRST INCIDENCE | 153 274 (T) 274 (T) 274 (T) |254 274 (T) 274 (T) 37 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.173N P=0.240N P=0.195N P=0.222N |P=0.577 P=0.447N P=0.080N P=0.663 |
|POLY 3 | P=0.205N P=0.299N P=0.232N P=0.260N |P=0.580N P=0.431N P=0.044N* P=0.615N |
|POLY 1.5 | P=0.211N P=0.310N P=0.256N P=0.276N |P=0.590N P=0.358N P=0.054N P=0.592N |
|POLY 6 | P=0.202N P=0.270N P=0.204N P=0.237N |P=0.586N P=0.507N P=0.051N P=0.673N |
|LOGISTIC REGRESSION| P=0.228N P=0.288N P=0.441N P=0.325N |P=0.582 P=0.474N P=0.054N P=0.674N |
|COCH-ARM / FISHERS | P=0.227N P=0.291N P=0.291N P=0.291N |P=0.524 P=0.314N P=0.152N P=0.675N |
|ORDER RESTRICTED | P=0.135N (e) (e) (e) |P=0.155N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 97013 TEST: 99 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/10 (60%) 3/10 (30%) 6/10 (60%) 3/10 (30%) |7/10 (70%) 6/10 (60%) 9/10 (90%) 5/10 (50%) |
|POLY-3 RATE (b) | 6/8.86 3/9.15 6/10.00 3/9.22 |7/7.17 6/6.77 9/9.56 5/6.66 |
|POLY-3 PERCENT (g) | 67.7% 32.8% 60.0% 32.5% |97.7% 88.7% 94.1% 75.1% |
|TERMINAL (d) | 4/6 (67%) 2/8 (25%) 5/9 (56%) 2/8 (25%) |5/5 (100%) 4/4 (100%) 7/7 (100%) 4/5 (80%) |
|FIRST INCIDENCE | 153 91 260 260 |51 96 229 184 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.137N P=0.137N P=0.317N P=0.107N |P=0.189N P=0.645 P=0.615N P=0.320N |
|POLY 3 | P=0.195N P=0.150N P=0.551N P=0.146N |P=0.150N P=0.754N P=0.879N P=0.302N |
|POLY 1.5 | P=0.207N P=0.168N P=0.602N P=0.164N |P=0.217N P=0.550N P=0.835 P=0.298N |
|POLY 6 | P=0.181N P=0.125N P=0.488N P=0.123N |P=0.132N P=1.000N P=0.987N P=0.373N |
|LOGISTIC REGRESSION| P=0.238N P=0.180N P=0.669N P=0.168N |P=0.135N P=0.574N P=0.692N P=0.225N |
|COCH-ARM / FISHERS | P=0.226N P=0.185N P=0.675N P=0.185N |P=0.304N P=0.500N P=0.291 P=0.325N |
|ORDER RESTRICTED | P=0.104N (e) (e) (e) |P=0.074N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/10 (60%) 7/10 (70%) 8/10 (80%) 7/10 (70%) |4/10 (40%) 4/10 (40%) 7/10 (70%) 6/10 (60%) |
|POLY-3 RATE (b) | 6/8.58 7/8.19 8/10.00 7/9.08 |4/5.97 4/4.87 7/9.58 6/6.66 |
|POLY-3 PERCENT (g) | 70.0% 85.5% 80.0% 77.1% |67.0% 82.2% 73.0% 90.1% |
|TERMINAL (d) | 4/6 (67%) 7/8 (88%) 7/9 (78%) 7/8 (88%) |4/5 (80%) 4/4 (100%) 5/7 (71%) 5/5 (100%) |
|FIRST INCIDENCE | 211 274 (T) 260 274 (T) |274 (T) 274 (T) 226 184 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.458N P=0.568N P=0.543N P=0.546N |P=0.182 P=0.545 P=0.479 P=0.257 |
|POLY 3 | P=0.545 P=0.428 P=0.516 P=0.580 |P=0.280 P=0.556 P=0.618 P=0.364 |
|POLY 1.5 | P=0.505 P=0.422 P=0.438 P=0.550 |P=0.249 P=0.642 P=0.514 P=0.359 |
|POLY 6 | P=0.562 P=0.467 P=0.583 P=0.601 |P=0.272 P=0.457 P=0.656 P=0.337 |
|LOGISTIC REGRESSION| P=0.516N P=0.571 P=0.585 P=0.692N |P=0.150 P=0.545 P=0.533 P=0.236 |
|COCH-ARM / FISHERS | P=0.408 P=0.500 P=0.314 P=0.500 |P=0.181 P=0.675N P=0.185 P=0.328 |
|ORDER RESTRICTED | P=0.465 (e) (e) (e) |P=0.243 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 97013 TEST: 99 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/7.65 0/8.19 1/9.85 0/9.08 |0/5.97 0/4.87 2/9.58 0/5.96 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.2% 0.0% |0.0% 0.0% 20.9% 0.0% |
|TERMINAL (d) | 0/6 (0%) 0/8 (0%) 1/9 (11%) 0/8 (0%) |0/5 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- 274 (T) --- |--- --- 226 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.729 (e) P=0.581 (e) |P=0.600 (e) P=0.331 (e) |
|POLY 3 | P=0.749 (e) P=0.550 (e) |P=0.610 (e) P=0.349 (e) |
|POLY 1.5 | P=0.729 (e) P=0.530 (e) |P=0.617 (e) P=0.323 (e) |
|POLY 6 | P=0.769 (e) P=0.570 (e) |P=0.585 (e) P=0.357 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.581 (e) |P=0.608 (e) P=0.204 (e) |
|COCH-ARM / FISHERS | P=0.696 (e) P=0.500 (e) |P=0.597 (e) P=0.237 (e) |
|ORDER RESTRICTED | P=0.425 (e) (e) (e) |P=0.331 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) |3/10 (30%) 0/10 (0%) 1/10 (10%) 1/9 (11%) |
|POLY-3 RATE (b) | 0/7.65 1/8.19 1/10.00 0/9.08 |3/6.17 0/4.87 1/8.76 1/5.92 |
|POLY-3 PERCENT (g) | 0.0% 12.2% 10.0% 0.0% |48.6% 0.0% 11.4% 16.9% |
|TERMINAL (d) | 0/6 (0%) 1/8 (13%) 0/9 (0%) 0/8 (0%) |2/5 (40%) 0/4 (0%) 1/7 (14%) 1/5 (20%) |
|FIRST INCIDENCE | --- 274 (T) 260 --- |254 --- 274 (T) 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.537N P=0.557 P=0.602 (e) |P=0.257N P=0.168N P=0.196N P=0.309N |
|POLY 3 | P=0.545N P=0.514 P=0.553 (e) |P=0.232N P=0.123N P=0.159N P=0.288N |
|POLY 1.5 | P=0.566N P=0.502 P=0.532 (e) |P=0.253N P=0.100N P=0.172N P=0.282N |
|POLY 6 | P=0.521N P=0.534 P=0.575 (e) |P=0.224N P=0.150N P=0.173N P=0.319N |
|LOGISTIC REGRESSION| P=0.566N P=0.557 P=0.510 (e) |P=0.247N P=0.134N P=0.156N P=0.289N |
|COCH-ARM / FISHERS | P=0.597N P=0.500 P=0.500 (e) |P=0.315N P=0.105N P=0.291N P=0.333N |
|ORDER RESTRICTED | P=0.412N (e) (e) (e) |P=0.071N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 97013 TEST: 99 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Infiltration Cellular Plasma Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) |
|POLY-3 RATE (b) | 2/8.03 0/8.19 0/9.85 0/9.08 |0/5.97 1/4.87 0/8.76 0/5.92 |
|POLY-3 PERCENT (g) | 24.9% 0.0% 0.0% 0.0% |0.0% 20.6% 0.0% 0.0% |
|TERMINAL (d) | 1/6 (17%) 0/8 (0%) 0/9 (0%) 0/8 (0%) |0/5 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 233 --- --- --- |--- 274 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.088N P=0.195N P=0.161N P=0.183N |P=0.553N P=0.455 (e) (e) |
|POLY 3 | P=0.101N P=0.218N P=0.179N P=0.195N |P=0.592N P=0.458 (e) (e) |
|POLY 1.5 | P=0.098N P=0.228N P=0.195N P=0.207N |P=0.579N P=0.478 (e) (e) |
|POLY 6 | P=0.107N P=0.203N P=0.165N P=0.184N |P=0.601N P=0.442 (e) (e) |
|LOGISTIC REGRESSION| P=0.108N P=0.225N P=0.230N P=0.221N |(e) P=0.455 (e) (e) |
|COCH-ARM / FISHERS | P=0.110N P=0.237N P=0.237N P=0.237N |P=0.585N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.015N* (e) (e) (e) |P=0.341N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/10 (10%) 0/10 (0%) 3/10 (30%) 1/10 (10%) |
|POLY-3 RATE (b) | |1/5.97 0/4.87 3/8.76 1/5.96 |
|POLY-3 PERCENT (g) | |16.8% 0.0% 34.3% 16.8% |
|TERMINAL (d) | |1/5 (20%) 0/4 (0%) 3/7 (43%) 1/5 (20%) |
|FIRST INCIDENCE | |274 (T) --- 274 (T) 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.507 P=0.545N P=0.421 P=0.773 |
|POLY 3 | |P=0.511 P=0.541N P=0.446 P=0.770 |
|POLY 1.5 | |P=0.507 P=0.522N P=0.424 P=0.762N |
|POLY 6 | |P=0.493 P=0.557N P=0.432 P=0.760 |
|LOGISTIC REGRESSION| |P=0.507 (e) P=0.421 P=0.773 |
|COCH-ARM / FISHERS | |P=0.468 P=0.500N P=0.291 P=0.763N |
|ORDER RESTRICTED | |P=0.361 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 97013 TEST: 99 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/10 (10%) 1/10 (10%) 2/10 (20%) 1/10 (10%) |
|POLY-3 RATE (b) | |1/6.17 1/5.81 2/9.20 1/5.96 |
|POLY-3 PERCENT (g) | |16.2% 17.2% 21.7% 16.8% |
|TERMINAL (d) | |0/5 (0%) 0/4 (0%) 1/7 (14%) 1/5 (20%) |
|FIRST INCIDENCE | |254 104 226 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.618 P=0.716 P=0.614 P=0.740 |
|POLY 3 | |P=0.594 P=0.756 P=0.639 P=0.762 |
|POLY 1.5 | |P=0.605 P=0.768 P=0.620 P=0.766N |
|POLY 6 | |P=0.566 P=0.739 P=0.631 P=0.744 |
|LOGISTIC REGRESSION| |P=0.610 P=0.768N P=0.596 P=0.775 |
|COCH-ARM / FISHERS | |P=0.596 P=0.763N P=0.500 P=0.763N |
|ORDER RESTRICTED | |P=0.677 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 1/10 (10%) 2/10 (20%) |0/10 (0%) 1/10 (10%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/7.65 2/8.19 1/9.85 2/9.08 |0/5.97 1/5.84 1/8.76 1/5.96 |
|POLY-3 PERCENT (g) | 13.1% 24.4% 10.2% 22.0% |0.0% 17.1% 11.4% 16.8% |
|TERMINAL (d) | 1/6 (17%) 2/8 (25%) 1/9 (11%) 2/8 (25%) |0/5 (0%) 0/4 (0%) 1/7 (14%) 1/5 (20%) |
|FIRST INCIDENCE | 274 (T) 274 (T) 274 (T) 274 (T) |--- 83 274 (T) 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.528 P=0.607 P=0.673N P=0.607 |P=0.396 P=0.521 P=0.567 P=0.500 |
|POLY 3 | P=0.516 P=0.525 P=0.702N P=0.562 |P=0.388 P=0.495 P=0.574 P=0.500 |
|POLY 1.5 | P=0.489 P=0.503 P=0.726N P=0.536 |P=0.396 P=0.505 P=0.564 P=0.506 |
|POLY 6 | P=0.542 P=0.562 P=0.675N P=0.593 |P=0.369 P=0.485 P=0.569 P=0.489 |
|LOGISTIC REGRESSION| P=0.528 P=0.607 P=0.673N P=0.607 |P=0.379 P=0.439 P=0.567 P=0.500 |
|COCH-ARM / FISHERS | P=0.441 P=0.500 P=0.763N P=0.500 |P=0.380 P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.511 (e) (e) (e) |P=0.318 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 97013 TEST: 99 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%) |0/10 (0%) 0/10 (0%) 2/10 (20%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/7.65 1/8.19 0/9.85 1/9.08 |0/5.97 0/4.87 2/8.76 1/5.96 |
|POLY-3 PERCENT (g) | 0.0% 12.2% 0.0% 11.0% |0.0% 0.0% 22.8% 16.8% |
|TERMINAL (d) | 0/6 (0%) 1/8 (13%) 0/9 (0%) 1/8 (13%) |0/5 (0%) 0/4 (0%) 2/7 (29%) 1/5 (20%) |
|FIRST INCIDENCE | --- 274 (T) --- 274 (T) |--- --- 274 (T) 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.448 P=0.557 (e) P=0.557 |P=0.253 (e) P=0.308 P=0.500 |
|POLY 3 | P=0.455 P=0.514 (e) P=0.534 |P=0.256 (e) P=0.322 P=0.500 |
|POLY 1.5 | P=0.434 P=0.502 (e) P=0.520 |P=0.258 (e) P=0.309 P=0.506 |
|POLY 6 | P=0.479 P=0.534 (e) P=0.551 |P=0.240 (e) P=0.313 P=0.489 |
|LOGISTIC REGRESSION| (e) P=0.557 (e) P=0.557 |(e) (e) P=0.308 P=0.500 |
|COCH-ARM / FISHERS | P=0.403 P=0.500 (e) P=0.500 |P=0.239 (e) P=0.237 P=0.500 |
|ORDER RESTRICTED | P=0.285 (e) (e) (e) |P=0.235 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 1/10 (10%) 0/10 (0%) |2/10 (20%) 1/10 (10%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/7.65 2/8.19 1/9.85 0/9.08 |2/5.97 1/4.87 0/8.76 1/6.47 |
|POLY-3 PERCENT (g) | 13.1% 24.4% 10.2% 0.0% |33.5% 20.6% 0.0% 15.5% |
|TERMINAL (d) | 1/6 (17%) 2/8 (25%) 1/9 (11%) 0/8 (0%) |2/5 (40%) 1/4 (25%) 0/7 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 274 (T) 274 (T) 274 (T) --- |274 (T) 274 (T) --- 217 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.180N P=0.607 P=0.673N P=0.443N |P=0.321N P=0.588N P=0.158N P=0.500N |
|POLY 3 | P=0.197N P=0.525 P=0.702N P=0.466N |P=0.318N P=0.579N P=0.141N P=0.469N |
|POLY 1.5 | P=0.214N P=0.503 P=0.726N P=0.480N |P=0.325N P=0.542N P=0.152N P=0.473N |
|POLY 6 | P=0.180N P=0.562 P=0.675N P=0.448N |P=0.315N P=0.610N P=0.144N P=0.470N |
|LOGISTIC REGRESSION| P=0.180N P=0.607 P=0.673N (e) |P=0.325N P=0.588N (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.238N P=0.500 P=0.763N P=0.500N |P=0.361N P=0.500N P=0.237N P=0.500N |
|ORDER RESTRICTED | P=0.192N (e) (e) (e) |P=0.153N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 97013 TEST: 99 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Control Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |2/10 (20%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/7.65 0/8.19 0/9.85 1/9.08 |2/5.97 0/4.87 0/8.76 1/5.96 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 11.0% |33.5% 0.0% 0.0% 16.8% |
|TERMINAL (d) | 0/6 (0%) 0/8 (0%) 0/9 (0%) 1/8 (13%) |2/5 (40%) 0/4 (0%) 0/7 (0%) 1/5 (20%) |
|FIRST INCIDENCE | --- --- --- 274 (T) |274 (T) --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.215 (e) (e) P=0.557 |P=0.428N P=0.277N P=0.158N P=0.500N |
|POLY 3 | P=0.220 (e) (e) P=0.534 |P=0.396N P=0.265N P=0.141N P=0.500N |
|POLY 1.5 | P=0.213 (e) (e) P=0.520 |P=0.417N P=0.242N P=0.152N P=0.489N |
|POLY 6 | P=0.226 (e) (e) P=0.551 |P=0.380N P=0.286N P=0.144N P=0.521N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.557 |P=0.428N (e) (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.196 (e) (e) P=0.500 |P=0.460N P=0.237N P=0.237N P=0.500N |
|ORDER RESTRICTED | P=0.151 (e) (e) (e) |P=0.101N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/10 (40%) 2/10 (20%) 3/10 (30%) 1/10 (10%) |3/10 (30%) 2/10 (20%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | 4/8.47 2/8.19 3/10.00 1/9.08 |3/6.17 2/4.87 1/8.76 2/5.96 |
|POLY-3 PERCENT (g) | 47.2% 24.4% 30.0% 11.0% |48.6% 41.1% 11.4% 33.5% |
|TERMINAL (d) | 3/6 (50%) 2/8 (25%) 2/9 (22%) 1/8 (13%) |2/5 (40%) 2/4 (50%) 1/7 (14%) 2/5 (40%) |
|FIRST INCIDENCE | 153 274 (T) 260 274 (T) |254 274 (T) 274 (T) 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.083N P=0.222N P=0.295N P=0.100N |P=0.345N P=0.636N P=0.196N P=0.519N |
|POLY 3 | P=0.104N P=0.326N P=0.394N P=0.117N |P=0.329N P=0.636N P=0.159N P=0.520N |
|POLY 1.5 | P=0.114N P=0.342N P=0.439N P=0.131N |P=0.340N P=0.570N P=0.172N P=0.494N |
|POLY 6 | P=0.096N P=0.285N P=0.337N P=0.098N |P=0.336N P=0.693N P=0.173N P=0.566N |
|LOGISTIC REGRESSION| P=0.112N P=0.308N P=0.574N P=0.156N |P=0.349N P=0.675N P=0.156N P=0.534N |
|COCH-ARM / FISHERS | P=0.133N P=0.314N P=0.500N P=0.152N |P=0.395N P=0.500N P=0.291N P=0.500N |
|ORDER RESTRICTED | P=0.073N (e) (e) (e) |P=0.236N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 97013 TEST: 99 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 2/8.25 0/8.19 0/9.85 0/9.08 |1/5.97 0/4.87 0/8.76 1/5.96 |
|POLY-3 PERCENT (g) | 24.3% 0.0% 0.0% 0.0% |16.8% 0.0% 0.0% 16.8% |
|TERMINAL (d) | 1/6 (17%) 0/8 (0%) 0/9 (0%) 0/8 (0%) |1/5 (20%) 0/4 (0%) 0/7 (0%) 1/5 (20%) |
|FIRST INCIDENCE | 202 --- --- --- |274 (T) --- --- 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.099N P=0.220N P=0.185N P=0.208N |P=0.623 P=0.545N P=0.433N P=0.773 |
|POLY 3 | P=0.098N P=0.224N P=0.184N P=0.201N |P=0.634 P=0.541N P=0.424N P=0.770 |
|POLY 1.5 | P=0.097N P=0.232N P=0.199N P=0.211N |P=0.624 P=0.522N P=0.434N P=0.762N |
|POLY 6 | P=0.103N P=0.210N P=0.170N P=0.190N |P=0.636 P=0.557N P=0.430N P=0.760 |
|LOGISTIC REGRESSION| P=0.123N P=0.226N P=0.329N P=0.259N |P=0.623 (e) (e) P=0.773 |
|COCH-ARM / FISHERS | P=0.110N P=0.237N P=0.237N P=0.237N |P=0.597 P=0.500N P=0.500N P=0.763N |
|ORDER RESTRICTED | P=0.016N* (e) (e) (e) |P=0.377 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 0/10 (0%) 1/10 (10%) | |
|POLY-3 RATE (b) | 1/7.65 2/8.19 0/9.85 1/9.08 | |
|POLY-3 PERCENT (g) | 13.1% 24.4% 0.0% 11.0% | |
|TERMINAL (d) | 1/6 (17%) 2/8 (25%) 0/9 (0%) 1/8 (13%) | |
|FIRST INCIDENCE | 274 (T) 274 (T) --- 274 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.429N P=0.607 P=0.419N P=0.702N | |
|POLY 3 | P=0.460N P=0.525 P=0.450N P=0.724N | |
|POLY 1.5 | P=0.475N P=0.503 P=0.469N P=0.740N | |
|POLY 6 | P=0.446N P=0.562 P=0.429N P=0.703N | |
|LOGISTIC REGRESSION| P=0.429N P=0.607 (e) P=0.702N | |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.500N P=0.763N | |
|ORDER RESTRICTED | P=0.318N (e) (e) (e) | |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 97013 TEST: 99 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/9 (11%) 0/10 (0%) 2/9 (22%) 1/9 (11%) |2/10 (20%) 6/10 (60%) 2/10 (20%) 2/10 (20%) |
|POLY-3 RATE (b) | 1/7.25 0/8.19 2/9.00 1/8.85 |2/7.92 6/10.00 2/9.62 2/7.35 |
|POLY-3 PERCENT (g) | 13.8% 0.0% 22.2% 11.3% |25.3% 60.0% 20.8% 27.2% |
|TERMINAL (d) | 0/5 (0%) 0/8 (0%) 2/9 (22%) 0/7 (0%) |0/5 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 202 --- 274 (T) 166 |51 83 226 133 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.547 P=0.523N P=0.648 P=0.749N |P=0.303N P=0.131 P=0.588N P=0.665N |
|POLY 3 | P=0.579 P=0.475N P=0.578 P=0.715N |P=0.332N P=0.162 P=0.630N P=0.682 |
|POLY 1.5 | P=0.552 P=0.483N P=0.548 P=0.733N |P=0.334N P=0.136 P=0.645N P=0.683 |
|POLY 6 | P=0.597 P=0.461N P=0.609 P=0.697N |P=0.333N P=0.179 P=0.626N P=0.682 |
|LOGISTIC REGRESSION| P=0.400 P=0.451N P=0.406 P=0.672 |P=0.442N P=0.040 * P=0.194 P=0.695 |
|COCH-ARM / FISHERS | P=0.488 P=0.474N P=0.500 P=0.765N |P=0.320N P=0.085 P=0.709N P=0.709N |
|ORDER RESTRICTED | P=0.432 (e) (e) (e) |P=0.326N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/9 (44%) 2/10 (20%) 1/9 (11%) 3/9 (33%) |3/10 (30%) 2/10 (20%) 2/10 (20%) 3/10 (30%) |
|POLY-3 RATE (b) | 4/7.63 2/8.19 1/9.00 3/8.22 |3/5.97 2/5.82 2/9.15 3/5.96 |
|POLY-3 PERCENT (g) | 52.4% 24.4% 11.1% 36.5% |50.3% 34.4% 21.9% 50.3% |
|TERMINAL (d) | 2/5 (40%) 2/8 (25%) 1/9 (11%) 2/7 (29%) |3/5 (60%) 1/4 (25%) 1/7 (14%) 3/5 (60%) |
|FIRST INCIDENCE | 202 274 (T) 274 (T) 260 |274 (T) 96 233 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.346N P=0.190N P=0.068N P=0.340N |P=0.602 P=0.607N P=0.339N P=0.730 |
|POLY 3 | P=0.422N P=0.267N P=0.088N P=0.449N |P=0.598 P=0.514N P=0.288N P=0.716 |
|POLY 1.5 | P=0.433N P=0.276N P=0.105N P=0.469N |P=0.590 P=0.491N P=0.323N P=0.692N |
|POLY 6 | P=0.417N P=0.248N P=0.075N P=0.427N |P=0.591 P=0.543N P=0.285N P=0.691 |
|LOGISTIC REGRESSION| P=0.422N P=0.240N P=0.167N P=0.453N |P=0.604N P=0.561N P=0.309N P=0.730 |
|COCH-ARM / FISHERS | P=0.470N P=0.259N P=0.147N P=0.500N |P=0.549 P=0.500N P=0.500N P=0.686N |
|ORDER RESTRICTED | P=0.167N (e) (e) (e) |P=0.446N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 97013 TEST: 99 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |2/10 (20%) 3/10 (30%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/7.65 0/8.19 0/9.85 3/9.08 |2/6.93 3/5.53 1/9.15 1/5.96 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 33.1% |28.9% 54.2% 10.9% 16.8% |
|TERMINAL (d) | 0/6 (0%) 0/8 (0%) 0/9 (0%) 3/8 (38%) |1/5 (20%) 2/4 (50%) 0/7 (0%) 1/5 (20%) |
|FIRST INCIDENCE | --- --- --- 274 (T) |96 190 233 274 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * (e) (e) P=0.159 |P=0.241N P=0.424 P=0.416N P=0.500N |
|POLY 3 | P=0.007 ** (e) (e) P=0.125 |P=0.253N P=0.375 P=0.399N P=0.557N |
|POLY 1.5 | P=0.006 ** (e) (e) P=0.111 |P=0.251N P=0.417 P=0.412N P=0.532N |
|POLY 6 | P=0.007 ** (e) (e) P=0.144 |P=0.262N P=0.357 P=0.403N P=0.581N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.159 |P=0.242N P=0.467 P=0.655N P=0.497N |
|COCH-ARM / FISHERS | P=0.010 * (e) (e) P=0.105 |P=0.263N P=0.500 P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.007 ** (e) (e) (e) |P=0.224N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |5/10 (50%) 4/10 (40%) 5/10 (50%) 7/10 (70%) |
|POLY-3 RATE (b) | |5/5.97 4/4.87 5/8.76 7/7.16 |
|POLY-3 PERCENT (g) | |83.8% 82.2% 57.1% 97.7% |
|TERMINAL (d) | |5/5 (100%) 4/4 (100%) 5/7 (71%) 5/5 (100%) |
|FIRST INCIDENCE | |274 (T) 274 (T) 274 (T) 184 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.150 P=1.000N P=0.308N P=0.257 |
|POLY 3 | |P=0.319 P=0.822N P=0.301N P=0.544 |
|POLY 1.5 | |P=0.258 P=0.639N P=0.367N P=0.420 |
|POLY 6 | |P=0.386 P=0.854 P=0.313N P=0.679 |
|LOGISTIC REGRESSION| |P=0.124 P=1.000N P=0.308N P=0.244 |
|COCH-ARM / FISHERS | |P=0.181 P=0.500N P=0.672N P=0.325 |
|ORDER RESTRICTED | |P=0.136 (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).