TDMS Study 97013-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 06/11/04
EXPERIMENT: 97013 TEST: 08 TIME: 08:49:00
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: 97013G
PATHOLOGIST: MISSING CAS: 75-27-4
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/KG
INCLUDE 002 0 MG/KG
INCLUDE 003 25 MG/KG
INCLUDE 004 25 MG/KG
INCLUDE 005 50 MG/KG
INCLUDE 006 50 MG/KG
INCLUDE 007 100 MG/KG
INCLUDE 008 100 MG/KG
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 06/11/04
EXPERIMENT: 97013 TEST: 08 TIME: 08:49:00
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: 97013G
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
Kidney: Renal Tubule Degeneration
Hypertrophy
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Hypertrophy
Liver: Hepatocyte Fatty Change
Vacuolization Cytoplasmic
Spleen: Lymphoid Follicle Atrophy
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMO
DICHLOR
Terminal Sacrifice at 26 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) | 6/15 (40%) 8/15 (53%) 5/15 (33%) 7/15 (47%) |0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 6/13.17 8/14.49 5/12.95 7/15.00 |0/13.13 0/14.48 0/13.51 0/13.35 |
|POLY-3 PERCENT (g) | 45.6% 55.2% 38.6% 46.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 6/13 (46%) 8/14 (57%) 5/12 (42%) 7/15 (47%) |0/11 (0%) 0/14 (0%) 0/13 (0%) 0/13 (0%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) 182 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.487N P=0.428 P=0.569N P=0.635 |(e) (e) (e) (e) |
|POLY 3 | P=0.507N P=0.451 P=0.514N P=0.621 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.527N P=0.440 P=0.490N P=0.598 |(e) (e) (e) (e) |
|POLY 6 | P=0.495N P=0.444 P=0.546N P=0.631 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.487N P=0.428 P=0.569N P=0.635 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.535 P=0.358 P=0.500N P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.539N (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) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 0/15 (0%) |7/15 (47%) 10/15 (67%) 8/15 (53%) 6/15 (40%) |
|POLY-3 RATE (b) | 0/13.17 2/14.49 0/12.95 0/15.00 |7/13.36 10/15.00 8/13.51 6/13.35 |
|POLY-3 PERCENT (g) | 0.0% 13.8% 0.0% 0.0% |52.4% 66.7% 59.2% 45.0% |
|TERMINAL (d) | 0/13 (0%) 2/14 (14%) 0/12 (0%) 0/15 (0%) |6/11 (55%) 9/14 (64%) 8/13 (62%) 6/13 (46%) |
|FIRST INCIDENCE | --- 182 (T) --- --- |168 143 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.383N P=0.252 (e) (e) |P=0.197N P=0.488 P=0.618N P=0.349N |
|POLY 3 | P=0.366N P=0.254 (e) (e) |P=0.313N P=0.350 P=0.513 P=0.501N |
|POLY 1.5 | P=0.371N P=0.251 (e) (e) |P=0.308N P=0.318 P=0.520 P=0.505N |
|POLY 6 | P=0.366N P=0.252 (e) (e) |P=0.305N P=0.391 P=0.521 P=0.485N |
|LOGISTIC REGRESSION| (e) P=0.252 (e) (e) |P=0.291N P=0.302 P=0.579 P=0.442N |
|COCH-ARM / FISHERS | P=0.404N P=0.241 (e) (e) |P=0.285N P=0.231 P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.233N (e) (e) (e) |P=0.356N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 26 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) | 3/15 (20%) 0/15 (0%) 0/15 (0%) 6/15 (40%) |4/15 (27%) 5/15 (33%) 5/15 (33%) 4/15 (27%) |
|POLY-3 RATE (b) | 3/14.01 0/14.49 0/12.95 6/15.00 |4/13.68 5/14.48 5/15.00 4/13.35 |
|POLY-3 PERCENT (g) | 21.4% 0.0% 0.0% 40.0% |29.2% 34.5% 33.3% 30.0% |
|TERMINAL (d) | 2/13 (15%) 0/14 (0%) 0/12 (0%) 6/15 (40%) |2/11 (18%) 5/14 (36%) 3/13 (23%) 4/13 (31%) |
|FIRST INCIDENCE | 98 --- --- 182 (T) |161 183 (T) 104 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058 P=0.109N P=0.126N P=0.298 |P=0.483N P=0.639 P=0.569 P=0.571N |
|POLY 3 | P=0.026 * P=0.099N P=0.120N P=0.252 |P=0.559N P=0.540 P=0.564 P=0.644 |
|POLY 1.5 | P=0.026 * P=0.098N P=0.111N P=0.248 |P=0.555N P=0.538 P=0.552 P=0.648 |
|POLY 6 | P=0.027 * P=0.102N P=0.129N P=0.252 |P=0.558N P=0.540 P=0.576 P=0.644 |
|LOGISTIC REGRESSION| P=0.031 * P=0.148N P=0.120N P=0.187 |P=0.538N P=0.546 P=0.472 P=0.657N |
|COCH-ARM / FISHERS | P=0.038 * P=0.112N P=0.112N P=0.213 |P=0.538N P=0.500 P=0.500 P=0.659N |
|ORDER RESTRICTED | P=0.005 ** (e) (e) (e) |P=0.659 (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) | 0/15 (0%) 1/15 (7%) 0/15 (0%) 0/15 (0%) |0/15 (0%) 0/15 (0%) 1/15 (7%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.17 1/14.49 0/12.95 0/15.00 |0/13.13 0/14.48 1/13.51 2/13.35 |
|POLY-3 PERCENT (g) | 0.0% 6.9% 0.0% 0.0% |0.0% 0.0% 7.4% 15.0% |
|TERMINAL (d) | 0/13 (0%) 1/14 (7%) 0/12 (0%) 0/15 (0%) |0/11 (0%) 0/14 (0%) 1/13 (8%) 2/13 (15%) |
|FIRST INCIDENCE | --- 182 (T) --- --- |--- --- 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.549N P=0.515 (e) (e) |P=0.073 (e) P=0.533 P=0.273 |
|POLY 3 | P=0.550N P=0.519 (e) (e) |P=0.063 (e) P=0.506 P=0.234 |
|POLY 1.5 | P=0.552N P=0.517 (e) (e) |P=0.063 (e) P=0.505 P=0.231 |
|POLY 6 | P=0.551N P=0.518 (e) (e) |P=0.065 (e) P=0.510 P=0.241 |
|LOGISTIC REGRESSION| (e) P=0.515 (e) (e) |(e) (e) P=0.533 P=0.273 |
|COCH-ARM / FISHERS | P=0.568N P=0.500 (e) (e) |P=0.067 (e) P=0.500 P=0.241 |
|ORDER RESTRICTED | P=0.376N (e) (e) (e) |P=0.071 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 26 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) | 2/15 (13%) 8/15 (53%) 3/15 (20%) 4/15 (27%) |1/15 (7%) 3/15 (20%) 3/15 (20%) 1/15 (7%) |
|POLY-3 RATE (b) | 2/13.17 8/14.49 3/12.95 4/15.00 |1/13.13 3/14.48 3/13.51 1/13.35 |
|POLY-3 PERCENT (g) | 15.2% 55.2% 23.2% 26.7% |7.6% 20.7% 22.2% 7.5% |
|TERMINAL (d) | 2/13 (15%) 8/14 (57%) 3/12 (25%) 4/15 (27%) |1/11 (9%) 3/14 (21%) 3/13 (23%) 1/13 (8%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) 182 (T) |183 (T) 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.511N P=0.035 * P=0.461 P=0.398 |P=0.455N P=0.390 P=0.360 P=0.727N |
|POLY 3 | P=0.498N P=0.029 * P=0.492 P=0.392 |P=0.499N P=0.334 P=0.307 P=0.758N |
|POLY 1.5 | P=0.517N P=0.028 * P=0.506 P=0.379 |P=0.503N P=0.326 P=0.307 P=0.760N |
|POLY 6 | P=0.490N P=0.028 * P=0.474 P=0.398 |P=0.484N P=0.346 P=0.314 P=0.751N |
|LOGISTIC REGRESSION| P=0.511N P=0.035 * P=0.461 P=0.398 |P=0.455N P=0.390 P=0.360 P=0.727N |
|COCH-ARM / FISHERS | P=0.558 P=0.025 * P=0.500 P=0.326 |P=0.500N P=0.299 P=0.299 P=0.759N |
|ORDER RESTRICTED | P=0.182 (e) (e) (e) |P=0.397N (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) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 4/15 (27%) |0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.17 0/14.49 0/12.95 4/15.00 |0/13.13 0/14.48 1/13.51 0/13.35 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 26.7% |0.0% 0.0% 7.4% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 4/15 (27%) |0/11 (0%) 0/14 (0%) 1/13 (8%) 0/13 (0%) |
|FIRST INCIDENCE | --- --- --- 182 (T) |--- --- 183 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** (e) (e) P=0.074 |P=0.710 (e) P=0.533 (e) |
|POLY 3 | P<0.001 ** (e) (e) P=0.062 |P=0.689 (e) P=0.506 (e) |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.059 |P=0.686 (e) P=0.505 (e) |
|POLY 6 | P<0.001 ** (e) (e) P=0.064 |P=0.697 (e) P=0.510 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.074 |(e) (e) P=0.533 (e) |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) P=0.050 |P=0.695 (e) P=0.500 (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.385 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 26 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) | 2/15 (13%) 1/15 (7%) 5/15 (33%) 4/15 (27%) |1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 2/13.17 1/14.49 5/14.48 4/15.00 |1/14.12 0/14.48 0/13.51 0/13.35 |
|POLY-3 PERCENT (g) | 15.2% 6.9% 34.5% 26.7% |7.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/13 (15%) 1/14 (7%) 3/12 (25%) 4/15 (27%) |0/11 (0%) 0/14 (0%) 0/13 (0%) 0/13 (0%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 113 182 (T) |41 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.190 P=0.473N P=0.202 P=0.398 |P=0.306N P=0.500N P=0.500N P=0.500N |
|POLY 3 | P=0.177 P=0.466N P=0.235 P=0.392 |P=0.305N P=0.495N P=0.509N P=0.511N |
|POLY 1.5 | P=0.167 P=0.470N P=0.230 P=0.379 |P=0.303N P=0.498N P=0.507N P=0.512N |
|POLY 6 | P=0.184 P=0.468N P=0.231 P=0.398 |P=0.310N P=0.490N P=0.506N P=0.506N |
|LOGISTIC REGRESSION| P=0.107 P=0.473N P=0.182 P=0.398 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.138 P=0.500N P=0.195 P=0.326 |P=0.305N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.158 (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 |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 4/15 (27%) 1/15 (7%) |1/15 (7%) 1/15 (7%) 1/15 (7%) 8/15 (53%) |
|POLY-3 RATE (b) | 0/13.17 0/14.49 4/12.95 1/15.00 |1/13.13 1/14.48 1/13.51 8/14.01 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 30.9% 6.7% |7.6% 6.9% 7.4% 57.1% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 4/12 (33%) 1/15 (7%) |1/11 (9%) 1/14 (7%) 1/13 (8%) 7/13 (54%) |
|FIRST INCIDENCE | --- --- 182 (T) 182 (T) |183 (T) 183 (T) 183 (T) 127 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.277 (e) P=0.045 * P=0.529 |P<0.001 ** P=0.710N P=0.727N P=0.018 * |
|POLY 3 | P=0.286 (e) P=0.041 * P=0.526 |P<0.001 ** P=0.739N P=0.755N P=0.004 ** |
|POLY 1.5 | P=0.273 (e) P=0.045 * P=0.521 |P<0.001 ** P=0.744N P=0.755N P=0.004 ** |
|POLY 6 | P=0.295 (e) P=0.036 * P=0.528 |P<0.001 ** P=0.732N P=0.751N P=0.006 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.045 * P=0.529 |P<0.001 ** P=0.710N P=0.727N P=0.008 ** |
|COCH-ARM / FISHERS | P=0.239 (e) P=0.050 P=0.500 |P<0.001 ** P=0.759N P=0.759N P=0.007 ** |
|ORDER RESTRICTED | P=0.057 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 26 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) | 6/15 (40%) 7/15 (47%) 9/15 (60%) 8/15 (53%) |11/15 (73%) 13/15 (87%) 13/15 (87%) 13/15 (87%) |
|POLY-3 RATE (b) | 6/13.17 7/14.49 9/12.95 8/15.00 |11/13.45 13/14.48 13/13.51 13/13.35 |
|POLY-3 PERCENT (g) | 45.6% 48.3% 69.5% 53.3% |81.8% 89.8% 96.2% 97.4% |
|TERMINAL (d) | 6/13 (46%) 7/14 (50%) 9/12 (75%) 8/15 (53%) |10/11 (91%) 13/14 (93%) 13/13 (100%) 13/13 (100%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) 182 (T) |161 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.390 P=0.572 P=0.149 P=0.500 |P=0.520 P=0.548N P=0.742 P=0.742 |
|POLY 3 | P=0.387 P=0.591 P=0.197 P=0.487 |P=0.104 P=0.473 P=0.253 P=0.218 |
|POLY 1.5 | P=0.361 P=0.580 P=0.228 P=0.462 |P=0.148 P=0.447 P=0.308 P=0.244 |
|POLY 6 | P=0.404 P=0.585 P=0.164 P=0.498 |P=0.089 P=0.510 P=0.225 P=0.218 |
|LOGISTIC REGRESSION| P=0.390 P=0.572 P=0.149 P=0.500 |P=0.191 P=0.674 P=0.400 P=0.401 |
|COCH-ARM / FISHERS | P=0.271 P=0.500 P=0.233 P=0.358 |P=0.279 P=0.326 P=0.326 P=0.326 |
|ORDER RESTRICTED | P=0.333 (e) (e) (e) |P=0.079 (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) | 1/15 (7%) 0/15 (0%) 1/15 (7%) 0/15 (0%) |1/15 (7%) 0/15 (0%) 4/15 (27%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/13.17 0/14.49 1/12.95 0/15.00 |1/13.13 0/14.48 4/13.51 1/13.35 |
|POLY-3 PERCENT (g) | 7.6% 0.0% 7.7% 0.0% |7.6% 0.0% 29.6% 7.5% |
|TERMINAL (d) | 1/13 (8%) 0/14 (0%) 1/12 (8%) 0/15 (0%) |1/11 (9%) 0/14 (0%) 4/13 (31%) 1/13 (8%) |
|FIRST INCIDENCE | 182 (T) --- 182 (T) --- |183 (T) --- 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.383N P=0.485N P=0.747 P=0.471N |P=0.479 P=0.452N P=0.217 P=0.727N |
|POLY 3 | P=0.399N P=0.481N P=0.758 P=0.474N |P=0.423 P=0.481N P=0.168 P=0.758N |
|POLY 1.5 | P=0.401N P=0.483N P=0.759N P=0.479N |P=0.421 P=0.485N P=0.168 P=0.760N |
|POLY 6 | P=0.396N P=0.482N P=0.750 P=0.472N |P=0.434 P=0.474N P=0.174 P=0.751N |
|LOGISTIC REGRESSION| P=0.383N (e) P=0.747 (e) |P=0.479 (e) P=0.217 P=0.727N |
|COCH-ARM / FISHERS | P=0.404N P=0.500N P=0.759N P=0.500N |P=0.442 P=0.500N P=0.165 P=0.759N |
|ORDER RESTRICTED | P=0.225N (e) (e) (e) |P=0.163 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 26 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) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |0/15 (0%) 5/15 (33%) 8/15 (53%) 7/15 (47%) |
|POLY-3 RATE (b) | 1/13.17 0/14.49 0/12.95 0/15.00 |0/13.13 5/14.48 8/13.51 7/13.35 |
|POLY-3 PERCENT (g) | 7.6% 0.0% 0.0% 0.0% |0.0% 34.5% 59.2% 52.5% |
|TERMINAL (d) | 1/13 (8%) 0/14 (0%) 0/12 (0%) 0/15 (0%) |0/11 (0%) 5/14 (36%) 8/13 (62%) 7/13 (54%) |
|FIRST INCIDENCE | 182 (T) --- --- --- |--- 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.296N P=0.485N P=0.516N P=0.471N |P=0.010 * P=0.047 * P=0.004 ** P=0.008 ** |
|POLY 3 | P=0.328N P=0.481N P=0.503N P=0.474N |P=0.003 ** P=0.023 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.324N P=0.483N P=0.498N P=0.479N |P=0.004 ** P=0.022 * P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.329N P=0.482N P=0.511N P=0.472N |P=0.004 ** P=0.026 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.296N (e) (e) (e) |(e) P=0.047 * P=0.004 ** P=0.008 ** |
|COCH-ARM / FISHERS | P=0.305N P=0.500N P=0.500N P=0.500N |P=0.008 ** P=0.021 * P<0.001 ** P=0.003 ** |
|ORDER RESTRICTED | P=0.100N (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) | 3/15 (20%) 1/15 (7%) 3/15 (20%) 3/15 (20%) |0/15 (0%) 6/15 (40%) 4/15 (27%) 3/15 (20%) |
|POLY-3 RATE (b) | 3/13.17 1/14.49 3/12.95 3/15.00 |0/13.13 6/14.48 4/13.51 3/13.35 |
|POLY-3 PERCENT (g) | 22.8% 6.9% 23.2% 20.0% |0.0% 41.4% 29.6% 22.5% |
|TERMINAL (d) | 3/13 (23%) 1/14 (7%) 3/12 (25%) 3/15 (20%) |0/11 (0%) 6/14 (43%) 4/13 (31%) 3/13 (23%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) 182 (T) |--- 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.514 P=0.271N P=0.636 P=0.602N |P=0.367 P=0.024 * P=0.076 P=0.144 |
|POLY 3 | P=0.498 P=0.262N P=0.666 P=0.607N |P=0.320 P=0.008 ** P=0.046 * P=0.107 |
|POLY 1.5 | P=0.488 P=0.266N P=0.667N P=0.619N |P=0.312 P=0.007 ** P=0.047 * P=0.105 |
|POLY 6 | P=0.506 P=0.264N P=0.648 P=0.601N |P=0.344 P=0.009 ** P=0.048 * P=0.112 |
|LOGISTIC REGRESSION| P=0.514 P=0.271N P=0.636 P=0.602N |(e) P=0.024 * P=0.076 P=0.144 |
|COCH-ARM / FISHERS | P=0.453 P=0.299N P=0.674N P=0.674N |P=0.317 P=0.008 ** P=0.050 P=0.112 |
|ORDER RESTRICTED | P=0.499 (e) (e) (e) |P=0.036 * (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 26 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 |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) |0/15 (0%) 0/15 (0%) 2/15 (13%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.17 0/14.49 0/12.95 1/15.00 |0/13.13 0/14.48 2/13.51 0/13.35 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.7% |0.0% 0.0% 14.8% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 1/15 (7%) |0/11 (0%) 0/14 (0%) 2/13 (15%) 0/13 (0%) |
|FIRST INCIDENCE | --- --- --- 182 (T) |--- --- 183 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.217 (e) (e) P=0.529 |P=0.617 (e) P=0.273 (e) |
|POLY 3 | P=0.212 (e) (e) P=0.526 |P=0.590 (e) P=0.237 (e) |
|POLY 1.5 | P=0.209 (e) (e) P=0.521 |P=0.587 (e) P=0.237 (e) |
|POLY 6 | P=0.214 (e) (e) P=0.528 |P=0.601 (e) P=0.241 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.529 |(e) (e) P=0.273 (e) |
|COCH-ARM / FISHERS | P=0.197 (e) (e) P=0.500 |P=0.596 (e) P=0.241 (e) |
|ORDER RESTRICTED | P=0.145 (e) (e) (e) |P=0.241 (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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |0/14 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/13.17 0/14.49 0/12.95 2/15.00 |0/13.12 0/14.48 0/13.51 1/14.01 |
|POLY-3 PERCENT (g) | 7.6% 0.0% 0.0% 13.3% |0.0% 0.0% 0.0% 7.1% |
|TERMINAL (d) | 1/13 (8%) 0/14 (0%) 0/12 (0%) 2/15 (13%) |0/11 (0%) 0/14 (0%) 0/13 (0%) 0/13 (0%) |
|FIRST INCIDENCE | 182 (T) --- --- 182 (T) |--- --- --- 127 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.273 P=0.485N P=0.516N P=0.551 |P=0.196 (e) (e) P=0.500 |
|POLY 3 | P=0.247 P=0.481N P=0.503N P=0.546 |P=0.201 (e) (e) P=0.513 |
|POLY 1.5 | P=0.245 P=0.483N P=0.498N P=0.537 |P=0.199 (e) (e) P=0.508 |
|POLY 6 | P=0.249 P=0.482N P=0.511N P=0.550 |P=0.206 (e) (e) P=0.522 |
|LOGISTIC REGRESSION| P=0.273 (e) (e) P=0.551 |P=0.328 (e) (e) P=0.681 |
|COCH-ARM / FISHERS | P=0.242 P=0.500N P=0.500N P=0.500 |P=0.202 (e) (e) P=0.517 |
|ORDER RESTRICTED | P=0.156 (e) (e) (e) |P=0.132 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 26 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 |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Infiltration Cellular Plasma Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 0/15 (0%) |1/14 (7%) 0/15 (0%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/13.17 2/15.00 0/12.95 0/15.00 |1/13.35 0/14.48 0/13.51 1/13.35 |
|POLY-3 PERCENT (g) | 0.0% 13.3% 0.0% 0.0% |7.5% 0.0% 0.0% 7.5% |
|TERMINAL (d) | 0/13 (0%) 1/14 (7%) 0/12 (0%) 0/15 (0%) |0/11 (0%) 0/14 (0%) 0/13 (0%) 1/13 (8%) |
|FIRST INCIDENCE | --- 143 --- --- |168 --- --- 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.387N P=0.264 (e) (e) |P=0.609 P=0.469N P=0.484N P=0.733N |
|POLY 3 | P=0.362N P=0.263 (e) (e) |P=0.593 P=0.484N P=0.498N P=0.761 |
|POLY 1.5 | P=0.369N P=0.256 (e) (e) |P=0.594 P=0.485N P=0.495N P=0.760N |
|POLY 6 | P=0.360N P=0.265 (e) (e) |P=0.593 P=0.481N P=0.496N P=0.758N |
|LOGISTIC REGRESSION| P=0.453N P=0.184 (e) (e) |P=0.610 P=0.468N P=0.451N P=0.758N |
|COCH-ARM / FISHERS | P=0.404N P=0.241 (e) (e) |P=0.608 P=0.483N P=0.483N P=0.741N |
|ORDER RESTRICTED | P=0.240N (e) (e) (e) |P=0.394 (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 |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |4/15 (27%) 2/15 (13%) 4/15 (27%) 4/15 (27%) |
|POLY-3 RATE (b) | |4/13.13 2/14.48 4/13.51 4/13.35 |
|POLY-3 PERCENT (g) | |30.5% 13.8% 29.6% 30.0% |
|TERMINAL (d) | |4/11 (36%) 2/14 (14%) 4/13 (31%) 4/13 (31%) |
|FIRST INCIDENCE | |183 (T) 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.522 P=0.213N P=0.556N P=0.556N |
|POLY 3 | |P=0.439 P=0.278N P=0.643N P=0.650N |
|POLY 1.5 | |P=0.440 P=0.289N P=0.642N P=0.656N |
|POLY 6 | |P=0.449 P=0.263N P=0.631N P=0.632N |
|LOGISTIC REGRESSION| |P=0.522 P=0.213N P=0.556N P=0.556N |
|COCH-ARM / FISHERS | |P=0.459 P=0.326N P=0.659N P=0.659N |
|ORDER RESTRICTED | |P=0.502 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 26 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 |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 2/15 (13%) 1/15 (7%) 1/15 (7%) |1/15 (7%) 0/15 (0%) 1/15 (7%) 2/15 (13%) |
|POLY-3 RATE (b) | 2/14.01 2/14.49 1/12.95 1/15.00 |1/13.45 0/14.48 1/13.51 2/13.35 |
|POLY-3 PERCENT (g) | 14.3% 13.8% 7.7% 6.7% |7.4% 0.0% 7.4% 15.0% |
|TERMINAL (d) | 1/13 (8%) 2/14 (14%) 1/12 (8%) 1/15 (7%) |0/11 (0%) 0/14 (0%) 1/13 (8%) 2/13 (15%) |
|FIRST INCIDENCE | 98 182 (T) 182 (T) 182 (T) |161 --- 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.302N P=0.670N P=0.511N P=0.459N |P=0.260 P=0.485N P=0.742N P=0.539 |
|POLY 3 | P=0.323N P=0.687N P=0.528N P=0.476N |P=0.231 P=0.485N P=0.760N P=0.497 |
|POLY 1.5 | P=0.324N P=0.684N P=0.511N P=0.478N |P=0.233 P=0.488N P=0.758N P=0.497 |
|POLY 6 | P=0.323N P=0.693N P=0.545N P=0.476N |P=0.232 P=0.483N P=0.760N P=0.502 |
|LOGISTIC REGRESSION| P=0.373N P=0.642 P=0.529N P=0.642N |P=0.238 P=0.545N P=0.768N P=0.501 |
|COCH-ARM / FISHERS | P=0.331N P=0.701N P=0.500N P=0.500N |P=0.242 P=0.500N P=0.759N P=0.500 |
|ORDER RESTRICTED | P=0.406N (e) (e) (e) |P=0.210 (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) | 1/15 (7%) 1/15 (7%) 2/15 (13%) 0/15 (0%) |0/15 (0%) 0/15 (0%) 2/15 (13%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/13.17 1/14.49 2/12.95 0/15.00 |0/13.13 0/14.48 2/13.51 1/13.35 |
|POLY-3 PERCENT (g) | 7.6% 6.9% 15.4% 0.0% |0.0% 0.0% 14.8% 7.5% |
|TERMINAL (d) | 1/13 (8%) 1/14 (7%) 2/12 (17%) 0/15 (0%) |0/11 (0%) 0/14 (0%) 2/13 (15%) 1/13 (8%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) --- |--- --- 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.334N P=0.748N P=0.471 P=0.471N |P=0.260 (e) P=0.273 P=0.533 |
|POLY 3 | P=0.328N P=0.739N P=0.494 P=0.474N |P=0.234 (e) P=0.237 P=0.503 |
|POLY 1.5 | P=0.336N P=0.742N P=0.504 P=0.479N |P=0.232 (e) P=0.237 P=0.501 |
|POLY 6 | P=0.324N P=0.741N P=0.481 P=0.472N |P=0.241 (e) P=0.241 P=0.509 |
|LOGISTIC REGRESSION| P=0.334N P=0.748N P=0.471 (e) |(e) (e) P=0.273 P=0.533 |
|COCH-ARM / FISHERS | P=0.363N P=0.759N P=0.500 P=0.500N |P=0.242 (e) P=0.241 P=0.500 |
|ORDER RESTRICTED | P=0.252N (e) (e) (e) |P=0.165 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 26 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: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 1/15 (7%) 0/15 (0%) |3/15 (20%) 0/15 (0%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/14.16 0/14.49 1/13.71 0/15.00 |3/14.67 0/14.48 0/13.51 1/14.33 |
|POLY-3 PERCENT (g) | 7.1% 0.0% 7.3% 0.0% |20.5% 0.0% 0.0% 7.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 0/15 (0%) |0/11 (0%) 0/14 (0%) 0/13 (0%) 0/13 (0%) |
|FIRST INCIDENCE | 41 --- 113 --- |41 --- --- 41 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.394N P=0.500N P=0.745N P=0.500N |P=0.247N P=0.111N P=0.119N P=0.300N |
|POLY 3 | P=0.400N P=0.495N P=0.754 P=0.488N |P=0.240N P=0.108N P=0.121N P=0.306N |
|POLY 1.5 | P=0.402N P=0.496N P=0.757 P=0.492N |P=0.239N P=0.107N P=0.116N P=0.304N |
|POLY 6 | P=0.397N P=0.497N P=0.749 P=0.487N |P=0.241N P=0.108N P=0.123N P=0.306N |
|LOGISTIC REGRESSION| P=0.527 (e) P=0.530 (e) |P=0.088N P=0.173N P=0.114N P=0.161N |
|COCH-ARM / FISHERS | P=0.404N P=0.500N P=0.759N P=0.500N |P=0.242N P=0.112N P=0.112N P=0.299N |
|ORDER RESTRICTED | P=0.240N (e) (e) (e) |P=0.034N* (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 |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 4/15 (27%) 1/15 (7%) 0/15 (0%) | |
|POLY-3 RATE (b) | 1/13.17 4/14.49 1/12.95 0/15.00 | |
|POLY-3 PERCENT (g) | 7.6% 27.6% 7.7% 0.0% | |
|TERMINAL (d) | 1/13 (8%) 4/14 (29%) 1/12 (8%) 0/15 (0%) | |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.136N P=0.189 P=0.747 P=0.471N | |
|POLY 3 | P=0.114N P=0.192 P=0.758 P=0.474N | |
|POLY 1.5 | P=0.119N P=0.189 P=0.759N P=0.479N | |
|POLY 6 | P=0.112N P=0.190 P=0.750 P=0.472N | |
|LOGISTIC REGRESSION| P=0.136N P=0.189 P=0.747 (e) | |
|COCH-ARM / FISHERS | P=0.154N P=0.165 P=0.759N P=0.500N | |
|ORDER RESTRICTED | P=0.085N (e) (e) (e) | |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 26 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 |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/14 (14%) 1/15 (7%) 3/15 (20%) 2/15 (13%) |2/13 (15%) 3/15 (20%) 1/15 (7%) 3/15 (20%) |
|POLY-3 RATE (b) | 2/14.00 1/14.49 3/15.00 2/15.00 |2/12.68 3/15.00 1/14.18 3/15.00 |
|POLY-3 PERCENT (g) | 14.3% 6.9% 20.0% 13.3% |15.8% 20.0% 7.1% 20.0% |
|TERMINAL (d) | 1/13 (8%) 1/14 (7%) 0/12 (0%) 2/15 (13%) |1/11 (9%) 2/14 (14%) 0/13 (0%) 1/13 (8%) |
|FIRST INCIDENCE | 98 182 (T) 113 182 (T) |41 143 126 41 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.544 P=0.475N P=0.525 P=0.651N |P=0.491 P=0.579 P=0.481N P=0.530 |
|POLY 3 | P=0.532 P=0.488N P=0.533 P=0.673N |P=0.534 P=0.579 P=0.460N P=0.579 |
|POLY 1.5 | P=0.529 P=0.483N P=0.533 P=0.673N |P=0.531 P=0.574 P=0.458N P=0.574 |
|POLY 6 | P=0.536 P=0.494N P=0.533 P=0.673N |P=0.540 P=0.587 P=0.458N P=0.587 |
|LOGISTIC REGRESSION| P=0.328 P=0.618N (e) P=0.651N |P=0.560N P=0.423 P=0.524N P=0.692 |
|COCH-ARM / FISHERS | P=0.524 P=0.473N P=0.535 P=0.674N |P=0.529 P=0.572 P=0.444N P=0.572 |
|ORDER RESTRICTED | P=0.504 (e) (e) (e) |P=0.546 (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 |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/14 (50%) 5/15 (33%) 4/15 (27%) 8/15 (53%) |2/13 (15%) 5/15 (33%) 5/15 (33%) 2/15 (13%) |
|POLY-3 RATE (b) | 7/14.00 5/15.00 4/13.71 8/15.00 |2/11.69 5/14.48 5/13.51 2/13.35 |
|POLY-3 PERCENT (g) | 50.0% 33.3% 29.2% 53.3% |17.1% 34.5% 37.0% 15.0% |
|TERMINAL (d) | 6/13 (46%) 4/14 (29%) 3/12 (25%) 8/15 (53%) |2/11 (18%) 5/14 (36%) 5/13 (39%) 2/13 (15%) |
|FIRST INCIDENCE | 98 143 113 182 (T) |183 (T) 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.467 P=0.307N P=0.268N P=0.632N |P=0.394N P=0.305 P=0.266 P=0.640N |
|POLY 3 | P=0.399 P=0.301N P=0.234N P=0.574 |P=0.409N P=0.292 P=0.255 P=0.651N |
|POLY 1.5 | P=0.402 P=0.301N P=0.213N P=0.574 |P=0.404N P=0.290 P=0.263 P=0.649N |
|POLY 6 | P=0.396 P=0.301N P=0.255N P=0.574 |P=0.408N P=0.293 P=0.250 P=0.651N |
|LOGISTIC REGRESSION| P=0.370 (e) P=0.148N P=0.632N |P=0.394N P=0.305 P=0.266 P=0.640N |
|COCH-ARM / FISHERS | P=0.408 P=0.297N P=0.181N P=0.576 |P=0.389N P=0.258 P=0.258 P=0.644N |
|ORDER RESTRICTED | P=0.309 (e) (e) (e) |P=0.322N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 26 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 |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 2/15 (13%) 0/15 (0%) 1/15 (7%) |2/15 (13%) 2/15 (13%) 3/15 (20%) 1/15 (7%) |
|POLY-3 RATE (b) | 2/13.17 2/14.49 0/12.95 1/15.00 |2/13.13 2/14.48 3/13.51 1/13.35 |
|POLY-3 PERCENT (g) | 15.2% 13.8% 0.0% 6.7% |15.2% 13.8% 22.2% 7.5% |
|TERMINAL (d) | 2/13 (15%) 2/14 (14%) 0/12 (0%) 1/15 (7%) |2/11 (18%) 2/14 (14%) 3/13 (23%) 1/13 (8%) |
|FIRST INCIDENCE | 182 (T) 182 (T) --- 182 (T) |183 (T) 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.262N P=0.675N P=0.253N P=0.449N |P=0.354N P=0.610N P=0.582 P=0.440N |
|POLY 3 | P=0.279N P=0.664N P=0.234N P=0.454N |P=0.408N P=0.663N P=0.514 P=0.494N |
|POLY 1.5 | P=0.281N P=0.668N P=0.227N P=0.463N |P=0.410N P=0.671N P=0.513 P=0.499N |
|POLY 6 | P=0.277N P=0.666N P=0.243N P=0.450N |P=0.397N P=0.652N P=0.524 P=0.483N |
|LOGISTIC REGRESSION| P=0.262N P=0.675N (e) P=0.449N |P=0.354N P=0.610N P=0.582 P=0.440N |
|COCH-ARM / FISHERS | P=0.290N P=0.701N P=0.241N P=0.500N |P=0.399N P=0.701N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.227N (e) (e) (e) |P=0.400N (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 |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |12/15 (80%) 9/15 (60%) 12/15 (80%) 13/15 (87%) |
|POLY-3 RATE (b) | |12/13.68 9/14.48 12/13.51 13/14.01 |
|POLY-3 PERCENT (g) | |87.7% 62.2% 88.8% 92.8% |
|TERMINAL (d) | |10/11 (91%) 9/14 (64%) 12/13 (92%) 12/13 (92%) |
|FIRST INCIDENCE | |161 183 (T) 183 (T) 127 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.397 P=0.044N* P=0.329N P=0.523N |
|POLY 3 | |P=0.185 P=0.122N P=0.704 P=0.577 |
|POLY 1.5 | |P=0.182 P=0.132N P=0.704N P=0.540 |
|POLY 6 | |P=0.207 P=0.116N P=0.688 P=0.634 |
|LOGISTIC REGRESSION| |P=0.150 P=0.088N P=0.737N P=0.474 |
|COCH-ARM / FISHERS | |P=0.235 P=0.213N P=0.674N P=0.500 |
|ORDER RESTRICTED | |P=0.140 (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).