TDMS Study 97013-93 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (SODIUM BROMATE) DATE: 12/08/03
EXPERIMENT: 97013 TEST: 93 TIME: 14:37:21
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: DOSED WATER NTP C#: 97013H
PATHOLOGIST: MISSING CAS: 7789-38-0
------------------------------------------------------------------------------------------------------------------------------------
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 (SODIUM BROMATE) DATE: 12/08/03
EXPERIMENT: 97013 TEST: 93 TIME: 14:37:21
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: DOSED WATER NTP C#: 97013H
PATHOLOGIST: MISSING CAS: 7789-38-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF WATER DISINFECTION MODEL (SODIUM BR
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Epididymis Infiltration Cellular Lymphocyte
Stomach, Forestomach Inflammation Chronic
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Angiectasis
Thyroid Gland: Follicle Cyst
===============================================================
Date: 12/08/03 EXPERIMENT: 97013 TEST: 93 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (SODI
UM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 1/10 (10%) 3/10 (30%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/9.82 1/9.07 1/9.48 3/9.43 |0/9.87 0/9.82 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 10.2% 11.0% 10.6% 31.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/9 (11%) 1/8 (13%) 1/8 (13%) 3/9 (33%) |0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 295 (T) 295 (T) 295 (T) 295 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.156 P=0.741 P=0.741 P=0.291 |(e) (e) (e) (e) |
|POLY 3 | P=0.144 P=0.743 P=0.753 P=0.275 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.146 P=0.751 P=0.756 P=0.281 |(e) (e) (e) (e) |
|POLY 6 | P=0.144 P=0.735 P=0.749 P=0.270 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.156 P=0.741 P=0.741 P=0.291 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.143 P=0.763N P=0.763N P=0.291 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.153 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 3/10 (30%) 2/10 (20%) 3/10 (30%) |8/10 (80%) 9/10 (90%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 3/9.82 3/9.40 2/9.48 3/9.43 |8/9.87 9/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 30.6% 31.9% 21.1% 31.8% |81.0% 90.0% 100.0% 100.0% |
|TERMINAL (d) | 3/9 (33%) 2/8 (25%) 2/8 (25%) 3/9 (33%) |8/9 (89%) 8/9 (89%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 295 (T) 258 295 (T) 295 (T) |295 (T) 276 295 (T) 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.535N P=0.618 P=0.560N P=0.686 |P=0.391 P=0.500 P=0.479 P=0.479 |
|POLY 3 | P=0.564N P=0.658 P=0.518N P=0.660 |P=0.103 P=0.527 P=0.241 P=0.241 |
|POLY 1.5 | P=0.559N P=0.666 P=0.510N P=0.667 |P=0.100 P=0.514 P=0.234 P=0.234 |
|POLY 6 | P=0.570N P=0.654 P=0.528N P=0.655 |P=0.109 P=0.552 P=0.257 P=0.257 |
|LOGISTIC REGRESSION| P=0.558N P=0.686 P=0.560N P=0.686 |P=0.138 P=0.465 P=0.479 P=0.479 |
|COCH-ARM / FISHERS | P=0.554N P=0.686N P=0.500N P=0.686N |P=0.097 P=0.500 P=0.237 P=0.237 |
|ORDER RESTRICTED | P=0.639N (e) (e) (e) |P=0.073 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 93 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (SODIU
M BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) | |
|POLY-3 RATE (b) | 0/9.82 2/9.07 0/9.48 0/9.43 | |
|POLY-3 PERCENT (g) | 0.0% 22.0% 0.0% 0.0% | |
|TERMINAL (d) | 0/9 (0%) 2/8 (25%) 0/8 (0%) 0/9 (0%) | |
|FIRST INCIDENCE | --- 295 (T) --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.259N P=0.207 (e) (e) | |
|POLY 3 | P=0.269N P=0.207 (e) (e) | |
|POLY 1.5 | P=0.262N P=0.215 (e) (e) | |
|POLY 6 | P=0.278N P=0.198 (e) (e) | |
|LOGISTIC REGRESSION| (e) P=0.207 (e) (e) | |
|COCH-ARM / FISHERS | P=0.259N P=0.237 (e) (e) | |
|ORDER RESTRICTED | P=0.218N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) | |
|POLY-3 RATE (b) | 0/9.82 0/9.07 0/9.48 2/9.43 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 21.2% | |
|TERMINAL (d) | 0/9 (0%) 0/8 (0%) 0/8 (0%) 2/9 (22%) | |
|FIRST INCIDENCE | --- --- --- 295 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047 * (e) (e) P=0.233 | |
|POLY 3 | P=0.035 * (e) (e) P=0.216 | |
|POLY 1.5 | P=0.035 * (e) (e) P=0.220 | |
|POLY 6 | P=0.035 * (e) (e) P=0.213 | |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.233 | |
|COCH-ARM / FISHERS | P=0.040 * (e) (e) P=0.237 | |
|ORDER RESTRICTED | P=0.020 * (e) (e) (e) | |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 93 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (SODIU
M BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) | |
|POLY-3 RATE (b) | 0/9.82 2/9.07 0/9.48 0/9.43 | |
|POLY-3 PERCENT (g) | 0.0% 22.0% 0.0% 0.0% | |
|TERMINAL (d) | 0/9 (0%) 2/8 (25%) 0/8 (0%) 0/9 (0%) | |
|FIRST INCIDENCE | --- 295 (T) --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.259N P=0.207 (e) (e) | |
|POLY 3 | P=0.269N P=0.207 (e) (e) | |
|POLY 1.5 | P=0.262N P=0.215 (e) (e) | |
|POLY 6 | P=0.278N P=0.198 (e) (e) | |
|LOGISTIC REGRESSION| (e) P=0.207 (e) (e) | |
|COCH-ARM / FISHERS | P=0.259N P=0.237 (e) (e) | |
|ORDER RESTRICTED | P=0.218N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/10 (90%) 7/10 (70%) 7/9 (78%) 7/10 (70%) |7/10 (70%) 7/10 (70%) 6/10 (60%) 8/10 (80%) |
|POLY-3 RATE (b) | 9/10.00 7/9.07 7/8.91 7/9.43 |7/10.00 7/10.00 6/10.00 8/10.00 |
|POLY-3 PERCENT (g) | 90.0% 77.2% 78.6% 74.2% |70.0% 70.0% 60.0% 80.0% |
|TERMINAL (d) | 8/9 (89%) 7/8 (88%) 7/8 (88%) 7/9 (78%) |6/9 (67%) 6/9 (67%) 6/10 (60%) 8/10 (80%) |
|FIRST INCIDENCE | 276 295 (T) 295 (T) 295 (T) |282 276 295 (T) 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.220N P=0.498N P=0.485N P=0.310N |P=0.574 P=0.648 P=0.395N P=0.631 |
|POLY 3 | P=0.326N P=0.443N P=0.481N P=0.376N |P=0.417 P=0.678 P=0.500N P=0.500 |
|POLY 1.5 | P=0.327N P=0.370N P=0.471N P=0.338N |P=0.417 P=0.678 P=0.500N P=0.500 |
|POLY 6 | P=0.324N P=0.553N P=0.498N P=0.423N |P=0.417 P=0.678 P=0.500N P=0.500 |
|LOGISTIC REGRESSION| P=0.250N P=0.576N P=0.429N P=0.395N |(e) (e) P=0.395N P=0.631 |
|COCH-ARM / FISHERS | P=0.326N P=0.291N P=0.458N P=0.291N |P=0.413 P=0.686N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.295N (e) (e) (e) |P=0.421 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 93 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (SODIU
M BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/9.82 0/9.07 0/9.48 0/9.43 |0/9.87 0/9.82 0/10.00 2/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/9 (0%) |0/9 (0%) 0/9 (0%) 0/10 (0%) 2/10 (20%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.049 * (e) (e) P=0.257 |
|POLY 3 | (e) (e) (e) (e) |P=0.036 * (e) (e) P=0.230 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.036 * (e) (e) P=0.228 |
|POLY 6 | (e) (e) (e) (e) |P=0.037 * (e) (e) P=0.232 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.257 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.024 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/10 (90%) 6/10 (60%) 8/10 (80%) 9/10 (90%) |9/10 (90%) 10/10 (100%) 8/10 (80%) 10/10 (100%) |
|POLY-3 RATE (b) | 9/9.82 6/9.40 8/9.48 9/9.43 |9/9.87 10/10.00 8/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 91.7% 63.8% 84.4% 95.4% |91.2% 100.0% 80.0% 100.0% |
|TERMINAL (d) | 9/9 (100%) 5/8 (63%) 8/8 (100%) 9/9 (100%) |9/9 (100%) 9/9 (100%) 8/10 (80%) 10/10 (100%) |
|FIRST INCIDENCE | 295 (T) 258 295 (T) 295 (T) |295 (T) 276 295 (T) 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.314 P=0.277N P=1.000N P=1.000N |P=0.377N P=0.500 P=0.257N P=1.000 |
|POLY 3 | P=0.215 P=0.167N P=0.589N P=0.748 |P=0.562 P=0.555 P=0.473N P=0.555 |
|POLY 1.5 | P=0.247 P=0.159N P=0.546N P=0.751 |P=0.546 P=0.526 P=0.486N P=0.526 |
|POLY 6 | P=0.180 P=0.169N P=0.661N P=0.772 |P=0.591 P=0.616 P=0.448N P=0.616 |
|LOGISTIC REGRESSION| P=0.218 P=0.263N P=1.000N P=1.000N |P=0.655N P=0.343 P=0.257N P=1.000 |
|COCH-ARM / FISHERS | P=0.290 P=0.152N P=0.500N P=0.763N |P=0.530 P=0.500 P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.202 (e) (e) (e) |P=0.315 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 93 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (SODIU
M BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/10 (70%) 9/10 (90%) 9/10 (90%) 6/10 (60%) |1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 7/9.82 9/9.40 9/10.00 6/10.00 |1/9.87 1/9.82 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 71.3% 95.7% 90.0% 60.0% |10.1% 10.2% 0.0% 0.0% |
|TERMINAL (d) | 7/9 (78%) 8/8 (100%) 7/8 (88%) 5/9 (56%) |1/9 (11%) 1/9 (11%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 295 (T) 258 244 223 |295 (T) 295 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.233N P=0.127 P=0.198 P=0.500N |P=0.189N P=0.767 P=0.479N P=0.479N |
|POLY 3 | P=0.167N P=0.191 P=0.315 P=0.478N |P=0.208N P=0.759 P=0.497N P=0.497N |
|POLY 1.5 | P=0.194N P=0.229 P=0.303 P=0.489N |P=0.209N P=0.760 P=0.499N P=0.499N |
|POLY 6 | P=0.135N P=0.159 P=0.336 P=0.460N |P=0.207N P=0.759 P=0.495N P=0.495N |
|LOGISTIC REGRESSION| P=0.240N P=0.092 P=0.275 P=0.477N |P=0.189N P=0.767 (e) (e) |
|COCH-ARM / FISHERS | P=0.235N P=0.291 P=0.291 P=0.500N |P=0.203N P=0.763N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.111N (e) (e) (e) |P=0.247N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/10 (90%) 9/10 (90%) 10/10 (100%) 10/10 (100%)|9/10 (90%) 10/10 (100%) 8/10 (80%) 10/10 (100%) |
|POLY-3 RATE (b) | 9/9.82 9/9.40 10/10.00 10/10.00 |9/9.87 10/10.00 8/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 91.7% 95.7% 100.0% 100.0% |91.2% 100.0% 80.0% 100.0% |
|TERMINAL (d) | 9/9 (100%) 8/8 (100%) 8/8 (100%) 9/9 (100%) |9/9 (100%) 9/9 (100%) 8/10 (80%) 10/10 (100%) |
|FIRST INCIDENCE | 295 (T) 258 244 223 |295 (T) 276 295 (T) 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.374 P=0.479 P=0.240 P=0.500 |P=0.377N P=0.500 P=0.257N P=1.000 |
|POLY 3 | P=0.289 P=0.742 P=0.583 P=0.583 |P=0.562 P=0.555 P=0.473N P=0.555 |
|POLY 1.5 | P=0.243 P=0.747 P=0.540 P=0.540 |P=0.546 P=0.526 P=0.486N P=0.526 |
|POLY 6 | P=0.398 P=0.764 P=0.680 P=0.680 |P=0.591 P=0.616 P=0.448N P=0.616 |
|LOGISTIC REGRESSION| P=0.112 P=0.348 P=0.372 P=0.417 |P=0.655N P=0.343 P=0.257N P=1.000 |
|COCH-ARM / FISHERS | P=0.203 P=0.763N P=0.500 P=0.500 |P=0.530 P=0.500 P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.159 (e) (e) (e) |P=0.315 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 93 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (SODIU
M BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Lung: Perivascular |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |4/10 (40%) 3/10 (30%) 4/10 (40%) 2/9 (22%) |
|POLY-3 RATE (b) | 0/9.82 0/9.07 0/9.48 0/9.43 |4/9.87 3/9.82 4/10.00 2/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |40.5% 30.6% 40.0% 22.2% |
|TERMINAL (d) | 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/9 (0%) |4/9 (44%) 3/9 (33%) 4/10 (40%) 2/9 (22%) |
|FIRST INCIDENCE | --- --- --- --- |295 (T) 295 (T) 295 (T) 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.275N P=0.500N P=0.603N P=0.314N |
|POLY 3 | (e) (e) (e) (e) |P=0.341N P=0.503N P=0.660N P=0.365N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.346N P=0.502N P=0.664N P=0.368N |
|POLY 6 | (e) (e) (e) (e) |P=0.331N P=0.506N P=0.653N P=0.358N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.275N P=0.500N P=0.603N P=0.314N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.346N P=0.500N P=0.675N P=0.370N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.338N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 2/10 (20%) 1/10 (10%) |1/10 (10%) 1/10 (10%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | 1/9.82 0/9.07 2/9.48 1/9.43 |1/9.87 1/10.00 1/10.00 2/10.00 |
|POLY-3 PERCENT (g) | 10.2% 0.0% 21.1% 10.6% |10.1% 10.0% 10.0% 20.0% |
|TERMINAL (d) | 1/9 (11%) 0/8 (0%) 2/8 (25%) 1/9 (11%) |1/9 (11%) 0/9 (0%) 1/10 (10%) 2/10 (20%) |
|FIRST INCIDENCE | 295 (T) --- 295 (T) 295 (T) |295 (T) 276 295 (T) 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.434 P=0.523N P=0.457 P=0.767 |P=0.373 P=0.760 P=0.743N P=0.539 |
|POLY 3 | P=0.425 P=0.516N P=0.487 P=0.752 |P=0.345 P=0.758N P=0.758N P=0.505 |
|POLY 1.5 | P=0.423 P=0.509N P=0.493 P=0.755 |P=0.344 P=0.759N P=0.759N P=0.502 |
|POLY 6 | P=0.430 P=0.523N P=0.480 P=0.750 |P=0.347 P=0.755N P=0.755N P=0.509 |
|LOGISTIC REGRESSION| P=0.434 (e) P=0.457 P=0.767 |P=0.183 P=0.736N P=0.743N P=0.539 |
|COCH-ARM / FISHERS | P=0.420 P=0.500N P=0.500 P=0.763N |P=0.335 P=0.763N P=0.763N P=0.500 |
|ORDER RESTRICTED | P=0.363 (e) (e) (e) |P=0.413 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 93 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (SODIU
M BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) |0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/9.82 0/9.07 1/9.48 2/9.43 |0/9.87 0/9.82 1/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.6% 21.2% |0.0% 0.0% 10.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/8 (0%) 1/8 (13%) 2/9 (22%) |0/9 (0%) 0/9 (0%) 1/10 (10%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- 295 (T) 295 (T) |--- --- 295 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.063 (e) P=0.477 P=0.233 |P=0.665 (e) P=0.521 (e) |
|POLY 3 | P=0.054 (e) P=0.493 P=0.216 |P=0.654 (e) P=0.503 (e) |
|POLY 1.5 | P=0.054 (e) P=0.496 P=0.220 |P=0.651 (e) P=0.501 (e) |
|POLY 6 | P=0.054 (e) P=0.489 P=0.213 |P=0.659 (e) P=0.505 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.477 P=0.233 |(e) (e) P=0.521 (e) |
|COCH-ARM / FISHERS | P=0.055 (e) P=0.500 P=0.237 |P=0.650 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.060 (e) (e) (e) |P=0.383 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/10 (30%) 3/10 (30%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | |3/10.00 3/9.82 1/10.00 2/10.00 |
|POLY-3 PERCENT (g) | |30.0% 30.6% 10.0% 20.0% |
|TERMINAL (d) | |2/9 (22%) 3/9 (33%) 1/10 (10%) 2/10 (20%) |
|FIRST INCIDENCE | |282 295 (T) 295 (T) 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.257N P=0.667 P=0.272N P=0.460N |
|POLY 3 | |P=0.301N P=0.670 P=0.292N P=0.500N |
|POLY 1.5 | |P=0.303N P=0.674 P=0.292N P=0.500N |
|POLY 6 | |P=0.298N P=0.662 P=0.292N P=0.500N |
|LOGISTIC REGRESSION| |P=0.336N P=0.680N P=0.272N P=0.460N |
|COCH-ARM / FISHERS | |P=0.298N P=0.686N P=0.291N P=0.500N |
|ORDER RESTRICTED | |P=0.339N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 93 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (SODIU
M BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 1/9 (11%) 3/10 (30%) 1/9 (11%) |0/10 (0%) 0/10 (0%) 2/10 (20%) 1/10 (10%) |
|POLY-3 RATE (b) | 3/9.82 1/8.67 3/9.48 1/9.00 |0/9.87 0/9.82 2/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 30.6% 11.5% 31.7% 11.1% |0.0% 0.0% 20.0% 10.0% |
|TERMINAL (d) | 3/9 (33%) 1/8 (13%) 3/8 (38%) 1/9 (11%) |0/9 (0%) 0/9 (0%) 2/10 (20%) 1/10 (10%) |
|FIRST INCIDENCE | 295 (T) 295 (T) 295 (T) 295 (T) |--- --- 295 (T) 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347N P=0.335N P=0.625 P=0.291N |P=0.229 (e) P=0.257 P=0.521 |
|POLY 3 | P=0.374N P=0.339N P=0.662 P=0.325N |P=0.206 (e) P=0.230 P=0.503 |
|POLY 1.5 | P=0.380N P=0.337N P=0.669 P=0.329N |P=0.204 (e) P=0.228 P=0.501 |
|POLY 6 | P=0.364N P=0.343N P=0.653 P=0.318N |P=0.211 (e) P=0.232 P=0.505 |
|LOGISTIC REGRESSION| P=0.347N P=0.335N P=0.625 P=0.291N |(e) (e) P=0.257 P=0.521 |
|COCH-ARM / FISHERS | P=0.385N P=0.333N P=0.686N P=0.333N |P=0.201 (e) P=0.237 P=0.500 |
|ORDER RESTRICTED | P=0.249N (e) (e) (e) |P=0.158 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/9 (0%) |0/10 (0%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/9.82 0/8.67 1/9.48 0/9.00 |0/9.87 1/9.82 2/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.6% 0.0% |0.0% 10.2% 20.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/8 (0%) 1/8 (13%) 0/9 (0%) |0/9 (0%) 1/9 (11%) 2/10 (20%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- 295 (T) --- |--- 295 (T) 295 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.651 (e) P=0.477 (e) |P=0.557N P=0.500 P=0.257 (e) |
|POLY 3 | P=0.657 (e) P=0.493 (e) |P=0.585N P=0.499 P=0.230 (e) |
|POLY 1.5 | P=0.651 (e) P=0.496 (e) |P=0.588N P=0.499 P=0.228 (e) |
|POLY 6 | P=0.668 (e) P=0.489 (e) |P=0.580N P=0.498 P=0.232 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.477 (e) |(e) P=0.500 P=0.257 (e) |
|COCH-ARM / FISHERS | P=0.644 (e) P=0.500 (e) |P=0.590N P=0.500 P=0.237 (e) |
|ORDER RESTRICTED | P=0.375 (e) (e) (e) |P=0.312N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 93 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (SODIU
M BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 2/10.00 0/9.48 0/9.43 |1/10.00 0/9.82 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 10.0% 20.0% 0.0% 0.0% |10.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/9 (0%) |0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 276 218 --- --- |282 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.141N P=0.462 P=0.521N P=0.521N |P=0.345N P=0.521N P=0.500N P=0.500N |
|POLY 3 | P=0.133N P=0.500 P=0.511N P=0.512N |P=0.349N P=0.504N P=0.500N P=0.500N |
|POLY 1.5 | P=0.130N P=0.500 P=0.506N P=0.507N |P=0.350N P=0.502N P=0.500N P=0.500N |
|POLY 6 | P=0.138N P=0.500 P=0.518N P=0.517N |P=0.346N P=0.507N P=0.500N P=0.500N |
|LOGISTIC REGRESSION| P=0.041N* (e) P=0.372N P=0.417N |P=0.662N P=0.343N (e) (e) |
|COCH-ARM / FISHERS | P=0.126N P=0.500 P=0.500N P=0.500N |P=0.350N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.167N (e) (e) (e) |P=0.121N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 3/10 (30%) 1/10 (10%) 0/10 (0%) |2/10 (20%) 1/10 (10%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/10.00 3/10.00 1/9.57 0/9.43 |2/10.00 1/9.82 0/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 10.0% 30.0% 10.5% 0.0% |20.0% 10.2% 0.0% 10.0% |
|TERMINAL (d) | 0/9 (0%) 1/8 (13%) 0/8 (0%) 0/9 (0%) |1/9 (11%) 1/9 (11%) 0/10 (0%) 1/10 (10%) |
|FIRST INCIDENCE | 276 218 286 --- |282 295 (T) --- 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.142N P=0.270 P=0.749 P=0.521N |P=0.343N P=0.512N P=0.228N P=0.475N |
|POLY 3 | P=0.135N P=0.292 P=0.751 P=0.512N |P=0.369N P=0.507N P=0.227N P=0.500N |
|POLY 1.5 | P=0.130N P=0.292 P=0.755 P=0.507N |P=0.370N P=0.503N P=0.227N P=0.500N |
|POLY 6 | P=0.141N P=0.292 P=0.745 P=0.517N |P=0.366N P=0.512N P=0.227N P=0.500N |
|LOGISTIC REGRESSION| P=0.073N (e) P=0.707N P=0.417N |P=0.474N P=0.465N (e) P=0.475N |
|COCH-ARM / FISHERS | P=0.124N P=0.291 P=0.763N P=0.500N |P=0.369N P=0.500N P=0.237N P=0.500N |
|ORDER RESTRICTED | P=0.145N (e) (e) (e) |P=0.215N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 93 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (SODIU
M BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 4/10 (40%) 0/10 (0%) 3/10 (30%) |2/10 (20%) 1/10 (10%) 0/10 (0%) 3/10 (30%) |
|POLY-3 RATE (b) | 2/10.00 4/10.00 0/9.48 3/9.43 |2/10.00 1/9.82 0/10.00 3/10.00 |
|POLY-3 PERCENT (g) | 20.0% 40.0% 0.0% 31.8% |20.0% 10.2% 0.0% 30.0% |
|TERMINAL (d) | 1/9 (11%) 2/8 (25%) 0/8 (0%) 3/9 (33%) |1/9 (11%) 1/9 (11%) 0/10 (0%) 3/10 (30%) |
|FIRST INCIDENCE | 276 218 --- 295 (T) |282 295 (T) --- 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.510N P=0.286 P=0.265N P=0.490 |P=0.352 P=0.512N P=0.228N P=0.540 |
|POLY 3 | P=0.545N P=0.318 P=0.239N P=0.471 |P=0.310 P=0.507N P=0.227N P=0.500 |
|POLY 1.5 | P=0.534N P=0.318 P=0.233N P=0.483 |P=0.309 P=0.503N P=0.227N P=0.500 |
|POLY 6 | P=0.559N P=0.318 P=0.248N P=0.458 |P=0.313 P=0.512N P=0.227N P=0.500 |
|LOGISTIC REGRESSION| P=0.499N (e) P=0.175N P=0.492 |P=0.229 P=0.465N (e) P=0.540 |
|COCH-ARM / FISHERS | P=0.519N P=0.314 P=0.237N P=0.500 |P=0.306 P=0.500N P=0.237N P=0.500 |
|ORDER RESTRICTED | P=0.361N (e) (e) (e) |P=0.164 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) | |
|POLY-3 RATE (b) | 0/9.82 2/9.07 0/9.48 0/9.43 | |
|POLY-3 PERCENT (g) | 0.0% 22.0% 0.0% 0.0% | |
|TERMINAL (d) | 0/9 (0%) 2/8 (25%) 0/8 (0%) 0/9 (0%) | |
|FIRST INCIDENCE | --- 295 (T) --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.259N P=0.207 (e) (e) | |
|POLY 3 | P=0.269N P=0.207 (e) (e) | |
|POLY 1.5 | P=0.262N P=0.215 (e) (e) | |
|POLY 6 | P=0.278N P=0.198 (e) (e) | |
|LOGISTIC REGRESSION| (e) P=0.207 (e) (e) | |
|COCH-ARM / FISHERS | P=0.259N P=0.237 (e) (e) | |
|ORDER RESTRICTED | P=0.218N (e) (e) (e) | |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 93 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (SODIU
M BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 4/10 (40%) 5/10 (50%) 1/10 (10%) | |
|POLY-3 RATE (b) | 2/9.82 4/9.07 5/9.48 1/9.43 | |
|POLY-3 PERCENT (g) | 20.4% 44.1% 52.8% 10.6% | |
|TERMINAL (d) | 2/9 (22%) 4/8 (50%) 5/8 (63%) 1/9 (11%) | |
|FIRST INCIDENCE | 295 (T) 295 (T) 295 (T) 295 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.263N P=0.252 P=0.124 P=0.500N | |
|POLY 3 | P=0.292N P=0.273 P=0.154 P=0.514N | |
|POLY 1.5 | P=0.289N P=0.291 P=0.163 P=0.509N | |
|POLY 6 | P=0.293N P=0.253 P=0.143 P=0.519N | |
|LOGISTIC REGRESSION| P=0.263N P=0.252 P=0.124 P=0.500N | |
|COCH-ARM / FISHERS | P=0.284N P=0.314 P=0.175 P=0.500N | |
|ORDER RESTRICTED | P=0.131N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/10 (50%) 4/10 (40%) 2/10 (20%) 7/10 (70%) |2/10 (20%) 4/10 (40%) 5/10 (50%) 3/10 (30%) |
|POLY-3 RATE (b) | 5/10.00 4/9.40 2/9.48 7/9.43 |2/9.87 4/9.82 5/10.00 3/10.00 |
|POLY-3 PERCENT (g) | 50.0% 42.5% 21.1% 74.2% |20.3% 40.7% 50.0% 30.0% |
|TERMINAL (d) | 4/9 (44%) 3/8 (38%) 2/8 (25%) 7/9 (78%) |2/9 (22%) 4/9 (44%) 5/10 (50%) 3/10 (30%) |
|FIRST INCIDENCE | 276 258 295 (T) 295 (T) |295 (T) 295 (T) 295 (T) 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.254 P=0.590N P=0.240N P=0.327 |P=0.569 P=0.314 P=0.225 P=0.553 |
|POLY 3 | P=0.192 P=0.548N P=0.196N P=0.266 |P=0.497 P=0.314 P=0.179 P=0.506 |
|POLY 1.5 | P=0.203 P=0.529N P=0.186N P=0.291 |P=0.491 P=0.315 P=0.177 P=0.503 |
|POLY 6 | P=0.179 P=0.568N P=0.213N P=0.241 |P=0.509 P=0.311 P=0.184 P=0.512 |
|LOGISTIC REGRESSION| P=0.212 P=0.510N P=0.187N P=0.264 |P=0.569 P=0.314 P=0.225 P=0.553 |
|COCH-ARM / FISHERS | P=0.222 P=0.500N P=0.175N P=0.325 |P=0.483 P=0.314 P=0.175 P=0.500 |
|ORDER RESTRICTED | P=0.073 (e) (e) (e) |P=0.287 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 93 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (SODIU
M BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |2/10 (20%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/9.82 0/9.07 0/9.48 0/9.00 |2/9.87 0/9.82 1/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 10.2% 0.0% 0.0% 0.0% |20.3% 0.0% 10.0% 10.0% |
|TERMINAL (d) | 1/9 (11%) 0/8 (0%) 0/8 (0%) 0/9 (0%) |2/9 (22%) 0/9 (0%) 1/10 (10%) 1/10 (10%) |
|FIRST INCIDENCE | 295 (T) --- --- --- |295 (T) --- 295 (T) 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.349N P=0.523N P=0.523N P=0.500N |P=0.540N P=0.233N P=0.461N P=0.461N |
|POLY 3 | P=0.357N P=0.516N P=0.507N P=0.517N |P=0.573N P=0.228N P=0.495N P=0.495N |
|POLY 1.5 | P=0.360N P=0.509N P=0.504N P=0.519N |P=0.575N P=0.227N P=0.498N P=0.498N |
|POLY 6 | P=0.354N P=0.523N P=0.511N P=0.514N |P=0.568N P=0.228N P=0.491N P=0.491N |
|LOGISTIC REGRESSION| P=0.349N (e) (e) (e) |P=0.540N (e) P=0.461N P=0.461N |
|COCH-ARM / FISHERS | P=0.362N P=0.500N P=0.500N P=0.526N |P=0.580N P=0.237N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.136N (e) (e) (e) |P=0.259N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/9.82 0/9.07 0/9.48 0/9.00 |0/9.87 0/9.82 0/10.00 2/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 0/9 (0%) 0/8 (0%) 0/8 (0%) 0/9 (0%) |0/9 (0%) 0/9 (0%) 0/10 (0%) 2/10 (20%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.049 * (e) (e) P=0.257 |
|POLY 3 | (e) (e) (e) (e) |P=0.036 * (e) (e) P=0.230 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.036 * (e) (e) P=0.228 |
|POLY 6 | (e) (e) (e) (e) |P=0.037 * (e) (e) P=0.232 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.257 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.024 * (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 93 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (SODIU
M BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |9/10 (90%) 10/10 (100%) 8/10 (80%) 8/10 (80%) |
|POLY-3 RATE (b) | |9/10.00 10/10.00 8/10.00 8/10.00 |
|POLY-3 PERCENT (g) | |90.0% 100.0% 80.0% 80.0% |
|TERMINAL (d) | |8/9 (89%) 9/9 (100%) 8/10 (80%) 8/10 (80%) |
|FIRST INCIDENCE | |282 276 295 (T) 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.087N P=0.488 P=0.330N P=0.330N |
|POLY 3 | |P=0.186N P=0.500 P=0.500N P=0.500N |
|POLY 1.5 | |P=0.186N P=0.500 P=0.500N P=0.500N |
|POLY 6 | |P=0.186N P=0.500 P=0.500N P=0.500N |
|LOGISTIC REGRESSION| |(e) (e) P=0.330N P=0.330N |
|COCH-ARM / FISHERS | |P=0.181N P=0.500 P=0.500N P=0.500N |
|ORDER RESTRICTED | |P=0.254N (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).