TDMS Study 97013-11 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (SODIUM BROMATE) DATE: 06/18/04
EXPERIMENT: 97013 TEST: 11 TIME: 09:20:07
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013B
PATHOLOGIST: TOFT, JOHN CAS: 7789-38-0
------------------------------------------------------------------------------------------------------------------------------------
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 64 MG/KG
INCLUDE 004 64 MG/KG
INCLUDE 005 128 MG/KG
INCLUDE 006 128 MG/KG
INCLUDE 007 256 MG/KG
INCLUDE 008 256 MG/KG
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (SODIUM BROMATE) DATE: 06/18/04
EXPERIMENT: 97013 TEST: 11 TIME: 09:20:07
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013B
PATHOLOGIST: TOFT, JOHN CAS: 7789-38-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF WATER DISINFECTION MODEL (SODIUM BR
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hypertrophy
Kidney Nephropathy
Thyroid Gland: Follicle Depletion Secretory
Thyroid Gland: Follicular Cell Hypertrophy
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Kidney Nephropathy
Ovary Cyst
Spleen Hematopoietic Cell Proliferation
Thyroid Gland Infiltration Cellular Lymphocyte
Thyroid Gland: Follicle Depletion Secretory
Thyroid Gland: Follicular Cell Hypertrophy
===============================================================
Date: 06/18/04 EXPERIMENT: 97013 TEST: 11 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SO
DIUM BR
Terminal Sacrifice at 26 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 |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |3/15 (20%) 3/15 (20%) 1/15 (7%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/12.62 0/12.43 0/13.58 0/15.00 |3/14.75 3/11.53 1/12.60 1/11.71 |
|POLY-3 PERCENT (g) | 7.9% 0.0% 0.0% 0.0% |20.4% 26.0% 7.9% 8.5% |
|TERMINAL (d) | 1/12 (8%) 0/11 (0%) 0/13 (0%) 0/15 (0%) |0/11 (0%) 3/10 (30%) 1/11 (9%) 1/11 (9%) |
|FIRST INCIDENCE | 181 (T) --- --- --- |60 182 (T) 182 (T) 182 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.277N P=0.517N P=0.484N P=0.455N |P=0.171N P=0.615 P=0.345N P=0.345N |
|POLY 3 | P=0.316N P=0.503N P=0.485N P=0.466N |P=0.202N P=0.547 P=0.358N P=0.387N |
|POLY 1.5 | P=0.314N P=0.502N P=0.488N P=0.473N |P=0.184N P=0.581 P=0.334N P=0.360N |
|POLY 6 | P=0.317N P=0.504N P=0.484N P=0.460N |P=0.216N P=0.525 P=0.383N P=0.402N |
|LOGISTIC REGRESSION| P=0.277N (e) (e) (e) |P=0.147N P=0.633N P=0.290N P=0.213N |
|COCH-ARM / FISHERS | P=0.305N P=0.500N P=0.500N P=0.500N |P=0.152N P=0.674N P=0.299N P=0.299N |
|ORDER RESTRICTED | P=0.094N (e) (e) (e) |P=0.243N (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 |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/15 (53%) 4/15 (27%) 1/15 (7%) 3/15 (20%) |0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 8/12.62 4/12.43 1/13.58 3/15.00 |0/12.95 0/11.53 0/12.60 0/11.71 |
|POLY-3 PERCENT (g) | 63.4% 32.2% 7.4% 20.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 8/12 (67%) 4/11 (36%) 1/13 (8%) 3/15 (20%) |0/11 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 181 (T) 181 (T) 181 (T) 181 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.013N* P=0.156N P=0.005N** P=0.022N* |(e) (e) (e) (e) |
|POLY 3 | P=0.015N* P=0.117N P<0.001N** P=0.020N* |(e) (e) (e) (e) |
|POLY 1.5 | P=0.018N* P=0.117N P<0.001N** P=0.026N* |(e) (e) (e) (e) |
|POLY 6 | P=0.013N* P=0.117N P<0.001N** P=0.017N* |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.013N* P=0.156N P=0.005N** P=0.022N* |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.038N* P=0.132N P=0.007N** P=0.064N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/04 EXPERIMENT: 97013 TEST: 11 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 26 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: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) |4/15 (27%) 3/15 (20%) 5/15 (33%) 3/15 (20%) |
|POLY-3 RATE (b) | 0/12.62 0/12.43 1/13.58 0/15.00 |4/13.78 3/11.53 5/13.96 3/11.71 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.4% 0.0% |29.0% 26.0% 35.8% 25.6% |
|TERMINAL (d) | 0/12 (0%) 0/11 (0%) 1/13 (8%) 0/15 (0%) |2/11 (18%) 3/10 (30%) 3/11 (27%) 3/11 (27%) |
|FIRST INCIDENCE | --- --- 181 (T) --- |146 182 (T) 108 182 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.723 (e) P=0.516 (e) |P=0.490N P=0.565N P=0.476 P=0.533N |
|POLY 3 | P=0.761 (e) P=0.515 (e) |P=0.549N P=0.606N P=0.509 P=0.596N |
|POLY 1.5 | P=0.746 (e) P=0.512 (e) |P=0.521N P=0.575N P=0.517 P=0.563N |
|POLY 6 | P=0.769N (e) P=0.516 (e) |P=0.566N P=0.628N P=0.495 P=0.615N |
|LOGISTIC REGRESSION| (e) (e) P=0.516 (e) |P=0.499N P=0.551N P=0.498 P=0.542N |
|COCH-ARM / FISHERS | P=0.695 (e) P=0.500 (e) |P=0.480N P=0.500N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.395 (e) (e) (e) |P=0.614N (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 |
|=================================================================================================================================|
| |
|Epididymis |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 2/15 (13%) | |
|POLY-3 RATE (b) | 1/13.10 0/12.43 0/13.58 2/15.00 | |
|POLY-3 PERCENT (g) | 7.6% 0.0% 0.0% 13.3% | |
|TERMINAL (d) | 0/12 (0%) 0/11 (0%) 0/13 (0%) 2/15 (13%) | |
|FIRST INCIDENCE | 146 --- --- 181 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.303 P=0.516N P=0.485N P=0.569 | |
|POLY 3 | P=0.270 P=0.510N P=0.493N P=0.548 | |
|POLY 1.5 | P=0.263 P=0.506N P=0.492N P=0.540 | |
|POLY 6 | P=0.275 P=0.516N P=0.496N P=0.550 | |
|LOGISTIC REGRESSION| P=0.237 P=0.499N P=0.531N P=0.482 | |
|COCH-ARM / FISHERS | P=0.242 P=0.500N P=0.500N P=0.500 | |
|ORDER RESTRICTED | P=0.160 (e) (e) (e) | |
|=================================================================================================================================|
Date: 06/18/04 EXPERIMENT: 97013 TEST: 11 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 26 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 |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/15 (53%) 8/15 (53%) 14/15 (93%) 14/15 (93%) |8/15 (53%) 7/15 (47%) 13/15 (87%) 15/15 (100%) |
|POLY-3 RATE (b) | 8/12.62 8/12.51 14/14.53 14/15.00 |8/13.21 7/13.38 13/14.51 15/15.00 |
|POLY-3 PERCENT (g) | 63.4% 63.9% 96.4% 93.3% |60.6% 52.3% 89.6% 100.0% |
|TERMINAL (d) | 8/12 (67%) 7/11 (64%) 13/13 (100%) 14/15 (93%) |7/11 (64%) 5/10 (50%) 10/11 (91%) 11/11 (100%) |
|FIRST INCIDENCE | 181 (T) 176 68 181 (T) |165 71 108 69 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.057 P=0.554 P=0.026 * P=0.106 |P=0.004 ** P=0.589N P=0.077 P=0.017 * |
|POLY 3 | P=0.013 * P=0.649 P=0.030 * P=0.060 |P<0.001 ** P=0.485N P=0.076 P=0.005 ** |
|POLY 1.5 | P=0.007 ** P=0.649 P=0.026 * P=0.040 * |P<0.001 ** P=0.489N P=0.068 P=0.003 ** |
|POLY 6 | P=0.019 * P=0.652 P=0.028 * P=0.079 |P<0.001 ** P=0.481N P=0.083 P=0.009 ** |
|LOGISTIC REGRESSION| P=0.012 * P=0.642 P=0.023 * P=0.106 |P<0.001 ** P=0.535N P=0.048 * P=0.003 ** |
|COCH-ARM / FISHERS | P=0.003 ** P=0.642N P=0.018 * P=0.018 * |P<0.001 ** P=0.500N P=0.054 P=0.003 ** |
|ORDER RESTRICTED | P=0.016 * (e) (e) (e) |P<0.001 ** (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: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 1/12.62 0/12.43 0/13.58 2/15.00 |1/13.30 0/11.53 0/12.60 0/11.71 |
|POLY-3 PERCENT (g) | 7.9% 0.0% 0.0% 13.3% |7.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/11 (0%) 0/13 (0%) 2/15 (13%) |0/11 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 181 (T) --- --- 181 (T) |158 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.308 P=0.517N P=0.484N P=0.580 |P=0.326N P=0.533N P=0.533N P=0.533N |
|POLY 3 | P=0.272 P=0.503N P=0.485N P=0.561 |P=0.283N P=0.528N P=0.511N P=0.525N |
|POLY 1.5 | P=0.264 P=0.502N P=0.488N P=0.547 |P=0.288N P=0.521N P=0.504N P=0.517N |
|POLY 6 | P=0.278 P=0.504N P=0.484N P=0.570 |P=0.284N P=0.532N P=0.518N P=0.528N |
|LOGISTIC REGRESSION| P=0.308 (e) (e) P=0.580 |P=0.302N P=0.492N P=0.507N P=0.491N |
|COCH-ARM / FISHERS | P=0.242 P=0.500N P=0.500N P=0.500 |P=0.305N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.169 (e) (e) (e) |P=0.144N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/04 EXPERIMENT: 97013 TEST: 11 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 26 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 |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 1/15 (7%) |2/15 (13%) 2/15 (13%) 2/15 (13%) 3/15 (20%) |
|POLY-3 RATE (b) | 0/12.62 0/12.43 1/13.58 1/15.00 |2/13.21 2/11.53 2/12.60 3/11.71 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.4% 6.7% |15.1% 17.4% 15.9% 25.6% |
|TERMINAL (d) | 0/12 (0%) 0/11 (0%) 1/13 (8%) 1/15 (7%) |1/11 (9%) 2/10 (20%) 2/11 (18%) 3/11 (27%) |
|FIRST INCIDENCE | --- --- 181 (T) 181 (T) |165 182 (T) 182 (T) 182 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.288 (e) P=0.516 P=0.545 |P=0.390 P=0.664 P=0.690 P=0.492 |
|POLY 3 | P=0.292 (e) P=0.515 P=0.534 |P=0.341 P=0.650 P=0.684 P=0.442 |
|POLY 1.5 | P=0.279 (e) P=0.512 P=0.527 |P=0.357 P=0.663 P=0.694 P=0.460 |
|POLY 6 | P=0.302 (e) P=0.516 P=0.539 |P=0.335 P=0.644 P=0.671 P=0.437 |
|LOGISTIC REGRESSION| (e) (e) P=0.516 P=0.545 |P=0.351 P=0.664 P=0.694 P=0.452 |
|COCH-ARM / FISHERS | P=0.233 (e) P=0.500 P=0.500 |P=0.380 P=0.701N P=0.701N P=0.500 |
|ORDER RESTRICTED | P=0.269 (e) (e) (e) |P=0.402 (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 |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/15 (67%) 6/15 (40%) 9/15 (60%) 11/15 (73%) |13/15 (87%) 12/15 (80%) 12/15 (80%) 12/15 (80%) |
|POLY-3 RATE (b) | 10/13.54 6/12.43 9/14.53 11/15.00 |13/14.04 12/12.72 12/13.09 12/12.66 |
|POLY-3 PERCENT (g) | 73.9% 48.3% 62.0% 73.3% |92.6% 94.3% 91.7% 94.8% |
|TERMINAL (d) | 9/12 (75%) 6/11 (55%) 8/13 (62%) 11/15 (73%) |10/11 (91%) 10/10 (100%) 11/11 (100%) 11/11 (100%) |
|FIRST INCIDENCE | 79 181 (T) 68 181 (T) |146 71 145 69 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.552N P=0.181N P=0.398N P=0.459N |P=0.393N P=0.629 P=0.558N P=0.538N |
|POLY 3 | P=0.415 P=0.171N P=0.394N P=0.649N |P=0.597 P=0.744 P=0.764N P=0.743 |
|POLY 1.5 | P=0.369 P=0.156N P=0.408N P=0.636 |P=0.541N P=0.732N P=0.598N P=0.707N |
|POLY 6 | P=0.453 P=0.178N P=0.389N P=0.619N |P=0.373 P=0.658 P=0.688 P=0.590 |
|LOGISTIC REGRESSION| P=0.361 P=0.129N P=0.473N P=0.648 |P=0.611 P=0.699 P=0.738N P=0.723 |
|COCH-ARM / FISHERS | P=0.238 P=0.136N P=0.500N P=0.500 |P=0.433N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.397N (e) (e) (e) |P=0.603 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/04 EXPERIMENT: 97013 TEST: 11 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 26 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: Hepatocyte |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 2/15 (13%) 0/15 (0%) 0/15 (0%) |1/15 (7%) 2/15 (13%) 1/15 (7%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/13.54 2/13.36 0/13.58 0/15.00 |1/12.95 2/11.53 1/12.60 1/12.66 |
|POLY-3 PERCENT (g) | 7.4% 15.0% 0.0% 0.0% |7.7% 17.4% 7.9% 7.9% |
|TERMINAL (d) | 0/12 (0%) 1/11 (9%) 0/13 (0%) 0/15 (0%) |1/11 (9%) 2/10 (20%) 1/11 (9%) 0/11 (0%) |
|FIRST INCIDENCE | 79 74 --- --- |182 (T) 182 (T) 182 (T) 69 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.170N P=0.481 P=0.500N P=0.486N |P=0.517N P=0.465 P=0.766 P=0.753N |
|POLY 3 | P=0.172N P=0.495 P=0.499N P=0.480N |P=0.536N P=0.458 P=0.756 P=0.757 |
|POLY 1.5 | P=0.174N P=0.498 P=0.498N P=0.484N |P=0.532N P=0.467 P=0.760 P=0.759 |
|POLY 6 | P=0.170N P=0.493 P=0.500N P=0.476N |P=0.532N P=0.458 P=0.752 P=0.761 |
|LOGISTIC REGRESSION| P=0.362N P=0.505 P=0.669N P=0.960N |P=0.526N P=0.465 P=0.766 P=0.726N |
|COCH-ARM / FISHERS | P=0.184N P=0.500 P=0.500N P=0.500N |P=0.531N P=0.500 P=0.759N P=0.759N |
|ORDER RESTRICTED | P=0.141N (e) (e) (e) |P=0.561N (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) | 6/15 (40%) 4/15 (27%) 3/15 (20%) 6/15 (40%) |3/15 (20%) 4/15 (27%) 3/15 (20%) 3/15 (20%) |
|POLY-3 RATE (b) | 6/13.61 4/12.43 3/13.58 6/15.00 |3/12.95 4/11.53 3/12.60 3/11.71 |
|POLY-3 PERCENT (g) | 44.1% 32.2% 22.1% 40.0% |23.2% 34.7% 23.8% 25.6% |
|TERMINAL (d) | 5/12 (42%) 4/11 (36%) 3/13 (23%) 6/15 (40%) |3/11 (27%) 4/10 (40%) 3/11 (27%) 3/11 (27%) |
|FIRST INCIDENCE | 42 181 (T) 181 (T) 181 (T) |182 (T) 182 (T) 182 (T) 182 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.428N P=0.407N P=0.184N P=0.468N |P=0.502N P=0.440 P=0.680 P=0.680 |
|POLY 3 | P=0.544N P=0.414N P=0.209N P=0.561N |P=0.566N P=0.429 P=0.662 P=0.625 |
|POLY 1.5 | P=0.567N P=0.403N P=0.212N P=0.586N |P=0.550N P=0.445 P=0.671 P=0.639 |
|POLY 6 | P=0.524N P=0.420N P=0.207N P=0.540N |P=0.565N P=0.428 P=0.653 P=0.629 |
|LOGISTIC REGRESSION| P=0.567N P=0.351N P=0.216N P=0.612 |P=0.502N P=0.440 P=0.680 P=0.680 |
|COCH-ARM / FISHERS | P=0.519 P=0.350N P=0.213N P=0.645N |P=0.521N P=0.500 P=0.674N P=0.674N |
|ORDER RESTRICTED | P=0.379N (e) (e) (e) |P=0.617 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/04 EXPERIMENT: 97013 TEST: 11 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 26 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 |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 0/15 (0%) 0/15 (0%) |0/15 (0%) 2/15 (13%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/12.62 1/13.36 0/13.58 0/15.00 |0/12.95 2/11.53 0/12.60 0/11.71 |
|POLY-3 PERCENT (g) | 0.0% 7.5% 0.0% 0.0% |0.0% 17.4% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/15 (0%) |0/11 (0%) 2/10 (20%) 0/11 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- 74 --- --- |--- 182 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.556N P=0.500 (e) (e) |P=0.399N P=0.213 (e) (e) |
|POLY 3 | P=0.549N P=0.511 (e) (e) |P=0.435N P=0.203 (e) (e) |
|POLY 1.5 | P=0.553N P=0.509 (e) (e) |P=0.426N P=0.209 (e) (e) |
|POLY 6 | P=0.547N P=0.512 (e) (e) |P=0.436N P=0.202 (e) (e) |
|LOGISTIC REGRESSION| P=0.863 P=0.494 (e) (e) |(e) P=0.213 (e) (e) |
|COCH-ARM / FISHERS | P=0.568N P=0.500 (e) (e) |P=0.404N P=0.241 (e) (e) |
|ORDER RESTRICTED | P=0.363N (e) (e) (e) |P=0.233N (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 Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |4/15 (27%) 2/14 (14%) 2/14 (14%) 3/15 (20%) |
|POLY-3 RATE (b) | 0/12.62 0/12.43 0/13.58 0/15.00 |4/12.95 2/11.20 2/12.09 3/11.71 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |30.9% 17.9% 16.5% 25.6% |
|TERMINAL (d) | 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/15 (0%) |4/11 (36%) 0/9 (0%) 1/10 (10%) 3/11 (27%) |
|FIRST INCIDENCE | --- --- --- --- |182 (T) 152 145 182 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.479N P=0.411N P=0.380N P=0.500N |
|POLY 3 | (e) (e) (e) (e) |P=0.493N P=0.397N P=0.357N P=0.561N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.482N P=0.397N P=0.354N P=0.543N |
|POLY 6 | (e) (e) (e) (e) |P=0.498N P=0.376N P=0.356N P=0.557N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.497N P=0.413N P=0.374N P=0.500N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.469N P=0.361N P=0.361N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.414N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/04 EXPERIMENT: 97013 TEST: 11 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 26 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) | |0/15 (0%) 0/15 (0%) 1/15 (7%) 3/15 (20%) |
|POLY-3 RATE (b) | |0/12.95 0/11.53 1/12.60 3/11.71 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 7.9% 25.6% |
|TERMINAL (d) | |0/11 (0%) 0/10 (0%) 1/11 (9%) 3/11 (27%) |
|FIRST INCIDENCE | |--- --- 182 (T) 182 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.020 * (e) P=0.500 P=0.112 |
|POLY 3 | |P=0.013 * (e) P=0.494 P=0.085 |
|POLY 1.5 | |P=0.014 * (e) P=0.499 P=0.090 |
|POLY 6 | |P=0.013 * (e) P=0.491 P=0.085 |
|LOGISTIC REGRESSION| |(e) (e) P=0.500 P=0.112 |
|COCH-ARM / FISHERS | |P=0.018 * (e) P=0.500 P=0.112 |
|ORDER RESTRICTED | |P=0.011 * (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: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 3/14 (21%) 4/15 (27%) 3/15 (20%) |2/15 (13%) 1/15 (7%) 2/15 (13%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/12.62 3/12.49 4/13.58 3/15.00 |2/13.78 1/11.78 2/12.60 0/11.71 |
|POLY-3 PERCENT (g) | 0.0% 24.0% 29.5% 20.0% |14.5% 8.5% 15.9% 0.0% |
|TERMINAL (d) | 0/12 (0%) 2/11 (18%) 4/13 (31%) 3/15 (20%) |0/11 (0%) 0/10 (0%) 2/11 (18%) 0/11 (0%) |
|FIRST INCIDENCE | --- 176 181 (T) 181 (T) |146 165 182 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.251 P=0.110 P=0.064 P=0.157 |P=0.221N P=0.547N P=0.657 P=0.286N |
|POLY 3 | P=0.241 P=0.101 P=0.052 P=0.141 |P=0.223N P=0.556N P=0.667 P=0.270N |
|POLY 1.5 | P=0.218 P=0.100 P=0.051 P=0.132 |P=0.211N P=0.541N P=0.685 P=0.256N |
|POLY 6 | P=0.258 P=0.101 P=0.053 P=0.147 |P=0.232N P=0.563N P=0.645 P=0.278N |
|LOGISTIC REGRESSION| P=0.227 P=0.106 P=0.064 P=0.157 |P=0.195N P=0.480N P=0.704 P=0.211N |
|COCH-ARM / FISHERS | P=0.154 P=0.100 P=0.050 P=0.112 |P=0.193N P=0.500N P=0.701N P=0.241N |
|ORDER RESTRICTED | P=0.072 (e) (e) (e) |P=0.177N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/04 EXPERIMENT: 97013 TEST: 11 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 26 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 |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 0/15 (0%) 3/15 (20%) 4/15 (27%) |0/15 (0%) 1/15 (7%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 2/12.62 0/12.43 3/13.58 4/15.00 |0/12.95 1/11.94 0/12.60 0/11.71 |
|POLY-3 PERCENT (g) | 15.9% 0.0% 22.1% 26.7% |0.0% 8.4% 0.0% 0.0% |
|TERMINAL (d) | 2/12 (17%) 0/11 (0%) 3/13 (23%) 4/15 (27%) |0/11 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 181 (T) --- 181 (T) 181 (T) |--- 152 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.177 P=0.254N P=0.539 P=0.439 |P=0.591N P=0.484 (e) (e) |
|POLY 3 | P=0.149 P=0.233N P=0.535 P=0.414 |P=0.580N P=0.484 (e) (e) |
|POLY 1.5 | P=0.135 P=0.232N P=0.529 P=0.394 |P=0.577N P=0.485 (e) (e) |
|POLY 6 | P=0.160 P=0.234N P=0.538 P=0.428 |P=0.580N P=0.489 (e) (e) |
|LOGISTIC REGRESSION| P=0.177 (e) P=0.539 P=0.439 |P=0.562N P=0.518 (e) (e) |
|COCH-ARM / FISHERS | P=0.100 P=0.241N P=0.500 P=0.326 |P=0.568N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.145 (e) (e) (e) |P=0.384N (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: Epidermis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/15 (20%) 2/15 (13%) 3/15 (20%) 4/15 (27%) |2/15 (13%) 3/15 (20%) 3/15 (20%) 1/15 (7%) |
|POLY-3 RATE (b) | 3/12.62 2/12.43 3/13.58 4/15.00 |2/12.95 3/11.53 3/12.60 1/11.71 |
|POLY-3 PERCENT (g) | 23.8% 16.1% 22.1% 26.7% |15.4% 26.0% 23.8% 8.5% |
|TERMINAL (d) | 3/12 (25%) 2/11 (18%) 3/13 (23%) 4/15 (27%) |2/11 (18%) 3/10 (30%) 3/11 (27%) 1/11 (9%) |
|FIRST INCIDENCE | 181 (T) 181 (T) 181 (T) 181 (T) |182 (T) 182 (T) 182 (T) 182 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.485 P=0.543N P=0.636N P=0.632 |P=0.318N P=0.453 P=0.500 P=0.500N |
|POLY 3 | P=0.441 P=0.507N P=0.638N P=0.600 |P=0.376N P=0.443 P=0.486 P=0.536N |
|POLY 1.5 | P=0.415 P=0.504N P=0.643N P=0.578 |P=0.363N P=0.456 P=0.497 P=0.526N |
|POLY 6 | P=0.460 P=0.510N P=0.635N P=0.616 |P=0.373N P=0.443 P=0.477 P=0.534N |
|LOGISTIC REGRESSION| P=0.485 P=0.543N P=0.636N P=0.632 |P=0.318N P=0.453 P=0.500 P=0.500N |
|COCH-ARM / FISHERS | P=0.331 P=0.500N P=0.674N P=0.500 |P=0.334N P=0.500 P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.533 (e) (e) (e) |P=0.325N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/04 EXPERIMENT: 97013 TEST: 11 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 26 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 |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 2/15 (13%) |3/15 (20%) 5/15 (33%) 9/15 (60%) 10/15 (67%) |
|POLY-3 RATE (b) | 0/12.62 0/12.43 1/13.58 2/15.00 |3/13.78 5/11.53 9/13.09 10/12.66 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.4% 13.3% |21.8% 43.4% 68.8% 79.0% |
|TERMINAL (d) | 0/12 (0%) 0/11 (0%) 1/13 (8%) 2/15 (13%) |1/11 (9%) 5/10 (50%) 8/11 (73%) 9/11 (82%) |
|FIRST INCIDENCE | --- --- 181 (T) 181 (T) |146 182 (T) 145 69 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.101 (e) P=0.516 P=0.286 |P=0.006 ** P=0.285 P=0.035 * P=0.018 * |
|POLY 3 | P=0.091 (e) P=0.515 P=0.273 |P<0.001 ** P=0.234 P=0.012 * P<0.001 ** |
|POLY 1.5 | P=0.085 (e) P=0.512 P=0.263 |P<0.001 ** P=0.264 P=0.017 * P=0.003 ** |
|POLY 6 | P=0.096 (e) P=0.516 P=0.280 |P<0.001 ** P=0.212 P=0.008 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.516 P=0.286 |P=0.002 ** P=0.282 P=0.028 * P=0.010 * |
|COCH-ARM / FISHERS | P=0.067 (e) P=0.500 P=0.241 |P=0.005 ** P=0.341 P=0.030 * P=0.013 * |
|ORDER RESTRICTED | P=0.097 (e) (e) (e) |P<0.001 ** (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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |1/15 (7%) 2/15 (13%) 1/15 (7%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/12.62 0/12.43 0/13.58 0/15.00 |1/13.44 2/12.69 1/13.39 1/12.47 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |7.4% 15.8% 7.5% 8.0% |
|TERMINAL (d) | 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/15 (0%) |0/11 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) |
|FIRST INCIDENCE | --- --- --- --- |146 81 108 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.550N P=0.464 P=0.742 P=0.725 |
|POLY 3 | (e) (e) (e) (e) |P=0.550N P=0.480 P=0.761 P=0.745 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.543N P=0.483 P=0.758N P=0.750 |
|POLY 6 | (e) (e) (e) (e) |P=0.551N P=0.482 P=0.756 P=0.746 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.499N P=0.602 P=0.732 P=0.729N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.531N P=0.500 P=0.759N P=0.759N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.588N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/04 EXPERIMENT: 97013 TEST: 11 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 26 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) | 1/15 (7%) 2/15 (13%) 1/15 (7%) 0/15 (0%) |2/15 (13%) 2/15 (13%) 1/15 (7%) 2/15 (13%) |
|POLY-3 RATE (b) | 1/13.61 2/13.09 1/13.58 0/15.00 |2/14.40 2/12.69 1/13.39 2/13.31 |
|POLY-3 PERCENT (g) | 7.4% 15.3% 7.4% 0.0% |13.9% 15.8% 7.5% 15.0% |
|TERMINAL (d) | 0/12 (0%) 0/11 (0%) 1/13 (8%) 0/15 (0%) |0/11 (0%) 0/10 (0%) 0/11 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 42 136 181 (T) --- |60 81 108 99 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.215N P=0.500 P=0.751N P=0.500N |P=0.590N P=0.663 P=0.520N P=0.664 |
|POLY 3 | P=0.220N P=0.486 P=0.761 P=0.481N |P=0.595N P=0.652 P=0.526N P=0.670 |
|POLY 1.5 | P=0.228N P=0.484 P=0.760 P=0.486N |P=0.591N P=0.661 P=0.516N P=0.675 |
|POLY 6 | P=0.215N P=0.492 P=0.761 P=0.476N |P=0.595N P=0.653 P=0.536N P=0.675 |
|LOGISTIC REGRESSION| P=0.389N P=0.504 P=0.691 (e) |P=0.513N P=0.539N P=0.234N P=0.493N |
|COCH-ARM / FISHERS | P=0.242N P=0.500 P=0.759N P=0.500N |P=0.581N P=0.701N P=0.500N P=0.701N |
|ORDER RESTRICTED | P=0.191N (e) (e) (e) |P=0.611N (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) | 2/15 (13%) 0/15 (0%) 2/15 (13%) 3/15 (20%) | |
|POLY-3 RATE (b) | 2/13.10 0/12.43 2/13.58 3/15.00 | |
|POLY-3 PERCENT (g) | 15.3% 0.0% 14.7% 20.0% | |
|TERMINAL (d) | 1/12 (8%) 0/11 (0%) 2/13 (15%) 3/15 (20%) | |
|FIRST INCIDENCE | 146 --- 181 (T) 181 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326 P=0.258N P=0.668N P=0.596 | |
|POLY 3 | P=0.289 P=0.242N P=0.687N P=0.564 | |
|POLY 1.5 | P=0.275 P=0.237N P=0.685N P=0.553 | |
|POLY 6 | P=0.298 P=0.248N P=0.693N P=0.567 | |
|LOGISTIC REGRESSION| P=0.269 P=0.232N P=0.693N P=0.522 | |
|COCH-ARM / FISHERS | P=0.227 P=0.241N P=0.701N P=0.500 | |
|ORDER RESTRICTED | P=0.267 (e) (e) (e) | |
|=================================================================================================================================|
Date: 06/18/04 EXPERIMENT: 97013 TEST: 11 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 26 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) | 1/14 (7%) 4/15 (27%) 1/15 (7%) 4/15 (27%) |1/15 (7%) 3/14 (21%) 4/15 (27%) 2/15 (13%) |
|POLY-3 RATE (b) | 1/13.08 4/14.02 1/14.05 4/15.00 |1/13.21 3/12.81 4/14.46 2/13.31 |
|POLY-3 PERCENT (g) | 7.6% 28.5% 7.1% 26.7% |7.6% 23.4% 27.7% 15.0% |
|TERMINAL (d) | 0/12 (0%) 1/11 (9%) 0/13 (0%) 4/15 (27%) |0/11 (0%) 1/10 (10%) 1/11 (9%) 0/11 (0%) |
|FIRST INCIDENCE | 146 74 146 181 (T) |165 67 108 99 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.313 P=0.176 P=0.748N P=0.242 |P=0.443 P=0.292 P=0.175 P=0.481 |
|POLY 3 | P=0.252 P=0.183 P=0.745N P=0.208 |P=0.468 P=0.284 P=0.190 P=0.503 |
|POLY 1.5 | P=0.245 P=0.180 P=0.746N P=0.202 |P=0.465 P=0.279 P=0.183 P=0.501 |
|POLY 6 | P=0.254 P=0.184 P=0.744N P=0.210 |P=0.482 P=0.291 P=0.198 P=0.510 |
|LOGISTIC REGRESSION| P=0.143 P=0.237 P=0.754N P=0.156 |P=0.545 P=0.386 P=0.138 P=0.599 |
|COCH-ARM / FISHERS | P=0.225 P=0.186 P=0.741N P=0.186 |P=0.465 P=0.272 P=0.165 P=0.500 |
|ORDER RESTRICTED | P=0.147 (e) (e) (e) |P=0.273 (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) | 2/14 (14%) 2/15 (13%) 2/15 (13%) 5/15 (33%) |2/15 (13%) 4/14 (29%) 2/15 (13%) 3/15 (20%) |
|POLY-3 RATE (b) | 2/12.61 2/12.43 2/13.58 5/15.00 |2/12.95 4/11.88 2/13.14 3/12.55 |
|POLY-3 PERCENT (g) | 15.9% 16.1% 14.7% 33.3% |15.4% 33.7% 15.2% 23.9% |
|TERMINAL (d) | 2/12 (17%) 2/11 (18%) 2/13 (15%) 5/15 (33%) |2/11 (18%) 3/10 (30%) 1/11 (9%) 2/11 (18%) |
|FIRST INCIDENCE | 181 (T) 181 (T) 181 (T) 181 (T) |182 (T) 71 140 99 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.184 P=0.672 P=0.673N P=0.298 |P=0.527 P=0.290 P=0.691 P=0.500 |
|POLY 3 | P=0.149 P=0.696 P=0.673N P=0.274 |P=0.519 P=0.279 P=0.696N P=0.485 |
|POLY 1.5 | P=0.137 P=0.701 P=0.674N P=0.258 |P=0.523 P=0.278 P=0.694N P=0.487 |
|POLY 6 | P=0.158 P=0.694 P=0.672N P=0.287 |P=0.529 P=0.292 P=0.695N P=0.495 |
|LOGISTIC REGRESSION| P=0.184 P=0.672 P=0.673N P=0.298 |P=0.542 P=0.287 P=0.704 P=0.496 |
|COCH-ARM / FISHERS | P=0.109 P=0.674N P=0.674N P=0.224 |P=0.535 P=0.291 P=0.701N P=0.500 |
|ORDER RESTRICTED | P=0.196 (e) (e) (e) |P=0.478 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/04 EXPERIMENT: 97013 TEST: 11 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 26 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 |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) |0/15 (0%) 6/15 (40%) 3/15 (20%) 12/15 (80%) |
|POLY-3 RATE (b) | 0/12.62 0/12.43 1/14.53 0/15.00 |0/12.95 6/11.53 3/12.60 12/12.66 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.9% 0.0% |0.0% 52.1% 23.8% 94.8% |
|TERMINAL (d) | 0/12 (0%) 0/11 (0%) 0/13 (0%) 0/15 (0%) |0/11 (0%) 6/10 (60%) 3/11 (27%) 11/11 (100%) |
|FIRST INCIDENCE | --- --- 68 --- |--- 182 (T) 182 (T) 69 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.704 (e) P=0.514 (e) |P<0.001 ** P=0.006 ** P=0.112 P<0.001 ** |
|POLY 3 | P=0.761 (e) P=0.528 (e) |P<0.001 ** P=0.002 ** P=0.098 P<0.001 ** |
|POLY 1.5 | P=0.745 (e) P=0.523 (e) |P<0.001 ** P=0.002 ** P=0.103 P<0.001 ** |
|POLY 6 | P=0.769N (e) P=0.530 (e) |P<0.001 ** P=0.002 ** P=0.093 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.401 (e) P=0.296 (e) |P<0.001 ** P=0.006 ** P=0.112 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.695 (e) P=0.500 (e) |P<0.001 ** P=0.008 ** P=0.112 P<0.001 ** |
|ORDER RESTRICTED | P=0.406 (e) (e) (e) |P<0.001 ** (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 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Depletion Secretory |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/15 (47%) 4/15 (27%) 5/15 (33%) 11/15 (73%) |6/15 (40%) 11/15 (73%) 13/15 (87%) 14/15 (93%) |
|POLY-3 RATE (b) | 7/12.62 4/12.43 5/14.53 11/15.00 |6/13.21 11/12.85 13/13.88 14/14.16 |
|POLY-3 PERCENT (g) | 55.5% 32.2% 34.4% 73.3% |45.4% 85.6% 93.7% 98.9% |
|TERMINAL (d) | 7/12 (58%) 4/11 (36%) 4/13 (31%) 11/15 (73%) |5/11 (46%) 9/10 (90%) 11/11 (100%) 11/11 (100%) |
|FIRST INCIDENCE | 181 (T) 181 (T) 68 181 (T) |165 81 108 69 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.156 P=0.267N P=0.294N P=0.343 |P=0.004 ** P=0.044 * P=0.013 * P=0.007 ** |
|POLY 3 | P=0.086 P=0.220N P=0.240N P=0.283 |P<0.001 ** P=0.029 * P=0.003 ** P<0.001 ** |
|POLY 1.5 | P=0.071 P=0.219N P=0.261N P=0.240 |P<0.001 ** P=0.034 * P=0.004 ** P<0.001 ** |
|POLY 6 | P=0.098 P=0.222N P=0.231N P=0.316 |P<0.001 ** P=0.029 * P=0.002 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.084 P=0.267N P=0.328N P=0.343 |P<0.001 ** P=0.032 * P=0.007 ** P=0.002 ** |
|COCH-ARM / FISHERS | P=0.044 * P=0.225N P=0.355N P=0.132 |P=0.002 ** P=0.070 P=0.010 * P=0.003 ** |
|ORDER RESTRICTED | P=0.053 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/04 EXPERIMENT: 97013 TEST: 11 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 26 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: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 7/15 (47%) 10/15 (67%) 14/15 (93%) |1/15 (7%) 9/15 (60%) 12/15 (80%) 13/15 (87%) |
|POLY-3 RATE (b) | 0/12.62 7/13.41 10/14.53 14/15.00 |1/12.95 9/11.94 12/13.14 13/13.40 |
|POLY-3 PERCENT (g) | 0.0% 52.2% 68.9% 93.3% |7.7% 75.4% 91.3% 97.0% |
|TERMINAL (d) | 0/12 (0%) 6/11 (55%) 9/13 (69%) 14/15 (93%) |1/11 (9%) 8/10 (80%) 11/11 (100%) 11/11 (100%) |
|FIRST INCIDENCE | --- 48 68 181 (T) |182 (T) 152 140 69 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (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) | |11/15 (73%) 9/15 (60%) 10/15 (67%) 10/15 (67%) |
|POLY-3 RATE (b) | |11/13.21 9/12.47 10/12.60 10/11.71 |
|POLY-3 PERCENT (g) | |83.3% 72.2% 79.4% 85.4% |
|TERMINAL (d) | |10/11 (91%) 8/10 (80%) 10/11 (91%) 10/11 (91%) |
|FIRST INCIDENCE | |165 71 182 (T) 182 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.434N P=0.482N P=0.510N P=0.510N |
|POLY 3 | |P=0.468 P=0.416N P=0.610N P=0.673 |
|POLY 1.5 | |P=0.545 P=0.395N P=0.533N P=0.676N |
|POLY 6 | |P=0.431 P=0.422N P=0.715N P=0.667 |
|LOGISTIC REGRESSION| |P=0.473 P=0.515N P=0.677N P=0.733N |
|COCH-ARM / FISHERS | |P=0.500N P=0.350N P=0.500N P=0.500N |
|ORDER RESTRICTED | |P=0.484 (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).