TDMS Study 97013-15 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (DICHLOROACETIC ACID) DATE: 01/27/05
EXPERIMENT: 97013 TEST: 15 TIME: 10:09:33
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013D
PATHOLOGIST: MISSING CAS: 79-43-6
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1 TGAC MICE
REASONS FOR REMOVAL: 25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/KG
INCLUDE 002 0 MG/KG
INCLUDE 003 31.25 MG/KG
INCLUDE 004 31.25 MG/KG
INCLUDE 005 125MG/KG
INCLUDE 006 125MG/KG
INCLUDE 007 500MG/KG
INCLUDE 008 500MG/KG
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (DICHLOROACETIC ACID) DATE: 01/27/05
EXPERIMENT: 97013 TEST: 15 TIME: 10:09:33
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013D
PATHOLOGIST: MISSING CAS: 79-43-6
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF WATER DISINFECTION MODEL (DICHLOROACET
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex: Subcapsular Hyperplasia
Kidney Nephropathy
Kidney: Renal Tubule Dilatation
Liver Hematopoietic Cell Proliferation
Inflammation Chronic
Liver: Hepatocyte Vacuolization Cytoplasmic
Pituitary Gland: Pars Distalis Cyst
Skin: Site of Application - Epidermis Hyperkeratosis
Hyperplasia
Spleen Hematopoietic Cell Proliferation
Thymus Cyst
Thymus: Thymocyte Necrosis
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
Liver Inflammation Chronic
Liver: Hepatocyte Necrosis
Vacuolization Cytoplasmic
Skin: Site of Application - Epidermis Hyperkeratosis
Hyperplasia
Thymus Atrophy
Cyst
Thyroid Gland: Follicle Degeneration
===============================================================
Date: 01/27/05 EXPERIMENT: 97013 TEST: 15 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHL
OROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |0/15 (0%) 2/15 (13%) 7/15 (47%) 4/15 (27%) |
|POLY-3 RATE (b) | 0/13.83 0/14.51 0/14.08 0/12.44 |0/11.79 2/12.90 7/14.15 4/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 15.5% 49.5% 26.7% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/14 (0%) 0/12 (0%) |0/11 (0%) 2/12 (17%) 7/14 (50%) 4/15 (27%) |
|FIRST INCIDENCE | --- --- --- --- |--- 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.298 P=0.254 P=0.012 * P=0.099 |
|POLY 3 | (e) (e) (e) (e) |P=0.304 P=0.251 P=0.004 ** P=0.081 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.253 P=0.249 P=0.003 ** P=0.070 |
|POLY 6 | (e) (e) (e) (e) |P=0.345 P=0.249 P=0.005 ** P=0.089 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.254 P=0.012 * P=0.099 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.166 P=0.241 P=0.003 ** P=0.050 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.012 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/15 (73%) 7/15 (47%) 7/15 (47%) 7/15 (47%) |0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 11/13.83 7/14.51 7/14.08 7/12.44 |0/11.79 0/12.90 0/14.15 0/15.00 |
|POLY-3 PERCENT (g) | 79.6% 48.3% 49.7% 56.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 11/13 (85%) 7/14 (50%) 7/14 (50%) 7/12 (58%) |0/11 (0%) 0/12 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) 182 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.407N P=0.071N P=0.071N P=0.160N |(e) (e) (e) (e) |
|POLY 3 | P=0.418N P=0.081N P=0.098N P=0.189N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.402N P=0.097N P=0.114N P=0.193N |(e) (e) (e) (e) |
|POLY 6 | P=0.420N P=0.070N P=0.079N P=0.175N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.407N P=0.071N P=0.071N P=0.160N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.271N P=0.132N P=0.132N P=0.132N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.111N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 15 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/15 (27%) 1/15 (7%) 2/15 (13%) 0/15 (0%) |5/15 (33%) 8/15 (53%) 6/15 (40%) 9/15 (60%) |
|POLY-3 RATE (b) | 4/13.83 1/14.51 2/14.08 0/12.44 |5/11.79 8/12.90 6/14.15 9/15.00 |
|POLY-3 PERCENT (g) | 28.9% 6.9% 14.2% 0.0% |42.4% 62.0% 42.4% 60.0% |
|TERMINAL (d) | 4/13 (31%) 1/14 (7%) 2/14 (14%) 0/12 (0%) |5/11 (46%) 8/12 (67%) 6/14 (43%) 9/15 (60%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) --- |183 (T) 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.101N P=0.144N P=0.289N P=0.064N |P=0.431 P=0.277 P=0.607N P=0.371 |
|POLY 3 | P=0.106N P=0.146N P=0.316N P=0.057N |P=0.352 P=0.283 P=0.650N P=0.307 |
|POLY 1.5 | P=0.103N P=0.152N P=0.325N P=0.057N |P=0.294 P=0.279 P=0.613 P=0.252 |
|POLY 6 | P=0.107N P=0.141N P=0.303N P=0.055N |P=0.397 P=0.275 P=0.625N P=0.346 |
|LOGISTIC REGRESSION| P=0.101N P=0.144N P=0.289N (e) |P=0.431 P=0.277 P=0.607N P=0.371 |
|COCH-ARM / FISHERS | P=0.085N P=0.165N P=0.326N P=0.050N |P=0.175 P=0.231 P=0.500 P=0.136 |
|ORDER RESTRICTED | P=0.018N* (e) (e) (e) |P=0.297 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Epididymis |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 1/15 (7%) 1/15 (7%) 1/15 (7%) | |
|POLY-3 RATE (b) | 2/13.83 1/14.51 1/14.08 1/12.44 | |
|POLY-3 PERCENT (g) | 14.5% 6.9% 7.1% 8.0% | |
|TERMINAL (d) | 2/13 (15%) 1/14 (7%) 1/14 (7%) 1/12 (8%) | |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) 182 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.568N P=0.473N P=0.473N P=0.529N | |
|POLY 3 | P=0.562N P=0.483N P=0.494N P=0.538N | |
|POLY 1.5 | P=0.558N P=0.489N P=0.499N P=0.536N | |
|POLY 6 | P=0.564N P=0.478N P=0.484N P=0.535N | |
|LOGISTIC REGRESSION| P=0.568N P=0.473N P=0.473N P=0.529N | |
|COCH-ARM / FISHERS | P=0.522N P=0.500N P=0.500N P=0.500N | |
|ORDER RESTRICTED | P=0.432N (e) (e) (e) | |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 15 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/15 (47%) 7/15 (47%) 11/15 (73%) 13/15 (87%) |3/15 (20%) 6/15 (40%) 5/15 (33%) 5/15 (33%) |
|POLY-3 RATE (b) | 7/13.83 7/14.51 11/14.08 13/13.06 |3/12.61 6/13.51 5/14.15 5/15.00 |
|POLY-3 PERCENT (g) | 50.6% 48.3% 78.1% 99.5% |23.8% 44.4% 35.3% 33.3% |
|TERMINAL (d) | 7/13 (54%) 7/14 (50%) 11/14 (79%) 12/12 (100%)|2/11 (18%) 5/12 (42%) 5/14 (36%) 5/15 (33%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) 132 |104 134 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.572N P=0.175 P=0.008 ** |P=0.501N P=0.271 P=0.480 P=0.524 |
|POLY 3 | P<0.001 ** P=0.597N P=0.125 P=0.002 ** |P=0.585N P=0.245 P=0.412 P=0.450 |
|POLY 1.5 | P<0.001 ** P=0.612N P=0.117 P=0.002 ** |P=0.594 P=0.243 P=0.398 P=0.425 |
|POLY 6 | P<0.001 ** P=0.583N P=0.145 P=0.003 ** |P=0.564N P=0.244 P=0.423 P=0.467 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.572N P=0.175 P=0.004 ** |P=0.566 P=0.227 P=0.379 P=0.358 |
|COCH-ARM / FISHERS | P=0.012 * P=0.642N P=0.132 P=0.025 * |P=0.496 P=0.213 P=0.341 P=0.341 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.366 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/15 (27%) 2/15 (13%) 2/15 (13%) 0/15 (0%) |2/15 (13%) 3/15 (20%) 3/15 (20%) 1/15 (7%) |
|POLY-3 RATE (b) | 4/13.83 2/14.51 2/14.08 0/12.44 |2/11.79 3/12.90 3/14.15 1/15.00 |
|POLY-3 PERCENT (g) | 28.9% 13.8% 14.2% 0.0% |17.0% 23.3% 21.2% 6.7% |
|TERMINAL (d) | 4/13 (31%) 2/14 (14%) 2/14 (14%) 0/12 (0%) |2/11 (18%) 3/12 (25%) 3/14 (21%) 1/15 (7%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) --- |183 (T) 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.073N P=0.289N P=0.289N P=0.064N |P=0.184N P=0.543 P=0.616 P=0.389N |
|POLY 3 | P=0.079N P=0.302N P=0.316N P=0.057N |P=0.200N P=0.543 P=0.587 P=0.415N |
|POLY 1.5 | P=0.077N P=0.311N P=0.325N P=0.057N |P=0.222N P=0.539 P=0.565 P=0.437N |
|POLY 6 | P=0.079N P=0.295N P=0.303N P=0.055N |P=0.185N P=0.541 P=0.601 P=0.401N |
|LOGISTIC REGRESSION| P=0.073N P=0.289N P=0.289N (e) |P=0.184N P=0.543 P=0.616 P=0.389N |
|COCH-ARM / FISHERS | P=0.061N P=0.326N P=0.326N P=0.050N |P=0.281N P=0.500 P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.027N* (e) (e) (e) |P=0.281N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 15 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/15 (20%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 3/14.25 0/14.51 0/14.08 0/12.44 |0/11.79 0/12.90 0/14.15 0/15.00 |
|POLY-3 PERCENT (g) | 21.1% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/13 (15%) 0/14 (0%) 0/14 (0%) 0/12 (0%) |0/11 (0%) 0/12 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | 152 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.205N P=0.112N P=0.112N P=0.140N |(e) (e) (e) (e) |
|POLY 3 | P=0.184N P=0.102N P=0.107N P=0.132N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.182N P=0.103N P=0.108N P=0.128N |(e) (e) (e) (e) |
|POLY 6 | P=0.184N P=0.103N P=0.106N P=0.134N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.174N P=0.125N P=0.110N P=0.117N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.183N P=0.112N P=0.112N P=0.112N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.009N** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 8/15 (53%) 4/15 (27%) 2/15 (13%) |11/15 (73%) 13/15 (87%) 14/15 (93%) 11/15 (73%) |
|POLY-3 RATE (b) | 2/13.83 8/14.51 4/14.08 2/12.44 |11/11.79 13/13.77 14/14.15 11/15.00 |
|POLY-3 PERCENT (g) | 14.5% 55.2% 28.4% 16.1% |93.3% 94.4% 98.9% 73.3% |
|TERMINAL (d) | 2/13 (15%) 8/14 (57%) 4/14 (29%) 2/12 (17%) |11/11 (100%) 12/12 (100%) 14/14 (100%) 11/15 (73%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) 182 (T) |183 (T) 93 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.206N P=0.035 * P=0.362 P=0.673 |P=0.003N** P=0.529 P=1.000N P=0.099N |
|POLY 3 | P=0.202N P=0.023 * P=0.334 P=0.661 |P=0.016N* P=0.850 P=0.676 P=0.197N |
|POLY 1.5 | P=0.199N P=0.021 * P=0.327 P=0.662 |P=0.067N P=0.655 P=0.381 P=0.320N |
|POLY 6 | P=0.199N P=0.024 * P=0.347 P=0.664 |P=0.003N** P=0.993 P=0.989 P=0.130N |
|LOGISTIC REGRESSION| P=0.206N P=0.035 * P=0.362 P=0.673 |P=0.015N* P=0.541 P=1.000N P=0.099N |
|COCH-ARM / FISHERS | P=0.157N P=0.025 * P=0.326 P=0.701N |P=0.372N P=0.326 P=0.165 P=0.659N |
|ORDER RESTRICTED | P=0.206 (e) (e) (e) |P=0.025N* (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 15 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 2/15 (13%) 0/15 (0%) 2/15 (13%) |1/15 (7%) 0/15 (0%) 0/15 (0%) 3/15 (20%) |
|POLY-3 RATE (b) | 1/14.58 2/14.51 0/14.08 2/13.44 |1/11.79 0/12.90 0/14.15 3/15.00 |
|POLY-3 PERCENT (g) | 6.9% 13.8% 0.0% 14.9% |8.5% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 0/13 (0%) 2/14 (14%) 0/14 (0%) 1/12 (8%) |1/11 (9%) 0/12 (0%) 0/14 (0%) 3/15 (20%) |
|FIRST INCIDENCE | 114 182 (T) --- 4 |183 (T) --- --- 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.413 P=0.517 P=0.514N P=0.474 |P=0.076 P=0.483N P=0.452N P=0.418 |
|POLY 3 | P=0.425 P=0.498 P=0.507N P=0.471 |P=0.052 P=0.482N P=0.464N P=0.392 |
|POLY 1.5 | P=0.431 P=0.499 P=0.507N P=0.478 |P=0.048 * P=0.484N P=0.473N P=0.367 |
|POLY 6 | P=0.422 P=0.498 P=0.505N P=0.469 |P=0.056 P=0.483N P=0.457N P=0.409 |
|LOGISTIC REGRESSION| P=0.601N P=0.346 P=0.339N P=0.737N |P=0.076 (e) (e) P=0.418 |
|COCH-ARM / FISHERS | P=0.449 P=0.500 P=0.500N P=0.500 |P=0.044 * P=0.500N P=0.500N P=0.299 |
|ORDER RESTRICTED | P=0.367 (e) (e) (e) |P=0.063 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/15 (20%) 4/15 (27%) 14/15 (93%) 15/15 (100%)|6/15 (40%) 4/15 (27%) 14/15 (93%) 15/15 (100%) |
|POLY-3 RATE (b) | 3/13.83 4/14.51 14/14.08 15/15.00 |6/11.79 4/12.90 14/14.15 15/15.00 |
|POLY-3 PERCENT (g) | 21.7% 27.6% 99.4% 100.0% |50.9% 31.0% 98.9% 100.0% |
|TERMINAL (d) | 3/13 (23%) 4/14 (29%) 14/14 (100%) 12/12 (100%)|6/11 (55%) 4/12 (33%) 14/14 (100%) 15/15 (100%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) 4 |183 (T) 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.545 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.277N P=0.012 * P=0.009 ** |
|POLY 3 | P<0.001 ** P=0.528 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.277N P=0.002 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.518 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.287N P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.537 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.279N P=0.003 ** P=0.002 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.545 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.277N P=0.012 * P=0.009 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.350N P=0.003 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 15 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 1/14 (7%) |3/15 (20%) 1/15 (7%) 4/15 (27%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.83 2/15.00 0/14.08 1/11.44 |3/11.79 1/13.52 4/14.15 2/15.00 |
|POLY-3 PERCENT (g) | 0.0% 13.3% 0.0% 8.7% |25.4% 7.4% 28.3% 13.3% |
|TERMINAL (d) | 0/13 (0%) 1/14 (7%) 0/14 (0%) 1/11 (9%) |3/11 (27%) 0/12 (0%) 4/14 (29%) 2/15 (13%) |
|FIRST INCIDENCE | --- 145 --- 182 (T) |183 (T) 132 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.585 P=0.256 (e) P=0.467 |P=0.419N P=0.266N P=0.644 P=0.352N |
|POLY 3 | P=0.589 P=0.250 (e) P=0.462 |P=0.466N P=0.245N P=0.607 P=0.387N |
|POLY 1.5 | P=0.590 P=0.243 (e) P=0.463 |P=0.491N P=0.256N P=0.581 P=0.416N |
|POLY 6 | P=0.591 P=0.258 (e) P=0.463 |P=0.448N P=0.240N P=0.625 P=0.368N |
|LOGISTIC REGRESSION| P=0.638 P=0.148 (e) P=0.467 |P=0.487N P=0.279N P=0.644 P=0.352N |
|COCH-ARM / FISHERS | P=0.619 P=0.241 (e) P=0.483 |P=0.554N P=0.299N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.286 (e) (e) (e) |P=0.347N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/15 (20%) 2/15 (13%) 1/15 (7%) 1/15 (7%) |
|POLY-3 RATE (b) | |3/11.79 2/13.52 1/14.15 1/15.00 |
|POLY-3 PERCENT (g) | |25.4% 14.8% 7.1% 6.7% |
|TERMINAL (d) | |3/11 (27%) 1/12 (8%) 1/14 (7%) 1/15 (7%) |
|FIRST INCIDENCE | |183 (T) 132 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.214N P=0.453N P=0.213N P=0.192N |
|POLY 3 | |P=0.255N P=0.434N P=0.231N P=0.213N |
|POLY 1.5 | |P=0.265N P=0.448N P=0.247N P=0.234N |
|POLY 6 | |P=0.249N P=0.427N P=0.220N P=0.201N |
|LOGISTIC REGRESSION| |P=0.260N P=0.471N P=0.213N P=0.192N |
|COCH-ARM / FISHERS | |P=0.291N P=0.500N P=0.299N P=0.299N |
|ORDER RESTRICTED | |P=0.126N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 15 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 0/14 (0%) 3/15 (20%) |3/15 (20%) 4/15 (27%) 3/15 (20%) 3/15 (20%) |
|POLY-3 RATE (b) | 0/13.83 1/14.51 0/14.00 3/12.44 |3/11.79 4/13.77 3/15.00 3/15.00 |
|POLY-3 PERCENT (g) | 0.0% 6.9% 0.0% 24.1% |25.4% 29.1% 20.0% 20.0% |
|TERMINAL (d) | 0/13 (0%) 1/14 (7%) 0/14 (0%) 3/12 (25%) |3/11 (27%) 3/12 (25%) 2/14 (14%) 3/15 (20%) |
|FIRST INCIDENCE | --- 182 (T) --- 182 (T) |183 (T) 93 98 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026 * P=0.515 (e) P=0.100 |P=0.389N P=0.556 P=0.558N P=0.514N |
|POLY 3 | P=0.027 * P=0.510 (e) P=0.086 |P=0.444N P=0.592 P=0.550N P=0.550N |
|POLY 1.5 | P=0.028 * P=0.506 (e) P=0.087 |P=0.468N P=0.575 P=0.583N P=0.583N |
|POLY 6 | P=0.027 * P=0.512 (e) P=0.087 |P=0.426N P=0.596 P=0.529N P=0.529N |
|LOGISTIC REGRESSION| (e) P=0.515 (e) P=0.100 |P=0.579N P=0.525 P=0.678N P=0.514N |
|COCH-ARM / FISHERS | P=0.039 * P=0.500 (e) P=0.112 |P=0.534N P=0.500 P=0.674N P=0.674N |
|ORDER RESTRICTED | P=0.011 * (e) (e) (e) |P=0.528N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 3/15 (20%) 2/15 (13%) 3/15 (20%) |3/15 (20%) 1/15 (7%) 1/15 (7%) 2/15 (13%) |
|POLY-3 RATE (b) | 2/13.83 3/14.51 2/14.08 3/12.44 |3/12.76 1/12.90 1/14.15 2/15.00 |
|POLY-3 PERCENT (g) | 14.5% 20.7% 14.2% 24.1% |23.5% 7.8% 7.1% 13.3% |
|TERMINAL (d) | 2/13 (15%) 3/14 (21%) 2/14 (14%) 3/12 (25%) |2/11 (18%) 1/12 (8%) 1/14 (7%) 2/15 (13%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) 182 (T) |57 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.420 P=0.536 P=0.675N P=0.461 |P=0.553N P=0.279N P=0.240N P=0.385N |
|POLY 3 | P=0.421 P=0.523 P=0.693N P=0.449 |P=0.606N P=0.291N P=0.259N P=0.423N |
|POLY 1.5 | P=0.427 P=0.515 P=0.698N P=0.451 |P=0.621N P=0.290N P=0.270N P=0.446N |
|POLY 6 | P=0.421 P=0.530 P=0.683N P=0.453 |P=0.593N P=0.295N P=0.249N P=0.407N |
|LOGISTIC REGRESSION| P=0.420 P=0.536 P=0.675N P=0.461 |P=0.578 P=0.338N P=0.383N P=0.654N |
|COCH-ARM / FISHERS | P=0.489 P=0.500 P=0.701N P=0.500 |P=0.642 P=0.299N P=0.299N P=0.500N |
|ORDER RESTRICTED | P=0.429 (e) (e) (e) |P=0.219N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 15 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Site of Application - Epidermis |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 7/15 (47%) 15/15 (100%) 14/15 (93%) |8/15 (53%) 9/15 (60%) 14/15 (93%) 14/15 (93%) |
|POLY-3 RATE (b) | 2/15.00 7/15.00 15/15.00 14/14.00 |8/12.61 9/14.39 14/15.00 14/15.00 |
|POLY-3 PERCENT (g) | 13.3% 46.7% 100.0% 100.0% |63.4% 62.5% 93.3% 93.3% |
|TERMINAL (d) | 0/13 (0%) 6/14 (43%) 14/14 (100%) 12/12 (100%)|7/11 (64%) 7/12 (58%) 13/14 (93%) 14/15 (93%) |
|FIRST INCIDENCE | 114 145 79 72 |104 93 98 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.091 P<0.001 ** P<0.001 ** |P=0.221 P=0.606 P=0.157 P=0.226 |
|POLY 3 | P<0.001 ** P=0.049 * P<0.001 ** P<0.001 ** |P=0.035 * P=0.634N P=0.061 P=0.061 |
|POLY 1.5 | P<0.001 ** P=0.049 * P<0.001 ** P<0.001 ** |P=0.024 * P=0.638 P=0.040 * P=0.040 * |
|POLY 6 | P<0.001 ** P=0.049 * P<0.001 ** P<0.001 ** |P=0.045 * P=0.624N P=0.079 P=0.079 |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P<0.001 ** |P=0.028 * P=0.555 P=0.039 * P=0.072 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.054 P<0.001 ** P<0.001 ** |P=0.014 * P=0.500 P=0.018 * P=0.018 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.030 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Site of Application - Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 2/15 (13%) 11/15 (73%) 13/15 (87%) |0/15 (0%) 1/15 (7%) 10/15 (67%) 13/15 (87%) |
|POLY-3 RATE (b) | 0/13.83 2/14.51 11/14.08 13/14.00 |0/11.79 1/13.51 10/14.15 13/15.00 |
|POLY-3 PERCENT (g) | 0.0% 13.8% 78.1% 92.9% |0.0% 7.4% 70.7% 86.7% |
|TERMINAL (d) | 0/13 (0%) 2/14 (14%) 11/14 (79%) 11/12 (92%) |0/11 (0%) 0/12 (0%) 10/14 (71%) 13/15 (87%) |
|FIRST INCIDENCE | --- 182 (T) 182 (T) 72 |--- 134 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.252 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.516 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.242 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.527 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.238 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.521 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.245 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.530 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.252 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.427 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.241 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 15 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/15 (20%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 3/14.25 0/14.51 0/14.08 0/12.44 |0/11.79 0/12.90 0/14.15 0/15.00 |
|POLY-3 PERCENT (g) | 21.1% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/13 (15%) 0/14 (0%) 0/14 (0%) 0/12 (0%) |0/11 (0%) 0/12 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | 152 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.205N P=0.112N P=0.112N P=0.140N |(e) (e) (e) (e) |
|POLY 3 | P=0.184N P=0.102N P=0.107N P=0.132N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.182N P=0.103N P=0.108N P=0.128N |(e) (e) (e) (e) |
|POLY 6 | P=0.184N P=0.103N P=0.106N P=0.134N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.174N P=0.125N P=0.110N P=0.117N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.183N P=0.112N P=0.112N P=0.112N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.009N** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 1/15 (7%) 1/15 (7%) 2/15 (13%) | |
|POLY-3 RATE (b) | 2/13.83 1/14.51 1/14.08 2/12.44 | |
|POLY-3 PERCENT (g) | 14.5% 6.9% 7.1% 16.1% | |
|TERMINAL (d) | 2/13 (15%) 1/14 (7%) 1/14 (7%) 2/12 (17%) | |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) 182 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.463 P=0.473N P=0.473N P=0.673 | |
|POLY 3 | P=0.460 P=0.483N P=0.494N P=0.661 | |
|POLY 1.5 | P=0.465 P=0.489N P=0.499N P=0.662 | |
|POLY 6 | P=0.459 P=0.478N P=0.484N P=0.664 | |
|LOGISTIC REGRESSION| P=0.463 P=0.473N P=0.473N P=0.673 | |
|COCH-ARM / FISHERS | P=0.513 P=0.500N P=0.500N P=0.701N | |
|ORDER RESTRICTED | P=0.476 (e) (e) (e) | |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 15 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 1/15 (7%) 0/15 (0%) 2/15 (13%) |3/15 (20%) 1/15 (7%) 1/15 (7%) 0/15 (0%) |
|POLY-3 RATE (b) | 1/14.25 1/15.00 0/14.08 2/13.06 |3/13.08 1/13.52 1/15.00 0/15.00 |
|POLY-3 PERCENT (g) | 7.0% 6.7% 0.0% 15.3% |22.9% 7.4% 6.7% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/14 (0%) 1/12 (8%) |1/11 (9%) 0/12 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | 152 145 --- 132 |104 132 98 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.273 P=0.753N P=0.500N P=0.465 |P=0.116N P=0.281N P=0.256N P=0.087N |
|POLY 3 | P=0.288 P=0.749N P=0.502N P=0.469 |P=0.119N P=0.284N P=0.248N P=0.082N |
|POLY 1.5 | P=0.289 P=0.753N P=0.503N P=0.468 |P=0.123N P=0.280N P=0.257N P=0.086N |
|POLY 6 | P=0.289 P=0.746N P=0.501N P=0.472 |P=0.116N P=0.291N P=0.246N P=0.081N |
|LOGISTIC REGRESSION| P=0.438 P=0.627 P=0.466N P=0.552 |P=0.310N P=0.376N P=0.503N P=0.190N |
|COCH-ARM / FISHERS | P=0.313 P=0.759N P=0.500N P=0.500 |P=0.132N P=0.299N P=0.299N P=0.112N |
|ORDER RESTRICTED | P=0.232 (e) (e) (e) |P=0.022N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/15 (40%) 1/15 (7%) 4/15 (27%) 2/15 (13%) |3/15 (20%) 8/15 (53%) 7/15 (47%) 9/15 (60%) |
|POLY-3 RATE (b) | 6/13.83 1/14.51 4/14.08 2/12.44 |3/11.79 8/12.90 7/14.15 9/15.00 |
|POLY-3 PERCENT (g) | 43.4% 6.9% 28.4% 16.1% |25.4% 62.0% 49.5% 60.0% |
|TERMINAL (d) | 6/13 (46%) 1/14 (7%) 4/14 (29%) 2/12 (17%) |3/11 (27%) 8/12 (67%) 7/14 (50%) 9/15 (60%) |
|FIRST INCIDENCE | 182 (T) 182 (T) 182 (T) 182 (T) |183 (T) 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.317N P=0.033N* P=0.296N P=0.130N |P=0.278 P=0.075 P=0.234 P=0.109 |
|POLY 3 | P=0.331N P=0.027N* P=0.336N P=0.135N |P=0.230 P=0.069 P=0.201 P=0.078 |
|POLY 1.5 | P=0.321N P=0.029N* P=0.349N P=0.135N |P=0.181 P=0.070 P=0.176 P=0.058 |
|POLY 6 | P=0.333N P=0.025N* P=0.317N P=0.131N |P=0.270 P=0.065 P=0.219 P=0.095 |
|LOGISTIC REGRESSION| P=0.317N P=0.033N* P=0.296N P=0.130N |P=0.278 P=0.075 P=0.234 P=0.109 |
|COCH-ARM / FISHERS | P=0.258N P=0.040N* P=0.350N P=0.107N |P=0.095 P=0.064 P=0.123 P=0.030 * |
|ORDER RESTRICTED | P=0.075N (e) (e) (e) |P=0.056 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 15 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus: Thymocyte |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.83 0/14.51 0/14.08 2/14.38 |0/11.79 0/12.90 0/14.15 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 13.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/14 (0%) 0/12 (0%) |0/11 (0%) 0/12 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- --- --- 4 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.040 * (e) (e) P=0.232 |(e) (e) (e) (e) |
|POLY 3 | P=0.038 * (e) (e) P=0.240 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.038 * (e) (e) P=0.237 |(e) (e) (e) (e) |
|POLY 6 | P=0.038 * (e) (e) P=0.243 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.040 * (e) (e) P=0.241 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.028 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/15 (20%) 3/15 (20%) 2/15 (13%) 1/15 (7%) |5/15 (33%) 4/15 (27%) 2/15 (13%) 1/15 (7%) |
|POLY-3 RATE (b) | 3/14.25 3/14.51 2/14.08 1/12.44 |5/11.79 4/12.90 2/14.15 1/15.00 |
|POLY-3 PERCENT (g) | 21.1% 20.7% 14.2% 8.0% |42.4% 31.0% 14.1% 6.7% |
|TERMINAL (d) | 2/13 (15%) 3/14 (21%) 2/14 (14%) 1/12 (8%) |5/11 (46%) 4/12 (33%) 2/14 (14%) 1/15 (7%) |
|FIRST INCIDENCE | 152 182 (T) 182 (T) 182 (T) |183 (T) 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.256N P=0.639N P=0.472N P=0.339N |P=0.033N* P=0.435N P=0.106N P=0.035N* |
|POLY 3 | P=0.265N P=0.663N P=0.506N P=0.349N |P=0.041N* P=0.434N P=0.119N P=0.035N* |
|POLY 1.5 | P=0.258N P=0.664N P=0.507N P=0.343N |P=0.048N* P=0.442N P=0.136N P=0.044N* |
|POLY 6 | P=0.268N P=0.665N P=0.502N P=0.353N |P=0.037N* P=0.438N P=0.109N P=0.030N* |
|LOGISTIC REGRESSION| P=0.245N P=0.673 P=0.500N P=0.320N |P=0.033N* P=0.435N P=0.106N P=0.035N* |
|COCH-ARM / FISHERS | P=0.210N P=0.674N P=0.500N P=0.299N |P=0.071N P=0.500N P=0.195N P=0.084N |
|ORDER RESTRICTED | P=0.305N (e) (e) (e) |P=0.017N* (e) (e) (e) |
|=================================================================================================================================|
Date: 01/27/05 EXPERIMENT: 97013 TEST: 15 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (DICHLO
ROACET
Terminal Sacrifice at 26 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 31.25 125MG/KG 500MG/KG |0 MG/KG 31.25 125MG/KG 500MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |10/15 (67%) 12/15 (80%) 10/15 (67%) 14/15 (93%) |
|POLY-3 RATE (b) | |10/11.79 12/13.77 10/14.15 14/15.00 |
|POLY-3 PERCENT (g) | |84.8% 87.2% 70.7% 93.3% |
|TERMINAL (d) | |10/11 (91%) 11/12 (92%) 10/14 (71%) 14/15 (93%) |
|FIRST INCIDENCE | |183 (T) 93 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.545 P=0.496 P=0.245N P=0.693 |
|POLY 3 | |P=0.278 P=0.669 P=0.349N P=0.466 |
|POLY 1.5 | |P=0.194 P=0.583 P=0.435N P=0.294 |
|POLY 6 | |P=0.363 P=0.702 P=0.290N P=0.598 |
|LOGISTIC REGRESSION| |P=0.359 P=0.503 P=0.245N P=0.693 |
|COCH-ARM / FISHERS | |P=0.086 P=0.341 P=0.650N P=0.084 |
|ORDER RESTRICTED | |P=0.284 (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).