TDMS Study 97013-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 06/11/04
EXPERIMENT: 97013 TEST: 06 TIME: 08:41:37
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013F
PATHOLOGIST: MISSING CAS: 75-27-4
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 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 (BROMODICHLOROMETHANE) DATE: 06/11/04
EXPERIMENT: 97013 TEST: 06 TIME: 08:41:37
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013F
PATHOLOGIST: MISSING CAS: 75-27-4
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF WATER DISINFECTION MODEL (BROMODICHLOR
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Kidney Nephropathy
Kidney: Renal Tubule Hypertrophy
===============================================================
Date: 06/11/04 EXPERIMENT: 97013 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMO
DICHLOR
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/15 (60%) 9/15 (60%) 6/15 (40%) 8/15 (53%) |0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 9/13.69 9/15.00 6/15.00 8/13.85 |0/12.19 0/12.21 0/12.88 0/11.87 |
|POLY-3 PERCENT (g) | 65.7% 60.0% 40.0% 57.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 9/13 (69%) 8/14 (57%) 6/15 (40%) 8/13 (62%) |0/11 (0%) 0/10 (0%) 0/12 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 183 (T) 133 183 (T) 183 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.369N P=0.549N P=0.126N P=0.500N |(e) (e) (e) (e) |
|POLY 3 | P=0.367N P=0.527N P=0.157N P=0.485N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.365N P=0.571N P=0.183N P=0.490N |(e) (e) (e) (e) |
|POLY 6 | P=0.372N P=0.484N P=0.134N P=0.484N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.353N P=0.599N P=0.126N P=0.500N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.363N P=0.645N P=0.233N P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.298N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 1/15 (7%) 0/15 (0%) 2/15 (13%) |8/15 (53%) 8/15 (53%) 11/15 (73%) 5/15 (33%) |
|POLY-3 RATE (b) | 1/13.69 1/14.38 0/15.00 2/13.85 |8/13.41 8/12.97 11/15.00 5/12.81 |
|POLY-3 PERCENT (g) | 7.3% 7.0% 0.0% 14.4% |59.7% 61.7% 73.3% 39.0% |
|TERMINAL (d) | 1/13 (8%) 1/14 (7%) 0/15 (0%) 2/13 (15%) |6/11 (55%) 6/10 (60%) 8/12 (67%) 4/10 (40%) |
|FIRST INCIDENCE | 183 (T) 183 (T) --- 183 (T) |93 126 110 71 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.358 P=0.748N P=0.471N P=0.500 |P=0.250N P=0.554 P=0.356 P=0.306N |
|POLY 3 | P=0.367 P=0.750N P=0.482N P=0.504 |P=0.197N P=0.614 P=0.357 P=0.251N |
|POLY 1.5 | P=0.367 P=0.754N P=0.489N P=0.503 |P=0.180N P=0.633 P=0.315 P=0.232N |
|POLY 6 | P=0.368 P=0.747N P=0.475N P=0.504 |P=0.235N P=0.588 P=0.387 P=0.290N |
|LOGISTIC REGRESSION| P=0.358 P=0.748N (e) P=0.500 |P=0.192N P=0.634N P=0.221 P=0.231N |
|COCH-ARM / FISHERS | P=0.363 P=0.759N P=0.500N P=0.500 |P=0.191N P=0.642N P=0.225 P=0.231N |
|ORDER RESTRICTED | P=0.261 (e) (e) (e) |P=0.132N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/15 (20%) 1/15 (7%) 0/15 (0%) 2/15 (13%) |6/15 (40%) 5/15 (33%) 5/15 (33%) 4/15 (27%) |
|POLY-3 RATE (b) | 3/14.46 1/14.38 0/15.00 2/13.85 |6/13.07 5/12.29 5/13.66 4/13.00 |
|POLY-3 PERCENT (g) | 20.8% 7.0% 0.0% 14.4% |45.9% 40.7% 36.6% 30.8% |
|TERMINAL (d) | 2/13 (15%) 1/14 (7%) 0/15 (0%) 2/13 (15%) |5/11 (46%) 4/10 (40%) 4/12 (33%) 2/10 (20%) |
|FIRST INCIDENCE | 113 183 (T) --- 183 (T) |93 179 110 105 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.445N P=0.283N P=0.105N P=0.500N |P=0.325N P=0.558N P=0.429N P=0.401N |
|POLY 3 | P=0.440N P=0.299N P=0.099N P=0.521N |P=0.270N P=0.553N P=0.462N P=0.349N |
|POLY 1.5 | P=0.441N P=0.299N P=0.102N P=0.513N |P=0.278N P=0.528N P=0.470N P=0.349N |
|POLY 6 | P=0.438N P=0.299N P=0.096N P=0.527N |P=0.264N P=0.575N P=0.456N P=0.350N |
|LOGISTIC REGRESSION| P=0.449N P=0.361N P=0.231N P=0.510N |P=0.291N P=0.493N P=0.497N P=0.349N |
|COCH-ARM / FISHERS | P=0.442N P=0.299N P=0.112N P=0.500N |P=0.289N P=0.500N P=0.500N P=0.350N |
|ORDER RESTRICTED | P=0.181N (e) (e) (e) |P=0.343N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 1/15 (7%) |2/15 (13%) 2/15 (13%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/13.69 0/14.38 0/15.00 1/13.85 |2/12.19 2/12.21 0/12.88 1/11.87 |
|POLY-3 PERCENT (g) | 7.3% 0.0% 0.0% 7.2% |16.4% 16.4% 0.0% 8.4% |
|TERMINAL (d) | 1/13 (8%) 0/14 (0%) 0/15 (0%) 1/13 (8%) |2/11 (18%) 2/10 (20%) 0/12 (0%) 1/10 (10%) |
|FIRST INCIDENCE | 183 (T) --- --- 183 (T) |184 (T) 184 (T) --- 184 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.596 P=0.485N P=0.471N P=0.765 |P=0.302N P=0.670 P=0.216N P=0.535N |
|POLY 3 | P=0.591 P=0.490N P=0.482N P=0.759N |P=0.288N P=0.702N P=0.217N P=0.510N |
|POLY 1.5 | P=0.592 P=0.494N P=0.489N P=0.759N |P=0.289N P=0.697N P=0.219N P=0.504N |
|POLY 6 | P=0.590 P=0.487N P=0.475N P=0.759N |P=0.289N P=0.697 P=0.216N P=0.520N |
|LOGISTIC REGRESSION| P=0.596 (e) (e) P=0.765 |P=0.302N P=0.670 (e) P=0.535N |
|COCH-ARM / FISHERS | P=0.596 P=0.500N P=0.500N P=0.759N |P=0.290N P=0.701N P=0.241N P=0.500N |
|ORDER RESTRICTED | P=0.390N (e) (e) (e) |P=0.258N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 06 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 27 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) | 7/15 (47%) 6/15 (40%) 7/15 (47%) 6/15 (40%) |0/15 (0%) 0/15 (0%) 2/15 (13%) 3/15 (20%) |
|POLY-3 RATE (b) | 7/14.46 6/14.38 7/15.00 6/13.85 |0/12.19 0/12.21 2/12.88 3/11.87 |
|POLY-3 PERCENT (g) | 48.4% 41.7% 46.7% 43.3% |0.0% 0.0% 15.5% 25.3% |
|TERMINAL (d) | 6/13 (46%) 6/14 (43%) 7/15 (47%) 6/13 (46%) |0/11 (0%) 0/10 (0%) 2/12 (17%) 3/10 (30%) |
|FIRST INCIDENCE | 113 183 (T) 183 (T) 183 (T) |--- --- 184 (T) 184 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.472N P=0.437N P=0.510N P=0.500N |P=0.019 * (e) P=0.254 P=0.096 |
|POLY 3 | P=0.500N P=0.505N P=0.605N P=0.541N |P=0.019 * (e) P=0.242 P=0.096 |
|POLY 1.5 | P=0.489N P=0.504N P=0.619N P=0.526N |P=0.020 * (e) P=0.241 P=0.101 |
|POLY 6 | P=0.510N P=0.504N P=0.588N P=0.554N |P=0.018 * (e) P=0.243 P=0.091 |
|LOGISTIC REGRESSION| P=0.461N P=0.500N P=0.602 P=0.496N |(e) (e) P=0.254 P=0.096 |
|COCH-ARM / FISHERS | P=0.465N P=0.500N P=0.642N P=0.500N |P=0.024 * (e) P=0.241 P=0.112 |
|ORDER RESTRICTED | P=0.616N (e) (e) (e) |P=0.025 * (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 |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) |0/15 (0%) 1/15 (7%) 1/15 (7%) 4/15 (27%) |
|POLY-3 RATE (b) | 0/13.69 0/14.38 0/15.00 1/13.85 |0/12.19 1/12.21 1/12.88 4/11.87 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.2% |0.0% 8.2% 7.8% 33.7% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/15 (0%) 1/13 (8%) |0/11 (0%) 1/10 (10%) 1/12 (8%) 4/10 (40%) |
|FIRST INCIDENCE | --- --- --- 183 (T) |--- 184 (T) 184 (T) 184 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.192 (e) (e) P=0.500 |P=0.011 * P=0.481 P=0.517 P=0.042 * |
|POLY 3 | P=0.198 (e) (e) P=0.502 |P=0.011 * P=0.500 P=0.511 P=0.037 * |
|POLY 1.5 | P=0.198 (e) (e) P=0.502 |P=0.011 * P=0.502 P=0.509 P=0.041 * |
|POLY 6 | P=0.197 (e) (e) P=0.502 |P=0.010 * P=0.496 P=0.512 P=0.034 * |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.500 |(e) P=0.481 P=0.517 P=0.042 * |
|COCH-ARM / FISHERS | P=0.197 (e) (e) P=0.500 |P=0.015 * P=0.500 P=0.500 P=0.050 |
|ORDER RESTRICTED | P=0.122 (e) (e) (e) |P=0.006 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 06 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 27 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) | 1/15 (7%) 1/15 (7%) 0/15 (0%) 1/15 (7%) |1/15 (7%) 1/15 (7%) 1/15 (7%) 3/15 (20%) |
|POLY-3 RATE (b) | 1/13.69 1/14.38 0/15.00 1/13.85 |1/12.19 1/12.21 1/12.88 3/12.18 |
|POLY-3 PERCENT (g) | 7.3% 7.0% 0.0% 7.2% |8.2% 8.2% 7.8% 24.6% |
|TERMINAL (d) | 1/13 (8%) 1/14 (7%) 0/15 (0%) 1/13 (8%) |1/11 (9%) 1/10 (10%) 1/12 (8%) 2/10 (20%) |
|FIRST INCIDENCE | 183 (T) 183 (T) --- 183 (T) |184 (T) 184 (T) 184 (T) 162 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.622N P=0.748N P=0.471N P=0.765 |P=0.143 P=0.744 P=0.746N P=0.276 |
|POLY 3 | P=0.610N P=0.750N P=0.482N P=0.759N |P=0.155 P=0.762N P=0.750N P=0.293 |
|POLY 1.5 | P=0.612N P=0.754N P=0.489N P=0.759N |P=0.156 P=0.759N P=0.752N P=0.296 |
|POLY 6 | P=0.608N P=0.747N P=0.475N P=0.759N |P=0.155 P=0.759 P=0.749N P=0.290 |
|LOGISTIC REGRESSION| P=0.622N P=0.748N (e) P=0.765 |P=0.141 P=0.744 P=0.746N P=0.281 |
|COCH-ARM / FISHERS | P=0.618N P=0.759N P=0.500N P=0.759N |P=0.154 P=0.759N P=0.759N P=0.299 |
|ORDER RESTRICTED | P=0.523N (e) (e) (e) |P=0.168 (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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/15 (53%) 8/15 (53%) 5/15 (33%) 6/15 (40%) |14/15 (93%) 11/15 (73%) 14/15 (93%) 11/15 (73%) |
|POLY-3 RATE (b) | 8/14.46 8/15.00 5/15.00 6/13.85 |14/14.35 11/13.39 14/15.00 11/12.18 |
|POLY-3 PERCENT (g) | 55.3% 53.3% 33.3% 43.3% |97.6% 82.1% 93.3% 90.3% |
|TERMINAL (d) | 7/13 (54%) 7/14 (50%) 5/15 (33%) 6/13 (46%) |11/11 (100%) 9/10 (90%) 11/12 (92%) 10/10 (100%) |
|FIRST INCIDENCE | 113 133 183 (T) 183 (T) |73 115 110 162 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.237N P=0.559N P=0.157N P=0.360N |P=0.322N P=0.330N P=0.479N P=0.322N |
|POLY 3 | P=0.262N P=0.600N P=0.205N P=0.398N |P=0.489N P=0.205N P=0.637N P=0.519N |
|POLY 1.5 | P=0.251N P=0.616N P=0.216N P=0.384N |P=0.369N P=0.184N P=0.699N P=0.311N |
|POLY 6 | P=0.272N P=0.581N P=0.192N P=0.411N |P=0.611N P=0.229N P=0.560N P=0.948N |
|LOGISTIC REGRESSION| P=0.228N P=0.610 P=0.268N P=0.351N |P=0.183N P=0.127N P=0.751N P=0.103N |
|COCH-ARM / FISHERS | P=0.228N P=0.642N P=0.231N P=0.358N |P=0.206N P=0.165N P=0.759N P=0.165N |
|ORDER RESTRICTED | P=0.295N (e) (e) (e) |P=0.296N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 06 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 27 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 |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 1/15 (7%) 1/15 (7%) 2/15 (13%) |3/15 (20%) 2/15 (13%) 4/15 (27%) 2/15 (13%) |
|POLY-3 RATE (b) | 1/13.69 1/14.38 1/15.00 2/14.61 |3/12.19 2/12.21 4/15.00 2/11.87 |
|POLY-3 PERCENT (g) | 7.3% 7.0% 6.7% 13.7% |24.6% 16.4% 26.7% 16.9% |
|TERMINAL (d) | 1/13 (8%) 1/14 (7%) 1/15 (7%) 1/13 (8%) |3/11 (27%) 2/10 (20%) 1/12 (8%) 2/10 (20%) |
|FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) 114 |184 (T) 184 (T) 110 184 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.348 P=0.748N P=0.732N P=0.508 |P=0.494N P=0.547N P=0.551 P=0.547N |
|POLY 3 | P=0.369 P=0.750N P=0.740N P=0.523 |P=0.480N P=0.499N P=0.620 P=0.513N |
|POLY 1.5 | P=0.363 P=0.754N P=0.748N P=0.515 |P=0.479N P=0.494N P=0.583 P=0.505N |
|POLY 6 | P=0.373 P=0.747N P=0.733N P=0.528 |P=0.485N P=0.509N P=0.649 P=0.527N |
|LOGISTIC REGRESSION| P=0.342 P=0.748N P=0.732N P=0.481 |P=0.477N P=0.547N P=0.451 P=0.547N |
|COCH-ARM / FISHERS | P=0.347 P=0.759N P=0.759N P=0.500 |P=0.478N P=0.500N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.427 (e) (e) (e) |P=0.520N (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) | 4/15 (27%) 2/15 (13%) 5/15 (33%) 4/15 (27%) |3/15 (20%) 7/15 (47%) 5/15 (33%) 5/15 (33%) |
|POLY-3 RATE (b) | 4/13.69 2/14.38 5/15.00 4/14.61 |3/12.85 7/12.21 5/12.88 5/12.18 |
|POLY-3 PERCENT (g) | 29.2% 13.9% 33.3% 27.4% |23.4% 57.3% 38.8% 41.0% |
|TERMINAL (d) | 4/13 (31%) 2/14 (14%) 5/15 (33%) 3/13 (23%) |2/11 (18%) 7/10 (70%) 5/12 (42%) 4/10 (40%) |
|FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) 114 |129 184 (T) 184 (T) 162 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.437 P=0.289N P=0.601 P=0.650N |P=0.386 P=0.085 P=0.389 P=0.307 |
|POLY 3 | P=0.476 P=0.301N P=0.564 P=0.618N |P=0.378 P=0.084 P=0.338 P=0.303 |
|POLY 1.5 | P=0.464 P=0.310N P=0.540 P=0.631N |P=0.400 P=0.100 P=0.347 P=0.320 |
|POLY 6 | P=0.483 P=0.294N P=0.585 P=0.609N |P=0.353 P=0.068 P=0.327 P=0.285 |
|LOGISTIC REGRESSION| P=0.440 P=0.289N P=0.601 P=0.658 |P=0.398 P=0.114 P=0.365 P=0.329 |
|COCH-ARM / FISHERS | P=0.440 P=0.326N P=0.500 P=0.659N |P=0.427 P=0.123 P=0.341 P=0.341 |
|ORDER RESTRICTED | P=0.469 (e) (e) (e) |P=0.196 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 06 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/15 (7%) 0/14 (0%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | |1/12.19 0/11.64 0/12.88 2/11.87 |
|POLY-3 PERCENT (g) | |8.2% 0.0% 0.0% 16.9% |
|TERMINAL (d) | |1/11 (9%) 0/10 (0%) 0/12 (0%) 2/10 (20%) |
|FIRST INCIDENCE | |184 (T) --- --- 184 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.227 P=0.519N P=0.483N P=0.465 |
|POLY 3 | |P=0.242 P=0.509N P=0.489N P=0.490 |
|POLY 1.5 | |P=0.244 P=0.509N P=0.491N P=0.496 |
|POLY 6 | |P=0.239 P=0.510N P=0.488N P=0.480 |
|LOGISTIC REGRESSION| |P=0.227 (e) (e) P=0.465 |
|COCH-ARM / FISHERS | |P=0.248 P=0.517N P=0.500N P=0.500 |
|ORDER RESTRICTED | |P=0.115 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |4/15 (27%) 1/15 (7%) 1/15 (7%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.69 0/14.38 0/15.00 0/13.85 |4/12.19 1/12.21 1/12.88 2/12.38 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |32.8% 8.2% 7.8% 16.2% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/13 (0%) |4/11 (36%) 1/10 (10%) 1/12 (8%) 1/10 (10%) |
|FIRST INCIDENCE | --- --- --- --- |184 (T) 184 (T) 184 (T) 145 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.320N P=0.189N P=0.136N P=0.367N |
|POLY 3 | (e) (e) (e) (e) |P=0.294N P=0.154N P=0.139N P=0.314N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.298N P=0.153N P=0.144N P=0.317N |
|POLY 6 | (e) (e) (e) (e) |P=0.289N P=0.159N P=0.137N P=0.314N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.310N P=0.189N P=0.136N P=0.334N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.304N P=0.165N P=0.165N P=0.326N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.104N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 06 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 27 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) | 1/15 (7%) 2/15 (13%) 1/15 (7%) 1/15 (7%) |2/15 (13%) 1/15 (7%) 1/15 (7%) 4/15 (27%) |
|POLY-3 RATE (b) | 1/13.69 2/14.38 1/15.00 1/14.24 |2/12.19 1/12.21 1/12.88 4/12.18 |
|POLY-3 PERCENT (g) | 7.3% 13.9% 6.7% 7.0% |16.4% 8.2% 7.8% 32.8% |
|TERMINAL (d) | 1/13 (8%) 2/14 (14%) 1/15 (7%) 0/13 (0%) |2/11 (18%) 1/10 (10%) 1/12 (8%) 3/10 (30%) |
|FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) 155 |184 (T) 184 (T) 184 (T) 162 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.529N P=0.527 P=0.732N P=0.752N |P=0.138 P=0.535N P=0.468N P=0.290 |
|POLY 3 | P=0.516N P=0.517 P=0.740N P=0.752N |P=0.149 P=0.499N P=0.480N P=0.320 |
|POLY 1.5 | P=0.522N P=0.511 P=0.748N P=0.756N |P=0.150 P=0.496N P=0.484N P=0.324 |
|POLY 6 | P=0.510N P=0.523 P=0.733N P=0.748N |P=0.149 P=0.507N P=0.479N P=0.316 |
|LOGISTIC REGRESSION| P=0.532N P=0.527 P=0.732N P=0.765 |P=0.135 P=0.535N P=0.468N P=0.297 |
|COCH-ARM / FISHERS | P=0.531N P=0.500 P=0.759N P=0.759N |P=0.152 P=0.500N P=0.500N P=0.326 |
|ORDER RESTRICTED | P=0.572N (e) (e) (e) |P=0.106 (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) | 3/15 (20%) 1/15 (7%) 2/15 (13%) 1/15 (7%) | |
|POLY-3 RATE (b) | 3/13.69 1/14.38 2/15.00 1/13.85 | |
|POLY-3 PERCENT (g) | 21.9% 7.0% 13.3% 7.2% | |
|TERMINAL (d) | 3/13 (23%) 1/14 (7%) 2/15 (13%) 1/13 (8%) | |
|FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) 183 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.269N P=0.271N P=0.431N P=0.297N | |
|POLY 3 | P=0.275N P=0.279N P=0.457N P=0.292N | |
|POLY 1.5 | P=0.275N P=0.285N P=0.473N P=0.294N | |
|POLY 6 | P=0.276N P=0.273N P=0.442N P=0.292N | |
|LOGISTIC REGRESSION| P=0.269N P=0.271N P=0.431N P=0.297N | |
|COCH-ARM / FISHERS | P=0.270N P=0.299N P=0.500N P=0.299N | |
|ORDER RESTRICTED | P=0.200N (e) (e) (e) | |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 06 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 27 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) | 1/15 (7%) 1/15 (7%) 0/15 (0%) 2/15 (13%) |0/15 (0%) 3/15 (20%) 1/15 (7%) 0/14 (0%) |
|POLY-3 RATE (b) | 1/14.24 1/14.38 0/15.00 2/15.00 |0/12.19 3/13.40 1/13.50 0/11.42 |
|POLY-3 PERCENT (g) | 7.0% 7.0% 0.0% 13.3% |0.0% 22.4% 7.4% 0.0% |
|TERMINAL (d) | 0/13 (0%) 1/14 (7%) 0/15 (0%) 0/13 (0%) |0/11 (0%) 0/10 (0%) 0/12 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 141 183 (T) --- 114 |--- 126 133 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.374 P=0.752N P=0.486N P=0.516 |P=0.377N P=0.124 P=0.516 (e) |
|POLY 3 | P=0.378 P=0.758N P=0.490N P=0.519 |P=0.363N P=0.122 P=0.520 (e) |
|POLY 1.5 | P=0.374 P=0.759N P=0.493N P=0.512 |P=0.367N P=0.116 P=0.515 (e) |
|POLY 6 | P=0.382 P=0.759N P=0.487N P=0.523 |P=0.362N P=0.127 P=0.525 (e) |
|LOGISTIC REGRESSION| P=0.320 P=0.719 P=0.858N P=0.425 |P=0.386N P=0.101 P=0.421 (e) |
|COCH-ARM / FISHERS | P=0.363 P=0.759N P=0.500N P=0.500 |P=0.382N P=0.112 P=0.500 (e) |
|ORDER RESTRICTED | P=0.283 (e) (e) (e) |P=0.237N (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 |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 2/15 (13%) 0/15 (0%) |2/15 (13%) 1/15 (7%) 1/15 (7%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/13.69 0/14.38 2/15.00 0/13.85 |2/12.19 1/12.21 1/12.88 1/11.87 |
|POLY-3 PERCENT (g) | 7.3% 0.0% 13.3% 0.0% |16.4% 8.2% 7.8% 8.4% |
|TERMINAL (d) | 1/13 (8%) 0/14 (0%) 2/15 (13%) 0/13 (0%) |2/11 (18%) 1/10 (10%) 1/12 (8%) 1/10 (10%) |
|FIRST INCIDENCE | 183 (T) --- 183 (T) --- |184 (T) 184 (T) 184 (T) 184 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.462N P=0.485N P=0.551 P=0.500N |P=0.422N P=0.535N P=0.468N P=0.535N |
|POLY 3 | P=0.465N P=0.490N P=0.532 P=0.498N |P=0.410N P=0.499N P=0.480N P=0.510N |
|POLY 1.5 | P=0.463N P=0.494N P=0.520 P=0.498N |P=0.409N P=0.496N P=0.484N P=0.504N |
|POLY 6 | P=0.468N P=0.487N P=0.543 P=0.498N |P=0.412N P=0.507N P=0.479N P=0.520N |
|LOGISTIC REGRESSION| P=0.462N (e) P=0.551 (e) |P=0.422N P=0.535N P=0.468N P=0.535N |
|COCH-ARM / FISHERS | P=0.460N P=0.500N P=0.500 P=0.500N |P=0.406N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.317N (e) (e) (e) |P=0.407N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 06 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMOD
ICHLOR
Terminal Sacrifice at 27 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 |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/15 (13%) 0/15 (0%) 1/15 (7%) 0/15 (0%) |
|POLY-3 RATE (b) | |2/12.19 0/12.21 1/12.88 0/11.87 |
|POLY-3 PERCENT (g) | |16.4% 0.0% 7.8% 0.0% |
|TERMINAL (d) | |2/11 (18%) 0/10 (0%) 1/12 (8%) 0/10 (0%) |
|FIRST INCIDENCE | |184 (T) --- 184 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.189N P=0.256N P=0.468N P=0.256N |
|POLY 3 | |P=0.183N P=0.229N P=0.480N P=0.235N |
|POLY 1.5 | |P=0.184N P=0.227N P=0.484N P=0.232N |
|POLY 6 | |P=0.183N P=0.233N P=0.479N P=0.241N |
|LOGISTIC REGRESSION| |P=0.189N (e) P=0.468N (e) |
|COCH-ARM / FISHERS | |P=0.184N P=0.241N P=0.500N P=0.241N |
|ORDER RESTRICTED | |P=0.072N (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) | |7/15 (47%) 6/15 (40%) 10/15 (67%) 6/15 (40%) |
|POLY-3 RATE (b) | |7/12.19 6/12.64 10/12.88 6/12.68 |
|POLY-3 PERCENT (g) | |57.4% 47.5% 77.7% 47.3% |
|TERMINAL (d) | |7/11 (64%) 5/10 (50%) 10/12 (83%) 5/10 (50%) |
|FIRST INCIDENCE | |184 (T) 153 184 (T) 105 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.574 P=0.589N P=0.279 P=0.584N |
|POLY 3 | |P=0.477N P=0.463N P=0.247 P=0.459N |
|POLY 1.5 | |P=0.485N P=0.469N P=0.249 P=0.467N |
|POLY 6 | |P=0.493N P=0.459N P=0.244 P=0.469N |
|LOGISTIC REGRESSION| |P=0.552N P=0.515N P=0.279 P=0.524N |
|COCH-ARM / FISHERS | |P=0.517N P=0.500N P=0.231 P=0.500N |
|ORDER RESTRICTED | |P=0.381N (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).