TDMS Study 97013-90 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (DICHLOROACETIC ACID) DATE: 12/05/03
EXPERIMENT: 97013 TEST: 90 TIME: 09:35:52
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: DOSED WATER NTP C#: 97013I
PATHOLOGIST: MISSING CAS: 79-43-6
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (DICHLOROACETIC ACID) DATE: 12/05/03
EXPERIMENT: 97013 TEST: 90 TIME: 09:35:52
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: DOSED WATER NTP C#: 97013I
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 Hypertrophy
Liver: Hepatocyte Fatty Change
Pituitary Gland: Pars Distalis Cyst
Thymus Cyst
Ectopic Parathyroid Gland
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Ovary Cyst
Thyroid Gland Infiltration Cellular Lymphocyte
===============================================================
Date: 12/05/03 EXPERIMENT: 97013 TEST: 90 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (DICHLOR
OACET
Terminal Sacrifice at 41 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/9.31 0/10.00 0/9.81 0/10.00 |0/10.00 2/10.00 0/10.00 0/9.37 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 20.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) |0/10 (0%) 1/9 (11%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 268 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.423N P=0.228 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.410N P=0.227 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.406N P=0.227 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.414N P=0.227 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.342N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.403N P=0.237 (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.242N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 3/10 (30%) 1/10 (10%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 3/9.31 3/10.00 1/9.81 0/10.00 |0/10.00 0/9.85 0/10.00 0/9.37 |
|POLY-3 PERCENT (g) | 32.2% 30.0% 10.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/9 (33%) 3/10 (30%) 1/9 (11%) 0/10 (0%) |0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | 282 (T) 282 (T) 282 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035N* P=0.629N P=0.291N P=0.093N |(e) (e) (e) (e) |
|POLY 3 | P=0.033N* P=0.643N P=0.270N P=0.081N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.034N* P=0.656N P=0.277N P=0.086N |(e) (e) (e) (e) |
|POLY 6 | P=0.031N* P=0.631N P=0.267N P=0.077N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.035N* P=0.629N P=0.291N (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.039N* P=0.686N P=0.291N P=0.105N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.044N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/05/03 EXPERIMENT: 97013 TEST: 90 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (DICHLORO
ACET
Terminal Sacrifice at 41 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 5/10 (50%) 3/10 (30%) 3/10 (30%) |10/10 (100%) 10/10 (100%) 9/10 (90%) 10/10 (100%) |
|POLY-3 RATE (b) | 3/9.31 5/10.00 3/9.81 3/10.00 |10/10.00 10/10.00 9/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 32.2% 50.0% 30.6% 30.0% |100.0% 100.0% 90.0% 100.0% |
|TERMINAL (d) | 3/9 (33%) 5/10 (50%) 3/9 (33%) 3/10 (30%) |10/10 (100%) 9/9 (100%) 9/10 (90%) 9/9 (100%) |
|FIRST INCIDENCE | 282 (T) 282 (T) 282 (T) 282 (T) |283 (T) 268 283 (T) 203 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.407N P=0.397 P=0.686 P=0.629N |P=0.458 (e) P=0.500N (e) |
|POLY 3 | P=0.415N P=0.375 P=0.654N P=0.643N |P=0.694N (e) P=0.500N (e) |
|POLY 1.5 | P=0.430N P=0.358 P=0.662N P=0.656N |P=0.694N (e) P=0.500N (e) |
|POLY 6 | P=0.403N P=0.391 P=0.650N P=0.631N |P=0.694N (e) P=0.500N (e) |
|LOGISTIC REGRESSION| P=0.407N P=0.397 P=0.686 P=0.629N |P=0.458 (e) P=0.500N (e) |
|COCH-ARM / FISHERS | P=0.455N P=0.325 P=0.686N P=0.686N |P=0.696N (e) P=0.500N (e) |
|ORDER RESTRICTED | P=0.486N (e) (e) (e) |P=0.381N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 2/10 (20%) 1/10 (10%) 3/10 (30%) | |
|POLY-3 RATE (b) | 3/9.31 2/10.00 1/9.81 3/10.00 | |
|POLY-3 PERCENT (g) | 32.2% 20.0% 10.2% 30.0% | |
|TERMINAL (d) | 3/9 (33%) 2/10 (20%) 1/9 (11%) 3/10 (30%) | |
|FIRST INCIDENCE | 282 (T) 282 (T) 282 (T) 282 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.589N P=0.447N P=0.291N P=0.629N | |
|POLY 3 | P=0.592 P=0.464N P=0.270N P=0.643N | |
|POLY 1.5 | P=0.586 P=0.477N P=0.277N P=0.656N | |
|POLY 6 | P=0.597 P=0.453N P=0.267N P=0.631N | |
|LOGISTIC REGRESSION| P=0.589N P=0.447N P=0.291N P=0.629N | |
|COCH-ARM / FISHERS | P=0.576 P=0.500N P=0.291N P=0.686N | |
|ORDER RESTRICTED | P=0.429N (e) (e) (e) | |
|=================================================================================================================================|
Date: 12/05/03 EXPERIMENT: 97013 TEST: 90 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (DICHLORO
ACET
Terminal Sacrifice at 41 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 2/10 (20%) 3/10 (30%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/9.31 0/10.00 0/9.81 0/10.00 |0/10.00 2/9.85 3/10.00 0/9.37 |
|POLY-3 PERCENT (g) | 10.8% 0.0% 0.0% 0.0% |0.0% 20.3% 30.0% 0.0% |
|TERMINAL (d) | 1/9 (11%) 0/10 (0%) 0/9 (0%) 0/10 (0%) |0/10 (0%) 2/9 (22%) 3/10 (30%) 0/9 (0%) |
|FIRST INCIDENCE | 282 (T) --- --- --- |--- 283 (T) 283 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.298N P=0.479N P=0.500N P=0.479N |P=0.557N P=0.210 P=0.111 (e) |
|POLY 3 | P=0.318N P=0.486N P=0.489N P=0.486N |P=0.572N P=0.223 P=0.095 (e) |
|POLY 1.5 | P=0.313N P=0.491N P=0.493N P=0.491N |P=0.557N P=0.225 P=0.095 (e) |
|POLY 6 | P=0.323N P=0.481N P=0.488N P=0.481N |P=0.587N P=0.220 P=0.095 (e) |
|LOGISTIC REGRESSION| P=0.298N (e) (e) (e) |(e) P=0.210 P=0.111 (e) |
|COCH-ARM / FISHERS | P=0.304N P=0.500N P=0.500N P=0.500N |P=0.532N P=0.237 P=0.105 (e) |
|ORDER RESTRICTED | P=0.108N (e) (e) (e) |P=0.193 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/10 (90%) 6/10 (60%) 8/10 (80%) 8/10 (80%) |4/10 (40%) 4/10 (40%) 7/10 (70%) 5/10 (50%) |
|POLY-3 RATE (b) | 9/9.31 6/10.00 8/9.81 8/10.00 |4/10.00 4/10.00 7/10.00 5/9.37 |
|POLY-3 PERCENT (g) | 96.7% 60.0% 81.5% 80.0% |40.0% 40.0% 70.0% 53.4% |
|TERMINAL (d) | 9/9 (100%) 6/10 (60%) 8/9 (89%) 8/10 (80%) |4/10 (40%) 3/9 (33%) 7/10 (70%) 5/9 (56%) |
|FIRST INCIDENCE | 282 (T) 282 (T) 282 (T) 282 (T) |283 (T) 268 283 (T) 283 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.448N P=0.063N P=0.500N P=0.257N |P=0.280 P=0.605 P=0.190 P=0.416 |
|POLY 3 | P=0.503N P=0.067N P=0.363N P=0.330N |P=0.272 P=0.667 P=0.186 P=0.449 |
|POLY 1.5 | P=0.530N P=0.092N P=0.415N P=0.396N |P=0.296 P=0.667 P=0.186 P=0.469 |
|POLY 6 | P=0.481N P=0.051N P=0.330N P=0.275N |P=0.249 P=0.667 P=0.186 P=0.429 |
|LOGISTIC REGRESSION| P=0.448N P=0.063N P=0.500N P=0.257N |P=0.267 (e) P=0.190 P=0.416 |
|COCH-ARM / FISHERS | P=0.576N P=0.152N P=0.500N P=0.500N |P=0.334 P=0.675N P=0.185 P=0.500 |
|ORDER RESTRICTED | P=0.161N (e) (e) (e) |P=0.275 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/05/03 EXPERIMENT: 97013 TEST: 90 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (DICHLORO
ACET
Terminal Sacrifice at 41 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 0/10 (0%) 1/10 (10%) |0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/9.31 2/10.00 0/9.81 1/10.00 |0/10.00 0/9.85 1/10.00 1/9.37 |
|POLY-3 PERCENT (g) | 10.8% 20.0% 0.0% 10.0% |0.0% 0.0% 10.0% 10.7% |
|TERMINAL (d) | 1/9 (11%) 2/10 (20%) 0/9 (0%) 1/10 (10%) |0/10 (0%) 0/9 (0%) 1/10 (10%) 1/9 (11%) |
|FIRST INCIDENCE | 282 (T) 282 (T) --- 282 (T) |--- --- 283 (T) 283 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.478N P=0.539 P=0.500N P=0.743N |P=0.220 (e) P=0.500 P=0.479 |
|POLY 3 | P=0.485N P=0.526 P=0.489N P=0.745N |P=0.219 (e) P=0.500 P=0.487 |
|POLY 1.5 | P=0.490N P=0.516 P=0.493N P=0.750N |P=0.226 (e) P=0.500 P=0.492 |
|POLY 6 | P=0.480N P=0.534 P=0.488N P=0.739N |P=0.213 (e) P=0.500 P=0.482 |
|LOGISTIC REGRESSION| P=0.478N P=0.539 (e) P=0.743N |(e) (e) P=0.500 P=0.479 |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.500N P=0.763N |P=0.231 (e) P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.366N (e) (e) (e) |P=0.239 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/10 (90%) 8/10 (80%) 7/10 (70%) 9/10 (90%) |10/10 (100%) 10/10 (100%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 9/9.31 8/10.00 7/9.81 9/10.00 |10/10.00 10/10.00 10/10.00 9/9.37 |
|POLY-3 PERCENT (g) | 96.7% 80.0% 71.4% 90.0% |100.0% 100.0% 100.0% 96.1% |
|TERMINAL (d) | 9/9 (100%) 8/10 (80%) 7/9 (78%) 9/10 (90%) |10/10 (100%) 9/9 (100%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | 282 (T) 282 (T) 282 (T) 282 (T) |283 (T) 268 283 (T) 283 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.493N P=0.257N P=0.233N P=0.521N |P=0.584N (e) (e) P=1.000N |
|POLY 3 | P=0.551N P=0.330N P=0.174N P=0.630N |P=0.592N (e) (e) P=0.948N |
|POLY 1.5 | P=0.582N P=0.396N P=0.213N P=0.694N |P=0.332N (e) (e) P=0.730N |
|POLY 6 | P=0.524N P=0.275N P=0.148N P=0.557N |P=0.999N (e) (e) P=1.000N |
|LOGISTIC REGRESSION| P=0.493N P=0.257N P=0.233N P=0.521N |P=0.584N (e) (e) P=1.000N |
|COCH-ARM / FISHERS | P=0.584 P=0.500N P=0.291N P=0.763N |P=0.196N (e) (e) P=0.500N |
|ORDER RESTRICTED | P=0.258N (e) (e) (e) |P=0.115N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/05/03 EXPERIMENT: 97013 TEST: 90 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (DICHLORO
ACET
Terminal Sacrifice at 41 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/10 (60%) 5/10 (50%) 0/10 (0%) 0/10 (0%) |1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 6/10.00 5/10.00 0/9.81 0/10.00 |1/10.00 0/9.85 0/10.00 0/9.37 |
|POLY-3 PERCENT (g) | 60.0% 50.0% 0.0% 0.0% |10.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 5/9 (56%) 5/10 (50%) 0/9 (0%) 0/10 (0%) |1/10 (10%) 0/9 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | 190 282 (T) --- --- |283 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.415N P=0.011N* P=0.009N** |P=0.314N P=0.521N P=0.500N P=0.521N |
|POLY 3 | P<0.001N** P=0.500N P<0.001N** P<0.001N** |P=0.297N P=0.503N P=0.500N P=0.513N |
|POLY 1.5 | P<0.001N** P=0.500N P<0.001N** P<0.001N** |P=0.301N P=0.502N P=0.500N P=0.508N |
|POLY 6 | P<0.001N** P=0.500N P<0.001N** P<0.001N** |P=0.293N P=0.506N P=0.500N P=0.518N |
|LOGISTIC REGRESSION| P<0.001N** P=0.415N P=0.010N* (e) |P=0.314N (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001N** P=0.500N P=0.005N** P=0.005N** |P=0.304N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.132N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/10 (90%) 10/10 (100%) 10/10 (100%) 10/10 (100%)|10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 9/9.31 10/10.00 10/10.00 10/10.00 |10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 96.7% 100.0% 100.0% 100.0% |100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 9/9 (100%) 10/10 (100%) 9/9 (100%) 10/10 (100%)|10/10 (100%) 9/9 (100%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | 282 (T) 282 (T) 263 282 (T) |283 (T) 268 283 (T) 203 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.706 P=1.000N P=0.521 P=1.000 |(e) (e) (e) (e) |
|POLY 3 | P=0.860 P=0.984 P=0.984 P=0.984 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.527 P=0.779 P=0.779 P=0.779 |(e) (e) (e) (e) |
|POLY 6 | P=1.000 P=1.000 P=1.000 P=1.000 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.706 P=1.000N (e) P=1.000 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.304 P=0.500 P=0.500 P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.114 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/05/03 EXPERIMENT: 97013 TEST: 90 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (DICHLORO
ACET
Terminal Sacrifice at 41 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/9.31 0/10.00 0/9.81 0/10.00 |0/10.00 2/9.85 0/10.00 0/9.37 |
|POLY-3 PERCENT (g) | 10.8% 0.0% 0.0% 0.0% |0.0% 20.3% 0.0% 0.0% |
|TERMINAL (d) | 1/9 (11%) 0/10 (0%) 0/9 (0%) 0/10 (0%) |0/10 (0%) 2/9 (22%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | 282 (T) --- --- --- |--- 283 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.298N P=0.479N P=0.500N P=0.479N |P=0.419N P=0.210 (e) (e) |
|POLY 3 | P=0.318N P=0.486N P=0.489N P=0.486N |P=0.412N P=0.223 (e) (e) |
|POLY 1.5 | P=0.313N P=0.491N P=0.493N P=0.491N |P=0.407N P=0.225 (e) (e) |
|POLY 6 | P=0.323N P=0.481N P=0.488N P=0.481N |P=0.417N P=0.220 (e) (e) |
|LOGISTIC REGRESSION| P=0.298N (e) (e) (e) |(e) P=0.210 (e) (e) |
|COCH-ARM / FISHERS | P=0.304N P=0.500N P=0.500N P=0.500N |P=0.403N P=0.237 (e) (e) |
|ORDER RESTRICTED | P=0.108N (e) (e) (e) |P=0.239N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/10 (0%) 1/10 (10%) 1/10 (10%) 7/10 (70%) |
|POLY-3 RATE (b) | |0/10.00 1/9.85 1/10.00 7/9.37 |
|POLY-3 PERCENT (g) | |0.0% 10.2% 10.0% 74.7% |
|TERMINAL (d) | |0/10 (0%) 1/9 (11%) 1/10 (10%) 7/9 (78%) |
|FIRST INCIDENCE | |--- 283 (T) 283 (T) 283 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P<0.001 ** P=0.479 P=0.500 P=0.002 ** |
|POLY 3 | |P<0.001 ** P=0.497 P=0.500 P<0.001 ** |
|POLY 1.5 | |P<0.001 ** P=0.498 P=0.500 P<0.001 ** |
|POLY 6 | |P<0.001 ** P=0.494 P=0.500 P<0.001 ** |
|LOGISTIC REGRESSION| |(e) P=0.479 P=0.500 P=0.002 ** |
|COCH-ARM / FISHERS | |P<0.001 ** P=0.500 P=0.500 P=0.002 ** |
|ORDER RESTRICTED | |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/05/03 EXPERIMENT: 97013 TEST: 90 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (DICHLORO
ACET
Terminal Sacrifice at 41 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/10 (40%) 2/10 (20%) 2/10 (20%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 4/9.31 2/10.00 2/9.81 0/10.00 |0/10.00 0/9.85 1/10.00 1/9.37 |
|POLY-3 PERCENT (g) | 43.0% 20.0% 20.4% 0.0% |0.0% 0.0% 10.0% 10.7% |
|TERMINAL (d) | 4/9 (44%) 2/10 (20%) 2/9 (22%) 0/10 (0%) |0/10 (0%) 0/9 (0%) 1/10 (10%) 1/9 (11%) |
|FIRST INCIDENCE | 282 (T) 282 (T) 282 (T) --- |--- --- 283 (T) 283 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027N* P=0.263N P=0.314N P=0.039N* |P=0.220 (e) P=0.500 P=0.479 |
|POLY 3 | P=0.025N* P=0.279N P=0.288N P=0.025N* |P=0.219 (e) P=0.500 P=0.487 |
|POLY 1.5 | P=0.026N* P=0.293N P=0.297N P=0.027N* |P=0.226 (e) P=0.500 P=0.492 |
|POLY 6 | P=0.024N* P=0.267N P=0.283N P=0.023N* |P=0.213 (e) P=0.500 P=0.482 |
|LOGISTIC REGRESSION| P=0.027N* P=0.263N P=0.314N (e) |(e) (e) P=0.500 P=0.479 |
|COCH-ARM / FISHERS | P=0.031N* P=0.314N P=0.314N P=0.043N* |P=0.231 (e) P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.011N* (e) (e) (e) |P=0.239 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |1/10 (10%) 2/10 (20%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 1/10.00 1/10.00 0/9.81 0/10.00 |1/10.00 2/9.85 0/10.00 2/10.00 |
|POLY-3 PERCENT (g) | 10.0% 10.0% 0.0% 0.0% |10.0% 20.3% 0.0% 20.0% |
|TERMINAL (d) | 0/9 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) |1/10 (10%) 2/9 (22%) 0/10 (0%) 1/9 (11%) |
|FIRST INCIDENCE | 190 282 (T) --- --- |283 (T) 283 (T) --- 203 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.232N P=0.749N P=0.500N P=0.500N |P=0.449 P=0.461 P=0.500N P=0.475 |
|POLY 3 | P=0.238N P=0.760 P=0.504N P=0.500N |P=0.469 P=0.495 P=0.500N P=0.500 |
|POLY 1.5 | P=0.237N P=0.760 P=0.502N P=0.500N |P=0.469 P=0.497 P=0.500N P=0.500 |
|POLY 6 | P=0.239N P=0.760 P=0.507N P=0.500N |P=0.470 P=0.490 P=0.500N P=0.500 |
|LOGISTIC REGRESSION| P=0.542N P=0.749N (e) (e) |P=0.561N P=0.461 (e) (e) |
|COCH-ARM / FISHERS | P=0.231N P=0.763N P=0.500N P=0.500N |P=0.468 P=0.500 P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.252N (e) (e) (e) |P=0.401 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/05/03 EXPERIMENT: 97013 TEST: 90 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (DICHLORO
ACET
Terminal Sacrifice at 41 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/10 (50%) 4/10 (40%) 2/10 (20%) 4/10 (40%) | |
|POLY-3 RATE (b) | 5/9.31 4/10.00 2/9.81 4/10.00 | |
|POLY-3 PERCENT (g) | 53.7% 40.0% 20.4% 40.0% | |
|TERMINAL (d) | 5/9 (56%) 4/10 (40%) 2/9 (22%) 4/10 (40%) | |
|FIRST INCIDENCE | 282 (T) 282 (T) 282 (T) 282 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.343N P=0.416N P=0.174N P=0.416N | |
|POLY 3 | P=0.368N P=0.444N P=0.146N P=0.444N | |
|POLY 1.5 | P=0.377N P=0.464N P=0.155N P=0.464N | |
|POLY 6 | P=0.361N P=0.425N P=0.142N P=0.425N | |
|LOGISTIC REGRESSION| P=0.343N P=0.416N P=0.174N P=0.416N | |
|COCH-ARM / FISHERS | P=0.391N P=0.500N P=0.175N P=0.500N | |
|ORDER RESTRICTED | P=0.241N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/10 (60%) 3/10 (30%) 2/10 (20%) 2/10 (20%) |9/10 (90%) 8/10 (80%) 7/10 (70%) 8/10 (80%) |
|POLY-3 RATE (b) | 6/10.00 3/10.00 2/9.81 2/10.00 |9/10.00 8/10.00 7/10.00 8/10.00 |
|POLY-3 PERCENT (g) | 60.0% 30.0% 20.4% 20.0% |90.0% 80.0% 70.0% 80.0% |
|TERMINAL (d) | 5/9 (56%) 3/10 (30%) 2/9 (22%) 2/10 (20%) |9/10 (90%) 7/9 (78%) 7/10 (70%) 7/9 (78%) |
|FIRST INCIDENCE | 190 282 (T) 282 (T) 282 (T) |283 (T) 268 283 (T) 203 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.057N P=0.159N P=0.101N P=0.078N |P=0.523N P=0.670N P=0.293N P=0.670N |
|POLY 3 | P=0.060N P=0.186N P=0.082N P=0.077N |P=0.398N P=0.500N P=0.292N P=0.500N |
|POLY 1.5 | P=0.060N P=0.186N P=0.080N P=0.077N |P=0.398N P=0.500N P=0.292N P=0.500N |
|POLY 6 | P=0.060N P=0.186N P=0.086N P=0.077N |P=0.398N P=0.500N P=0.292N P=0.500N |
|LOGISTIC REGRESSION| P=0.088N P=0.159N P=0.109N P=0.078N |P=0.523N (e) P=0.293N (e) |
|COCH-ARM / FISHERS | P=0.062N P=0.185N P=0.085N P=0.085N |P=0.395N P=0.500N P=0.291N P=0.500N |
|ORDER RESTRICTED | P=0.036N* (e) (e) (e) |P=0.331N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/05/03 EXPERIMENT: 97013 TEST: 90 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (DICHLORO
ACET
Terminal Sacrifice at 41 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Ectopic Parathyroid Gland |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 3/10 (30%) |0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/9.31 0/10.00 2/9.81 3/10.00 |0/10.00 1/10.00 0/10.00 0/9.37 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 20.4% 30.0% |0.0% 10.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) 2/9 (22%) 3/10 (30%) |0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- 282 (T) 282 (T) |--- 268 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027 * (e) P=0.233 P=0.129 |P=0.584N P=0.500 (e) (e) |
|POLY 3 | P=0.021 * (e) P=0.239 P=0.108 |P=0.569N P=0.500 (e) (e) |
|POLY 1.5 | P=0.020 * (e) P=0.235 P=0.103 |P=0.568N P=0.500 (e) (e) |
|POLY 6 | P=0.022 * (e) P=0.240 P=0.113 |P=0.569N P=0.500 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.233 P=0.129 |P=0.468N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.022 * (e) P=0.237 P=0.105 |P=0.568N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.030 * (e) (e) (e) |P=0.393N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 1/9.31 1/10.00 0/9.81 0/10.00 |0/10.00 0/9.85 0/10.00 2/9.37 |
|POLY-3 PERCENT (g) | 10.8% 10.0% 0.0% 0.0% |0.0% 0.0% 0.0% 21.4% |
|TERMINAL (d) | 1/9 (11%) 1/10 (10%) 0/9 (0%) 0/10 (0%) |0/10 (0%) 0/9 (0%) 0/10 (0%) 2/9 (22%) |
|FIRST INCIDENCE | 282 (T) 282 (T) --- --- |--- --- --- 283 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224N P=0.743N P=0.500N P=0.479N |P=0.040 * (e) (e) P=0.210 |
|POLY 3 | P=0.232N P=0.745N P=0.489N P=0.486N |P=0.036 * (e) (e) P=0.211 |
|POLY 1.5 | P=0.234N P=0.750N P=0.493N P=0.491N |P=0.036 * (e) (e) P=0.217 |
|POLY 6 | P=0.231N P=0.739N P=0.488N P=0.481N |P=0.035 * (e) (e) P=0.205 |
|LOGISTIC REGRESSION| P=0.224N P=0.743N (e) (e) |(e) (e) (e) P=0.210 |
|COCH-ARM / FISHERS | P=0.231N P=0.763N P=0.500N P=0.500N |P=0.043 * (e) (e) P=0.237 |
|ORDER RESTRICTED | P=0.237N (e) (e) (e) |P=0.018 * (e) (e) (e) |
|=================================================================================================================================|
Date: 12/05/03 EXPERIMENT: 97013 TEST: 90 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (DICHLORO
ACET
Terminal Sacrifice at 41 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/10 (20%) 1/10 (10%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | |2/10.00 1/10.00 1/10.00 0/9.37 |
|POLY-3 PERCENT (g) | |20.0% 10.0% 10.0% 0.0% |
|TERMINAL (d) | |2/10 (20%) 0/9 (0%) 1/10 (10%) 0/9 (0%) |
|FIRST INCIDENCE | |283 (T) 268 283 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.162N P=0.525N P=0.500N P=0.257N |
|POLY 3 | |P=0.157N P=0.500N P=0.500N P=0.242N |
|POLY 1.5 | |P=0.154N P=0.500N P=0.500N P=0.236N |
|POLY 6 | |P=0.160N P=0.500N P=0.500N P=0.248N |
|LOGISTIC REGRESSION| |P=0.123N (e) P=0.500N (e) |
|COCH-ARM / FISHERS | |P=0.143N P=0.500N P=0.500N P=0.237N |
|ORDER RESTRICTED | |P=0.122N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 500 MG/L 1000MG/L 2000MG/L |0 MG/L 500 MG/L 1000MG/L 2000MG/L |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |7/10 (70%) 9/10 (90%) 9/10 (90%) 9/10 (90%) |
|POLY-3 RATE (b) | |7/10.00 9/10.00 9/10.00 9/9.37 |
|POLY-3 PERCENT (g) | |70.0% 90.0% 90.0% 96.1% |
|TERMINAL (d) | |7/10 (70%) 8/9 (89%) 9/10 (90%) 9/9 (100%) |
|FIRST INCIDENCE | |283 (T) 268 283 (T) 283 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.130 P=0.195 P=0.293 P=0.129 |
|POLY 3 | |P=0.113 P=0.292 P=0.292 P=0.171 |
|POLY 1.5 | |P=0.153 P=0.292 P=0.292 P=0.215 |
|POLY 6 | |P=0.083 P=0.292 P=0.292 P=0.134 |
|LOGISTIC REGRESSION| |P=0.081 (e) P=0.293 P=0.129 |
|COCH-ARM / FISHERS | |P=0.227 P=0.291 P=0.291 P=0.291 |
|ORDER RESTRICTED | |P=0.070 (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).