TDMS Study 97013-96 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 10/08/03
EXPERIMENT: 97013 TEST: 96 TIME: 15:30:51
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-65406 ROUTE: DOSED WATER NTP C#: 97013J
PATHOLOGIST: MISSING CAS: 75-27-4
------------------------------------------------------------------------------------------------------------------------------------
FINAL/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 (BROMODICHLOROMETHANE) DATE: 10/08/03
EXPERIMENT: 97013 TEST: 96 TIME: 15:30:51
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-65406 ROUTE: DOSED WATER NTP C#: 97013J
PATHOLOGIST: MISSING CAS: 75-27-4
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF WATER DISINFECTION MODEL (BROMODICHLOR
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Kidney Nephropathy
Kidney: Renal Tubule Degeneration
Vacuolization Cytoplasmic
Liver Inflammation
Necrosis
Liver: Hepatocyte Fatty Change
Spleen Atrophy
Thymus Atrophy
Cyst
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Kidney Casts Protein
Nephropathy
Liver: Hepatocyte Fatty Change
===============================================================
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODI
CHLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 4/10 (40%) 2/10 (20%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/9.42 4/10.00 2/9.82 0/7.80 |0/9.90 0/9.23 0/10.00 0/8.48 |
|POLY-3 PERCENT (g) | 21.2% 40.0% 20.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/9 (22%) 4/10 (40%) 2/9 (22%) 0/7 (0%) |0/9 (0%) 0/9 (0%) 0/10 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 296 (T) 296 (T) 296 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140N P=0.371 P=0.709 P=0.290N |(e) (e) (e) (e) |
|POLY 3 | P=0.132N P=0.348 P=0.688N P=0.272N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.120N P=0.336 P=0.693N P=0.260N |(e) (e) (e) (e) |
|POLY 6 | P=0.139N P=0.362 P=0.684N P=0.280N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.140N P=0.371 P=0.709 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.091N P=0.314 P=0.709N P=0.237N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.104N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 2/10 (20%) 3/10 (30%) 2/10 (20%) |9/10 (90%) 10/10 (100%) 10/10 (100%) 8/10 (80%) |
|POLY-3 RATE (b) | 2/9.42 2/10.00 3/9.82 2/7.80 |9/10.00 10/10.00 10/10.00 8/9.01 |
|POLY-3 PERCENT (g) | 21.2% 20.0% 30.6% 25.7% |90.0% 100.0% 100.0% 88.8% |
|TERMINAL (d) | 2/9 (22%) 2/10 (20%) 3/9 (33%) 2/7 (29%) |8/9 (89%) 9/9 (100%) 10/10 (100%) 7/8 (88%) |
|FIRST INCIDENCE | 296 (T) 296 (T) 296 (T) 296 (T) |287 183 297 (T) 231 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.435 P=0.667N P=0.500 P=0.611 |P=0.542N P=0.488 P=0.749 P=0.686 |
|POLY 3 | P=0.454 P=0.680N P=0.521 P=0.633 |P=0.577N P=0.500 P=0.500 P=0.735N |
|POLY 1.5 | P=0.484 P=0.689N P=0.513 P=0.651 |P=0.545N P=0.500 P=0.500 P=0.718N |
|POLY 6 | P=0.433 P=0.671N P=0.526 P=0.620 |P=0.579N P=0.500 P=0.500 P=0.737N |
|LOGISTIC REGRESSION| P=0.435 P=0.667N P=0.500 P=0.611 |P=0.501N (e) P=0.749 P=0.773N |
|COCH-ARM / FISHERS | P=0.576 P=0.709N P=0.500 P=0.709N |P=0.239N P=0.500 P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.573 (e) (e) (e) |P=0.363N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |8/10 (80%) 1/10 (10%) 5/10 (50%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/9.42 0/10.00 1/10.00 0/7.80 |8/9.90 1/9.23 5/10.00 3/9.01 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.0% 0.0% |80.8% 10.8% 50.0% 33.3% |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/7 (0%) |8/9 (89%) 1/9 (11%) 5/10 (50%) 2/8 (25%) |
|FIRST INCIDENCE | --- --- 277 --- |297 (T) 297 (T) 297 (T) 231 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.671 (e) P=0.521 (e) |P=0.146N P=0.003N** P=0.098N P=0.073N |
|POLY 3 | P=0.590 (e) P=0.512 (e) |P=0.094N P<0.001N** P=0.164N P=0.040N* |
|POLY 1.5 | P=0.620 (e) P=0.507 (e) |P=0.098N P<0.001N** P=0.169N P=0.040N* |
|POLY 6 | P=0.567 (e) P=0.517 (e) |P=0.088N P<0.001N** P=0.155N P=0.037N* |
|LOGISTIC REGRESSION| P=0.729 (e) P=0.421 (e) |P=0.142N P=0.003N** P=0.098N P=0.053N |
|COCH-ARM / FISHERS | P=0.696 (e) P=0.500 (e) |P=0.107N P=0.003N** P=0.175N P=0.035N* |
|ORDER RESTRICTED | P=0.396 (e) (e) (e) |P=0.012N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |1/10 (10%) 4/10 (40%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/9.42 0/10.00 0/9.82 0/7.80 |1/9.90 4/9.23 0/10.00 1/8.48 |
|POLY-3 PERCENT (g) | 10.6% 0.0% 0.0% 0.0% |10.1% 43.3% 0.0% 11.8% |
|TERMINAL (d) | 1/9 (11%) 0/10 (0%) 0/9 (0%) 0/7 (0%) |1/9 (11%) 4/9 (44%) 0/10 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 296 (T) --- --- --- |297 (T) 297 (T) --- 297 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.334N P=0.479N P=0.500N P=0.550N |P=0.360N P=0.153 P=0.479N P=0.741 |
|POLY 3 | P=0.281N P=0.488N P=0.492N P=0.537N |P=0.360N P=0.123 P=0.498N P=0.726 |
|POLY 1.5 | P=0.289N P=0.493N P=0.495N P=0.528N |P=0.353N P=0.131 P=0.499N P=0.732 |
|POLY 6 | P=0.276N P=0.483N P=0.489N P=0.543N |P=0.364N P=0.120 P=0.496N P=0.721 |
|LOGISTIC REGRESSION| P=0.334N (e) (e) (e) |P=0.360N P=0.153 (e) P=0.741 |
|COCH-ARM / FISHERS | P=0.304N P=0.500N P=0.500N P=0.500N |P=0.327N P=0.152 P=0.500N P=0.763N |
|ORDER RESTRICTED | P=0.155N (e) (e) (e) |P=0.163N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/10 (50%) 4/10 (40%) 9/10 (90%) 8/10 (80%) |3/10 (30%) 1/10 (10%) 8/10 (80%) 0/10 (0%) |
|POLY-3 RATE (b) | 5/9.42 4/10.00 9/9.82 8/8.61 |3/10.00 1/10.00 8/10.00 0/8.48 |
|POLY-3 PERCENT (g) | 53.1% 40.0% 91.7% 93.0% |30.0% 10.0% 80.0% 0.0% |
|TERMINAL (d) | 5/9 (56%) 4/10 (40%) 9/9 (100%) 7/7 (100%) |2/9 (22%) 0/9 (0%) 8/10 (80%) 0/8 (0%) |
|FIRST INCIDENCE | 296 (T) 296 (T) 296 (T) 170 |287 183 297 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.416N P=0.049 * P=0.041 * |P=0.302N P=0.315N P=0.078 P=0.147N |
|POLY 3 | P=0.007 ** P=0.453N P=0.066 P=0.068 |P=0.355N P=0.292N P=0.024 * P=0.128N |
|POLY 1.5 | P=0.011 * P=0.472N P=0.064 P=0.087 |P=0.316N P=0.292N P=0.024 * P=0.121N |
|POLY 6 | P=0.005 ** P=0.432N P=0.066 P=0.057 |P=0.391N P=0.292N P=0.024 * P=0.135N |
|LOGISTIC REGRESSION| P=0.010 * P=0.416N P=0.049 * P=0.066 |P=0.239N (e) P=0.078 P=0.127N |
|COCH-ARM / FISHERS | P=0.046 * P=0.500N P=0.070 P=0.175 |P=0.242N P=0.291N P=0.035 * P=0.105N |
|ORDER RESTRICTED | P=0.013 * (e) (e) (e) |P=0.015N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 6/10 (60%) 10/10 (100%)|0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/9.42 0/10.00 6/9.82 10/10.00 |0/9.90 0/9.23 0/10.00 0/8.48 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 61.1% 100.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) 6/9 (67%) 7/7 (100%) |0/9 (0%) 0/9 (0%) 0/10 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 296 (T) 95 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.008 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.008 ** P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.005 ** P<0.001 ** |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 3/10 (30%) 2/10 (20%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/9.42 0/10.00 3/9.82 2/7.80 |0/9.90 0/9.23 0/10.00 0/8.48 |
|POLY-3 PERCENT (g) | 10.6% 0.0% 30.6% 25.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/9 (11%) 0/10 (0%) 3/9 (33%) 2/7 (29%) |0/9 (0%) 0/9 (0%) 0/10 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 296 (T) --- 296 (T) 296 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.141 P=0.479N P=0.291 P=0.407 |(e) (e) (e) (e) |
|POLY 3 | P=0.145 P=0.488N P=0.307 P=0.431 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.164 P=0.493N P=0.301 P=0.449 |(e) (e) (e) (e) |
|POLY 6 | P=0.132 P=0.483N P=0.311 P=0.420 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.141 (e) P=0.291 P=0.407 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.227 P=0.500N P=0.291 P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.162 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/10 (100%) 5/10 (50%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 10/10.00 5/10.00 0/9.82 0/7.80 |0/9.90 0/9.23 0/10.00 0/8.48 |
|POLY-3 PERCENT (g) | 100.0% 50.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 9/9 (100%) 5/10 (50%) 0/9 (0%) 0/7 (0%) |0/9 (0%) 0/9 (0%) 0/10 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 221 296 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.016N* P<0.001N** P<0.001N** |(e) (e) (e) (e) |
|POLY 3 | P<0.001N** P=0.008N** P<0.001N** P<0.001N** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001N** P=0.008N** P<0.001N** P<0.001N** |(e) (e) (e) (e) |
|POLY 6 | P<0.001N** P=0.008N** P<0.001N** P<0.001N** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001N** P=0.016N* P<0.001N** P<0.001N** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001N** P=0.016N* P<0.001N** P<0.001N** |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |2/10 (20%) 1/10 (10%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/9.42 0/10.00 0/9.82 1/7.80 |2/10.00 1/10.00 0/10.00 1/9.01 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 12.8% |20.0% 10.0% 0.0% 11.1% |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 1/7 (14%) |1/9 (11%) 0/9 (0%) 0/10 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- 296 (T) |287 183 --- 231 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.158 (e) (e) P=0.450 |P=0.398N P=0.512N P=0.228N P=0.551N |
|POLY 3 | P=0.172 (e) (e) P=0.462 |P=0.369N P=0.500N P=0.227N P=0.537N |
|POLY 1.5 | P=0.179 (e) (e) P=0.472 |P=0.368N P=0.500N P=0.227N P=0.534N |
|POLY 6 | P=0.168 (e) (e) P=0.456 |P=0.369N P=0.500N P=0.227N P=0.538N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.450 |P=0.191N (e) (e) P=0.462N |
|COCH-ARM / FISHERS | P=0.196 (e) (e) P=0.500 |P=0.361N P=0.500N P=0.237N P=0.500N |
|ORDER RESTRICTED | P=0.092 (e) (e) (e) |P=0.245N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |2/10 (20%) 4/10 (40%) 4/10 (40%) 2/10 (20%) |
|POLY-3 RATE (b) | 1/9.42 2/10.00 0/9.82 0/7.80 |2/9.90 4/9.23 4/10.00 2/8.48 |
|POLY-3 PERCENT (g) | 10.6% 20.0% 0.0% 0.0% |20.2% 43.3% 40.0% 23.6% |
|TERMINAL (d) | 1/9 (11%) 2/10 (20%) 0/9 (0%) 0/7 (0%) |2/9 (22%) 4/9 (44%) 4/10 (40%) 2/8 (25%) |
|FIRST INCIDENCE | 296 (T) 296 (T) --- --- |297 (T) 297 (T) 297 (T) 297 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222N P=0.539 P=0.500N P=0.550N |P=0.565N P=0.314 P=0.371 P=0.665 |
|POLY 3 | P=0.191N P=0.522 P=0.492N P=0.537N |P=0.569 P=0.279 P=0.322 P=0.644 |
|POLY 1.5 | P=0.190N P=0.513 P=0.495N P=0.528N |P=0.581N P=0.291 P=0.320 P=0.656 |
|POLY 6 | P=0.191N P=0.531 P=0.489N P=0.543N |P=0.554 P=0.274 P=0.327 P=0.636 |
|LOGISTIC REGRESSION| P=0.222N P=0.539 (e) (e) |P=0.565N P=0.314 P=0.371 P=0.665 |
|COCH-ARM / FISHERS | P=0.181N P=0.500 P=0.500N P=0.500N |P=0.500N P=0.314 P=0.314 P=0.709N |
|ORDER RESTRICTED | P=0.208N (e) (e) (e) |P=0.386 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/10 (90%) 5/10 (50%) 7/10 (70%) 6/10 (60%) |8/10 (80%) 7/10 (70%) 8/10 (80%) 7/10 (70%) |
|POLY-3 RATE (b) | 9/9.42 5/10.00 7/9.82 6/8.61 |8/9.90 7/9.23 8/10.00 7/8.48 |
|POLY-3 PERCENT (g) | 95.6% 50.0% 71.3% 69.7% |80.8% 75.8% 80.0% 82.6% |
|TERMINAL (d) | 9/9 (100%) 5/10 (50%) 7/9 (78%) 5/7 (71%) |8/9 (89%) 7/9 (78%) 8/10 (80%) 7/8 (88%) |
|FIRST INCIDENCE | 296 (T) 296 (T) 296 (T) 170 |297 (T) 297 (T) 297 (T) 297 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.571N P=0.029N* P=0.233N P=0.453N |P=0.601 P=0.500N P=0.539N P=0.741N |
|POLY 3 | P=0.325N P=0.026N* P=0.194N P=0.180N |P=0.534 P=0.612N P=0.691N P=0.691 |
|POLY 1.5 | P=0.305N P=0.037N* P=0.231N P=0.182N |P=0.567 P=0.575N P=0.696N P=0.705N |
|POLY 6 | P=0.341N P=0.018N* P=0.161N P=0.171N |P=0.506 P=0.631N P=0.680N P=0.663 |
|LOGISTIC REGRESSION| P=0.410N P=0.029N* P=0.233N P=0.311N |P=0.601 P=0.500N P=0.539N P=0.741N |
|COCH-ARM / FISHERS | P=0.229N P=0.070N P=0.291N P=0.152N |P=0.451N P=0.500N P=0.709N P=0.500N |
|ORDER RESTRICTED | P=0.094N (e) (e) (e) |P=0.642 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |3/10 (30%) 2/10 (20%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/9.42 0/10.00 0/9.82 2/9.57 |3/10.00 2/9.23 1/10.00 1/9.47 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 20.9% |30.0% 21.7% 10.0% 10.6% |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/7 (0%) |2/9 (22%) 2/9 (22%) 1/10 (10%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- 95 |287 297 (T) 297 (T) 57 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.043 * (e) (e) P=0.228 |P=0.216N P=0.510N P=0.272N P=0.347N |
|POLY 3 | P=0.037 * (e) (e) P=0.230 |P=0.189N P=0.539N P=0.292N P=0.312N |
|POLY 1.5 | P=0.038 * (e) (e) P=0.229 |P=0.187N P=0.526N P=0.292N P=0.304N |
|POLY 6 | P=0.036 * (e) (e) P=0.229 |P=0.192N P=0.549N P=0.292N P=0.323N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.079N P=0.535N P=0.272N P=0.100N |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.237 |P=0.180N P=0.500N P=0.291N P=0.291N |
|ORDER RESTRICTED | P=0.024 * (e) (e) (e) |P=0.212N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/10 (80%) 4/10 (40%) 3/10 (30%) 4/10 (40%) |2/10 (20%) 2/10 (20%) 3/10 (30%) 6/10 (60%) |
|POLY-3 RATE (b) | 8/10.00 4/10.00 3/10.00 4/8.22 |2/9.90 2/10.00 3/10.00 6/8.48 |
|POLY-3 PERCENT (g) | 80.0% 40.0% 30.0% 48.7% |20.2% 20.0% 30.0% 70.8% |
|TERMINAL (d) | 7/9 (78%) 4/10 (40%) 2/9 (22%) 3/7 (43%) |2/9 (22%) 1/9 (11%) 3/10 (30%) 6/8 (75%) |
|FIRST INCIDENCE | 221 296 (T) 277 246 |297 (T) 183 297 (T) 297 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.234N P=0.070N P=0.060N P=0.258N |P=0.020 * P=0.700 P=0.553 P=0.051 |
|POLY 3 | P=0.131N P=0.077N P=0.024N* P=0.182N |P=0.014 * P=0.699N P=0.505 P=0.031 * |
|POLY 1.5 | P=0.119N P=0.077N P=0.024N* P=0.147N |P=0.016 * P=0.700N P=0.502 P=0.038 * |
|POLY 6 | P=0.137N P=0.077N P=0.024N* P=0.201N |P=0.012 * P=0.696N P=0.509 P=0.027 * |
|LOGISTIC REGRESSION| P=0.116N P=0.070N (e) P=0.141N |P=0.024 * P=0.562N P=0.553 P=0.051 |
|COCH-ARM / FISHERS | P=0.090N P=0.085N P=0.035N* P=0.085N |P=0.030 * P=0.709N P=0.500 P=0.085 |
|ORDER RESTRICTED | P=0.057N (e) (e) (e) |P=0.013 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/10 (90%) 10/10 (100%) 10/10 (100%) 9/10 (90%) |9/10 (90%) 9/10 (90%) 10/10 (100%) 8/10 (80%) |
|POLY-3 RATE (b) | 9/9.42 10/10.00 10/10.00 9/9.19 |9/9.90 9/9.23 10/10.00 8/8.48 |
|POLY-3 PERCENT (g) | 95.6% 100.0% 100.0% 97.9% |90.9% 97.5% 100.0% 94.4% |
|TERMINAL (d) | 9/9 (100%) 10/10 (100%) 9/9 (100%) 7/7 (100%) |9/9 (100%) 9/9 (100%) 10/10 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 296 (T) 296 (T) 277 95 |297 (T) 297 (T) 297 (T) 297 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054 P=1.000 P=0.521 P=0.227 |P=1.000 P=1.000 P=1.000 P=1.000 |
|POLY 3 | P=0.836 P=0.909 P=0.909 P=0.946 |P=0.559 P=0.652 P=0.541 P=0.743 |
|POLY 1.5 | P=0.763 P=0.699 P=0.699 P=0.838 |P=0.637 P=0.699 P=0.520 P=0.781 |
|POLY 6 | P=0.997 P=1.000 P=1.000 P=1.000 |P=0.471 P=0.630 P=0.586 P=0.717 |
|LOGISTIC REGRESSION| P=0.322 P=1.000 (e) P=0.540 |P=1.000 P=1.000 P=1.000 P=1.000 |
|COCH-ARM / FISHERS | P=0.597N P=0.500 P=0.500 P=0.763N |P=0.361N P=0.763N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.231 (e) (e) (e) |P=0.339 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/9.42 0/10.00 0/9.82 2/9.03 |1/10.00 0/9.23 0/10.00 0/8.48 |
|POLY-3 PERCENT (g) | 10.6% 0.0% 0.0% 22.1% |10.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/9 (11%) 0/10 (0%) 0/9 (0%) 0/7 (0%) |0/9 (0%) 0/9 (0%) 0/10 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 296 (T) --- --- 170 |287 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.205 P=0.479N P=0.500N P=0.446 |P=0.326N P=0.521N P=0.500N P=0.545N |
|POLY 3 | P=0.227 P=0.488N P=0.492N P=0.485 |P=0.279N P=0.516N P=0.500N P=0.533N |
|POLY 1.5 | P=0.229 P=0.493N P=0.495N P=0.482 |P=0.285N P=0.511N P=0.500N P=0.526N |
|POLY 6 | P=0.226 P=0.483N P=0.489N P=0.493 |P=0.273N P=0.520N P=0.500N P=0.539N |
|LOGISTIC REGRESSION| P=0.498 (e) (e) P=0.670 |P=0.300N P=0.486N (e) P=0.513N |
|COCH-ARM / FISHERS | P=0.239 P=0.500N P=0.500N P=0.500 |P=0.304N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.106 (e) (e) (e) |P=0.151N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/10 (30%) 2/9 (22%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | |3/10.00 2/8.23 1/10.00 2/9.01 |
|POLY-3 PERCENT (g) | |30.0% 24.3% 10.0% 22.2% |
|TERMINAL (d) | |2/9 (22%) 2/8 (25%) 1/10 (10%) 1/8 (13%) |
|FIRST INCIDENCE | |287 297 (T) 297 (T) 231 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.434N P=0.556N P=0.272N P=0.563N |
|POLY 3 | |P=0.400N P=0.595N P=0.292N P=0.551N |
|POLY 1.5 | |P=0.401N P=0.581N P=0.292N P=0.547N |
|POLY 6 | |P=0.398N P=0.606N P=0.292N P=0.552N |
|LOGISTIC REGRESSION| |P=0.387N P=0.596N P=0.272N P=0.503N |
|COCH-ARM / FISHERS | |P=0.380N P=0.556N P=0.291N P=0.500N |
|ORDER RESTRICTED | |P=0.367N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/10 (40%) 3/9 (33%) 3/10 (30%) 3/10 (30%) |1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 4/10.00 3/9.00 3/9.82 3/7.80 |1/9.90 0/9.23 0/10.00 0/8.48 |
|POLY-3 PERCENT (g) | 40.0% 33.3% 30.6% 38.5% |10.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/9 (33%) 3/9 (33%) 3/9 (33%) 3/7 (43%) |1/9 (11%) 0/9 (0%) 0/10 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 221 296 (T) 296 (T) 296 (T) |297 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.589N P=0.500N P=0.500N P=0.651N |P=0.314N P=0.500N P=0.479N P=0.523N |
|POLY 3 | P=0.537N P=0.566N P=0.511N P=0.655N |P=0.280N P=0.514N P=0.498N P=0.531N |
|POLY 1.5 | P=0.505N P=0.566N P=0.506N P=0.612N |P=0.286N P=0.510N P=0.499N P=0.525N |
|POLY 6 | P=0.563N P=0.566N P=0.521N P=0.667 |P=0.275N P=0.516N P=0.496N P=0.535N |
|LOGISTIC REGRESSION| P=0.498N P=0.500N P=0.577N P=0.588N |P=0.314N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.410N P=0.570N P=0.500N P=0.500N |P=0.304N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.622N (e) (e) (e) |P=0.149N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/2 (100%) |0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.00 2/2.00 |0/0.00 0/0.00 0/1.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/2 (100%) |0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 296 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/9.42 0/10.00 0/9.82 3/10.00 |0/9.90 0/9.23 0/10.00 1/9.47 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 30.0% |0.0% 0.0% 0.0% 10.6% |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/7 (0%) |0/9 (0%) 0/9 (0%) 0/10 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- 95 |--- --- --- 57 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * (e) (e) P=0.111 |P=0.199 (e) (e) P=0.500 |
|POLY 3 | P=0.006 ** (e) (e) P=0.106 |P=0.196 (e) (e) P=0.491 |
|POLY 1.5 | P=0.006 ** (e) (e) P=0.102 |P=0.198 (e) (e) P=0.495 |
|POLY 6 | P=0.006 ** (e) (e) P=0.111 |P=0.195 (e) (e) P=0.488 |
|LOGISTIC REGRESSION| P=0.091 (e) (e) P=0.310 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.010 * (e) (e) P=0.105 |P=0.196 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.004 ** (e) (e) (e) |P=0.112 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |2/10 (20%) 1/10 (10%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 1/10.00 0/10.00 0/9.82 0/7.80 |2/10.00 1/10.00 0/10.00 2/9.01 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% |20.0% 10.0% 0.0% 22.2% |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/7 (0%) |1/9 (11%) 0/9 (0%) 0/10 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 221 --- --- --- |287 183 --- 231 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.328N P=0.500N P=0.500N P=0.545N |P=0.555 P=0.512N P=0.228N P=0.643 |
|POLY 3 | P=0.273N P=0.500N P=0.504N P=0.549N |P=0.573 P=0.500N P=0.227N P=0.663 |
|POLY 1.5 | P=0.284N P=0.500N P=0.502N P=0.535N |P=0.575 P=0.500N P=0.227N P=0.667 |
|POLY 6 | P=0.265N P=0.500N P=0.507N P=0.559N |P=0.573 P=0.500N P=0.227N P=0.663 |
|LOGISTIC REGRESSION| P=0.102N (e) (e) P=0.354N |P=0.513N (e) (e) P=0.708N |
|COCH-ARM / FISHERS | P=0.304N P=0.500N P=0.500N P=0.500N |P=0.596 P=0.500N P=0.237N P=0.709N |
|ORDER RESTRICTED | P=0.169N (e) (e) (e) |P=0.352 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 1/10 (10%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/9.42 0/10.00 0/9.82 0/7.80 |0/9.90 1/10.00 0/10.00 2/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 10.0% 0.0% 20.0% |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/7 (0%) |0/9 (0%) 0/9 (0%) 0/10 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 183 --- 57 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.131 P=0.500 (e) P=0.228 |
|POLY 3 | (e) (e) (e) (e) |P=0.134 P=0.502 (e) P=0.229 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.133 P=0.501 (e) P=0.228 |
|POLY 6 | (e) (e) (e) (e) |P=0.135 P=0.504 (e) P=0.231 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.132 P=0.500 (e) P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.067 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 1/10 (10%) 1/10 (10%) |0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 1/10.00 1/9.82 1/8.22 |0/9.90 2/9.23 0/10.00 0/8.48 |
|POLY-3 PERCENT (g) | 10.0% 10.0% 10.2% 12.2% |0.0% 21.7% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 1/10 (10%) 1/9 (11%) 0/7 (0%) |0/9 (0%) 2/9 (22%) 0/10 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 221 296 (T) 296 (T) 246 |--- 297 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.572 P=0.749N P=0.760 P=0.722 |P=0.423N P=0.233 (e) (e) |
|POLY 3 | P=0.563 P=0.760 P=0.756 P=0.716 |P=0.430N P=0.209 (e) (e) |
|POLY 1.5 | P=0.580 P=0.760 P=0.758 P=0.727 |P=0.424N P=0.215 (e) (e) |
|POLY 6 | P=0.555 P=0.760 P=0.753 P=0.710 |P=0.432N P=0.207 (e) (e) |
|LOGISTIC REGRESSION| P=0.507N P=0.749N P=0.592 P=0.682N |(e) P=0.233 (e) (e) |
|COCH-ARM / FISHERS | P=0.639 P=0.763N P=0.763N P=0.763N |P=0.403N P=0.237 (e) (e) |
|ORDER RESTRICTED | P=0.681 (e) (e) (e) |P=0.246N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 2/10 (20%) 1/10 (10%) 3/10 (30%) | |
|POLY-3 RATE (b) | 2/9.42 2/10.00 1/9.82 3/8.22 | |
|POLY-3 PERCENT (g) | 21.2% 20.0% 10.2% 36.5% | |
|TERMINAL (d) | 2/9 (22%) 2/10 (20%) 1/9 (11%) 2/7 (29%) | |
|FIRST INCIDENCE | 296 (T) 296 (T) 296 (T) 246 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.280 P=0.667N P=0.500N P=0.392 | |
|POLY 3 | P=0.345 P=0.680N P=0.485N P=0.432 | |
|POLY 1.5 | P=0.354 P=0.689N P=0.490N P=0.443 | |
|POLY 6 | P=0.343 P=0.671N P=0.481N P=0.433 | |
|LOGISTIC REGRESSION| P=0.333 P=0.667N P=0.500N P=0.427 | |
|COCH-ARM / FISHERS | P=0.395 P=0.709N P=0.500N P=0.500 | |
|ORDER RESTRICTED | P=0.279 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/10 (30%) |2/10 (20%) 1/9 (11%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/9.42 0/10.00 1/10.00 3/10.00 |2/10.00 1/9.00 0/10.00 2/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.0% 30.0% |20.0% 11.1% 0.0% 20.0% |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/7 (0%) |1/9 (11%) 1/9 (11%) 0/10 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 277 95 |287 297 (T) --- 57 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014 * (e) P=0.521 P=0.111 |P=0.564 P=0.512N P=0.228N P=0.652 |
|POLY 3 | P=0.014 * (e) P=0.512 P=0.106 |P=0.605 P=0.538N P=0.227N P=0.702 |
|POLY 1.5 | P=0.014 * (e) P=0.507 P=0.102 |P=0.605 P=0.538N P=0.227N P=0.702 |
|POLY 6 | P=0.015 * (e) P=0.517 P=0.111 |P=0.605 P=0.538N P=0.227N P=0.702 |
|LOGISTIC REGRESSION| P=0.133 (e) P=0.421 P=0.310 |(e) P=0.512N (e) (e) |
|COCH-ARM / FISHERS | P=0.016 * (e) P=0.500 P=0.105 |P=0.607 P=0.542N P=0.237N P=0.709N |
|ORDER RESTRICTED | P=0.016 * (e) (e) (e) |P=0.401N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/10 (80%) 7/10 (70%) 3/10 (30%) 4/10 (40%) |7/10 (70%) 6/9 (67%) 8/10 (80%) 8/10 (80%) |
|POLY-3 RATE (b) | 8/9.42 7/10.00 3/10.00 4/9.57 |7/10.00 6/9.00 8/10.00 8/8.48 |
|POLY-3 PERCENT (g) | 85.0% 70.0% 30.0% 41.8% |70.0% 66.7% 80.0% 94.4% |
|TERMINAL (d) | 8/9 (89%) 7/10 (70%) 2/9 (22%) 2/7 (29%) |6/9 (67%) 6/9 (67%) 8/10 (80%) 8/8 (100%) |
|FIRST INCIDENCE | 296 (T) 296 (T) 277 95 |287 297 (T) 297 (T) 297 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.131N P=0.333N P=0.045N* P=0.243N |P=0.158 P=0.509N P=0.631 P=0.311 |
|POLY 3 | P=0.023N* P=0.405N P=0.012N* P=0.055N |P=0.129 P=0.626N P=0.500 P=0.226 |
|POLY 1.5 | P=0.025N* P=0.444N P=0.016N* P=0.062N |P=0.164 P=0.626N P=0.500 P=0.283 |
|POLY 6 | P=0.023N* P=0.363N P=0.008N** P=0.051N |P=0.103 P=0.626N P=0.500 P=0.177 |
|LOGISTIC REGRESSION| P=0.015N* P=0.333N P=0.024N* P=0.058N |P=0.091 P=0.509N P=0.631 P=0.170 |
|COCH-ARM / FISHERS | P=0.034N* P=0.500N P=0.035N* P=0.085N |P=0.339 P=0.630N P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.015N* (e) (e) (e) |P=0.151 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/10 (20%) 1/10 (10%) 2/10 (20%) 1/10 (10%) |
|POLY-3 RATE (b) | |2/9.90 1/9.23 2/10.00 1/8.48 |
|POLY-3 PERCENT (g) | |20.2% 10.8% 20.0% 11.8% |
|TERMINAL (d) | |2/9 (22%) 1/9 (11%) 2/10 (20%) 1/8 (13%) |
|FIRST INCIDENCE | |297 (T) 297 (T) 297 (T) 297 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.480N P=0.500N P=0.667N P=0.543N |
|POLY 3 | |P=0.482N P=0.525N P=0.699N P=0.556N |
|POLY 1.5 | |P=0.477N P=0.517N P=0.700N P=0.545N |
|POLY 6 | |P=0.486N P=0.529N P=0.696N P=0.563N |
|LOGISTIC REGRESSION| |P=0.480N P=0.500N P=0.667N P=0.543N |
|COCH-ARM / FISHERS | |P=0.441N P=0.500N P=0.709N P=0.500N |
|ORDER RESTRICTED | |P=0.507N (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 97013 TEST: 96 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 175 MG/L 350 MG/L 700 MG/L |0 MG/L 175 MG/L 350 MG/L 700 MG/L |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |8/10 (80%) 8/10 (80%) 8/10 (80%) 6/10 (60%) |
|POLY-3 RATE (b) | |8/9.90 8/9.23 8/10.00 6/8.48 |
|POLY-3 PERCENT (g) | |80.8% 86.6% 80.0% 70.8% |
|TERMINAL (d) | |8/9 (89%) 8/9 (89%) 8/10 (80%) 6/8 (75%) |
|FIRST INCIDENCE | |297 (T) 297 (T) 297 (T) 297 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.286N P=0.767 P=0.539N P=0.457N |
|POLY 3 | |P=0.356N P=0.606 P=0.691N P=0.518N |
|POLY 1.5 | |P=0.328N P=0.641 P=0.696N P=0.475N |
|POLY 6 | |P=0.378N P=0.589 P=0.680N P=0.552N |
|LOGISTIC REGRESSION| |P=0.286N P=0.767 P=0.539N P=0.457N |
|COCH-ARM / FISHERS | |P=0.194N P=0.709N P=0.709N P=0.314N |
|ORDER RESTRICTED | |P=0.403N (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).