TDMS Study 97013-04 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: 04 TIME: 08:34:06
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-65406 ROUTE: DOSED WATER NTP C#: 97013E
PATHOLOGIST: MISSING CAS: 75-27-4
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/L
INCLUDE 002 0 MG/L
INCLUDE 003 175 MG/L
INCLUDE 004 175 MG/L
INCLUDE 005 350 MG/L
INCLUDE 006 350 MG/L
INCLUDE 007 700 MG/L
INCLUDE 008 700 MG/L
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 06/11/04
EXPERIMENT: 97013 TEST: 04 TIME: 08:34:06
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-65406 ROUTE: DOSED WATER NTP C#: 97013E
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 Casts Protein
Nephropathy
Kidney: Renal Tubule Degeneration
Dilatation
Vacuolization Cytoplasmic
Liver: Hepatocyte Fatty Change
Vacuolization Cytoplasmic
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Kidney Casts Protein
Liver: Hepatocyte Fatty Change
Thymus Cyst
===============================================================
Date: 06/11/04 EXPERIMENT: 97013 TEST: 04 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODI
CHLOR
Terminal Sacrifice at 27 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 0/15 (0%) |0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 2/15.00 0/15.00 0/15.00 |0/15.00 0/15.00 0/14.01 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 13.3% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 0/15 (0%) |0/15 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- 184 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.405N P=0.236 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.402N P=0.232 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.402N P=0.232 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.402N P=0.232 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.236 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.404N P=0.241 (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.237N (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 |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 2/15 (13%) |0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 2/15.00 0/15.00 2/15.00 |0/15.00 0/15.00 0/14.01 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 13.3% 0.0% 13.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 2/15 (13%) |0/15 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- 184 (T) --- 184 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.244 P=0.236 (e) P=0.236 |(e) (e) (e) (e) |
|POLY 3 | P=0.241 P=0.232 (e) P=0.232 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.241 P=0.232 (e) P=0.232 |(e) (e) (e) (e) |
|POLY 6 | P=0.241 P=0.232 (e) P=0.232 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.236 (e) P=0.236 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.242 P=0.241 (e) P=0.241 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.108 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 04 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 27 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: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 3/15 (20%) 1/15 (7%) 3/15 (20%) |13/15 (87%) 12/15 (80%) 14/15 (93%) 14/15 (93%) |
|POLY-3 RATE (b) | 2/15.00 3/15.00 1/15.00 3/15.00 |13/15.00 12/15.00 14/15.00 14/15.00 |
|POLY-3 PERCENT (g) | 13.3% 20.0% 6.7% 20.0% |86.7% 80.0% 93.3% 93.3% |
|TERMINAL (d) | 2/15 (13%) 3/15 (20%) 1/15 (7%) 3/15 (20%) |13/15 (87%) 12/15 (80%) 13/14 (93%) 14/15 (93%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) 184 (T) |185 (T) 185 (T) 36 185 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.476 P=0.500 P=0.500N P=0.500 |P=0.269 P=0.500N P=0.322 P=0.500 |
|POLY 3 | P=0.476 P=0.500 P=0.500N P=0.500 |P=0.274 P=0.500N P=0.500 P=0.500 |
|POLY 1.5 | P=0.476 P=0.500 P=0.500N P=0.500 |P=0.274 P=0.500N P=0.500 P=0.500 |
|POLY 6 | P=0.476 P=0.500 P=0.500N P=0.500 |P=0.274 P=0.500N P=0.500 P=0.500 |
|LOGISTIC REGRESSION| P=0.476 P=0.500 P=0.500N P=0.500 |P=0.269 P=0.500N (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.476 P=0.500 P=0.500N P=0.500 |P=0.270 P=0.500N P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.486 (e) (e) (e) |P=0.319 (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 |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 5/15 (33%) 4/15 (27%) 7/15 (47%) |3/15 (20%) 10/15 (67%) 7/15 (47%) 6/15 (40%) |
|POLY-3 RATE (b) | 1/15.00 5/15.00 4/15.00 7/15.00 |3/15.00 10/15.00 7/14.01 6/15.00 |
|POLY-3 PERCENT (g) | 6.7% 33.3% 26.7% 46.7% |20.0% 66.7% 50.0% 40.0% |
|TERMINAL (d) | 1/15 (7%) 5/15 (33%) 4/15 (27%) 7/15 (47%) |3/15 (20%) 10/15 (67%) 7/14 (50%) 6/15 (40%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) 184 (T) |185 (T) 185 (T) 185 (T) 185 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.024 * P=0.089 P=0.168 P=0.021 * |P=0.389 P=0.015 * P=0.099 P=0.217 |
|POLY 3 | P=0.021 * P=0.080 P=0.163 P=0.013 * |P=0.386 P=0.008 ** P=0.092 P=0.215 |
|POLY 1.5 | P=0.021 * P=0.080 P=0.163 P=0.013 * |P=0.387 P=0.008 ** P=0.094 P=0.215 |
|POLY 6 | P=0.021 * P=0.080 P=0.163 P=0.013 * |P=0.386 P=0.008 ** P=0.092 P=0.215 |
|LOGISTIC REGRESSION| P=0.024 * P=0.089 P=0.168 P=0.021 * |P=0.389 P=0.015 * P=0.099 P=0.217 |
|COCH-ARM / FISHERS | P=0.024 * P=0.084 P=0.165 P=0.018 * |P=0.396 P=0.013 * P=0.123 P=0.213 |
|ORDER RESTRICTED | P=0.009 ** (e) (e) (e) |P=0.046 * (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 04 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 27 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) | 7/15 (47%) 3/15 (20%) 11/15 (73%) 13/15 (87%) |2/15 (13%) 2/15 (13%) 2/15 (13%) 0/15 (0%) |
|POLY-3 RATE (b) | 7/15.00 3/15.00 11/15.00 13/15.00 |2/15.00 2/15.00 2/14.01 0/15.00 |
|POLY-3 PERCENT (g) | 46.7% 20.0% 73.3% 86.7% |13.3% 13.3% 14.3% 0.0% |
|TERMINAL (d) | 7/15 (47%) 3/15 (20%) 11/15 (73%) 13/15 (87%) |2/15 (13%) 2/15 (13%) 2/14 (14%) 0/15 (0%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) 184 (T) |185 (T) 185 (T) 185 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.127N P=0.136 P=0.028 * |P=0.160N P=0.701 P=0.676 P=0.236N |
|POLY 3 | P<0.001 ** P=0.121N P=0.131 P=0.019 * |P=0.159N P=0.698 P=0.673 P=0.232N |
|POLY 1.5 | P<0.001 ** P=0.121N P=0.131 P=0.019 * |P=0.159N P=0.698 P=0.675 P=0.232N |
|POLY 6 | P<0.001 ** P=0.121N P=0.131 P=0.019 * |P=0.159N P=0.698 P=0.673 P=0.232N |
|LOGISTIC REGRESSION| P=0.002 ** P=0.127N P=0.136 P=0.028 * |P=0.158N P=0.701 P=0.676 (e) |
|COCH-ARM / FISHERS | P=0.002 ** P=0.123N P=0.132 P=0.025 * |P=0.154N P=0.701N P=0.701N P=0.241N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.170N (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) | 0/15 (0%) 0/15 (0%) 9/15 (60%) 12/15 (80%) |0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 9/15.00 12/15.00 |0/15.00 0/15.00 0/14.01 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 60.0% 80.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 9/15 (60%) 12/15 (80%) |0/15 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- --- 184 (T) 184 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** 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| (e) (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 04 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 27 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) | 0/15 (0%) 5/15 (33%) 4/15 (27%) 6/15 (40%) |0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 5/15.00 4/15.00 6/15.00 |0/15.00 0/15.00 0/14.01 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 33.3% 26.7% 40.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 5/15 (33%) 4/15 (27%) 6/15 (40%) |0/15 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- 184 (T) 184 (T) 184 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026 * P=0.027 * P=0.057 P=0.012 * |(e) (e) (e) (e) |
|POLY 3 | P=0.021 * P=0.017 * P=0.045 * P=0.005 ** |(e) (e) (e) (e) |
|POLY 1.5 | P=0.021 * P=0.017 * P=0.045 * P=0.005 ** |(e) (e) (e) (e) |
|POLY 6 | P=0.021 * P=0.017 * P=0.045 * P=0.005 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.027 * P=0.057 P=0.012 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.025 * P=0.021 * P=0.050 P=0.008 ** |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.006 ** (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) | 14/15 (93%) 1/15 (7%) 0/15 (0%) 0/15 (0%) |0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 14/15.00 1/15.00 0/15.00 0/15.00 |0/15.00 0/15.00 0/14.01 0/15.00 |
|POLY-3 PERCENT (g) | 93.3% 6.7% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 14/15 (93%) 1/15 (7%) 0/15 (0%) 0/15 (0%) |0/15 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | 184 (T) 184 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |(e) (e) (e) (e) |
|POLY 3 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |(e) (e) (e) (e) |
|POLY 6 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001N** P<0.001N** (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 04 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 27 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 |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |1/15 (7%) 4/15 (27%) 4/15 (27%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 0/15.00 |1/15.00 4/15.00 4/14.01 1/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.7% 26.7% 28.6% 6.7% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |1/15 (7%) 4/15 (27%) 4/14 (29%) 1/15 (7%) |
|FIRST INCIDENCE | --- --- --- --- |185 (T) 185 (T) 185 (T) 185 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.458N P=0.168 P=0.147 P=0.764 |
|POLY 3 | (e) (e) (e) (e) |P=0.455N P=0.163 P=0.141 P=0.760 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.455N P=0.163 P=0.143 P=0.760 |
|POLY 6 | (e) (e) (e) (e) |P=0.455N P=0.163 P=0.141 P=0.760 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.458N P=0.168 P=0.143 P=0.764 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.453N P=0.165 P=0.165 P=0.759N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.243 (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 |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/15 (80%) 14/15 (93%) 13/15 (87%) 13/15 (87%) |13/15 (87%) 13/15 (87%) 12/15 (80%) 12/15 (80%) |
|POLY-3 RATE (b) | 12/15.00 14/15.00 13/15.00 13/15.00 |13/15.00 13/15.00 12/14.01 12/15.00 |
|POLY-3 PERCENT (g) | 80.0% 93.3% 86.7% 86.7% |86.7% 86.7% 85.7% 80.0% |
|TERMINAL (d) | 12/15 (80%) 14/15 (93%) 13/15 (87%) 13/15 (87%) |13/15 (87%) 13/15 (87%) 12/14 (86%) 12/15 (80%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) 184 (T) |185 (T) 185 (T) 185 (T) 185 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500 P=0.299 P=0.500 P=0.500 |P=0.378N P=0.701 P=0.676N P=0.500N |
|POLY 3 | P=0.500 P=0.298 P=0.500 P=0.500 |P=0.380N P=0.698 P=0.672N P=0.500N |
|POLY 1.5 | P=0.500 P=0.298 P=0.500 P=0.500 |P=0.379N P=0.698 P=0.658N P=0.500N |
|POLY 6 | P=0.500 P=0.298 P=0.500 P=0.500 |P=0.380N P=0.698 P=0.673N P=0.500N |
|LOGISTIC REGRESSION| P=0.500 P=0.299 P=0.500 P=0.500 |P=0.378N P=0.701 P=0.679N P=0.500N |
|COCH-ARM / FISHERS | P=0.500 P=0.299 P=0.500 P=0.500 |P=0.363N P=0.701N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.385 (e) (e) (e) |P=0.488N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 04 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 27 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 |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |0/15 (0%) 2/15 (13%) 2/15 (13%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 0/15.00 |0/15.00 2/15.00 2/14.01 1/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 13.3% 14.3% 6.7% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |0/15 (0%) 2/15 (13%) 2/14 (14%) 1/15 (7%) |
|FIRST INCIDENCE | --- --- --- --- |--- 185 (T) 185 (T) 185 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.466 P=0.236 P=0.221 P=0.500 |
|POLY 3 | (e) (e) (e) (e) |P=0.469 P=0.232 P=0.216 P=0.500 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.469 P=0.232 P=0.217 P=0.500 |
|POLY 6 | (e) (e) (e) (e) |P=0.469 P=0.232 P=0.216 P=0.500 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.466 P=0.236 P=0.221 P=0.500 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.469 P=0.241 P=0.241 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.209 (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 |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/15 (27%) 5/15 (33%) 1/15 (7%) 0/15 (0%) |0/15 (0%) 1/15 (7%) 1/15 (7%) 10/15 (67%) |
|POLY-3 RATE (b) | 4/15.00 5/15.00 1/15.00 0/15.00 |0/15.00 1/15.00 1/14.01 10/15.00 |
|POLY-3 PERCENT (g) | 26.7% 33.3% 6.7% 0.0% |0.0% 6.7% 7.1% 66.7% |
|TERMINAL (d) | 4/15 (27%) 5/15 (33%) 1/15 (7%) 0/15 (0%) |0/15 (0%) 1/15 (7%) 1/14 (7%) 10/15 (67%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) --- |--- 185 (T) 185 (T) 185 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014N* P=0.500 P=0.168N P=0.057N |P<0.001 ** P=0.500 P=0.486 P<0.001 ** |
|POLY 3 | P=0.010N* P=0.500 P=0.163N P=0.045N* |P<0.001 ** P=0.500 P=0.486 P<0.001 ** |
|POLY 1.5 | P=0.010N* P=0.500 P=0.163N P=0.045N* |P<0.001 ** P=0.500 P=0.487 P<0.001 ** |
|POLY 6 | P=0.010N* P=0.500 P=0.163N P=0.045N* |P<0.001 ** P=0.500 P=0.486 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.014N* P=0.500 P=0.168N (e) |(e) P=0.500 P=0.486 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.013N* P=0.500 P=0.165N P=0.050N |P<0.001 ** P=0.500 P=0.500 P<0.001 ** |
|ORDER RESTRICTED | P=0.014N* (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 04 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 27 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 |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/15 (100%) 15/15 (100%) 13/15 (87%) 11/15 (73%) |11/15 (73%) 10/15 (67%) 7/15 (47%) 11/15 (73%) |
|POLY-3 RATE (b) | 15/15.00 15/15.00 13/15.00 11/15.00 |11/15.00 10/15.00 7/14.01 11/15.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 86.7% 73.3% |73.3% 66.7% 50.0% 73.3% |
|TERMINAL (d) | 15/15 (100%) 15/15 (100%) 13/15 (87%) 11/15 (73%) |11/15 (73%) 10/15 (67%) 7/14 (50%) 11/15 (73%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) 184 (T) |185 (T) 185 (T) 185 (T) 185 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.007N** (e) P=0.236N P=0.057N |P=0.566N P=0.500N P=0.185N P=0.658 |
|POLY 3 | P=0.005N** (e) P=0.232N P=0.045N* |P=0.570N P=0.500N P=0.182N P=0.655 |
|POLY 1.5 | P=0.005N** (e) P=0.232N P=0.045N* |P=0.569N P=0.500N P=0.177N P=0.655 |
|POLY 6 | P=0.005N** (e) P=0.232N P=0.045N* |P=0.570N P=0.500N P=0.183N P=0.655 |
|LOGISTIC REGRESSION| P=0.007N** (e) P=0.236N P=0.057N |P=0.566N P=0.500N P=0.185N P=0.658 |
|COCH-ARM / FISHERS | P=0.007N** (e) P=0.241N P=0.050N |P=0.555N P=0.500N P=0.132N P=0.659N |
|ORDER RESTRICTED | P=0.007N** (e) (e) (e) |P=0.409N (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) | |2/15 (13%) 1/15 (7%) 2/15 (13%) 5/15 (33%) |
|POLY-3 RATE (b) | |2/15.00 1/15.00 2/14.01 5/15.00 |
|POLY-3 PERCENT (g) | |13.3% 6.7% 14.3% 33.3% |
|TERMINAL (d) | |2/15 (13%) 1/15 (7%) 2/14 (14%) 5/15 (33%) |
|FIRST INCIDENCE | |185 (T) 185 (T) 185 (T) 185 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.066 P=0.500N P=0.676 P=0.198 |
|POLY 3 | |P=0.062 P=0.500N P=0.673 P=0.195 |
|POLY 1.5 | |P=0.062 P=0.500N P=0.675 P=0.195 |
|POLY 6 | |P=0.062 P=0.500N P=0.673 P=0.195 |
|LOGISTIC REGRESSION| |P=0.066 P=0.500N P=0.676 P=0.198 |
|COCH-ARM / FISHERS | |P=0.064 P=0.500N P=0.701N P=0.195 |
|ORDER RESTRICTED | |P=0.062 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 04 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 27 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) | 3/15 (20%) 1/15 (7%) 1/15 (7%) 4/15 (27%) |0/15 (0%) 0/15 (0%) 1/15 (7%) 2/15 (13%) |
|POLY-3 RATE (b) | 3/15.00 1/15.00 1/15.00 4/15.00 |0/15.00 0/15.00 1/14.01 2/15.00 |
|POLY-3 PERCENT (g) | 20.0% 6.7% 6.7% 26.7% |0.0% 0.0% 7.1% 13.3% |
|TERMINAL (d) | 3/15 (20%) 1/15 (7%) 1/15 (7%) 4/15 (27%) |0/15 (0%) 0/15 (0%) 1/14 (7%) 2/15 (13%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) 184 (T) |--- --- 185 (T) 185 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.293 P=0.299N P=0.299N P=0.500 |P=0.069 (e) P=0.486 P=0.236 |
|POLY 3 | P=0.292 P=0.298N P=0.298N P=0.500 |P=0.067 (e) P=0.486 P=0.232 |
|POLY 1.5 | P=0.292 P=0.298N P=0.298N P=0.500 |P=0.067 (e) P=0.487 P=0.232 |
|POLY 6 | P=0.292 P=0.298N P=0.298N P=0.500 |P=0.067 (e) P=0.486 P=0.232 |
|LOGISTIC REGRESSION| P=0.293 P=0.299N P=0.299N P=0.500 |(e) (e) P=0.486 P=0.236 |
|COCH-ARM / FISHERS | P=0.291 P=0.299N P=0.299N P=0.500 |P=0.067 (e) P=0.500 P=0.241 |
|ORDER RESTRICTED | P=0.182 (e) (e) (e) |P=0.069 (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 |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 2/15 (13%) | |
|POLY-3 RATE (b) | 0/15.00 1/15.00 1/15.00 2/15.00 | |
|POLY-3 PERCENT (g) | 0.0% 6.7% 6.7% 13.3% | |
|TERMINAL (d) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 2/15 (13%) | |
|FIRST INCIDENCE | --- 184 (T) 184 (T) 184 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.149 P=0.500 P=0.500 P=0.236 | |
|POLY 3 | P=0.151 P=0.500 P=0.500 P=0.232 | |
|POLY 1.5 | P=0.151 P=0.500 P=0.500 P=0.232 | |
|POLY 6 | P=0.151 P=0.500 P=0.500 P=0.232 | |
|LOGISTIC REGRESSION| (e) P=0.500 P=0.500 P=0.236 | |
|COCH-ARM / FISHERS | P=0.147 P=0.500 P=0.500 P=0.241 | |
|ORDER RESTRICTED | P=0.114 (e) (e) (e) | |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 04 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 27 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) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 1/15 (7%) | |
|POLY-3 RATE (b) | 0/15.00 2/15.00 0/15.00 1/15.00 | |
|POLY-3 PERCENT (g) | 0.0% 13.3% 0.0% 6.7% | |
|TERMINAL (d) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 1/15 (7%) | |
|FIRST INCIDENCE | --- 184 (T) --- 184 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.540 P=0.236 (e) P=0.500 | |
|POLY 3 | P=0.540 P=0.232 (e) P=0.500 | |
|POLY 1.5 | P=0.540 P=0.232 (e) P=0.500 | |
|POLY 6 | P=0.540 P=0.232 (e) P=0.500 | |
|LOGISTIC REGRESSION| (e) P=0.236 (e) P=0.500 | |
|COCH-ARM / FISHERS | P=0.540 P=0.241 (e) P=0.500 | |
|ORDER RESTRICTED | P=0.319 (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 |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/15 (60%) 12/15 (80%) 6/15 (40%) 9/15 (60%) |6/15 (40%) 11/15 (73%) 9/15 (60%) 11/15 (73%) |
|POLY-3 RATE (b) | 9/15.00 12/15.00 6/15.00 9/15.00 |6/15.00 11/15.00 9/14.01 11/15.00 |
|POLY-3 PERCENT (g) | 60.0% 80.0% 40.0% 60.0% |40.0% 73.3% 64.3% 73.3% |
|TERMINAL (d) | 9/15 (60%) 12/15 (80%) 6/15 (40%) 9/15 (60%) |6/15 (40%) 11/15 (73%) 9/14 (64%) 11/15 (73%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) 184 (T) |185 (T) 185 (T) 185 (T) 185 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.362N P=0.217 P=0.236N P=0.643 |P=0.092 P=0.074 P=0.179 P=0.074 |
|POLY 3 | P=0.360N P=0.215 P=0.236N P=0.641 |P=0.087 P=0.065 P=0.177 P=0.065 |
|POLY 1.5 | P=0.360N P=0.215 P=0.236N P=0.641 |P=0.088 P=0.065 P=0.181 P=0.065 |
|POLY 6 | P=0.360N P=0.215 P=0.236N P=0.641 |P=0.087 P=0.065 P=0.176 P=0.065 |
|LOGISTIC REGRESSION| P=0.362N P=0.217 P=0.236N P=0.643 |P=0.091 P=0.074 P=0.179 P=0.074 |
|COCH-ARM / FISHERS | P=0.361N P=0.213 P=0.233N P=0.645N |P=0.097 P=0.070 P=0.233 P=0.070 |
|ORDER RESTRICTED | P=0.203N (e) (e) (e) |P=0.038 * (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 04 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODIC
HLOR
Terminal Sacrifice at 27 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) | |8/15 (53%) 7/15 (47%) 9/15 (60%) 8/15 (53%) |
|POLY-3 RATE (b) | |8/15.00 7/15.00 9/14.01 8/15.00 |
|POLY-3 PERCENT (g) | |53.3% 46.7% 64.3% 53.3% |
|TERMINAL (d) | |8/15 (53%) 7/15 (47%) 9/14 (64%) 8/15 (53%) |
|FIRST INCIDENCE | |185 (T) 185 (T) 185 (T) 185 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.491 P=0.500N P=0.414 P=0.641 |
|POLY 3 | |P=0.493 P=0.500N P=0.416 P=0.638 |
|POLY 1.5 | |P=0.494 P=0.500N P=0.422 P=0.638 |
|POLY 6 | |P=0.493 P=0.500N P=0.415 P=0.638 |
|LOGISTIC REGRESSION| |P=0.491 P=0.500N P=0.414 P=0.641 |
|COCH-ARM / FISHERS | |P=0.500 P=0.500N P=0.500 P=0.642N |
|ORDER RESTRICTED | |P=0.505 (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).