TDMS Study 97013-94 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (SODIUM BROMATE) DATE: 12/08/03
EXPERIMENT: 97013 TEST: 94 TIME: 14:44:33
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: DOSED WATER NTP C#: 97013H
PATHOLOGIST: MISSING CAS: 7789-38-0
------------------------------------------------------------------------------------------------------------------------------------
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 (SODIUM BROMATE) DATE: 12/08/03
EXPERIMENT: 97013 TEST: 94 TIME: 14:44:33
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: DOSED WATER NTP C#: 97013H
PATHOLOGIST: MISSING CAS: 7789-38-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF WATER DISINFECTION MODEL (SODIUM BR
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hypertrophy
Epididymis Degeneration
Kidney Hydronephrosis
Nephropathy
Kidney: Renal Tubule Degeneration
Hypertrophy
Pituitary Gland: Pars Distalis Hypertrophy
Testes: Bilateral, Germinal Epithelium
Degeneration
Testes: Germinal Epithelium Degeneration
Testes: Interstitial Cell Hyperplasia
Thymus Atrophy
Thyroid Gland Infiltration Cellular Lymphocyte
Thyroid Gland: Follicle Depletion Secretory
Thyroid Gland: Follicular Cell Hypertrophy
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex: Subcapsular Hyperplasia
Kidney Mineralization
Nephropathy
Kidney: Renal Tubule Degeneration
Hypertrophy
Liver Inflammation Chronic
Ovary Atrophy
Pituitary Gland: Pars Distalis Cyst
Hypertrophy
Spleen Hematopoietic Cell Proliferation
Stomach, Forestomach: Epithelium Hyperkeratosis
Hyperplasia
Thymus Atrophy
Thyroid Gland Infiltration Cellular Lymphocyte
Thyroid Gland: Follicle Depletion Secretory
Thyroid Gland: Follicular Cell Hypertrophy
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SO
DIUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/10 (50%) 7/10 (70%) 6/10 (60%) 1/10 (10%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 5/7.25 7/7.33 6/7.78 1/7.49 |0/7.62 0/7.61 0/6.52 0/4.58 |
|POLY-3 PERCENT (g) | 69.0% 95.4% 77.1% 13.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 5/6 (83%) 7/7 (100%) 6/6 (100%) 1/4 (25%) |0/7 (0%) 0/5 (0%) 0/4 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 295 (T) 295 (T) 295 (T) 295 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.018N* P=0.469 P=0.500 P=0.130N |(e) (e) (e) (e) |
|POLY 3 | P<0.001N** P=0.218 P=0.599 P=0.030N* |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001N** P=0.219 P=0.566 P=0.037N* |(e) (e) (e) (e) |
|POLY 6 | P<0.001N** P=0.303 P=0.638 P=0.027N* |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.018N* P=0.469 P=0.500 P=0.130N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.017N* P=0.325 P=0.500 P=0.070N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |1/10 (10%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/7.25 0/7.33 0/7.78 0/7.49 |1/7.62 2/7.69 0/6.52 0/4.58 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |13.1% 26.0% 0.0% 0.0% |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/4 (0%) |1/7 (14%) 1/5 (20%) 0/4 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- |295 (T) 287 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.285N P=0.421 P=0.612N P=0.748N |
|POLY 3 | (e) (e) (e) (e) |P=0.188N P=0.503 P=0.531N P=0.597N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.155N P=0.506 P=0.514N P=0.563N |
|POLY 6 | (e) (e) (e) (e) |P=0.226N P=0.497 P=0.545N P=0.629N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.227N P=0.483 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.126N P=0.500 P=0.500N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.276N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |5/10 (50%) 6/10 (60%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/7.25 0/7.33 0/7.78 0/7.49 |5/9.01 6/7.77 1/6.52 0/4.58 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |55.5% 77.3% 15.4% 0.0% |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/4 (0%) |3/7 (43%) 4/5 (80%) 1/4 (25%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- |93 287 295 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.028N* P=0.329 P=0.197N P=0.141N |
|POLY 3 | (e) (e) (e) (e) |P=0.005N** P=0.340 P=0.140N P=0.086N |
|POLY 1.5 | (e) (e) (e) (e) |P<0.001N** P=0.390 P=0.097N P=0.041N* |
|POLY 6 | (e) (e) (e) (e) |P=0.015N* P=0.293 P=0.183N P=0.156N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.003N** P=0.510 P=0.074N P=0.024N* |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P<0.001N** P=0.500 P=0.070N P=0.016N* |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.014N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 0/10 (0%) 7/10 (70%) | |
|POLY-3 RATE (b) | 1/7.72 1/7.33 0/7.78 7/8.48 | |
|POLY-3 PERCENT (g) | 13.0% 13.6% 0.0% 82.5% | |
|TERMINAL (d) | 0/6 (0%) 1/7 (14%) 0/6 (0%) 3/4 (75%) | |
|FIRST INCIDENCE | 239 295 (T) --- 246 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.743N P=0.473N P=0.022 * | |
|POLY 3 | P<0.001 ** P=0.754 P=0.498N P=0.002 ** | |
|POLY 1.5 | P<0.001 ** P=0.751 P=0.496N P=0.002 ** | |
|POLY 6 | P<0.001 ** P=0.760 P=0.504N P=0.002 ** | |
|LOGISTIC REGRESSION| P<0.001 ** P=0.770 P=0.514N P=0.011 * | |
|COCH-ARM / FISHERS | P<0.001 ** P=0.763N P=0.500N P=0.010 * | |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) | |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/7.25 0/7.33 0/7.78 2/7.89 |0/7.62 0/7.61 0/6.52 0/4.58 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 25.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/4 (0%) |0/7 (0%) 0/5 (0%) 0/4 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- 263 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * (e) (e) P=0.236 |(e) (e) (e) (e) |
|POLY 3 | P=0.037 * (e) (e) P=0.241 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.038 * (e) (e) P=0.238 |(e) (e) (e) (e) |
|POLY 6 | P=0.036 * (e) (e) P=0.242 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.041 * (e) (e) P=0.233 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.040 * (e) (e) P=0.237 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.027 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/7.25 0/7.33 0/7.78 1/7.60 |0/7.62 0/7.61 1/7.46 2/5.78 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 13.2% |0.0% 0.0% 13.4% 34.6% |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/4 (0%) |0/7 (0%) 0/5 (0%) 0/4 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- 284 |--- --- 115 8 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.152 (e) (e) P=0.464 |P=0.042 * (e) P=0.545 P=0.180 |
|POLY 3 | P=0.192 (e) (e) P=0.510 |P=0.033 * (e) P=0.496 P=0.157 |
|POLY 1.5 | P=0.194 (e) (e) P=0.509 |P=0.038 * (e) P=0.506 P=0.186 |
|POLY 6 | P=0.183 (e) (e) P=0.505 |P=0.029 * (e) P=0.486 P=0.134 |
|LOGISTIC REGRESSION| P=0.182 (e) (e) P=0.501 |P=0.109 (e) P=0.380 P=0.308 |
|COCH-ARM / FISHERS | P=0.184 (e) (e) P=0.500 |P=0.055 (e) P=0.500 P=0.237 |
|ORDER RESTRICTED | P=0.127 (e) (e) (e) |P=0.033 * (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/10 (70%) 6/10 (60%) 7/10 (70%) 10/10 (100%)|6/10 (60%) 6/10 (60%) 8/10 (80%) 8/10 (80%) |
|POLY-3 RATE (b) | 7/8.22 6/8.30 7/9.41 10/10.00 |6/9.03 6/8.12 8/8.26 8/8.09 |
|POLY-3 PERCENT (g) | 85.2% 72.3% 74.4% 100.0% |66.4% 73.9% 96.8% 98.9% |
|TERMINAL (d) | 6/6 (100%) 5/7 (71%) 5/6 (83%) 4/4 (100%) |4/7 (57%) 3/5 (60%) 4/4 (100%) 2/2 (100%) |
|FIRST INCIDENCE | 93 93 144 127 |57 255 144 8 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.013 * P=0.350N P=0.672N P=0.077 |P=0.002 ** P=0.478 P=0.109 P=0.027 * |
|POLY 3 | P=0.126 P=0.482N P=0.514N P=0.319 |P=0.032 * P=0.573 P=0.147 P=0.123 |
|POLY 1.5 | P=0.083 P=0.533N P=0.590N P=0.167 |P=0.050 P=0.592 P=0.199 P=0.154 |
|POLY 6 | P=0.188 P=0.373N P=0.421N P=0.865 |P=0.028 * P=0.561 P=0.121 P=0.116 |
|LOGISTIC REGRESSION| P=0.050 P=0.531N P=0.667N P=0.116 |P=0.054 P=0.674N P=0.292 P=0.239 |
|COCH-ARM / FISHERS | P=0.043 * P=0.500N P=0.686N P=0.105 |P=0.157 P=0.675N P=0.314 P=0.314 |
|ORDER RESTRICTED | P=0.111 (e) (e) (e) |P=0.037 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney: Cortex |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/7.25 0/7.33 0/7.78 1/7.60 |0/7.62 2/7.69 0/6.52 0/4.58 |
|POLY-3 PERCENT (g) | 13.8% 0.0% 0.0% 13.2% |0.0% 26.0% 0.0% 0.0% |
|TERMINAL (d) | 1/6 (17%) 0/7 (0%) 0/6 (0%) 0/4 (0%) |0/7 (0%) 1/5 (20%) 0/4 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 295 (T) --- --- 284 |--- 287 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.460 P=0.469N P=0.500N P=0.694 |P=0.448N P=0.203 (e) (e) |
|POLY 3 | P=0.545 P=0.498N P=0.486N P=0.756N |P=0.345N P=0.223 (e) (e) |
|POLY 1.5 | P=0.552 P=0.505N P=0.489N P=0.754N |P=0.294N P=0.226 (e) (e) |
|POLY 6 | P=0.526 P=0.484N P=0.483N P=0.763N |P=0.402N P=0.218 (e) (e) |
|LOGISTIC REGRESSION| P=0.526 (e) (e) P=0.769 |P=0.383N P=0.217 (e) (e) |
|COCH-ARM / FISHERS | P=0.537 P=0.500N P=0.500N P=0.763N |P=0.259N P=0.237 (e) (e) |
|ORDER RESTRICTED | P=0.381N (e) (e) (e) |P=0.347N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney: Glomerulus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |0/10 (0%) 1/10 (10%) 2/10 (20%) 1/10 (10%) |
|POLY-3 RATE (b) | 2/8.97 0/7.33 0/7.78 2/8.83 |0/7.62 1/8.49 2/7.48 1/4.75 |
|POLY-3 PERCENT (g) | 22.3% 0.0% 0.0% 22.6% |0.0% 11.8% 26.7% 21.1% |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/4 (0%) |0/7 (0%) 0/5 (0%) 0/4 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 93 --- --- 127 |--- 144 144 277 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.465 P=0.265N P=0.240N P=0.657N |P=0.215 P=0.523 P=0.235 P=0.331 |
|POLY 3 | P=0.464 P=0.274N P=0.259N P=0.701 |P=0.197 P=0.522 P=0.216 P=0.407 |
|POLY 1.5 | P=0.462 P=0.269N P=0.248N P=0.703 |P=0.242 P=0.518 P=0.227 P=0.439 |
|POLY 6 | P=0.449 P=0.268N P=0.267N P=0.694 |P=0.164 P=0.520 P=0.208 P=0.379 |
|LOGISTIC REGRESSION| P=0.228 P=0.115N P=0.260N P=0.613 |P=0.408 P=0.488 P=0.228 P=0.393 |
|COCH-ARM / FISHERS | P=0.420 P=0.237N P=0.237N P=0.709N |P=0.369 P=0.500 P=0.237 P=0.500 |
|ORDER RESTRICTED | P=0.265 (e) (e) (e) |P=0.232 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 8/10 (80%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 7/10 (70%) |
|POLY-3 RATE (b) | 0/7.25 0/7.33 1/8.52 8/8.48 |0/7.62 0/7.61 0/6.52 7/7.40 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 11.7% 94.3% |0.0% 0.0% 0.0% 94.6% |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 0/6 (0%) 4/4 (100%) |0/7 (0%) 0/5 (0%) 0/4 (0%) 2/2 (100%) |
|FIRST INCIDENCE | --- --- 188 246 |--- --- --- 8 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.523 P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.532 P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.522 P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.541 P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.430 P<0.001 ** |P<0.001 ** (e) (e) P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P<0.001 ** |P<0.001 ** (e) (e) P=0.002 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 6/10 (60%) |0/10 (0%) 0/10 (0%) 2/10 (20%) 5/10 (50%) |
|POLY-3 RATE (b) | 0/7.25 0/7.33 1/7.78 6/7.96 |0/7.62 0/7.61 2/7.22 5/6.71 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 12.9% 75.4% |0.0% 0.0% 27.7% 74.5% |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 1/6 (17%) 4/4 (100%) |0/7 (0%) 0/5 (0%) 1/4 (25%) 2/2 (100%) |
|FIRST INCIDENCE | --- --- 295 (T) 263 |--- --- 197 188 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.500 P=0.004 ** |P<0.001 ** (e) P=0.167 P=0.003 ** |
|POLY 3 | P<0.001 ** (e) P=0.514 P<0.001 ** |P<0.001 ** (e) P=0.208 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.511 P<0.001 ** |P<0.001 ** (e) P=0.220 P=0.002 ** |
|POLY 6 | P<0.001 ** (e) P=0.517 P<0.001 ** |P<0.001 ** (e) P=0.200 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.500 P=0.004 ** |P<0.001 ** (e) P=0.226 P=0.011 * |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P=0.005 ** |P<0.001 ** (e) P=0.237 P=0.016 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 2/10 (20%) 1/10 (10%) |3/10 (30%) 4/10 (40%) 6/10 (60%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/7.81 0/7.33 2/8.20 1/7.60 |3/9.01 4/8.04 6/8.24 1/5.54 |
|POLY-3 PERCENT (g) | 12.8% 0.0% 24.4% 13.2% |33.3% 49.8% 72.8% 18.0% |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 1/6 (17%) 0/4 (0%) |1/7 (14%) 2/5 (40%) 3/4 (75%) 0/2 (0%) |
|FIRST INCIDENCE | 224 --- 246 284 |93 255 115 93 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.394 P=0.527N P=0.533 P=0.740 |P=0.512 P=0.432 P=0.121 P=0.476N |
|POLY 3 | P=0.424 P=0.513N P=0.518 P=0.759 |P=0.578 P=0.425 P=0.116 P=0.489N |
|POLY 1.5 | P=0.442 P=0.513N P=0.515 P=0.763N |P=0.434N P=0.445 P=0.146 P=0.415N |
|POLY 6 | P=0.383 P=0.507N P=0.521 P=0.746 |P=0.412 P=0.411 P=0.096 P=0.566N |
|LOGISTIC REGRESSION| P=0.428 P=0.491N P=0.498 P=0.772 |P=0.232N P=0.501 P=0.188 P=0.201N |
|COCH-ARM / FISHERS | P=0.420 P=0.500N P=0.500 P=0.763N |P=0.212N P=0.500 P=0.185 P=0.291N |
|ORDER RESTRICTED | P=0.381 (e) (e) (e) |P=0.186N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/10 (50%) 5/10 (50%) 7/10 (70%) 4/10 (40%) |10/10 (100%) 6/10 (60%) 7/10 (70%) 5/10 (50%) |
|POLY-3 RATE (b) | 5/7.81 5/8.06 7/8.94 4/8.26 |10/10.00 6/8.04 7/8.24 5/6.94 |
|POLY-3 PERCENT (g) | 64.0% 62.0% 78.3% 48.4% |100.0% 74.6% 85.0% 72.1% |
|TERMINAL (d) | 4/6 (67%) 4/7 (57%) 5/6 (83%) 2/4 (50%) |7/7 (100%) 4/5 (80%) 4/4 (100%) 2/2 (100%) |
|FIRST INCIDENCE | 224 192 188 218 |57 255 115 93 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.432 P=0.578N P=0.366 P=0.642 |P=0.250 P=0.314N P=0.640 P=0.540 |
|POLY 3 | P=0.374N P=0.666N P=0.459 P=0.449N |P=0.155N P=0.158N P=0.350N P=0.117N |
|POLY 1.5 | P=0.370N P=0.682 P=0.413 P=0.457N |P=0.096N P=0.112N P=0.205N P=0.058N |
|POLY 6 | P=0.420N P=0.616N P=0.503 P=0.462N |P=0.259N P=0.188N P=0.496N P=0.221N |
|LOGISTIC REGRESSION| P=0.388N P=0.671 P=0.370 P=0.465N |P=0.113N P=0.035N* P=0.100N P=0.030N* |
|COCH-ARM / FISHERS | P=0.452N P=0.672N P=0.325 P=0.500N |P=0.052N P=0.043N* P=0.105N P=0.016N* |
|ORDER RESTRICTED | P=0.321N (e) (e) (e) |P=0.069N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/7.25 0/7.33 1/7.78 0/7.49 |0/7.62 0/7.61 1/6.60 0/4.58 |
|POLY-3 PERCENT (g) | 27.6% 0.0% 12.9% 0.0% |0.0% 0.0% 15.2% 0.0% |
|TERMINAL (d) | 2/6 (33%) 0/7 (0%) 1/6 (17%) 0/4 (0%) |0/7 (0%) 0/5 (0%) 0/4 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 295 (T) --- 295 (T) --- |--- --- 287 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.335N P=0.196N P=0.500N P=0.323N |P=0.512 (e) P=0.469 (e) |
|POLY 3 | P=0.236N P=0.217N P=0.473N P=0.211N |P=0.478 (e) P=0.471 (e) |
|POLY 1.5 | P=0.229N P=0.227N P=0.480N P=0.213N |P=0.524 (e) P=0.487 (e) |
|POLY 6 | P=0.258N P=0.200N P=0.469N P=0.218N |P=0.430 (e) P=0.459 (e) |
|LOGISTIC REGRESSION| P=0.335N (e) P=0.500N (e) |P=0.569 (e) P=0.462 (e) |
|COCH-ARM / FISHERS | P=0.246N P=0.237N P=0.500N P=0.237N |P=0.650 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.056N (e) (e) (e) |P=0.380 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/10 (50%) 6/10 (60%) 6/10 (60%) 3/10 (30%) |7/10 (70%) 4/10 (40%) 4/10 (40%) 3/10 (30%) |
|POLY-3 RATE (b) | 5/7.25 6/7.33 6/7.78 3/7.49 |7/7.62 4/7.69 4/7.46 3/5.28 |
|POLY-3 PERCENT (g) | 69.0% 81.8% 77.1% 40.0% |91.9% 52.0% 53.6% 56.9% |
|TERMINAL (d) | 5/6 (83%) 6/7 (86%) 6/6 (100%) 3/4 (75%) |7/7 (100%) 3/5 (60%) 3/4 (75%) 2/2 (100%) |
|FIRST INCIDENCE | 295 (T) 295 (T) 295 (T) 295 (T) |295 (T) 287 115 197 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.602N P=0.735 P=0.500 P=0.677N |P=0.317 P=0.421N P=0.672N P=0.443 |
|POLY 3 | P=0.082N P=0.517 P=0.599 P=0.265N |P=0.215N P=0.099N P=0.108N P=0.171N |
|POLY 1.5 | P=0.097N P=0.469 P=0.566 P=0.279N |P=0.157N P=0.111N P=0.099N P=0.113N |
|POLY 6 | P=0.096N P=0.622 P=0.638 P=0.274N |P=0.288N P=0.091N P=0.124N P=0.277N |
|LOGISTIC REGRESSION| P=0.602N P=0.735 P=0.500 P=0.677N |P=0.350N P=0.152N P=0.220N P=0.454N |
|COCH-ARM / FISHERS | P=0.178N P=0.500 P=0.500 P=0.325N |P=0.105N P=0.185N P=0.185N P=0.089N |
|ORDER RESTRICTED | P=0.079N (e) (e) (e) |P=0.123N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/9 (22%) 0/10 (0%) 4/10 (40%) 1/7 (14%) |2/9 (22%) 4/10 (40%) 2/10 (20%) 2/9 (22%) |
|POLY-3 RATE (b) | 2/6.81 0/7.33 4/10.00 1/6.12 |2/8.58 4/7.96 2/7.30 2/6.48 |
|POLY-3 PERCENT (g) | 29.4% 0.0% 40.0% 16.4% |23.3% 50.3% 27.4% 30.9% |
|TERMINAL (d) | 2/6 (33%) 0/7 (0%) 0/6 (0%) 0/3 (0%) |1/7 (14%) 3/5 (60%) 0/4 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 295 (T) --- 144 218 |93 255 197 93 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.475 P=0.196N P=0.390 P=0.633N |P=0.492 P=0.233 P=0.626 P=0.593 |
|POLY 3 | P=0.515 P=0.201N P=0.527 P=0.541N |P=0.535N P=0.268 P=0.644 P=0.597 |
|POLY 1.5 | P=0.505 P=0.206N P=0.480 P=0.548N |P=0.473N P=0.282 P=0.672 P=0.642 |
|POLY 6 | P=0.477 P=0.192N P=0.566 P=0.553N |P=0.572 P=0.265 P=0.634 P=0.545 |
|LOGISTIC REGRESSION| P=0.343 (e) P=0.340 P=0.582N |P=0.300N P=0.372 P=0.597N P=0.318N |
|COCH-ARM / FISHERS | P=0.400 P=0.211N P=0.370 P=0.600N |P=0.388N P=0.370 P=0.667N P=0.712N |
|ORDER RESTRICTED | P=0.397 (e) (e) (e) |P=0.470 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |2/2 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.00 0/0.00 |2/2.00 0/0.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |100.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |2/2 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- |295 (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) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/10 (10%) 0/9 (0%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | |1/7.62 0/7.60 1/6.52 2/5.27 |
|POLY-3 PERCENT (g) | |13.1% 0.0% 15.4% 38.0% |
|TERMINAL (d) | |1/7 (14%) 0/5 (0%) 1/4 (25%) 1/2 (50%) |
|FIRST INCIDENCE | |295 (T) --- 295 (T) 199 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.035 * P=0.567N P=0.638 P=0.180 |
|POLY 3 | |P=0.123 P=0.500N P=0.730 P=0.363 |
|POLY 1.5 | |P=0.141 P=0.499N P=0.750 P=0.408 |
|POLY 6 | |P=0.111 P=0.506N P=0.713 P=0.319 |
|LOGISTIC REGRESSION| |P=0.103 (e) P=0.638 P=0.374 |
|COCH-ARM / FISHERS | |P=0.204 P=0.526N P=0.763N P=0.500 |
|ORDER RESTRICTED | |P=0.107 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/10 (10%) 3/9 (33%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | |1/8.04 3/7.96 1/6.52 0/4.58 |
|POLY-3 PERCENT (g) | |12.4% 37.7% 15.4% 0.0% |
|TERMINAL (d) | |0/7 (0%) 2/5 (40%) 1/4 (25%) 0/2 (0%) |
|FIRST INCIDENCE | |246 255 295 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.335N P=0.257 P=0.664 P=0.638N |
|POLY 3 | |P=0.270N P=0.281 P=0.716 P=0.605N |
|POLY 1.5 | |P=0.193N P=0.286 P=0.743 P=0.568N |
|POLY 6 | |P=0.365N P=0.269 P=0.690 P=0.641N |
|LOGISTIC REGRESSION| |P=0.193N P=0.269 P=0.758 P=0.538N |
|COCH-ARM / FISHERS | |P=0.116N P=0.249 P=0.763N P=0.500N |
|ORDER RESTRICTED | |P=0.258N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |3/10 (30%) 2/10 (20%) 0/9 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/7.25 0/7.33 0/7.78 0/7.49 |3/8.04 2/7.61 0/6.32 0/4.58 |
|POLY-3 PERCENT (g) | 13.8% 0.0% 0.0% 0.0% |37.3% 26.3% 0.0% 0.0% |
|TERMINAL (d) | 1/6 (17%) 0/7 (0%) 0/6 (0%) 0/4 (0%) |2/7 (29%) 2/5 (40%) 0/4 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 295 (T) --- --- --- |246 295 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.407N P=0.469N P=0.500N P=0.581N |P=0.109N P=0.633N P=0.210N P=0.351N |
|POLY 3 | P=0.349N P=0.498N P=0.486N P=0.493N |P=0.052N P=0.529N P=0.135N P=0.223N |
|POLY 1.5 | P=0.345N P=0.505N P=0.489N P=0.492N |P=0.039N* P=0.509N P=0.117N P=0.163N |
|POLY 6 | P=0.354N P=0.484N P=0.483N P=0.501N |P=0.067N P=0.560N P=0.155N P=0.297N |
|LOGISTIC REGRESSION| P=0.407N (e) (e) (e) |P=0.056N P=0.500N P=0.128N P=0.188N |
|COCH-ARM / FISHERS | P=0.350N P=0.500N P=0.500N P=0.500N |P=0.032N* P=0.500N P=0.124N P=0.105N |
|ORDER RESTRICTED | P=0.112N (e) (e) (e) |P=0.101N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |0/10 (0%) 0/10 (0%) 2/9 (22%) 6/10 (60%) |
|POLY-3 RATE (b) | 0/7.25 0/7.33 0/7.78 2/7.89 |0/7.62 0/7.61 2/7.02 6/6.40 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 25.3% |0.0% 0.0% 28.5% 93.8% |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/4 (0%) |0/7 (0%) 0/5 (0%) 1/4 (25%) 2/2 (100%) |
|FIRST INCIDENCE | --- --- --- 263 |--- --- 197 188 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * (e) (e) P=0.236 |P<0.001 ** (e) P=0.167 P<0.001 ** |
|POLY 3 | P=0.037 * (e) (e) P=0.241 |P<0.001 ** (e) P=0.200 P<0.001 ** |
|POLY 1.5 | P=0.038 * (e) (e) P=0.238 |P<0.001 ** (e) P=0.205 P<0.001 ** |
|POLY 6 | P=0.036 * (e) (e) P=0.242 |P<0.001 ** (e) P=0.198 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.041 * (e) (e) P=0.233 |P<0.001 ** (e) P=0.204 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.040 * (e) (e) P=0.237 |P<0.001 ** (e) P=0.211 P=0.005 ** |
|ORDER RESTRICTED | P=0.027 * (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland: Duct |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 2/2 (100%) 2/3 (67%) 1/1 (100%) | |
|POLY-3 RATE (b) | 0/0.00 2/2.00 2/2.58 1/1.00 | |
|POLY-3 PERCENT (g) | 0.0% 100.0% 77.5% 100.0% | |
|TERMINAL (d) | 0/0 (0%) 2/2 (100%) 2/2 (100%) 1/1 (100%) | |
|FIRST INCIDENCE | --- 295 (T) 295 (T) 295 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000N (e) P=1.000 (e) | |
|POLY 3 | (e) (e) (e) (e) | |
|POLY 1.5 | (e) (e) (e) (e) | |
|POLY 6 | (e) (e) (e) (e) | |
|LOGISTIC REGRESSION| (e) (e) P=1.000 (e) | |
|COCH-ARM / FISHERS | P=0.764N (e) P=1.000 (e) | |
|ORDER RESTRICTED | (e) (e) (e) (e) | |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Skin: Epidermis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/9 (33%) 4/9 (44%) 3/9 (33%) 1/8 (13%) |5/6 (83%) 3/8 (38%) 2/8 (25%) 3/4 (75%) |
|POLY-3 RATE (b) | 3/7.00 4/8.03 3/7.52 1/6.41 |5/6.00 3/7.49 2/5.46 3/4.00 |
|POLY-3 PERCENT (g) | 42.9% 49.8% 39.9% 15.6% |83.3% 40.1% 36.7% 75.0% |
|TERMINAL (d) | 3/6 (50%) 3/7 (43%) 3/6 (50%) 1/3 (33%) |5/6 (83%) 3/5 (60%) 2/3 (67%) 1/2 (50%) |
|FIRST INCIDENCE | 295 (T) 192 295 (T) 295 (T) |295 (T) 295 (T) 295 (T) 199 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364N P=0.586 P=0.710 P=0.588N |P=0.206 P=0.430N P=0.605N P=0.374 |
|POLY 3 | P=0.154N P=0.594 P=0.657N P=0.311N |P=0.587 P=0.134N P=0.138N P=0.668N |
|POLY 1.5 | P=0.142N P=0.553 P=0.661N P=0.306N |P=0.604 P=0.122N P=0.081N P=0.668N |
|POLY 6 | P=0.196N P=0.644 P=0.654N P=0.341N |P=0.593 P=0.156N P=0.208N P=0.668N |
|LOGISTIC REGRESSION| P=0.145N P=0.514 P=0.710 P=0.588N |P=0.446 P=0.430N P=0.605N (e) |
|COCH-ARM / FISHERS | P=0.158N P=0.500 P=0.690N P=0.335N |P=0.568N P=0.121N P=0.051N P=0.667N |
|ORDER RESTRICTED | P=0.210N (e) (e) (e) |P=0.233N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |3/10 (30%) 3/10 (30%) 6/10 (60%) 4/10 (40%) |
|POLY-3 RATE (b) | 0/7.25 1/8.06 2/8.94 0/7.49 |3/8.04 3/8.04 6/8.24 4/7.19 |
|POLY-3 PERCENT (g) | 0.0% 12.4% 22.4% 0.0% |37.3% 37.3% 72.8% 55.7% |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/4 (0%) |2/7 (29%) 1/5 (20%) 3/4 (75%) 1/2 (50%) |
|FIRST INCIDENCE | --- 192 188 --- |246 255 115 93 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.542N P=0.500 P=0.285 (e) |P=0.038 * P=0.596 P=0.086 P=0.179 |
|POLY 3 | P=0.585N P=0.521 P=0.276 (e) |P=0.186 P=0.688N P=0.169 P=0.422 |
|POLY 1.5 | P=0.577N P=0.507 P=0.258 (e) |P=0.239 P=0.682N P=0.194 P=0.466 |
|POLY 6 | P=0.622N P=0.540 P=0.296 (e) |P=0.123 P=0.680 P=0.144 P=0.351 |
|LOGISTIC REGRESSION| P=0.654 P=0.529 P=0.184 (e) |P=0.243 P=0.689N P=0.166 P=0.503 |
|COCH-ARM / FISHERS | P=0.590N P=0.500 P=0.237 (e) |P=0.297 P=0.686N P=0.185 P=0.500 |
|ORDER RESTRICTED | P=0.346N (e) (e) (e) |P=0.229 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 2/10 (20%) 1/10 (10%) 2/10 (20%) |1/10 (10%) 2/10 (20%) 1/10 (10%) 7/10 (70%) |
|POLY-3 RATE (b) | 2/8.28 2/9.03 1/8.52 2/8.38 |1/8.59 2/7.69 1/6.60 7/9.06 |
|POLY-3 PERCENT (g) | 24.2% 22.2% 11.7% 23.9% |11.7% 26.0% 15.2% 77.3% |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 0/6 (0%) 0/4 (0%) |0/7 (0%) 1/5 (20%) 0/4 (0%) 0/2 (0%) |
|FIRST INCIDENCE | 224 93 188 218 |93 287 287 8 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.510N P=0.670 P=0.471N P=0.655N |P<0.001 ** P=0.461 P=0.755 P=0.013 * |
|POLY 3 | P=0.571N P=0.673N P=0.489N P=0.704N |P<0.001 ** P=0.459 P=0.702 P=0.003 ** |
|POLY 1.5 | P=0.560N P=0.685N P=0.486N P=0.697N |P<0.001 ** P=0.470 P=0.727 P=0.003 ** |
|POLY 6 | P=0.592N P=0.664N P=0.501N P=0.698 |P<0.001 ** P=0.450 P=0.685 P=0.003 ** |
|LOGISTIC REGRESSION| P=0.546 P=0.675N P=0.558N P=0.694 |P=0.006 ** P=0.496 P=0.773 P=0.022 * |
|COCH-ARM / FISHERS | P=0.563N P=0.709N P=0.500N P=0.709N |P=0.003 ** P=0.500 P=0.763N P=0.010 * |
|ORDER RESTRICTED | P=0.592N (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/10 (40%) 2/10 (20%) 3/10 (30%) 5/10 (50%) |5/10 (50%) 6/10 (60%) 4/10 (40%) 8/10 (80%) |
|POLY-3 RATE (b) | 4/9.25 2/9.03 3/8.52 5/8.38 |5/9.58 6/8.57 4/7.30 8/9.06 |
|POLY-3 PERCENT (g) | 43.3% 22.2% 35.2% 59.7% |52.2% 70.0% 54.8% 88.3% |
|TERMINAL (d) | 1/6 (17%) 0/7 (0%) 2/6 (33%) 3/4 (75%) |3/7 (43%) 4/5 (80%) 2/4 (50%) 1/2 (50%) |
|FIRST INCIDENCE | 93 93 188 218 |57 144 197 8 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.207 P=0.354N P=0.480N P=0.414 |P=0.013 * P=0.331 P=0.583 P=0.047 * |
|POLY 3 | P=0.182 P=0.326N P=0.553N P=0.418 |P=0.103 P=0.386 P=0.643 P=0.106 |
|POLY 1.5 | P=0.208 P=0.333N P=0.534N P=0.447 |P=0.115 P=0.398 P=0.660N P=0.112 |
|POLY 6 | P=0.149 P=0.317N P=0.579N P=0.376 |P=0.110 P=0.372 P=0.622 P=0.116 |
|LOGISTIC REGRESSION| P=0.193 P=0.231N P=0.553N P=0.482 |P=0.187 P=0.497 P=0.492N P=0.303 |
|COCH-ARM / FISHERS | P=0.237 P=0.314N P=0.500N P=0.500 |P=0.175 P=0.500 P=0.500N P=0.175 |
|ORDER RESTRICTED | P=0.198 (e) (e) (e) |P=0.057 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Testes: Bilateral, Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 3/10 (30%) 8/10 (80%) | |
|POLY-3 RATE (b) | 0/7.25 0/7.33 3/8.52 8/8.48 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 35.2% 94.3% | |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 2/6 (33%) 4/4 (100%) | |
|FIRST INCIDENCE | --- --- 188 246 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.124 P<0.001 ** | |
|POLY 3 | P<0.001 ** (e) P=0.120 P<0.001 ** | |
|POLY 1.5 | P<0.001 ** (e) P=0.112 P<0.001 ** | |
|POLY 6 | P<0.001 ** (e) P=0.129 P<0.001 ** | |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.106 P<0.001 ** | |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.105 P<0.001 ** | |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 5/10 (50%) 8/10 (80%) | |
|POLY-3 RATE (b) | 1/7.72 1/7.33 5/8.70 8/8.48 | |
|POLY-3 PERCENT (g) | 13.0% 13.6% 57.5% 94.3% | |
|TERMINAL (d) | 0/6 (0%) 1/7 (14%) 3/6 (50%) 4/4 (100%) | |
|FIRST INCIDENCE | 239 295 (T) 188 246 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.743N P=0.115 P=0.008 ** | |
|POLY 3 | P<0.001 ** P=0.754 P=0.076 P<0.001 ** | |
|POLY 1.5 | P<0.001 ** P=0.751 P=0.071 P<0.001 ** | |
|POLY 6 | P<0.001 ** P=0.760 P=0.079 P<0.001 ** | |
|LOGISTIC REGRESSION| P<0.001 ** P=0.770 P=0.075 P=0.003 ** | |
|COCH-ARM / FISHERS | P<0.001 ** P=0.763N P=0.070 P=0.003 ** | |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) | |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) | |
|POLY-3 RATE (b) | 0/7.25 0/7.33 0/7.78 3/7.89 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 38.0% | |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 0/6 (0%) 1/4 (25%) | |
|FIRST INCIDENCE | --- --- --- 263 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** (e) (e) P=0.099 | |
|POLY 3 | P=0.005 ** (e) (e) P=0.101 | |
|POLY 1.5 | P=0.005 ** (e) (e) P=0.100 | |
|POLY 6 | P=0.005 ** (e) (e) P=0.100 | |
|LOGISTIC REGRESSION| P=0.009 ** (e) (e) P=0.105 | |
|COCH-ARM / FISHERS | P=0.009 ** (e) (e) P=0.105 | |
|ORDER RESTRICTED | P=0.004 ** (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/10 (50%) 1/10 (10%) 3/9 (33%) 6/9 (67%) |2/10 (20%) 5/10 (50%) 6/10 (60%) 9/10 (90%) |
|POLY-3 RATE (b) | 5/10.00 1/8.30 3/9.00 6/9.00 |2/9.58 5/9.00 6/9.30 9/9.30 |
|POLY-3 PERCENT (g) | 50.0% 12.0% 33.3% 66.7% |20.9% 55.5% 64.5% 96.8% |
|TERMINAL (d) | 1/6 (17%) 0/7 (0%) 0/6 (0%) 0/3 (0%) |0/7 (0%) 1/5 (20%) 1/4 (25%) 2/2 (100%) |
|FIRST INCIDENCE | 93 93 144 127 |57 144 115 8 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.201 P=0.120N P=0.320N P=0.497 |P<0.001 ** P=0.211 P=0.125 P=0.005 ** |
|POLY 3 | P=0.119 P=0.106N P=0.398N P=0.398 |P<0.001 ** P=0.141 P=0.061 P<0.001 ** |
|POLY 1.5 | P=0.107 P=0.093N P=0.398N P=0.398 |P<0.001 ** P=0.136 P=0.066 P<0.001 ** |
|POLY 6 | P=0.126 P=0.115N P=0.398N P=0.398 |P<0.001 ** P=0.150 P=0.061 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.039 * P=0.029N* (e) (e) |P=0.007 ** P=0.145 P=0.086 P=0.008 ** |
|COCH-ARM / FISHERS | P=0.084 P=0.070N P=0.395N P=0.395 |P=0.003 ** P=0.175 P=0.085 P=0.003 ** |
|ORDER RESTRICTED | P=0.089 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 1/10 (10%) 0/9 (0%) 1/9 (11%) |0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 3/7.25 1/7.33 0/6.96 1/6.60 |0/7.62 0/7.61 1/7.22 1/4.58 |
|POLY-3 PERCENT (g) | 41.4% 13.6% 0.0% 15.2% |0.0% 0.0% 13.9% 21.9% |
|TERMINAL (d) | 3/6 (50%) 1/7 (14%) 0/6 (0%) 0/3 (0%) |0/7 (0%) 0/5 (0%) 0/4 (0%) 1/2 (50%) |
|FIRST INCIDENCE | 295 (T) 295 (T) --- 284 |--- --- 197 295 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.376N P=0.224N P=0.101N P=0.521N |P=0.099 (e) P=0.473 P=0.252 |
|POLY 3 | P=0.231N P=0.274N P=0.089N P=0.314N |P=0.133 (e) P=0.489 P=0.401 |
|POLY 1.5 | P=0.227N P=0.292N P=0.096N P=0.314N |P=0.147 (e) P=0.498 P=0.436 |
|POLY 6 | P=0.241N P=0.246N P=0.082N P=0.329N |P=0.126 (e) P=0.483 P=0.365 |
|LOGISTIC REGRESSION| P=0.290N P=0.224N (e) P=0.415N |P=0.175 (e) P=0.496 P=0.252 |
|COCH-ARM / FISHERS | P=0.247N P=0.291N P=0.124N P=0.333N |P=0.203 (e) P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.071N (e) (e) (e) |P=0.165 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 4/9 (44%) |0/10 (0%) 2/9 (22%) 7/10 (70%) 8/10 (80%) |
|POLY-3 RATE (b) | 0/7.25 0/7.33 0/7.78 4/7.98 |0/7.62 2/7.68 7/8.18 8/8.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 50.1% |0.0% 26.0% 85.6% 99.3% |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 0/6 (0%) 1/4 (25%) |0/7 (0%) 1/5 (20%) 4/4 (100%) 2/2 (100%) |
|FIRST INCIDENCE | --- --- --- 263 |--- 287 144 93 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** (e) (e) P=0.053 |P<0.001 ** P=0.203 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.034 * |P<0.001 ** P=0.223 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.030 * |P<0.001 ** P=0.225 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.037 * |P<0.001 ** P=0.218 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.002 ** (e) (e) P=0.044 * |P<0.001 ** P=0.218 P=0.002 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.033 * |P<0.001 ** P=0.211 P=0.002 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Depletion Secretory |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 4/10 (40%) 4/10 (40%) 7/9 (78%) |1/10 (10%) 8/9 (89%) 9/10 (90%) 10/10 (100%) |
|POLY-3 RATE (b) | 3/7.81 4/8.06 4/8.38 7/7.98 |1/7.62 8/8.92 9/9.20 10/10.00 |
|POLY-3 PERCENT (g) | 38.4% 49.6% 47.8% 87.7% |13.1% 89.7% 97.8% 100.0% |
|TERMINAL (d) | 2/6 (33%) 3/7 (43%) 2/6 (33%) 4/4 (100%) |1/7 (14%) 5/5 (100%) 4/4 (100%) 2/2 (100%) |
|FIRST INCIDENCE | 224 192 246 263 |295 (T) 144 115 8 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026 * P=0.555 P=0.536 P=0.050 |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.034 * P=0.521 P=0.547 P=0.042 * |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.037 * P=0.495 P=0.534 P=0.046 * |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.027 * P=0.558 P=0.565 P=0.032 * |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.053 P=0.489 P=0.536 P=0.078 |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.032 * P=0.500 P=0.500 P=0.051 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P=0.029 * (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 6/10 (60%) 8/10 (80%) 8/9 (89%) |0/10 (0%) 8/9 (89%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/7.25 6/8.31 8/8.38 8/8.40 |0/7.62 8/8.12 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 72.2% 95.5% 95.2% |0.0% 98.6% 100.0% 100.0% |
|TERMINAL (d) | 0/6 (0%) 5/7 (71%) 6/6 (100%) 4/4 (100%) |0/7 (0%) 5/5 (100%) 4/4 (100%) 2/2 (100%) |
|FIRST INCIDENCE | --- 89 246 246 |--- 255 115 8 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.013 * P=0.002 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 94 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 43 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/10 (0%) 3/10 (30%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | |0/7.62 3/7.96 0/6.52 0/4.58 |
|POLY-3 PERCENT (g) | |0.0% 37.7% 0.0% 0.0% |
|TERMINAL (d) | |0/7 (0%) 2/5 (40%) 0/4 (0%) 0/2 (0%) |
|FIRST INCIDENCE | |--- 255 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.323N P=0.086 (e) (e) |
|POLY 3 | |P=0.229N P=0.096 (e) (e) |
|POLY 1.5 | |P=0.180N P=0.095 (e) (e) |
|POLY 6 | |P=0.288N P=0.096 (e) (e) |
|LOGISTIC REGRESSION| |P=0.232N P=0.102 (e) (e) |
|COCH-ARM / FISHERS | |P=0.161N P=0.105 (e) (e) |
|ORDER RESTRICTED | |P=0.250N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/L 80 MG/L 400 MG/L 800 MG/L |0 MG/L 80 MG/L 400 MG/L 800 MG/L |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |8/10 (80%) 7/10 (70%) 5/10 (50%) 2/10 (20%) |
|POLY-3 RATE (b) | |8/8.04 7/8.12 5/7.48 2/5.27 |
|POLY-3 PERCENT (g) | |99.5% 86.2% 66.9% 38.0% |
|TERMINAL (d) | |7/7 (100%) 4/5 (80%) 3/4 (75%) 1/2 (50%) |
|FIRST INCIDENCE | |246 255 144 199 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.353N P=0.542 P=0.674N P=0.502N |
|POLY 3 | |P=0.005N** P=0.470N P=0.111N P=0.008N** |
|POLY 1.5 | |P<0.001N** P=0.455N P=0.079N P=0.002N** |
|POLY 6 | |P=0.019N* P=0.495N P=0.178N P=0.029N* |
|LOGISTIC REGRESSION| |P=0.015N* P=0.465N P=0.190N P=0.040N* |
|COCH-ARM / FISHERS | |P=0.003N** P=0.500N P=0.175N P=0.012N* |
|ORDER RESTRICTED | |P=0.004N** (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).