TDMS Study 96007-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) DATE: 10/14/02
EXPERIMENT: 96007 TEST: 01 TIME: 15:30:07
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-75411 ROUTE: GAVAGE NTP C#: 96007D
PATHOLOGIST: MISSING CAS: 57465-28-8
------------------------------------------------------------------------------------------------------------------------------------
31 WEEK SSAC
REASONS FOR REMOVAL: 25017 Scheduled Sacrifice
REMOVAL DATE RANGE: 092498 092598
TREATMENT GROUPS: INCLUDE 001 0 NG/KG
INCLUDE 002 10 NG/KG
INCLUDE 003 30 NG/KG
INCLUDE 004 100 NG/KG
INCLUDE 005 175 NG/KG
INCLUDE 006 300 NG/KG
INCLUDE 007 550 NG/KG
INCLUDE 008 1000 NG/KG
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-126) DATE: 10/14/02
EXPERIMENT: 96007 TEST: 01 TIME: 15:30:07
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-75411 ROUTE: GAVAGE NTP C#: 96007D
PATHOLOGIST: MISSING CAS: 57465-28-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-12
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Liver Hepatocyte, Multinucleate
Mixed Cell Focus
Necrosis
Pigmentation
Toxic Hepatopathy
Liver: Hepatocyte Hypertrophy
Lung: Alveolar Epithelium Metaplasia Bronchiolar
Ovary Atrophy
Spleen Pigmentation
Thymus Atrophy
Thyroid Gland: Follicular Cell Hypertrophy
===============================================================
Date: 10/14/02 EXPERIMENT: 96007 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-12
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 3/10 (30%) 2/9 (22%) 3/10 (30%) 2/10 (20%) 4/10 (40%) 0/10 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 2/2.08 3/3.07 2/2.07 3/3.07 2/2.08 4/4.06 0/0.09 4/4.06 |
|POLY-3 PERCENT (g) | 96.4% 97.9% 96.8% 97.9% 96.4% 98.6% 0.0% 98.6% |
|INT SACRIFICE 1 (c)| 2/10 (20%) 3/10 (30%) 2/9 (22.2%) 3/10 (30%) 2/10 (20%) 4/10 (40%) 0/10 (0%) 4/10 (40%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) --- 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.425 P=0.500 P=0.667 P=0.500 P=0.707 P=0.317 P=0.234N P=0.317 |
|POLY 3 | P=0.395 P=0.354 P=0.502 P=0.354 P=0.544 P=0.204 P=0.068N P=0.204 |
|POLY 1.5 | P=0.400 P=0.367 P=0.517 P=0.367 P=0.559 P=0.214 P=0.079N P=0.214 |
|POLY 6 | P=0.394 P=0.353 P=0.501 P=0.353 P=0.543 P=0.203 P=0.067N P=0.203 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.424 P=0.500 P=0.667 P=0.500 P=0.709N P=0.314 P=0.237N P=0.314 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocyte, Multinucleate |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 8/10 (80%) |
|POLY-3 RATE (b) | 0/0.09 0/0.09 0/0.09 0/0.09 0/0.09 0/0.09 2/2.08 8/8.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 96.4% 99.8% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 8/10 (80%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) (e) P=0.234 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) (e) P=0.068 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) (e) P=0.079 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) (e) P=0.067 P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) (e) P=0.237 P<0.001 ** |
|=================================================================================================================================|
Date: 10/14/02 EXPERIMENT: 96007 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-12
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/10 (70%) 10/10 (100%) 9/9 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 7/7.03 10/10.00 9/9.00 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 99.6% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 7/10 (70%) 10/10 (100%) 9/9 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.143 P=0.111 P=0.129 P=0.111 P=0.111 P=0.111 P=0.111 P=0.111 |
|POLY 3 | P=0.119 P=0.076 P=0.093 P=0.076 P=0.076 P=0.076 P=0.076 P=0.076 |
|POLY 1.5 | P=0.117 P=0.078 P=0.095 P=0.078 P=0.078 P=0.078 P=0.078 P=0.078 |
|POLY 6 | P=0.121 P=0.077 P=0.094 P=0.077 P=0.077 P=0.077 P=0.077 P=0.077 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.141 P=0.105 P=0.124 P=0.105 P=0.105 P=0.105 P=0.105 P=0.105 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 2/9 (22%) 3/10 (30%) 3/10 (30%) 2/10 (20%) 3/10 (30%) 6/10 (60%) |
|POLY-3 RATE (b) | 0/0.09 2/2.08 2/2.07 3/3.07 3/3.07 2/2.08 3/3.07 6/6.04 |
|POLY-3 PERCENT (g) | 0.0% 96.4% 96.8% 97.9% 97.9% 96.4% 97.9% 99.4% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 2/10 (20%) 2/9 (22.2%) 3/10 (30%) 3/10 (30%) 2/10 (20%) 3/10 (30%) 6/10 (60%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007 ** P=0.234 P=0.210 P=0.111 P=0.111 P=0.234 P=0.111 P=0.009 ** |
|POLY 3 | P=0.005 ** P=0.068 P=0.056 P=0.025 * P=0.025 * P=0.068 P=0.025 * P<0.001 ** |
|POLY 1.5 | P=0.005 ** P=0.079 P=0.066 P=0.029 * P=0.029 * P=0.079 P=0.029 * P<0.001 ** |
|POLY 6 | P=0.005 ** P=0.067 P=0.055 P=0.025 * P=0.025 * P=0.067 P=0.025 * P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.007 ** P=0.237 P=0.211 P=0.105 P=0.105 P=0.237 P=0.105 P=0.005 ** |
|=================================================================================================================================|
Date: 10/14/02 EXPERIMENT: 96007 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-12
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/0.09 0/0.09 0/0.09 1/1.09 0/0.09 0/0.09 1/1.09 2/2.08 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 92.2% 0.0% 0.0% 92.2% 96.4% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 211 (I) --- --- 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * (e) (e) P=0.500 (e) (e) P=0.500 P=0.234 |
|POLY 3 | P=0.008 ** (e) (e) P=0.161 (e) (e) P=0.161 P=0.068 |
|POLY 1.5 | P=0.009 ** (e) (e) P=0.189 (e) (e) P=0.189 P=0.079 |
|POLY 6 | P=0.008 ** (e) (e) P=0.159 (e) (e) P=0.159 P=0.067 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.018 * (e) (e) P=0.500 (e) (e) P=0.500 P=0.237 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 3/10 (30%) 5/10 (50%) 8/10 (80%) 8/10 (80%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.09 0/0.09 0/0.09 3/3.07 5/5.05 8/8.02 8/8.02 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 97.9% 99.1% 99.8% 99.8% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 3/10 (30%) 5/10 (50%) 8/10 (80%) 8/10 (80%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.111 P=0.022 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001N** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.029 * P=0.002 ** P<0.001 ** P<0.001 ** P<0.001N** |
|POLY 6 | P<0.001 ** (e) (e) P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001N** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.105 P=0.016 * P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 10/14/02 EXPERIMENT: 96007 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-12
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Toxic Hepatopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.09 0/0.09 0/0.09 0/0.09 0/0.09 0/0.09 0/0.09 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- --- 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) (e) (e) P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 3/10 (30%) 4/9 (44%) 6/10 (60%) 6/10 (60%) 8/10 (80%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.09 3/3.07 4/4.05 6/6.04 6/6.04 8/8.02 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 97.9% 98.8% 99.4% 99.4% 99.8% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 3/10 (30%) 4/9 (44.4%) 6/10 (60%) 6/10 (60%) 8/10 (80%) 10/10 (100%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.111 P=0.039 * P=0.009 ** P=0.009 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.025 * P=0.004 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.029 * P=0.005 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.025 * P=0.004 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.105 P=0.033 * P=0.005 ** P=0.005 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 10/14/02 EXPERIMENT: 96007 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-12
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 3/10 (30%) 2/9 (22%) 3/10 (30%) 1/10 (10%) 1/10 (10%) 1/10 (10%) 4/10 (40%) |
|POLY-3 RATE (b) | 2/2.08 3/3.07 2/2.07 3/3.07 1/1.09 1/1.09 1/1.09 4/4.06 |
|POLY-3 PERCENT (g) | 96.4% 97.9% 96.8% 97.9% 92.2% 92.2% 92.2% 98.6% |
|INT SACRIFICE 1 (c)| 2/10 (20%) 3/10 (30%) 2/9 (22.2%) 3/10 (30%) 1/10 (10%) 1/10 (10%) 1/10 (10%) 4/10 (40%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.327 P=0.500 P=0.667 P=0.500 P=0.500N P=0.500N P=0.500N P=0.317 |
|POLY 3 | P=0.297 P=0.354 P=0.502 P=0.354 P=0.301N P=0.301N P=0.301N P=0.204 |
|POLY 1.5 | P=0.301 P=0.367 P=0.517 P=0.367 P=0.319N P=0.319N P=0.319N P=0.214 |
|POLY 6 | P=0.296 P=0.353 P=0.501 P=0.353 P=0.299N P=0.299N P=0.299N P=0.203 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.326 P=0.500 P=0.667 P=0.500 P=0.500N P=0.500N P=0.500N P=0.314 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Metaplasia Bronchiolar |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/0.09 0/0.09 0/0.09 0/0.09 0/0.09 1/1.09 0/0.09 2/2.08 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 92.2% 0.0% 96.4% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 2/10 (20%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 211 (I) --- 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.012 * (e) (e) (e) (e) P=0.500 (e) P=0.234 |
|POLY 3 | P=0.004 ** (e) (e) (e) (e) P=0.161 (e) P=0.068 |
|POLY 1.5 | P=0.005 ** (e) (e) (e) (e) P=0.189 (e) P=0.079 |
|POLY 6 | P=0.004 ** (e) (e) (e) (e) P=0.159 (e) P=0.067 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.012 * (e) (e) (e) (e) P=0.500 (e) P=0.237 |
|=================================================================================================================================|
Date: 10/14/02 EXPERIMENT: 96007 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-12
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/10 (80%) 8/10 (80%) 4/9 (44%) 10/10 (100%) 9/10 (90%) 10/10 (100%) 7/10 (70%) 4/10 (40%) |
|POLY-3 RATE (b) | 8/8.02 8/8.02 4/4.05 10/10.00 9/9.01 10/10.00 7/7.03 4/4.06 |
|POLY-3 PERCENT (g) | 99.8% 99.8% 98.8% 100.0% 99.9% 100.0% 99.6% 98.6% |
|INT SACRIFICE 1 (c)| 8/10 (80%) 8/10 (80%) 4/9 (44.4%) 10/10 (100%) 9/10 (90%) 10/10 (100%) 7/10 (70%) 4/10 (40%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.020N* P=0.707 P=0.136N P=0.234 P=0.500 P=0.234 P=0.500N P=0.091N |
|POLY 3 | P=0.008N** P=0.667 P=0.085N P=0.203 P=0.466 P=0.203 P=0.452N P=0.048N* |
|POLY 1.5 | P=0.008N** P=0.669 P=0.089N P=0.204 P=0.468 P=0.204 P=0.456N P=0.051N |
|POLY 6 | P=0.008N** P=0.669 P=0.085N P=0.205 P=0.469 P=0.205 P=0.454N P=0.048N* |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) (e) P=0.085N |
|COCH-ARM / FISHERS | P=0.019N* P=0.709N P=0.130N P=0.237 P=0.500 P=0.237 P=0.500N P=0.085N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/0.00 0/0.01 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|INT SACRIFICE 1 (c)| 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) --- --- --- --- --- --- 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.642N (e) (e) (e) (e) (e) P=0.077N (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) P<0.001N** (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) P=1.000 (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) P=1.000 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.645N (e) (e) (e) (e) (e) P=0.091N (e) |
|=================================================================================================================================|
Date: 10/14/02 EXPERIMENT: 96007 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-12
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 3/10 (30%) 1/9 (11%) 3/10 (30%) 3/10 (30%) 3/10 (30%) 8/10 (80%) 10/10 (100%) |
|POLY-3 RATE (b) | 2/2.08 3/3.07 1/1.08 3/3.07 3/3.07 3/3.07 8/8.02 10/10.00 |
|POLY-3 PERCENT (g) | 96.4% 97.9% 93.0% 97.9% 97.9% 97.9% 99.8% 100.0% |
|INT SACRIFICE 1 (c)| 2/10 (20%) 3/10 (30%) 1/9 (11.1%) 3/10 (30%) 3/10 (30%) 3/10 (30%) 8/10 (80%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500 P=0.539N P=0.500 P=0.500 P=0.500 P=0.015 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.354 P=0.337N P=0.354 P=0.354 P=0.354 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.367 P=0.355N P=0.367 P=0.367 P=0.367 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.353 P=0.335N P=0.353 P=0.353 P=0.353 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) P=0.013 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.542N P=0.500 P=0.500 P=0.500 P=0.012 * P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 3/3 (100%) 3/3 (100%) 5/5 (100%) 6/6 (100%) 5/5 (100%) 5/5 (100%) 7/10 (70%) |
|POLY-3 RATE (b) | 0/0.09 3/3.00 3/3.00 5/5.00 6/6.00 5/5.00 5/5.00 7/7.03 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% 99.6% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 3/3 (100%) 3/3 (100%) 5/5 (100%) 6/6 (100%) 5/5 (100%) 5/5 (100%) 7/10 (70%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.159 P=0.003 ** P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P=0.003 ** |
|POLY 3 | P=0.020 * P=0.003 ** P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.019 * P=0.003 ** P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.022 * P=0.003 ** P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.156 P=0.003 ** P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P=0.002 ** |
|=================================================================================================================================|
Date: 10/14/02 EXPERIMENT: 96007 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (PCB-12
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 10 NG/KG 30 NG/KG 100 175 300 550 1000 |
| | NG/KG NG/KG NG/KG NG/KG NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/1 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 5/5.05 0/0.00 0/0.00 0/0.01 1/1.00 0/0.00 0/0.00 4/4.06 |
|POLY-3 PERCENT (g) | 99.1% 0.0% 0.0% 0.0% 100.0% 0.0% 0.0% 98.6% |
|INT SACRIFICE 1 (c)| 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/1 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 211 (I) --- --- --- 211 (I) --- --- 211 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.408N P=1.000N P=1.000N P=0.536N P=0.536 P=1.000N P=1.000 P=0.500N |
|POLY 3 | (e) (e) (e) P=0.185N P=0.484 (e) (e) P=0.407N |
|POLY 1.5 | (e) (e) (e) P=0.210N P=0.493 (e) (e) P=0.415N |
|POLY 6 | (e) (e) (e) P=0.183N P=0.485 (e) (e) P=0.407N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.406N P=1.000 P=1.000 P=0.545N P=0.545 P=1.000 P=1.000 P=0.500N |
|=================================================================================================================================|
(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).