TDMS Study 96007-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) DATE: 07/14/03
EXPERIMENT: 96007 TEST: 05 TIME: 15:05:09
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007F
PATHOLOGIST: SELLS, DONALD CAS: 57117-31-4
------------------------------------------------------------------------------------------------------------------------------------
53 WEEK SSAC RATS
REASONS FOR REMOVAL: 25017 Scheduled Sacrifice
REMOVAL DATE RANGE: 040600 040700
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) DATE: 07/14/03
EXPERIMENT: 96007 TEST: 05 TIME: 15:05:09
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007F
PATHOLOGIST: SELLS, DONALD CAS: 57117-31-4
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TOXIC EQUIVALENCY FACTOR EVALUATION(
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Liver Fatty Change Diffuse
Pigmentation
Liver: Bile Duct Cyst
Liver: Hepatocyte Hypertrophy
Multinucleated
Mammary Gland Hyperplasia
Ovary Atrophy
Cyst
Thyroid Gland: C-Cell Hyperplasia
Thyroid Gland: Follicular Cell Hypertrophy
Uterus Inflammation Chronic
Metaplasia
Uterus: Endometrium Hyperplasia Cystic
Uterus: Epithelium Hyperplasia
===============================================================
Date: 07/14/03 EXPERIMENT: 96007 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/8 (13%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/8 (25%) |
|POLY-3 RATE (b) | 1/1.34 0/0.00 0/0.00 0/0.00 0/0.00 2/2.30 |
|POLY-3 PERCENT (g) | 74.4% 0.0% 0.0% 0.0% 0.0% 87.1% |
|INT SACRIFICE 1 (c)| 1/8 (12.5%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/8 (25%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) --- --- --- --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.388 P=1.000N P=1.000N P=1.000N P=1.000N P=0.500 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.314 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.348 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.304 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.384 P=1.000 P=1.000 P=1.000 P=1.000 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/8 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/8 (75%) |
|POLY-3 RATE (b) | 4/4.20 0/0.00 0/0.00 0/0.00 0/0.00 6/6.10 |
|POLY-3 PERCENT (g) | 95.3% 0.0% 0.0% 0.0% 0.0% 98.4% |
|INT SACRIFICE 1 (c)| 4/8 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/8 (75%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) --- --- --- --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.233 P=1.000N P=1.000N P=1.000N P=1.000N P=0.309 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.243 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.255 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.240 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.225 P=1.000 P=1.000 P=1.000 P=1.000 P=0.304 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/14/03 EXPERIMENT: 96007 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/8 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/8 (25%) |
|POLY-3 RATE (b) | 0/0.39 0/0.00 0/0.00 0/0.00 0/0.00 2/2.30 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 87.1% |
|INT SACRIFICE 1 (c)| 0/8 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/8 (25%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.143 (e) (e) (e) (e) P=0.232 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.069 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.093 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.064 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.135 (e) (e) (e) (e) P=0.233 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/8 (13%) 1/8 (13%) 0/8 (0%) 3/8 (38%) 0/8 (0%) 1/8 (13%) |
|POLY-3 RATE (b) | 1/1.34 1/1.34 0/0.39 3/3.25 0/0.39 1/1.34 |
|POLY-3 PERCENT (g) | 74.4% 74.4% 0.0% 92.4% 0.0% 74.4% |
|INT SACRIFICE 1 (c)| 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 3/8 (37.5%) 0/8 (0%) 1/8 (12.5%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) 366 (I) --- 366 (I) --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.574N P=0.768 P=0.500N P=0.288 P=0.500N P=0.768 |
|POLY 3 | P=0.468N P=0.548 P=0.173N P=0.156 P=0.173N P=0.548 |
|POLY 1.5 | P=0.487N P=0.590 P=0.228N P=0.180 P=0.228N P=0.590 |
|POLY 6 | P=0.463N P=0.536 P=0.159N P=0.149 P=0.159N P=0.536 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.575N P=0.767N P=0.500N P=0.285 P=0.500N P=0.767N |
|ORDER RESTRICTED | P=0.412N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/14/03 EXPERIMENT: 96007 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 3/8 (38%) |
|POLY-3 RATE (b) | 0/0.39 0/0.39 0/0.39 0/0.39 0/0.39 3/3.25 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 92.4% |
|INT SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 3/8 (37.5%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.107 |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.022 * |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.031 * |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.020 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.100 |
|ORDER RESTRICTED | P=0.154 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/8 (100%) 8/8 (100%) 8/8 (100%) 7/8 (88%) 8/8 (100%) 8/8 (100%) |
|POLY-3 RATE (b) | 8/8.00 8/8.00 8/8.00 7/7.05 8/8.00 8/8.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 99.3% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 8/8 (100%) 8/8 (100%) 8/8 (100%) 7/8 (87.5%) 8/8 (100%) 8/8 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) 366 (I) 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.706 (e) (e) P=0.500N (e) (e) |
|POLY 3 | P=0.708 (e) (e) P=0.476N (e) (e) |
|POLY 1.5 | P=0.707 (e) (e) P=0.480N (e) (e) |
|POLY 6 | P=0.710 (e) (e) P=0.478N (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.708 (e) (e) P=0.500N (e) (e) |
|ORDER RESTRICTED | P=0.507N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/14/03 EXPERIMENT: 96007 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/8 (88%) 6/8 (75%) 6/8 (75%) 8/8 (100%) 6/8 (75%) 6/8 (75%) |
|POLY-3 RATE (b) | 7/7.05 6/6.10 6/6.10 8/8.00 6/6.10 6/6.10 |
|POLY-3 PERCENT (g) | 99.3% 98.4% 98.4% 100.0% 98.4% 98.4% |
|INT SACRIFICE 1 (c)| 7/8 (87.5%) 6/8 (75%) 6/8 (75%) 8/8 (100%) 6/8 (75%) 6/8 (75%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) 366 (I) 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.419N P=0.500N P=0.500N P=0.500 P=0.500N P=0.500N |
|POLY 3 | P=0.396N P=0.456N P=0.456N P=0.476 P=0.456N P=0.456N |
|POLY 1.5 | P=0.400N P=0.464N P=0.464N P=0.480 P=0.464N P=0.464N |
|POLY 6 | P=0.395N P=0.456N P=0.456N P=0.478 P=0.456N P=0.456N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.418N P=0.500N P=0.500N P=0.500 P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.491N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/8 (13%) 1/8 (13%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 0/8 (0%) |
|POLY-3 RATE (b) | 1/1.34 1/1.34 2/2.30 0/0.39 0/0.39 0/0.39 |
|POLY-3 PERCENT (g) | 74.4% 74.4% 87.1% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 1/8 (12.5%) 1/8 (12.5%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.147N P=0.768 P=0.500 P=0.500N P=0.500N P=0.500N |
|POLY 3 | P=0.075N P=0.548 P=0.314 P=0.173N P=0.173N P=0.173N |
|POLY 1.5 | P=0.086N P=0.590 P=0.348 P=0.228N P=0.228N P=0.228N |
|POLY 6 | P=0.074N P=0.536 P=0.304 P=0.159N P=0.159N P=0.159N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.144N P=0.767N P=0.500 P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.281N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/14/03 EXPERIMENT: 96007 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/8 (0%) 1/8 (13%) 1/8 (13%) 6/8 (75%) 7/8 (88%) 8/8 (100%) |
|POLY-3 RATE (b) | 0/0.39 1/1.34 1/1.34 6/6.10 7/7.05 8/8.00 |
|POLY-3 PERCENT (g) | 0.0% 74.4% 74.4% 98.4% 99.3% 100.0% |
|INT SACRIFICE 1 (c)| 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 6/8 (75%) 7/8 (87.5%) 8/8 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 366 (I) 366 (I) 366 (I) 366 (I) 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500 P=0.500 P=0.006 ** P=0.002 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.173 P=0.173 P<0.001 ** P<0.001 ** P<0.001N** |
|POLY 1.5 | P<0.001 ** P=0.228 P=0.228 P<0.001 ** P<0.001 ** P<0.001N** |
|POLY 6 | P<0.001 ** P=0.159 P=0.159 P<0.001 ** P<0.001 ** P<0.001N** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 P=0.003 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) |
|POLY-3 RATE (b) | 0/0.39 0/0.39 0/0.39 0/0.39 0/0.39 2/2.30 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 87.1% |
|INT SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.010 * (e) (e) (e) (e) P=0.232 |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.069 |
|POLY 1.5 | P=0.002 ** (e) (e) (e) (e) P=0.093 |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.064 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.233 |
|ORDER RESTRICTED | P=0.220 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/14/03 EXPERIMENT: 96007 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/8 (13%) 3/8 (38%) 3/8 (38%) 3/8 (38%) 5/8 (63%) 7/8 (88%) |
|POLY-3 RATE (b) | 1/1.34 3/3.25 3/3.25 3/3.25 5/5.15 7/7.05 |
|POLY-3 PERCENT (g) | 74.4% 92.4% 92.4% 92.4% 97.1% 99.3% |
|INT SACRIFICE 1 (c)| 1/8 (12.5%) 3/8 (37.5%) 3/8 (37.5%) 3/8 (37.5%) 5/8 (62.5%) 7/8 (87.5%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) 366 (I) 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.288 P=0.288 P=0.288 P=0.067 P=0.008 ** |
|POLY 3 | P<0.001 ** P=0.156 P=0.156 P=0.156 P=0.016 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.180 P=0.180 P=0.180 P=0.021 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.149 P=0.149 P=0.149 P=0.015 * P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.002 ** P=0.285 P=0.285 P=0.285 P=0.059 P=0.005 ** |
|ORDER RESTRICTED | P=0.010 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Multinucleated |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (13%) 2/8 (25%) |
|POLY-3 RATE (b) | 0/0.39 0/0.39 0/0.39 0/0.39 1/1.34 2/2.30 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 74.4% 87.1% |
|INT SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 2/8 (25%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 366 (I) 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.015 * (e) (e) (e) P=0.500 P=0.232 |
|POLY 3 | P=0.004 ** (e) (e) (e) P=0.173 P=0.069 |
|POLY 1.5 | P=0.006 ** (e) (e) (e) P=0.228 P=0.093 |
|POLY 6 | P=0.004 ** (e) (e) (e) P=0.159 P=0.064 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.014 * (e) (e) (e) P=0.500 P=0.233 |
|ORDER RESTRICTED | P=0.234 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/14/03 EXPERIMENT: 96007 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/8 (50%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/8 (25%) |
|POLY-3 RATE (b) | 4/4.20 1/1.00 0/0.00 0/0.00 0/0.00 2/2.30 |
|POLY-3 PERCENT (g) | 95.3% 100.0% 0.0% 0.0% 0.0% 87.1% |
|INT SACRIFICE 1 (c)| 4/8 (50%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/8 (25%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) 366 (I) --- --- --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.167N P=0.545 P=1.000 P=1.000N P=1.000 P=0.309N |
|POLY 3 | (e) P=0.487 (e) (e) (e) P=0.204N |
|POLY 1.5 | (e) P=0.506 (e) (e) (e) P=0.224N |
|POLY 6 | (e) P=0.482 (e) (e) (e) P=0.199N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.159N P=0.556 P=1.000 P=1.000 P=1.000 P=0.304N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/8 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/2 (0%) 3/8 (38%) |
|POLY-3 RATE (b) | 0/0.39 0/0.05 0/0.05 0/0.00 0/0.10 3/3.25 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 92.4% |
|INT SACRIFICE 1 (c)| 0/8 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/2 (0%) 3/8 (37.5%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.036 * (e) (e) (e) (e) P=0.107 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.022 * |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.031 * |
|POLY 6 | (e) (e) (e) (e) (e) P=0.020 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.032 * (e) (e) (e) (e) P=0.100 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/14/03 EXPERIMENT: 96007 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/8 (100%) 0/1 (0%) 0/2 (0%) 0/1 (0%) 0/0 (0%) 7/8 (88%) |
|POLY-3 RATE (b) | 8/8.00 0/0.05 0/0.10 0/0.05 0/0.00 7/7.05 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 0.0% 99.3% |
|INT SACRIFICE 1 (c)| 8/8 (100%) 0/1 (0%) 0/2 (0%) 0/1 (0%) 0/0 (0%) 7/8 (87.5%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) --- --- --- --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.339 P=0.108N P=0.020N* P=0.108N (e) P=0.500N |
|POLY 3 | (e) P=0.111N P=0.022 * P=0.111N (e) P=0.476N |
|POLY 1.5 | (e) P=0.111N P=0.022 * P=0.111N (e) P=0.480N |
|POLY 6 | (e) P=0.111N P=0.022 * P=0.111N (e) P=0.478N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.335 P=0.111N P=0.022N* P=0.111N (e) P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/8 (13%) 0/1 (0%) 2/2 (100%) 0/1 (0%) 0/0 (0%) 0/8 (0%) |
|POLY-3 RATE (b) | 1/1.34 0/0.05 2/2.00 0/0.05 0/0.00 0/0.39 |
|POLY-3 PERCENT (g) | 74.4% 0.0% 100.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 1/8 (12.5%) 0/1 (0%) 2/2 (100%) 0/1 (0%) 0/0 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) --- 366 (I) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.152N P=0.892N P=0.070 P=0.892N P=1.000N P=0.500N |
|POLY 3 | (e) P=0.399N P<0.001 ** P=0.399N (e) P=0.173N |
|POLY 1.5 | (e) P=0.504N P=0.003 ** P=0.504N (e) P=0.228N |
|POLY 6 | (e) P=0.371N P<0.001 ** P=0.371N (e) P=0.159N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.146N P=0.889N P=0.067 P=0.889N P=1.000 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/14/03 EXPERIMENT: 96007 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/8 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/8 (25%) |
|POLY-3 RATE (b) | 0/0.39 0/0.00 0/0.00 0/0.00 0/0.00 2/2.30 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 87.1% |
|INT SACRIFICE 1 (c)| 0/8 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/8 (25%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.143 (e) (e) (e) (e) P=0.232 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.069 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.093 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.064 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.135 (e) (e) (e) (e) P=0.233 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/8 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/8 (100%) |
|POLY-3 RATE (b) | 8/8.00 0/0.00 0/0.00 0/0.00 0/0.00 8/8.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|INT SACRIFICE 1 (c)| 8/8 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/8 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) --- --- --- --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/14/03 EXPERIMENT: 96007 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/8 (63%) 4/8 (50%) 6/8 (75%) 6/8 (75%) 5/8 (63%) 7/8 (88%) |
|POLY-3 RATE (b) | 5/5.15 4/4.20 6/6.10 6/6.10 5/5.15 7/7.05 |
|POLY-3 PERCENT (g) | 97.1% 95.3% 98.4% 98.4% 97.1% 99.3% |
|INT SACRIFICE 1 (c)| 5/8 (62.5%) 4/8 (50%) 6/8 (75%) 6/8 (75%) 5/8 (62.5%) 7/8 (87.5%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) 366 (I) 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.161 P=0.500N P=0.500 P=0.500 P=0.691 P=0.288 |
|POLY 3 | P=0.162 P=0.420N P=0.439 P=0.439 P=0.623 P=0.237 |
|POLY 1.5 | P=0.163 P=0.435N P=0.450 P=0.450 P=0.634 P=0.247 |
|POLY 6 | P=0.162 P=0.417N P=0.437 P=0.437 P=0.621 P=0.235 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.159 P=0.500N P=0.500 P=0.500 P=0.696N P=0.285 |
|ORDER RESTRICTED | P=0.161 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) |
|POLY-3 RATE (b) | 0/0.39 0/0.39 0/0.34 0/0.39 0/0.39 2/2.30 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 87.1% |
|INT SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * (e) (e) (e) (e) P=0.232 |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.069 |
|POLY 1.5 | P=0.003 ** (e) (e) (e) (e) P=0.093 |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.064 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.233 |
|ORDER RESTRICTED | P=0.216 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/14/03 EXPERIMENT: 96007 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/8 (25%) 3/8 (38%) 1/7 (14%) 3/8 (38%) 4/8 (50%) 5/8 (63%) |
|POLY-3 RATE (b) | 2/2.30 3/3.25 1/1.30 3/3.25 4/4.20 5/5.15 |
|POLY-3 PERCENT (g) | 87.1% 92.4% 77.2% 92.4% 95.3% 97.1% |
|INT SACRIFICE 1 (c)| 2/8 (25%) 3/8 (37.5%) 1/7 (14.3%) 3/8 (37.5%) 4/8 (50%) 5/8 (62.5%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) 366 (I) 366 (I) 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.052 P=0.500 P=0.550N P=0.500 P=0.309 P=0.165 |
|POLY 3 | P=0.045 * P=0.366 P=0.361N P=0.366 P=0.204 P=0.089 |
|POLY 1.5 | P=0.046 * P=0.391 P=0.396N P=0.391 P=0.224 P=0.101 |
|POLY 6 | P=0.044 * P=0.360 P=0.351N P=0.360 P=0.199 P=0.085 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.051 P=0.500 P=0.554N P=0.500 P=0.304 P=0.157 |
|ORDER RESTRICTED | P=0.174 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/8 (25%) 0/1 (0%) 0/2 (0%) 0/1 (0%) 0/1 (0%) 1/8 (13%) |
|POLY-3 RATE (b) | 2/2.30 0/0.05 0/0.10 0/0.05 0/0.05 1/1.34 |
|POLY-3 PERCENT (g) | 87.1% 0.0% 0.0% 0.0% 0.0% 74.4% |
|INT SACRIFICE 1 (c)| 2/8 (25%) 0/1 (0%) 0/2 (0%) 0/1 (0%) 0/1 (0%) 1/8 (12.5%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) --- --- --- --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.499N P=0.748N P=0.574N P=0.748N P=0.748N P=0.500N |
|POLY 3 | P=0.399N P=0.326N P=0.247N P=0.326N P=0.326N P=0.314N |
|POLY 1.5 | P=0.415N P=0.403N P=0.303N P=0.403N P=0.403N P=0.348N |
|POLY 6 | P=0.396N P=0.306N P=0.233N P=0.306N P=0.306N P=0.304N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.498N P=0.778N P=0.622N P=0.778N P=0.778N P=0.500N |
|ORDER RESTRICTED | P=0.097N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/14/03 EXPERIMENT: 96007 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/8 (0%) 0/1 (0%) 2/2 (100%) 0/1 (0%) 1/1 (100%) 0/8 (0%) |
|POLY-3 RATE (b) | 0/0.39 0/0.05 2/2.00 0/0.05 1/1.00 0/0.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% 0.0% 100.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/8 (0%) 0/1 (0%) 2/2 (100%) 0/1 (0%) 1/1 (100%) 0/8 (0%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 366 (I) --- 366 (I) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.326N (e) P=0.020 * (e) P=0.108 (e) |
|POLY 3 | P=0.322N (e) P=0.022N* (e) P=0.111N (e) |
|POLY 1.5 | P=0.322N (e) P=0.022N* (e) P=0.111N (e) |
|POLY 6 | P=0.322N (e) P=0.022N* (e) P=0.111N (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.322N (e) P=0.022 * (e) P=0.111 (e) |
|ORDER RESTRICTED | P=0.093 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/8 (100%) 1/1 (100%) 1/2 (50%) 0/1 (0%) 0/1 (0%) 7/8 (88%) |
|POLY-3 RATE (b) | 8/8.00 1/1.00 1/1.05 0/0.05 0/0.05 7/7.05 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 95.3% 0.0% 0.0% 99.3% |
|INT SACRIFICE 1 (c)| 8/8 (100%) 1/1 (100%) 1/2 (50%) 0/1 (0%) 0/1 (0%) 7/8 (87.5%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) 366 (I) 366 (I) --- --- 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.587N (e) P=0.227N P=0.108N P=0.108N P=0.500N |
|POLY 3 | P=0.610N (e) P=0.050N P=0.111 P=0.111 P=0.476N |
|POLY 1.5 | P=0.610N (e) P=0.066N P=0.111 P=0.111 P=0.480N |
|POLY 6 | P=0.611N (e) P=0.047N* P=0.111 P=0.111 P=0.478N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.589N (e) P=0.200N P=0.111N P=0.111N P=0.500N |
|ORDER RESTRICTED | P=0.002N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/14/03 EXPERIMENT: 96007 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION(
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/8 (75%) 0/1 (0%) 0/2 (0%) 1/1 (100%) 1/1 (100%) 8/8 (100%) |
|POLY-3 RATE (b) | 6/6.10 0/0.05 0/0.10 1/1.00 1/1.00 8/8.00 |
|POLY-3 PERCENT (g) | 98.4% 0.0% 0.0% 100.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 6/8 (75%) 0/1 (0%) 0/2 (0%) 1/1 (100%) 1/1 (100%) 8/8 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 366 (I) --- --- 366 (I) 366 (I) 366 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.040 * P=0.362N P=0.142N P=0.748 P=0.748 P=0.232 |
|POLY 3 | P=0.008 ** P=0.071N P=0.016N* P=0.724 P=0.724 P=0.191 |
|POLY 1.5 | P=0.008 ** P=0.103N P=0.024N* P=0.727 P=0.727 P=0.197 |
|POLY 6 | P=0.008 ** P=0.064N P=0.014N* P=0.725 P=0.725 P=0.191 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.036 * P=0.333N P=0.133N P=0.778 P=0.778 P=0.233 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 |
| | NG/KG |
|=================================================================================================================================|
| |
|Uterus: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/8 (0%) 0/1 (0%) 2/2 (100%) 0/1 (0%) 0/1 (0%) 0/8 (0%) |
|POLY-3 RATE (b) | 0/0.39 0/0.05 2/2.00 0/0.05 0/0.05 0/0.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/8 (0%) 0/1 (0%) 2/2 (100%) 0/1 (0%) 0/1 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 366 (I) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.277N (e) P=0.020 * (e) (e) (e) |
|POLY 3 | P=0.272N (e) P=0.022N* (e) (e) (e) |
|POLY 1.5 | P=0.272N (e) P=0.022N* (e) (e) (e) |
|POLY 6 | P=0.272N (e) P=0.022N* (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.272N (e) P=0.022 * (e) (e) (e) |
|ORDER RESTRICTED | P=0.156N (e) (e) (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).