TDMS Study 96007-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) DATE: 04/22/03
EXPERIMENT: 96007 TEST: 04 TIME: 10:36:11
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007B
PATHOLOGIST: SELLS, DONALD CAS: TEFDIOXINMIX
------------------------------------------------------------------------------------------------------------------------------------
31 WEEK SSAC/FINAL#1
REASONS FOR REMOVAL: 25017 Scheduled Sacrifice
REMOVAL DATE RANGE: 011399 011499
TREATMENT GROUPS: INCLUDE 001 TERT.MIXCONTROL
INCLUDE 002 TERT.MIXTEQ=10
INCLUDE 003 TERT.MIXTEQ=22
INCLUDE 004 TERT.MIXTEQ=46
INCLUDE 005 TERT.MIXTEQ=100
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (DIOXIN MIXTURE) DATE: 04/22/03
EXPERIMENT: 96007 TEST: 04 TIME: 10:36:11
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007B
PATHOLOGIST: SELLS, DONALD CAS: TEFDIOXINMIX
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia
Hypertrophy
Liver Inflammation
Pigmentation
Liver: Hepatocyte Hypertrophy
Multinucleated
Pancreas: Acinus Vacuolization Cytoplasmic
Thymus Atrophy
Thyroid Gland: Follicular Cell Hypertrophy
Uterus Inflammation
===============================================================
Date: 04/22/03 EXPERIMENT: 96007 TEST: 04 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 1/1.09 0/0.10 0/0.10 0/0.10 2/2.08 |
|POLY-3 PERCENT (g) | 92.1% 0.0% 0.0% 0.0% 96.3% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 212 (I) --- --- --- 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.137 P=0.500N P=0.500N P=0.500N P=0.500 |
|POLY 3 | P=0.067 P=0.161N P=0.161N P=0.161N P=0.301 |
|POLY 1.5 | P=0.072 P=0.189N P=0.189N P=0.189N P=0.319 |
|POLY 6 | P=0.067 P=0.159N P=0.159N P=0.159N P=0.299 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.135 P=0.500N P=0.500N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.020 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 1/10 (10%) 1/10 (10%) 1/10 (10%) 3/10 (30%) |
|POLY-3 RATE (b) | 5/5.05 1/1.09 1/1.09 1/1.09 3/3.07 |
|POLY-3 PERCENT (g) | 99.1% 92.1% 92.1% 92.1% 97.8% |
|INT SACRIFICE 1 (c)| 5/10 (50%) 1/10 (10%) 1/10 (10%) 1/10 (10%) 3/10 (30%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 212 (I) 212 (I) 212 (I) 212 (I) 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.551N P=0.077N P=0.077N P=0.077N P=0.328N |
|POLY 3 | P=0.486N P=0.023N* P=0.023N* P=0.023N* P=0.235N |
|POLY 1.5 | P=0.491N P=0.026N* P=0.026N* P=0.026N* P=0.243N |
|POLY 6 | P=0.484N P=0.023N* P=0.023N* P=0.023N* P=0.235N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.551N P=0.070N P=0.070N P=0.070N P=0.325N |
|ORDER RESTRICTED | P=0.027N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/22/03 EXPERIMENT: 96007 TEST: 04 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/10 (80%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 8/8.02 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 99.8% 100.0% 100.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 8/10 (80%) 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%) |
|FIRST INCIDENCE | 212 (I) 212 (I) 212 (I) 212 (I) 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.188 P=0.234 P=0.234 P=0.234 P=0.234 |
|POLY 3 | P=0.179 P=0.203 P=0.203 P=0.203 P=0.203 |
|POLY 1.5 | P=0.178 P=0.204 P=0.204 P=0.204 P=0.204 |
|POLY 6 | P=0.182 P=0.205 P=0.205 P=0.205 P=0.205 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.186 P=0.237 P=0.237 P=0.237 P=0.237 |
|ORDER RESTRICTED | P=0.008 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/10 (60%) 4/10 (40%) 5/10 (50%) 8/10 (80%) 8/10 (80%) |
|POLY-3 RATE (b) | 6/6.04 4/4.06 5/5.05 8/8.02 8/8.02 |
|POLY-3 PERCENT (g) | 99.4% 98.6% 99.1% 99.8% 99.8% |
|INT SACRIFICE 1 (c)| 6/10 (60%) 4/10 (40%) 5/10 (50%) 8/10 (80%) 8/10 (80%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 212 (I) 212 (I) 212 (I) 212 (I) 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.065 P=0.331N P=0.500N P=0.317 P=0.317 |
|POLY 3 | P=0.057 P=0.254N P=0.424N P=0.266 P=0.266 |
|POLY 1.5 | P=0.058 P=0.261N P=0.430N P=0.271 P=0.271 |
|POLY 6 | P=0.058 P=0.254N P=0.425N P=0.267 P=0.267 |
|LOGISTIC REGRESSION| (e) P=0.327N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.063 P=0.328N P=0.500N P=0.314 P=0.314 |
|ORDER RESTRICTED | P=0.114 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/22/03 EXPERIMENT: 96007 TEST: 04 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 4/10 (40%) 9/10 (90%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.10 4/4.06 9/9.01 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 98.6% 99.9% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 4/10 (40%) 9/10 (90%) 10/10 (100%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 212 (I) 212 (I) 212 (I) 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.051 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.043 * P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 3/10 (30%) 5/10 (50%) 9/10 (90%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/0.10 3/3.07 5/5.05 9/9.01 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 97.8% 99.1% 99.9% 100.0% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 3/10 (30%) 5/10 (50%) 9/10 (90%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 212 (I) 212 (I) 212 (I) 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.111 P=0.022 * P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.030 * P=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.105 P=0.016 * P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/22/03 EXPERIMENT: 96007 TEST: 04 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Multinucleated |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 8/10 (80%) |
|POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 1/1.09 8/8.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 92.1% 99.8% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 8/10 (80%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 212 (I) 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.500 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.161 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.189 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.159 P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P<0.001 ** |
|ORDER RESTRICTED | P=0.008 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 9/10 (90%) 9/10 (90%) 8/10 (80%) 9/10 (90%) |
|POLY-3 RATE (b) | 10/10.00 9/9.01 9/9.01 8/8.02 9/9.01 |
|POLY-3 PERCENT (g) | 100.0% 99.9% 99.9% 99.8% 99.9% |
|INT SACRIFICE 1 (c)| 10/10 (100%) 9/10 (90%) 9/10 (90%) 8/10 (80%) 9/10 (90%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 212 (I) 212 (I) 212 (I) 212 (I) 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.402N P=0.500N P=0.500N P=0.234N P=0.500N |
|POLY 3 | P=0.396N P=0.484N P=0.484N P=0.203N P=0.484N |
|POLY 1.5 | P=0.396N P=0.483N P=0.483N P=0.204N P=0.483N |
|POLY 6 | P=0.397N P=0.489N P=0.489N P=0.205N P=0.489N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.401N P=0.500N P=0.500N P=0.237N P=0.500N |
|ORDER RESTRICTED | P=0.233N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/22/03 EXPERIMENT: 96007 TEST: 04 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/1.09 1/1.09 2/2.08 0/0.10 0/0.10 |
|POLY-3 PERCENT (g) | 92.1% 92.1% 96.3% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 2/10 (20%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 212 (I) 212 (I) 212 (I) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.187N P=0.766 P=0.500 P=0.500N P=0.500N |
|POLY 3 | P=0.104N P=0.531 P=0.301 P=0.161N P=0.161N |
|POLY 1.5 | P=0.108N P=0.553 P=0.319 P=0.189N P=0.189N |
|POLY 6 | P=0.104N P=0.529 P=0.299 P=0.159N P=0.159N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.185N P=0.763N P=0.500 P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.290N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 0/0.10 0/0.10 0/0.10 0/0.10 5/5.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 99.1% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.022 * |
|POLY 3 | P<0.001 ** (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.002 ** |
|POLY 6 | P<0.001 ** (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.016 * |
|ORDER RESTRICTED | P=0.119 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/22/03 EXPERIMENT: 96007 TEST: 04 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 0/0.00 0/0.00 0/0.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 100.0% |
|INT SACRIFICE 1 (c)| 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 212 (I) --- --- --- 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Stomach, Glandular: Glands |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/0.10 0/0.00 0/0.00 0/0.00 2/2.08 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 96.3% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.145 (e) (e) (e) P=0.234 |
|POLY 3 | (e) (e) (e) (e) P=0.068 |
|POLY 1.5 | (e) (e) (e) (e) P=0.079 |
|POLY 6 | (e) (e) (e) (e) P=0.067 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.138 (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/22/03 EXPERIMENT: 96007 TEST: 04 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 3/10 (30%) 7/10 (70%) 7/9 (78%) |
|POLY-3 RATE (b) | 0/0.10 0/0.10 3/3.07 7/7.03 7/7.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 97.8% 99.6% 99.7% |
|INT SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 3/10 (30%) 7/10 (70%) 7/9 (77.8%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 212 (I) 212 (I) 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.111 P=0.003 ** P=0.002 ** |
|POLY 3 | P<0.001 ** (e) P=0.025 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.030 * P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.025 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.105 P=0.002 ** P<0.001 ** |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 5/10 (50%) 1/10 (10%) 4/10 (40%) 3/10 (30%) |
|POLY-3 RATE (b) | 1/1.09 5/5.05 1/1.09 4/4.06 3/3.07 |
|POLY-3 PERCENT (g) | 92.1% 99.1% 92.1% 98.6% 97.8% |
|INT SACRIFICE 1 (c)| 1/10 (10%) 5/10 (50%) 1/10 (10%) 4/10 (40%) 3/10 (30%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 212 (I) 212 (I) 212 (I) 212 (I) 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.395 P=0.077 P=0.766 P=0.157 P=0.293 |
|POLY 3 | P=0.330 P=0.023 * P=0.531 P=0.067 P=0.153 |
|POLY 1.5 | P=0.335 P=0.026 * P=0.553 P=0.074 P=0.166 |
|POLY 6 | P=0.331 P=0.023 * P=0.529 P=0.066 P=0.152 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.394 P=0.070 P=0.763N P=0.152 P=0.291 |
|ORDER RESTRICTED | P=0.141 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/22/03 EXPERIMENT: 96007 TEST: 04 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/10 (40%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 4/4.06 0/0.10 1/1.09 0/0.10 2/2.08 |
|POLY-3 PERCENT (g) | 98.6% 0.0% 92.1% 0.0% 96.3% |
|INT SACRIFICE 1 (c)| 4/10 (40%) 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%) |
|FIRST INCIDENCE | 212 (I) --- 212 (I) --- 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.500N P=0.051N P=0.157N P=0.051N P=0.317N |
|POLY 3 | P=0.409N P=0.007N** P=0.067N P=0.007N** P=0.204N |
|POLY 1.5 | P=0.415N P=0.009N** P=0.074N P=0.009N** P=0.214N |
|POLY 6 | P=0.407N P=0.007N** P=0.066N P=0.007N** P=0.203N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.043N* P=0.152N P=0.043N* P=0.314N |
|ORDER RESTRICTED | P=0.009N** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Uterus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/10 (80%) 9/10 (90%) 8/10 (80%) 8/10 (80%) 8/10 (80%) |
|POLY-3 RATE (b) | 8/8.02 9/9.01 8/8.02 8/8.02 8/8.02 |
|POLY-3 PERCENT (g) | 99.8% 99.9% 99.8% 99.8% 99.8% |
|INT SACRIFICE 1 (c)| 8/10 (80%) 9/10 (90%) 8/10 (80%) 8/10 (80%) 8/10 (80%) |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 212 (I) 212 (I) 212 (I) 212 (I) 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.506N P=0.500 P=0.707 P=0.707 P=0.707 |
|POLY 3 | P=0.486N P=0.466 P=0.667 P=0.667 P=0.667 |
|POLY 1.5 | P=0.487N P=0.468 P=0.669 P=0.669 P=0.669 |
|POLY 6 | P=0.487N P=0.469 P=0.669 P=0.669 P=0.669 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.506N P=0.500 P=0.709N P=0.709N P=0.709N |
|ORDER RESTRICTED | P=0.664N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/22/03 EXPERIMENT: 96007 TEST: 04 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (DIOX
Terminal Sacrifice at 143 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | TERT.MIX TERT.MIX TERT.MIX TERT.MIX TERT.MIX |
| | CONTROL TEQ=10 TEQ=22 TEQ=46 TEQ=100 |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 2/2.08 0/0.10 1/1.09 0/0.10 2/2.08 |
|POLY-3 PERCENT (g) | 96.3% 0.0% 92.1% 0.0% 96.3% |
|INT SACRIFICE 1 (c)| 2/10 (20%) 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%) |
|FIRST INCIDENCE | 212 (I) --- 212 (I) --- 212 (I) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.412 P=0.234N P=0.500N P=0.234N P=0.707 |
|POLY 3 | P=0.307 P=0.068N P=0.301N P=0.068N P=0.544N |
|POLY 1.5 | P=0.317 P=0.079N P=0.319N P=0.079N P=0.559 |
|POLY 6 | P=0.306 P=0.067N P=0.299N P=0.067N P=0.543 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.411 P=0.237N P=0.500N P=0.237N P=0.709N |
|ORDER RESTRICTED | P=0.191 (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).