TDMS Study 96021-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) DATE: 12/15/03
EXPERIMENT: 96021 TEST: 01 TIME: 11:07:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96021
PATHOLOGIST: SELLS, DONALD CAS: 35065-27-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL#4 RATS CTRL VS TREATED
REASONS FOR REMOVAL: 25018 Dosing Accident
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 UG/KG
INCLUDE 002 10 UG/KG
INCLUDE 003 100 UG/KG
INCLUDE 004 300 UG/KG
INCLUDE 005 1000 UG/KG
INCLUDE 006 3000 UG/KG
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) DATE: 12/15/03
EXPERIMENT: 96021 TEST: 01 TIME: 11:07:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96021
PATHOLOGIST: SELLS, DONALD CAS: 35065-27-1
Rats(SPRAGUE-DAWLEY)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Brain
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Parathyroid Gland
Pituitary Gland
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (PCB 153) DATE: 12/15/03
EXPERIMENT: 96021 TEST: 01 TIME: 11:07:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: C96021
PATHOLOGIST: SELLS, DONALD CAS: 35065-27-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TOXIC EQUIVALENCY FACTOR EVALUATION (
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
Uterus Polyp Stromal
Vagina Schwannoma Malignant
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 1
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/53 (4%) 1/54 (2%) 4/53 (8%) 4/53 (8%) 2/53 (4%) 3/51 (6%) |
|POLY-3 RATE (b) | 2/39.13 1/31.01 4/41.12 4/36.33 2/38.33 3/33.81 |
|POLY-3 PERCENT (g) | 5.1% 3.2% 9.7% 11.0% 5.2% 8.9% |
|TERMINAL (d) | 1/24 (4%) 1/16 (6%) 4/28 (14%) 4/21 (19%) 2/20 (10%) 1/21 (5%) |
|FIRST INCIDENCE | 701 731 (T) 731 (T) 731 (T) 731 (T) 586 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.467 P=0.635N P=0.412 P=0.276 P=0.641 P=0.421 |
|POLY 3 | P=0.486 P=0.580N P=0.359 P=0.301 P=0.688 P=0.433 |
|POLY 1.5 | P=0.490 P=0.551N P=0.351 P=0.309 P=0.691 P=0.449 |
|POLY 6 | P=0.486 P=0.607N P=0.374 P=0.296 P=0.682 P=0.426 |
|LOGISTIC REGRESSION| P=0.447 P=0.629N P=0.409 P=0.287 P=0.676 P=0.425 |
|COCH-ARM / FISHERS | P=0.489 P=0.493N P=0.339 P=0.339 P=0.691N P=0.482 |
|ORDER RESTRICTED | P=0.414 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/53 (6%) 2/54 (4%) 4/53 (8%) 4/53 (8%) 2/53 (4%) 3/51 (6%) |
|POLY-3 RATE (b) | 3/39.55 2/31.01 4/41.12 4/36.33 2/38.33 3/33.81 |
|POLY-3 PERCENT (g) | 7.6% 6.5% 9.7% 11.0% 5.2% 8.9% |
|TERMINAL (d) | 1/24 (4%) 2/16 (13%) 4/28 (14%) 4/21 (19%) 2/20 (10%) 1/21 (5%) |
|FIRST INCIDENCE | 608 731 (T) 731 (T) 731 (T) 731 (T) 586 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.589N P=0.664N P=0.573 P=0.434 P=0.553N P=0.569 |
|POLY 3 | P=0.572N P=0.609N P=0.521 P=0.453 P=0.514N P=0.589 |
|POLY 1.5 | P=0.565N P=0.569N P=0.514 P=0.464 P=0.506N P=0.608 |
|POLY 6 | P=0.578N P=0.647N P=0.534 P=0.443 P=0.527N P=0.578 |
|LOGISTIC REGRESSION| P=0.579 P=0.638N P=0.551 P=0.457 P=0.514N P=0.597 |
|COCH-ARM / FISHERS | P=0.563N P=0.491N P=0.500 P=0.500 P=0.500N P=0.642 |
|ORDER RESTRICTED | P=0.686N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 2
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Liver |
| Cholangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/39.01 0/31.01 0/41.12 0/36.33 2/38.45 0/33.11 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 5.2% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/16 (0%) 0/28 (0%) 0/21 (0%) 1/20 (5%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- --- --- 702 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.616 (e) (e) (e) P=0.224 (e) |
|POLY 3 | P=0.568 (e) (e) (e) P=0.233 (e) |
|POLY 1.5 | P=0.587 (e) (e) (e) P=0.236 (e) |
|POLY 6 | P=0.552 (e) (e) (e) P=0.230 (e) |
|LOGISTIC REGRESSION| P=0.605 (e) (e) (e) P=0.226 (e) |
|COCH-ARM / FISHERS | P=0.615 (e) (e) (e) P=0.248 (e) |
|ORDER RESTRICTED | P=0.187 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/52 (2%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 2/53 (4%) 0/51 (0%) |
|POLY-3 RATE (b) | 1/38.91 0/31.01 0/41.12 0/36.33 2/38.33 0/33.11 |
|POLY-3 PERCENT (g) | 2.6% 0.0% 0.0% 0.0% 5.2% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/16 (0%) 0/28 (0%) 0/21 (0%) 2/20 (10%) 0/21 (0%) |
|FIRST INCIDENCE | 701 --- --- --- 731 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.687N P=0.573N P=0.465N P=0.524N P=0.453 P=0.533N |
|POLY 3 | P=0.693N P=0.545N P=0.489N P=0.514N P=0.495 P=0.532N |
|POLY 1.5 | P=0.685N P=0.527N P=0.492N P=0.510N P=0.501 P=0.522N |
|POLY 6 | P=0.700 P=0.561N P=0.483N P=0.516N P=0.487 P=0.540N |
|LOGISTIC REGRESSION| P=0.697N P=0.561N P=0.485N P=0.514N P=0.481 P=0.536N |
|COCH-ARM / FISHERS | P=0.677N P=0.491N P=0.495N P=0.495N P=0.507 P=0.505N |
|ORDER RESTRICTED | P=0.319N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 3
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/54 (0%) 1/53 (2%) 1/53 (2%) 3/53 (6%) 2/51 (4%) |
|POLY-3 RATE (b) | 2/39.01 0/31.01 1/41.12 1/36.33 3/38.33 2/33.52 |
|POLY-3 PERCENT (g) | 5.1% 0.0% 2.4% 2.8% 7.8% 6.0% |
|TERMINAL (d) | 2/24 (8%) 0/16 (0%) 1/28 (4%) 1/21 (5%) 3/20 (15%) 1/21 (5%) |
|FIRST INCIDENCE | 731 (T) --- 731 (T) 731 (T) 731 (T) 612 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.253 P=0.330N P=0.446N P=0.547N P=0.415 P=0.636 |
|POLY 3 | P=0.255 P=0.291N P=0.482N P=0.525N P=0.492 P=0.639 |
|POLY 1.5 | P=0.262 P=0.271N P=0.489N P=0.520N P=0.497 P=0.653 |
|POLY 6 | P=0.250 P=0.310N P=0.469N P=0.527N P=0.485 P=0.633 |
|LOGISTIC REGRESSION| P=0.236 (e) P=0.446N P=0.547N P=0.415 P=0.628 |
|COCH-ARM / FISHERS | P=0.268 P=0.243N P=0.500N P=0.500N P=0.500 P=0.676 |
|ORDER RESTRICTED | P=0.330 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 8/53 (15%) 6/54 (11%) 7/53 (13%) 5/53 (9%) 6/53 (11%) 2/51 (4%) |
|POLY-3 RATE (b) | 8/39.57 6/34.92 7/44.00 5/38.04 6/39.84 2/34.52 |
|POLY-3 PERCENT (g) | 20.2% 17.2% 15.9% 13.1% 15.1% 5.8% |
|TERMINAL (d) | 6/24 (25%) 1/16 (6%) 2/28 (7%) 1/21 (5%) 4/20 (20%) 0/21 (0%) |
|FIRST INCIDENCE | 608 250 443 263 452 79 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.072N P=0.602 P=0.416N P=0.353N P=0.486N P=0.083N |
|POLY 3 | P=0.072N P=0.485N P=0.410N P=0.297N P=0.378N P=0.068N |
|POLY 1.5 | P=0.063N P=0.448N P=0.446N P=0.298N P=0.379N P=0.061N |
|POLY 6 | P=0.082N P=0.514N P=0.363N P=0.290N P=0.384N P=0.071N |
|LOGISTIC REGRESSION| P=0.054N P=0.368N P=0.493N P=0.310N P=0.398N P=0.060N |
|COCH-ARM / FISHERS | P=0.058N P=0.373N P=0.500N P=0.278N P=0.388N P=0.053N |
|ORDER RESTRICTED | P=0.066N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 4
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 9/53 (17%) 6/54 (11%) 8/53 (15%) 5/53 (9%) 7/53 (13%) 3/51 (6%) |
|POLY-3 RATE (b) | 9/39.57 6/34.92 8/44.00 5/38.04 7/39.84 3/34.52 |
|POLY-3 PERCENT (g) | 22.8% 17.2% 18.2% 13.1% 17.6% 8.7% |
|TERMINAL (d) | 7/24 (29%) 1/16 (6%) 3/28 (11%) 1/21 (5%) 5/20 (25%) 1/21 (5%) |
|FIRST INCIDENCE | 608 250 443 263 452 79 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.116N P=0.531N P=0.404N P=0.265N P=0.506N P=0.106N |
|POLY 3 | P=0.118N P=0.378N P=0.403N P=0.208N P=0.383N P=0.090N |
|POLY 1.5 | P=0.105N P=0.344N P=0.442N P=0.210N P=0.384N P=0.081N |
|POLY 6 | P=0.134N P=0.405N P=0.351N P=0.201N P=0.389N P=0.095N |
|LOGISTIC REGRESSION| P=0.094N P=0.290N P=0.483N P=0.225N P=0.408N P=0.087N |
|COCH-ARM / FISHERS | P=0.097N P=0.276N P=0.500N P=0.195N P=0.393N P=0.070N |
|ORDER RESTRICTED | P=0.086N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 41/53 (77%) 34/54 (63%) 36/53 (68%) 35/53 (66%) 39/53 (74%) 32/51 (63%) |
|POLY-3 RATE (b) | 41/49.26 34/43.20 36/47.95 35/46.05 39/49.19 32/44.62 |
|POLY-3 PERCENT (g) | 83.2% 78.7% 75.1% 76.0% 79.3% 71.7% |
|TERMINAL (d) | 19/24 (79%) 13/16 (81%) 22/28 (79%) 14/21 (67%) 13/20 (65%) 13/21 (62%) |
|FIRST INCIDENCE | 399 310 418 269 341 360 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.459N P=0.291 P=0.103N P=0.422N P=0.481 P=0.393N |
|POLY 3 | P=0.190N P=0.377N P=0.214N P=0.255N P=0.399N P=0.123N |
|POLY 1.5 | P=0.208N P=0.237N P=0.188N P=0.230N P=0.393N P=0.103N |
|POLY 6 | P=0.182N P=0.513N P=0.262N P=0.266N P=0.398N P=0.148N |
|LOGISTIC REGRESSION| P=0.295N P=0.206N P=0.166N P=0.192N P=0.413N P=0.095N |
|COCH-ARM / FISHERS | P=0.266N P=0.078N P=0.192N P=0.140N P=0.411N P=0.078N |
|ORDER RESTRICTED | P=0.128N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 5
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 41/53 (77%) 34/54 (63%) 36/53 (68%) 36/53 (68%) 41/53 (77%) 33/51 (65%) |
|POLY-3 RATE (b) | 41/49.26 34/43.20 36/47.95 36/46.05 41/49.19 33/44.62 |
|POLY-3 PERCENT (g) | 83.2% 78.7% 75.1% 78.2% 83.4% 74.0% |
|TERMINAL (d) | 19/24 (79%) 13/16 (81%) 22/28 (79%) 15/21 (71%) 15/20 (75%) 14/21 (67%) |
|FIRST INCIDENCE | 399 310 418 269 341 360 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.527 P=0.291 P=0.103N P=0.480N P=0.366 P=0.452N |
|POLY 3 | P=0.294N P=0.377N P=0.214N P=0.349N P=0.607 P=0.184N |
|POLY 1.5 | P=0.310N P=0.237N P=0.188N P=0.313N P=0.599N P=0.154N |
|POLY 6 | P=0.291N P=0.513N P=0.262N P=0.368N P=0.609 P=0.222N |
|LOGISTIC REGRESSION| P=0.401N P=0.206N P=0.166N P=0.262N P=0.590 P=0.141N |
|COCH-ARM / FISHERS | P=0.363N P=0.078N P=0.192N P=0.192N P=0.592N P=0.114N |
|ORDER RESTRICTED | P=0.206N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 43/53 (81%) 37/54 (69%) 40/53 (75%) 38/53 (72%) 42/53 (79%) 34/51 (67%) |
|POLY-3 RATE (b) | 43/49.39 37/45.93 40/50.65 38/47.11 42/49.93 34/45.62 |
|POLY-3 PERCENT (g) | 87.1% 80.6% 79.0% 80.7% 84.1% 74.5% |
|TERMINAL (d) | 20/24 (83%) 13/16 (81%) 22/28 (79%) 15/21 (71%) 15/20 (75%) 14/21 (67%) |
|FIRST INCIDENCE | 399 250 418 263 341 79 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.408N P=0.230 P=0.173N P=0.492N P=0.414 P=0.409N |
|POLY 3 | P=0.158N P=0.260N P=0.195N P=0.268N P=0.445N P=0.081N |
|POLY 1.5 | P=0.147N P=0.184N P=0.223N P=0.252N P=0.453N P=0.069N |
|POLY 6 | P=0.176N P=0.357N P=0.185N P=0.277N P=0.437N P=0.103N |
|LOGISTIC REGRESSION| P=0.199N P=0.186N P=0.308N P=0.247N P=0.502N P=0.080N |
|COCH-ARM / FISHERS | P=0.187N P=0.100N P=0.319N P=0.180N P=0.500N P=0.072N |
|ORDER RESTRICTED | P=0.077N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 6
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/54 (4%) 0/53 (0%) 1/53 (2%) 0/53 (0%) 1/51 (2%) |
|POLY-3 RATE (b) | 0/39.01 2/31.41 0/41.12 1/36.33 0/38.33 1/33.11 |
|POLY-3 PERCENT (g) | 0.0% 6.4% 0.0% 2.8% 0.0% 3.0% |
|TERMINAL (d) | 0/24 (0%) 1/16 (6%) 0/28 (0%) 1/21 (5%) 0/20 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- 616 --- 731 (T) --- 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.591 P=0.177 (e) P=0.473 (e) P=0.473 |
|POLY 3 | P=0.545 P=0.192 (e) P=0.486 (e) P=0.467 |
|POLY 1.5 | P=0.566 P=0.207 (e) P=0.488 (e) P=0.476 |
|POLY 6 | P=0.524 P=0.180 (e) P=0.485 (e) P=0.461 |
|LOGISTIC REGRESSION| P=0.588 P=0.188 (e) P=0.473 (e) P=0.473 |
|COCH-ARM / FISHERS | P=0.604 P=0.252 (e) P=0.500 (e) P=0.490 |
|ORDER RESTRICTED | P=0.309 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/54 (4%) 0/53 (0%) 1/53 (2%) 0/53 (0%) 1/51 (2%) |
|POLY-3 RATE (b) | 0/39.01 2/31.41 0/41.12 1/36.33 0/38.33 1/33.11 |
|POLY-3 PERCENT (g) | 0.0% 6.4% 0.0% 2.8% 0.0% 3.0% |
|TERMINAL (d) | 0/24 (0%) 1/16 (6%) 0/28 (0%) 1/21 (5%) 0/20 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- 616 --- 731 (T) --- 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.591 P=0.177 (e) P=0.473 (e) P=0.473 |
|POLY 3 | P=0.545 P=0.192 (e) P=0.486 (e) P=0.467 |
|POLY 1.5 | P=0.566 P=0.207 (e) P=0.488 (e) P=0.476 |
|POLY 6 | P=0.524 P=0.180 (e) P=0.485 (e) P=0.461 |
|LOGISTIC REGRESSION| P=0.588 P=0.188 (e) P=0.473 (e) P=0.473 |
|COCH-ARM / FISHERS | P=0.604 P=0.252 (e) P=0.500 (e) P=0.490 |
|ORDER RESTRICTED | P=0.309 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 7
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/54 (4%) 0/53 (0%) 1/53 (2%) 0/53 (0%) 1/51 (2%) |
|POLY-3 RATE (b) | 0/39.01 2/31.41 0/41.12 1/36.33 0/38.33 1/33.11 |
|POLY-3 PERCENT (g) | 0.0% 6.4% 0.0% 2.8% 0.0% 3.0% |
|TERMINAL (d) | 0/24 (0%) 1/16 (6%) 0/28 (0%) 1/21 (5%) 0/20 (0%) 1/21 (5%) |
|FIRST INCIDENCE | --- 616 --- 731 (T) --- 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.591 P=0.177 (e) P=0.473 (e) P=0.473 |
|POLY 3 | P=0.545 P=0.192 (e) P=0.486 (e) P=0.467 |
|POLY 1.5 | P=0.566 P=0.207 (e) P=0.488 (e) P=0.476 |
|POLY 6 | P=0.524 P=0.180 (e) P=0.485 (e) P=0.461 |
|LOGISTIC REGRESSION| P=0.588 P=0.188 (e) P=0.473 (e) P=0.473 |
|COCH-ARM / FISHERS | P=0.604 P=0.252 (e) P=0.500 (e) P=0.490 |
|ORDER RESTRICTED | P=0.309 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 0/46 (0%) 0/50 (0%) 0/47 (0%) 2/46 (4%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/36.68 0/27.75 0/38.12 0/32.21 2/33.00 0/30.97 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 6.1% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/15 (0%) 0/25 (0%) 0/18 (0%) 1/16 (6%) 0/20 (0%) |
|FIRST INCIDENCE | --- --- --- --- 579 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.609 (e) (e) (e) P=0.200 (e) |
|POLY 3 | P=0.565 (e) (e) (e) P=0.213 (e) |
|POLY 1.5 | P=0.586 (e) (e) (e) P=0.218 (e) |
|POLY 6 | P=0.551 (e) (e) (e) P=0.206 (e) |
|LOGISTIC REGRESSION| P=0.614 (e) (e) (e) P=0.220 (e) |
|COCH-ARM / FISHERS | P=0.621 (e) (e) (e) P=0.232 (e) |
|ORDER RESTRICTED | P=0.165 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 8
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 18/53 (34%) 19/54 (35%) 19/53 (36%) 19/53 (36%) 24/53 (45%) 11/50 (22%) |
|POLY-3 RATE (b) | 18/41.75 19/34.40 19/42.89 19/39.93 24/41.43 11/34.40 |
|POLY-3 PERCENT (g) | 43.1% 55.2% 44.3% 47.6% 57.9% 32.0% |
|TERMINAL (d) | 10/24 (42%) 10/16 (63%) 13/28 (46%) 9/21 (43%) 12/20 (60%) 7/21 (33%) |
|FIRST INCIDENCE | 211 502 429 443 579 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.114N P=0.101 P=0.440N P=0.376 P=0.099 P=0.217N |
|POLY 3 | P=0.120N P=0.195 P=0.545 P=0.425 P=0.116 P=0.218N |
|POLY 1.5 | P=0.096N P=0.287 P=0.524 P=0.422 P=0.129 P=0.184N |
|POLY 6 | P=0.159N P=0.142 P=0.579 P=0.450 P=0.109 P=0.255N |
|LOGISTIC REGRESSION| P=0.095N P=0.175 P=0.574 P=0.406 P=0.128 P=0.204N |
|COCH-ARM / FISHERS | P=0.081N P=0.528 P=0.500 P=0.500 P=0.160 P=0.129N |
|ORDER RESTRICTED | P=0.095N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 18/53 (34%) 19/54 (35%) 19/53 (36%) 19/53 (36%) 24/53 (45%) 12/50 (24%) |
|POLY-3 RATE (b) | 18/41.75 19/34.40 19/42.89 19/39.93 24/41.43 12/34.62 |
|POLY-3 PERCENT (g) | 43.1% 55.2% 44.3% 47.6% 57.9% 34.7% |
|TERMINAL (d) | 10/24 (42%) 10/16 (63%) 13/28 (46%) 9/21 (43%) 12/20 (60%) 7/21 (33%) |
|FIRST INCIDENCE | 211 502 429 443 579 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.171N P=0.101 P=0.440N P=0.376 P=0.099 P=0.294N |
|POLY 3 | P=0.182N P=0.195 P=0.545 P=0.425 P=0.116 P=0.298N |
|POLY 1.5 | P=0.151N P=0.287 P=0.524 P=0.422 P=0.129 P=0.257N |
|POLY 6 | P=0.226N P=0.142 P=0.579 P=0.450 P=0.109 P=0.336N |
|LOGISTIC REGRESSION| P=0.152N P=0.175 P=0.574 P=0.406 P=0.128 P=0.283N |
|COCH-ARM / FISHERS | P=0.127N P=0.528 P=0.500 P=0.500 P=0.160 P=0.185N |
|ORDER RESTRICTED | P=0.158N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 9
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/54 (4%) 0/53 (0%) 1/53 (2%) 2/53 (4%) 1/51 (2%) |
|POLY-3 RATE (b) | 0/39.01 2/31.14 0/41.12 1/36.33 2/39.53 1/33.89 |
|POLY-3 PERCENT (g) | 0.0% 6.4% 0.0% 2.8% 5.1% 3.0% |
|TERMINAL (d) | 0/24 (0%) 1/16 (6%) 0/28 (0%) 1/21 (5%) 0/20 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 696 --- 731 (T) 479 443 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.479 P=0.158 (e) P=0.473 P=0.239 P=0.482 |
|POLY 3 | P=0.436 P=0.190 (e) P=0.486 P=0.239 P=0.472 |
|POLY 1.5 | P=0.459 P=0.207 (e) P=0.488 P=0.239 P=0.479 |
|POLY 6 | P=0.415 P=0.177 (e) P=0.485 P=0.240 P=0.468 |
|LOGISTIC REGRESSION| P=0.500 P=0.164 (e) P=0.473 P=0.224 P=0.576 |
|COCH-ARM / FISHERS | P=0.499 P=0.252 (e) P=0.500 P=0.248 P=0.490 |
|ORDER RESTRICTED | P=0.255 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/54 (0%) 2/53 (4%) 1/53 (2%) 1/53 (2%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/39.01 0/31.01 2/41.59 1/36.49 1/38.33 0/33.11 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 2.7% 2.6% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/16 (0%) 1/28 (4%) 0/21 (0%) 1/20 (5%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- 591 691 731 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.449N (e) P=0.257 P=0.485 P=0.464 (e) |
|POLY 3 | P=0.420N (e) P=0.251 P=0.487 P=0.497 (e) |
|POLY 1.5 | P=0.421N (e) P=0.246 P=0.489 P=0.499 (e) |
|POLY 6 | P=0.418N (e) P=0.261 P=0.487 P=0.494 (e) |
|LOGISTIC REGRESSION| P=0.443N (e) P=0.240 P=0.486 P=0.464 (e) |
|COCH-ARM / FISHERS | P=0.429N (e) P=0.248 P=0.500 P=0.500 (e) |
|ORDER RESTRICTED | P=0.365 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 10
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/54 (4%) 3/53 (6%) 1/53 (2%) 3/53 (6%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/39.01 2/32.88 3/41.86 1/36.49 3/39.06 0/33.11 |
|POLY-3 PERCENT (g) | 0.0% 6.1% 7.2% 2.7% 7.7% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/16 (0%) 1/28 (4%) 0/21 (0%) 1/20 (5%) 0/21 (0%) |
|FIRST INCIDENCE | --- 261 591 691 510 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.294N P=0.235 P=0.144 P=0.485 P=0.111 (e) |
|POLY 3 | P=0.312N P=0.201 P=0.131 P=0.487 P=0.118 (e) |
|POLY 1.5 | P=0.298N P=0.214 P=0.126 P=0.489 P=0.119 (e) |
|POLY 6 | P=0.325N P=0.189 P=0.140 P=0.487 P=0.116 (e) |
|LOGISTIC REGRESSION| P=0.270N P=0.492 P=0.122 P=0.486 P=0.120 (e) |
|COCH-ARM / FISHERS | P=0.277N P=0.252 P=0.121 P=0.500 P=0.121 (e) |
|ORDER RESTRICTED | P=0.266 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/54 (4%) 2/53 (4%) 0/53 (0%) 2/53 (4%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/39.01 2/32.88 2/41.39 0/36.33 2/39.06 0/33.11 |
|POLY-3 PERCENT (g) | 0.0% 6.1% 4.8% 0.0% 5.1% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/16 (0%) 1/28 (4%) 0/21 (0%) 0/20 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 261 656 --- 510 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.344N P=0.235 P=0.277 (e) P=0.235 (e) |
|POLY 3 | P=0.370N P=0.201 P=0.250 (e) P=0.237 (e) |
|POLY 1.5 | P=0.356N P=0.214 P=0.245 (e) P=0.238 (e) |
|POLY 6 | P=0.382N P=0.189 P=0.260 (e) P=0.236 (e) |
|LOGISTIC REGRESSION| P=0.323N P=0.492 P=0.250 (e) P=0.238 (e) |
|COCH-ARM / FISHERS | P=0.335N P=0.252 P=0.248 (e) P=0.248 (e) |
|ORDER RESTRICTED | P=0.328N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 11
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 16/51 (31%) 13/52 (25%) 17/53 (32%) 12/53 (23%) 22/53 (42%) 7/51 (14%) |
|POLY-3 RATE (b) | 16/39.99 13/32.09 17/43.11 12/38.16 22/40.39 7/33.34 |
|POLY-3 PERCENT (g) | 40.0% 40.5% 39.4% 31.5% 54.5% 21.0% |
|TERMINAL (d) | 10/24 (42%) 10/16 (63%) 11/28 (39%) 7/21 (33%) 15/20 (75%) 6/21 (29%) |
|FIRST INCIDENCE | 555 438 443 528 555 668 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.075N P=0.378 P=0.478N P=0.373N P=0.063 P=0.069N |
|POLY 3 | P=0.090N P=0.581 P=0.569N P=0.285N P=0.129 P=0.062N |
|POLY 1.5 | P=0.065N P=0.500N P=0.583N P=0.271N P=0.157 P=0.045N* |
|POLY 6 | P=0.131N P=0.470 P=0.545N P=0.297N P=0.099 P=0.085N |
|LOGISTIC REGRESSION| P=0.070N P=0.510 P=0.562N P=0.296N P=0.121 P=0.064N |
|COCH-ARM / FISHERS | P=0.049N* P=0.309N P=0.553 P=0.217N P=0.192 P=0.028N* |
|ORDER RESTRICTED | P=0.051N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/51 (4%) 2/52 (4%) 1/53 (2%) 1/53 (2%) 2/53 (4%) 0/51 (0%) |
|POLY-3 RATE (b) | 2/38.11 2/30.30 1/41.12 1/36.64 2/38.33 0/33.11 |
|POLY-3 PERCENT (g) | 5.3% 6.6% 2.4% 2.7% 5.2% 0.0% |
|TERMINAL (d) | 2/24 (8%) 2/16 (13%) 1/28 (4%) 0/21 (0%) 2/20 (10%) 0/21 (0%) |
|FIRST INCIDENCE | 731 (T) 731 (T) 731 (T) 647 731 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.223N P=0.542 P=0.446N P=0.527N P=0.630 P=0.267N |
|POLY 3 | P=0.238N P=0.609 P=0.473N P=0.514N P=0.693N P=0.269N |
|POLY 1.5 | P=0.226N P=0.641 P=0.478N P=0.509N P=0.686N P=0.258N |
|POLY 6 | P=0.253N P=0.579 P=0.464N P=0.515N P=0.690 P=0.278N |
|LOGISTIC REGRESSION| P=0.225N P=0.542 P=0.446N P=0.521N P=0.630 (e) |
|COCH-ARM / FISHERS | P=0.209N P=0.684N P=0.485N P=0.485N P=0.676N P=0.248N |
|ORDER RESTRICTED | P=0.169N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 12
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 18/51 (35%) 15/52 (29%) 18/53 (34%) 13/53 (25%) 23/53 (43%) 7/51 (14%) |
|POLY-3 RATE (b) | 18/39.99 15/32.09 18/43.11 13/38.46 23/40.39 7/33.34 |
|POLY-3 PERCENT (g) | 45.0% 46.8% 41.8% 33.8% 57.0% 21.0% |
|TERMINAL (d) | 12/24 (50%) 12/16 (75%) 12/28 (43%) 7/21 (33%) 16/20 (80%) 6/21 (29%) |
|FIRST INCIDENCE | 555 438 443 528 555 668 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.032N* P=0.308 P=0.382N P=0.309N P=0.081 P=0.028N* |
|POLY 3 | P=0.038N* P=0.538 P=0.468N P=0.209N P=0.185 P=0.023N* |
|POLY 1.5 | P=0.027N* P=0.526N P=0.487N P=0.203N P=0.219 P=0.016N* |
|POLY 6 | P=0.060N P=0.408 P=0.437N P=0.208N P=0.146 P=0.033N* |
|LOGISTIC REGRESSION| P=0.028N* P=0.435 P=0.460N P=0.233N P=0.167 P=0.026N* |
|COCH-ARM / FISHERS | P=0.021N* P=0.312N P=0.525N P=0.162N P=0.260 P=0.010N* |
|ORDER RESTRICTED | P=0.018N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 1/54 (2%) 2/53 (4%) 0/53 (0%) 1/53 (2%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/39.01 1/31.14 2/41.96 0/36.33 1/38.34 0/33.11 |
|POLY-3 PERCENT (g) | 0.0% 3.2% 4.8% 0.0% 2.6% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/16 (0%) 0/28 (0%) 0/21 (0%) 0/20 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 696 527 --- 729 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.399N P=0.423 P=0.262 (e) P=0.473 (e) |
|POLY 3 | P=0.384N P=0.455 P=0.253 (e) P=0.497 (e) |
|POLY 1.5 | P=0.379N P=0.472 P=0.247 (e) P=0.499 (e) |
|POLY 6 | P=0.388N P=0.442 P=0.265 (e) P=0.494 (e) |
|LOGISTIC REGRESSION| P=0.382N P=0.442 P=0.220 (e) P=0.482 (e) |
|COCH-ARM / FISHERS | P=0.376N P=0.505 P=0.248 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.365N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 13
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Leiomyosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/54 (0%) 0/53 (0%) 3/53 (6%) 0/53 (0%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/39.01 0/31.01 0/41.12 3/36.33 0/38.33 0/33.11 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 8.3% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/16 (0%) 0/28 (0%) 3/21 (14%) 0/20 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- --- 731 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.450N (e) (e) P=0.096 (e) (e) |
|POLY 3 | P=0.454N (e) (e) P=0.105 (e) (e) |
|POLY 1.5 | P=0.451N (e) (e) P=0.108 (e) (e) |
|POLY 6 | P=0.460N (e) (e) P=0.103 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.096 (e) (e) |
|COCH-ARM / FISHERS | P=0.444N (e) (e) P=0.121 (e) (e) |
|ORDER RESTRICTED | P=0.276 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 7/53 (13%) 9/54 (17%) 4/53 (8%) 6/53 (11%) 3/53 (6%) 2/51 (4%) |
|POLY-3 RATE (b) | 7/39.74 9/32.68 4/41.73 6/37.10 3/39.40 2/33.11 |
|POLY-3 PERCENT (g) | 17.6% 27.5% 9.6% 16.2% 7.6% 6.0% |
|TERMINAL (d) | 4/24 (17%) 5/16 (31%) 3/28 (11%) 3/21 (14%) 1/20 (5%) 2/21 (10%) |
|FIRST INCIDENCE | 590 590 530 647 467 731 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.047N* P=0.148 P=0.201N P=0.578N P=0.209N P=0.129N |
|POLY 3 | P=0.051N P=0.232 P=0.230N P=0.554N P=0.156N P=0.126N |
|POLY 1.5 | P=0.044N* P=0.285 P=0.242N P=0.545N P=0.156N P=0.112N |
|POLY 6 | P=0.060N P=0.197 P=0.213N P=0.556N P=0.159N P=0.140N |
|LOGISTIC REGRESSION| P=0.041N* P=0.189 P=0.226N P=0.558N P=0.163N P=0.129N |
|COCH-ARM / FISHERS | P=0.037N* P=0.409 P=0.263N P=0.500N P=0.160N P=0.090N |
|ORDER RESTRICTED | P=0.035N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 14
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 1/54 (2%) 2/53 (4%) 0/53 (0%) 0/53 (0%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/39.01 1/31.22 2/41.12 0/36.33 0/38.33 0/33.11 |
|POLY-3 PERCENT (g) | 0.0% 3.2% 4.9% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/16 (0%) 2/28 (7%) 0/21 (0%) 0/20 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 675 731 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.312N P=0.433 P=0.272 (e) (e) (e) |
|POLY 3 | P=0.297N P=0.456 P=0.249 (e) (e) (e) |
|POLY 1.5 | P=0.297N P=0.472 P=0.244 (e) (e) (e) |
|POLY 6 | P=0.296N P=0.443 P=0.256 (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.312N P=0.455 P=0.272 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.302N P=0.505 P=0.248 (e) (e) (e) |
|ORDER RESTRICTED | P=0.296N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Vagina |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/53 (0%) 2/54 (4%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 0/51 (0%) |
|POLY-3 RATE (b) | 0/39.01 2/31.96 0/41.12 0/36.33 0/38.33 0/33.11 |
|POLY-3 PERCENT (g) | 0.0% 6.3% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/16 (6%) 0/28 (0%) 0/21 (0%) 0/20 (0%) 0/21 (0%) |
|FIRST INCIDENCE | --- 261 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.392N P=0.196 (e) (e) (e) (e) |
|POLY 3 | P=0.441N P=0.195 (e) (e) (e) (e) |
|POLY 1.5 | P=0.422N P=0.210 (e) (e) (e) (e) |
|POLY 6 | P=0.460N P=0.183 (e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.380N P=0.323 (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.390N P=0.252 (e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.182N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 15
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|Vagina |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/53 (2%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 0/53 (0%) 3/51 (6%) |
|POLY-3 RATE (b) | 1/39.14 0/31.01 0/41.12 0/36.33 0/38.33 3/34.55 |
|POLY-3 PERCENT (g) | 2.6% 0.0% 0.0% 0.0% 0.0% 8.7% |
|TERMINAL (d) | 0/24 (0%) 0/16 (0%) 0/28 (0%) 0/21 (0%) 0/20 (0%) 1/21 (5%) |
|FIRST INCIDENCE | 696 --- --- --- --- 442 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** P=0.577N P=0.467N P=0.539N P=0.507N P=0.253 |
|POLY 3 | P=0.007 ** P=0.546N P=0.490N P=0.515N P=0.504N P=0.260 |
|POLY 1.5 | P=0.007 ** P=0.529N P=0.494N P=0.512N P=0.502N P=0.270 |
|POLY 6 | P=0.007 ** P=0.561N P=0.484N P=0.517N P=0.508N P=0.255 |
|LOGISTIC REGRESSION| P=0.008 ** P=0.558N P=0.487N P=0.515N P=0.505N P=0.311 |
|COCH-ARM / FISHERS | P=0.007 ** P=0.495N P=0.500N P=0.500N P=0.500N P=0.294 |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 2/53 (4%) 0/54 (0%) 0/53 (0%) 0/53 (0%) 3/53 (6%) 0/51 (0%) |
|POLY-3 RATE (b) | 2/39.53 0/31.01 0/41.12 0/36.33 3/39.68 0/33.11 |
|POLY-3 PERCENT (g) | 5.1% 0.0% 0.0% 0.0% 7.6% 0.0% |
|TERMINAL (d) | 1/24 (4%) 0/16 (0%) 0/28 (0%) 0/21 (0%) 0/20 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 571 --- --- --- 497 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.583N P=0.318N P=0.228N P=0.269N P=0.472 P=0.282N |
|POLY 3 | P=0.591N P=0.295N P=0.228N P=0.256N P=0.502 P=0.278N |
|POLY 1.5 | P=0.580N P=0.272N P=0.231N P=0.252N P=0.502 P=0.266N |
|POLY 6 | P=0.603N P=0.316N P=0.222N P=0.259N P=0.500 P=0.287N |
|LOGISTIC REGRESSION| P=0.567N P=0.265N P=0.237N P=0.245N P=0.500 P=0.258N |
|COCH-ARM / FISHERS | P=0.569N P=0.243N P=0.248N P=0.248N P=0.500 P=0.257N |
|ORDER RESTRICTED | P=0.125N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 16
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 50/53 (94%) 41/54 (76%) 45/53 (85%) 46/53 (87%) 49/53 (92%) 40/51 (78%) |
|POLY-3 RATE (b) | 50/51.13 41/44.71 45/50.28 46/48.45 49/50.80 40/45.55 |
|POLY-3 PERCENT (g) | 97.8% 91.7% 89.5% 94.9% 96.5% 87.8% |
|TERMINAL (d) | 24/24 (100%) 16/16 (100%) 25/28 (89%) 19/21 (91%) 19/20 (95%) 18/21 (86%) |
|FIRST INCIDENCE | 211 310 418 269 341 360 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.477N P=0.260 P=0.086N P=0.530 P=0.377 P=0.414N |
|POLY 3 | P=0.118N P=0.114N P=0.063N P=0.396N P=0.598N P=0.034N* |
|POLY 1.5 | P=0.125N P=0.042N* P=0.073N P=0.384N P=0.566N P=0.028N* |
|POLY 6 | P=0.134N P=0.236N P=0.065N P=0.316N P=0.586N P=0.048N* |
|LOGISTIC REGRESSION| P=0.212N P=0.081N P=0.076N P=0.337N P=0.483N P=0.038N* |
|COCH-ARM / FISHERS | P=0.183N P=0.007N** P=0.101N P=0.160N P=0.500N P=0.017N* |
|ORDER RESTRICTED | P=0.015N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 12/53 (23%) 20/54 (37%) 16/53 (30%) 14/53 (26%) 14/53 (26%) 12/51 (24%) |
|POLY-3 RATE (b) | 12/41.43 20/40.62 16/44.73 14/39.78 14/41.91 12/38.88 |
|POLY-3 PERCENT (g) | 29.0% 49.2% 35.8% 35.2% 33.4% 30.9% |
|TERMINAL (d) | 7/24 (29%) 6/16 (38%) 7/28 (25%) 6/21 (29%) 6/20 (30%) 3/21 (14%) |
|FIRST INCIDENCE | 442 250 443 222 452 79 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.299N P=0.015 * P=0.388 P=0.318 P=0.312 P=0.421 |
|POLY 3 | P=0.248N P=0.042 * P=0.327 P=0.356 P=0.419 P=0.523 |
|POLY 1.5 | P=0.237N P=0.052 P=0.296 P=0.367 P=0.420 P=0.532 |
|POLY 6 | P=0.254N P=0.036 * P=0.380 P=0.354 P=0.410 P=0.535 |
|LOGISTIC REGRESSION| P=0.221N P=0.111 P=0.269 P=0.376 P=0.407 P=0.587N |
|COCH-ARM / FISHERS | P=0.230N P=0.078 P=0.255 P=0.411 P=0.411 P=0.549 |
|ORDER RESTRICTED | P=0.402N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/15/03 EXPERIMENT: 96021 TEST: 01 Page 17
Statistical Analysis of Primary Tumors in Rats(SPRAGUE-DAWLEY) - TOXIC EQUIVALENCY FACTOR EVALUATION (
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 UG/KG 10 UG/KG 100 300 1000 3000 |
| | UG/KG UG/KG UG/KG UG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 52/53 (98%) 51/54 (94%) 49/53 (92%) 48/53 (91%) 51/53 (96%) 48/51 (94%) |
|POLY-3 RATE (b) | 52/52.21 51/51.54 49/51.80 48/50.38 51/52.14 48/50.33 |
|POLY-3 PERCENT (g) | 99.6% 99.0% 94.6% 95.3% 97.8% 95.4% |
|TERMINAL (d) | 24/24 (100%) 16/16 (100%) 26/28 (93%) 19/21 (91%) 19/20 (95%) 19/21 (91%) |
|FIRST INCIDENCE | 211 250 418 222 341 79 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.366 P=0.042 * P=0.146N P=0.521 P=0.380 P=0.335 |
|POLY 3 | P=0.327N P=0.936N P=0.146N P=0.201N P=0.527N P=0.211N |
|POLY 1.5 | P=0.400N P=0.621N P=0.145N P=0.181N P=0.528N P=0.229N |
|POLY 6 | P=0.284N P=1.000N P=0.181N P=0.219N P=0.510N P=0.216N |
|LOGISTIC REGRESSION| P=0.561 P=0.615N P=0.154N P=0.184N P=0.478N P=0.306N |
|COCH-ARM / FISHERS | P=0.591 P=0.316N P=0.181N P=0.103N P=0.500N P=0.294N |
|ORDER RESTRICTED | P=0.145N (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).