TDMS Study 88050-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus METHACRYLONITRILE DATE: 02/24/00
EXPERIMENT: 88050 TEST: 05 TIME: 14:26:16
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: 88050B
PATHOLOGIST: YARRINGTON, JOHN CAS: 126-98-7
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1 2 YEAR CHRONIC RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus METHACRYLONITRILE DATE: 02/24/00
EXPERIMENT: 88050 TEST: 05 TIME: 14:26:16
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: 88050B
PATHOLOGIST: YARRINGTON, JOHN CAS: 126-98-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF METHACRYLONITRILE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hematopoietic Cell Proliferation
Vacuolization Cytoplasmic
Adrenal Medulla Hyperplasia
Heart Cardiomyopathy
Kidney Inflammation Chronic
Nephropathy
Liver Basophilic Focus
Clear Cell Focus
Fatty Change
Inflammation Chronic
Mixed Cell Focus
Necrosis
Vacuolization Cytoplasmic
Liver: Bile Duct Hyperplasia
Mammary Gland Galactocele
Mesentery: Fat Inflammation Chronic
Nose: Olfactory Epithelium Atrophy
Metaplasia
Pancreas Hyperplasia
Preputial Gland Inflammation Chronic
Prostate Hyperplasia
Inflammation
Stomach, Glandular Ulcer
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Angiectasis
Necrosis
Bone Marrow Hyperplasia
Clitoral Gland Hyperplasia
Kidney Inflammation Chronic
Liver Fatty Change
Mixed Cell Focus
Vacuolization Cytoplasmic
Liver: Bile Duct Hyperplasia
Nose: Olfactory Epithelium Atrophy
Metaplasia
Spleen Hematopoietic Cell Proliferation
Stomach, Glandular Erosion
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 12/50 (24%) 9/50 (18%) |23/50 (46%) 6/50 (12%) 12/50 (24%) 19/50 (38%) |
|POLY-3 ADJUSTED (b)| 12.2% 6.7% 26.5% 20.9% |48.5% 13.6% 27.5% 42.6% |
|TERMINAL (d) | 5/25 (20%) 3/34 (9%) 10/35 (29%) 9/31 (29%) |22/38 (58%) 5/33 (15%) 10/34 (29%) 18/36 (50%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 480 729 (T) |438 527 603 589 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.107 P=0.198N P=0.174 P=0.322 |P=0.237 P<0.001N** P=0.038N* P=0.341N |
|POLY 3 | P=0.086 P=0.304N P=0.080 P=0.219 |P=0.214 P<0.001N** P=0.029N* P=0.360N |
|POLY 1.5 | P=0.089 P=0.322N P=0.068 P=0.211 |P=0.219 P<0.001N** P=0.025N* P=0.331N |
|POLY 6 | P=0.086 P=0.280N P=0.102 P=0.234 |P=0.212 P<0.001N** P=0.031N* P=0.384N |
|LOGISTIC REGRESSION| P=0.094 P=0.198N P=0.083 P=0.322 |P=0.205 P<0.001N** P=0.033N* P=0.369N |
|COCH-ARM / FISHERS | P=0.092 P=0.357N P=0.054 P=0.194 |P=0.242 P<0.001N** P=0.018N* P=0.272N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 1/31 (3%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- 603 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.043 * (e) (e) P=0.271 |(e) (e) (e) (e) |
|POLY 3 | P=0.041 * (e) (e) P=0.251 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.041 * (e) (e) P=0.246 |(e) (e) (e) (e) |
|POLY 6 | P=0.041 * (e) (e) P=0.259 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.041 * (e) (e) P=0.233 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 10/50 (20%) 11/50 (22%) 8/50 (16%) |7/50 (14%) 6/50 (12%) 10/50 (20%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 22.0% 22.2% 23.8% 18.5% |15.0% 13.6% 23.1% 15.8% |
|TERMINAL (d) | 9/25 (36%) 10/34 (29%) 8/35 (23%) 7/31 (23%) |7/38 (18%) 3/33 (9%) 7/34 (21%) 6/36 (17%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 464 708 |731 (T) 690 690 641 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.318N P=0.401N P=0.509N P=0.306N |P=0.526 P=0.605N P=0.218 P=0.570 |
|POLY 3 | P=0.376N P=0.595 P=0.524 P=0.451N |P=0.505 P=0.545N P=0.239 P=0.576 |
|POLY 1.5 | P=0.378N P=0.562 P=0.474 P=0.467N |P=0.513 P=0.529N P=0.256 P=0.587 |
|POLY 6 | P=0.368N P=0.569N P=0.593 P=0.423N |P=0.501 P=0.560N P=0.229 P=0.566 |
|LOGISTIC REGRESSION| P=0.374N P=0.401N P=0.450 P=0.339N |P=0.498 P=0.580N P=0.211 P=0.553 |
|COCH-ARM / FISHERS | P=0.388N P=0.500 P=0.402 P=0.500N |P=0.530 P=0.500N P=0.298 P=0.613N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% 0.0% |0.0% 0.0% 0.0% 4.5% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- 687 --- |--- --- --- 595 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.792N (e) P=0.548 (e) |P=0.042 * (e) (e) P=0.224 |
|POLY 3 | P=0.785N (e) P=0.517 (e) |P=0.040 * (e) (e) P=0.227 |
|POLY 1.5 | P=0.785N (e) P=0.510 (e) |P=0.040 * (e) (e) P=0.230 |
|POLY 6 | P=0.784N (e) P=0.528 (e) |P=0.040 * (e) (e) P=0.225 |
|LOGISTIC REGRESSION| P=0.786N (e) P=0.504 (e) |P=0.043 * (e) (e) P=0.261 |
|COCH-ARM / FISHERS | P=0.786N (e) P=0.500 (e) |P=0.042 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 3/50 (6%) 3/50 (6%) 5/50 (10%) |4/50 (8%) 1/50 (2%) 2/50 (4%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 19.3% 6.6% 6.7% 11.1% |8.4% 2.3% 4.6% 13.3% |
|TERMINAL (d) | 5/25 (20%) 2/34 (6%) 1/35 (3%) 1/31 (3%) |2/38 (5%) 1/33 (3%) 1/34 (3%) 4/36 (11%) |
|FIRST INCIDENCE | 617 697 712 456 |514 731 (T) 696 553 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.423N P=0.045N* P=0.042N* P=0.203N |P=0.098 P=0.220N P=0.391N P=0.335 |
|POLY 3 | P=0.448N P=0.073N P=0.077N P=0.223N |P=0.095 P=0.207N P=0.385N P=0.336 |
|POLY 1.5 | P=0.450N P=0.081N P=0.085N P=0.241N |P=0.095 P=0.196N P=0.369N P=0.347 |
|POLY 6 | P=0.446N P=0.064N P=0.065N P=0.203N |P=0.097 P=0.220N P=0.398N P=0.326 |
|LOGISTIC REGRESSION| P=0.458N P=0.067N P=0.069N P=0.288N |P=0.100 P=0.135N P=0.286N P=0.443 |
|COCH-ARM / FISHERS | P=0.457N P=0.100N P=0.100N P=0.277N |P=0.096 P=0.181N P=0.339N P=0.370 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 5/50 (10%) 7/50 (14%) 7/50 (14%) |2/50 (4%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 26.1% 11.0% 15.6% 16.0% |4.3% 0.0% 7.0% 2.3% |
|TERMINAL (d) | 6/25 (24%) 4/34 (12%) 3/35 (9%) 6/31 (19%) |2/38 (5%) 0/33 (0%) 1/34 (3%) 1/36 (3%) |
|FIRST INCIDENCE | 474 645 688 466 |731 (T) --- 696 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.341N P=0.031N* P=0.091N P=0.124N |P=0.575N P=0.270N P=0.451 P=0.519N |
|POLY 3 | P=0.391N P=0.058N P=0.172N P=0.186N |P=0.582N P=0.252N P=0.465 P=0.519N |
|POLY 1.5 | P=0.386N P=0.067N P=0.190N P=0.195N |P=0.581N P=0.247N P=0.475 P=0.513N |
|POLY 6 | P=0.398N P=0.049N* P=0.146N P=0.174N |P=0.583N P=0.259N P=0.458 P=0.526N |
|LOGISTIC REGRESSION| P=0.377N P=0.063N P=0.173N P=0.195N |P=0.591N (e) P=0.455 P=0.519N |
|COCH-ARM / FISHERS | P=0.383N P=0.086N P=0.218N P=0.218N |P=0.577N P=0.247N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 14/50 (28%) 19/50 (38%) 20/50 (40%) |12/50 (24%) 11/50 (22%) 12/50 (24%) 25/50 (50%) |
|POLY-3 ADJUSTED (b)| 38.7% 30.7% 41.7% 44.4% |25.0% 24.3% 27.4% 52.2% |
|TERMINAL (d) | 10/25 (40%) 11/34 (32%) 16/35 (46%) 15/31 (48%) |8/38 (21%) 7/33 (21%) 10/34 (29%) 18/36 (50%) |
|FIRST INCIDENCE | 439 641 464 466 |438 441 434 246 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.255 P=0.110N P=0.350N P=0.573N |P<0.001 ** P=0.556 P=0.471 P=0.007 ** |
|POLY 3 | P=0.189 P=0.281N P=0.472 P=0.372 |P<0.001 ** P=0.565N P=0.491 P=0.004 ** |
|POLY 1.5 | P=0.190 P=0.295N P=0.451 P=0.364 |P<0.001 ** P=0.540N P=0.524 P=0.005 ** |
|POLY 6 | P=0.194 P=0.260N P=0.515 P=0.394 |P<0.001 ** P=0.592N P=0.460 P=0.004 ** |
|LOGISTIC REGRESSION| P=0.194 P=0.279N P=0.466 P=0.368 |P<0.001 ** P=0.442N P=0.581 P=0.011 * |
|COCH-ARM / FISHERS | P=0.189 P=0.333N P=0.418 P=0.339 |P<0.001 ** P=0.500N P=0.592N P=0.006 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% 2.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 439 --- 691 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.266N P=0.220N P=0.454N P=0.223N |(e) (e) (e) (e) |
|POLY 3 | P=0.283N P=0.220N P=0.477N P=0.230N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.279N P=0.226N P=0.487N P=0.232N |(e) (e) (e) (e) |
|POLY 6 | P=0.289N P=0.213N P=0.461N P=0.226N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.290N P=0.304N P=0.545N P=0.278N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.271N P=0.247N P=0.500N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 4/48 (8%) 5/50 (10%) 1/48 (2%) |
|POLY-3 ADJUSTED (b)| |2.2% 9.5% 11.5% 2.4% |
|TERMINAL (d) | |1/37 (3%) 3/31 (10%) 2/34 (6%) 1/34 (3%) |
|FIRST INCIDENCE | |731 (T) 599 686 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.350N P=0.138 P=0.087 P=0.743 |
|POLY 3 | |P=0.369N P=0.155 P=0.090 P=0.742 |
|POLY 1.5 | |P=0.359N P=0.161 P=0.094 P=0.747 |
|POLY 6 | |P=0.380N P=0.148 P=0.087 P=0.738 |
|LOGISTIC REGRESSION| |P=0.352N P=0.164 P=0.090 P=0.743 |
|COCH-ARM / FISHERS | |P=0.339N P=0.175 P=0.107 P=0.747 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |10/49 (20%) 7/48 (15%) 10/50 (20%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| |21.9% 16.7% 23.3% 4.8% |
|TERMINAL (d) | |10/37 (27%) 4/31 (13%) 10/34 (29%) 2/34 (6%) |
|FIRST INCIDENCE | |731 (T) 686 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.020N* P=0.438N P=0.516 P=0.021N* |
|POLY 3 | |P=0.021N* P=0.365N P=0.541 P=0.019N* |
|POLY 1.5 | |P=0.020N* P=0.346N P=0.564 P=0.018N* |
|POLY 6 | |P=0.022N* P=0.385N P=0.523 P=0.021N* |
|LOGISTIC REGRESSION| |P=0.022N* P=0.421N P=0.516 P=0.021N* |
|COCH-ARM / FISHERS | |P=0.020N* P=0.314N P=0.579N P=0.015N* |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |6/49 (12%) 2/48 (4%) 5/50 (10%) 8/48 (17%) |
|POLY-3 ADJUSTED (b)| |13.1% 4.8% 11.6% 18.7% |
|TERMINAL (d) | |5/37 (14%) 2/31 (7%) 4/34 (12%) 7/34 (21%) |
|FIRST INCIDENCE | |719 731 (T) 704 499 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.113 P=0.196N P=0.564N P=0.328 |
|POLY 3 | |P=0.107 P=0.164N P=0.541N P=0.336 |
|POLY 1.5 | |P=0.108 P=0.155N P=0.524N P=0.347 |
|POLY 6 | |P=0.108 P=0.176N P=0.553N P=0.324 |
|LOGISTIC REGRESSION| |P=0.098 P=0.193N P=0.564N P=0.333 |
|COCH-ARM / FISHERS | |P=0.111 P=0.141N P=0.486N P=0.371 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Esophagus: Periesophageal Tissue |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 4.5% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 328 508 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.524N P=0.500 P=0.221 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.534N P=0.491 P=0.225 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.528N P=0.495 P=0.228 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.539N P=0.486 P=0.224 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.386N (e) P=0.392 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.515N P=0.500 P=0.247 (e) |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) |4/4 (100%) 1/1 (100%) 3/3 (100%) 1/1 (100%) |
|POLY-3 ADJUSTED (b)| 0.0% 100.0% 0.0% 0.0% |100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) |3/3 (100%) 1/1 (100%) 2/2 (100%) 1/1 (100%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |718 731 (T) 711 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000N P=1.000N (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) P=1.000N (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) P=1.000N (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) P=1.000N (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=1.000N (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=1.000 P=0.500 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Eye: Lens |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) |3/4 (75%) 0/1 (0%) 2/3 (67%) 0/1 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 100.0% 0.0% 0.0% |76.0% 0.0% 66.7% 0.0% |
|TERMINAL (d) | 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) |3/3 (100%) 0/1 (0%) 1/2 (50%) 0/1 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |731 (T) --- 711 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000N P=1.000N (e) (e) |P=0.278N P=0.282N P=0.732N P=0.282N |
|POLY 3 | (e) P=1.000N (e) (e) |P=0.361N P=0.403N P=0.691N P=0.403N |
|POLY 1.5 | (e) P=1.000N (e) (e) |P=0.364N P=0.407N P=0.694N P=0.407N |
|POLY 6 | (e) P=1.000N (e) (e) |P=0.356N P=0.394N P=0.686N P=0.394N |
|LOGISTIC REGRESSION| (e) P=1.000N (e) (e) |P=0.361N (e) P=0.765N (e) |
|COCH-ARM / FISHERS | P=1.000 P=0.500 (e) (e) |P=0.358N P=0.400N P=0.714N P=0.400N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |3/4 (75%) 1/1 (100%) 3/3 (100%) 1/1 (100%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |76.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |3/3 (100%) 1/1 (100%) 2/2 (100%) 1/1 (100%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) 731 (T) 711 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.789N P=1.000 P=0.474 P=1.000 |
|POLY 3 | (e) (e) (e) (e) |P=0.630 P=0.764 P=0.574 P=0.764 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.620 P=0.757 P=0.565 P=0.757 |
|POLY 6 | (e) (e) (e) (e) |P=0.650 P=0.780 P=0.594 P=0.780 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.693 P=1.000 P=0.409 P=1.000 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.635 P=0.800 P=0.571 P=0.800 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 43/50 (86%) 48/50 (96%) 41/50 (82%) 46/50 (92%) |24/50 (48%) 19/50 (38%) 16/50 (32%) 21/50 (42%) |
|POLY-3 ADJUSTED (b)| 89.9% 97.0% 84.8% 93.4% |50.0% 42.3% 35.1% 46.0% |
|TERMINAL (d) | 25/25 (100%) 34/34 (100%) 31/35 (89%) 28/31 (90%) |19/38 (50%) 14/33 (42%) 10/34 (29%) 17/36 (47%) |
|FIRST INCIDENCE | 439 400 276 351 |438 599 325 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.460N P=0.172N P=0.015N* P=0.308N |P=0.491N P=0.409N P=0.179N P=0.444N |
|POLY 3 | P=0.524 P=0.133 P=0.322N P=0.391 |P=0.519N P=0.295N P=0.103N P=0.428N |
|POLY 1.5 | P=0.497 P=0.127 P=0.320N P=0.360 |P=0.511N P=0.264N P=0.094N P=0.403N |
|POLY 6 | P=0.599N P=0.153 P=0.312N P=0.476 |P=0.522N P=0.326N P=0.111N P=0.447N |
|LOGISTIC REGRESSION| P=0.445 P=0.145 P=0.319N P=0.325 |P=0.510N P=0.274N P=0.073N P=0.402N |
|COCH-ARM / FISHERS | P=0.420 P=0.080 P=0.393N P=0.262 |P=0.485N P=0.210N P=0.076N P=0.344N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 7.1% 2.2% 2.2% 6.9% |0.0% 2.3% 4.6% 2.3% |
|TERMINAL (d) | 0/25 (0%) 1/34 (3%) 0/35 (0%) 1/31 (3%) |0/38 (0%) 0/33 (0%) 1/34 (3%) 1/36 (3%) |
|FIRST INCIDENCE | 474 729 (T) 712 662 |--- 617 696 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.430 P=0.256N P=0.259N P=0.614N |P=0.495 P=0.482 P=0.217 P=0.489 |
|POLY 3 | P=0.406 P=0.282N P=0.287N P=0.650N |P=0.479 P=0.489 P=0.220 P=0.489 |
|POLY 1.5 | P=0.410 P=0.290N P=0.294N P=0.653N |P=0.486 P=0.493 P=0.225 P=0.493 |
|POLY 6 | P=0.405 P=0.273N P=0.274N P=0.642N |P=0.473 P=0.484 P=0.217 P=0.485 |
|LOGISTIC REGRESSION| P=0.405 P=0.377N P=0.349N P=0.632 |P=0.499 P=0.567 P=0.222 P=0.489 |
|COCH-ARM / FISHERS | P=0.414 P=0.309N P=0.309N P=0.661N |P=0.500 P=0.500 P=0.247 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 8/50 (16%) 7/50 (14%) 5/50 (10%) |2/50 (4%) 5/50 (10%) 5/50 (10%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 24.0% 17.6% 15.8% 11.6% |4.3% 11.5% 11.6% 9.1% |
|TERMINAL (d) | 8/25 (32%) 7/34 (21%) 7/35 (20%) 5/31 (16%) |2/38 (5%) 5/33 (15%) 5/34 (15%) 4/36 (11%) |
|FIRST INCIDENCE | 549 641 729 (T) 729 (T) |731 (T) 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.088N P=0.176N P=0.103N P=0.060N |P=0.477 P=0.162 P=0.172 P=0.311 |
|POLY 3 | P=0.125N P=0.320N P=0.246N P=0.111N |P=0.443 P=0.190 P=0.184 P=0.312 |
|POLY 1.5 | P=0.123N P=0.346N P=0.265N P=0.117N |P=0.453 P=0.200 P=0.194 P=0.320 |
|POLY 6 | P=0.126N P=0.288N P=0.215N P=0.103N |P=0.433 P=0.179 P=0.177 P=0.303 |
|LOGISTIC REGRESSION| P=0.109N P=0.292N P=0.200N P=0.096N |P=0.477 P=0.162 P=0.172 P=0.311 |
|COCH-ARM / FISHERS | P=0.123N P=0.398N P=0.298N P=0.131N |P=0.473 P=0.218 P=0.218 P=0.339 |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Ileum |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.6% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 1/35 (3%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 662 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.693N (e) P=0.298 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.695N (e) P=0.253 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.695N (e) P=0.244 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.693N (e) P=0.267 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.696N (e) P=0.242 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.697N (e) P=0.242 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 2/35 (6%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.687N (e) P=0.315 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.696N (e) P=0.256 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.696N (e) P=0.248 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.694N (e) P=0.268 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.315 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.697N (e) P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.2% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |438 --- 724 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.278N P=0.262N P=0.541N P=0.256N |
|POLY 3 | (e) (e) (e) (e) |P=0.266N P=0.256N P=0.534N P=0.254N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.268N P=0.249N P=0.524N P=0.248N |
|POLY 6 | (e) (e) (e) (e) |P=0.264N P=0.264N P=0.542N P=0.260N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.244N P=0.124N P=0.395N P=0.129N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.271N P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.4% 2.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 2/34 (6%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 729 (T) 617 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.363N P=0.308 P=0.523 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.360N P=0.259 P=0.518 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.365N P=0.252 P=0.511 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.351N P=0.270 P=0.530 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.377N P=0.308 P=0.476 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.378N P=0.247 P=0.500 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 25/50 (50%) 22/50 (44%) 18/50 (36%) |4/50 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 21.1% 54.2% 48.5% 41.0% |9.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 6/25 (24%) 22/34 (65%) 20/35 (57%) 15/31 (48%) |1/25 (4%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 439 474 474 603 |668 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.446 P=0.011 * P=0.044 * P=0.101 |P=0.073N P=0.041N* P=0.040N* P=0.051N |
|POLY 3 | P=0.361 P<0.001 ** P=0.005 ** P=0.035 * |P=0.082N P=0.050N P=0.051N P=0.055N |
|POLY 1.5 | P=0.361 P<0.001 ** P=0.004 ** P=0.035 * |P=0.079N P=0.053N P=0.055N P=0.056N |
|POLY 6 | P=0.379 P<0.001 ** P=0.007 ** P=0.038 * |P=0.086N P=0.046N* P=0.046N* P=0.052N |
|LOGISTIC REGRESSION| P=0.366 P=0.002 ** P=0.007 ** P=0.044 * |P=0.075N P=0.052N P=0.054N P=0.056N |
|COCH-ARM / FISHERS | P=0.356 P<0.001 ** P=0.004 ** P=0.035 * |P=0.077N P=0.059N P=0.059N P=0.059N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 44/50 (88%) 48/50 (96%) 46/50 (92%) 47/50 (94%) |29/50 (58%) 27/50 (54%) 29/50 (58%) 25/50 (50%) |
|POLY-3 ADJUSTED (b)| 94.4% 97.6% 92.9% 95.7% |61.0% 58.7% 65.5% 53.4% |
|TERMINAL (d) | 25/25 (100%) 33/34 (97%) 35/35 (100%) 30/31 (97%) |24/38 (63%) 22/33 (67%) 24/34 (71%) 20/36 (56%) |
|FIRST INCIDENCE | 453 474 276 456 |589 505 434 246 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.469N P=0.131N P=0.048N* P=0.286N |P=0.275N P=0.448 P=0.333 P=0.385N |
|POLY 3 | P=0.622 P=0.375 P=0.549N P=0.581 |P=0.249N P=0.491N P=0.409 P=0.292N |
|POLY 1.5 | P=0.533 P=0.268 P=0.648N P=0.449 |P=0.249N P=0.465N P=0.463 P=0.281N |
|POLY 6 | P=0.523N P=0.567 P=0.452N P=0.683N |P=0.258N P=0.523N P=0.361 P=0.312N |
|LOGISTIC REGRESSION| P=0.402 P=0.340 P=0.485 P=0.339 |P=0.305N P=0.539N P=0.370 P=0.311N |
|COCH-ARM / FISHERS | P=0.363 P=0.134 P=0.370 P=0.243 |P=0.266N P=0.420N P=0.580N P=0.274N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |3/50 (6%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.4% 6.7% 2.3% |6.3% 6.8% 4.6% 0.0% |
|TERMINAL (d) | 0/25 (0%) 2/34 (6%) 2/35 (6%) 1/31 (3%) |1/38 (3%) 1/33 (3%) 1/34 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- 729 (T) 722 729 (T) |589 617 661 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.635N P=0.308 P=0.187 P=0.543 |P=0.082N P=0.606 P=0.547N P=0.137N |
|POLY 3 | P=0.636 P=0.259 P=0.134 P=0.510 |P=0.080N P=0.630 P=0.540N P=0.132N |
|POLY 1.5 | P=0.631 P=0.252 P=0.128 P=0.507 |P=0.078N P=0.642 P=0.528N P=0.127N |
|POLY 6 | P=0.636N P=0.270 P=0.145 P=0.516 |P=0.083N P=0.616 P=0.551N P=0.137N |
|LOGISTIC REGRESSION| P=0.639N P=0.308 P=0.166 P=0.543 |P=0.071N P=0.630N P=0.473N P=0.098N |
|COCH-ARM / FISHERS | P=0.618 P=0.247 P=0.121 P=0.500 |P=0.073N P=0.661N P=0.500N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 7/50 (14%) 4/49 (8%) |0/50 (0%) 1/49 (2%) 2/48 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.8% 8.9% 15.6% 9.5% |0.0% 2.3% 4.7% 2.3% |
|TERMINAL (d) | 1/25 (4%) 4/34 (12%) 5/35 (14%) 4/31 (13%) |0/38 (0%) 1/33 (3%) 2/34 (6%) 1/36 (3%) |
|FIRST INCIDENCE | 584 729 (T) 642 729 (T) |--- 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.461 P=0.469 P=0.172 P=0.426 |P=0.502 P=0.472 P=0.214 P=0.489 |
|POLY 3 | P=0.414 P=0.377 P=0.098 P=0.346 |P=0.481 P=0.486 P=0.216 P=0.489 |
|POLY 1.5 | P=0.413 P=0.364 P=0.090 P=0.341 |P=0.488 P=0.490 P=0.219 P=0.493 |
|POLY 6 | P=0.420 P=0.394 P=0.112 P=0.356 |P=0.475 P=0.481 P=0.214 P=0.485 |
|LOGISTIC REGRESSION| P=0.416 P=0.378 P=0.096 P=0.353 |(e) P=0.472 P=0.214 P=0.489 |
|COCH-ARM / FISHERS | P=0.406 P=0.339 P=0.080 P=0.329 |P=0.503 P=0.495 P=0.237 P=0.500 |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 33/50 (66%) 35/50 (70%) 13/49 (27%) |43/50 (86%) 43/49 (88%) 35/48 (73%) 39/50 (78%) |
|POLY-3 ADJUSTED (b)| 58.6% 71.0% 75.4% 30.8% |89.4% 91.7% 77.4% 83.9% |
|TERMINAL (d) | 19/25 (76%) 28/34 (82%) 31/35 (89%) 13/31 (42%) |36/38 (95%) 33/33 (100%) 31/34 (91%) 33/36 (92%) |
|FIRST INCIDENCE | 439 536 464 729 (T) |438 505 256 499 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.504N P=0.568 P<0.001N** |P=0.191N P=0.141 P=0.243N P=0.434N |
|POLY 3 | P<0.001N** P=0.146 P=0.060 P=0.006N** |P=0.191N P=0.489 P=0.082N P=0.298N |
|POLY 1.5 | P<0.001N** P=0.137 P=0.055 P=0.006N** |P=0.179N P=0.485 P=0.083N P=0.277N |
|POLY 6 | P<0.001N** P=0.167 P=0.075 P=0.006N** |P=0.191N P=0.510 P=0.082N P=0.305N |
|LOGISTIC REGRESSION| P<0.001N** P=0.216 P=0.083 P=0.004N** |P=0.202N P=0.337 P=0.139N P=0.402N |
|COCH-ARM / FISHERS | P<0.001N** P=0.111 P=0.050 P=0.008N** |P=0.144N P=0.516 P=0.087N P=0.218N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 16/50 (32%) 16/50 (32%) 4/49 (8%) |4/50 (8%) 2/49 (4%) 1/48 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 19.6% 35.5% 36.0% 9.5% |8.6% 4.6% 2.4% 6.7% |
|TERMINAL (d) | 8/25 (32%) 16/34 (47%) 16/35 (46%) 4/31 (13%) |4/38 (11%) 2/33 (6%) 1/34 (3%) 2/36 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |731 (T) 731 (T) 731 (T) 589 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.008N** P=0.187 P=0.213 P=0.082N |P=0.593N P=0.403N P=0.214N P=0.532N |
|POLY 3 | P=0.017N* P=0.077 P=0.070 P=0.158N |P=0.591N P=0.371N P=0.209N P=0.525N |
|POLY 1.5 | P=0.019N* P=0.066 P=0.061 P=0.168N |P=0.591N P=0.361N P=0.204N P=0.517N |
|POLY 6 | P=0.014N* P=0.093 P=0.091 P=0.143N |P=0.590N P=0.382N P=0.212N P=0.531N |
|LOGISTIC REGRESSION| P=0.008N** P=0.187 P=0.213 P=0.082N |P=0.606N P=0.403N P=0.214N P=0.519N |
|COCH-ARM / FISHERS | P=0.028N* P=0.050 P=0.050 P=0.188N |P=0.588N P=0.349N P=0.194N P=0.500N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) 5/50 (10%) 6/49 (12%) |1/50 (2%) 0/49 (0%) 1/48 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 15.3% 11.1% 14.2% |2.1% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 1/25 (4%) 5/34 (15%) 3/35 (9%) 5/31 (16%) |1/38 (3%) 0/33 (0%) 1/34 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 474 589 617 710 |731 (T) --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.419 P=0.280 P=0.495 P=0.340 |P=0.463N P=0.528N P=0.737 P=0.511N |
|POLY 3 | P=0.372 P=0.199 P=0.399 P=0.248 |P=0.464N P=0.514N P=0.739 P=0.511N |
|POLY 1.5 | P=0.372 P=0.184 P=0.381 P=0.244 |P=0.464N P=0.510N P=0.742 P=0.507N |
|POLY 6 | P=0.376 P=0.221 P=0.430 P=0.260 |P=0.463N P=0.519N P=0.737 P=0.515N |
|LOGISTIC REGRESSION| P=0.370 P=0.153 P=0.355 P=0.252 |P=0.463N (e) P=0.737 (e) |
|COCH-ARM / FISHERS | P=0.366 P=0.159 P=0.357 P=0.233 |P=0.462N P=0.505N P=0.742 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 8/50 (16%) 9/50 (18%) 7/49 (14%) |0/50 (0%) 0/49 (0%) 3/48 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 23.9% 17.6% 19.9% 16.4% |0.0% 0.0% 7.0% 0.0% |
|TERMINAL (d) | 8/25 (32%) 7/34 (21%) 7/35 (20%) 6/31 (19%) |0/38 (0%) 0/33 (0%) 2/34 (6%) 0/36 (0%) |
|FIRST INCIDENCE | 453 641 474 603 |--- --- 470 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252N P=0.177N P=0.240N P=0.166N |P=0.646N (e) P=0.107 (e) |
|POLY 3 | P=0.324N P=0.324N P=0.426N P=0.278N |P=0.665N (e) P=0.105 (e) |
|POLY 1.5 | P=0.323N P=0.349N P=0.456N P=0.290N |P=0.660N (e) P=0.107 (e) |
|POLY 6 | P=0.320N P=0.290N P=0.380N P=0.257N |P=0.669N (e) P=0.104 (e) |
|LOGISTIC REGRESSION| P=0.314N P=0.314N P=0.451N P=0.272N |P=0.622N (e) P=0.139 (e) |
|COCH-ARM / FISHERS | P=0.324N P=0.398N P=0.500N P=0.314N |P=0.647N (e) P=0.114 (e) |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 18/50 (36%) 21/50 (42%) 9/49 (18%) |21/50 (42%) 13/49 (27%) 11/48 (23%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 50.8% 38.7% 44.9% 20.5% |45.1% 28.9% 26.0% 15.4% |
|TERMINAL (d) | 15/25 (60%) 13/34 (38%) 18/35 (51%) 5/31 (16%) |21/38 (55%) 11/33 (33%) 11/34 (32%) 4/36 (11%) |
|FIRST INCIDENCE | 38 474 276 530 |731 (T) 328 731 (T) 527 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002N** P=0.043N* P=0.089N P<0.001N** |P=0.004N** P=0.143N P=0.044N* P=0.003N** |
|POLY 3 | P=0.003N** P=0.165N P=0.358N P=0.002N** |P=0.003N** P=0.080N P=0.046N* P<0.001N** |
|POLY 1.5 | P=0.003N** P=0.186N P=0.389N P=0.002N** |P=0.004N** P=0.078N P=0.043N* P<0.001N** |
|POLY 6 | P=0.002N** P=0.134N P=0.308N P<0.001N** |P=0.003N** P=0.085N P=0.047N* P<0.001N** |
|LOGISTIC REGRESSION| P=0.004N** P=0.242N P=0.465N P=0.004N** |P=0.005N** P=0.097N P=0.044N* P=0.003N** |
|COCH-ARM / FISHERS | P=0.003N** P=0.208N P=0.420N P=0.003N** |P=0.004N** P=0.079N P=0.036N* P=0.002N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 5/50 (10%) 9/50 (18%) 6/49 (12%) |9/50 (18%) 7/49 (14%) 8/48 (17%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 19.3% 11.1% 19.2% 14.1% |19.1% 15.5% 18.5% 25.4% |
|TERMINAL (d) | 4/25 (16%) 4/34 (12%) 5/35 (14%) 5/31 (16%) |7/38 (18%) 4/33 (12%) 7/34 (21%) 6/36 (17%) |
|FIRST INCIDENCE | 629 716 464 662 |616 328 325 500 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.417N P=0.139N P=0.496N P=0.264N |P=0.165 P=0.496N P=0.596N P=0.275 |
|POLY 3 | P=0.481N P=0.223N P=0.606N P=0.367N |P=0.173 P=0.428N P=0.575N P=0.313 |
|POLY 1.5 | P=0.478N P=0.240N P=0.566 P=0.378N |P=0.166 P=0.419N P=0.563N P=0.309 |
|POLY 6 | P=0.481N P=0.203N P=0.555N P=0.351N |P=0.184 P=0.443N P=0.588N P=0.321 |
|LOGISTIC REGRESSION| P=0.474N P=0.191N P=0.486 P=0.343N |P=0.193 P=0.354N P=0.538N P=0.379 |
|COCH-ARM / FISHERS | P=0.477N P=0.277N P=0.500 P=0.403N |P=0.164 P=0.410N P=0.537N P=0.312 |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 21/50 (42%) 29/50 (58%) 10/49 (20%) |8/50 (16%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 19.4% 44.9% 63.2% 23.7% |19.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 7/25 (28%) 16/34 (47%) 27/35 (77%) 10/31 (32%) |6/25 (24%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 639 474 464 729 (T) |453 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.115N P=0.036 * P<0.001 ** P=0.595 |P=0.008N** P=0.002N** P<0.001N** P=0.002N** |
|POLY 3 | P=0.182N P=0.008 ** P<0.001 ** P=0.418 |P=0.008N** P=0.002N** P=0.003N** P=0.003N** |
|POLY 1.5 | P=0.183N P=0.006 ** P<0.001 ** P=0.406 |P=0.008N** P=0.003N** P=0.003N** P=0.003N** |
|POLY 6 | P=0.175N P=0.013 * P<0.001 ** P=0.439 |P=0.009N** P=0.002N** P=0.002N** P=0.003N** |
|LOGISTIC REGRESSION| P=0.194N P=0.009 ** P<0.001 ** P=0.505 |P=0.010N* P=0.004N** P=0.004N** P=0.005N** |
|COCH-ARM / FISHERS | P=0.215N P=0.004 ** P<0.001 ** P=0.379 |P=0.010N* P=0.003N** P=0.003N** P=0.003N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 23/50 (46%) 22/50 (44%) 10/49 (20%) |2/50 (4%) 7/49 (14%) 8/48 (17%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 38.9% 51.0% 49.5% 23.7% |4.3% 15.9% 18.9% 11.3% |
|TERMINAL (d) | 15/25 (60%) 23/34 (68%) 22/35 (63%) 10/31 (32%) |1/38 (3%) 6/33 (18%) 8/34 (24%) 5/36 (14%) |
|FIRST INCIDENCE | 668 729 (T) 729 (T) 729 (T) |719 527 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002N** P=0.488 P=0.577N P=0.023N* |P=0.468 P=0.057 P=0.031 * P=0.195 |
|POLY 3 | P=0.013N* P=0.174 P=0.216 P=0.098N |P=0.425 P=0.065 P=0.031 * P=0.194 |
|POLY 1.5 | P=0.015N* P=0.150 P=0.187 P=0.111N |P=0.441 P=0.069 P=0.033 * P=0.201 |
|POLY 6 | P=0.010N* P=0.212 P=0.272 P=0.081N |P=0.410 P=0.061 P=0.029 * P=0.186 |
|LOGISTIC REGRESSION| P=0.003N** P=0.340 P=0.493 P=0.041N* |P=0.440 P=0.071 P=0.028 * P=0.183 |
|COCH-ARM / FISHERS | P=0.023N* P=0.109 P=0.151 P=0.140N |P=0.473 P=0.075 P=0.039 * P=0.218 |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 0/50 (0%) 3/49 (6%) |2/50 (4%) 3/49 (6%) 1/48 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 9.6% 2.2% 0.0% 6.9% |4.3% 6.8% 2.4% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |1/38 (3%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 549 716 --- 466 |616 505 711 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.549 P=0.134N P=0.045N* P=0.449N |P=0.115N P=0.458 P=0.543N P=0.258N |
|POLY 3 | P=0.521 P=0.156N P=0.053N P=0.480N |P=0.113N P=0.474 P=0.535N P=0.252N |
|POLY 1.5 | P=0.524 P=0.163N P=0.056N P=0.490N |P=0.109N P=0.481 P=0.530N P=0.247N |
|POLY 6 | P=0.519 P=0.147N P=0.048N* P=0.465N |P=0.116N P=0.467 P=0.540N P=0.257N |
|LOGISTIC REGRESSION| P=0.513 P=0.185N P=0.065N P=0.547N |P=0.089N P=0.577 P=0.499N P=0.213N |
|COCH-ARM / FISHERS | P=0.528 P=0.181N P=0.059N P=0.511N |P=0.104N P=0.490 P=0.515N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |2/50 (4%) 0/49 (0%) 3/48 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% 0.0% |4.2% 0.0% 7.1% 0.0% |
|TERMINAL (d) | 0/25 (0%) 1/34 (3%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 1/34 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |616 --- 704 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.567N P=0.561 (e) (e) |P=0.309N P=0.273N P=0.443 P=0.266N |
|POLY 3 | P=0.566N P=0.519 (e) (e) |P=0.304N P=0.256N P=0.454 P=0.252N |
|POLY 1.5 | P=0.571N P=0.513 (e) (e) |P=0.301N P=0.250N P=0.461 P=0.247N |
|POLY 6 | P=0.560N P=0.528 (e) (e) |P=0.306N P=0.263N P=0.448 P=0.258N |
|LOGISTIC REGRESSION| (e) P=0.561 (e) (e) |P=0.296N P=0.212N P=0.483 P=0.207N |
|COCH-ARM / FISHERS | P=0.580N P=0.500 (e) (e) |P=0.295N P=0.253N P=0.480 P=0.247N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 18/50 (36%) 23/50 (46%) 28/49 (57%) |7/50 (14%) 14/49 (29%) 17/48 (35%) 30/50 (60%) |
|POLY-3 ADJUSTED (b)| 32.8% 39.9% 51.5% 64.7% |14.9% 31.7% 40.0% 67.2% |
|TERMINAL (d) | 9/25 (36%) 18/34 (53%) 22/35 (63%) 25/31 (81%) |5/38 (13%) 12/33 (36%) 16/34 (47%) 29/36 (81%) |
|FIRST INCIDENCE | 453 729 (T) 662 533 |616 609 696 553 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.549N P=0.297 P=0.025 * |P<0.001 ** P=0.036 * P=0.007 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.315 P=0.055 P=0.002 ** |P<0.001 ** P=0.047 * P=0.006 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.300 P=0.051 P=0.002 ** |P<0.001 ** P=0.052 P=0.007 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.336 P=0.067 P=0.002 ** |P<0.001 ** P=0.041 * P=0.005 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.002 ** P=0.401 P=0.092 P=0.005 ** |P<0.001 ** P=0.050 P=0.007 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.002 ** P=0.260 P=0.048 * P=0.003 ** |P<0.001 ** P=0.063 P=0.012 * P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 48/50 (96%) 48/50 (96%) 36/49 (73%) |14/50 (28%) 5/49 (10%) 13/48 (27%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 89.5% 97.9% 98.4% 77.8% |29.9% 11.4% 29.6% 19.7% |
|TERMINAL (d) | 23/25 (92%) 34/34 (100%) 35/35 (100%) 23/31 (74%) |10/38 (26%) 3/33 (9%) 8/34 (24%) 4/36 (11%) |
|FIRST INCIDENCE | 453 474 464 530 |716 690 434 500 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.019N* P=0.233N P=0.192N P=0.036N* |P=0.419N P=0.052N P=0.540 P=0.233N |
|POLY 3 | P<0.001N** P=0.076 P=0.058 P=0.094N |P=0.386N P=0.026N* P=0.579N P=0.183N |
|POLY 1.5 | P<0.001N** P=0.066 P=0.051 P=0.103N |P=0.393N P=0.024N* P=0.576N P=0.181N |
|POLY 6 | P<0.001N** P=0.106 P=0.079 P=0.075N |P=0.373N P=0.029N* P=0.573N P=0.183N |
|LOGISTIC REGRESSION| P=0.003N** P=0.121 P=0.069 P=0.093N |P=0.411N P=0.035N* P=0.587 P=0.182N |
|COCH-ARM / FISHERS | P=0.005N** P=0.046 * P=0.046 * P=0.150N |P=0.396N P=0.022N* P=0.550N P=0.171N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.3% 2.2% 0.0% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 536 662 --- |--- --- 508 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.380N P=0.260 P=0.535 (e) |P=0.787N (e) P=0.483 (e) |
|POLY 3 | P=0.359N P=0.265 P=0.518 (e) |P=0.790N (e) P=0.487 (e) |
|POLY 1.5 | P=0.365N P=0.255 P=0.510 (e) |P=0.789N (e) P=0.491 (e) |
|POLY 6 | P=0.350N P=0.279 P=0.529 (e) |P=0.791N (e) P=0.484 (e) |
|LOGISTIC REGRESSION| P=0.408N P=0.144 P=0.494 (e) |P=0.755N (e) P=0.693 (e) |
|COCH-ARM / FISHERS | P=0.378N P=0.247 P=0.500 (e) |P=0.786N (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 9.4% 0.0% 4.3% 0.0% |0.0% 2.3% 4.5% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 453 --- 276 --- |--- 540 470 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.111N P=0.055N P=0.311N P=0.059N |P=0.515N P=0.492 P=0.229 (e) |
|POLY 3 | P=0.117N P=0.053N P=0.302N P=0.059N |P=0.533N P=0.490 P=0.227 (e) |
|POLY 1.5 | P=0.114N P=0.055N P=0.314N P=0.059N |P=0.527N P=0.493 P=0.229 (e) |
|POLY 6 | P=0.120N P=0.051N P=0.286N P=0.058N |P=0.539N P=0.485 P=0.225 (e) |
|LOGISTIC REGRESSION| P=0.139N P=0.094N P=0.454N P=0.080N |P=0.406N P=0.640 P=0.490 (e) |
|COCH-ARM / FISHERS | P=0.111N P=0.059N P=0.339N P=0.059N |P=0.515N P=0.500 P=0.247 (e) |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 4/50 (8%) 6/50 (12%) |5/50 (10%) 4/50 (8%) 4/50 (8%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 4.8% 6.6% 9.0% 13.8% |10.6% 9.0% 9.3% 9.1% |
|TERMINAL (d) | 1/25 (4%) 2/34 (6%) 3/35 (9%) 4/31 (13%) |2/38 (5%) 3/33 (9%) 3/34 (9%) 4/36 (11%) |
|FIRST INCIDENCE | 439 696 722 618 |616 540 724 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.109 P=0.602 P=0.470 P=0.202 |P=0.498N P=0.575N P=0.571N P=0.543N |
|POLY 3 | P=0.094 P=0.537 P=0.367 P=0.145 |P=0.519N P=0.542N P=0.559N P=0.544N |
|POLY 1.5 | P=0.094 P=0.524 P=0.355 P=0.142 |P=0.509N P=0.526N P=0.540N P=0.528N |
|POLY 6 | P=0.096 P=0.555 P=0.389 P=0.154 |P=0.529N P=0.561N P=0.577N P=0.561N |
|LOGISTIC REGRESSION| P=0.093 P=0.474 P=0.338 P=0.136 |P=0.507N P=0.476N P=0.535N P=0.522N |
|COCH-ARM / FISHERS | P=0.092 P=0.500 P=0.339 P=0.134 |P=0.494N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 8/50 (16%) 6/50 (12%) 4/50 (8%) |6/50 (12%) 3/50 (6%) 4/50 (8%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 7.3% 17.6% 13.5% 9.2% |12.9% 6.9% 9.3% 13.6% |
|TERMINAL (d) | 3/25 (12%) 6/34 (18%) 6/35 (17%) 3/31 (10%) |5/38 (13%) 3/33 (9%) 4/34 (12%) 6/36 (17%) |
|FIRST INCIDENCE | 729 (T) 681 729 (T) 645 |718 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.362N P=0.218 P=0.428 P=0.608 |P=0.382 P=0.317N P=0.444N P=0.580 |
|POLY 3 | P=0.381N P=0.133 P=0.284 P=0.532 |P=0.368 P=0.276N P=0.422N P=0.580 |
|POLY 1.5 | P=0.389N P=0.120 P=0.267 P=0.521 |P=0.372 P=0.263N P=0.406N P=0.594 |
|POLY 6 | P=0.367N P=0.153 P=0.312 P=0.550 |P=0.364 P=0.291N P=0.435N P=0.567 |
|LOGISTIC REGRESSION| P=0.389N P=0.164 P=0.428 P=0.551 |P=0.370 P=0.313N P=0.450N P=0.565 |
|COCH-ARM / FISHERS | P=0.408N P=0.100 P=0.243 P=0.500 |P=0.380 P=0.243N P=0.370N P=0.620N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 4/50 (8%) 1/49 (2%) 4/49 (8%) |1/50 (2%) 1/49 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 8.8% 2.3% 9.4% |2.1% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 0/25 (0%) 3/34 (9%) 1/34 (3%) 3/31 (10%) |1/38 (3%) 0/32 (0%) 0/34 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 716 589 729 (T) 680 |731 (T) 721 --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.271 P=0.267 P=0.694N P=0.244 |P=0.677 P=0.729 P=0.522N P=0.750 |
|POLY 3 | P=0.258 P=0.218 P=0.744N P=0.196 |P=0.671 P=0.741 P=0.516N P=0.748 |
|POLY 1.5 | P=0.254 P=0.206 P=0.750N P=0.190 |P=0.674 P=0.746 P=0.511N P=0.752 |
|POLY 6 | P=0.266 P=0.233 P=0.733N P=0.205 |P=0.670 P=0.734 P=0.520N P=0.744 |
|LOGISTIC REGRESSION| P=0.249 P=0.202 P=0.725N P=0.206 |P=0.671 P=0.732 (e) P=0.750 |
|COCH-ARM / FISHERS | P=0.244 P=0.187 P=0.753N P=0.181 |P=0.679 P=0.747 P=0.500N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 1/50 (2%) 0/49 (0%) 2/49 (4%) |0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.3% 2.2% 0.0% 4.7% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/34 (0%) 0/34 (0%) 0/31 (0%) |0/38 (0%) 0/32 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 617 697 --- 662 |--- --- 711 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.611N P=0.242N P=0.092N P=0.450N |P=0.792N (e) P=0.469 (e) |
|POLY 3 | P=0.631N P=0.271N P=0.108N P=0.479N |P=0.788N (e) P=0.484 (e) |
|POLY 1.5 | P=0.628N P=0.279N P=0.112N P=0.485N |P=0.787N (e) P=0.489 (e) |
|POLY 6 | P=0.634N P=0.261N P=0.102N P=0.469N |P=0.789N (e) P=0.481 (e) |
|LOGISTIC REGRESSION| P=0.627N P=0.311N P=0.125N P=0.510N |P=0.787N (e) P=0.488 (e) |
|COCH-ARM / FISHERS | P=0.622N P=0.301N P=0.121N P=0.500N |P=0.785N (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 4/50 (8%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.9% 6.6% 2.2% 9.3% |0.0% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 1/25 (4%) 2/34 (6%) 0/35 (0%) 4/31 (13%) |0/38 (0%) 1/33 (3%) 0/34 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 724 697 662 729 (T) |--- 731 (T) --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.298 P=0.620 P=0.411N P=0.436 |P=0.465 P=0.472 (e) P=0.489 |
|POLY 3 | P=0.280 P=0.545 P=0.469N P=0.361 |P=0.450 P=0.487 (e) P=0.489 |
|POLY 1.5 | P=0.280 P=0.529 P=0.482N P=0.353 |P=0.454 P=0.492 (e) P=0.493 |
|POLY 6 | P=0.281 P=0.566 P=0.450N P=0.373 |P=0.445 P=0.481 (e) P=0.485 |
|LOGISTIC REGRESSION| P=0.280 P=0.584 P=0.472N P=0.423 |(e) P=0.472 (e) P=0.489 |
|COCH-ARM / FISHERS | P=0.275 P=0.500 P=0.500N P=0.339 |P=0.464 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 1/35 (3%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 662 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.693N (e) P=0.298 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.696N (e) P=0.257 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.696N (e) P=0.249 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.693N (e) P=0.271 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.697N (e) P=0.246 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.697N (e) P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 5/50 (10%) 0/49 (0%) 1/49 (2%) |13/50 (26%) 9/50 (18%) 9/50 (18%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.9% 0.0% 2.4% |27.6% 20.0% 20.7% 20.1% |
|TERMINAL (d) | 0/22 (0%) 1/34 (3%) 0/34 (0%) 1/31 (3%) |10/38 (26%) 5/33 (15%) 8/34 (24%) 8/36 (22%) |
|FIRST INCIDENCE | --- 592 --- 729 (T) |679 599 603 527 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.350N P=0.062 (e) P=0.568 |P=0.321N P=0.358N P=0.336N P=0.286N |
|POLY 3 | P=0.319N P=0.052 (e) P=0.525 |P=0.334N P=0.268N P=0.302N P=0.275N |
|POLY 1.5 | P=0.331N P=0.047 * (e) P=0.521 |P=0.325N P=0.257N P=0.281N P=0.261N |
|POLY 6 | P=0.302N P=0.060 (e) P=0.532 |P=0.346N P=0.279N P=0.320N P=0.292N |
|LOGISTIC REGRESSION| P=0.357N P=0.038 * (e) P=0.568 |P=0.330N P=0.259N P=0.312N P=0.279N |
|COCH-ARM / FISHERS | P=0.358N P=0.035 * (e) P=0.516 |P=0.309N P=0.235N P=0.235N P=0.235N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/46 (4%) 3/50 (6%) 4/49 (8%) 4/49 (8%) |8/50 (16%) 11/50 (22%) 9/50 (18%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 5.4% 6.7% 9.2% 9.4% |17.1% 24.6% 20.9% 13.6% |
|TERMINAL (d) | 2/22 (9%) 3/34 (9%) 4/34 (12%) 3/31 (10%) |6/38 (16%) 7/33 (21%) 8/34 (24%) 4/36 (11%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 726 |674 609 711 707 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.384 P=0.671N P=0.550 P=0.495 |P=0.212N P=0.213 P=0.396 P=0.438N |
|POLY 3 | P=0.344 P=0.586 P=0.409 P=0.397 |P=0.230N P=0.263 P=0.423 P=0.433N |
|POLY 1.5 | P=0.341 P=0.569 P=0.392 P=0.387 |P=0.219N P=0.278 P=0.447 P=0.417N |
|POLY 6 | P=0.350 P=0.607 P=0.436 P=0.414 |P=0.242N P=0.249 P=0.403 P=0.450N |
|LOGISTIC REGRESSION| P=0.384 P=0.671N P=0.550 P=0.488 |P=0.221N P=0.262 P=0.403 P=0.446N |
|COCH-ARM / FISHERS | P=0.333 P=0.540 P=0.369 P=0.369 |P=0.199N P=0.306 P=0.500 P=0.387N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/13 (46%) 12/13 (92%) 11/11 (100%) 9/12 (75%) |2/13 (15%) 0/13 (0%) 0/11 (0%) 0/12 (0%) |
|POLY-3 ADJUSTED (b)| 52.1% 92.3% 100.0% 77.8% |17.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 5/6 (83%) 10/11 (91%) 9/9 (100%) 8/10 (80%) |1/6 (17%) 0/11 (0%) 0/9 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 629 641 688 645 |701 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.342N P=0.445 P=0.319 P=0.622N |P=0.221N P=0.157N P=0.172N P=0.172N |
|POLY 3 | P=0.466 P=0.022 * P=0.004 ** P=0.187 |P=0.266N P=0.205N P=0.240N P=0.228N |
|POLY 1.5 | P=0.426 P=0.015 * P=0.003 ** P=0.168 |P=0.259N P=0.215N P=0.251N P=0.236N |
|POLY 6 | P=0.511 P=0.037 * P=0.007 ** P=0.216 |P=0.275N P=0.195N P=0.227N P=0.219N |
|LOGISTIC REGRESSION| P=0.448 P=0.038 * P=0.021 * P=0.221 |P=0.246N P=0.197N P=0.230N P=0.220N |
|COCH-ARM / FISHERS | P=0.371 P=0.015 * P=0.005 ** P=0.144 |P=0.253N P=0.240N P=0.283N P=0.260N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/13 (8%) 1/13 (8%) 0/11 (0%) 1/12 (8%) |1/7 (14%) 1/2 (50%) 4/8 (50%) 2/4 (50%) |
|POLY-3 ADJUSTED (b)| 8.9% 8.0% 0.0% 8.6% |14.6% 50.0% 57.6% 58.3% |
|TERMINAL (d) | 0/6 (0%) 1/11 (9%) 0/9 (0%) 0/10 (0%) |0/5 (0%) 0/1 (0%) 2/3 (67%) 2/3 (67%) |
|FIRST INCIDENCE | 716 729 (T) --- 603 |514 505 603 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.678N P=0.671N P=0.455N P=0.735N |P=0.379 P=0.749 P=0.110 P=0.368 |
|POLY 3 | P=0.673 P=0.737N P=0.509N P=0.752N |P=0.194 P=0.465 P=0.125 P=0.237 |
|POLY 1.5 | P=0.667 P=0.746N P=0.519N P=0.760 |P=0.227 P=0.463 P=0.144 P=0.256 |
|POLY 6 | P=0.682 P=0.725N P=0.498N P=0.738N |P=0.161 P=0.470 P=0.106 P=0.217 |
|LOGISTIC REGRESSION| P=0.625 P=0.721N P=0.503N P=0.704 |P=0.261 (e) P=0.209 P=0.291 |
|COCH-ARM / FISHERS | P=0.661 P=0.760N P=0.542N P=0.740 |P=0.271 P=0.417 P=0.182 P=0.279 |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) 6/49 (12%) 6/50 (12%) |3/50 (6%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.2% 15.2% 13.5% 13.9% |7.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 4/34 (12%) 6/35 (17%) 4/31 (13%) |0/25 (0%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 563 589 729 (T) 680 |674 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.429 P=0.273 P=0.396 P=0.334 |P=0.127N P=0.092N P=0.088N P=0.103N |
|POLY 3 | P=0.395 P=0.199 P=0.272 P=0.259 |P=0.145N P=0.103N P=0.106N P=0.111N |
|POLY 1.5 | P=0.397 P=0.184 P=0.258 P=0.255 |P=0.140N P=0.108N P=0.112N P=0.113N |
|POLY 6 | P=0.396 P=0.219 P=0.293 P=0.267 |P=0.151N P=0.098N P=0.099N P=0.107N |
|LOGISTIC REGRESSION| P=0.395 P=0.150 P=0.265 P=0.259 |P=0.133N P=0.108N P=0.112N P=0.113N |
|COCH-ARM / FISHERS | P=0.390 P=0.159 P=0.233 P=0.243 |P=0.135N P=0.121N P=0.125N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/49 (0%) 1/50 (2%) |0/50 (0%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 4.9% 2.2% 0.0% 2.3% |0.0% 6.8% 2.3% 4.4% |
|TERMINAL (d) | 0/25 (0%) 1/34 (3%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 1/34 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 710 729 (T) --- 456 |--- 617 731 (T) 553 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.484N P=0.414N P=0.184N P=0.457N |P=0.427 P=0.106 P=0.478 P=0.223 |
|POLY 3 | P=0.506N P=0.467N P=0.220N P=0.477N |P=0.422 P=0.110 P=0.484 P=0.230 |
|POLY 1.5 | P=0.503N P=0.478N P=0.228N P=0.484N |P=0.426 P=0.113 P=0.489 P=0.232 |
|POLY 6 | P=0.510N P=0.453N P=0.209N P=0.466N |P=0.420 P=0.106 P=0.480 P=0.229 |
|LOGISTIC REGRESSION| P=0.510N P=0.437N P=0.204N P=0.531N |P=0.460 P=0.132 P=0.478 P=0.330 |
|COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.253N P=0.500N |P=0.437 P=0.121 P=0.500 P=0.247 |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 48/50 (96%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 19/50 (38%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 98.7% |0.0% 0.0% 2.3% 40.2% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 31/31 (100%)|0/38 (0%) 0/33 (0%) 0/34 (0%) 12/36 (33%) |
|FIRST INCIDENCE | --- --- --- 351 |--- --- 651 499 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) P=0.486 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) P=0.485 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) P=0.489 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) P=0.482 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) P=0.537 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) P=0.500 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 47/50 (94%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 47/50 (94%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 97.9% |0.0% 0.0% 0.0% 97.1% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 31/31 (100%)|0/38 (0%) 0/33 (0%) 0/34 (0%) 36/36 (100%) |
|FIRST INCIDENCE | --- --- --- 351 |--- --- --- 499 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Ovary: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| |6.4% 2.3% 2.3% 2.3% |
|TERMINAL (d) | |3/38 (8%) 0/33 (0%) 1/34 (3%) 1/36 (3%) |
|FIRST INCIDENCE | |731 (T) 721 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.343N P=0.355N P=0.345N P=0.324N |
|POLY 3 | |P=0.342N P=0.329N P=0.335N P=0.326N |
|POLY 1.5 | |P=0.343N P=0.320N P=0.326N P=0.319N |
|POLY 6 | |P=0.342N P=0.339N P=0.342N P=0.332N |
|LOGISTIC REGRESSION| |P=0.351N P=0.352N P=0.345N P=0.324N |
|COCH-ARM / FISHERS | |P=0.342N P=0.309N P=0.309N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Ovary: Periovarian Tissue |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| |8.6% 6.8% 4.6% 6.8% |
|TERMINAL (d) | |3/38 (8%) 2/33 (6%) 1/34 (3%) 3/36 (8%) |
|FIRST INCIDENCE | |716 575 256 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.504N P=0.573N P=0.388N P=0.535N |
|POLY 3 | |P=0.514N P=0.530N P=0.365N P=0.531N |
|POLY 1.5 | |P=0.509N P=0.519N P=0.356N P=0.521N |
|POLY 6 | |P=0.518N P=0.543N P=0.374N P=0.542N |
|LOGISTIC REGRESSION| |P=0.488N P=0.515N P=0.247N P=0.545N |
|COCH-ARM / FISHERS | |P=0.500N P=0.500N P=0.339N P=0.500N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 6.8% 0.0% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 2/25 (8%) 0/34 (0%) 3/35 (9%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 1/34 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.272N P=0.173N P=0.652 P=0.192N |P=0.782N (e) P=0.478 (e) |
|POLY 3 | P=0.307N P=0.217N P=0.538 P=0.225N |P=0.790N (e) P=0.484 (e) |
|POLY 1.5 | P=0.302N P=0.225N P=0.522 P=0.229N |P=0.789N (e) P=0.489 (e) |
|POLY 6 | P=0.311N P=0.207N P=0.562 P=0.219N |P=0.791N (e) P=0.480 (e) |
|LOGISTIC REGRESSION| P=0.272N (e) P=0.652 (e) |(e) (e) P=0.478 (e) |
|COCH-ARM / FISHERS | P=0.295N P=0.253N P=0.500 P=0.247N |P=0.786N (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 10/49 (20%) 11/50 (22%) 12/50 (24%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.8% 22.3% 24.6% 27.3% |2.1% 0.0% 2.3% 2.3% |
|TERMINAL (d) | 4/25 (16%) 10/34 (29%) 9/35 (26%) 7/31 (23%) |1/38 (3%) 0/33 (0%) 1/34 (3%) 1/36 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 642 645 |731 (T) --- 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.096 P=0.190 P=0.150 P=0.070 |P=0.545 P=0.528N P=0.737 P=0.750 |
|POLY 3 | P=0.090 P=0.100 P=0.063 P=0.035 * |P=0.540 P=0.513N P=0.742 P=0.748 |
|POLY 1.5 | P=0.085 P=0.088 P=0.055 P=0.031 * |P=0.541 P=0.508N P=0.748 P=0.752 |
|POLY 6 | P=0.103 P=0.117 P=0.080 P=0.042 * |P=0.539 P=0.519N P=0.738 P=0.744 |
|LOGISTIC REGRESSION| P=0.076 P=0.190 P=0.092 P=0.038 * |P=0.545 (e) P=0.737 P=0.750 |
|COCH-ARM / FISHERS | P=0.079 P=0.068 P=0.045 * P=0.027 * |P=0.545 P=0.500N P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 13/49 (27%) 12/50 (24%) 14/50 (28%) |8/50 (16%) 4/50 (8%) 7/50 (14%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 24.1% 28.3% 25.8% 31.7% |17.0% 9.1% 16.3% 22.4% |
|TERMINAL (d) | 7/25 (28%) 10/34 (29%) 9/35 (26%) 10/31 (32%) |6/38 (16%) 3/33 (9%) 6/34 (18%) 8/36 (22%) |
|FIRST INCIDENCE | 657 474 464 530 |589 609 711 595 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.338 P=0.583N P=0.502N P=0.427 |P=0.151 P=0.254N P=0.597N P=0.344 |
|POLY 3 | P=0.297 P=0.420 P=0.528 P=0.295 |P=0.138 P=0.211N P=0.576N P=0.348 |
|POLY 1.5 | P=0.295 P=0.378 P=0.481 P=0.277 |P=0.142 P=0.198N P=0.552N P=0.364 |
|POLY 6 | P=0.304 P=0.470 P=0.588 P=0.325 |P=0.136 P=0.226N P=0.596N P=0.333 |
|LOGISTIC REGRESSION| P=0.287 P=0.419 P=0.428 P=0.295 |P=0.135 P=0.192N P=0.573N P=0.358 |
|COCH-ARM / FISHERS | P=0.285 P=0.298 P=0.405 P=0.241 |P=0.150 P=0.178N P=0.500N P=0.398 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |6/50 (12%) 4/50 (8%) 3/50 (6%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% 6.7% 0.0% |12.8% 9.2% 6.9% 11.3% |
|TERMINAL (d) | 1/25 (4%) 0/34 (0%) 2/35 (6%) 0/31 (0%) |5/38 (13%) 4/33 (12%) 2/34 (6%) 5/36 (14%) |
|FIRST INCIDENCE | 579 --- 722 --- |679 731 (T) 661 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.279N P=0.197N P=0.622 P=0.214N |P=0.571N P=0.456N P=0.300N P=0.539N |
|POLY 3 | P=0.305N P=0.219N P=0.532 P=0.228N |P=0.581 P=0.415N P=0.283N P=0.542N |
|POLY 1.5 | P=0.301N P=0.225N P=0.520 P=0.231N |P=0.580N P=0.397N P=0.271N P=0.527N |
|POLY 6 | P=0.309N P=0.211N P=0.553 P=0.224N |P=0.577 P=0.435N P=0.292N P=0.557N |
|LOGISTIC REGRESSION| P=0.295N P=0.252N P=0.524 P=0.244N |P=0.572 P=0.441N P=0.283N P=0.557N |
|COCH-ARM / FISHERS | P=0.297N P=0.247N P=0.500 P=0.247N |P=0.571N P=0.370N P=0.243N P=0.500N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 7/50 (14%) 1/50 (2%) |19/50 (38%) 13/50 (26%) 14/50 (28%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| 12.0% 11.0% 15.7% 2.3% |39.2% 29.2% 31.7% 32.5% |
|TERMINAL (d) | 2/25 (8%) 2/34 (6%) 5/35 (14%) 0/31 (0%) |14/38 (37%) 10/33 (30%) 10/34 (29%) 9/36 (25%) |
|FIRST INCIDENCE | 617 645 712 530 |438 505 470 500 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.065N P=0.482N P=0.584 P=0.083N |P=0.427N P=0.277N P=0.329N P=0.352N |
|POLY 3 | P=0.070N P=0.573N P=0.425 P=0.090N |P=0.418N P=0.213N P=0.298N P=0.321N |
|POLY 1.5 | P=0.070N P=0.592N P=0.407 P=0.094N |P=0.420N P=0.184N P=0.264N P=0.303N |
|POLY 6 | P=0.069N P=0.548N P=0.453 P=0.086N |P=0.410N P=0.250N P=0.327N P=0.334N |
|LOGISTIC REGRESSION| P=0.072N P=0.611N P=0.442 P=0.109N |P=0.426N P=0.151N P=0.219N P=0.237N |
|COCH-ARM / FISHERS | P=0.074N P=0.630N P=0.380 P=0.102N |P=0.413N P=0.142N P=0.198N P=0.263N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 17/50 (34%) 16/50 (32%) 10/50 (20%) |20/50 (40%) 23/50 (46%) 16/50 (32%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 30.0% 36.0% 34.6% 22.8% |41.5% 50.1% 36.3% 35.7% |
|TERMINAL (d) | 6/25 (24%) 12/34 (35%) 11/35 (31%) 7/31 (23%) |16/38 (42%) 18/33 (55%) 14/34 (41%) 13/36 (36%) |
|FIRST INCIDENCE | 439 474 464 530 |438 441 434 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.115N P=0.542 P=0.525N P=0.194N |P=0.145N P=0.181 P=0.413N P=0.344N |
|POLY 3 | P=0.146N P=0.352 P=0.407 P=0.297N |P=0.185N P=0.262 P=0.384N P=0.359N |
|POLY 1.5 | P=0.140N P=0.318 P=0.376 P=0.302N |P=0.168N P=0.293 P=0.344N P=0.326N |
|POLY 6 | P=0.150N P=0.398 P=0.457 P=0.286N |P=0.203N P=0.227 P=0.421N P=0.394N |
|LOGISTIC REGRESSION| P=0.136N P=0.250 P=0.338 P=0.302N |P=0.154N P=0.329 P=0.320N P=0.308N |
|COCH-ARM / FISHERS | P=0.138N P=0.257 P=0.330 P=0.318N |P=0.138N P=0.343 P=0.266N P=0.266N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 45/50 (90%) 46/50 (92%) 45/49 (92%) | |
|POLY-3 ADJUSTED (b)| 58.4% 92.7% 94.8% 93.6% | |
|TERMINAL (d) | 15/25 (60%) 32/34 (94%) 34/35 (97%) 28/30 (93%) | |
|FIRST INCIDENCE | 474 474 464 351 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033 * P=0.061 P=0.052 P=0.018 * | |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |
|POLY 6 | P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** | |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 2.3% 7.0% | |
|TERMINAL (d) | 0/25 (0%) 1/34 (3%) 1/35 (3%) 3/31 (10%) | |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.067 P=0.561 P=0.567 P=0.160 | |
|POLY 3 | P=0.066 P=0.519 P=0.516 P=0.128 | |
|POLY 1.5 | P=0.066 P=0.513 P=0.510 P=0.125 | |
|POLY 6 | P=0.068 P=0.528 P=0.527 P=0.133 | |
|LOGISTIC REGRESSION| (e) P=0.561 P=0.567 P=0.160 | |
|COCH-ARM / FISHERS | P=0.064 P=0.500 P=0.500 P=0.121 | |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 5/50 (10%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 11.0% 4.6% | |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 4/35 (11%) 2/31 (7%) | |
|FIRST INCIDENCE | --- --- 276 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222 (e) P=0.062 P=0.286 | |
|POLY 3 | P=0.208 (e) P=0.040 * P=0.249 | |
|POLY 1.5 | P=0.208 (e) P=0.036 * P=0.245 | |
|POLY 6 | P=0.212 (e) P=0.046 * P=0.255 | |
|LOGISTIC REGRESSION| P=0.203 (e) P=0.025 * P=0.286 | |
|COCH-ARM / FISHERS | P=0.208 (e) P=0.028 * P=0.247 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 25/50 (50%) 17/50 (34%) 24/50 (48%) | |
|POLY-3 ADJUSTED (b)| 56.2% 52.0% 36.3% 52.9% | |
|TERMINAL (d) | 12/25 (48%) 16/34 (47%) 11/35 (31%) 14/31 (45%) | |
|FIRST INCIDENCE | 474 400 464 533 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.409N P=0.205N P=0.017N* P=0.261N | |
|POLY 3 | P=0.515N P=0.423N P=0.042N* P=0.458N | |
|POLY 1.5 | P=0.500N P=0.468N P=0.051N P=0.465N | |
|POLY 6 | P=0.520N P=0.378N P=0.031N* P=0.439N | |
|LOGISTIC REGRESSION| P=0.477N P=0.533N P=0.067N P=0.437N | |
|COCH-ARM / FISHERS | P=0.484N P=0.579N P=0.078N P=0.500N | |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 4/50 (8%) | |
|POLY-3 ADJUSTED (b)| 2.4% 4.4% 2.3% 9.2% | |
|TERMINAL (d) | 0/25 (0%) 2/34 (6%) 1/35 (3%) 3/31 (10%) | |
|FIRST INCIDENCE | 724 729 (T) 729 (T) 645 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.119 P=0.597 P=0.693N P=0.242 | |
|POLY 3 | P=0.113 P=0.534 P=0.742N P=0.196 | |
|POLY 1.5 | P=0.112 P=0.522 P=0.750N P=0.190 | |
|POLY 6 | P=0.115 P=0.549 P=0.730N P=0.206 | |
|LOGISTIC REGRESSION| P=0.109 P=0.581 P=0.707N P=0.200 | |
|COCH-ARM / FISHERS | P=0.108 P=0.500 P=0.753N P=0.181 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.5% 2.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/34 (0%) 1/35 (3%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 689 662 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355 (e) P=0.304 P=0.516 |(e) (e) (e) (e) |
|POLY 3 | P=0.361 (e) P=0.263 P=0.516 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.358 (e) P=0.254 P=0.512 |(e) (e) (e) (e) |
|POLY 6 | P=0.367 (e) P=0.277 P=0.523 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.354 (e) P=0.263 P=0.500 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.353 (e) P=0.253 P=0.505 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/34 (0%) 1/35 (3%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 689 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.692N (e) P=0.304 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.693N (e) P=0.263 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.693N (e) P=0.254 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.690N (e) P=0.277 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.694N (e) P=0.263 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.695N (e) P=0.253 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 4/50 (8%) 4/49 (8%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 14.5% 8.9% 9.0% 9.4% |2.1% 2.3% 2.3% 0.0% |
|TERMINAL (d) | 4/25 (16%) 4/34 (12%) 3/35 (9%) 3/30 (10%) |0/38 (0%) 1/33 (3%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 639 729 (T) 712 624 |690 731 (T) 651 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.380N P=0.209N P=0.201N P=0.277N |P=0.331N P=0.731 P=0.742 P=0.514N |
|POLY 3 | P=0.420N P=0.315N P=0.323N P=0.351N |P=0.331N P=0.745 P=0.743 P=0.512N |
|POLY 1.5 | P=0.418N P=0.333N P=0.341N P=0.361N |P=0.329N P=0.751 P=0.748 P=0.508N |
|POLY 6 | P=0.420N P=0.293N P=0.295N P=0.336N |P=0.333N P=0.738 P=0.739 P=0.516N |
|LOGISTIC REGRESSION| P=0.409N P=0.271N P=0.282N P=0.344N |P=0.322N P=0.754 P=0.747N P=0.493N |
|COCH-ARM / FISHERS | P=0.418N P=0.370N P=0.370N P=0.383N |P=0.323N P=0.753N P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 3/50 (6%) 7/49 (14%) |1/50 (2%) 8/50 (16%) 7/50 (14%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 9.4% 6.6% 6.6% 15.6% |2.1% 17.0% 16.2% 10.8% |
|TERMINAL (d) | 1/25 (4%) 1/34 (3%) 0/35 (0%) 1/30 (3%) |0/38 (0%) 2/33 (6%) 5/34 (15%) 1/36 (3%) |
|FIRST INCIDENCE | 474 641 464 456 |438 328 711 246 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123 P=0.404N P=0.434N P=0.319 |P=0.429 P=0.018 * P=0.025 * P=0.101 |
|POLY 3 | P=0.113 P=0.464N P=0.460N P=0.291 |P=0.414 P=0.015 * P=0.021 * P=0.096 |
|POLY 1.5 | P=0.110 P=0.475N P=0.476N P=0.277 |P=0.421 P=0.016 * P=0.024 * P=0.098 |
|POLY 6 | P=0.119 P=0.448N P=0.436N P=0.313 |P=0.410 P=0.015 * P=0.019 * P=0.095 |
|LOGISTIC REGRESSION| P=0.085 P=0.574N P=0.586N P=0.177 |P=0.515 P=0.044 * P=0.032 * P=0.218 |
|COCH-ARM / FISHERS | P=0.104 P=0.500N P=0.500N P=0.251 |P=0.435 P=0.015 * P=0.030 * P=0.102 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 7.3% 6.6% 0.0% 2.3% |2.1% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 1/25 (4%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 1/33 (3%) 0/34 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 701 696 --- 657 |616 731 (T) --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.183N P=0.556N P=0.080N P=0.259N |P=0.671 P=0.732 P=0.522N P=0.742 |
|POLY 3 | P=0.192N P=0.616N P=0.105N P=0.286N |P=0.668 P=0.744 P=0.518N P=0.746 |
|POLY 1.5 | P=0.192N P=0.632N P=0.110N P=0.292N |P=0.671 P=0.750 P=0.512N P=0.751 |
|POLY 6 | P=0.192N P=0.593N P=0.097N P=0.275N |P=0.665 P=0.736 P=0.523N P=0.741 |
|LOGISTIC REGRESSION| P=0.191N P=0.612N P=0.096N P=0.287N |P=0.677 P=0.745N P=0.430N P=0.747N |
|COCH-ARM / FISHERS | P=0.194N P=0.661N P=0.121N P=0.309N |P=0.677 P=0.753N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% 0.0% |2.1% 4.5% 2.3% 0.0% |
|TERMINAL (d) | 0/25 (0%) 1/34 (3%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 1/33 (3%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |616 505 696 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.567N P=0.561 (e) (e) |P=0.242N P=0.468 P=0.737 P=0.522N |
|POLY 3 | P=0.563N P=0.519 (e) (e) |P=0.245N P=0.479 P=0.741 P=0.513N |
|POLY 1.5 | P=0.567N P=0.513 (e) (e) |P=0.240N P=0.487 P=0.747 P=0.508N |
|POLY 6 | P=0.557N P=0.528 (e) (e) |P=0.250N P=0.470 P=0.736 P=0.518N |
|LOGISTIC REGRESSION| (e) P=0.561 (e) (e) |P=0.208N P=0.615 P=0.735N P=0.437N |
|COCH-ARM / FISHERS | P=0.576N P=0.500 (e) (e) |P=0.231N P=0.500 P=0.753N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 4.4% 4.5% 0.0% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 607 696 617 --- |--- --- 690 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.149N P=0.632N P=0.626N P=0.221N |P=0.787N (e) P=0.481 (e) |
|POLY 3 | P=0.157N P=0.661N P=0.665N P=0.228N |P=0.790N (e) P=0.485 (e) |
|POLY 1.5 | P=0.156N P=0.672N P=0.677N P=0.231N |P=0.789N (e) P=0.489 (e) |
|POLY 6 | P=0.157N P=0.647N P=0.647N P=0.224N |P=0.791N (e) P=0.481 (e) |
|LOGISTIC REGRESSION| P=0.158N P=0.690 P=0.685 P=0.244N |P=0.786N (e) P=0.504 (e) |
|COCH-ARM / FISHERS | P=0.156N P=0.691N P=0.691N P=0.247N |P=0.786N (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 5/50 (10%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 7.2% 0.0% 11.2% 4.5% |2.1% 2.3% 4.6% 11.0% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 2/35 (6%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 1/34 (3%) 1/36 (3%) |
|FIRST INCIDENCE | 453 --- 712 456 |514 721 711 500 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.603 P=0.100N P=0.502 P=0.473N |P=0.029 * P=0.744 P=0.457 P=0.098 |
|POLY 3 | P=0.592 P=0.106N P=0.390 P=0.472N |P=0.026 * P=0.743 P=0.468 P=0.093 |
|POLY 1.5 | P=0.590 P=0.110N P=0.377 P=0.481N |P=0.026 * P=0.749 P=0.478 P=0.096 |
|POLY 6 | P=0.596 P=0.101N P=0.415 P=0.460N |P=0.026 * P=0.735 P=0.460 P=0.092 |
|LOGISTIC REGRESSION| P=0.560 P=0.150N P=0.361 P=0.615N |P=0.030 * P=0.699N P=0.563 P=0.165 |
|COCH-ARM / FISHERS | P=0.582 P=0.121N P=0.357 P=0.500N |P=0.027 * P=0.753N P=0.500 P=0.102 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.6% 0.0% 0.0% 0.0% |2.1% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 617 --- --- --- |616 --- --- 595 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.072N P=0.046N* P=0.044N* P=0.053N |P=0.522 P=0.522N P=0.522N P=0.738 |
|POLY 3 | P=0.081N P=0.050N P=0.052N P=0.055N |P=0.539 P=0.515N P=0.518N P=0.748 |
|POLY 1.5 | P=0.078N P=0.054N P=0.055N P=0.057N |P=0.538 P=0.509N P=0.512N P=0.752 |
|POLY 6 | P=0.085N P=0.047N* P=0.048N* P=0.054N |P=0.542 P=0.522N P=0.523N P=0.745 |
|LOGISTIC REGRESSION| P=0.077N P=0.060N P=0.060N P=0.061N |P=0.569 P=0.432N P=0.430N P=0.696N |
|COCH-ARM / FISHERS | P=0.077N P=0.059N P=0.059N P=0.059N |P=0.536 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 6/50 (12%) 5/50 (10%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 14.4% 13.2% 11.0% 4.6% | |
|TERMINAL (d) | 2/25 (8%) 4/34 (12%) 3/35 (9%) 2/31 (7%) | |
|FIRST INCIDENCE | 617 697 464 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075N P=0.444N P=0.339N P=0.093N | |
|POLY 3 | P=0.086N P=0.559N P=0.438N P=0.120N | |
|POLY 1.5 | P=0.085N P=0.579N P=0.462N P=0.124N | |
|POLY 6 | P=0.086N P=0.534N P=0.405N P=0.115N | |
|LOGISTIC REGRESSION| P=0.083N P=0.545N P=0.493N P=0.115N | |
|COCH-ARM / FISHERS | P=0.086N P=0.620N P=0.500N P=0.134N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 6/50 (12%) 4/50 (8%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 20.2% 13.2% 8.8% 6.7% | |
|TERMINAL (d) | 1/25 (4%) 3/34 (9%) 2/35 (6%) 0/31 (0%) | |
|FIRST INCIDENCE | 453 697 464 351 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.067N P=0.191N P=0.084N P=0.061N | |
|POLY 3 | P=0.063N P=0.273N P=0.106N P=0.056N | |
|POLY 1.5 | P=0.062N P=0.275N P=0.110N P=0.056N | |
|POLY 6 | P=0.063N P=0.266N P=0.098N P=0.055N | |
|LOGISTIC REGRESSION| P=0.071N P=0.383N P=0.163N P=0.089N | |
|COCH-ARM / FISHERS | P=0.065N P=0.288N P=0.117N P=0.061N | |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 29/50 (58%) 35/50 (70%) 29/50 (58%) |36/50 (72%) 25/50 (50%) 37/50 (74%) 32/50 (64%) |
|POLY-3 ADJUSTED (b)| 54.5% 62.2% 74.8% 66.1% |76.0% 56.1% 82.9% 70.3% |
|TERMINAL (d) | 15/25 (60%) 22/34 (65%) 28/35 (80%) 24/31 (77%) |35/38 (92%) 20/33 (61%) 31/34 (91%) 29/36 (81%) |
|FIRST INCIDENCE | 617 592 464 624 |438 609 470 499 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.408 P=0.496N P=0.314 P=0.495 |P=0.519 P=0.087N P=0.130 P=0.366N |
|POLY 3 | P=0.233 P=0.296 P=0.030 * P=0.178 |P=0.476 P=0.029N* P=0.273 P=0.345N |
|POLY 1.5 | P=0.256 P=0.241 P=0.020 * P=0.176 |P=0.484 P=0.025N* P=0.332 P=0.320N |
|POLY 6 | P=0.209 P=0.378 P=0.053 P=0.187 |P=0.470 P=0.030N* P=0.255 P=0.358N |
|LOGISTIC REGRESSION| P=0.272 P=0.367 P=0.030 * P=0.265 |P=0.396 P=0.052N P=0.196 P=0.428N |
|COCH-ARM / FISHERS | P=0.270 P=0.158 P=0.013 * P=0.158 |P=0.513 P=0.020N* P=0.500 P=0.260N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.1% 0.0% 0.0% 2.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 493 --- --- 645 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.442N P=0.099N P=0.103N P=0.277N |(e) (e) (e) (e) |
|POLY 3 | P=0.465N P=0.107N P=0.109N P=0.294N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.459N P=0.110N P=0.113N P=0.297N |(e) (e) (e) (e) |
|POLY 6 | P=0.473N P=0.102N P=0.103N P=0.287N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.477N P=0.157N P=0.143N P=0.347N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.448N P=0.121N P=0.121N P=0.309N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| |4.3% 4.5% 4.6% 4.5% |
|TERMINAL (d) | |2/38 (5%) 1/33 (3%) 1/34 (3%) 1/36 (3%) |
|FIRST INCIDENCE | |731 (T) 609 256 589 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.613 P=0.647 P=0.663 P=0.671 |
|POLY 3 | |P=0.610 P=0.673 P=0.673 P=0.678 |
|POLY 1.5 | |P=0.612 P=0.681 P=0.680 P=0.682 |
|POLY 6 | |P=0.608 P=0.666 P=0.666 P=0.673 |
|LOGISTIC REGRESSION| |P=0.588N P=0.695 P=0.571N P=0.691N |
|COCH-ARM / FISHERS | |P=0.621 P=0.691N P=0.691N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| |0.0% 4.6% 0.0% 0.0% |
|TERMINAL (d) | |0/38 (0%) 2/33 (6%) 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | |--- 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.370N P=0.208 (e) (e) |
|POLY 3 | |P=0.385N P=0.223 (e) (e) |
|POLY 1.5 | |P=0.379N P=0.228 (e) (e) |
|POLY 6 | |P=0.392N P=0.217 (e) (e) |
|LOGISTIC REGRESSION| |(e) P=0.208 (e) (e) |
|COCH-ARM / FISHERS | |P=0.369N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - METHACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus: Cervix |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| |0.0% 0.0% 7.0% 2.3% |
|TERMINAL (d) | |0/38 (0%) 0/33 (0%) 2/34 (6%) 1/36 (3%) |
|FIRST INCIDENCE | |--- --- 711 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.379 (e) P=0.102 P=0.489 |
|POLY 3 | |P=0.364 (e) P=0.105 P=0.489 |
|POLY 1.5 | |P=0.369 (e) P=0.109 P=0.493 |
|POLY 6 | |P=0.359 (e) P=0.102 P=0.485 |
|LOGISTIC REGRESSION| |P=0.371 (e) P=0.102 P=0.489 |
|COCH-ARM / FISHERS | |P=0.381 (e) P=0.121 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 1/50 (2%) 3/50 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| |8.5% 2.3% 6.9% 6.8% |
|TERMINAL (d) | |2/38 (5%) 1/33 (3%) 1/34 (3%) 2/36 (6%) |
|FIRST INCIDENCE | |679 731 (T) 661 730 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.550 P=0.225N P=0.559N P=0.532N |
|POLY 3 | |P=0.547 P=0.201N P=0.542N P=0.533N |
|POLY 1.5 | |P=0.549 P=0.193N P=0.530N P=0.522N |
|POLY 6 | |P=0.545 P=0.212N P=0.551N P=0.546N |
|LOGISTIC REGRESSION| |P=0.540 P=0.201N P=0.524N P=0.538N |
|COCH-ARM / FISHERS | |P=0.555 P=0.181N P=0.500N P=0.500N |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(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.
(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).