TDMS Study 50215-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus ACRYLONITRILE DATE: 10/31/00
EXPERIMENT: 50215 TEST: 03 TIME: 12:46:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55388 ROUTE: GAVAGE NTP C#: 50215B
PATHOLOGIST: MISSING CAS: 107-13-1
------------------------------------------------------------------------------------------------------------------------------------
MICE FINAL#1
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus ACRYLONITRILE DATE: 10/31/00
EXPERIMENT: 50215 TEST: 03 TIME: 12:46:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: GAVAGE NTP C#: 50215B
PATHOLOGIST: MISSING CAS: 107-13-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF ACRYLONITRILE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hypertrophy
Adrenal Cortex: Subcapsular Hyperplasia
Bone Marrow: Myeloid Cell Hyperplasia
Epididymis Infiltration Cellular Mononuclear Cell
Eye Synechia
Eye: Cornea Inflammation Chronic
Harderian Gland Hyperplasia
Infiltration Cellular Mononuclear Cell
Kidney Mineralization
Nephropathy
Kidney: Cortex Cyst
Kidney: Renal Tubule Hyperplasia
Liver Basophilic Focus
Clear Cell Focus
Inflammation Chronic
Mixed Cell Focus
Necrosis
Vacuolization Cytoplasmic
Lung: Alveolar Epithelium Hyperplasia
Lymph Node, Mandibular Hyperplasia Lymphoid
Lymph Node, Mesenteric Ectasia
Hyperplasia Lymphoid
Mesentery: Fat Necrosis
Nose: Nasolacrimal Duct Inflammation
Preputial Gland Infiltration Cellular Mononuclear Cell
Inflammation Chronic
Preputial Gland: Duct Ectasia
Prostate Infiltration Cellular Mononuclear Cell
Salivary Glands Infiltration Cellular Mononuclear Cell
Spleen Hematopoietic Cell Proliferation
Stomach, Forestomach Hyperkeratosis Diffuse
Hyperkeratosis Focal
Stomach, Forestomach: Epithelium Hyperplasia Focal
Stomach, Glandular: Glands Ectasia
Thymus: Thymocyte Necrosis
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex: Subcapsular Hyperplasia
Bone Marrow: Myeloid Cell Hyperplasia
Harderian Gland Hyperplasia
Infiltration Cellular Mononuclear Cell
Heart Inflammation Chronic
Kidney Nephropathy
Liver Angiectasis
Basophilic Focus
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus ACRYLONITRILE DATE: 10/31/00
EXPERIMENT: 50215 TEST: 03 TIME: 12:46:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: GAVAGE NTP C#: 50215B
PATHOLOGIST: MISSING CAS: 107-13-1
Eosinophilic Focus
Inflammation Chronic
Mixed Cell Focus
Necrosis
Pigmentation
Vacuolization Cytoplasmic
Lymph Node, Mandibular Hyperplasia Lymphoid
Ovary Atrophy
Cyst
Mineralization
Thrombosis
Pancreas Infiltration Cellular Mononuclear Cell
Pituitary Gland: Pars Distalis Hyperplasia
Salivary Glands Infiltration Cellular Mononuclear Cell
Spleen Hematopoietic Cell Proliferation
Stomach, Forestomach Hyperkeratosis Diffuse
Stomach, Forestomach: Epithelium Hyperplasia Focal
Thyroid Gland: Follicle Cyst
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 0/46.03 0/45.28 0/30.48 |1/47.44 2/44.19 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.1% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 1/32 (3%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |562 696 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.181N P=0.449 P=0.504N P=0.561N |
|POLY 3 | (e) (e) (e) (e) |P=0.159N P=0.475 P=0.502N P=0.558N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.151N P=0.485 P=0.502N P=0.541N |
|POLY 6 | (e) (e) (e) (e) |P=0.169N P=0.463 P=0.501N P=0.574N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.115N P=0.537 P=0.445N P=0.400N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.141N P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 21/50 (42%) 19/50 (38%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 19/46.19 21/46.68 19/45.28 2/30.48 |0/46.90 0/44.06 0/47.00 1/35.19 |
|POLY-3 PERCENT (g) | 41.1% 45.0% 42.0% 6.6% |0.0% 0.0% 0.0% 2.8% |
|TERMINAL (d) | 19/38 (50%) 20/42 (48%) 19/39 (49%) 2/14 (14%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 1/23 (4%) |
|FIRST INCIDENCE | 730 (T) 518 730 (T) 730 (T) |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030N* P=0.581 P=0.546N P=0.023N* |P=0.131 (e) (e) P=0.395 |
|POLY 3 | P=0.004N** P=0.434 P=0.552 P<0.001N** |P=0.168 (e) (e) P=0.444 |
|POLY 1.5 | P<0.001N** P=0.400 P=0.555 P<0.001N** |P=0.165 (e) (e) P=0.460 |
|POLY 6 | P=0.017N* P=0.478 P=0.559 P=0.003N** |P=0.179 (e) (e) P=0.429 |
|LOGISTIC REGRESSION| P=0.006N** P=0.449 P=0.546N P=0.023N* |(e) (e) (e) P=0.395 |
|COCH-ARM / FISHERS | P<0.001N** P=0.419 P=0.582N P<0.001N** |P=0.188 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 43/50 (86%) 40/50 (80%) 36/50 (72%) |50/50 (100%) 49/50 (98%) 47/50 (94%) 49/50 (98%) |
|POLY-3 RATE (b) | 45/50.00 43/46.96 40/47.30 36/40.97 |50/50.00 49/49.79 47/49.30 49/49.02 |
|POLY-3 PERCENT (g) | 90.0% 91.6% 84.6% 87.9% |100.0% 98.4% 95.3% 100.0% |
|TERMINAL (d) | 33/38 (87%) 40/42 (95%) 34/39 (87%) 12/14 (86%) |39/39 (100%) 32/32 (100%) 38/39 (97%) 23/23 (100%) |
|FIRST INCIDENCE | 464 535 497 239 |338 354 190 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.151N P=0.186N P<0.001 ** |P<0.001 ** P=0.108 P=0.315N P<0.001 ** |
|POLY 3 | P=0.291N P=0.534 P=0.304N P=0.505N |P=0.642N P=0.606N P=0.174N P=1.000N |
|POLY 1.5 | P=0.135N P=0.587 P=0.235N P=0.276N |P=0.596N P=0.550N P=0.145N P=1.000N |
|POLY 6 | P=0.460N P=0.464 P=0.389N P=0.587 |P=0.650N P=0.729N P=0.218N P=1.000N |
|LOGISTIC REGRESSION| P=0.412N P=0.529N P=0.168N P=0.376N |P=0.607N P=0.516N P=0.129N P=0.996N |
|COCH-ARM / FISHERS | P=0.009N** P=0.380N P=0.131N P=0.020N* |P=0.345N P=0.500N P=0.121N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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 RATE (b) | 0/46.19 0/46.03 2/45.28 0/30.48 |0/46.90 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 2/39 (5%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- 730 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.353 (e) P=0.244 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.325 (e) P=0.233 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.381 (e) P=0.233 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.270 (e) P=0.233 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.244 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.545 (e) P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow: Myeloid Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/50 (8%) 2/50 (4%) |1/50 (2%) 5/50 (10%) 3/50 (6%) 5/50 (10%) |
|POLY-3 RATE (b) | 0/46.19 1/46.03 4/45.93 2/31.43 |1/47.44 5/44.80 3/47.31 5/36.96 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 8.7% 6.4% |2.1% 11.2% 6.3% 13.5% |
|TERMINAL (d) | 0/38 (0%) 1/42 (2%) 1/39 (3%) 0/14 (0%) |0/39 (0%) 1/32 (3%) 2/39 (5%) 0/23 (0%) |
|FIRST INCIDENCE | --- 730 (T) 626 502 |562 633 646 386 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035 * P=0.520 P=0.068 P=0.153 |P=0.087 P=0.083 P=0.304 P=0.048 * |
|POLY 3 | P=0.052 P=0.499 P=0.060 P=0.164 |P=0.119 P=0.089 P=0.304 P=0.055 |
|POLY 1.5 | P=0.072 P=0.496 P=0.059 P=0.184 |P=0.135 P=0.094 P=0.304 P=0.066 |
|POLY 6 | P=0.038 * P=0.504 P=0.061 P=0.147 |P=0.109 P=0.083 P=0.307 P=0.048 * |
|LOGISTIC REGRESSION| P=0.146 P=0.520 P=0.066 P=0.285 |P=0.262 P=0.122 P=0.320 P=0.149 |
|COCH-ARM / FISHERS | P=0.154 P=0.500 P=0.059 P=0.247 |P=0.199 P=0.102 P=0.309 P=0.102 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 2/46.80 0/45.28 0/30.48 |0/46.90 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 535 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.362N P=0.245 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.338N P=0.240 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.309N P=0.235 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.368N P=0.247 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.226N P=0.271 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.284N P=0.247 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/48 (0%) 0/49 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | |2/46.98 0/42.38 0/46.06 0/34.05 |
|POLY-3 PERCENT (g) | |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | |1/39 (3%) 0/32 (0%) 0/39 (0%) 0/22 (0%) |
|FIRST INCIDENCE | |708 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.185N P=0.283N P=0.232N P=0.363N |
|POLY 3 | |P=0.139N P=0.261N P=0.242N P=0.315N |
|POLY 1.5 | |P=0.142N P=0.255N P=0.243N P=0.294N |
|POLY 6 | |P=0.139N P=0.268N P=0.240N P=0.336N |
|LOGISTIC REGRESSION| |P=0.178N P=0.264N P=0.242N P=0.330N |
|COCH-ARM / FISHERS | |P=0.155N P=0.258N P=0.253N P=0.258N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 1/48 (2%) 0/49 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | |3/46.90 1/42.38 0/46.06 1/34.05 |
|POLY-3 PERCENT (g) | |6.4% 2.4% 0.0% 2.9% |
|TERMINAL (d) | |3/39 (8%) 1/32 (3%) 0/39 (0%) 1/22 (5%) |
|FIRST INCIDENCE | |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.328N P=0.378N P=0.121N P=0.524N |
|POLY 3 | |P=0.228N P=0.342N P=0.122N P=0.427N |
|POLY 1.5 | |P=0.229N P=0.333N P=0.123N P=0.395N |
|POLY 6 | |P=0.227N P=0.353N P=0.120N P=0.458N |
|LOGISTIC REGRESSION| |P=0.328N P=0.378N (e) P=0.524N |
|COCH-ARM / FISHERS | |P=0.228N P=0.324N P=0.125N P=0.324N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Epididymis |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 31/50 (62%) 38/50 (76%) 16/50 (32%) | |
|POLY-3 RATE (b) | 41/48.70 31/46.80 38/48.16 16/33.51 | |
|POLY-3 PERCENT (g) | 84.2% 66.2% 78.9% 47.8% | |
|TERMINAL (d) | 32/38 (84%) 29/42 (69%) 32/39 (82%) 8/14 (57%) | |
|FIRST INCIDENCE | 528 535 211 239 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.361 P=0.008N** P=0.303N P=0.453N | |
|POLY 3 | P=0.006N** P=0.032N* P=0.337N P<0.001N** | |
|POLY 1.5 | P<0.001N** P=0.034N* P=0.323N P<0.001N** | |
|POLY 6 | P=0.043N* P=0.032N* P=0.366N P=0.003N** | |
|LOGISTIC REGRESSION| P=0.002N** P=0.027N* P=0.346N P<0.001N** | |
|COCH-ARM / FISHERS | P<0.001N** P=0.022N* P=0.312N P<0.001N** | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Epididymis |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |
|POLY-3 RATE (b) | 2/46.19 0/46.03 1/45.39 0/30.48 | |
|POLY-3 PERCENT (g) | 4.3% 0.0% 2.2% 0.0% | |
|TERMINAL (d) | 2/38 (5%) 0/42 (0%) 0/39 (0%) 0/14 (0%) | |
|FIRST INCIDENCE | 730 (T) --- 702 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.395N P=0.217N P=0.494N P=0.475N | |
|POLY 3 | P=0.324N P=0.238N P=0.506N P=0.340N | |
|POLY 1.5 | P=0.283N P=0.242N P=0.506N P=0.305N | |
|POLY 6 | P=0.369N P=0.233N P=0.504N P=0.377N | |
|LOGISTIC REGRESSION| P=0.337N (e) P=0.506N (e) | |
|COCH-ARM / FISHERS | P=0.242N P=0.247N P=0.500N P=0.247N | |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Esophagus |
| Perforation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.19 2/48.03 0/45.28 0/30.48 |0/46.90 0/44.06 0/46.06 1/36.19 |
|POLY-3 PERCENT (g) | 0.0% 4.2% 0.0% 0.0% |0.0% 0.0% 0.0% 2.8% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 3 --- --- |--- --- --- 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.284N P=0.238 (e) (e) |P=0.188 (e) (e) P=0.500 |
|POLY 3 | P=0.338N P=0.246 (e) (e) |P=0.165 (e) (e) P=0.449 |
|POLY 1.5 | P=0.308N P=0.242 (e) (e) |P=0.168 (e) (e) P=0.464 |
|POLY 6 | P=0.368N P=0.251 (e) (e) |P=0.174 (e) (e) P=0.435 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.284N P=0.247 (e) (e) |P=0.188 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Eye |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 1/1 (100%) 4/6 (67%) 2/3 (67%) |0/0 (0%) 1/1 (100%) 1/2 (50%) 7/9 (78%) |
|POLY-3 RATE (b) | 0/0.00 1/1.00 4/6.00 2/3.00 |0/0.00 1/1.00 1/2.00 7/9.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 66.7% 66.7% |0.0% 100.0% 50.0% 77.8% |
|TERMINAL (d) | 0/0 (0%) 1/1 (100%) 2/4 (50%) 0/1 (0%) |0/0 (0%) 1/1 (100%) 0/1 (0%) 6/8 (75%) |
|FIRST INCIDENCE | --- 730 (T) 497 554 |--- 729 (T) 639 352 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.094 (e) P=0.237 P=0.102 |P=0.180 (e) P=0.505 P=0.441 |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.586N (e) P=1.000 P=1.000 |P=0.696 (e) P=1.000 P=1.000 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Eye |
| Synechia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/1 (0%) 2/6 (33%) 2/3 (67%) |0/0 (0%) 0/1 (0%) 1/2 (50%) 1/9 (11%) |
|POLY-3 RATE (b) | 0/0.00 0/1.00 2/5.46 2/3.00 |0/0.00 0/1.00 1/2.00 1/8.11 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 36.6% 66.7% |0.0% 0.0% 50.0% 12.3% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 1/4 (25%) 0/1 (0%) |0/0 (0%) 0/1 (0%) 0/1 (0%) 1/8 (13%) |
|FIRST INCIDENCE | --- --- 497 554 |--- --- 639 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * (e) P=0.496 P=0.102 |P=0.468 (e) P=0.505 P=1.000 |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.277 (e) (e) (e) |P=0.565N (e) (e) P=1.000 |
|COCH-ARM / FISHERS | P=0.242 (e) P=1.000 P=1.000 |P=0.568N (e) P=1.000 P=1.000 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Eye: Cornea |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/1 (0%) 3/6 (50%) 3/3 (100%) |0/0 (0%) 1/1 (100%) 0/2 (0%) 5/9 (56%) |
|POLY-3 RATE (b) | 0/0.00 0/1.00 3/5.32 3/3.00 |0/0.00 1/1.00 0/1.67 5/8.11 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 56.4% 100.0% |0.0% 100.0% 0.0% 61.6% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 2/4 (50%) 1/1 (100%) |0/0 (0%) 1/1 (100%) 0/1 (0%) 5/8 (63%) |
|FIRST INCIDENCE | --- --- 563 554 |--- 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** (e) P=0.500 (e) |P=0.665N (e) (e) P=1.000N |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.089 (e) (e) (e) |(e) (e) (e) P=1.000N |
|COCH-ARM / FISHERS | P=0.090 (e) P=1.000 (e) |P=0.648 (e) (e) P=1.000 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Eye: Lens |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 1/1 (100%) 3/6 (50%) 2/3 (67%) |0/0 (0%) 0/1 (0%) 0/2 (0%) 2/9 (22%) |
|POLY-3 RATE (b) | 0/0.00 1/1.00 3/5.46 2/3.00 |0/0.00 0/1.00 0/1.67 2/9.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 55.0% 66.7% |0.0% 0.0% 0.0% 22.2% |
|TERMINAL (d) | 0/0 (0%) 1/1 (100%) 2/4 (50%) 0/1 (0%) |0/0 (0%) 0/1 (0%) 0/1 (0%) 1/8 (13%) |
|FIRST INCIDENCE | --- 730 (T) 497 554 |--- --- --- 352 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.116 (e) P=0.496 P=0.102 |P=0.134 (e) (e) P=0.441 |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.659N (e) (e) (e) |P=0.526 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.680N (e) P=1.000 P=1.000 |P=0.432 (e) (e) P=1.000 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 7/50 (14%) 4/50 (8%) |5/49 (10%) 4/50 (8%) 6/49 (12%) 8/49 (16%) |
|POLY-3 RATE (b) | 1/46.27 4/46.03 7/45.69 4/31.14 |5/46.16 4/44.06 6/46.06 8/36.72 |
|POLY-3 PERCENT (g) | 2.2% 8.7% 15.3% 12.8% |10.8% 9.1% 13.0% 21.8% |
|TERMINAL (d) | 0/38 (0%) 4/42 (10%) 6/39 (15%) 2/14 (14%) |5/39 (13%) 4/32 (13%) 6/39 (15%) 5/23 (22%) |
|FIRST INCIDENCE | 712 730 (T) 610 547 |729 (T) 729 (T) 729 (T) 386 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.208 P=0.036 * P=0.031 * |P=0.026 * P=0.624N P=0.500 P=0.066 |
|POLY 3 | P=0.050 P=0.177 P=0.029 * P=0.086 |P=0.072 P=0.529N P=0.499 P=0.147 |
|POLY 1.5 | P=0.078 P=0.173 P=0.029 * P=0.109 |P=0.083 P=0.512N P=0.497 P=0.177 |
|POLY 6 | P=0.032 * P=0.183 P=0.029 * P=0.067 |P=0.065 P=0.552N P=0.502 P=0.123 |
|LOGISTIC REGRESSION| P=0.059 P=0.188 P=0.031 * P=0.085 |P=0.068 P=0.624N P=0.500 P=0.194 |
|COCH-ARM / FISHERS | P=0.201 P=0.181 P=0.030 * P=0.181 |P=0.134 P=0.487N P=0.500 P=0.276 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 25/50 (50%) 26/50 (52%) 14/50 (28%) |40/49 (82%) 30/50 (60%) 33/49 (67%) 23/49 (47%) |
|POLY-3 RATE (b) | 33/47.49 25/47.17 26/45.79 14/34.09 |40/47.06 30/47.68 33/46.89 23/39.05 |
|POLY-3 PERCENT (g) | 69.5% 53.0% 56.8% 41.1% |85.0% 62.9% 70.4% 58.9% |
|TERMINAL (d) | 29/38 (76%) 22/42 (52%) 23/39 (59%) 7/14 (50%) |35/39 (90%) 20/32 (63%) 28/39 (72%) 12/23 (52%) |
|FIRST INCIDENCE | 528 518 626 283 |653 354 645 352 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.407 P=0.029N* P=0.090N P=0.566 |P=0.365N P=0.299N P=0.099N P=0.429N |
|POLY 3 | P=0.024N* P=0.072N P=0.139N P=0.007N** |P=0.031N* P=0.010N* P=0.067N P=0.004N** |
|POLY 1.5 | P=0.006N** P=0.088N P=0.133N P=0.002N** |P=0.019N* P=0.011N* P=0.074N P=0.002N** |
|POLY 6 | P=0.067N P=0.054N P=0.139N P=0.025N* |P=0.042N* P=0.010N* P=0.059N P=0.007N** |
|LOGISTIC REGRESSION| P=0.027N* P=0.086N P=0.123N P=0.013N* |P=0.038N* P=0.025N* P=0.069N P=0.015N* |
|COCH-ARM / FISHERS | P<0.001N** P=0.078N P=0.111N P<0.001N** |P=0.002N** P=0.016N* P=0.082N P<0.001N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/46.19 3/46.35 2/45.28 1/30.48 |0/46.90 1/44.24 1/47.00 3/35.49 |
|POLY-3 PERCENT (g) | 2.2% 6.5% 4.4% 3.3% |0.0% 2.3% 2.1% 8.5% |
|TERMINAL (d) | 1/38 (3%) 1/42 (2%) 2/39 (5%) 1/14 (7%) |0/39 (0%) 0/32 (0%) 1/39 (3%) 2/23 (9%) |
|FIRST INCIDENCE | 730 (T) 689 730 (T) 730 (T) |--- 683 729 (T) 649 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.484 P=0.338 P=0.509 P=0.525 |P=0.022 * P=0.475 P=0.500 P=0.053 |
|POLY 3 | P=0.586N P=0.307 P=0.493 P=0.659 |P=0.040 * P=0.488 P=0.500 P=0.077 |
|POLY 1.5 | P=0.526N P=0.300 P=0.494 P=0.694 |P=0.043 * P=0.493 P=0.500 P=0.087 |
|POLY 6 | P=0.559 P=0.316 P=0.494 P=0.622 |P=0.039 * P=0.483 P=0.502 P=0.069 |
|LOGISTIC REGRESSION| P=0.604 P=0.301 P=0.509 P=0.525 |P=0.035 * P=0.511 P=0.500 P=0.074 |
|COCH-ARM / FISHERS | P=0.414N P=0.309 P=0.500 P=0.753N |P=0.059 P=0.500 P=0.500 P=0.121 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.53 0/46.03 0/45.28 1/30.96 |1/47.23 1/44.24 0/47.00 1/36.08 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 3.2% |2.1% 2.3% 0.0% 2.8% |
|TERMINAL (d) | 1/38 (3%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 636 --- --- 588 |638 683 --- 352 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.638 P=0.224N P=0.239N P=0.729 |P=0.645 P=0.739 P=0.500N P=0.715 |
|POLY 3 | P=0.521N P=0.240N P=0.243N P=0.635N |P=0.591N P=0.746 P=0.501N P=0.697 |
|POLY 1.5 | P=0.510N P=0.243N P=0.242N P=0.594N |P=0.592N P=0.752 P=0.501N P=0.716 |
|POLY 6 | P=0.526N P=0.236N P=0.244N P=0.674N |P=0.595N P=0.738 P=0.500N P=0.677 |
|LOGISTIC REGRESSION| P=0.495N P=0.230N P=0.226N P=0.529N |P=0.375N P=0.741N P=0.479N P=0.602N |
|COCH-ARM / FISHERS | P=0.519N P=0.247N P=0.247N P=0.500N |P=0.592N P=0.753N P=0.500N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum: Peyer's Patch |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.19 1/46.03 0/45.28 0/30.48 |0/46.90 1/44.06 1/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 4.3% 2.2% 0.0% 0.0% |0.0% 2.3% 2.1% 0.0% |
|TERMINAL (d) | 2/38 (5%) 1/42 (2%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 1/32 (3%) 1/39 (3%) 0/23 (0%) |
|FIRST INCIDENCE | 730 (T) 730 (T) --- --- |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.178N P=0.465N P=0.233N P=0.475N |P=0.636N P=0.461 P=0.500 (e) |
|POLY 3 | P=0.122N P=0.501N P=0.242N P=0.340N |P=0.617N P=0.488 P=0.500 (e) |
|POLY 1.5 | P=0.110N P=0.507N P=0.241N P=0.305N |P=0.590N P=0.493 P=0.500 (e) |
|POLY 6 | P=0.134N P=0.494N P=0.241N P=0.377N |P=0.648N P=0.481 P=0.502 (e) |
|LOGISTIC REGRESSION| P=0.178N P=0.465N (e) (e) |(e) P=0.461 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.104N P=0.500N P=0.247N P=0.247N |P=0.545N P=0.500 P=0.500 (e) |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 3/50 (6%) 5/50 (10%) |2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/46.65 3/46.03 3/45.93 5/31.11 |2/47.18 3/44.43 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 10.7% 6.5% 6.5% 16.1% |4.2% 6.8% 0.0% 0.0% |
|TERMINAL (d) | 3/38 (8%) 3/42 (7%) 2/39 (5%) 2/14 (14%) |1/39 (3%) 1/32 (3%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 617 730 (T) 512 656 |653 665 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.088 P=0.316N P=0.357N P=0.156 |P=0.078N P=0.424 P=0.245N P=0.352N |
|POLY 3 | P=0.311 P=0.364N P=0.365N P=0.370 |P=0.062N P=0.473 P=0.238N P=0.308N |
|POLY 1.5 | P=0.345 P=0.370N P=0.365N P=0.450 |P=0.058N P=0.484 P=0.239N P=0.286N |
|POLY 6 | P=0.290 P=0.356N P=0.364N P=0.298 |P=0.067N P=0.459 P=0.237N P=0.330N |
|LOGISTIC REGRESSION| P=0.301 P=0.363N P=0.337N P=0.346 |P=0.052N P=0.509 P=0.234N P=0.270N |
|COCH-ARM / FISHERS | P=0.467 P=0.357N P=0.357N P=0.630N |P=0.051N P=0.500 P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.19 3/46.03 3/45.28 2/31.46 |2/46.90 2/44.59 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 4.3% 6.5% 6.6% 6.4% |4.3% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 2/38 (5%) 3/42 (7%) 3/39 (8%) 1/14 (7%) |2/39 (5%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 730 (T) 211 |729 (T) 633 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.272 P=0.546 P=0.512 P=0.409 |P=0.101N P=0.641 P=0.238N P=0.361N |
|POLY 3 | P=0.452 P=0.498 P=0.491 P=0.548 |P=0.081N P=0.676 P=0.237N P=0.306N |
|POLY 1.5 | P=0.504 P=0.491 P=0.492 P=0.597 |P=0.078N P=0.683 P=0.238N P=0.285N |
|POLY 6 | P=0.405 P=0.508 P=0.492 P=0.496 |P=0.085N P=0.667 P=0.235N P=0.327N |
|LOGISTIC REGRESSION| P=0.567N P=0.546 P=0.512 P=0.631N |P=0.073N P=0.689N (e) (e) |
|COCH-ARM / FISHERS | P=0.521N P=0.500 P=0.500 P=0.691N |P=0.072N P=0.691N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 5/50 (10%) 3/50 (6%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/46.19 2/46.03 5/45.28 3/31.13 |2/46.90 1/44.06 0/47.00 1/35.19 |
|POLY-3 PERCENT (g) | 10.8% 4.3% 11.0% 9.6% |4.3% 2.3% 0.0% 2.8% |
|TERMINAL (d) | 5/38 (13%) 2/42 (5%) 5/39 (13%) 1/14 (7%) |2/39 (5%) 1/32 (3%) 0/39 (0%) 1/23 (4%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 730 (T) 554 |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.188 P=0.177N P=0.615N P=0.445 |P=0.487N P=0.569N P=0.238N P=0.681N |
|POLY 3 | P=0.426 P=0.218N P=0.618 P=0.581N |P=0.374N P=0.522N P=0.237N P=0.598N |
|POLY 1.5 | P=0.492 P=0.225N P=0.619 P=0.511N |P=0.374N P=0.513N P=0.238N P=0.570N |
|POLY 6 | P=0.369 P=0.209N P=0.620 P=0.635 |P=0.374N P=0.533N P=0.235N P=0.623N |
|LOGISTIC REGRESSION| P=0.376 P=0.177N P=0.615N P=0.632N |P=0.487N P=0.569N (e) P=0.681N |
|COCH-ARM / FISHERS | P=0.474N P=0.218N P=0.630N P=0.357N |P=0.373N P=0.500N P=0.247N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 28/50 (56%) 32/50 (64%) 18/50 (36%) |4/50 (8%) 3/50 (6%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 23/46.85 28/46.70 32/48.86 18/33.44 |4/46.90 3/44.43 2/47.14 4/35.62 |
|POLY-3 PERCENT (g) | 49.1% 60.0% 65.5% 53.8% |8.5% 6.8% 4.2% 11.2% |
|TERMINAL (d) | 19/38 (50%) 26/42 (62%) 24/39 (62%) 10/14 (71%) |4/39 (10%) 1/32 (3%) 1/39 (3%) 2/23 (9%) |
|FIRST INCIDENCE | 582 535 211 494 |729 (T) 665 695 640 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.369 P=0.088 P=0.008 ** |P=0.339 P=0.600N P=0.335N P=0.364 |
|POLY 3 | P=0.316 P=0.196 P=0.075 P=0.424 |P=0.451 P=0.529N P=0.335N P=0.486 |
|POLY 1.5 | P=0.520 P=0.177 P=0.064 P=0.578N |P=0.468 P=0.518N P=0.338N P=0.531 |
|POLY 6 | P=0.179 P=0.221 P=0.093 P=0.268 |P=0.445 P=0.543N P=0.330N P=0.447 |
|LOGISTIC REGRESSION| P=0.409 P=0.209 P=0.053 P=0.254 |P=0.415 P=0.537N P=0.331N P=0.445 |
|COCH-ARM / FISHERS | P=0.116N P=0.212 P=0.054 P=0.208N |P=0.546 P=0.500N P=0.339N P=0.643N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 39/50 (78%) 42/50 (84%) 19/50 (38%) |14/50 (28%) 6/50 (12%) 10/50 (20%) 5/50 (10%) |
|POLY-3 RATE (b) | 41/47.61 39/46.10 42/46.80 19/32.37 |14/46.90 6/44.19 10/47.09 5/35.29 |
|POLY-3 PERCENT (g) | 86.1% 84.6% 89.7% 58.7% |29.9% 13.6% 21.2% 14.2% |
|TERMINAL (d) | 37/38 (97%) 38/42 (91%) 38/39 (97%) 11/14 (79%) |14/39 (36%) 5/32 (16%) 9/39 (23%) 4/23 (17%) |
|FIRST INCIDENCE | 528 714 512 410 |729 (T) 696 708 704 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.041 * P=0.062N P=0.606 P=0.222 |P=0.250N P=0.097N P=0.234N P=0.193N |
|POLY 3 | P=0.005N** P=0.536N P=0.404 P=0.002N** |P=0.155N P=0.050N P=0.235N P=0.081N |
|POLY 1.5 | P<0.001N** P=0.550N P=0.417 P<0.001N** |P=0.125N P=0.045N* P=0.241N P=0.055N |
|POLY 6 | P=0.060N P=0.509N P=0.420 P=0.020N* |P=0.179N P=0.057N P=0.226N P=0.112N |
|LOGISTIC REGRESSION| P=0.090N P=0.311N P=0.364 P=0.054N |P=0.220N P=0.081N P=0.207N P=0.164N |
|COCH-ARM / FISHERS | P<0.001N** P=0.402N P=0.500 P<0.001N** |P=0.062N P=0.039N* P=0.241N P=0.020N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Cortex |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 13/50 (26%) 13/50 (26%) 4/50 (8%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 10/46.26 13/46.03 13/45.71 4/31.78 |0/46.90 2/44.41 2/47.00 1/35.19 |
|POLY-3 PERCENT (g) | 21.6% 28.2% 28.4% 12.6% |0.0% 4.5% 4.3% 2.8% |
|TERMINAL (d) | 9/38 (24%) 13/42 (31%) 11/39 (28%) 1/14 (7%) |0/39 (0%) 1/32 (3%) 2/39 (5%) 1/23 (4%) |
|FIRST INCIDENCE | 714 730 (T) 626 525 |--- 633 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500 P=0.416 P=0.338 P=0.591N |P=0.382 P=0.214 P=0.238 P=0.395 |
|POLY 3 | P=0.247N P=0.311 P=0.304 P=0.242N |P=0.377 P=0.225 P=0.238 P=0.444 |
|POLY 1.5 | P=0.153N P=0.297 P=0.303 P=0.176N |P=0.409 P=0.230 P=0.237 P=0.460 |
|POLY 6 | P=0.354N P=0.330 P=0.311 P=0.317N |P=0.352 P=0.219 P=0.239 P=0.429 |
|LOGISTIC REGRESSION| P=0.259N P=0.368 P=0.300 P=0.256N |P=0.435 P=0.248 P=0.238 P=0.395 |
|COCH-ARM / FISHERS | P=0.039N* P=0.318 P=0.318 P=0.074N |P=0.515 P=0.247 P=0.247 P=0.500 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 4/50 (8%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/46.19 5/46.03 4/45.28 0/30.48 |0/46.90 1/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 10.8% 10.9% 8.8% 0.0% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 5/38 (13%) 5/42 (12%) 4/39 (10%) 0/14 (0%) |0/39 (0%) 1/32 (3%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 730 (T) --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140N P=0.567N P=0.484N P=0.187N |P=0.528N P=0.461 (e) (e) |
|POLY 3 | P=0.085N P=0.628 P=0.513N P=0.087N |P=0.474N P=0.488 (e) (e) |
|POLY 1.5 | P=0.056N P=0.618 P=0.511N P=0.063N |P=0.463N P=0.493 (e) (e) |
|POLY 6 | P=0.125N P=0.619N P=0.511N P=0.117N |P=0.492N P=0.481 (e) (e) |
|LOGISTIC REGRESSION| P=0.140N P=0.567N P=0.484N (e) |(e) P=0.461 (e) (e) |
|COCH-ARM / FISHERS | P=0.023N* P=0.630N P=0.500N P=0.028N* |P=0.468N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 5/50 (10%) 1/50 (2%) |1/50 (2%) 3/50 (6%) 9/50 (18%) 8/50 (16%) |
|POLY-3 RATE (b) | 1/46.19 2/46.68 5/45.28 1/30.48 |1/46.90 3/44.38 9/47.34 8/35.49 |
|POLY-3 PERCENT (g) | 2.2% 4.3% 11.0% 3.3% |2.1% 6.8% 19.0% 22.5% |
|TERMINAL (d) | 1/38 (3%) 1/42 (2%) 5/39 (13%) 1/14 (7%) |1/39 (3%) 2/32 (6%) 7/39 (18%) 7/23 (30%) |
|FIRST INCIDENCE | 730 (T) 518 730 (T) 730 (T) |729 (T) 643 646 649 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.196 P=0.521 P=0.109 P=0.525 |P<0.001 ** P=0.250 P=0.011 * P<0.001 ** |
|POLY 3 | P=0.266 P=0.504 P=0.097 P=0.659 |P<0.001 ** P=0.286 P=0.008 ** P=0.004 ** |
|POLY 1.5 | P=0.345 P=0.496 P=0.098 P=0.694 |P=0.002 ** P=0.294 P=0.008 ** P=0.006 ** |
|POLY 6 | P=0.197 P=0.513 P=0.097 P=0.622 |P<0.001 ** P=0.276 P=0.009 ** P=0.003 ** |
|LOGISTIC REGRESSION| P=0.391 P=0.527 P=0.109 P=0.525 |P<0.001 ** P=0.293 P=0.010 * P=0.002 ** |
|COCH-ARM / FISHERS | P=0.554 P=0.500 P=0.102 P=0.753N |P=0.008 ** P=0.309 P=0.008 ** P=0.015 * |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 5/50 (10%) 4/50 (8%) |1/50 (2%) 6/50 (12%) 4/50 (8%) 6/50 (12%) |
|POLY-3 RATE (b) | 1/46.19 5/46.19 5/45.28 4/32.18 |1/46.90 6/44.21 4/47.00 6/35.19 |
|POLY-3 PERCENT (g) | 2.2% 10.8% 11.0% 12.4% |2.1% 13.6% 8.5% 17.1% |
|TERMINAL (d) | 1/38 (3%) 4/42 (10%) 5/39 (13%) 1/14 (7%) |1/39 (3%) 4/32 (13%) 4/39 (10%) 6/23 (26%) |
|FIRST INCIDENCE | 730 (T) 689 730 (T) 283 |729 (T) 696 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.031 * P=0.128 P=0.109 P=0.048 * |P=0.035 * P=0.035 * P=0.179 P=0.008 ** |
|POLY 3 | P=0.124 P=0.101 P=0.097 P=0.092 |P=0.071 P=0.047 * P=0.180 P=0.023 * |
|POLY 1.5 | P=0.161 P=0.098 P=0.098 P=0.114 |P=0.085 P=0.051 P=0.178 P=0.030 * |
|POLY 6 | P=0.096 P=0.107 P=0.097 P=0.073 |P=0.061 P=0.043 * P=0.182 P=0.017 * |
|LOGISTIC REGRESSION| P=0.219 P=0.105 P=0.109 P=0.230 |P=0.039 * P=0.039 * P=0.179 P=0.008 ** |
|COCH-ARM / FISHERS | P=0.295 P=0.102 P=0.102 P=0.181 |P=0.149 P=0.056 P=0.181 P=0.056 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 24/50 (48%) 16/50 (32%) 4/50 (8%) |5/50 (10%) 3/50 (6%) 6/50 (12%) 5/50 (10%) |
|POLY-3 RATE (b) | 19/46.94 24/46.64 16/45.28 4/31.14 |5/47.06 3/45.25 6/47.14 5/36.63 |
|POLY-3 PERCENT (g) | 40.5% 51.5% 35.3% 12.9% |10.6% 6.6% 12.7% 13.7% |
|TERMINAL (d) | 18/38 (47%) 23/42 (55%) 16/39 (41%) 1/14 (7%) |3/39 (8%) 1/32 (3%) 4/39 (10%) 3/23 (13%) |
|FIRST INCIDENCE | 464 535 730 (T) 554 |708 354 708 382 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.044N* P=0.337 P=0.294N P=0.129N |P=0.190 P=0.447N P=0.516 P=0.341 |
|POLY 3 | P=0.003N** P=0.194 P=0.384N P=0.009N** |P=0.253 P=0.378N P=0.501 P=0.467 |
|POLY 1.5 | P<0.001N** P=0.178 P=0.374N P=0.003N** |P=0.285 P=0.368N P=0.498 P=0.513 |
|POLY 6 | P=0.010N* P=0.219 P=0.385N P=0.023N* |P=0.232 P=0.393N P=0.506 P=0.424 |
|LOGISTIC REGRESSION| P=0.003N** P=0.196 P=0.358N P=0.014N* |P=0.419 P=0.301N P=0.505 P=0.588 |
|COCH-ARM / FISHERS | P<0.001N** P=0.210 P=0.338N P<0.001N** |P=0.401 P=0.357N P=0.500 P=0.630N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 10/50 (20%) 4/50 (8%) |9/50 (18%) 7/50 (14%) 18/50 (36%) 11/50 (22%) |
|POLY-3 RATE (b) | 5/46.44 5/46.10 10/45.28 4/30.64 |9/46.90 7/44.06 18/47.31 11/35.49 |
|POLY-3 PERCENT (g) | 10.8% 10.9% 22.1% 13.1% |19.2% 15.9% 38.1% 31.0% |
|TERMINAL (d) | 4/38 (11%) 4/42 (10%) 10/39 (26%) 2/14 (14%) |9/39 (23%) 7/32 (22%) 17/39 (44%) 10/23 (44%) |
|FIRST INCIDENCE | 664 714 730 (T) 695 |729 (T) 729 (T) 646 649 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.059 P=0.572N P=0.141 P=0.248 |P=0.008 ** P=0.565N P=0.031 * P=0.048 * |
|POLY 3 | P=0.213 P=0.625 P=0.117 P=0.521 |P=0.026 * P=0.445N P=0.034 * P=0.167 |
|POLY 1.5 | P=0.313 P=0.616 P=0.120 P=0.602 |P=0.044 * P=0.424N P=0.033 * P=0.224 |
|POLY 6 | P=0.138 P=0.623N P=0.116 P=0.438 |P=0.017 * P=0.474N P=0.036 * P=0.123 |
|LOGISTIC REGRESSION| P=0.145 P=0.628N P=0.123 P=0.405 |P=0.013 * P=0.565N P=0.038 * P=0.072 |
|COCH-ARM / FISHERS | P=0.528N P=0.630N P=0.131 P=0.500N |P=0.154 P=0.393N P=0.035 * P=0.402 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.19 2/46.03 1/45.39 1/30.76 |1/47.44 4/44.21 3/47.00 1/35.19 |
|POLY-3 PERCENT (g) | 4.3% 4.3% 2.2% 3.3% |2.1% 9.1% 6.4% 2.8% |
|TERMINAL (d) | 2/38 (5%) 2/42 (5%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 2/32 (6%) 3/39 (8%) 1/23 (4%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 702 656 |562 696 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.595N P=0.658N P=0.494N P=0.693 |P=0.530N P=0.140 P=0.305 P=0.665 |
|POLY 3 | P=0.420N P=0.692 P=0.506N P=0.635N |P=0.508N P=0.158 P=0.302 P=0.689 |
|POLY 1.5 | P=0.382N P=0.687 P=0.506N P=0.594N |P=0.463N P=0.167 P=0.302 P=0.711 |
|POLY 6 | P=0.453N P=0.687N P=0.504N P=0.673N |P=0.552N P=0.148 P=0.303 P=0.667 |
|LOGISTIC REGRESSION| P=0.462N P=0.658N P=0.506N P=0.669N |P=0.446N P=0.189 P=0.311 P=0.766N |
|COCH-ARM / FISHERS | P=0.321N P=0.691N P=0.500N P=0.500N |P=0.361N P=0.181 P=0.309 P=0.753N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.19 1/46.03 2/45.28 0/30.48 |0/46.90 0/44.06 1/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 4.3% 2.2% 4.4% 0.0% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 2/38 (5%) 1/42 (2%) 2/39 (5%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 1/39 (3%) 0/23 (0%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 730 (T) --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.453N P=0.465N P=0.686N P=0.475N |P=0.610 (e) P=0.500 (e) |
|POLY 3 | P=0.366N P=0.501N P=0.687 P=0.340N |P=0.526 (e) P=0.500 (e) |
|POLY 1.5 | P=0.306N P=0.507N P=0.687 P=0.305N |P=0.555 (e) P=0.500 (e) |
|POLY 6 | P=0.432N P=0.494N P=0.688 P=0.377N |P=0.508 (e) P=0.502 (e) |
|LOGISTIC REGRESSION| P=0.453N P=0.465N P=0.686N (e) |(e) (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.222N P=0.500N P=0.691N P=0.247N |P=0.656 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 33/50 (66%) 33/50 (66%) 11/50 (22%) |42/50 (84%) 34/50 (68%) 40/50 (80%) 32/50 (64%) |
|POLY-3 RATE (b) | 25/46.29 33/47.60 33/45.93 11/31.52 |42/47.95 34/45.74 40/47.70 32/40.43 |
|POLY-3 PERCENT (g) | 54.0% 69.3% 71.9% 34.9% |87.6% 74.3% 83.9% 79.2% |
|TERMINAL (d) | 23/38 (61%) 29/42 (69%) 32/39 (82%) 8/14 (57%) |36/39 (92%) 30/32 (94%) 36/39 (92%) 20/23 (87%) |
|FIRST INCIDENCE | 712 518 512 494 |653 468 645 352 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.273 P=0.191 P=0.073 P=0.414 |P=0.038 * P=0.517N P=0.394N P=0.080 |
|POLY 3 | P=0.093N P=0.090 P=0.052 P=0.075N |P=0.391N P=0.069N P=0.405N P=0.199N |
|POLY 1.5 | P=0.018N* P=0.067 P=0.057 P=0.030N* |P=0.297N P=0.056N P=0.414N P=0.117N |
|POLY 6 | P=0.290N P=0.127 P=0.051 P=0.165N |P=0.454N P=0.100N P=0.397N P=0.302N |
|LOGISTIC REGRESSION| P=0.147N P=0.068 P=0.050 P=0.289N |P=0.373 P=0.147N P=0.348N P=0.395N |
|COCH-ARM / FISHERS | P<0.001N** P=0.078 P=0.078 P=0.003N** |P=0.067N P=0.050N P=0.398N P=0.020N* |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 13/50 (26%) 13/50 (26%) 3/50 (6%) |3/50 (6%) 15/50 (30%) 16/50 (32%) 13/50 (26%) |
|POLY-3 RATE (b) | 9/46.19 13/46.19 13/45.28 3/30.62 |3/46.98 15/44.83 16/47.70 13/36.26 |
|POLY-3 PERCENT (g) | 19.5% 28.1% 28.7% 9.8% |6.4% 33.5% 33.5% 35.9% |
|TERMINAL (d) | 9/38 (24%) 12/42 (29%) 13/39 (33%) 2/14 (14%) |2/39 (5%) 12/32 (38%) 12/39 (31%) 11/23 (48%) |
|FIRST INCIDENCE | 730 (T) 689 730 (T) 695 |708 643 645 547 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.559N P=0.319 P=0.248 P=0.558N |P=0.003 ** P<0.001 ** P=0.002 ** P<0.001 ** |
|POLY 3 | P=0.249N P=0.232 P=0.215 P=0.213N |P=0.007 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.140N P=0.219 P=0.218 P=0.150N |P=0.013 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.386N P=0.251 P=0.216 P=0.293N |P=0.004 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.371N P=0.268 P=0.248 P=0.394N |P=0.008 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.030N* P=0.235 P=0.235 P=0.061N |P=0.065 P=0.002 ** P<0.001 ** P=0.006 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 10/50 (20%) 5/50 (10%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 3/50 (6%) 6/50 (12%) |
|POLY-3 RATE (b) | 4/47.27 10/48.51 5/45.56 0/30.48 |1/47.18 3/44.62 3/47.00 6/36.43 |
|POLY-3 PERCENT (g) | 8.5% 20.6% 11.0% 0.0% |2.1% 6.7% 6.4% 16.5% |
|TERMINAL (d) | 1/38 (3%) 5/42 (12%) 3/39 (8%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 3/39 (8%) 2/23 (9%) |
|FIRST INCIDENCE | 528 4 685 --- |653 665 729 (T) 513 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.082N P=0.102 P=0.500 P=0.189N |P=0.010 * P=0.261 P=0.303 P=0.017 * |
|POLY 3 | P=0.070N P=0.080 P=0.477 P=0.141N |P=0.021 * P=0.286 P=0.304 P=0.025 * |
|POLY 1.5 | P=0.039N* P=0.075 P=0.482 P=0.109N |P=0.024 * P=0.294 P=0.304 P=0.032 * |
|POLY 6 | P=0.117N P=0.088 P=0.475 P=0.181N |P=0.019 * P=0.277 P=0.305 P=0.021 * |
|LOGISTIC REGRESSION| P=0.004N** P=0.113 P=0.523 P=0.050N |P=0.031 * P=0.331 P=0.305 P=0.042 * |
|COCH-ARM / FISHERS | P=0.011N* P=0.074 P=0.500 P=0.059N |P=0.042 * P=0.309 P=0.309 P=0.056 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 3/50 (6%) 0/50 (0%) |6/50 (12%) 18/50 (36%) 13/50 (26%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.19 4/46.19 3/45.28 0/30.48 |6/47.16 18/44.95 13/47.09 1/35.19 |
|POLY-3 PERCENT (g) | 0.0% 8.7% 6.6% 0.0% |12.7% 40.1% 27.6% 2.8% |
|TERMINAL (d) | 0/38 (0%) 3/42 (7%) 3/39 (8%) 0/14 (0%) |5/39 (13%) 14/32 (44%) 11/39 (28%) 1/23 (4%) |
|FIRST INCIDENCE | --- 689 730 (T) --- |659 648 716 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.588N P=0.077 P=0.126 (e) |P=0.048N* P<0.001 ** P=0.067 P=0.182N |
|POLY 3 | P=0.515N P=0.060 P=0.115 (e) |P=0.044N* P=0.002 ** P=0.059 P=0.120N |
|POLY 1.5 | P=0.427N P=0.058 P=0.116 (e) |P=0.024N* P=0.003 ** P=0.059 P=0.098N |
|POLY 6 | P=0.600 P=0.063 P=0.116 (e) |P=0.074N P=0.002 ** P=0.060 P=0.146N |
|LOGISTIC REGRESSION| P=0.489N P=0.062 P=0.126 (e) |P=0.029N* P=0.002 ** P=0.066 P=0.138N |
|COCH-ARM / FISHERS | P=0.279N P=0.059 P=0.121 (e) |P=0.006N** P=0.005 ** P=0.062 P=0.056N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 30/50 (60%) 23/50 (46%) 17/50 (34%) |9/50 (18%) 12/50 (24%) 15/50 (30%) 21/50 (42%) |
|POLY-3 RATE (b) | 18/46.94 30/46.19 23/45.82 17/35.05 |9/48.35 12/44.80 15/47.00 21/39.05 |
|POLY-3 PERCENT (g) | 38.4% 65.0% 50.2% 48.5% |18.6% 26.8% 31.9% 53.8% |
|TERMINAL (d) | 17/38 (45%) 29/42 (69%) 22/39 (56%) 8/14 (57%) |5/39 (13%) 11/32 (34%) 15/39 (39%) 15/23 (65%) |
|FIRST INCIDENCE | 464 689 563 410 |338 468 729 (T) 352 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** P=0.031 * P=0.224 P=0.005 ** |P<0.001 ** P=0.180 P=0.127 P<0.001 ** |
|POLY 3 | P=0.504 P=0.007 ** P=0.171 P=0.244 |P<0.001 ** P=0.244 P=0.103 P<0.001 ** |
|POLY 1.5 | P=0.416N P=0.007 ** P=0.178 P=0.350 |P<0.001 ** P=0.270 P=0.107 P<0.001 ** |
|POLY 6 | P=0.385 P=0.008 ** P=0.172 P=0.168 |P<0.001 ** P=0.211 P=0.099 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.401 P=0.013 * P=0.180 P=0.284 |P<0.001 ** P=0.338 P=0.121 P=0.004 ** |
|COCH-ARM / FISHERS | P=0.117N P=0.014 * P=0.208 P=0.500N |P=0.004 ** P=0.312 P=0.121 P=0.008 ** |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Portal |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 0/46.03 0/45.28 0/30.48 |2/46.90 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |2/39 (5%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.186N P=0.283N P=0.238N P=0.361N |
|POLY 3 | (e) (e) (e) (e) |P=0.137N P=0.251N P=0.237N P=0.306N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.139N P=0.246N P=0.238N P=0.285N |
|POLY 6 | (e) (e) (e) (e) |P=0.136N P=0.259N P=0.235N P=0.327N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.186N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.152N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Erythrophagocytosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.19 0/46.03 2/45.28 0/30.48 |1/47.09 0/44.06 0/47.00 1/35.19 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 4.4% 0.0% |2.1% 0.0% 0.0% 2.8% |
|TERMINAL (d) | 1/38 (3%) 0/42 (0%) 2/39 (5%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 1/23 (4%) |
|FIRST INCIDENCE | 730 (T) --- 730 (T) --- |677 --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.591 P=0.480N P=0.509 P=0.699N |P=0.466 P=0.529N P=0.496N P=0.648 |
|POLY 3 | P=0.586 P=0.501N P=0.493 P=0.580N |P=0.523 P=0.513N P=0.500N P=0.691 |
|POLY 1.5 | P=0.619N P=0.504N P=0.494 P=0.555N |P=0.518 P=0.508N P=0.501N P=0.713 |
|POLY 6 | P=0.533 P=0.496N P=0.494 P=0.604N |P=0.539 P=0.520N P=0.500N P=0.670 |
|LOGISTIC REGRESSION| P=0.591 (e) P=0.509 (e) |P=0.509 P=0.486N P=0.493N P=0.711 |
|COCH-ARM / FISHERS | P=0.519N P=0.500N P=0.500 P=0.500N |P=0.545 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.19 2/47.19 0/45.28 1/31.48 |0/46.90 2/44.38 0/47.00 2/36.22 |
|POLY-3 PERCENT (g) | 0.0% 4.2% 0.0% 3.2% |0.0% 4.5% 0.0% 5.5% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 3 --- 114 |--- 683 --- 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.578 P=0.247 (e) P=0.492 |P=0.235 P=0.207 (e) P=0.187 |
|POLY 3 | P=0.571 P=0.242 (e) P=0.426 |P=0.266 P=0.225 (e) P=0.185 |
|POLY 1.5 | P=0.570 P=0.238 (e) P=0.450 |P=0.275 P=0.230 (e) P=0.200 |
|POLY 6 | P=0.580 P=0.248 (e) P=0.402 |P=0.267 P=0.219 (e) P=0.172 |
|LOGISTIC REGRESSION| P=0.342N P=0.469 (e) (e) |P=0.563 P=0.244 (e) P=0.508 |
|COCH-ARM / FISHERS | P=0.628 P=0.247 (e) P=0.500 |P=0.313 P=0.247 (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/46.27 1/46.03 3/45.28 0/30.48 |1/46.90 3/44.28 1/47.00 1/35.19 |
|POLY-3 PERCENT (g) | 8.7% 2.2% 6.6% 0.0% |2.1% 6.8% 2.1% 2.8% |
|TERMINAL (d) | 3/38 (8%) 1/42 (2%) 3/39 (8%) 0/14 (0%) |1/39 (3%) 2/32 (6%) 1/39 (3%) 1/23 (4%) |
|FIRST INCIDENCE | 712 730 (T) 730 (T) --- |729 (T) 673 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.295N P=0.157N P=0.492N P=0.242N |P=0.511N P=0.244 P=0.762 P=0.639 |
|POLY 3 | P=0.218N P=0.180N P=0.512N P=0.135N |P=0.443N P=0.285 P=0.760N P=0.692 |
|POLY 1.5 | P=0.166N P=0.185N P=0.510N P=0.106N |P=0.421N P=0.293 P=0.760 P=0.713 |
|POLY 6 | P=0.279N P=0.174N P=0.511N P=0.172N |P=0.465N P=0.275 P=0.758N P=0.672 |
|LOGISTIC REGRESSION| P=0.241N P=0.169N P=0.504N P=0.181N |P=0.477N P=0.280 P=0.762 P=0.639 |
|COCH-ARM / FISHERS | P=0.101N P=0.181N P=0.500N P=0.059N |P=0.370N P=0.309 P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.19 0/46.03 2/45.39 0/30.48 |0/46.90 0/44.06 1/47.00 1/35.19 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 4.4% 0.0% |0.0% 0.0% 2.1% 2.8% |
|TERMINAL (d) | 1/38 (3%) 0/42 (0%) 1/39 (3%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 1/39 (3%) 1/23 (4%) |
|FIRST INCIDENCE | 730 (T) --- 702 --- |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.605 P=0.480N P=0.506 P=0.699N |P=0.137 (e) P=0.500 P=0.395 |
|POLY 3 | P=0.586 P=0.501N P=0.494 P=0.580N |P=0.153 (e) P=0.500 P=0.444 |
|POLY 1.5 | P=0.619N P=0.504N P=0.494 P=0.555N |P=0.163 (e) P=0.500 P=0.460 |
|POLY 6 | P=0.533 P=0.496N P=0.496 P=0.604N |P=0.148 (e) P=0.502 P=0.429 |
|LOGISTIC REGRESSION| P=0.663 (e) P=0.494 (e) |(e) (e) P=0.500 P=0.395 |
|COCH-ARM / FISHERS | P=0.519N P=0.500N P=0.500 P=0.500N |P=0.212 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 0/46.03 0/45.28 0/30.48 |0/46.90 2/45.21 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 424 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.322N P=0.235 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.311N P=0.229 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.296N P=0.233 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.328N P=0.224 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.112N P=0.293 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.284N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 5/50 (10%) 6/50 (12%) |2/50 (4%) 2/50 (4%) 4/50 (8%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/46.82 3/46.03 5/45.28 6/31.45 |2/47.18 2/44.06 4/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 8.5% 6.5% 11.0% 19.1% |4.2% 4.5% 8.5% 0.0% |
|TERMINAL (d) | 3/38 (8%) 3/42 (7%) 5/39 (13%) 3/14 (21%) |1/39 (3%) 2/32 (6%) 4/39 (10%) 0/23 (0%) |
|FIRST INCIDENCE | 528 730 (T) 730 (T) 410 |653 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.008 ** P=0.457N P=0.510 P=0.046 * |P=0.381N P=0.627 P=0.335 P=0.352N |
|POLY 3 | P=0.080 P=0.509N P=0.479 P=0.161 |P=0.386N P=0.669 P=0.336 P=0.308N |
|POLY 1.5 | P=0.106 P=0.515N P=0.484 P=0.217 |P=0.340N P=0.679 P=0.335 P=0.286N |
|POLY 6 | P=0.063 P=0.501N P=0.477 P=0.115 |P=0.432N P=0.655 P=0.337 P=0.330N |
|LOGISTIC REGRESSION| P=0.081 P=0.502N P=0.494 P=0.222 |P=0.345N P=0.682 P=0.337 P=0.270N |
|COCH-ARM / FISHERS | P=0.202 P=0.500N P=0.500 P=0.370 |P=0.243N P=0.691N P=0.339 P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |2/50 (4%) 3/50 (6%) 4/50 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/46.19 0/46.03 4/45.39 0/30.48 |2/47.18 3/44.52 4/47.31 4/35.19 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 8.8% 0.0% |4.2% 6.7% 8.5% 11.4% |
|TERMINAL (d) | 1/38 (3%) 0/42 (0%) 3/39 (8%) 0/14 (0%) |0/39 (0%) 1/32 (3%) 3/39 (8%) 4/23 (17%) |
|FIRST INCIDENCE | 730 (T) --- 702 --- |677 647 645 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.351 P=0.480N P=0.188 P=0.699N |P=0.113 P=0.432 P=0.348 P=0.142 |
|POLY 3 | P=0.345 P=0.501N P=0.173 P=0.580N |P=0.155 P=0.474 P=0.339 P=0.216 |
|POLY 1.5 | P=0.430 P=0.504N P=0.174 P=0.555N |P=0.178 P=0.484 P=0.337 P=0.249 |
|POLY 6 | P=0.263 P=0.496N P=0.175 P=0.604N |P=0.139 P=0.460 P=0.342 P=0.187 |
|LOGISTIC REGRESSION| P=0.431 (e) P=0.174 (e) |P=0.167 P=0.515 P=0.338 P=0.182 |
|COCH-ARM / FISHERS | P=0.601N P=0.500N P=0.181 P=0.500N |P=0.267 P=0.500 P=0.339 P=0.339 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/47 (2%) 5/47 (11%) 4/47 (9%) |4/49 (8%) 7/49 (14%) 12/47 (26%) 9/50 (18%) |
|POLY-3 RATE (b) | 1/45.27 1/43.26 5/43.11 4/30.10 |4/45.90 7/43.45 12/44.22 9/36.46 |
|POLY-3 PERCENT (g) | 2.2% 2.3% 11.6% 13.3% |8.7% 16.1% 27.1% 24.7% |
|TERMINAL (d) | 0/37 (0%) 1/41 (2%) 4/38 (11%) 1/14 (7%) |4/38 (11%) 5/32 (16%) 10/38 (26%) 7/23 (30%) |
|FIRST INCIDENCE | 712 730 (T) 512 494 |729 (T) 665 711 494 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.746N P=0.109 P=0.048 * |P=0.011 * P=0.175 P=0.030 * P=0.017 * |
|POLY 3 | P=0.016 * P=0.750 P=0.090 P=0.083 |P=0.025 * P=0.230 P=0.020 * P=0.047 * |
|POLY 1.5 | P=0.023 * P=0.747 P=0.090 P=0.103 |P=0.037 * P=0.242 P=0.020 * P=0.063 |
|POLY 6 | P=0.011 * P=0.756 P=0.092 P=0.067 |P=0.018 * P=0.215 P=0.021 * P=0.036 * |
|LOGISTIC REGRESSION| P=0.047 * P=0.755 P=0.097 P=0.148 |P=0.025 * P=0.203 P=0.025 * P=0.050 |
|COCH-ARM / FISHERS | P=0.060 P=0.742 P=0.093 P=0.168 |P=0.104 P=0.262 P=0.021 * P=0.125 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 4/50 (8%) 5/50 (10%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/46.19 1/46.03 1/45.28 0/30.48 |2/46.98 4/44.54 5/47.14 4/36.44 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 2.2% 0.0% |4.3% 9.0% 10.6% 11.0% |
|TERMINAL (d) | 0/38 (0%) 1/42 (2%) 1/39 (3%) 0/14 (0%) |1/39 (3%) 2/32 (6%) 4/39 (10%) 1/23 (4%) |
|FIRST INCIDENCE | --- 730 (T) 730 (T) --- |708 633 695 513 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.681 P=0.520 P=0.505 (e) |P=0.153 P=0.266 P=0.227 P=0.173 |
|POLY 3 | P=0.659 P=0.499 P=0.496 (e) |P=0.193 P=0.313 P=0.218 P=0.230 |
|POLY 1.5 | P=0.618N P=0.496 P=0.496 (e) |P=0.221 P=0.323 P=0.216 P=0.257 |
|POLY 6 | P=0.630 P=0.504 P=0.497 (e) |P=0.175 P=0.301 P=0.221 P=0.208 |
|LOGISTIC REGRESSION| (e) P=0.520 P=0.505 (e) |P=0.269 P=0.329 P=0.218 P=0.318 |
|COCH-ARM / FISHERS | P=0.545N P=0.500 P=0.500 (e) |P=0.325 P=0.339 P=0.218 P=0.339 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/49 (0%) 2/48 (4%) |1/50 (2%) 0/49 (0%) 2/50 (4%) 0/47 (0%) |
|POLY-3 RATE (b) | 0/44.60 0/44.80 0/44.28 2/29.58 |1/46.90 0/43.20 2/47.00 0/33.60 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.8% |2.1% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/38 (0%) 1/14 (7%) |1/39 (3%) 0/32 (0%) 2/39 (5%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- 588 |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** (e) (e) P=0.093 |P=0.639N P=0.539N P=0.500 P=0.614N |
|POLY 3 | P=0.042 * (e) (e) P=0.160 |P=0.616N P=0.516N P=0.501 P=0.565N |
|POLY 1.5 | P=0.037 * (e) (e) P=0.181 |P=0.591N P=0.511N P=0.499 P=0.551N |
|POLY 6 | P=0.051 (e) (e) P=0.142 |P=0.616 P=0.523N P=0.503 P=0.578N |
|LOGISTIC REGRESSION| P=0.036 * (e) (e) P=0.187 |P=0.639N (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |P=0.533N P=0.505N P=0.500 P=0.515N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/48 (0%) 0/49 (0%) 2/48 (4%) |1/50 (2%) 1/49 (2%) 1/50 (2%) 0/47 (0%) |
|POLY-3 RATE (b) | 1/44.63 0/44.80 0/44.28 2/29.58 |1/46.90 1/43.33 1/47.06 0/33.60 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 6.8% |2.1% 2.3% 2.1% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/38 (0%) 1/14 (7%) |1/39 (3%) 0/32 (0%) 0/39 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 723 --- --- 588 |729 (T) 696 715 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.076 P=0.490N P=0.505N P=0.239 |P=0.384N P=0.715 P=0.752N P=0.614N |
|POLY 3 | P=0.207 P=0.499N P=0.502N P=0.363 |P=0.365N P=0.743 P=0.760N P=0.565N |
|POLY 1.5 | P=0.195 P=0.503N P=0.500N P=0.404 |P=0.348N P=0.748 P=0.760 P=0.551N |
|POLY 6 | P=0.228 P=0.495N P=0.502N P=0.325 |P=0.385N P=0.736 P=0.758N P=0.578N |
|LOGISTIC REGRESSION| P=0.175 P=0.497N P=0.502N P=0.399 |P=0.361N P=0.748 P=0.761N (e) |
|COCH-ARM / FISHERS | P=0.214 P=0.500N P=0.495N P=0.500 |P=0.314N P=0.747 P=0.753N P=0.515N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 1/48 (2%) 0/49 (0%) 0/48 (0%) |3/50 (6%) 1/49 (2%) 3/50 (6%) 1/47 (2%) |
|POLY-3 RATE (b) | 4/44.60 1/44.80 0/44.28 0/29.10 |3/46.90 1/43.33 3/47.00 1/33.86 |
|POLY-3 PERCENT (g) | 9.0% 2.2% 0.0% 0.0% |6.4% 2.3% 6.4% 3.0% |
|TERMINAL (d) | 4/38 (11%) 1/42 (2%) 0/38 (0%) 0/14 (0%) |3/39 (8%) 0/32 (0%) 3/39 (8%) 0/22 (0%) |
|FIRST INCIDENCE | 730 (T) 730 (T) --- --- |729 (T) 696 729 (T) 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.061N P=0.151N P=0.063N P=0.251N |P=0.536N P=0.380N P=0.664 P=0.508N |
|POLY 3 | P=0.033N* P=0.177N P=0.061N P=0.137N |P=0.477N P=0.334N P=0.661N P=0.429N |
|POLY 1.5 | P=0.028N* P=0.183N P=0.060N P=0.107N |P=0.454N P=0.326N P=0.661 P=0.401N |
|POLY 6 | P=0.037N* P=0.170N P=0.061N P=0.174N |P=0.499N P=0.345N P=0.658N P=0.455N |
|LOGISTIC REGRESSION| P=0.061N P=0.151N (e) (e) |P=0.489N P=0.348N P=0.664 P=0.437N |
|COCH-ARM / FISHERS | P=0.026N* P=0.181N P=0.056N P=0.059N |P=0.384N P=0.316N P=0.661N P=0.332N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/48 (0%) 0/49 (0%) 1/48 (2%) |1/50 (2%) 2/49 (4%) 0/50 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 1/44.60 0/44.80 0/44.28 1/29.58 |1/46.90 2/43.55 0/47.00 0/33.60 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 3.4% |2.1% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 1/38 (3%) 0/42 (0%) 0/38 (0%) 0/14 (0%) |1/39 (3%) 1/32 (3%) 0/39 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 730 (T) --- --- 588 |729 (T) 633 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.395 P=0.480N P=0.500N P=0.581 |P=0.186N P=0.449 P=0.500N P=0.614N |
|POLY 3 | P=0.530 P=0.499N P=0.501N P=0.661 |P=0.160N P=0.474 P=0.500N P=0.565N |
|POLY 1.5 | P=0.515 P=0.503N P=0.500N P=0.694 |P=0.155N P=0.482 P=0.500N P=0.551N |
|POLY 6 | P=0.553 P=0.494N P=0.502N P=0.626 |P=0.168N P=0.465 P=0.498N P=0.578N |
|LOGISTIC REGRESSION| P=0.560 (e) (e) P=0.755 |P=0.153N P=0.497 (e) (e) |
|COCH-ARM / FISHERS | P=0.546 P=0.500N P=0.495N P=0.753N |P=0.147N P=0.492 P=0.500N P=0.515N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/8 (0%) 0/6 (0%) 2/8 (25%) 0/3 (0%) |0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/7.69 0/5.84 2/7.35 0/2.07 |0/8.46 0/8.78 0/9.56 0/8.57 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 27.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/6 (0%) 0/5 (0%) 0/5 (0%) 0/0 (0%) |0/7 (0%) 0/7 (0%) 0/8 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- 685 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.404 (e) P=0.242 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.226 (e) P=0.210 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.277 (e) P=0.214 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.174 (e) P=0.209 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.416 (e) P=0.242 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.385 (e) P=0.233 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/8 (25%) 3/6 (50%) 4/8 (50%) 2/3 (67%) |5/9 (56%) 7/10 (70%) 8/10 (80%) 6/10 (60%) |
|POLY-3 RATE (b) | 2/7.69 3/5.84 4/7.35 2/2.78 |5/8.74 7/9.66 8/9.87 6/8.76 |
|POLY-3 PERCENT (g) | 26.0% 51.4% 54.4% 71.9% |57.2% 72.5% 81.1% 68.5% |
|TERMINAL (d) | 2/6 (33%) 3/5 (60%) 2/5 (40%) 0/0 (0%) |4/7 (57%) 5/7 (71%) 7/8 (88%) 5/5 (100%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 685 525 |653 468 646 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033 * P=0.396 P=0.268 P=0.113 |P=0.158 P=0.321 P=0.283 P=0.176 |
|POLY 3 | P=0.168 P=0.354 P=0.278 P=0.266 |P=0.420 P=0.423 P=0.270 P=0.502 |
|POLY 1.5 | P=0.181 P=0.352 P=0.288 P=0.276 |P=0.486 P=0.427 P=0.266 P=0.547 |
|POLY 6 | P=0.151 P=0.357 P=0.276 P=0.249 |P=0.330 P=0.420 P=0.276 P=0.434 |
|LOGISTIC REGRESSION| P=0.155 P=0.396 P=0.247 P=0.526 |P=0.526 P=0.447 P=0.266 P=0.429 |
|COCH-ARM / FISHERS | P=0.190 P=0.343 P=0.304 P=0.279 |P=0.572 P=0.430 P=0.259 P=0.605 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 4/50 (8%) 7/50 (14%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/46.47 1/46.03 4/45.45 7/31.87 |1/46.90 0/44.06 0/47.00 1/35.19 |
|POLY-3 PERCENT (g) | 8.6% 2.2% 8.8% 22.0% |2.1% 0.0% 0.0% 2.8% |
|TERMINAL (d) | 2/38 (5%) 1/42 (2%) 2/39 (5%) 1/14 (7%) |1/39 (3%) 0/32 (0%) 0/39 (0%) 1/23 (4%) |
|FIRST INCIDENCE | 664 730 (T) 702 505 |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.161N P=0.636N P=0.024 * |P=0.460 P=0.539N P=0.500N P=0.639 |
|POLY 3 | P=0.021 * P=0.182N P=0.631 P=0.095 |P=0.523 P=0.512N P=0.500N P=0.692 |
|POLY 1.5 | P=0.027 * P=0.186N P=0.632 P=0.134 |P=0.518 P=0.507N P=0.500N P=0.713 |
|POLY 6 | P=0.017 * P=0.176N P=0.632 P=0.067 |P=0.539 P=0.519N P=0.498N P=0.672 |
|LOGISTIC REGRESSION| P=0.016 * P=0.182N P=0.634 P=0.103 |P=0.460 (e) (e) P=0.639 |
|COCH-ARM / FISHERS | P=0.056 P=0.181N P=0.643N P=0.262 |P=0.545 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Oral Mucosa: Gingival |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 0/0 (0%) 3/4 (75%) 0/1 (0%) |0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 2/2.00 0/0.00 3/4.00 0/0.94 |0/0.00 0/1.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 75.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 3/4 (75%) 0/0 (0%) |0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 714 --- 730 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225N (e) P=0.245N P=0.457N |(e) (e) (e) (e) |
|POLY 3 | (e) (e) P=0.631N P=1.000N |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) P=0.631N P=1.000N |(e) (e) (e) (e) |
|POLY 6 | (e) (e) P=0.631N P=1.000N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.153N (e) P=0.245N P=0.379N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.152N (e) P=0.667N P=0.333N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Oral Mucosa: Gingival |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 0/0 (0%) 4/4 (100%) 1/1 (100%) |0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 2/2.00 0/0.00 4/4.00 1/1.00 |0/0.00 0/1.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 100.0% 100.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 4/4 (100%) 0/0 (0%) |0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 714 --- 730 (T) 716 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | |1/47.16 1/44.24 2/47.00 0/35.19 |
|POLY-3 PERCENT (g) | |2.1% 2.3% 4.3% 0.0% |
|TERMINAL (d) | |0/39 (0%) 0/32 (0%) 2/39 (5%) 0/23 (0%) |
|FIRST INCIDENCE | |659 683 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.480N P=0.731 P=0.497 P=0.585N |
|POLY 3 | |P=0.476N P=0.746 P=0.499 P=0.557N |
|POLY 1.5 | |P=0.442N P=0.752 P=0.498 P=0.541N |
|POLY 6 | |P=0.512N P=0.739 P=0.500 P=0.573N |
|LOGISTIC REGRESSION| |P=0.413N P=0.746N P=0.500 P=0.502N |
|COCH-ARM / FISHERS | |P=0.373N P=0.753N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |6/50 (12%) 8/50 (16%) 45/50 (90%) 40/50 (80%) |
|POLY-3 RATE (b) | |6/47.72 8/45.09 45/48.07 40/41.09 |
|POLY-3 PERCENT (g) | |12.6% 17.7% 93.6% 97.4% |
|TERMINAL (d) | |3/39 (8%) 3/32 (9%) 37/39 (95%) 23/23 (100%) |
|FIRST INCIDENCE | |562 633 639 429 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P<0.001 ** P=0.284 P<0.001 ** P<0.001 ** |
|POLY 3 | |P<0.001 ** P=0.343 P<0.001 ** P<0.001 ** |
|POLY 1.5 | |P<0.001 ** P=0.360 P<0.001 ** P<0.001 ** |
|POLY 6 | |P<0.001 ** P=0.325 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| |P<0.001 ** P=0.406 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | |P<0.001 ** P=0.387 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |12/50 (24%) 20/50 (40%) 27/50 (54%) 19/50 (38%) |
|POLY-3 RATE (b) | |12/48.16 20/44.35 27/48.13 19/37.43 |
|POLY-3 PERCENT (g) | |24.9% 45.1% 56.1% 50.8% |
|TERMINAL (d) | |9/39 (23%) 18/32 (56%) 22/39 (56%) 14/23 (61%) |
|FIRST INCIDENCE | |338 688 516 382 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.002 ** P=0.016 * P=0.004 ** P=0.002 ** |
|POLY 3 | |P=0.008 ** P=0.032 * P<0.001 ** P=0.011 * |
|POLY 1.5 | |P=0.019 * P=0.042 * P<0.001 ** P=0.022 * |
|POLY 6 | |P=0.004 ** P=0.022 * P<0.001 ** P=0.005 ** |
|LOGISTIC REGRESSION| |P=0.016 * P=0.046 * P=0.002 ** P=0.026 * |
|COCH-ARM / FISHERS | |P=0.127 P=0.066 P=0.002 ** P=0.097 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | |0/46.90 0/44.06 2/47.00 2/36.08 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 4.3% 5.5% |
|TERMINAL (d) | |0/39 (0%) 0/32 (0%) 2/39 (5%) 1/23 (4%) |
|FIRST INCIDENCE | |--- --- 729 (T) 352 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.036 * (e) P=0.238 P=0.177 |
|POLY 3 | |P=0.042 * (e) P=0.238 P=0.184 |
|POLY 1.5 | |P=0.048 * (e) P=0.237 P=0.199 |
|POLY 6 | |P=0.038 * (e) P=0.239 P=0.172 |
|LOGISTIC REGRESSION| |P=0.096 (e) P=0.238 P=0.343 |
|COCH-ARM / FISHERS | |P=0.072 (e) P=0.247 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | |0/46.90 1/44.06 3/47.00 2/35.19 |
|POLY-3 PERCENT (g) | |0.0% 2.3% 6.4% 5.7% |
|TERMINAL (d) | |0/39 (0%) 1/32 (3%) 3/39 (8%) 2/23 (9%) |
|FIRST INCIDENCE | |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.068 P=0.461 P=0.121 P=0.132 |
|POLY 3 | |P=0.084 P=0.488 P=0.119 P=0.180 |
|POLY 1.5 | |P=0.099 P=0.493 P=0.119 P=0.195 |
|POLY 6 | |P=0.074 P=0.481 P=0.120 P=0.167 |
|LOGISTIC REGRESSION| |(e) P=0.461 P=0.121 P=0.132 |
|COCH-ARM / FISHERS | |P=0.159 P=0.500 P=0.121 P=0.247 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | |0/46.90 0/44.06 0/47.00 2/35.29 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 0.0% 5.7% |
|TERMINAL (d) | |0/39 (0%) 0/32 (0%) 0/39 (0%) 1/23 (4%) |
|FIRST INCIDENCE | |--- --- --- 704 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.021 * (e) (e) P=0.141 |
|POLY 3 | |P=0.038 * (e) (e) P=0.181 |
|POLY 1.5 | |P=0.037 * (e) (e) P=0.196 |
|POLY 6 | |P=0.042 * (e) (e) P=0.168 |
|LOGISTIC REGRESSION| |P=0.024 * (e) (e) P=0.158 |
|COCH-ARM / FISHERS | |P=0.043 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 9/50 (18%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.19 2/46.03 1/45.28 0/30.48 |2/46.90 1/44.06 9/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 2.2% 4.3% 2.2% 0.0% |4.3% 2.3% 19.2% 0.0% |
|TERMINAL (d) | 1/38 (3%) 2/42 (5%) 1/39 (3%) 0/14 (0%) |2/39 (5%) 1/32 (3%) 9/39 (23%) 0/23 (0%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 730 (T) --- |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.395N P=0.535 P=0.756N P=0.699N |P=0.440 P=0.569N P=0.026 * P=0.361N |
|POLY 3 | P=0.313N P=0.499 P=0.756 P=0.580N |P=0.363 P=0.522N P=0.025 * P=0.306N |
|POLY 1.5 | P=0.269N P=0.493 P=0.756 P=0.555N |P=0.442 P=0.513N P=0.025 * P=0.285N |
|POLY 6 | P=0.361N P=0.506 P=0.757 P=0.604N |P=0.297 P=0.533N P=0.026 * P=0.327N |
|LOGISTIC REGRESSION| P=0.395N P=0.535 P=0.756N (e) |P=0.440 P=0.569N P=0.026 * (e) |
|COCH-ARM / FISHERS | P=0.209N P=0.500 P=0.753N P=0.500N |P=0.500N P=0.500N P=0.026 * P=0.247N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 1/46.03 0/45.28 1/30.68 |2/47.24 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 3.3% |4.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 1/42 (2%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 730 (T) --- 679 |659 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.287 P=0.520 (e) P=0.371 |P=0.182N P=0.276N P=0.234N P=0.346N |
|POLY 3 | P=0.416 P=0.499 (e) P=0.421 |P=0.137N P=0.253N P=0.238N P=0.308N |
|POLY 1.5 | P=0.405 P=0.496 (e) P=0.445 |P=0.139N P=0.246N P=0.239N P=0.286N |
|POLY 6 | P=0.435 P=0.504 (e) P=0.398 |P=0.136N P=0.262N P=0.238N P=0.331N |
|LOGISTIC REGRESSION| P=0.377 P=0.520 (e) P=0.445 |P=0.145N P=0.224N P=0.231N P=0.258N |
|COCH-ARM / FISHERS | P=0.455 P=0.500 (e) P=0.500 |P=0.152N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/42 (5%) 0/44 (0%) 0/34 (0%) 1/41 (2%) |1/43 (2%) 1/39 (3%) 0/37 (0%) 0/34 (0%) |
|POLY-3 RATE (b) | 2/39.31 0/42.80 0/31.49 1/24.92 |1/40.62 1/35.01 0/35.07 0/23.45 |
|POLY-3 PERCENT (g) | 5.1% 0.0% 0.0% 4.0% |2.5% 2.9% 0.0% 0.0% |
|TERMINAL (d) | 1/31 (3%) 0/40 (0%) 0/27 (0%) 1/12 (8%) |0/34 (0%) 1/29 (3%) 0/29 (0%) 0/17 (0%) |
|FIRST INCIDENCE | 528 --- --- 730 (T) |704 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.611 P=0.218N P=0.262N P=0.721 |P=0.272N P=0.719 P=0.491N P=0.596N |
|POLY 3 | P=0.564N P=0.218N P=0.287N P=0.650N |P=0.252N P=0.727 P=0.529N P=0.605N |
|POLY 1.5 | P=0.552N P=0.222N P=0.289N P=0.608N |P=0.241N P=0.731 P=0.529N P=0.589N |
|POLY 6 | P=0.571N P=0.213N P=0.285N P=0.688N |P=0.261N P=0.723 P=0.530N P=0.617N |
|LOGISTIC REGRESSION| P=0.514N P=0.328N P=0.231N P=0.567N |P=0.276N P=0.732 P=0.533N P=0.603N |
|COCH-ARM / FISHERS | P=0.539N P=0.236N P=0.302N P=0.509N |P=0.242N P=0.728 P=0.537N P=0.558N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 2/46 (4%) 3/47 (6%) 2/47 (4%) |0/48 (0%) 0/49 (0%) 1/48 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/45.19 2/42.03 3/43.10 2/28.82 |0/44.90 0/43.87 1/45.06 0/34.75 |
|POLY-3 PERCENT (g) | 6.6% 4.8% 7.0% 6.9% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 3/37 (8%) 2/38 (5%) 2/37 (5%) 2/14 (14%) |0/37 (0%) 0/32 (0%) 1/38 (3%) 0/23 (0%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 515 730 (T) |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.317 P=0.488N P=0.659 P=0.447 |P=0.614 (e) P=0.505 (e) |
|POLY 3 | P=0.490 P=0.533N P=0.640 P=0.657 |P=0.530 (e) P=0.501 (e) |
|POLY 1.5 | P=0.537 P=0.540N P=0.638 P=0.641N |P=0.558 (e) P=0.500 (e) |
|POLY 6 | P=0.451 P=0.524N P=0.646 P=0.602 |P=0.513 (e) P=0.503 (e) |
|LOGISTIC REGRESSION| P=0.510 P=0.488N P=0.651 P=0.447 |(e) (e) P=0.505 (e) |
|COCH-ARM / FISHERS | P=0.489N P=0.530N P=0.641 P=0.520N |P=0.658 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/46 (0%) 0/47 (0%) 0/47 (0%) |10/48 (21%) 8/49 (16%) 6/48 (13%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/45.19 0/42.03 0/42.45 0/28.82 |10/45.09 8/43.87 6/45.06 2/35.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |22.2% 18.2% 13.3% 5.7% |
|TERMINAL (d) | 0/37 (0%) 0/38 (0%) 0/37 (0%) 0/14 (0%) |9/37 (24%) 8/32 (25%) 6/38 (16%) 1/23 (4%) |
|FIRST INCIDENCE | --- --- --- --- |677 729 (T) 729 (T) 547 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.038N* P=0.533N P=0.188N P=0.086N |
|POLY 3 | (e) (e) (e) (e) |P=0.026N* P=0.422N P=0.205N P=0.040N* |
|POLY 1.5 | (e) (e) (e) (e) |P=0.021N* P=0.402N P=0.208N P=0.029N* |
|POLY 6 | (e) (e) (e) (e) |P=0.031N* P=0.451N P=0.200N P=0.052N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.030N* P=0.493N P=0.186N P=0.041N* |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.009N** P=0.379N P=0.206N P=0.012N* |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/49 (22%) 13/50 (26%) 11/50 (22%) 13/50 (26%) | |
|POLY-3 RATE (b) | 11/46.15 13/46.19 11/45.45 13/35.20 | |
|POLY-3 PERCENT (g) | 23.8% 28.1% 24.2% 36.9% | |
|TERMINAL (d) | 9/37 (24%) 12/42 (29%) 10/39 (26%) 3/14 (21%) | |
|FIRST INCIDENCE | 528 689 685 410 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.007 ** P=0.534 P=0.551N P=0.017 * | |
|POLY 3 | P=0.183 P=0.408 P=0.580 P=0.152 | |
|POLY 1.5 | P=0.243 P=0.398 P=0.588 P=0.213 | |
|POLY 6 | P=0.142 P=0.423 P=0.577 P=0.108 | |
|LOGISTIC REGRESSION| P=0.241 P=0.417 P=0.592N P=0.318 | |
|COCH-ARM / FISHERS | P=0.453 P=0.430 P=0.574N P=0.430 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/49 (18%) 3/50 (6%) 8/50 (16%) 2/50 (4%) | |
|POLY-3 RATE (b) | 9/45.26 3/46.19 8/45.87 2/30.49 | |
|POLY-3 PERCENT (g) | 19.9% 6.5% 17.4% 6.6% | |
|TERMINAL (d) | 8/37 (22%) 2/42 (5%) 5/39 (13%) 1/14 (7%) | |
|FIRST INCIDENCE | 714 689 610 728 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.514N P=0.042N* P=0.468N P=0.341N | |
|POLY 3 | P=0.290N P=0.054N P=0.488N P=0.107N | |
|POLY 1.5 | P=0.201N P=0.059N P=0.491N P=0.068N | |
|POLY 6 | P=0.390N P=0.049N* P=0.476N P=0.161N | |
|LOGISTIC REGRESSION| P=0.305N P=0.050N P=0.496N P=0.232N | |
|COCH-ARM / FISHERS | P=0.085N P=0.056N P=0.482N P=0.023N* | |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 36
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland: Duct |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/49 (35%) 11/50 (22%) 22/50 (44%) 16/50 (32%) | |
|POLY-3 RATE (b) | 17/46.34 11/46.26 22/45.65 16/34.51 | |
|POLY-3 PERCENT (g) | 36.7% 23.8% 48.2% 46.4% | |
|TERMINAL (d) | 14/37 (38%) 9/42 (21%) 21/39 (54%) 6/14 (43%) | |
|FIRST INCIDENCE | 528 689 626 410 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.080N P=0.255 P=0.013 * | |
|POLY 3 | P=0.040 * P=0.129N P=0.181 P=0.260 | |
|POLY 1.5 | P=0.085 P=0.136N P=0.192 P=0.378 | |
|POLY 6 | P=0.019 * P=0.118N P=0.174 P=0.170 | |
|LOGISTIC REGRESSION| P=0.045 * P=0.125N P=0.204 P=0.333 | |
|COCH-ARM / FISHERS | P=0.324 P=0.119N P=0.229 P=0.472N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Prostate |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 31/50 (62%) 29/50 (58%) 22/50 (44%) | |
|POLY-3 RATE (b) | 36/48.70 31/46.80 29/46.88 22/35.91 | |
|POLY-3 PERCENT (g) | 73.9% 66.2% 61.9% 61.3% | |
|TERMINAL (d) | 27/38 (71%) 29/42 (69%) 26/39 (67%) 10/14 (71%) | |
|FIRST INCIDENCE | 528 535 515 239 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.032 * P=0.096N P=0.113N P=0.073 | |
|POLY 3 | P=0.126N P=0.274N P=0.144N P=0.151N | |
|POLY 1.5 | P=0.050N P=0.275N P=0.131N P=0.057N | |
|POLY 6 | P=0.257N P=0.280N P=0.163N P=0.330N | |
|LOGISTIC REGRESSION| P=0.125N P=0.231N P=0.122N P=0.119N | |
|COCH-ARM / FISHERS | P=0.003N** P=0.198N P=0.104N P=0.004N** | |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 37
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |
|POLY-3 RATE (b) | 2/46.69 2/46.19 0/45.28 0/30.48 | |
|POLY-3 PERCENT (g) | 4.3% 4.3% 0.0% 0.0% | |
|TERMINAL (d) | 1/38 (3%) 1/42 (2%) 0/39 (0%) 0/14 (0%) | |
|FIRST INCIDENCE | 582 689 --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.133N P=0.672N P=0.244N P=0.422N | |
|POLY 3 | P=0.096N P=0.690 P=0.244N P=0.342N | |
|POLY 1.5 | P=0.084N P=0.685 P=0.243N P=0.306N | |
|POLY 6 | P=0.108N P=0.691N P=0.245N P=0.382N | |
|LOGISTIC REGRESSION| P=0.069N P=0.687N P=0.205N P=0.240N | |
|COCH-ARM / FISHERS | P=0.072N P=0.691N P=0.247N P=0.247N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Salivary Glands |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 34/50 (68%) 36/50 (72%) 23/50 (46%) |36/50 (72%) 32/50 (64%) 32/49 (65%) 15/50 (30%) |
|POLY-3 RATE (b) | 35/48.55 34/47.28 36/47.72 23/35.14 |36/48.16 32/47.19 32/46.47 15/37.73 |
|POLY-3 PERCENT (g) | 72.1% 71.9% 75.5% 65.5% |74.8% 67.8% 68.9% 39.8% |
|TERMINAL (d) | 29/38 (76%) 32/42 (76%) 30/39 (77%) 12/14 (86%) |31/39 (80%) 23/32 (72%) 29/39 (74%) 10/23 (44%) |
|FIRST INCIDENCE | 528 518 497 274 |562 424 639 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.264N P=0.543 P=0.015 * |P=0.020N* P=0.417 P=0.255N P=0.053N |
|POLY 3 | P=0.362N P=0.583N P=0.443 P=0.337N |P<0.001N** P=0.296N P=0.339N P<0.001N** |
|POLY 1.5 | P=0.152N P=0.582 P=0.451 P=0.152N |P<0.001N** P=0.278N P=0.334N P<0.001N** |
|POLY 6 | P=0.483 P=0.575N P=0.442 P=0.582N |P=0.003N** P=0.325N P=0.343N P=0.002N** |
|LOGISTIC REGRESSION| P=0.285N P=0.561N P=0.454 P=0.338N |P<0.001N** P=0.338N P=0.288N P<0.001N** |
|COCH-ARM / FISHERS | P=0.007N** P=0.500N P=0.500 P=0.013N* |P<0.001N** P=0.260N P=0.308N P<0.001N** |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 38
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 0/46.03 0/45.28 0/30.48 |1/46.90 2/44.39 1/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.1% 4.5% 2.1% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |1/39 (3%) 1/32 (3%) 1/39 (3%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 640 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.282N P=0.449 P=0.762 P=0.605N |
|POLY 3 | (e) (e) (e) (e) |P=0.267N P=0.481 P=0.760N P=0.556N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.247N P=0.489 P=0.760 P=0.540N |
|POLY 6 | (e) (e) (e) (e) |P=0.289N P=0.471 P=0.758N P=0.571N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.243N P=0.501 P=0.762 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.209N P=0.500 P=0.753N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 0/46.03 0/45.28 0/30.48 |0/46.90 2/44.39 1/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.5% 2.1% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 1/32 (3%) 1/39 (3%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 640 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.459N P=0.214 P=0.500 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.454N P=0.225 P=0.500 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.425N P=0.230 P=0.500 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.487N P=0.219 P=0.502 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.404N P=0.246 P=0.500 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.372N P=0.247 P=0.500 (e) |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 39
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 7/50 (14%) 16/50 (32%) 12/50 (24%) |17/50 (34%) 23/50 (46%) 24/50 (48%) 21/50 (42%) |
|POLY-3 RATE (b) | 17/49.10 7/46.19 16/47.69 12/33.65 |17/47.93 23/46.93 24/48.34 21/39.98 |
|POLY-3 PERCENT (g) | 34.6% 15.2% 33.6% 35.7% |35.5% 49.0% 49.7% 52.5% |
|TERMINAL (d) | 8/38 (21%) 6/42 (14%) 8/39 (21%) 3/14 (21%) |14/39 (36%) 13/32 (41%) 16/39 (41%) 9/23 (39%) |
|FIRST INCIDENCE | 464 689 515 502 |562 468 639 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027 * P=0.018N* P=0.501N P=0.198 |P=0.030 * P=0.063 P=0.141 P=0.015 * |
|POLY 3 | P=0.204 P=0.024N* P=0.541N P=0.553 |P=0.104 P=0.128 P=0.114 P=0.080 |
|POLY 1.5 | P=0.294 P=0.023N* P=0.534N P=0.484N |P=0.144 P=0.137 P=0.108 P=0.115 |
|POLY 6 | P=0.146 P=0.025N* P=0.539N P=0.422 |P=0.086 P=0.120 P=0.126 P=0.062 |
|LOGISTIC REGRESSION| P=0.461 P=0.016N* P=0.449N P=0.342N |P=0.207 P=0.151 P=0.110 P=0.159 |
|COCH-ARM / FISHERS | P=0.500N P=0.017N* P=0.500N P=0.189N |P=0.344 P=0.154 P=0.111 P=0.268 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |18/50 (36%) 16/50 (32%) 17/50 (34%) 10/50 (20%) |
|POLY-3 RATE (b) | 2/46.19 0/46.03 0/45.28 0/30.48 |18/46.98 16/44.37 17/47.00 10/35.68 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |38.3% 36.1% 36.2% 28.0% |
|TERMINAL (d) | 2/38 (5%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |17/39 (44%) 14/32 (44%) 17/39 (44%) 9/23 (39%) |
|FIRST INCIDENCE | 730 (T) --- --- --- |708 653 729 (T) 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.226N P=0.217N P=0.233N P=0.475N |P=0.391N P=0.473 P=0.497N P=0.511N |
|POLY 3 | P=0.158N P=0.238N P=0.242N P=0.340N |P=0.218N P=0.498N P=0.499N P=0.230N |
|POLY 1.5 | P=0.145N P=0.242N P=0.241N P=0.305N |P=0.163N P=0.464N P=0.505N P=0.163N |
|POLY 6 | P=0.170N P=0.233N P=0.241N P=0.377N |P=0.268N P=0.541N P=0.491N P=0.303N |
|LOGISTIC REGRESSION| P=0.226N (e) (e) (e) |P=0.321N P=0.537 P=0.451N P=0.391N |
|COCH-ARM / FISHERS | P=0.152N P=0.247N P=0.247N P=0.247N |P=0.056N P=0.417N P=0.500N P=0.059N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 40
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 6/50 (12%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/46.19 0/46.03 3/46.21 6/33.07 |1/46.98 0/44.06 2/47.04 3/37.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.5% 18.2% |2.1% 0.0% 4.3% 8.1% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 1/39 (3%) 1/23 (4%) |
|FIRST INCIDENCE | --- --- 515 239 |708 --- 721 185 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.123 P=0.003 ** |P=0.041 * P=0.537N P=0.511 P=0.208 |
|POLY 3 | P<0.001 ** (e) P=0.119 P=0.004 ** |P=0.054 P=0.513N P=0.500 P=0.227 |
|POLY 1.5 | P<0.001 ** (e) P=0.118 P=0.007 ** |P=0.060 P=0.507N P=0.499 P=0.249 |
|POLY 6 | P<0.001 ** (e) P=0.121 P=0.003 ** |P=0.052 P=0.520N P=0.503 P=0.206 |
|LOGISTIC REGRESSION| P=0.004 ** (e) P=0.146 P=0.034 * |P=0.207 P=0.506N P=0.501 P=0.596 |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.121 P=0.013 * |P=0.081 P=0.500N P=0.500 P=0.309 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 4/50 (8%) 6/50 (12%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.27 3/46.10 4/46.56 6/31.93 |1/46.90 1/44.34 0/47.00 1/35.52 |
|POLY-3 PERCENT (g) | 4.3% 6.5% 8.6% 18.8% |2.1% 2.3% 0.0% 2.8% |
|TERMINAL (d) | 1/38 (3%) 2/42 (5%) 1/39 (3%) 3/14 (21%) |1/39 (3%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 712 714 512 477 |729 (T) 653 --- 640 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.533 P=0.335 P=0.012 * |P=0.621 P=0.723 P=0.500N P=0.663 |
|POLY 3 | P=0.031 * P=0.498 P=0.340 P=0.048 * |P=0.592N P=0.748 P=0.500N P=0.695 |
|POLY 1.5 | P=0.039 * P=0.491 P=0.336 P=0.067 |P=0.591N P=0.753 P=0.500N P=0.714 |
|POLY 6 | P=0.026 * P=0.508 P=0.347 P=0.033 * |P=0.596N P=0.742 P=0.498N P=0.676 |
|LOGISTIC REGRESSION| P=0.064 P=0.506 P=0.384 P=0.069 |P=0.589N P=0.758N (e) P=0.740 |
|COCH-ARM / FISHERS | P=0.081 P=0.500 P=0.339 P=0.134 |P=0.592N P=0.753N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 41
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.19 3/46.26 1/45.82 2/30.56 |1/47.16 2/44.50 2/47.04 1/35.19 |
|POLY-3 PERCENT (g) | 2.2% 6.5% 2.2% 6.5% |2.1% 4.5% 4.3% 2.8% |
|TERMINAL (d) | 1/38 (3%) 1/42 (2%) 0/39 (0%) 1/14 (7%) |0/39 (0%) 0/32 (0%) 1/39 (3%) 1/23 (4%) |
|FIRST INCIDENCE | 730 (T) 689 563 709 |659 653 721 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.294 P=0.336 P=0.758 P=0.206 |P=0.553 P=0.451 P=0.500 P=0.650 |
|POLY 3 | P=0.469 P=0.306 P=0.759 P=0.363 |P=0.554 P=0.480 P=0.499 P=0.691 |
|POLY 1.5 | P=0.489 P=0.299 P=0.758 P=0.405 |P=0.585 P=0.488 P=0.498 P=0.712 |
|POLY 6 | P=0.460 P=0.315 P=0.760N P=0.322 |P=0.530 P=0.470 P=0.500 P=0.669 |
|LOGISTIC REGRESSION| P=0.496 P=0.301 P=0.735N P=0.271 |P=0.578N P=0.533 P=0.501 P=0.726 |
|COCH-ARM / FISHERS | P=0.586 P=0.309 P=0.753N P=0.500 |P=0.527N P=0.500 P=0.500 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 2/46.26 1/45.96 0/30.48 |1/47.16 1/44.22 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 2.2% 0.0% |2.1% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 689 497 --- |659 688 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500N P=0.253 P=0.500 (e) |P=0.254N P=0.728 P=0.504N P=0.585N |
|POLY 3 | P=0.509N P=0.238 P=0.499 (e) |P=0.217N P=0.746 P=0.501N P=0.557N |
|POLY 1.5 | P=0.453N P=0.234 P=0.498 (e) |P=0.212N P=0.752 P=0.501N P=0.541N |
|POLY 6 | P=0.566N P=0.243 P=0.501 (e) |P=0.225N P=0.738 P=0.500N P=0.573N |
|LOGISTIC REGRESSION| P=0.318N P=0.236 P=0.664 (e) |P=0.196N P=0.747N P=0.487N P=0.502N |
|COCH-ARM / FISHERS | P=0.372N P=0.247 P=0.500 (e) |P=0.212N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 42
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 8/50 (16%) 9/50 (18%) |2/50 (4%) 2/50 (4%) 5/50 (10%) 7/50 (14%) |
|POLY-3 RATE (b) | 2/46.27 4/46.26 8/47.46 9/32.92 |2/46.98 2/44.50 5/47.17 7/37.18 |
|POLY-3 PERCENT (g) | 4.3% 8.7% 16.9% 27.3% |4.3% 4.5% 10.6% 18.8% |
|TERMINAL (d) | 1/38 (3%) 2/42 (5%) 3/39 (8%) 4/14 (29%) |1/39 (3%) 0/32 (0%) 3/39 (8%) 3/23 (13%) |
|FIRST INCIDENCE | 712 689 497 337 |708 653 695 382 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.374 P=0.055 P<0.001 ** |P=0.004 ** P=0.631 P=0.230 P=0.022 * |
|POLY 3 | P=0.002 ** P=0.337 P=0.050 P=0.004 ** |P=0.009 ** P=0.674 P=0.218 P=0.036 * |
|POLY 1.5 | P=0.003 ** P=0.329 P=0.047 * P=0.008 ** |P=0.011 * P=0.682 P=0.216 P=0.045 * |
|POLY 6 | P<0.001 ** P=0.348 P=0.053 P=0.002 ** |P=0.008 ** P=0.665 P=0.221 P=0.030 * |
|LOGISTIC REGRESSION| P=0.013 * P=0.333 P=0.062 P=0.014 * |P=0.019 * P=0.690N P=0.218 P=0.072 |
|COCH-ARM / FISHERS | P=0.013 * P=0.339 P=0.046 * P=0.026 * |P=0.022 * P=0.691N P=0.218 P=0.080 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 2/46.19 0/45.28 0/30.48 |1/46.90 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 0.0% 0.0% |2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 1/42 (2%) 0/39 (0%) 0/14 (0%) |1/39 (3%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 689 --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.407N P=0.259 (e) (e) |P=0.390N P=0.539N P=0.500N P=0.605N |
|POLY 3 | P=0.339N P=0.237 (e) (e) |P=0.313N P=0.512N P=0.500N P=0.556N |
|POLY 1.5 | P=0.310N P=0.233 (e) (e) |P=0.315N P=0.507N P=0.500N P=0.540N |
|POLY 6 | P=0.368N P=0.243 (e) (e) |P=0.316N P=0.519N P=0.498N P=0.571N |
|LOGISTIC REGRESSION| P=0.337N P=0.235 (e) (e) |P=0.390N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.284N P=0.247 (e) (e) |P=0.344N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 43
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 0/46.03 1/45.45 0/30.48 |2/46.90 0/44.06 1/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |4.3% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |2/39 (5%) 0/32 (0%) 1/39 (3%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- 685 --- |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.581 (e) P=0.505 (e) |P=0.313N P=0.283N P=0.500N P=0.361N |
|POLY 3 | P=0.495 (e) P=0.497 (e) |P=0.272N P=0.251N P=0.499N P=0.306N |
|POLY 1.5 | P=0.527 (e) P=0.497 (e) |P=0.261N P=0.246N P=0.501N P=0.285N |
|POLY 6 | P=0.462 (e) P=0.498 (e) |P=0.284N P=0.259N P=0.497N P=0.327N |
|LOGISTIC REGRESSION| P=0.648 (e) P=0.508 (e) |P=0.313N (e) P=0.500N (e) |
|COCH-ARM / FISHERS | P=0.656 (e) P=0.500 (e) |P=0.242N P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular: Glands |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 7/50 (14%) 11/50 (22%) 4/50 (8%) |11/50 (22%) 11/50 (22%) 6/50 (12%) 6/50 (12%) |
|POLY-3 RATE (b) | 2/46.19 7/46.35 11/45.34 4/30.48 |11/47.18 11/44.08 6/47.00 6/36.05 |
|POLY-3 PERCENT (g) | 4.3% 15.1% 24.3% 13.1% |23.3% 25.0% 12.8% 16.6% |
|TERMINAL (d) | 2/38 (5%) 5/42 (12%) 10/39 (26%) 4/14 (29%) |10/39 (26%) 10/32 (31%) 6/39 (15%) 5/23 (22%) |
|FIRST INCIDENCE | 730 (T) 689 714 730 (T) |653 724 729 (T) 382 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * P=0.109 P=0.010 * P=0.034 * |P=0.242N P=0.391 P=0.143N P=0.518N |
|POLY 3 | P=0.087 P=0.080 P=0.006 ** P=0.176 |P=0.130N P=0.525 P=0.143N P=0.321N |
|POLY 1.5 | P=0.157 P=0.075 P=0.006 ** P=0.220 |P=0.110N P=0.554 P=0.145N P=0.260N |
|POLY 6 | P=0.044 * P=0.086 P=0.006 ** P=0.137 |P=0.148N P=0.485 P=0.141N P=0.385N |
|LOGISTIC REGRESSION| P=0.055 P=0.080 P=0.008 ** P=0.034 * |P=0.171N P=0.441 P=0.133N P=0.307N |
|COCH-ARM / FISHERS | P=0.417 P=0.080 P=0.007 ** P=0.339 |P=0.062N P=0.595N P=0.143N P=0.143N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 44
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |
|POLY-3 RATE (b) | 2/46.19 1/46.03 2/45.45 0/30.48 | |
|POLY-3 PERCENT (g) | 4.3% 2.2% 4.4% 0.0% | |
|TERMINAL (d) | 2/38 (5%) 1/42 (2%) 1/39 (3%) 0/14 (0%) | |
|FIRST INCIDENCE | 730 (T) 730 (T) 685 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.439N P=0.465N P=0.684N P=0.475N | |
|POLY 3 | P=0.366N P=0.501N P=0.688 P=0.340N | |
|POLY 1.5 | P=0.306N P=0.507N P=0.688 P=0.305N | |
|POLY 6 | P=0.431N P=0.494N P=0.691 P=0.377N | |
|LOGISTIC REGRESSION| P=0.353N P=0.465N P=0.689 (e) | |
|COCH-ARM / FISHERS | P=0.222N P=0.500N P=0.691N P=0.247N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 1/50 (2%) | |
|POLY-3 RATE (b) | 2/46.69 1/46.03 3/45.42 1/30.54 | |
|POLY-3 PERCENT (g) | 4.3% 2.2% 6.6% 3.3% | |
|TERMINAL (d) | 1/38 (3%) 1/42 (2%) 1/39 (3%) 0/14 (0%) | |
|FIRST INCIDENCE | 582 730 (T) 709 716 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.393 P=0.482N P=0.495 P=0.708 | |
|POLY 3 | P=0.475 P=0.505N P=0.488 P=0.640N | |
|POLY 1.5 | P=0.533 P=0.509N P=0.490 P=0.597N | |
|POLY 6 | P=0.421 P=0.500N P=0.488 P=0.681N | |
|LOGISTIC REGRESSION| P=0.577 P=0.489N P=0.508 P=0.589N | |
|COCH-ARM / FISHERS | P=0.512N P=0.500N P=0.500 P=0.500N | |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 45
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/47 (15%) 4/47 (9%) 7/44 (16%) 4/46 (9%) |6/50 (12%) 11/50 (22%) 4/47 (9%) 10/50 (20%) |
|POLY-3 RATE (b) | 7/44.49 4/44.20 7/41.42 4/29.55 |6/48.59 11/46.80 4/44.83 10/39.02 |
|POLY-3 PERCENT (g) | 15.7% 9.1% 16.9% 13.5% |12.4% 23.5% 8.9% 25.6% |
|TERMINAL (d) | 1/35 (3%) 1/40 (3%) 1/34 (3%) 0/13 (0%) |0/39 (0%) 1/32 (3%) 1/37 (3%) 0/23 (0%) |
|FIRST INCIDENCE | 582 535 497 502 |562 468 639 386 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.363 P=0.247N P=0.588 P=0.583 |P=0.171 P=0.110 P=0.370N P=0.067 |
|POLY 3 | P=0.459 P=0.265N P=0.557 P=0.528N |P=0.249 P=0.123 P=0.421N P=0.095 |
|POLY 1.5 | P=0.539 P=0.274N P=0.554 P=0.449N |P=0.278 P=0.131 P=0.419N P=0.118 |
|POLY 6 | P=0.392 P=0.254N P=0.564 P=0.603N |P=0.227 P=0.116 P=0.424N P=0.077 |
|LOGISTIC REGRESSION| P=0.274N P=0.227N P=0.589N P=0.279N |P=0.495N P=0.220 P=0.383N P=0.323 |
|COCH-ARM / FISHERS | P=0.367N P=0.261N P=0.561 P=0.274N |P=0.387 P=0.143 P=0.410N P=0.207 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Ectopic Parathyroid Gland |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/47 (0%) 0/44 (0%) 0/46 (0%) |1/50 (2%) 2/50 (4%) 0/47 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.19 0/43.10 0/39.34 0/27.71 |1/46.90 2/45.34 0/44.31 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.1% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/34 (0%) 0/13 (0%) |1/39 (3%) 0/32 (0%) 0/37 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 468 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.176N P=0.472 P=0.511N P=0.605N |
|POLY 3 | (e) (e) (e) (e) |P=0.163N P=0.488 P=0.511N P=0.556N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.154N P=0.493 P=0.513N P=0.540N |
|POLY 6 | (e) (e) (e) (e) |P=0.172N P=0.481 P=0.509N P=0.571N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.059N P=0.590 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.144N P=0.500 P=0.515N P=0.500N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 46
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/47 (0%) 0/44 (0%) 0/46 (0%) |1/50 (2%) 0/50 (0%) 2/47 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.19 0/43.10 0/39.34 0/27.71 |1/46.90 0/44.06 2/44.31 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.1% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/34 (0%) 0/13 (0%) |1/39 (3%) 0/32 (0%) 2/37 (5%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.632N P=0.539N P=0.482 P=0.605N |
|POLY 3 | (e) (e) (e) (e) |P=0.617N P=0.512N P=0.480 P=0.556N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.585N P=0.507N P=0.478 P=0.540N |
|POLY 6 | (e) (e) (e) (e) |P=0.611 P=0.519N P=0.484 P=0.571N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.632N (e) P=0.482 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.521N P=0.500N P=0.477 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus: Thymocyte |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 1/47 (2%) 0/44 (0%) 3/46 (7%) |1/50 (2%) 0/50 (0%) 0/47 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.19 1/44.10 0/39.34 3/29.29 |1/47.80 0/44.06 0/44.31 1/36.19 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 10.2% |2.1% 0.0% 0.0% 2.8% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/34 (0%) 0/13 (0%) |0/39 (0%) 0/32 (0%) 0/37 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 4 --- 114 |338 --- --- 135 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * P=0.496 (e) P=0.059 |P=0.534 P=0.500N P=0.504N P=0.749 |
|POLY 3 | P=0.041 * P=0.504 (e) P=0.065 |P=0.517 P=0.516N P=0.515N P=0.694 |
|POLY 1.5 | P=0.039 * P=0.501 (e) P=0.077 |P=0.518 P=0.510N P=0.515N P=0.715 |
|POLY 6 | P=0.046 * P=0.509 (e) P=0.054 |P=0.530 P=0.523N P=0.513N P=0.674 |
|LOGISTIC REGRESSION| P=0.221 (e) (e) P=0.279 |P=0.119N (e) P=0.301N P=0.147N |
|COCH-ARM / FISHERS | P=0.050 P=0.500 (e) P=0.117 |P=0.543 P=0.500N P=0.515N P=0.753N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 47
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 5/50 (10%) 1/50 (2%) |6/50 (12%) 4/50 (8%) 3/49 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/46.53 3/46.03 5/45.65 1/30.48 |6/46.90 4/44.06 3/46.06 1/35.19 |
|POLY-3 PERCENT (g) | 6.5% 6.5% 11.0% 3.3% |12.8% 9.1% 6.5% 2.8% |
|TERMINAL (d) | 2/38 (5%) 3/42 (7%) 4/39 (10%) 1/14 (7%) |6/39 (15%) 4/32 (13%) 3/39 (8%) 1/23 (4%) |
|FIRST INCIDENCE | 636 730 (T) 626 730 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.481 P=0.619N P=0.366 P=0.644N |P=0.098N P=0.498N P=0.241N P=0.183N |
|POLY 3 | P=0.551N P=0.657 P=0.346 P=0.467N |P=0.075N P=0.409N P=0.251N P=0.119N |
|POLY 1.5 | P=0.454N P=0.651 P=0.347 P=0.413N |P=0.065N P=0.393N P=0.254N P=0.097N |
|POLY 6 | P=0.510 P=0.660N P=0.348 P=0.523N |P=0.085N P=0.430N P=0.247N P=0.142N |
|LOGISTIC REGRESSION| P=0.491N P=0.658 P=0.353 P=0.487N |P=0.098N P=0.498N P=0.241N P=0.183N |
|COCH-ARM / FISHERS | P=0.283N P=0.661N P=0.357 P=0.309N |P=0.042N* P=0.370N P=0.254N P=0.056N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/9 (100%) 5/5 (100%) 3/4 (75%) 2/3 (67%) |0/0 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) |
|POLY-3 RATE (b) | 9/9.00 5/5.00 3/4.00 2/2.52 |0/0.00 0/0.00 1/1.00 0/0.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 75.0% 79.3% |0.0% 0.0% 100.0% 0.0% |
|TERMINAL (d) | 8/8 (100%) 5/5 (100%) 3/4 (75%) 1/1 (100%) |0/0 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 714 730 (T) 730 (T) 716 |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.611 (e) P=0.171N P=0.554 |(e) (e) (e) (e) |
|POLY 3 | P=0.115N (e) P=0.329N P=0.668N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.086N (e) P=0.329N P=0.424N |(e) (e) (e) (e) |
|POLY 6 | P=0.197N (e) P=0.329N P=0.994N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.484N (e) P=0.171N (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.065N (e) P=0.308N P=0.250N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 48
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | |1/46.98 2/44.06 3/47.31 1/35.52 |
|POLY-3 PERCENT (g) | |2.1% 4.5% 6.3% 2.8% |
|TERMINAL (d) | |0/39 (0%) 2/32 (6%) 2/39 (5%) 0/23 (0%) |
|FIRST INCIDENCE | |708 729 (T) 646 640 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.491 P=0.433 P=0.312 P=0.667 |
|POLY 3 | |P=0.482 P=0.478 P=0.308 P=0.694 |
|POLY 1.5 | |P=0.520 P=0.487 P=0.306 P=0.714 |
|POLY 6 | |P=0.455 P=0.466 P=0.312 P=0.675 |
|LOGISTIC REGRESSION| |P=0.573 P=0.459 P=0.306 P=0.755 |
|COCH-ARM / FISHERS | |P=0.561N P=0.500 P=0.309 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | |1/47.00 2/44.24 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | |2.1% 4.5% 0.0% 0.0% |
|TERMINAL (d) | |0/39 (0%) 1/32 (3%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | |704 683 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.181N P=0.439 P=0.491N P=0.588N |
|POLY 3 | |P=0.158N P=0.479 P=0.500N P=0.557N |
|POLY 1.5 | |P=0.151N P=0.488 P=0.501N P=0.540N |
|POLY 6 | |P=0.167N P=0.468 P=0.499N P=0.572N |
|LOGISTIC REGRESSION| |P=0.158N P=0.493 P=0.500N P=0.554N |
|COCH-ARM / FISHERS | |P=0.141N P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 49
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |40/50 (80%) 41/50 (82%) 29/50 (58%) 19/50 (38%) |
|POLY-3 RATE (b) | |40/47.59 41/47.30 29/47.36 19/36.27 |
|POLY-3 PERCENT (g) | |84.1% 86.7% 61.2% 52.4% |
|TERMINAL (d) | |36/39 (92%) 30/32 (94%) 27/39 (69%) 15/23 (65%) |
|FIRST INCIDENCE | |653 468 645 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.003N** P=0.046 * P=0.009N** P=0.099N |
|POLY 3 | |P<0.001N** P=0.470 P=0.008N** P<0.001N** |
|POLY 1.5 | |P<0.001N** P=0.477 P=0.011N* P<0.001N** |
|POLY 6 | |P<0.001N** P=0.473 P=0.006N** P=0.002N** |
|LOGISTIC REGRESSION| |P<0.001N** P=0.254 P=0.006N** P=0.014N* |
|COCH-ARM / FISHERS | |P<0.001N** P=0.500 P=0.015N* P<0.001N** |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).