TDMS Study 88138-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus BENZOPHENONE DATE: 07/21/03
EXPERIMENT: 88138 TEST: 03 TIME: 15:27:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55388 ROUTE: DOSED FEED NTP C#: 88138B
PATHOLOGIST: MISSING CAS: 119-61-9
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1 RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus BENZOPHENONE DATE: 07/21/03
EXPERIMENT: 88138 TEST: 03 TIME: 15:27:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED FEED NTP C#: 88138B
PATHOLOGIST: MISSING CAS: 119-61-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF BENZOPHENONE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hematopoietic Cell Proliferation
Hyperplasia
Hypertrophy
Vacuolization Cytoplasmic
Adrenal Medulla Hyperplasia
Blood Vessel Mineralization
Bone Fibrous Osteodystrophy
Bone Marrow Inflammation Granulomatous
Myelofibrosis
Bone Marrow: Erythroid Cell Hyperplasia
Bone Marrow: Myeloid Cell Hyperplasia
Brain Necrosis
Epididymis Granuloma Sperm
Eye: Retina Degeneration
Heart Cardiomyopathy
Mineralization
Intestine Large, Cecum Inflammation
Mineralization
Kidney Nephropathy
Kidney: Cortex Mineralization
Kidney: Medulla Mineralization
Kidney: Pelvis Inflammation
Kidney: Pelvis, Transitional Epithelium
Hyperplasia
Kidney: Renal Tubule Cyst
Hyperplasia
Liver Basophilic Focus
Clear Cell Focus
Degeneration Cystic
Eosinophilic Focus
Fatty Change Diffuse
Inflammation Chronic
Mixed Cell Focus
Necrosis
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte, Centrilobular Hypertrophy
Lung Inflammation Acute
Mineralization
Lung: Alveolar Epithelium Hyperplasia
Lung: Alveolus Infiltration Cellular Histiocyte
Lymph Node, Mesenteric Atrophy
Ectasia
Infiltration Cellular Histiocyte
Lymph Node: Mediastinal Ectasia
Hyperplasia
Infiltration Cellular Plasma Cell
Lymph Node: Pancreatic Ectasia
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus BENZOPHENONE DATE: 07/21/03
EXPERIMENT: 88138 TEST: 03 TIME: 15:27:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED FEED NTP C#: 88138B
PATHOLOGIST: MISSING CAS: 119-61-9
Inflammation
Mesentery: Fat Necrosis
Nose Inflammation
Pancreas Cyst
Inflammation
Pancreas: Acinus Atrophy
Parathyroid Gland Hyperplasia
Pituitary Gland Angiectasis
Cyst
Hyperplasia
Prostate Atrophy
Inflammation
Seminal Vesicle Atrophy
Mineralization
Spleen Hematopoietic Cell Proliferation
Hyperplasia Lymphoid
Inflammation Granulomatous
Pigmentation Hemosiderin
Stomach, Forestomach Hyperplasia
Inflammation
Mineralization
Ulcer
Stomach, Glandular Inflammation
Mineralization
Ulcer
Testes: Germinal Epithelium Degeneration
Testes: Interstitial Cell Hyperplasia
Thymus Atrophy
Ectopic Parathyroid Gland
Thyroid Gland: C-Cell Hyperplasia
Trachea Inflammation
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Angiectasis
Adrenal Medulla Necrosis
Bone Fibrous Osteodystrophy
Bone Marrow Myelofibrosis
Bone Marrow: Erythroid Cell Hyperplasia
Bone Marrow: Myeloid Cell Hyperplasia
Clitoral Gland Hyperplasia
Harderian Gland Infiltration Cellular Lymphoid
Kidney: Medulla Mineralization
Liver Basophilic Focus
Degeneration Cystic
Eosinophilic Focus
Fatty Change Diffuse
Inflammation Chronic
Mixed Cell Focus
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte, Centrilobular Hypertrophy
Liver: Oval Cell Hyperplasia
Lung Inflammation Granulomatous
Lymph Node: Deep Cervical Infiltration Cellular Histiocyte
Infiltration Cellular Plasma Cell
Lymph Node: Mediastinal Hemorrhage
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus BENZOPHENONE DATE: 07/21/03
EXPERIMENT: 88138 TEST: 03 TIME: 15:27:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED FEED NTP C#: 88138B
PATHOLOGIST: MISSING CAS: 119-61-9
Mammary Gland Galactocele
Mesentery: Fat Necrosis
Pancreas Inflammation
Pancreas: Acinus Atrophy
Pituitary Gland Angiectasis
Spleen Hematopoietic Cell Proliferation
Spleen: Lymphoid Follicle Atrophy
Stomach, Glandular Inflammation
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/49 (8%) 2/50 (4%) 1/50 (2%) |42/50 (84%) 36/50 (72%) 18/50 (36%) 24/50 (48%) |
|POLY-3 RATE (b) | 4/42.08 4/41.92 2/44.46 1/32.16 |42/47.20 36/48.60 18/47.66 24/47.36 |
|POLY-3 PERCENT (g) | 9.5% 9.5% 4.5% 3.1% |89.0% 74.1% 37.8% 50.7% |
|TERMINAL (d) | 4/22 (18%) 2/27 (7%) 1/31 (3%) 0/2 (0%) |31/32 (97%) 30/38 (79%) 16/37 (43%) 19/34 (56%) |
|FIRST INCIDENCE | 729 (T) 373 687 691 |528 613 662 528 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.398N P=0.548N P=0.199N P=0.546 |P<0.001N** P=0.014N* P<0.001N** P<0.001N** |
|POLY 3 | P=0.139N P=0.642 P=0.311N P=0.270N |P<0.001N** P=0.046N* P<0.001N** P<0.001N** |
|POLY 1.5 | P=0.118N P=0.635 P=0.324N P=0.222N |P<0.001N** P=0.055N P<0.001N** P<0.001N** |
|POLY 6 | P=0.172N P=0.632N P=0.290N P=0.366N |P<0.001N** P=0.049N* P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.123N P=0.631 P=0.251N P=0.719 |P<0.001N** P=0.026N* P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P=0.094N P=0.631 P=0.339N P=0.181N |P<0.001N** P=0.114N P<0.001N** P<0.001N** |
|ORDER RESTRICTED | P=0.242N (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.76 0/40.97 0/44.30 0/32.01 |3/44.94 2/47.49 2/47.41 0/45.76 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |6.7% 4.2% 4.2% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |1/32 (3%) 2/38 (5%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 495 --- --- --- |430 729 (T) 679 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.308N P=0.508N P=0.504N P=0.504N |P=0.083N P=0.443N P=0.458N P=0.121N |
|POLY 3 | P=0.258N P=0.509N P=0.493N P=0.557N |P=0.086N P=0.475N P=0.476N P=0.115N |
|POLY 1.5 | P=0.284N P=0.508N P=0.497N P=0.529N |P=0.085N P=0.482N P=0.483N P=0.116N |
|POLY 6 | P=0.229N P=0.506N P=0.486N P=0.602N |P=0.088N P=0.470N P=0.471N P=0.117N |
|LOGISTIC REGRESSION| P=0.293N P=0.367N P=0.599N P=0.511N |P=0.104N P=0.586N P=0.602N P=0.156N |
|COCH-ARM / FISHERS | P=0.305N P=0.505N P=0.500N P=0.500N |P=0.086N P=0.500N P=0.500N P=0.121N |
|ORDER RESTRICTED | P=0.178N (e) (e) (e) |P=0.074N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/49 (0%) 2/50 (4%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 5/43.16 0/40.97 2/44.46 0/32.01 |3/44.12 1/47.49 2/47.30 2/45.76 |
|POLY-3 PERCENT (g) | 11.6% 0.0% 4.5% 0.0% |6.8% 2.1% 4.2% 4.4% |
|TERMINAL (d) | 2/22 (9%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |3/32 (9%) 1/38 (3%) 0/37 (0%) 2/34 (6%) |
|FIRST INCIDENCE | 549 --- 687 --- |729 (T) 729 (T) 709 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.076N P=0.032N* P=0.151N P=0.227N |P=0.495N P=0.245N P=0.439N P=0.472N |
|POLY 3 | P=0.037N* P=0.034N* P=0.203N P=0.065N |P=0.501N P=0.279N P=0.468N P=0.483N |
|POLY 1.5 | P=0.032N* P=0.034N* P=0.210N P=0.045N* |P=0.499N P=0.287N P=0.478N P=0.487N |
|POLY 6 | P=0.045N* P=0.034N* P=0.192N P=0.116N |P=0.505N P=0.274N P=0.462N P=0.485N |
|LOGISTIC REGRESSION| P=0.028N* P=0.033N* P=0.225N P=0.033N* |P=0.511N P=0.245N P=0.463N P=0.472N |
|COCH-ARM / FISHERS | P=0.029N* P=0.030N* P=0.218N P=0.028N* |P=0.500N P=0.309N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.012N* (e) (e) (e) |P=0.364N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/49 (8%) 11/50 (22%) 4/50 (8%) |6/50 (12%) 10/50 (20%) 6/50 (12%) 6/50 (12%) |
|POLY-3 RATE (b) | 1/42.26 4/41.44 11/44.91 4/32.81 |6/44.14 10/48.39 6/47.78 6/45.93 |
|POLY-3 PERCENT (g) | 2.4% 9.7% 24.5% 12.2% |13.6% 20.7% 12.6% 13.1% |
|TERMINAL (d) | 0/22 (0%) 3/27 (11%) 8/31 (26%) 1/2 (50%) |5/32 (16%) 6/38 (16%) 4/37 (11%) 5/34 (15%) |
|FIRST INCIDENCE | 681 590 624 624 |725 633 644 686 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.225 P=0.013 * P=0.010 * |P=0.381N P=0.319 P=0.518N P=0.581N |
|POLY 3 | P=0.043 * P=0.172 P=0.003 ** P=0.111 |P=0.367N P=0.267 P=0.564N P=0.593N |
|POLY 1.5 | P=0.088 P=0.170 P=0.002 ** P=0.141 |P=0.371N P=0.246 P=0.582N P=0.598N |
|POLY 6 | P=0.011 * P=0.178 P=0.003 ** P=0.072 |P=0.371N P=0.289 P=0.548N P=0.594N |
|LOGISTIC REGRESSION| P=0.030 * P=0.171 P=0.004 ** P=0.075 |P=0.378N P=0.244 P=0.574N P=0.618N |
|COCH-ARM / FISHERS | P=0.173 P=0.175 P=0.002 ** P=0.181 |P=0.391N P=0.207 P=0.620N P=0.620N |
|ORDER RESTRICTED | P=0.021 * (e) (e) (e) |P=0.442N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 2/49 (4%) 3/50 (6%) 3/50 (6%) |7/50 (14%) 5/50 (10%) 5/50 (10%) 8/50 (16%) |
|POLY-3 RATE (b) | 8/42.68 2/41.05 3/44.31 3/32.45 |7/44.47 5/47.58 5/47.22 8/46.80 |
|POLY-3 PERCENT (g) | 18.7% 4.9% 6.8% 9.3% |15.7% 10.5% 10.6% 17.1% |
|TERMINAL (d) | 4/22 (18%) 1/27 (4%) 2/31 (7%) 1/2 (50%) |5/32 (16%) 3/38 (8%) 5/37 (14%) 5/34 (15%) |
|FIRST INCIDENCE | 676 710 726 662 |637 710 729 (T) 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.570 P=0.032N* P=0.042N* P=0.266 |P=0.381 P=0.283N P=0.291N P=0.540 |
|POLY 3 | P=0.142N P=0.050N P=0.085N P=0.207N |P=0.391 P=0.333N P=0.338N P=0.543 |
|POLY 1.5 | P=0.126N P=0.051N P=0.092N P=0.146N |P=0.388 P=0.346N P=0.349N P=0.532 |
|POLY 6 | P=0.158N P=0.047N* P=0.076N P=0.345N |P=0.388 P=0.324N P=0.333N P=0.544 |
|LOGISTIC REGRESSION| P=0.324N P=0.046N* P=0.067N P=0.562N |P=0.381 P=0.322N P=0.323N P=0.509 |
|COCH-ARM / FISHERS | P=0.107N P=0.049N* P=0.100N P=0.100N |P=0.372 P=0.380N P=0.380N P=0.500 |
|ORDER RESTRICTED | P=0.074N (e) (e) (e) |P=0.396 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/49 (8%) 0/50 (0%) 1/50 (2%) |5/50 (10%) 7/50 (14%) 5/50 (10%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/42.64 4/42.02 0/44.30 1/32.71 |5/45.17 7/47.99 5/47.30 2/45.92 |
|POLY-3 PERCENT (g) | 2.4% 9.5% 0.0% 3.1% |11.1% 14.6% 10.6% 4.4% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |1/32 (3%) 3/38 (8%) 4/37 (11%) 1/34 (3%) |
|FIRST INCIDENCE | 553 624 --- 487 |430 653 709 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.511N P=0.181 P=0.504N P=0.747 |P=0.122N P=0.475 P=0.557N P=0.214N |
|POLY 3 | P=0.381N P=0.173 P=0.492N P=0.698 |P=0.115N P=0.423 P=0.601N P=0.209N |
|POLY 1.5 | P=0.362N P=0.171 P=0.496N P=0.730 |P=0.114N P=0.410 P=0.608N P=0.210N |
|POLY 6 | P=0.400N P=0.183 P=0.485N P=0.638 |P=0.119N P=0.433 P=0.598N P=0.213N |
|LOGISTIC REGRESSION| P=0.245N P=0.191 P=0.551N P=0.715N |P=0.124N P=0.324 P=0.603 P=0.246N |
|COCH-ARM / FISHERS | P=0.335N P=0.175 P=0.500N P=0.753N |P=0.118N P=0.380 P=0.630N P=0.218N |
|ORDER RESTRICTED | P=0.250N (e) (e) (e) |P=0.143N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 27/49 (55%) 31/50 (62%) 27/50 (54%) |14/50 (28%) 16/50 (32%) 15/50 (30%) 20/50 (40%) |
|POLY-3 RATE (b) | 27/47.51 27/46.76 31/48.48 27/40.73 |14/44.91 16/48.30 15/48.78 20/47.93 |
|POLY-3 PERCENT (g) | 56.8% 57.8% 63.9% 66.3% |31.2% 33.1% 30.8% 41.7% |
|TERMINAL (d) | 8/22 (36%) 13/27 (48%) 18/31 (58%) 1/2 (50%) |10/32 (31%) 10/38 (26%) 8/37 (22%) 11/34 (32%) |
|FIRST INCIDENCE | 425 344 494 529 |528 609 528 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.407N P=0.408N P<0.001 ** |P=0.153 P=0.561N P=0.519N P=0.213 |
|POLY 3 | P=0.170 P=0.548 P=0.306 P=0.235 |P=0.163 P=0.508 P=0.571N P=0.200 |
|POLY 1.5 | P=0.303 P=0.544 P=0.290 P=0.387 |P=0.151 P=0.479 P=0.571 P=0.181 |
|POLY 6 | P=0.062 P=0.551 P=0.330 P=0.080 |P=0.175 P=0.533 P=0.541N P=0.219 |
|LOGISTIC REGRESSION| P=0.435N P=0.556 P=0.221 P=0.582N |P=0.126 P=0.492 P=0.526 P=0.162 |
|COCH-ARM / FISHERS | P=0.516 P=0.537 P=0.272 P=0.579N |P=0.125 P=0.414 P=0.500 P=0.146 |
|ORDER RESTRICTED | P=0.286 (e) (e) (e) |P=0.229 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 8/49 (16%) 11/50 (22%) 5/50 (10%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/43.90 8/41.16 11/45.30 5/33.05 |0/44.12 1/47.49 2/47.33 0/45.76 |
|POLY-3 PERCENT (g) | 13.7% 19.4% 24.3% 15.1% |0.0% 2.1% 4.2% 0.0% |
|TERMINAL (d) | 2/22 (9%) 6/27 (22%) 5/31 (16%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 425 702 543 604 |--- 729 (T) 701 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047 * P=0.485 P=0.308 P=0.174 |P=0.618N P=0.534 P=0.264 (e) |
|POLY 3 | P=0.400 P=0.336 P=0.156 P=0.558 |P=0.605N P=0.515 P=0.253 (e) |
|POLY 1.5 | P=0.537 P=0.346 P=0.148 P=0.603N |P=0.607N P=0.510 P=0.248 (e) |
|POLY 6 | P=0.226 P=0.335 P=0.173 P=0.403 |P=0.608N P=0.518 P=0.257 (e) |
|LOGISTIC REGRESSION| P=0.502 P=0.368 P=0.129 P=0.481N |P=0.615N P=0.534 P=0.251 (e) |
|COCH-ARM / FISHERS | P=0.415N P=0.371 P=0.143 P=0.500N |P=0.616N P=0.500 P=0.247 (e) |
|ORDER RESTRICTED | P=0.371 (e) (e) (e) |P=0.337N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 0/40.97 0/44.30 0/32.01 |2/44.35 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |673 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.115N P=0.221N P=0.227N P=0.241N |
|POLY 3 | (e) (e) (e) (e) |P=0.119N P=0.222N P=0.224N P=0.230N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.117N P=0.227N P=0.227N P=0.231N |
|POLY 6 | (e) (e) (e) (e) |P=0.119N P=0.220N P=0.222N P=0.232N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.117N P=0.236N P=0.236N P=0.235N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.247N P=0.247N P=0.247N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.027N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 11/50 (22%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/42.08 1/41.93 1/44.31 11/36.43 |0/44.12 0/47.49 0/47.22 1/45.78 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 2.3% 30.2% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 624 726 488 |--- --- --- 725 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.486 P=0.566 P<0.001 ** |P=0.193 (e) (e) P=0.512 |
|POLY 3 | P<0.001 ** P=0.499 P=0.510 P<0.001 ** |P=0.200 (e) (e) P=0.507 |
|POLY 1.5 | P<0.001 ** P=0.498 P=0.505 P<0.001 ** |P=0.200 (e) (e) P=0.506 |
|POLY 6 | P<0.001 ** P=0.504 P=0.519 P<0.001 ** |P=0.198 (e) (e) P=0.507 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.522 P=0.551 P=0.003 ** |P=0.193 (e) (e) P=0.501 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 P<0.001 ** |P=0.198 (e) (e) P=0.500 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.127 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 1/44.45 4/33.05 |0/44.12 0/47.49 0/47.22 2/45.95 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 12.1% |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 1/34 (3%) |
|FIRST INCIDENCE | --- --- 691 593 |--- --- --- 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.546 P=0.008 ** |P=0.046 * (e) (e) P=0.254 |
|POLY 3 | P=0.003 ** (e) P=0.511 P=0.035 * |P=0.046 * (e) (e) P=0.246 |
|POLY 1.5 | P=0.004 ** (e) P=0.506 P=0.046 * |P=0.046 * (e) (e) P=0.244 |
|POLY 6 | P=0.003 ** (e) P=0.520 P=0.022 * |P=0.045 * (e) (e) P=0.246 |
|LOGISTIC REGRESSION| P=0.005 ** (e) P=0.502 P=0.041 * |P=0.046 * (e) (e) P=0.241 |
|COCH-ARM / FISHERS | P=0.006 ** (e) P=0.500 P=0.059 |P=0.046 * (e) (e) P=0.247 |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) |P=0.033 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/42.08 0/40.97 1/44.30 2/32.71 |1/44.12 1/47.49 1/47.22 1/46.48 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 6.1% |2.3% 2.1% 2.1% 2.2% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |1/32 (3%) 1/38 (3%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 529 |729 (T) 729 (T) 729 (T) 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011 * (e) P=0.568 P=0.119 |P=0.629N P=0.723N P=0.729N P=0.747N |
|POLY 3 | P=0.048 * (e) P=0.510 P=0.186 |P=0.625N P=0.744N P=0.745N P=0.749N |
|POLY 1.5 | P=0.058 (e) P=0.505 P=0.210 |P=0.626N P=0.749N P=0.750N P=0.752N |
|POLY 6 | P=0.040 * (e) P=0.519 P=0.150 |P=0.626N P=0.740N P=0.742N P=0.749N |
|LOGISTIC REGRESSION| P=0.078 (e) P=0.568 P=0.296 |P=0.583 P=0.723N P=0.729N P=0.692 |
|COCH-ARM / FISHERS | P=0.071 (e) P=0.500 P=0.247 |P=0.634 P=0.753N P=0.753N P=0.753N |
|ORDER RESTRICTED | P=0.046 * (e) (e) (e) |P=0.727N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 2/50 (4%) 2/50 (4%) |2/50 (4%) 0/50 (0%) 2/50 (4%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/42.08 1/41.05 2/44.47 2/32.92 |2/44.14 0/47.49 2/47.22 6/46.14 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 4.5% 6.1% |4.5% 0.0% 4.2% 13.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |1/32 (3%) 0/38 (0%) 2/37 (5%) 4/34 (12%) |
|FIRST INCIDENCE | --- 709 708 549 |724 --- 729 (T) 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030 * P=0.528 P=0.310 P=0.156 |P=0.018 * P=0.213N P=0.652N P=0.154 |
|POLY 3 | P=0.101 P=0.495 P=0.250 P=0.187 |P=0.017 * P=0.221N P=0.669N P=0.147 |
|POLY 1.5 | P=0.128 P=0.494 P=0.244 P=0.210 |P=0.017 * P=0.226N P=0.676N P=0.144 |
|POLY 6 | P=0.071 P=0.500 P=0.260 P=0.152 |P=0.017 * P=0.218N P=0.665N P=0.148 |
|LOGISTIC REGRESSION| P=0.167 P=0.499 P=0.252 P=0.333 |P=0.018 * P=0.216N P=0.670N P=0.144 |
|COCH-ARM / FISHERS | P=0.162 P=0.495 P=0.247 P=0.247 |P=0.019 * P=0.247N P=0.691N P=0.134 |
|ORDER RESTRICTED | P=0.116 (e) (e) (e) |P=0.015 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow: Erythroid Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 3/49 (6%) 10/50 (20%) 10/50 (20%) |8/50 (16%) 6/50 (12%) 7/50 (14%) 2/50 (4%) |
|POLY-3 RATE (b) | 13/44.57 3/41.05 10/45.15 10/35.85 |8/45.92 6/48.39 7/48.30 2/45.76 |
|POLY-3 PERCENT (g) | 29.2% 7.3% 22.2% 27.9% |17.4% 12.4% 14.5% 4.4% |
|TERMINAL (d) | 6/22 (27%) 2/27 (7%) 7/31 (23%) 0/2 (0%) |1/32 (3%) 2/38 (5%) 3/37 (8%) 2/34 (6%) |
|FIRST INCIDENCE | 495 709 543 529 |528 609 528 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026 * P=0.005N** P=0.143N P=0.066 |P=0.051N P=0.324N P=0.430N P=0.051N |
|POLY 3 | P=0.406 P=0.008N** P=0.301N P=0.549N |P=0.049N* P=0.347N P=0.458N P=0.045N* |
|POLY 1.5 | P=0.477 P=0.008N** P=0.310N P=0.434N |P=0.046N* P=0.357N P=0.468N P=0.044N* |
|POLY 6 | P=0.311 P=0.008N** P=0.281N P=0.462 |P=0.055N P=0.345N P=0.458N P=0.050N |
|LOGISTIC REGRESSION| P=0.545N P=0.008N** P=0.324N P=0.241N |P=0.063N P=0.502N P=0.614 P=0.055N |
|COCH-ARM / FISHERS | P=0.543N P=0.007N** P=0.318N P=0.318N |P=0.046N* P=0.387N P=0.500N P=0.046N* |
|ORDER RESTRICTED | P=0.209N (e) (e) (e) |P=0.041N* (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow: Myeloid Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 27/49 (55%) 20/50 (40%) 14/50 (28%) |11/50 (22%) 13/50 (26%) 20/50 (40%) 13/50 (26%) |
|POLY-3 RATE (b) | 21/47.01 27/47.10 20/47.91 14/37.72 |11/46.08 13/48.83 20/49.81 13/48.56 |
|POLY-3 PERCENT (g) | 44.7% 57.3% 41.8% 37.1% |23.9% 26.6% 40.2% 26.8% |
|TERMINAL (d) | 4/22 (18%) 11/27 (41%) 7/31 (23%) 0/2 (0%) |4/32 (13%) 7/38 (18%) 8/37 (22%) 6/34 (18%) |
|FIRST INCIDENCE | 425 373 494 487 |358 609 528 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.247 P=0.312 P=0.255N P=0.145 |P=0.351 P=0.548 P=0.119 P=0.458 |
|POLY 3 | P=0.150N P=0.151 P=0.468N P=0.313N |P=0.383 P=0.471 P=0.067 P=0.465 |
|POLY 1.5 | P=0.074N P=0.139 P=0.485N P=0.195N |P=0.366 P=0.451 P=0.056 P=0.448 |
|POLY 6 | P=0.322N P=0.178 P=0.435N P=0.554N |P=0.391 P=0.490 P=0.082 P=0.476 |
|LOGISTIC REGRESSION| P=0.004N** P=0.140 P=0.569 P=0.021N* |P=0.255 P=0.309 P=0.019 * P=0.305 |
|COCH-ARM / FISHERS | P=0.027N* P=0.135 P=0.500N P=0.104N |P=0.326 P=0.408 P=0.041 * P=0.408 |
|ORDER RESTRICTED | P=0.162N (e) (e) (e) |P=0.242 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 2/50 (4%) 5/50 (10%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/42.85 5/44.61 2/44.86 5/33.28 |2/44.71 1/47.49 2/47.56 0/45.76 |
|POLY-3 PERCENT (g) | 11.7% 11.2% 4.5% 15.0% |4.5% 2.1% 4.2% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 1/2 (50%) |0/32 (0%) 1/38 (3%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 676 344 613 601 |624 729 (T) 633 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.269 P=0.618N P=0.164N P=0.082 |P=0.191N P=0.462N P=0.652N P=0.227N |
|POLY 3 | P=0.509 P=0.605N P=0.197N P=0.465 |P=0.201N P=0.479N P=0.671N P=0.232N |
|POLY 1.5 | P=0.555 P=0.615N P=0.206N P=0.547 |P=0.199N P=0.484N P=0.677N P=0.232N |
|POLY 6 | P=0.471 P=0.590N P=0.183N P=0.328 |P=0.204N P=0.477N P=0.669N P=0.235N |
|LOGISTIC REGRESSION| P=0.329N P=0.527N P=0.225N P=0.452 |P=0.228N P=0.551N P=0.636 P=0.268N |
|COCH-ARM / FISHERS | P=0.517N P=0.630N P=0.218N P=0.630N |P=0.200N P=0.500N P=0.691N P=0.247N |
|ORDER RESTRICTED | P=0.334 (e) (e) (e) |P=0.151N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.96 4/42.47 0/44.30 0/32.01 |0/44.12 1/47.77 1/47.22 1/46.13 |
|POLY-3 PERCENT (g) | 4.7% 9.4% 0.0% 0.0% |0.0% 2.1% 2.1% 2.2% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 549 590 --- --- |--- 653 729 (T) 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.117N P=0.353 P=0.239N P=0.354N |P=0.395 P=0.523 P=0.529 P=0.513 |
|POLY 3 | P=0.079N P=0.331 P=0.230N P=0.308N |P=0.398 P=0.516 P=0.514 P=0.509 |
|POLY 1.5 | P=0.071N P=0.331 P=0.234N P=0.272N |P=0.396 P=0.511 P=0.510 P=0.507 |
|POLY 6 | P=0.093N P=0.340 P=0.224N P=0.376N |P=0.398 P=0.520 P=0.516 P=0.509 |
|LOGISTIC REGRESSION| P=0.045N* P=0.363 P=0.269N P=0.148N |P=0.343 P=0.443 P=0.529 P=0.441 |
|COCH-ARM / FISHERS | P=0.061N P=0.339 P=0.247N P=0.247N |P=0.384 P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.098N (e) (e) (e) |P=0.337 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | |3/44.33 2/47.49 1/47.22 0/45.76 |
|POLY-3 PERCENT (g) | |6.8% 4.2% 2.1% 0.0% |
|TERMINAL (d) | |2/32 (6%) 2/38 (5%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | |673 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.056N P=0.429N P=0.261N P=0.113N |
|POLY 3 | |P=0.060N P=0.469N P=0.283N P=0.113N |
|POLY 1.5 | |P=0.060N P=0.478N P=0.289N P=0.114N |
|POLY 6 | |P=0.061N P=0.464N P=0.280N P=0.114N |
|LOGISTIC REGRESSION| |P=0.058N P=0.465N P=0.282N P=0.115N |
|COCH-ARM / FISHERS | |P=0.062N P=0.500N P=0.309N P=0.121N |
|ORDER RESTRICTED | |P=0.052N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |6/50 (12%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | |6/44.12 1/47.49 2/47.22 1/45.76 |
|POLY-3 PERCENT (g) | |13.6% 2.1% 4.2% 2.2% |
|TERMINAL (d) | |6/32 (19%) 1/38 (3%) 2/37 (5%) 1/34 (3%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.043N* P=0.034N* P=0.090N P=0.047N* |
|POLY 3 | |P=0.050N P=0.045N* P=0.112N P=0.050N |
|POLY 1.5 | |P=0.049N* P=0.048N* P=0.118N P=0.051N |
|POLY 6 | |P=0.051N P=0.043N* P=0.108N P=0.050N |
|LOGISTIC REGRESSION| |P=0.043N* P=0.034N* P=0.090N P=0.047N* |
|COCH-ARM / FISHERS | |P=0.050N P=0.056N P=0.134N P=0.056N |
|ORDER RESTRICTED | |P=0.011N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | |2/44.12 2/47.49 2/47.22 0/45.76 |
|POLY-3 PERCENT (g) | |4.5% 4.2% 4.2% 0.0% |
|TERMINAL (d) | |2/32 (6%) 2/38 (5%) 2/37 (5%) 0/34 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.153N P=0.632N P=0.642N P=0.225N |
|POLY 3 | |P=0.159N P=0.667N P=0.669N P=0.229N |
|POLY 1.5 | |P=0.159N P=0.675N P=0.676N P=0.231N |
|POLY 6 | |P=0.161N P=0.662N P=0.665N P=0.230N |
|LOGISTIC REGRESSION| |P=0.153N P=0.632N P=0.642N (e) |
|COCH-ARM / FISHERS | |P=0.163N P=0.691N P=0.691N P=0.247N |
|ORDER RESTRICTED | |P=0.182N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Granuloma Sperm |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 RATE (b) | 1/42.17 0/41.56 1/44.30 2/32.48 | |
|POLY-3 PERCENT (g) | 2.4% 0.0% 2.3% 6.2% | |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) | |
|FIRST INCIDENCE | 704 --- 729 (T) 641 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.044 * P=0.480N P=0.691N P=0.167 | |
|POLY 3 | P=0.199 P=0.503N P=0.750N P=0.410 | |
|POLY 1.5 | P=0.221 P=0.503N P=0.755N P=0.454 | |
|POLY 6 | P=0.183 P=0.500N P=0.741N P=0.339 | |
|LOGISTIC REGRESSION| P=0.164 P=0.501N P=0.736N P=0.363 | |
|COCH-ARM / FISHERS | P=0.247 P=0.500N P=0.753N P=0.500 | |
|ORDER RESTRICTED | P=0.151 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 4/50 (8%) 1/50 (2%) | |
|POLY-3 RATE (b) | 3/43.33 0/41.56 4/44.30 1/32.61 | |
|POLY-3 PERCENT (g) | 6.9% 0.0% 9.0% 3.1% | |
|TERMINAL (d) | 1/22 (5%) 0/27 (0%) 4/31 (13%) 0/2 (0%) | |
|FIRST INCIDENCE | 495 --- 729 (T) 537 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.508 P=0.118N P=0.627 P=0.488N | |
|POLY 3 | P=0.519N P=0.126N P=0.512 P=0.413N | |
|POLY 1.5 | P=0.463N P=0.124N P=0.505 P=0.359N | |
|POLY 6 | P=0.524 P=0.125N P=0.527 P=0.507N | |
|LOGISTIC REGRESSION| P=0.357N P=0.080N P=0.478 P=0.145N | |
|COCH-ARM / FISHERS | P=0.404N P=0.121N P=0.500 P=0.309N | |
|ORDER RESTRICTED | P=0.368N (e) (e) (e) | |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 0/44.30 0/32.01 |1/44.12 1/47.49 2/47.22 1/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 2.1% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |1/32 (3%) 1/38 (3%) 2/37 (5%) 1/34 (3%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.599 P=0.723N P=0.551 P=0.748N |
|POLY 3 | (e) (e) (e) (e) |P=0.597 P=0.744N P=0.524 P=0.753N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.597 P=0.749N P=0.517 P=0.754N |
|POLY 6 | (e) (e) (e) (e) |P=0.592 P=0.740N P=0.528 P=0.754N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.599 P=0.723N P=0.551 P=0.748N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.591 P=0.753N P=0.500 P=0.753N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.597 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Lens |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/42.73 0/41.56 1/44.46 0/32.01 |1/44.12 1/47.49 2/47.22 2/45.95 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 2.3% 0.0% |2.3% 2.1% 4.2% 4.4% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |1/32 (3%) 1/38 (3%) 2/37 (5%) 1/34 (3%) |
|FIRST INCIDENCE | 632 --- 687 --- |729 (T) 729 (T) 729 (T) 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.290N P=0.256N P=0.469N P=0.408N |P=0.341 P=0.723N P=0.551 P=0.522 |
|POLY 3 | P=0.204N P=0.243N P=0.486N P=0.306N |P=0.345 P=0.744N P=0.524 P=0.514 |
|POLY 1.5 | P=0.197N P=0.242N P=0.493N P=0.271N |P=0.345 P=0.749N P=0.517 P=0.511 |
|POLY 6 | P=0.222N P=0.242N P=0.474N P=0.374N |P=0.343 P=0.740N P=0.528 P=0.514 |
|LOGISTIC REGRESSION| P=0.168N P=0.219N P=0.524N P=0.193N |P=0.338 P=0.723N P=0.551 P=0.511 |
|COCH-ARM / FISHERS | P=0.188N P=0.247N P=0.500N P=0.247N |P=0.337 P=0.753N P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.125N (e) (e) (e) |P=0.450 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 5/50 (10%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 4/50 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | 5/43.22 2/41.62 5/44.85 0/32.01 |2/44.14 2/47.77 4/47.22 4/45.95 |
|POLY-3 PERCENT (g) | 11.6% 4.8% 11.2% 0.0% |4.5% 4.2% 8.5% 8.7% |
|TERMINAL (d) | 0/22 (0%) 1/27 (4%) 1/31 (3%) 0/2 (0%) |1/32 (3%) 1/38 (3%) 4/37 (11%) 3/34 (9%) |
|FIRST INCIDENCE | 632 715 687 --- |724 653 729 (T) 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.255N P=0.211N P=0.514N P=0.215N |P=0.213 P=0.644N P=0.397 P=0.359 |
|POLY 3 | P=0.111N P=0.231N P=0.607N P=0.065N |P=0.217 P=0.665N P=0.369 P=0.356 |
|POLY 1.5 | P=0.078N P=0.227N P=0.618N P=0.045N* |P=0.218 P=0.674N P=0.360 P=0.352 |
|POLY 6 | P=0.190N P=0.232N P=0.588N P=0.118N |P=0.213 P=0.658N P=0.375 P=0.355 |
|LOGISTIC REGRESSION| P=0.077N P=0.219N P=0.626 P=0.035N* |P=0.213 P=0.684N P=0.370 P=0.350 |
|COCH-ARM / FISHERS | P=0.054N P=0.218N P=0.630N P=0.028N* |P=0.210 P=0.691N P=0.339 P=0.339 |
|ORDER RESTRICTED | P=0.051N (e) (e) (e) |P=0.325 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Infiltration Cellular Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 4/50 (8%) 9/50 (18%) 3/50 (6%) |14/50 (28%) 10/50 (20%) 6/50 (12%) 9/50 (18%) |
|POLY-3 RATE (b) | 9/42.66 4/41.56 9/45.76 3/33.89 |14/44.35 10/48.02 6/47.22 9/46.17 |
|POLY-3 PERCENT (g) | 21.1% 9.6% 19.7% 8.9% |31.6% 20.8% 12.7% 19.5% |
|TERMINAL (d) | 7/22 (32%) 4/27 (15%) 6/31 (19%) 0/2 (0%) |11/32 (34%) 8/38 (21%) 6/37 (16%) 7/34 (21%) |
|FIRST INCIDENCE | 638 729 (T) 543 487 |697 613 729 (T) 638 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500 P=0.060N P=0.368N P=0.542 |P=0.124N P=0.134N P=0.019N* P=0.145N |
|POLY 3 | P=0.193N P=0.122N P=0.539N P=0.125N |P=0.122N P=0.173N P=0.025N* P=0.139N |
|POLY 1.5 | P=0.143N P=0.122N P=0.568N P=0.088N |P=0.123N P=0.194N P=0.028N* P=0.146N |
|POLY 6 | P=0.287N P=0.118N P=0.491N P=0.220N |P=0.125N P=0.159N P=0.023N* P=0.138N |
|LOGISTIC REGRESSION| P=0.139N P=0.101N P=0.583N P=0.081N |P=0.122N P=0.169N P=0.023N* P=0.148N |
|COCH-ARM / FISHERS | P=0.103N P=0.117N P=0.602N P=0.061N |P=0.132N P=0.241N P=0.039N* P=0.171N |
|ORDER RESTRICTED | P=0.117N (e) (e) (e) |P=0.051N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 48/50 (96%) 47/50 (94%) 49/50 (98%) |46/50 (92%) 46/50 (92%) 48/50 (96%) 46/50 (92%) |
|POLY-3 RATE (b) | 48/49.67 48/48.24 47/49.53 49/49.92 |46/48.16 46/49.57 48/49.38 46/49.09 |
|POLY-3 PERCENT (g) | 96.6% 99.5% 94.9% 98.2% |95.5% 92.8% 97.2% 93.7% |
|TERMINAL (d) | 21/22 (96%) 27/27 (100%) 29/31 (94%) 2/2 (100%) |31/32 (97%) 36/38 (95%) 36/37 (97%) 32/34 (94%) |
|FIRST INCIDENCE | 425 484 486 487 |430 609 609 528 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.257N P=0.044N* P<0.001 ** |P=0.515N P=0.133N P=0.295N P=0.415N |
|POLY 3 | P=0.566 P=0.370 P=0.528N P=0.563 |P=0.523N P=0.443N P=0.539 P=0.522N |
|POLY 1.5 | P=0.510 P=0.471 P=0.517N P=0.533 |P=0.527N P=0.482N P=0.497 P=0.536N |
|POLY 6 | P=0.612 P=0.357 P=0.536N P=0.609 |P=0.551N P=0.466N P=0.528 P=0.555N |
|LOGISTIC REGRESSION| P=0.280 P=0.535 P=0.495N P=0.720 |P=0.414N P=0.341N P=0.664N P=0.411N |
|COCH-ARM / FISHERS | P=0.404 P=0.691N P=0.500N P=0.500 |P=0.537 P=0.643N P=0.339 P=0.643N |
|ORDER RESTRICTED | P=0.483 (e) (e) (e) |P=0.530N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 2/44.31 6/33.68 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 17.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 726 604 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.316 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** (e) P=0.249 P=0.006 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** (e) P=0.243 P=0.010 * |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** (e) P=0.259 P=0.003 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.300 P=0.010 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.247 P=0.013 * |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/42.48 5/42.82 2/44.89 1/32.54 |0/44.12 1/47.90 0/47.22 1/46.04 |
|POLY-3 PERCENT (g) | 7.1% 11.7% 4.5% 3.1% |0.0% 2.1% 0.0% 2.2% |
|TERMINAL (d) | 0/22 (0%) 2/27 (7%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 676 484 543 569 |--- 613 --- 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.363N P=0.404 P=0.417N P=0.689N |P=0.414 P=0.517 (e) P=0.519 |
|POLY 3 | P=0.201N P=0.360 P=0.475N P=0.406N |P=0.419 P=0.516 (e) P=0.509 |
|POLY 1.5 | P=0.169N P=0.356 P=0.486N P=0.355N |P=0.416 P=0.511 (e) P=0.507 |
|POLY 6 | P=0.253N P=0.372 P=0.457N P=0.498N |P=0.419 P=0.521 (e) P=0.509 |
|LOGISTIC REGRESSION| P=0.102N P=0.365 P=0.518N P=0.338N |P=0.324 P=0.390 (e) P=0.468 |
|COCH-ARM / FISHERS | P=0.135N P=0.357 P=0.500N P=0.309N |P=0.405 P=0.500 (e) P=0.500 |
|ORDER RESTRICTED | P=0.244N (e) (e) (e) |P=0.259 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Endocardium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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) | 0/42.08 2/41.56 0/44.30 0/32.01 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 2/27 (7%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.689N P=0.284 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.431N P=0.234 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.422N P=0.234 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.454N P=0.237 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.284 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.303N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 4/50 (8%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 0/44.30 4/33.59 |0/44.12 1/47.91 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 11.9% |0.0% 2.1% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- 593 |--- 609 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.027 * |P=0.565N P=0.521 (e) (e) |
|POLY 3 | P=0.002 ** (e) (e) P=0.036 * |P=0.552N P=0.516 (e) (e) |
|POLY 1.5 | P=0.002 ** (e) (e) P=0.046 * |P=0.557N P=0.511 (e) (e) |
|POLY 6 | P=0.002 ** (e) (e) P=0.023 * |P=0.549N P=0.521 (e) (e) |
|LOGISTIC REGRESSION| P=0.008 ** (e) (e) P=0.099 |P=0.652N P=0.385 (e) (e) |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) P=0.059 |P=0.567N P=0.500 (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.389N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 0/44.30 2/32.78 |0/44.12 0/47.49 1/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.1% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- 604 |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.023 * (e) (e) P=0.155 |P=0.700 (e) P=0.529 (e) |
|POLY 3 | P=0.039 * (e) (e) P=0.186 |P=0.698 (e) P=0.514 (e) |
|POLY 1.5 | P=0.041 * (e) (e) P=0.210 |P=0.698 (e) P=0.510 (e) |
|POLY 6 | P=0.042 * (e) (e) P=0.151 |P=0.693 (e) P=0.516 (e) |
|LOGISTIC REGRESSION| P=0.069 (e) (e) P=0.295 |(e) (e) P=0.529 (e) |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |P=0.694 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.015 * (e) (e) (e) |P=0.393 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/42.08 1/41.84 1/44.38 0/32.01 |1/44.12 3/47.49 2/47.22 3/45.93 |
|POLY-3 PERCENT (g) | 2.4% 2.4% 2.3% 0.0% |2.3% 6.3% 4.2% 6.5% |
|TERMINAL (d) | 1/22 (5%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |1/32 (3%) 3/38 (8%) 2/37 (5%) 2/34 (6%) |
|FIRST INCIDENCE | 729 (T) 653 708 --- |729 (T) 729 (T) 729 (T) 686 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523N P=0.741N P=0.685N P=0.934N |P=0.302 P=0.368 P=0.551 P=0.323 |
|POLY 3 | P=0.359N P=0.760 P=0.749N P=0.554N |P=0.318 P=0.332 P=0.524 P=0.320 |
|POLY 1.5 | P=0.338N P=0.758 P=0.754N P=0.527N |P=0.315 P=0.324 P=0.517 P=0.317 |
|POLY 6 | P=0.405N P=0.758N P=0.739N P=0.598N |P=0.316 P=0.338 P=0.528 P=0.319 |
|LOGISTIC REGRESSION| P=0.377N P=0.760 P=0.732N (e) |P=0.295 P=0.368 P=0.551 P=0.316 |
|COCH-ARM / FISHERS | P=0.311N P=0.753N P=0.753N P=0.500N |P=0.302 P=0.309 P=0.500 P=0.309 |
|ORDER RESTRICTED | P=0.383N (e) (e) (e) |P=0.283 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 6/50 (12%) 8/50 (16%) 5/50 (10%) |8/50 (16%) 8/50 (16%) 14/50 (28%) 6/50 (12%) |
|POLY-3 RATE (b) | 6/43.91 6/41.96 8/45.23 5/33.28 |8/45.08 8/47.99 14/47.22 6/45.76 |
|POLY-3 PERCENT (g) | 13.7% 14.3% 17.7% 15.0% |17.8% 16.7% 29.7% 13.1% |
|TERMINAL (d) | 3/22 (14%) 4/27 (15%) 5/31 (16%) 1/2 (50%) |6/32 (19%) 5/38 (13%) 14/37 (38%) 6/34 (18%) |
|FIRST INCIDENCE | 425 641 499 537 |528 633 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.077 P=0.534N P=0.570 P=0.128 |P=0.384N P=0.479N P=0.195 P=0.341N |
|POLY 3 | P=0.433 P=0.589 P=0.409 P=0.562 |P=0.405N P=0.554N P=0.135 P=0.375N |
|POLY 1.5 | P=0.538 P=0.597 P=0.397 P=0.601N |P=0.396N P=0.569N P=0.130 P=0.373N |
|POLY 6 | P=0.297 P=0.593 P=0.436 P=0.407 |P=0.428N P=0.544N P=0.134 P=0.386N |
|LOGISTIC REGRESSION| P=0.486N P=0.612N P=0.343 P=0.382N |P=0.385N P=0.607N P=0.148 P=0.366N |
|COCH-ARM / FISHERS | P=0.457N P=0.620N P=0.387 P=0.500N |P=0.402N P=0.607N P=0.114 P=0.387N |
|ORDER RESTRICTED | P=0.578 (e) (e) (e) |P=0.254N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 0/44.30 0/32.01 |0/44.12 1/47.49 2/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.1% 4.2% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 2/37 (5%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.615N P=0.534 P=0.271 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.605N P=0.515 P=0.253 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.607N P=0.510 P=0.248 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.608N P=0.518 P=0.256 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.534 P=0.271 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.616N P=0.500 P=0.247 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.337N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 4/50 (8%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/43.30 1/41.56 4/44.99 2/32.50 |0/44.12 0/47.49 2/47.84 1/46.25 |
|POLY-3 PERCENT (g) | 9.2% 2.4% 8.9% 6.2% |0.0% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 1/22 (5%) 1/27 (4%) 3/31 (10%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 495 729 (T) 494 613 |--- --- 528 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.414 P=0.168N P=0.538N P=0.626 |P=0.250 (e) P=0.263 P=0.513 |
|POLY 3 | P=0.507N P=0.190N P=0.622N P=0.476N |P=0.253 (e) P=0.256 P=0.509 |
|POLY 1.5 | P=0.456N P=0.187N P=0.632N P=0.407N |P=0.252 (e) P=0.250 P=0.507 |
|POLY 6 | P=0.536 P=0.190N P=0.606N P=0.593N |P=0.251 (e) P=0.260 P=0.510 |
|LOGISTIC REGRESSION| P=0.365N P=0.166N P=0.604 P=0.282N |P=0.143 (e) P=0.140 P=0.395 |
|COCH-ARM / FISHERS | P=0.397N P=0.181N P=0.643N P=0.339N |P=0.246 (e) P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.462N (e) (e) (e) |P=0.183 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.26 3/42.47 0/44.30 0/32.01 |0/44.12 1/47.77 2/47.58 1/45.95 |
|POLY-3 PERCENT (g) | 2.4% 7.1% 0.0% 0.0% |0.0% 2.1% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 1/27 (4%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 680 526 --- --- |--- 653 662 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.248N P=0.322 P=0.468N P=0.713N |P=0.370 P=0.523 P=0.261 P=0.505 |
|POLY 3 | P=0.176N P=0.306 P=0.491N P=0.554N |P=0.379 P=0.516 P=0.254 P=0.508 |
|POLY 1.5 | P=0.166N P=0.304 P=0.495N P=0.528N |P=0.377 P=0.511 P=0.249 P=0.506 |
|POLY 6 | P=0.195N P=0.315 P=0.483N P=0.599N |P=0.376 P=0.520 P=0.259 P=0.508 |
|LOGISTIC REGRESSION| P=0.128N P=0.322 P=0.504N P=0.584N |P=0.328 P=0.443 P=0.209 P=0.491 |
|COCH-ARM / FISHERS | P=0.153N P=0.309 P=0.500N P=0.500N |P=0.366 P=0.500 P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.170N (e) (e) (e) |P=0.241 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 45/50 (90%) 50/50 (100%) 50/50 (100%)|47/50 (94%) 49/50 (98%) 48/50 (96%) 49/50 (98%) |
|POLY-3 RATE (b) | 50/50.00 45/47.44 50/50.00 50/50.00 |47/48.85 49/49.87 48/49.90 49/49.29 |
|POLY-3 PERCENT (g) | 100.0% 94.9% 100.0% 100.0% |96.2% 98.3% 96.2% 99.4% |
|TERMINAL (d) | 22/22 (100%) 26/27 (96%) 31/31 (100%) 2/2 (100%) |31/32 (97%) 38/38 (100%) 37/37 (100%) 34/34 (100%) |
|FIRST INCIDENCE | 425 344 486 487 |358 609 528 528 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.083N (e) (e) |P=0.461 P=0.215N P=0.229N P=0.548N |
|POLY 3 | P=0.335 P=0.116N (e) (e) |P=0.280 P=0.499 P=0.705N P=0.330 |
|POLY 1.5 | P=0.257 P=0.059N (e) (e) |P=0.295 P=0.445 P=0.658 P=0.337 |
|POLY 6 | P=0.456 P=0.263N (e) (e) |P=0.263 P=0.532 P=0.691N P=0.320 |
|LOGISTIC REGRESSION| P=0.136 P=0.051N (e) (e) |P=0.453 P=0.536 P=0.689 P=0.560 |
|COCH-ARM / FISHERS | P=0.199 P=0.028N* (e) (e) |P=0.279 P=0.309 P=0.500 P=0.309 |
|ORDER RESTRICTED | P=0.119 (e) (e) (e) |P=0.219 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Cortex |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/50 (8%) 14/50 (28%) |2/50 (4%) 1/50 (2%) 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/42.08 1/42.46 4/44.41 14/37.07 |2/44.12 1/47.49 4/47.56 1/45.76 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 9.0% 37.8% |4.5% 2.1% 8.4% 2.2% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 2/31 (7%) 0/2 (0%) |2/32 (6%) 1/38 (3%) 3/37 (8%) 1/34 (3%) |
|FIRST INCIDENCE | --- 344 705 488 |729 (T) 729 (T) 633 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.500 P=0.118 P<0.001 ** |P=0.491N P=0.440N P=0.403 P=0.479N |
|POLY 3 | P<0.001 ** P=0.502 P=0.067 P<0.001 ** |P=0.496N P=0.474N P=0.373 P=0.487N |
|POLY 1.5 | P<0.001 ** P=0.500 P=0.064 P<0.001 ** |P=0.495N P=0.482N P=0.362 P=0.490N |
|POLY 6 | P<0.001 ** P=0.506 P=0.073 P<0.001 ** |P=0.502N P=0.469N P=0.381 P=0.489N |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.086 P<0.001 ** |P=0.494N P=0.440N P=0.362 P=0.479N |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.059 P<0.001 ** |P=0.500N P=0.500N P=0.339 P=0.500N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.407N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Medulla |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 49/50 (98%) 47/50 (94%) 49/50 (98%) |43/50 (86%) 49/50 (98%) 49/50 (98%) 46/50 (92%) |
|POLY-3 RATE (b) | 47/49.19 49/49.88 47/49.84 49/49.30 |43/48.66 49/50.00 49/49.85 46/50.00 |
|POLY-3 PERCENT (g) | 95.6% 98.2% 94.3% 99.4% |88.4% 98.0% 98.3% 92.0% |
|TERMINAL (d) | 21/22 (96%) 27/27 (100%) 29/31 (94%) 2/2 (100%) |27/32 (84%) 37/38 (97%) 37/37 (100%) 30/34 (88%) |
|FIRST INCIDENCE | 425 344 486 488 |358 609 528 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.361N P=0.060N P<0.001 ** |P=0.446 P=0.518N P=0.549 P=0.507 |
|POLY 3 | P=0.268 P=0.417 P=0.573N P=0.254 |P=0.464 P=0.061 P=0.050 P=0.394 |
|POLY 1.5 | P=0.277 P=0.364 P=0.613N P=0.265 |P=0.414 P=0.049 * P=0.044 * P=0.353 |
|POLY 6 | P=0.284 P=0.498 P=0.519N P=0.282 |P=0.505 P=0.073 P=0.051 P=0.430 |
|LOGISTIC REGRESSION| P=0.283 P=0.295 P=0.657N P=0.179 |P=0.340 P=0.053 P=0.054 P=0.290 |
|COCH-ARM / FISHERS | P=0.313 P=0.309 P=0.661N P=0.309 |P=0.297 P=0.030 * P=0.030 * P=0.262 |
|ORDER RESTRICTED | P=0.187 (e) (e) (e) |P=0.069 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 1/44.30 1/32.15 |1/44.12 0/47.49 4/47.58 2/46.48 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 3.1% |2.3% 0.0% 8.4% 4.3% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |1/32 (3%) 0/38 (0%) 2/37 (5%) 1/34 (3%) |
|FIRST INCIDENCE | --- --- 729 (T) 694 |729 (T) --- 662 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.041 * (e) P=0.568 P=0.261 |P=0.240 P=0.466N P=0.223 P=0.521 |
|POLY 3 | P=0.166 (e) P=0.510 P=0.447 |P=0.245 P=0.485N P=0.203 P=0.518 |
|POLY 1.5 | P=0.199 (e) P=0.505 P=0.473 |P=0.244 P=0.490N P=0.195 P=0.514 |
|POLY 6 | P=0.132 (e) P=0.519 P=0.404 |P=0.241 P=0.482N P=0.209 P=0.519 |
|LOGISTIC REGRESSION| P=0.102 (e) P=0.568 P=0.359 |P=0.205 (e) P=0.191 P=0.435 |
|COCH-ARM / FISHERS | P=0.235 (e) P=0.500 P=0.500 |P=0.237 P=0.500N P=0.181 P=0.500 |
|ORDER RESTRICTED | P=0.204 (e) (e) (e) |P=0.147 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Pelvis, Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 11/50 (22%) 29/50 (58%) 34/50 (68%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/42.16 11/41.80 29/45.78 34/43.12 |1/44.12 2/47.77 2/47.22 4/46.04 |
|POLY-3 PERCENT (g) | 2.4% 26.3% 63.3% 78.9% |2.3% 4.2% 4.2% 8.7% |
|TERMINAL (d) | 0/22 (0%) 9/27 (33%) 21/31 (68%) 1/2 (50%) |1/32 (3%) 1/38 (3%) 2/37 (5%) 2/34 (6%) |
|FIRST INCIDENCE | 709 698 590 488 |729 (T) 653 729 (T) 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** |P=0.116 P=0.553 P=0.551 P=0.202 |
|POLY 3 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P=0.119 P=0.528 P=0.524 P=0.192 |
|POLY 1.5 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P=0.119 P=0.519 P=0.517 P=0.189 |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P=0.118 P=0.535 P=0.528 P=0.192 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P=0.115 P=0.504 P=0.551 P=0.189 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P=0.113 P=0.500 P=0.500 P=0.181 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.126 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 9/50 (18%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 1/44.30 9/34.63 |0/44.12 0/47.49 0/47.22 1/45.95 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 26.0% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 604 |--- --- --- 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.568 P<0.001 ** |P=0.200 (e) (e) P=0.514 |
|POLY 3 | P<0.001 ** (e) P=0.510 P<0.001 ** |P=0.200 (e) (e) P=0.508 |
|POLY 1.5 | P<0.001 ** (e) P=0.505 P<0.001 ** |P=0.200 (e) (e) P=0.506 |
|POLY 6 | P<0.001 ** (e) P=0.519 P<0.001 ** |P=0.199 (e) (e) P=0.508 |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.568 P<0.001 ** |P=0.187 (e) (e) P=0.489 |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P<0.001 ** |P=0.198 (e) (e) P=0.500 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.128 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 20/50 (40%) 23/50 (46%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.23 5/41.56 20/45.31 23/39.89 |0/44.12 1/47.49 1/47.30 1/45.95 |
|POLY-3 PERCENT (g) | 2.4% 12.0% 44.1% 57.7% |0.0% 2.1% 2.1% 2.2% |
|TERMINAL (d) | 0/22 (0%) 5/27 (19%) 14/31 (45%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 690 729 (T) 624 529 |--- 729 (T) 709 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.149 P<0.001 ** P<0.001 ** |P=0.386 P=0.534 P=0.516 P=0.514 |
|POLY 3 | P<0.001 ** P=0.096 P<0.001 ** P<0.001 ** |P=0.397 P=0.515 P=0.514 P=0.508 |
|POLY 1.5 | P<0.001 ** P=0.097 P<0.001 ** P<0.001 ** |P=0.395 P=0.510 P=0.510 P=0.506 |
|POLY 6 | P<0.001 ** P=0.098 P<0.001 ** P<0.001 ** |P=0.396 P=0.518 P=0.517 P=0.508 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.116 P<0.001 ** P<0.001 ** |P=0.384 P=0.534 P=0.508 P=0.489 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.102 P<0.001 ** P<0.001 ** |P=0.384 P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.336 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.09 1/41.67 2/44.77 0/32.01 |0/44.12 0/47.49 0/47.22 1/46.09 |
|POLY-3 PERCENT (g) | 2.4% 2.4% 4.5% 0.0% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 726 702 590 --- |--- --- --- 638 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.613N P=0.728N P=0.582 P=0.886N |P=0.206 (e) (e) P=0.523 |
|POLY 3 | P=0.457N P=0.759 P=0.522 P=0.554N |P=0.201 (e) (e) P=0.509 |
|POLY 1.5 | P=0.414N P=0.758 P=0.511 P=0.527N |P=0.201 (e) (e) P=0.507 |
|POLY 6 | P=0.544N P=0.760N P=0.539 P=0.598N |P=0.200 (e) (e) P=0.509 |
|LOGISTIC REGRESSION| P=0.417N P=0.759N P=0.495 P=0.858N |P=0.158 (e) (e) P=0.455 |
|COCH-ARM / FISHERS | P=0.366N P=0.753N P=0.500 P=0.500N |P=0.198 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.337N (e) (e) (e) |P=0.129 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 5/50 (10%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/42.08 1/41.56 0/44.30 0/32.01 |2/44.20 2/47.57 5/47.22 1/45.76 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 0.0% |4.5% 4.2% 10.6% 2.2% |
|TERMINAL (d) | 0/22 (0%) 1/27 (4%) 0/31 (0%) 0/2 (0%) |1/32 (3%) 1/38 (3%) 5/37 (14%) 1/34 (3%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |708 710 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.814N P=0.541 (e) (e) |P=0.456N P=0.647N P=0.272 P=0.492N |
|POLY 3 | P=0.560N P=0.498 (e) (e) |P=0.448N P=0.667N P=0.244 P=0.488N |
|POLY 1.5 | P=0.568N P=0.497 (e) (e) |P=0.448N P=0.675N P=0.236 P=0.490N |
|POLY 6 | P=0.563N P=0.501 (e) (e) |P=0.456N P=0.662N P=0.248 P=0.490N |
|LOGISTIC REGRESSION| (e) P=0.541 (e) (e) |P=0.462N P=0.666N P=0.248 P=0.492N |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.456N P=0.691N P=0.218 P=0.500N |
|ORDER RESTRICTED | P=0.428N (e) (e) (e) |P=0.297N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 25/50 (50%) 32/50 (64%) 19/50 (38%) |48/50 (96%) 48/50 (96%) 41/50 (82%) 43/50 (86%) |
|POLY-3 RATE (b) | 24/43.26 25/41.77 32/46.14 19/37.67 |48/49.04 48/49.60 41/48.16 43/48.26 |
|POLY-3 PERCENT (g) | 55.5% 59.9% 69.4% 50.4% |97.9% 96.8% 85.1% 89.1% |
|TERMINAL (d) | 19/22 (86%) 22/27 (82%) 25/31 (81%) 0/2 (0%) |32/32 (100%) 37/38 (97%) 36/37 (97%) 33/34 (97%) |
|FIRST INCIDENCE | 495 709 499 488 |358 609 609 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.254N P=0.541N P<0.001 ** |P=0.089N P=0.122N P=0.006N** P=0.114N |
|POLY 3 | P=0.419N P=0.422 P=0.115 P=0.403N |P=0.024N* P=0.619N P=0.019N* P=0.066N |
|POLY 1.5 | P=0.296N P=0.445 P=0.094 P=0.299N |P=0.020N* P=0.617N P=0.016N* P=0.056N |
|POLY 6 | P=0.461 P=0.420 P=0.167 P=0.597N |P=0.045N* P=0.668N P=0.032N* P=0.116N |
|LOGISTIC REGRESSION| P=0.102 P=0.596N P=0.140 P=0.303 |P=0.009N** P=0.441N P=0.004N** P=0.028N* |
|COCH-ARM / FISHERS | P=0.195N P=0.500 P=0.079 P=0.210N |P=0.028N* P=0.691N P=0.026N* P=0.080N |
|ORDER RESTRICTED | P=0.219N (e) (e) (e) |P=0.018N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 19/50 (38%) 18/50 (36%) 0/50 (0%) |15/50 (30%) 13/50 (26%) 10/50 (20%) 10/50 (20%) |
|POLY-3 RATE (b) | 19/42.17 19/41.72 18/44.89 0/32.01 |15/44.20 13/47.49 10/47.33 10/45.93 |
|POLY-3 PERCENT (g) | 45.1% 45.6% 40.1% 0.0% |33.9% 27.4% 21.1% 21.8% |
|TERMINAL (d) | 18/22 (82%) 17/27 (63%) 17/31 (55%) 0/2 (0%) |14/32 (44%) 13/38 (34%) 9/37 (24%) 9/34 (27%) |
|FIRST INCIDENCE | 704 704 543 --- |708 729 (T) 701 686 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009N** P=0.224N P=0.051N P=0.047N* |P=0.110N P=0.214N P=0.086N P=0.130N |
|POLY 3 | P<0.001N** P=0.571 P=0.399N P<0.001N** |P=0.116N P=0.325N P=0.126N P=0.144N |
|POLY 1.5 | P<0.001N** P=0.565 P=0.447N P<0.001N** |P=0.119N P=0.350N P=0.141N P=0.152N |
|POLY 6 | P<0.001N** P=0.584N P=0.320N P<0.001N** |P=0.118N P=0.307N P=0.116N P=0.143N |
|LOGISTIC REGRESSION| P=0.004N** P=0.334N P=0.187N P=0.018N* |P=0.140N P=0.287N P=0.119N P=0.170N |
|COCH-ARM / FISHERS | P<0.001N** P=0.582N P=0.500N P<0.001N** |P=0.131N P=0.412N P=0.178N P=0.178N |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.139N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 11/50 (22%) 20/50 (40%) 15/50 (30%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 8/42.99 11/42.86 20/44.87 15/36.32 |1/44.12 0/47.49 3/47.30 4/45.82 |
|POLY-3 PERCENT (g) | 18.6% 25.7% 44.6% 41.3% |2.3% 0.0% 6.3% 8.7% |
|TERMINAL (d) | 2/22 (9%) 6/27 (22%) 14/31 (45%) 1/2 (50%) |1/32 (3%) 0/38 (0%) 1/37 (3%) 3/34 (9%) |
|FIRST INCIDENCE | 676 590 687 529 |729 (T) --- 709 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.414 P=0.076 P<0.001 ** |P=0.042 * P=0.466N P=0.357 P=0.194 |
|POLY 3 | P=0.007 ** P=0.298 P=0.006 ** P=0.020 * |P=0.043 * P=0.485N P=0.331 P=0.190 |
|POLY 1.5 | P=0.018 * P=0.296 P=0.006 ** P=0.040 * |P=0.044 * P=0.490N P=0.323 P=0.188 |
|POLY 6 | P<0.001 ** P=0.311 P=0.008 ** P=0.005 ** |P=0.042 * P=0.482N P=0.336 P=0.189 |
|LOGISTIC REGRESSION| P=0.003 ** P=0.295 P=0.014 * P=0.020 * |P=0.040 * (e) P=0.334 P=0.178 |
|COCH-ARM / FISHERS | P=0.048 * P=0.306 P=0.007 ** P=0.077 |P=0.044 * P=0.500N P=0.309 P=0.181 |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) |P=0.056 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 14/50 (28%) 10/50 (20%) 9/50 (18%) |0/50 (0%) 6/50 (12%) 6/50 (12%) 9/50 (18%) |
|POLY-3 RATE (b) | 5/42.43 14/41.74 10/45.05 9/35.47 |0/44.12 6/47.49 6/47.22 9/45.93 |
|POLY-3 PERCENT (g) | 11.8% 33.5% 22.2% 25.4% |0.0% 12.6% 12.7% 19.6% |
|TERMINAL (d) | 3/22 (14%) 12/27 (44%) 8/31 (26%) 0/2 (0%) |0/32 (0%) 6/38 (16%) 6/37 (16%) 8/34 (24%) |
|FIRST INCIDENCE | 634 704 543 507 |--- 729 (T) 729 (T) 686 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.049 * P=0.300 P=0.002 ** |P=0.005 ** P=0.028 * P=0.026 * P=0.003 ** |
|POLY 3 | P=0.207 P=0.014 * P=0.155 P=0.101 |P=0.006 ** P=0.020 * P=0.019 * P=0.002 ** |
|POLY 1.5 | P=0.284 P=0.015 * P=0.143 P=0.142 |P=0.006 ** P=0.018 * P=0.018 * P=0.002 ** |
|POLY 6 | P=0.117 P=0.014 * P=0.178 P=0.051 |P=0.006 ** P=0.020 * P=0.020 * P=0.002 ** |
|LOGISTIC REGRESSION| P=0.149 P=0.023 * P=0.159 P=0.214 |P=0.004 ** P=0.028 * P=0.026 * P=0.003 ** |
|COCH-ARM / FISHERS | P=0.381 P=0.020 * P=0.131 P=0.194 |P=0.006 ** P=0.013 * P=0.013 * P<0.001 ** |
|ORDER RESTRICTED | P=0.089 (e) (e) (e) |P=0.002 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 20/50 (40%) 22/50 (44%) 15/50 (30%) |11/50 (22%) 8/50 (16%) 9/50 (18%) 20/50 (40%) |
|POLY-3 RATE (b) | 22/47.41 20/47.19 22/47.99 15/37.37 |11/46.98 8/48.87 9/47.96 20/47.86 |
|POLY-3 PERCENT (g) | 46.4% 42.4% 45.8% 40.1% |23.4% 16.4% 18.8% 41.8% |
|TERMINAL (d) | 2/22 (9%) 5/27 (19%) 12/31 (39%) 0/2 (0%) |2/32 (6%) 4/38 (11%) 4/37 (11%) 11/34 (32%) |
|FIRST INCIDENCE | 425 344 486 488 |288 609 633 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.110 P=0.364N P=0.298N P=0.101 |P=0.016 * P=0.237N P=0.327N P=0.083 |
|POLY 3 | P=0.362N P=0.426N P=0.560N P=0.359N |P=0.008 ** P=0.272N P=0.381N P=0.043 * |
|POLY 1.5 | P=0.219N P=0.423N P=0.566N P=0.215N |P=0.008 ** P=0.284N P=0.387N P=0.042 * |
|POLY 6 | P=0.464 P=0.433N P=0.559N P=0.548 |P=0.008 ** P=0.262N P=0.378N P=0.044 * |
|LOGISTIC REGRESSION| P=0.019N* P=0.372N P=0.476 P=0.040N* |P=0.005 ** P=0.558N P=0.572N P=0.025 * |
|COCH-ARM / FISHERS | P=0.098N P=0.420N P=0.580N P=0.107N |P=0.009 ** P=0.306N P=0.402N P=0.041 * |
|ORDER RESTRICTED | P=0.455N (e) (e) (e) |P=0.007 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |1/50 (2%) 6/50 (12%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/43.01 1/41.64 2/44.30 4/34.20 |1/44.12 6/47.63 4/47.55 2/45.76 |
|POLY-3 PERCENT (g) | 9.3% 2.4% 4.5% 11.7% |2.3% 12.6% 8.4% 4.4% |
|TERMINAL (d) | 1/22 (5%) 0/27 (0%) 2/31 (7%) 0/2 (0%) |1/32 (3%) 5/38 (13%) 2/37 (5%) 2/34 (6%) |
|FIRST INCIDENCE | 549 709 729 (T) 529 |729 (T) 693 662 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.156 P=0.168N P=0.249N P=0.323 |P=0.515N P=0.089 P=0.223 P=0.521 |
|POLY 3 | P=0.371 P=0.188N P=0.323N P=0.513 |P=0.492N P=0.069 P=0.202 P=0.513 |
|POLY 1.5 | P=0.401 P=0.186N P=0.330N P=0.578 |P=0.497N P=0.065 P=0.195 P=0.510 |
|POLY 6 | P=0.339 P=0.186N P=0.310N P=0.401 |P=0.495N P=0.073 P=0.208 P=0.511 |
|LOGISTIC REGRESSION| P=0.537 P=0.176N P=0.342N P=0.433N |P=0.513N P=0.074 P=0.193 P=0.521 |
|COCH-ARM / FISHERS | P=0.437 P=0.181N P=0.339N P=0.643N |P=0.519N P=0.056 P=0.181 P=0.500 |
|ORDER RESTRICTED | P=0.233 (e) (e) (e) |P=0.197 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 1/50 (2%) 1/50 (2%) |5/50 (10%) 6/50 (12%) 6/50 (12%) 6/50 (12%) |
|POLY-3 RATE (b) | 2/42.36 6/42.03 1/44.30 1/32.54 |5/44.18 6/47.84 6/47.41 6/46.02 |
|POLY-3 PERCENT (g) | 4.7% 14.3% 2.3% 3.1% |11.3% 12.5% 12.7% 13.0% |
|TERMINAL (d) | 0/22 (0%) 5/27 (19%) 1/31 (3%) 0/2 (0%) |2/32 (6%) 5/38 (13%) 5/37 (14%) 5/34 (15%) |
|FIRST INCIDENCE | 680 590 729 (T) 569 |724 633 679 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.489N P=0.187 P=0.412N P=0.712 |P=0.461 P=0.594 P=0.575 P=0.520 |
|POLY 3 | P=0.224N P=0.129 P=0.484N P=0.590N |P=0.473 P=0.555 P=0.549 P=0.529 |
|POLY 1.5 | P=0.194N P=0.129 P=0.492N P=0.546N |P=0.471 P=0.538 P=0.534 P=0.522 |
|POLY 6 | P=0.270N P=0.132 P=0.472N P=0.663N |P=0.468 P=0.569 P=0.560 P=0.528 |
|LOGISTIC REGRESSION| P=0.227N P=0.131 P=0.481N P=0.498N |P=0.465 P=0.557 P=0.558 P=0.518 |
|COCH-ARM / FISHERS | P=0.162N P=0.134 P=0.500N P=0.500N |P=0.455 P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.188N (e) (e) (e) |P=0.628 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 21/50 (42%) 35/50 (70%) 33/50 (66%) |46/50 (92%) 38/50 (76%) 29/50 (58%) 30/50 (60%) |
|POLY-3 RATE (b) | 22/43.43 21/42.28 35/46.53 33/44.29 |46/49.75 38/48.53 29/47.60 30/46.57 |
|POLY-3 PERCENT (g) | 50.7% 49.7% 75.2% 74.5% |92.5% 78.3% 60.9% 64.4% |
|TERMINAL (d) | 17/22 (77%) 18/27 (67%) 27/31 (87%) 1/2 (50%) |31/32 (97%) 32/38 (84%) 26/37 (70%) 25/34 (74%) |
|FIRST INCIDENCE | 506 543 486 488 |288 613 679 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.183N P=0.219 P<0.001 ** |P<0.001N** P=0.006N** P<0.001N** P<0.001N** |
|POLY 3 | P=0.002 ** P=0.551N P=0.009 ** P=0.011 * |P<0.001N** P=0.037N* P<0.001N** P<0.001N** |
|POLY 1.5 | P=0.002 ** P=0.539N P=0.007 ** P=0.015 * |P<0.001N** P=0.031N* P<0.001N** P<0.001N** |
|POLY 6 | P<0.001 ** P=0.541N P=0.014 * P=0.008 ** |P<0.001N** P=0.048N* P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.487N P=0.013 * P=0.008 ** |P<0.001N** P=0.024N* P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P=0.004 ** P=0.500N P=0.007 ** P=0.022 * |P<0.001N** P=0.027N* P<0.001N** P<0.001N** |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.76 0/41.56 0/44.30 2/32.23 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 6.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 495 --- --- 694 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113 P=0.508N P=0.504N P=0.241 |(e) (e) (e) (e) |
|POLY 3 | P=0.229 P=0.506N P=0.493N P=0.403 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.234 P=0.505N P=0.497N P=0.450 |(e) (e) (e) (e) |
|POLY 6 | P=0.250 P=0.504N P=0.486N P=0.329 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.299 P=0.363N P=0.599N P=0.568 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.076 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 17/50 (34%) 22/50 (44%) 4/50 (8%) |10/50 (20%) 11/50 (22%) 5/50 (10%) 5/50 (10%) |
|POLY-3 RATE (b) | 9/42.22 17/41.69 22/44.40 4/33.20 |10/44.60 11/47.85 5/47.30 5/45.93 |
|POLY-3 PERCENT (g) | 21.3% 40.8% 49.6% 12.1% |22.4% 23.0% 10.6% 10.9% |
|TERMINAL (d) | 8/22 (36%) 15/27 (56%) 20/31 (65%) 1/2 (50%) |7/32 (22%) 9/38 (24%) 4/37 (11%) 4/34 (12%) |
|FIRST INCIDENCE | 693 710 708 488 |624 633 709 686 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.129 P=0.044 * P=0.104 |P=0.049N* P=0.537N P=0.090N P=0.118N |
|POLY 3 | P=0.322N P=0.041 * P=0.004 ** P=0.226N |P=0.047N* P=0.572 P=0.104N P=0.115N |
|POLY 1.5 | P=0.164N P=0.044 * P=0.004 ** P=0.165N |P=0.047N* P=0.551 P=0.111N P=0.118N |
|POLY 6 | P=0.399 P=0.040 * P=0.005 ** P=0.366N |P=0.048N* P=0.586 P=0.100N P=0.118N |
|LOGISTIC REGRESSION| P=0.155 P=0.079 P=0.024 * P=0.543N |P=0.047N* P=0.581 P=0.099N P=0.115N |
|COCH-ARM / FISHERS | P=0.078N P=0.055 P=0.004 ** P=0.117N |P=0.053N P=0.500 P=0.131N P=0.131N |
|ORDER RESTRICTED | P=0.011N* (e) (e) (e) |P=0.098N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 19/50 (38%) 9/50 (18%) 14/50 (28%) |12/50 (24%) 6/50 (12%) 11/50 (22%) 12/50 (24%) |
|POLY-3 RATE (b) | 19/47.03 19/47.36 9/46.35 14/37.37 |12/44.54 6/48.82 11/48.44 12/47.49 |
|POLY-3 PERCENT (g) | 40.4% 40.1% 19.4% 37.5% |26.9% 12.3% 22.7% 25.3% |
|TERMINAL (d) | 3/22 (14%) 5/27 (19%) 1/31 (3%) 1/2 (50%) |6/32 (19%) 1/38 (3%) 3/37 (8%) 6/34 (18%) |
|FIRST INCIDENCE | 425 344 494 487 |673 609 633 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.320 P=0.494N P=0.015N* P=0.088 |P=0.359 P=0.069N P=0.394N P=0.549N |
|POLY 3 | P=0.227N P=0.572N P=0.021N* P=0.480N |P=0.372 P=0.062N P=0.409N P=0.522N |
|POLY 1.5 | P=0.158N P=0.577N P=0.021N* P=0.332N |P=0.369 P=0.072N P=0.438N P=0.542N |
|POLY 6 | P=0.333N P=0.560N P=0.020N* P=0.454 |P=0.369 P=0.054N P=0.382N P=0.510N |
|LOGISTIC REGRESSION| P=0.008N** P=0.535N P=0.032N* P=0.047N* |P=0.324 P=0.091N P=0.452N P=0.574N |
|COCH-ARM / FISHERS | P=0.093N P=0.582N P=0.022N* P=0.198N |P=0.350 P=0.096N P=0.500N P=0.592N |
|ORDER RESTRICTED | P=0.171N (e) (e) (e) |P=0.339N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 46/50 (92%) 48/50 (96%) 50/50 (100%)|10/50 (20%) 35/50 (70%) 39/50 (78%) 40/50 (80%) |
|POLY-3 RATE (b) | 49/49.20 46/47.43 48/49.30 50/50.00 |10/44.61 35/48.63 39/48.84 40/47.51 |
|POLY-3 PERCENT (g) | 99.6% 97.0% 97.4% 100.0% |22.4% 72.0% 79.9% 84.2% |
|TERMINAL (d) | 22/22 (100%) 27/27 (100%) 30/31 (97%) 2/2 (100%) |7/32 (22%) 29/38 (76%) 31/37 (84%) 31/34 (91%) |
|FIRST INCIDENCE | 495 499 494 487 |634 613 609 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.130N P=0.037N* P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.475 P=0.394N P=0.464N P=1.000 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.336 P=0.272N P=0.468N P=0.891 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.599 P=0.545N P=0.481N P=1.000 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.124 P=0.346N P=0.419N (e) |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.199 P=0.181N P=0.500N P=0.500 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P=0.257 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte, Centrilobular |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 17/50 (34%) 31/50 (62%) 19/50 (38%) |0/50 (0%) 27/50 (54%) 30/50 (60%) 33/50 (66%) |
|POLY-3 RATE (b) | 0/42.08 17/42.38 31/45.76 19/39.17 |0/44.12 27/47.63 30/47.47 33/46.27 |
|POLY-3 PERCENT (g) | 0.0% 40.1% 67.8% 48.5% |0.0% 56.7% 63.2% 71.3% |
|TERMINAL (d) | 0/22 (0%) 13/27 (48%) 27/31 (87%) 0/2 (0%) |0/32 (0%) 25/38 (66%) 29/37 (78%) 30/34 (88%) |
|FIRST INCIDENCE | --- 543 486 487 |--- 697 662 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 0/44.30 0/32.01 |0/44.12 0/47.49 0/47.22 3/46.80 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 6.4% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 1/34 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.013 * (e) (e) P=0.138 |
|POLY 3 | (e) (e) (e) (e) |P=0.011 * (e) (e) P=0.130 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.011 * (e) (e) P=0.127 |
|POLY 6 | (e) (e) (e) (e) |P=0.011 * (e) (e) P=0.131 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.004 ** (e) (e) P=0.059 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.012 * (e) (e) P=0.121 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.010 * (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/49 (4%) 5/50 (10%) 7/50 (14%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.24 2/41.90 5/44.48 7/34.41 |0/44.12 2/47.49 1/47.33 0/45.76 |
|POLY-3 PERCENT (g) | 4.7% 4.8% 11.2% 20.3% |0.0% 4.2% 2.1% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 2/31 (7%) 0/2 (0%) |0/32 (0%) 2/38 (5%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 709 373 708 540 |--- 729 (T) 701 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.656N P=0.352 P=0.002 ** |P=0.460N P=0.277 P=0.515 (e) |
|POLY 3 | P=0.011 * P=0.692 P=0.237 P=0.038 * |P=0.442N P=0.254 P=0.514 (e) |
|POLY 1.5 | P=0.017 * P=0.688 P=0.227 P=0.055 |P=0.446N P=0.249 P=0.510 (e) |
|POLY 6 | P=0.006 ** P=0.690N P=0.255 P=0.019 * |P=0.442N P=0.258 P=0.517 (e) |
|LOGISTIC REGRESSION| P=0.036 * P=0.671N P=0.268 P=0.077 |P=0.457N P=0.277 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.027 * P=0.684 P=0.218 P=0.080 |P=0.461N P=0.247 P=0.500 (e) |
|ORDER RESTRICTED | P=0.017 * (e) (e) (e) |P=0.332N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/49 (8%) 5/50 (10%) 2/50 (4%) |12/50 (24%) 5/50 (10%) 9/50 (18%) 7/50 (14%) |
|POLY-3 RATE (b) | 2/42.28 4/41.60 5/44.99 2/33.09 |12/45.47 5/47.62 9/48.03 7/46.53 |
|POLY-3 PERCENT (g) | 4.7% 9.6% 11.1% 6.0% |26.4% 10.5% 18.7% 15.1% |
|TERMINAL (d) | 1/22 (5%) 2/27 (7%) 4/31 (13%) 0/2 (0%) |8/32 (25%) 4/38 (11%) 5/37 (14%) 4/34 (12%) |
|FIRST INCIDENCE | 676 609 494 529 |543 697 528 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.209 P=0.377 P=0.333 P=0.402 |P=0.226N P=0.031N* P=0.224N P=0.137N |
|POLY 3 | P=0.456 P=0.329 P=0.241 P=0.603 |P=0.225N P=0.041N* P=0.262N P=0.138N |
|POLY 1.5 | P=0.545 P=0.325 P=0.230 P=0.649 |P=0.224N P=0.044N* P=0.275N P=0.139N |
|POLY 6 | P=0.326 P=0.341 P=0.260 P=0.518 |P=0.230N P=0.041N* P=0.258N P=0.143N |
|LOGISTIC REGRESSION| P=0.513N P=0.324 P=0.216 P=0.633N |P=0.236N P=0.049N* P=0.319N P=0.151N |
|COCH-ARM / FISHERS | P=0.515N P=0.329 P=0.218 P=0.691N |P=0.230N P=0.054N P=0.312N P=0.154N |
|ORDER RESTRICTED | P=0.398 (e) (e) (e) |P=0.110N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 10/50 (20%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 0/40.97 2/44.31 10/35.76 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 28.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 726 488 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.316 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** (e) P=0.249 P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** (e) P=0.243 P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** (e) P=0.259 P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.300 P=0.004 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.247 P<0.001 ** |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 5/49 (10%) 13/50 (26%) 7/50 (14%) |18/50 (36%) 18/50 (36%) 13/50 (26%) 15/50 (30%) |
|POLY-3 RATE (b) | 16/43.76 5/41.05 13/45.19 7/34.87 |18/45.45 18/47.79 13/47.53 15/46.44 |
|POLY-3 PERCENT (g) | 36.6% 12.2% 28.8% 20.1% |39.6% 37.7% 27.4% 32.3% |
|TERMINAL (d) | 10/22 (46%) 4/27 (15%) 7/31 (23%) 0/2 (0%) |13/32 (41%) 14/38 (37%) 12/37 (32%) 13/34 (38%) |
|FIRST INCIDENCE | 495 709 590 488 |543 693 644 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.245 P=0.002N** P=0.105N P=0.238 |P=0.220N P=0.358N P=0.097N P=0.270N |
|POLY 3 | P=0.163N P=0.007N** P=0.287N P=0.084N |P=0.221N P=0.508N P=0.149N P=0.304N |
|POLY 1.5 | P=0.115N P=0.007N** P=0.309N P=0.049N* |P=0.221N P=0.526N P=0.160N P=0.306N |
|POLY 6 | P=0.252N P=0.006N** P=0.245N P=0.189N |P=0.233N P=0.504N P=0.147N P=0.317N |
|LOGISTIC REGRESSION| P=0.180N P=0.007N** P=0.278N P=0.062N |P=0.214N P=0.476N P=0.142N P=0.292N |
|COCH-ARM / FISHERS | P=0.080N P=0.007N** P=0.330N P=0.028N* |P=0.236N P=0.582N P=0.194N P=0.335N |
|ORDER RESTRICTED | P=0.071N (e) (e) (e) |P=0.257N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 47/49 (96%) 49/50 (98%) 50/50 (100%)|50/50 (100%) 50/50 (100%) 50/50 (100%) 50/50 (100%) |
|POLY-3 RATE (b) | 46/48.55 47/47.72 49/49.31 50/50.00 |50/50.00 50/50.00 50/50.00 50/50.00 |
|POLY-3 PERCENT (g) | 94.8% 98.5% 99.4% 100.0% |100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 22/22 (100%) 27/27 (100%) 31/31 (100%) 2/2 (100%) |32/32 (100%) 38/38 (100%) 37/37 (100%) 34/34 (100%) |
|FIRST INCIDENCE | 425 344 486 487 |288 609 528 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.289N P=0.103N P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.032 * P=0.286 P=0.176 P=0.113 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.027 * P=0.304 P=0.166 P=0.081 |(e) (e) (e) (e) |
|POLY 6 | P=0.072 P=0.317 P=0.250 P=0.215 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.014 * P=0.246 P=0.214 P=0.028 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.029 * P=0.349 P=0.181 P=0.059 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.007 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Bronchiole |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/49 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.13 3/40.97 0/44.30 0/32.01 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 2.4% 7.3% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 3/27 (11%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 715 729 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.345N P=0.376 P=0.451N P=0.898N |(e) (e) (e) (e) |
|POLY 3 | P=0.175N P=0.295 P=0.490N P=0.554N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.165N P=0.294 P=0.495N P=0.528N |(e) (e) (e) (e) |
|POLY 6 | P=0.192N P=0.301 P=0.482N P=0.598N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.306N P=0.342 P=0.477N P=0.755N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.152N P=0.301 P=0.500N P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.163N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 2/41.11 0/44.30 0/32.01 |0/44.12 0/47.49 1/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 4.9% 0.0% 0.0% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 709 --- --- |--- --- 728 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.688N P=0.272 (e) (e) |P=0.701 (e) P=0.534 (e) |
|POLY 3 | P=0.429N P=0.232 (e) (e) |P=0.698 (e) P=0.514 (e) |
|POLY 1.5 | P=0.420N P=0.231 (e) (e) |P=0.698 (e) P=0.510 (e) |
|POLY 6 | P=0.452N P=0.237 (e) (e) |P=0.693 (e) P=0.516 (e) |
|LOGISTIC REGRESSION| P=0.534N P=0.237 (e) (e) |P=0.693 (e) P=0.515 (e) |
|COCH-ARM / FISHERS | P=0.403N P=0.242 (e) (e) |P=0.694 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.301N (e) (e) (e) |P=0.393 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.08 0/41.56 0/44.30 6/33.67 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 17.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 488 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.459N P=0.432N P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.002 ** P=0.502N P=0.490N P=0.027 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.002 ** P=0.503N P=0.495N P=0.039 * |(e) (e) (e) (e) |
|POLY 6 | P=0.002 ** P=0.499N P=0.481N P=0.013 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.003 ** (e) (e) P=0.034 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.003 ** P=0.500N P=0.500N P=0.056 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 5/50 (10%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/42.78 2/41.56 5/44.30 4/33.46 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 9.4% 4.8% 11.3% 12.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/22 (9%) 2/27 (7%) 5/31 (16%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 495 729 (T) 729 (T) 549 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035 * P=0.272N P=0.595N P=0.135 |(e) (e) (e) (e) |
|POLY 3 | P=0.310 P=0.350N P=0.522 P=0.503 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.372 P=0.348N P=0.511 P=0.572 |(e) (e) (e) (e) |
|POLY 6 | P=0.231 P=0.345N P=0.544 P=0.388 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.330 P=0.341N P=0.529 P=0.624N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.446 P=0.339N P=0.500 P=0.643N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.389 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 41/50 (82%) 48/50 (96%) 46/50 (92%) |50/50 (100%) 49/50 (98%) 48/50 (96%) 49/50 (98%) |
|POLY-3 RATE (b) | 47/48.80 41/45.20 48/49.75 46/48.63 |50/50.00 49/50.00 48/49.66 49/49.81 |
|POLY-3 PERCENT (g) | 96.3% 90.7% 96.5% 94.6% |100.0% 98.0% 96.7% 98.4% |
|TERMINAL (d) | 22/22 (100%) 27/27 (100%) 31/31 (100%) 1/2 (50%) |32/32 (100%) 37/38 (97%) 36/37 (97%) 34/34 (100%) |
|FIRST INCIDENCE | 425 499 486 487 |288 609 528 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.043N* P=0.063N P<0.001 ** |P=0.424N P=0.096N P=0.103N P=0.340N |
|POLY 3 | P=0.600N P=0.198N P=0.711 P=0.538N |P=0.424N P=0.500N P=0.289N P=0.593N |
|POLY 1.5 | P=0.521 P=0.120N P=0.619 P=0.515N |P=0.395N P=0.500N P=0.262N P=0.544N |
|POLY 6 | P=0.552N P=0.350N P=0.700N P=0.582N |P=0.484N P=0.500N P=0.343N P=0.701N |
|LOGISTIC REGRESSION| P=0.167 P=0.084N P=0.542 P=0.652 |P=0.353N (e) P=0.209N P=0.489N |
|COCH-ARM / FISHERS | P=0.401 P=0.061N P=0.500 P=0.500N |P=0.366N P=0.500N P=0.247N P=0.500N |
|ORDER RESTRICTED | P=0.438N (e) (e) (e) |P=0.252N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Infiltration Cellular Plasma Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 0/44.30 0/32.01 |0/44.12 1/47.57 1/47.22 2/46.27 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.1% 2.1% 4.3% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 710 729 (T) 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.151 P=0.520 P=0.529 P=0.253 |
|POLY 3 | (e) (e) (e) (e) |P=0.162 P=0.515 P=0.514 P=0.248 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.160 P=0.510 P=0.510 P=0.245 |
|POLY 6 | (e) (e) (e) (e) |P=0.162 P=0.518 P=0.516 P=0.248 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.140 P=0.509 P=0.529 P=0.196 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.153 P=0.500 P=0.500 P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.127 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Deep Cervical |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/19 (11%) 0/20 (0%) 0/16 (0%) 1/19 (5%) |1/8 (13%) 0/8 (0%) 0/11 (0%) 0/12 (0%) |
|POLY-3 RATE (b) | 2/15.00 0/13.24 0/14.06 1/11.59 |1/6.66 0/7.07 0/9.49 0/10.39 |
|POLY-3 PERCENT (g) | 13.3% 0.0% 0.0% 8.6% |15.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/3 (0%) 0/4 (0%) 0/8 (0%) 0/0 (0%) |0/0 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) |
|FIRST INCIDENCE | 715 --- --- 569 |624 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.680N P=0.206N P=0.178N P=0.612 |P=0.298N P=0.487N P=0.483N P=0.487N |
|POLY 3 | P=0.410N P=0.260N P=0.245N P=0.591N |P=0.259N P=0.488N P=0.428N P=0.410N |
|POLY 1.5 | P=0.440N P=0.246N P=0.259N P=0.549N |P=0.257N P=0.491N P=0.429N P=0.411N |
|POLY 6 | P=0.356N P=0.269N P=0.221N P=0.655N |P=0.256N P=0.487N P=0.431N P=0.414N |
|LOGISTIC REGRESSION| P=0.527N P=0.222N P=0.122N P=0.685N |P=0.321N P=0.590N P=0.518N P=0.517N |
|COCH-ARM / FISHERS | P=0.471N P=0.231N P=0.287N P=0.500N |P=0.250N P=0.500N P=0.421N P=0.400N |
|ORDER RESTRICTED | P=0.186N (e) (e) (e) |P=0.065N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Deep Cervical |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/19 (0%) 0/20 (0%) 0/16 (0%) 0/19 (0%) |3/8 (38%) 0/8 (0%) 0/11 (0%) 0/12 (0%) |
|POLY-3 RATE (b) | 0/14.93 0/13.24 0/14.06 0/11.07 |3/6.76 0/7.07 0/9.49 0/10.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |44.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/3 (0%) 0/4 (0%) 0/8 (0%) 0/0 (0%) |0/0 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- --- --- --- |624 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.047N* P=0.110N P=0.113N P=0.123N |
|POLY 3 | (e) (e) (e) (e) |P=0.010N* P=0.069N P=0.034N* P=0.026N* |
|POLY 1.5 | (e) (e) (e) (e) |P=0.011N* P=0.074N P=0.036N* P=0.028N* |
|POLY 6 | (e) (e) (e) (e) |P=0.009N** P=0.067N P=0.034N* P=0.027N* |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.022N* P=0.088N P=0.050N P=0.041N* |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.023N* P=0.100N P=0.058N P=0.049N* |
|ORDER RESTRICTED | (e) (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Deep Cervical |
| Infiltration Cellular Plasma Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/19 (5%) 2/20 (10%) 0/16 (0%) 2/19 (11%) |3/8 (38%) 0/8 (0%) 0/11 (0%) 2/12 (17%) |
|POLY-3 RATE (b) | 1/14.99 2/13.32 0/14.06 2/12.03 |3/6.47 0/7.07 0/9.49 2/10.84 |
|POLY-3 PERCENT (g) | 6.7% 15.0% 0.0% 16.6% |46.4% 0.0% 0.0% 18.5% |
|TERMINAL (d) | 0/3 (0%) 1/4 (25%) 0/8 (0%) 0/0 (0%) |0/0 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) |
|FIRST INCIDENCE | 715 709 --- 569 |708 --- --- 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.216 P=0.567 P=0.443N P=0.262 |P=0.541N P=0.110N P=0.115N P=0.504N |
|POLY 3 | P=0.414 P=0.457 P=0.513N P=0.421 |P=0.383N P=0.061N P=0.029N* P=0.246N |
|POLY 1.5 | P=0.430 P=0.478 P=0.523N P=0.457 |P=0.378N P=0.069N P=0.033N* P=0.266N |
|POLY 6 | P=0.406 P=0.443 P=0.493N P=0.370 |P=0.383N P=0.053N P=0.026N* P=0.228N |
|LOGISTIC REGRESSION| P=0.394 P=0.487 P=0.434N P=0.528 |P=0.359N P=0.053N P=0.032N* P=0.254N |
|COCH-ARM / FISHERS | P=0.457 P=0.520 P=0.543N P=0.500 |P=0.375N P=0.100N P=0.058N P=0.296N |
|ORDER RESTRICTED | P=0.300 (e) (e) (e) |P=0.018N* (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/19 (16%) 0/20 (0%) 4/16 (25%) 3/19 (16%) |0/8 (0%) 0/8 (0%) 0/11 (0%) 0/12 (0%) |
|POLY-3 RATE (b) | 3/15.48 0/13.24 4/14.06 3/12.03 |0/6.28 0/7.07 0/9.49 0/10.39 |
|POLY-3 PERCENT (g) | 19.4% 0.0% 28.5% 24.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/3 (33%) 0/4 (0%) 4/8 (50%) 0/0 (0%) |0/0 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) |
|FIRST INCIDENCE | 634 --- 729 (T) 488 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.049 * P=0.114N P=0.438N P=0.151 |(e) (e) (e) (e) |
|POLY 3 | P=0.259 P=0.136N P=0.443 P=0.546 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.305 P=0.123N P=0.422 P=0.605 |(e) (e) (e) (e) |
|POLY 6 | P=0.197 P=0.150N P=0.483 P=0.446 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.186 P=0.136N P=0.590 P=0.557 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.349 P=0.106N P=0.398 P=0.670N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.209 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/19 (5%) 0/20 (0%) 1/16 (6%) 2/19 (11%) |0/8 (0%) 0/8 (0%) 0/11 (0%) 2/12 (17%) |
|POLY-3 RATE (b) | 1/15.27 0/13.24 1/14.06 2/11.99 |0/6.28 0/7.07 0/9.49 2/10.67 |
|POLY-3 PERCENT (g) | 6.6% 0.0% 7.1% 16.7% |0.0% 0.0% 0.0% 18.8% |
|TERMINAL (d) | 0/3 (0%) 0/4 (0%) 1/8 (13%) 0/0 (0%) |0/0 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) |
|FIRST INCIDENCE | 634 --- 729 (T) 549 |--- --- --- 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113 P=0.515N P=0.658N P=0.348 |P=0.046 * (e) (e) P=0.258 |
|POLY 3 | P=0.206 P=0.529N P=0.744 P=0.413 |P=0.075 (e) (e) P=0.357 |
|POLY 1.5 | P=0.223 P=0.515N P=0.733 P=0.453 |P=0.074 (e) (e) P=0.346 |
|POLY 6 | P=0.189 P=0.541N P=0.764N P=0.356 |P=0.075 (e) (e) P=0.369 |
|LOGISTIC REGRESSION| P=0.243 P=0.480N P=0.736 P=0.655 |P=0.074 (e) (e) P=0.342 |
|COCH-ARM / FISHERS | P=0.238 P=0.487N P=0.713 P=0.500 |P=0.074 (e) (e) P=0.347 |
|ORDER RESTRICTED | P=0.153 (e) (e) (e) |P=0.099 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/19 (0%) 0/20 (0%) 1/16 (6%) 2/19 (11%) |0/8 (0%) 0/8 (0%) 0/11 (0%) 0/12 (0%) |
|POLY-3 RATE (b) | 0/14.93 0/13.24 1/14.06 2/12.26 |0/6.28 0/7.07 0/9.49 0/10.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.1% 16.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/3 (0%) 0/4 (0%) 1/8 (13%) 0/0 (0%) |0/0 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 507 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * (e) P=0.695 P=0.226 |(e) (e) (e) (e) |
|POLY 3 | P=0.051 (e) P=0.488 P=0.187 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.059 (e) P=0.477 P=0.207 |(e) (e) (e) (e) |
|POLY 6 | P=0.042 * (e) P=0.509 P=0.158 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.087 (e) P=0.695 P=0.605 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.067 (e) P=0.457 P=0.243 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.045 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/19 (11%) 0/20 (0%) 0/16 (0%) 0/19 (0%) |0/8 (0%) 0/8 (0%) 1/11 (9%) 1/12 (8%) |
|POLY-3 RATE (b) | 2/15.72 0/13.24 0/14.06 0/11.07 |0/6.28 0/7.07 1/9.49 1/10.47 |
|POLY-3 PERCENT (g) | 12.7% 0.0% 0.0% 0.0% |0.0% 0.0% 10.5% 9.6% |
|TERMINAL (d) | 0/3 (0%) 0/4 (0%) 0/8 (0%) 0/0 (0%) |0/0 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) |
|FIRST INCIDENCE | 584 --- --- --- |--- --- 729 (T) 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.143N P=0.248N P=0.232N P=0.363N |P=0.303 (e) P=1.000 P=0.500 |
|POLY 3 | P=0.082N P=0.272N P=0.256N P=0.318N |P=0.339 (e) P=0.581 P=0.600 |
|POLY 1.5 | P=0.098N P=0.253N P=0.265N P=0.276N |P=0.333 (e) P=0.575 P=0.593 |
|POLY 6 | P=0.073N P=0.292N P=0.241N P=0.391N |P=0.342 (e) P=0.588 P=0.607 |
|LOGISTIC REGRESSION| P=0.107N P=0.170N P=0.334N P=0.144N |P=0.312 (e) P=1.000 P=0.612 |
|COCH-ARM / FISHERS | P=0.120N P=0.231N P=0.287N P=0.243N |P=0.314 (e) P=0.579 P=0.600 |
|ORDER RESTRICTED | P=0.068N (e) (e) (e) |P=0.352 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Infiltration Cellular Plasma Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/19 (0%) 1/20 (5%) 2/16 (13%) 3/19 (16%) |2/8 (25%) 1/8 (13%) 4/11 (36%) 2/12 (17%) |
|POLY-3 RATE (b) | 0/14.93 1/13.36 2/14.23 3/12.26 |2/7.21 1/7.22 4/9.85 2/10.48 |
|POLY-3 PERCENT (g) | 0.0% 7.5% 14.1% 24.5% |27.8% 13.9% 40.6% 19.1% |
|TERMINAL (d) | 0/3 (0%) 0/4 (0%) 0/8 (0%) 0/0 (0%) |0/0 (0%) 0/3 (0%) 1/4 (25%) 0/3 (0%) |
|FIRST INCIDENCE | --- 698 708 537 |430 690 662 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.532 P=0.303 P=0.044 * |P=0.519 P=0.477N P=0.538 P=0.689N |
|POLY 3 | P=0.033 * P=0.478 P=0.219 P=0.072 |P=0.519N P=0.499N P=0.486 P=0.558N |
|POLY 1.5 | P=0.042 * P=0.488 P=0.206 P=0.088 |P=0.509N P=0.500N P=0.487 P=0.551N |
|POLY 6 | P=0.025 * P=0.472 P=0.246 P=0.054 |P=0.540N P=0.495N P=0.489 P=0.571N |
|LOGISTIC REGRESSION| P=0.037 * P=0.470 P=0.257 P=0.141 |P=0.549N P=0.706N P=0.413 P=0.695N |
|COCH-ARM / FISHERS | P=0.055 P=0.513 P=0.202 P=0.115 |P=0.500N P=0.500N P=0.494 P=0.535N |
|ORDER RESTRICTED | P=0.029 * (e) (e) (e) |P=0.516N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/19 (0%) 0/20 (0%) 2/16 (13%) 2/19 (11%) |0/8 (0%) 0/8 (0%) 0/11 (0%) 0/12 (0%) |
|POLY-3 RATE (b) | 0/14.93 0/13.24 2/14.06 2/11.59 |0/6.28 0/7.07 0/9.49 0/10.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 14.2% 17.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/3 (0%) 0/4 (0%) 2/8 (25%) 0/0 (0%) |0/0 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 604 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** (e) P=0.470 P=0.069 |(e) (e) (e) (e) |
|POLY 3 | P=0.046 * (e) P=0.216 P=0.175 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.060 (e) P=0.205 P=0.201 |(e) (e) (e) (e) |
|POLY 6 | P=0.031 * (e) P=0.239 P=0.142 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.024 * (e) P=0.470 P=0.147 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.081 (e) P=0.202 P=0.243 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.072 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/19 (0%) 0/20 (0%) 1/16 (6%) 1/19 (5%) |0/8 (0%) 2/8 (25%) 0/11 (0%) 0/12 (0%) |
|POLY-3 RATE (b) | 0/14.93 0/13.24 1/14.06 1/11.41 |0/6.28 2/7.09 0/9.49 0/10.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.1% 8.8% |0.0% 28.2% 0.0% 0.0% |
|TERMINAL (d) | 0/3 (0%) 0/4 (0%) 1/8 (13%) 0/0 (0%) |0/0 (0%) 1/3 (33%) 0/4 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 634 |--- 725 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.078 (e) P=0.695 P=0.380 |P=0.283N P=0.539 (e) (e) |
|POLY 3 | P=0.167 (e) P=0.488 P=0.447 |P=0.263N P=0.247 (e) (e) |
|POLY 1.5 | P=0.198 (e) P=0.477 P=0.471 |P=0.277N P=0.238 (e) (e) |
|POLY 6 | P=0.136 (e) P=0.509 P=0.410 |P=0.249N P=0.258 (e) (e) |
|LOGISTIC REGRESSION| P=0.158 (e) P=0.695 P=0.502 |P=0.248N P=0.543 (e) (e) |
|COCH-ARM / FISHERS | P=0.231 (e) P=0.457 P=0.500 |P=0.314N P=0.233 (e) (e) |
|ORDER RESTRICTED | P=0.200 (e) (e) (e) |P=0.171N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/19 (5%) 1/20 (5%) 2/16 (13%) 0/19 (0%) |0/8 (0%) 3/8 (38%) 0/11 (0%) 1/12 (8%) |
|POLY-3 RATE (b) | 1/14.93 1/13.36 2/14.06 0/11.07 |0/6.28 3/7.09 0/9.49 1/10.57 |
|POLY-3 PERCENT (g) | 6.7% 7.5% 14.2% 0.0% |0.0% 42.3% 0.0% 9.5% |
|TERMINAL (d) | 1/3 (33%) 0/4 (0%) 2/8 (25%) 0/0 (0%) |0/0 (0%) 2/3 (67%) 0/4 (0%) 0/3 (0%) |
|FIRST INCIDENCE | 729 (T) 698 729 (T) --- |--- 725 --- 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.662N P=0.710N P=0.678N P=1.000N |P=0.483N P=0.539 (e) P=0.500 |
|POLY 3 | P=0.470N P=0.738 P=0.478 P=0.559N |P=0.442N P=0.100 (e) P=0.602 |
|POLY 1.5 | P=0.425N P=0.749 P=0.459 P=0.531N |P=0.463N P=0.095 (e) P=0.594 |
|POLY 6 | P=0.559N P=0.734 P=0.516 P=0.601N |P=0.418N P=0.104 (e) P=0.610 |
|LOGISTIC REGRESSION| P=0.568N P=0.757 P=0.678N (e) |P=0.487N (e) (e) P=0.586 |
|COCH-ARM / FISHERS | P=0.376N P=0.744N P=0.434 P=0.500N |P=0.500N P=0.100 (e) P=0.600 |
|ORDER RESTRICTED | P=0.305N (e) (e) (e) |P=0.230N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/19 (0%) 0/20 (0%) 3/16 (19%) 1/19 (5%) |0/8 (0%) 0/8 (0%) 0/11 (0%) 0/12 (0%) |
|POLY-3 RATE (b) | 0/14.93 0/13.24 3/14.47 1/11.15 |0/6.28 0/7.07 0/9.49 0/10.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 20.7% 9.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/3 (0%) 0/4 (0%) 2/8 (25%) 0/0 (0%) |0/0 (0%) 0/3 (0%) 0/4 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- --- 613 708 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.040 * (e) P=0.244 P=0.172 |(e) (e) (e) (e) |
|POLY 3 | P=0.114 (e) P=0.099 P=0.442 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.167 (e) P=0.089 P=0.469 |(e) (e) (e) (e) |
|POLY 6 | P=0.063 (e) P=0.121 P=0.401 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.112 (e) P=0.092 P=0.284 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.238 (e) P=0.086 P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.104 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/19 (0%) 0/20 (0%) 0/16 (0%) 0/19 (0%) |0/8 (0%) 2/8 (25%) 0/11 (0%) 0/12 (0%) |
|POLY-3 RATE (b) | 0/14.93 0/13.24 0/14.06 0/11.07 |0/6.28 2/7.09 0/9.49 0/10.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 28.2% 0.0% 0.0% |
|TERMINAL (d) | 0/3 (0%) 0/4 (0%) 0/8 (0%) 0/0 (0%) |0/0 (0%) 1/3 (33%) 0/4 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 725 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.283N P=0.539 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.263N P=0.247 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.277N P=0.238 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.249N P=0.258 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.248N P=0.543 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.314N P=0.233 (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.171N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/48 (0%) 1/50 (2%) 0/50 (0%) |7/50 (14%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/42.61 0/39.64 1/44.40 0/32.01 |7/44.35 3/47.57 2/47.30 2/45.95 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 2.3% 0.0% |15.8% 6.3% 4.2% 4.4% |
|TERMINAL (d) | 0/22 (0%) 0/26 (0%) 0/31 (0%) 0/2 (0%) |5/32 (16%) 2/38 (5%) 1/37 (3%) 1/34 (3%) |
|FIRST INCIDENCE | 632 --- 705 --- |673 710 709 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.288N P=0.250N P=0.445N P=0.425N |P=0.055N P=0.111N P=0.060N P=0.076N |
|POLY 3 | P=0.202N P=0.253N P=0.486N P=0.306N |P=0.054N P=0.130N P=0.064N P=0.070N |
|POLY 1.5 | P=0.196N P=0.252N P=0.492N P=0.271N |P=0.054N P=0.138N P=0.069N P=0.072N |
|POLY 6 | P=0.220N P=0.252N P=0.474N P=0.373N |P=0.055N P=0.125N P=0.062N P=0.071N |
|LOGISTIC REGRESSION| P=0.183N P=0.237N P=0.512N P=0.228N |P=0.051N P=0.124N P=0.063N P=0.073N |
|COCH-ARM / FISHERS | P=0.187N P=0.258N P=0.500N P=0.247N |P=0.056N P=0.159N P=0.080N P=0.080N |
|ORDER RESTRICTED | P=0.124N (e) (e) (e) |P=0.027N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 4/50 (8%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/42.08 0/39.64 0/44.30 0/32.01 |3/44.28 4/47.49 1/47.22 3/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.8% 8.4% 2.1% 6.6% |
|TERMINAL (d) | 0/22 (0%) 0/26 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 4/38 (11%) 1/37 (3%) 3/34 (9%) |
|FIRST INCIDENCE | --- --- --- --- |697 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.479N P=0.578 P=0.275N P=0.650N |
|POLY 3 | (e) (e) (e) (e) |P=0.468N P=0.538 P=0.283N P=0.647N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.469N P=0.527 P=0.289N P=0.649N |
|POLY 6 | (e) (e) (e) (e) |P=0.471N P=0.544 P=0.279N P=0.651N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.487N P=0.550 P=0.278N P=0.654N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.479N P=0.500 P=0.309N P=0.661N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.405N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/9 (78%) 7/12 (58%) 7/8 (88%) 3/4 (75%) |11/12 (92%) 18/18 (100%) 10/10 (100%) 4/6 (67%) |
|POLY-3 RATE (b) | 7/7.74 7/10.27 7/7.92 3/3.66 |11/11.98 18/18.00 10/10.00 4/5.51 |
|POLY-3 PERCENT (g) | 90.4% 68.2% 88.4% 82.0% |91.8% 100.0% 100.0% 72.7% |
|TERMINAL (d) | 5/5 (100%) 7/8 (88%) 4/4 (100%) 0/0 (0%) |7/7 (100%) 13/13 (100%) 10/10 (100%) 4/5 (80%) |
|FIRST INCIDENCE | 704 729 (T) 543 681 |673 690 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.025 * P=0.134N P=0.610 P=0.035 * |P=0.004N** P=0.556 P=0.060N P=0.033N* |
|POLY 3 | P=0.664 P=0.261N P=0.780N P=0.758N |P=0.166N P=0.427 P=0.544 P=0.370N |
|POLY 1.5 | P=0.591 P=0.284N P=0.726 P=0.723N |P=0.111N P=0.422 P=0.540 P=0.314N |
|POLY 6 | P=0.638N P=0.267N P=0.705N P=0.891N |P=0.265N P=0.435 P=0.552 P=0.451N |
|LOGISTIC REGRESSION| P=0.558 P=0.398N P=0.739 (e) |P=0.243N P=0.422 P=0.548 P=0.430N |
|COCH-ARM / FISHERS | P=0.500 P=0.324N P=0.547 P=0.706N |P=0.077N P=0.400 P=0.545 P=0.245N |
|ORDER RESTRICTED | P=0.516N (e) (e) (e) |P=0.061N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) 8/50 (16%) 9/50 (18%) |2/50 (4%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 7/44.40 7/42.91 8/44.38 9/35.61 |2/44.20 1/47.49 3/47.53 1/45.76 |
|POLY-3 PERCENT (g) | 15.8% 16.3% 18.0% 25.3% |4.5% 2.1% 6.3% 2.2% |
|TERMINAL (d) | 1/22 (5%) 3/27 (11%) 7/31 (23%) 0/2 (0%) |1/32 (3%) 1/38 (3%) 2/37 (5%) 1/34 (3%) |
|FIRST INCIDENCE | 425 535 708 487 |708 729 (T) 644 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * P=0.557N P=0.521N P=0.047 * |P=0.469N P=0.455N P=0.554 P=0.492N |
|POLY 3 | P=0.167 P=0.587 P=0.500 P=0.219 |P=0.472N P=0.475N P=0.533 P=0.488N |
|POLY 1.5 | P=0.227 P=0.592 P=0.497 P=0.295 |P=0.471N P=0.482N P=0.523 P=0.490N |
|POLY 6 | P=0.104 P=0.596 P=0.514 P=0.123 |P=0.477N P=0.470N P=0.540 P=0.490N |
|LOGISTIC REGRESSION| P=0.392 P=0.575N P=0.476 P=0.525N |P=0.468N P=0.468N P=0.515 P=0.492N |
|COCH-ARM / FISHERS | P=0.310 P=0.613N P=0.500 P=0.393 |P=0.474N P=0.500N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.230 (e) (e) (e) |P=0.449N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.76 2/42.74 1/44.30 0/32.01 |0/44.12 0/47.49 2/47.72 0/45.76 |
|POLY-3 PERCENT (g) | 2.3% 4.7% 2.3% 0.0% |0.0% 0.0% 4.2% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 495 484 729 (T) --- |--- --- 633 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.308N P=0.493 P=0.725N P=0.504N |P=0.593 (e) P=0.263 (e) |
|POLY 3 | P=0.309N P=0.500 P=0.753N P=0.557N |P=0.600 (e) P=0.255 (e) |
|POLY 1.5 | P=0.281N P=0.498 P=0.757N P=0.529N |P=0.601 (e) P=0.249 (e) |
|POLY 6 | P=0.365N P=0.508 P=0.745N P=0.602N |P=0.593 (e) P=0.260 (e) |
|LOGISTIC REGRESSION| P=0.182N P=0.668 P=0.735 P=0.511N |P=0.552 (e) P=0.183 (e) |
|COCH-ARM / FISHERS | P=0.247N P=0.500 P=0.753N P=0.500N |P=0.595 (e) P=0.247 (e) |
|ORDER RESTRICTED | P=0.289N (e) (e) (e) |P=0.263 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Oral Mucosa: Gingival |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/8 (100%) 6/8 (75%) 5/5 (100%) 5/7 (71%) |4/4 (100%) 7/8 (88%) 4/4 (100%) 4/4 (100%) |
|POLY-3 RATE (b) | 8/8.00 6/8.00 5/5.00 5/6.29 |4/4.00 7/7.85 4/4.00 4/4.00 |
|POLY-3 PERCENT (g) | 100.0% 75.0% 100.0% 79.5% |100.0% 89.2% 100.0% 100.0% |
|TERMINAL (d) | 1/1 (100%) 4/6 (67%) 3/3 (100%) 0/0 (0%) |1/1 (100%) 6/6 (100%) 0/0 (0%) 1/1 (100%) |
|FIRST INCIDENCE | 634 526 687 487 |358 609 609 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.254 P=0.064N (e) P=0.188 |P=0.437 P=0.278N (e) (e) |
|POLY 3 | P=0.339N P=0.223N (e) P=0.308N |P=0.658 P=0.697N (e) (e) |
|POLY 1.5 | P=0.264N P=0.223N (e) P=0.238N |P=0.634 P=0.665N (e) (e) |
|POLY 6 | P=0.477N P=0.223N (e) P=0.511N |P=0.710 P=0.763N (e) (e) |
|LOGISTIC REGRESSION| P=0.140N (e) (e) P=0.200N |P=0.608 P=0.709N (e) (e) |
|COCH-ARM / FISHERS | P=0.194N P=0.233N (e) P=0.200N |P=0.619 P=0.667N (e) (e) |
|ORDER RESTRICTED | P=0.157N (e) (e) (e) |P=0.502 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |6/50 (12%) 13/50 (26%) 10/50 (20%) 9/50 (18%) |
|POLY-3 RATE (b) | |6/44.16 13/47.62 10/47.72 9/46.02 |
|POLY-3 PERCENT (g) | |13.6% 27.3% 21.0% 19.6% |
|TERMINAL (d) | |4/32 (13%) 12/38 (32%) 8/37 (22%) 8/34 (24%) |
|FIRST INCIDENCE | |724 697 609 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.435 P=0.125 P=0.294 P=0.322 |
|POLY 3 | |P=0.466 P=0.085 P=0.257 P=0.317 |
|POLY 1.5 | |P=0.459 P=0.077 P=0.241 P=0.311 |
|POLY 6 | |P=0.463 P=0.090 P=0.269 P=0.315 |
|LOGISTIC REGRESSION| |P=0.429 P=0.091 P=0.256 P=0.296 |
|COCH-ARM / FISHERS | |P=0.428 P=0.062 P=0.207 P=0.288 |
|ORDER RESTRICTED | |P=0.232 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 0/44.30 3/32.40 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 9.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 1/2 (50%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- 624 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.009 ** (e) (e) P=0.078 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.010 * (e) (e) P=0.096 |(e) (e) (e) (e) |
|POLY 6 | P=0.012 * (e) (e) P=0.055 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.003 ** (e) (e) P=0.023 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.012 * (e) (e) P=0.121 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.003 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 47
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 16/50 (32%) 6/50 (12%) 9/50 (18%) |12/50 (24%) 3/50 (6%) 2/50 (4%) 6/50 (12%) |
|POLY-3 RATE (b) | 14/43.45 16/43.47 6/45.45 9/35.41 |12/44.91 3/47.62 2/47.84 6/46.02 |
|POLY-3 PERCENT (g) | 32.2% 36.8% 13.2% 25.4% |26.7% 6.3% 4.2% 13.0% |
|TERMINAL (d) | 8/22 (36%) 7/27 (26%) 3/31 (10%) 0/2 (0%) |6/32 (19%) 2/38 (5%) 1/37 (3%) 5/34 (15%) |
|FIRST INCIDENCE | 495 499 543 507 |637 697 528 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.332 P=0.577N P=0.011N* P=0.048 * |P=0.109N P=0.008N** P=0.004N** P=0.091N |
|POLY 3 | P=0.105N P=0.411 P=0.026N* P=0.338N |P=0.104N P=0.007N** P=0.002N** P=0.083N |
|POLY 1.5 | P=0.080N P=0.403 P=0.031N* P=0.248N |P=0.103N P=0.008N** P=0.003N** P=0.084N |
|POLY 6 | P=0.142N P=0.445 P=0.020N* P=0.518N |P=0.106N P=0.007N** P=0.002N** P=0.087N |
|LOGISTIC REGRESSION| P=0.081N P=0.397 P=0.038N* P=0.305N |P=0.106N P=0.009N** P=0.004N** P=0.082N |
|COCH-ARM / FISHERS | P=0.058N P=0.414 P=0.039N* P=0.171N |P=0.108N P=0.011N* P=0.004N** P=0.096N |
|ORDER RESTRICTED | P=0.088N (e) (e) (e) |P=0.003N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 21/50 (42%) 22/50 (44%) 10/50 (20%) |17/50 (34%) 10/50 (20%) 11/50 (22%) 12/50 (24%) |
|POLY-3 RATE (b) | 20/44.80 21/43.65 22/45.96 10/34.77 |17/44.84 10/47.91 11/48.17 12/47.46 |
|POLY-3 PERCENT (g) | 44.7% 48.1% 47.9% 28.8% |37.9% 20.9% 22.8% 25.3% |
|TERMINAL (d) | 9/22 (41%) 13/27 (48%) 16/31 (52%) 0/2 (0%) |12/32 (38%) 8/38 (21%) 7/37 (19%) 6/34 (18%) |
|FIRST INCIDENCE | 425 543 499 549 |613 613 528 528 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123 P=0.448N P=0.318N P=0.104 |P=0.240N P=0.041N* P=0.081N P=0.179N |
|POLY 3 | P=0.105N P=0.454 P=0.461 P=0.105N |P=0.207N P=0.055N P=0.085N P=0.138N |
|POLY 1.5 | P=0.044N* P=0.462 P=0.441 P=0.053N |P=0.215N P=0.063N P=0.098N P=0.152N |
|POLY 6 | P=0.280N P=0.467 P=0.496 P=0.272N |P=0.203N P=0.051N P=0.078N P=0.132N |
|LOGISTIC REGRESSION| P=0.099N P=0.478 P=0.462 P=0.120N |P=0.232N P=0.054N P=0.100N P=0.169N |
|COCH-ARM / FISHERS | P=0.015N* P=0.500 P=0.420 P=0.024N* |P=0.237N P=0.088N P=0.133N P=0.189N |
|ORDER RESTRICTED | P=0.082N (e) (e) (e) |P=0.079N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 48
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/45 (2%) 19/48 (40%) 32/49 (65%) |0/47 (0%) 1/48 (2%) 0/44 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | 2/41.64 1/37.46 19/43.91 32/41.22 |0/42.45 1/45.49 0/42.04 1/44.23 |
|POLY-3 PERCENT (g) | 4.8% 2.7% 43.3% 77.6% |0.0% 2.2% 0.0% 2.3% |
|TERMINAL (d) | 2/22 (9%) 0/25 (0%) 13/31 (42%) 1/2 (50%) |0/32 (0%) 1/36 (3%) 0/34 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 653 624 488 |--- 729 (T) --- 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.473N P<0.001 ** P<0.001 ** |P=0.409 P=0.523 (e) P=0.514 |
|POLY 3 | P<0.001 ** P=0.537N P<0.001 ** P<0.001 ** |P=0.415 P=0.514 (e) P=0.508 |
|POLY 1.5 | P<0.001 ** P=0.537N P<0.001 ** P<0.001 ** |P=0.414 P=0.512 (e) P=0.508 |
|POLY 6 | P<0.001 ** P=0.531N P<0.001 ** P<0.001 ** |P=0.411 P=0.514 (e) P=0.506 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.538N P<0.001 ** P<0.001 ** |P=0.406 P=0.523 (e) P=0.494 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.532N P<0.001 ** P<0.001 ** |P=0.408 P=0.505 (e) P=0.505 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.259 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 10/50 (20%) 11/50 (22%) 3/50 (6%) |30/50 (60%) 30/50 (60%) 23/50 (46%) 23/50 (46%) |
|POLY-3 RATE (b) | 4/42.51 10/42.39 11/44.67 3/32.61 |30/46.39 30/48.62 23/48.36 23/47.58 |
|POLY-3 PERCENT (g) | 9.4% 23.6% 24.6% 9.2% |64.7% 61.7% 47.6% 48.3% |
|TERMINAL (d) | 1/22 (5%) 7/27 (26%) 10/31 (32%) 1/2 (50%) |22/32 (69%) 23/38 (61%) 17/37 (46%) 15/34 (44%) |
|FIRST INCIDENCE | 676 526 624 593 |430 613 633 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060 P=0.135 P=0.140 P=0.181 |P=0.070N P=0.259N P=0.047N* P=0.101N |
|POLY 3 | P=0.523 P=0.068 P=0.052 P=0.642N |P=0.041N* P=0.465N P=0.067N P=0.078N |
|POLY 1.5 | P=0.429N P=0.069 P=0.048 * P=0.573N |P=0.045N* P=0.499N P=0.079N P=0.087N |
|POLY 6 | P=0.293 P=0.071 P=0.060 P=0.544 |P=0.038N* P=0.436N P=0.056N P=0.071N |
|LOGISTIC REGRESSION| P=0.412 P=0.071 P=0.068 P=0.545 |P=0.046N* P=0.456N P=0.075N P=0.089N |
|COCH-ARM / FISHERS | P=0.291N P=0.074 P=0.045 * P=0.500N |P=0.057N P=0.581N P=0.115N P=0.115N |
|ORDER RESTRICTED | P=0.190 (e) (e) (e) |P=0.074N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 49
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 1/50 (2%) 5/50 (10%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 6/42.65 3/41.56 1/44.30 5/34.41 |2/45.00 1/47.49 1/47.22 2/46.38 |
|POLY-3 PERCENT (g) | 14.1% 7.2% 2.3% 14.5% |4.4% 2.1% 2.1% 4.3% |
|TERMINAL (d) | 2/22 (9%) 3/27 (11%) 1/31 (3%) 0/2 (0%) |1/32 (3%) 1/38 (3%) 1/37 (3%) 1/34 (3%) |
|FIRST INCIDENCE | 645 729 (T) 729 (T) 488 |358 729 (T) 729 (T) 528 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.210 P=0.181N P=0.028N* P=0.168 |P=0.563 P=0.458N P=0.464N P=0.676N |
|POLY 3 | P=0.514N P=0.253N P=0.049N* P=0.606 |P=0.558 P=0.481N P=0.483N P=0.683N |
|POLY 1.5 | P=0.503N P=0.251N P=0.053N P=0.576N |P=0.558 P=0.487N P=0.488N P=0.685N |
|POLY 6 | P=0.505N P=0.250N P=0.044N* P=0.474 |P=0.556 P=0.477N P=0.480N P=0.684N |
|LOGISTIC REGRESSION| P=0.484N P=0.234N P=0.047N* P=0.457N |P=0.420 P=0.705N P=0.688N P=0.531 |
|COCH-ARM / FISHERS | P=0.482N P=0.243N P=0.056N P=0.500N |P=0.556 P=0.500N P=0.500N P=0.691N |
|ORDER RESTRICTED | P=0.256 (e) (e) (e) |P=0.525N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 21/50 (42%) 12/50 (24%) 13/50 (26%) |23/50 (46%) 24/50 (48%) 20/50 (40%) 18/50 (36%) |
|POLY-3 RATE (b) | 16/44.21 21/42.91 12/45.76 13/34.80 |23/45.99 24/48.27 20/48.01 18/47.22 |
|POLY-3 PERCENT (g) | 36.2% 48.9% 26.2% 37.4% |50.0% 49.7% 41.7% 38.1% |
|TERMINAL (d) | 10/22 (46%) 16/27 (59%) 7/31 (23%) 1/2 (50%) |16/32 (50%) 19/38 (50%) 16/37 (43%) 13/34 (38%) |
|FIRST INCIDENCE | 506 543 543 593 |528 609 633 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.023 * P=0.389 P=0.085N P=0.002 ** |P=0.129N P=0.389N P=0.189N P=0.171N |
|POLY 3 | P=0.325N P=0.156 P=0.212N P=0.552 |P=0.107N P=0.571N P=0.272N P=0.170N |
|POLY 1.5 | P=0.229N P=0.169 P=0.231N P=0.485N |P=0.110N P=0.571 P=0.288N P=0.176N |
|POLY 6 | P=0.461N P=0.152 P=0.180N P=0.312 |P=0.111N P=0.568N P=0.269N P=0.174N |
|LOGISTIC REGRESSION| P=0.439N P=0.185 P=0.243N P=0.383 |P=0.110N P=0.553N P=0.265N P=0.178N |
|COCH-ARM / FISHERS | P=0.139N P=0.204 P=0.252N P=0.330N |P=0.128N P=0.500 P=0.343N P=0.208N |
|ORDER RESTRICTED | P=0.239N (e) (e) (e) |P=0.194N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 50
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/49 (2%) | |
|POLY-3 RATE (b) | 2/43.08 2/41.56 1/44.30 1/32.00 | |
|POLY-3 PERCENT (g) | 4.6% 4.8% 2.3% 3.1% | |
|TERMINAL (d) | 0/22 (0%) 2/27 (7%) 1/31 (3%) 0/2 (0%) | |
|FIRST INCIDENCE | 506 729 (T) 729 (T) 529 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.560N P=0.667N P=0.463N P=0.563N | |
|POLY 3 | P=0.393N P=0.681 P=0.490N P=0.601N | |
|POLY 1.5 | P=0.373N P=0.684 P=0.495N P=0.556N | |
|POLY 6 | P=0.418N P=0.682 P=0.480N P=0.674N | |
|LOGISTIC REGRESSION| P=0.286N P=0.680N P=0.542N P=0.329N | |
|COCH-ARM / FISHERS | P=0.344N P=0.691N P=0.500N P=0.508N | |
|ORDER RESTRICTED | P=0.515N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 7/50 (14%) 8/50 (16%) 4/50 (8%) | |
|POLY-3 RATE (b) | 4/42.62 7/41.84 8/44.30 4/32.97 | |
|POLY-3 PERCENT (g) | 9.4% 16.7% 18.1% 12.1% | |
|TERMINAL (d) | 1/22 (5%) 4/27 (15%) 8/31 (26%) 1/2 (50%) | |
|FIRST INCIDENCE | 632 698 729 (T) 537 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027 * P=0.352 P=0.353 P=0.084 | |
|POLY 3 | P=0.401 P=0.248 P=0.194 P=0.497 | |
|POLY 1.5 | P=0.513 P=0.251 P=0.186 P=0.570 | |
|POLY 6 | P=0.246 P=0.252 P=0.208 P=0.369 | |
|LOGISTIC REGRESSION| P=0.236 P=0.261 P=0.239 P=0.480 | |
|COCH-ARM / FISHERS | P=0.485N P=0.262 P=0.178 P=0.643N | |
|ORDER RESTRICTED | P=0.349 (e) (e) (e) | |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 51
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 4/50 (8%) 0/50 (0%) | |
|POLY-3 RATE (b) | 2/42.09 3/41.56 4/44.38 0/32.01 | |
|POLY-3 PERCENT (g) | 4.8% 7.2% 9.0% 0.0% | |
|TERMINAL (d) | 1/22 (5%) 3/27 (11%) 3/31 (10%) 0/2 (0%) | |
|FIRST INCIDENCE | 725 729 (T) 708 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.616 P=0.585 P=0.496 P=0.767N | |
|POLY 3 | P=0.320N P=0.494 P=0.362 P=0.303N | |
|POLY 1.5 | P=0.254N P=0.494 P=0.350 P=0.269N | |
|POLY 6 | P=0.450N P=0.501 P=0.382 P=0.367N | |
|LOGISTIC REGRESSION| P=0.606N P=0.568 P=0.448 P=0.701N | |
|COCH-ARM / FISHERS | P=0.194N P=0.500 P=0.339 P=0.247N | |
|ORDER RESTRICTED | P=0.169N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 17/50 (34%) 26/50 (52%) 26/50 (52%) | |
|POLY-3 RATE (b) | 18/45.27 17/43.38 26/47.66 26/40.41 | |
|POLY-3 PERCENT (g) | 39.8% 39.2% 54.6% 64.3% | |
|TERMINAL (d) | 6/22 (27%) 9/27 (33%) 15/31 (48%) 2/2 (100%) | |
|FIRST INCIDENCE | 495 484 486 487 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.349N P=0.390 P<0.001 ** | |
|POLY 3 | P=0.005 ** P=0.565N P=0.107 P=0.014 * | |
|POLY 1.5 | P=0.011 * P=0.546N P=0.093 P=0.034 * | |
|POLY 6 | P<0.001 ** P=0.571N P=0.134 P=0.003 ** | |
|LOGISTIC REGRESSION| P=0.016 * P=0.512N P=0.071 P=0.065 | |
|COCH-ARM / FISHERS | P=0.028 * P=0.500N P=0.079 P=0.079 | |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) | |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 52
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 3/50 (6%) 0/49 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/41.64 1/41.88 3/44.38 0/31.45 |2/44.12 0/47.49 1/47.22 1/45.76 |
|POLY-3 PERCENT (g) | 2.4% 2.4% 6.8% 0.0% |4.5% 0.0% 2.1% 2.2% |
|TERMINAL (d) | 1/22 (5%) 0/27 (0%) 2/31 (7%) 0/2 (0%) |2/32 (6%) 0/38 (0%) 1/37 (3%) 1/34 (3%) |
|FIRST INCIDENCE | 729 (T) 641 708 --- |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.549 P=0.741N P=0.432 P=0.934N |P=0.495N P=0.201N P=0.449N P=0.479N |
|POLY 3 | P=0.540N P=0.760N P=0.328 P=0.555N |P=0.507N P=0.221N P=0.476N P=0.487N |
|POLY 1.5 | P=0.476N P=0.759N P=0.321 P=0.528N |P=0.504N P=0.226N P=0.483N P=0.490N |
|POLY 6 | P=0.516 P=0.756N P=0.343 P=0.599N |P=0.510N P=0.218N P=0.472N P=0.489N |
|LOGISTIC REGRESSION| P=0.592N P=0.760N P=0.382 (e) |P=0.495N (e) P=0.449N P=0.479N |
|COCH-ARM / FISHERS | P=0.410N P=0.747N P=0.316 P=0.500N |P=0.500N P=0.247N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.296N (e) (e) (e) |P=0.254N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.64 2/41.56 0/44.30 0/31.45 |0/44.12 0/47.49 1/47.41 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 0.0% 0.0% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/22 (0%) 2/27 (7%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- --- 679 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.689N P=0.284 (e) (e) |P=0.702 (e) P=0.523 (e) |
|POLY 3 | P=0.433N P=0.236 (e) (e) |P=0.698 (e) P=0.514 (e) |
|POLY 1.5 | P=0.424N P=0.237 (e) (e) |P=0.698 (e) P=0.510 (e) |
|POLY 6 | P=0.457N P=0.238 (e) (e) |P=0.693 (e) P=0.518 (e) |
|LOGISTIC REGRESSION| (e) P=0.284 (e) (e) |P=0.680 (e) P=0.478 (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.253 (e) (e) |P=0.694 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.306N (e) (e) (e) |P=0.393 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 53
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) 8/50 (16%) 4/49 (8%) | |
|POLY-3 RATE (b) | 3/42.52 7/41.84 8/44.30 4/32.54 | |
|POLY-3 PERCENT (g) | 7.1% 16.7% 18.1% 12.3% | |
|TERMINAL (d) | 1/22 (5%) 4/27 (15%) 8/31 (26%) 1/2 (50%) | |
|FIRST INCIDENCE | 632 698 729 (T) 537 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * P=0.230 P=0.222 P=0.046 * | |
|POLY 3 | P=0.294 P=0.148 P=0.110 P=0.357 | |
|POLY 1.5 | P=0.397 P=0.150 P=0.105 P=0.421 | |
|POLY 6 | P=0.163 P=0.152 P=0.120 P=0.255 | |
|LOGISTIC REGRESSION| P=0.155 P=0.158 P=0.143 P=0.364 | |
|COCH-ARM / FISHERS | P=0.516 P=0.159 P=0.100 P=0.489 | |
|ORDER RESTRICTED | P=0.224 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 4/49 (8%) | |
|POLY-3 RATE (b) | 0/42.08 0/41.56 0/44.30 4/32.68 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 12.2% | |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) | |
|FIRST INCIDENCE | --- --- --- 621 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.008 ** | |
|POLY 3 | P=0.002 ** (e) (e) P=0.034 * | |
|POLY 1.5 | P=0.002 ** (e) (e) P=0.044 * | |
|POLY 6 | P=0.002 ** (e) (e) P=0.021 * | |
|LOGISTIC REGRESSION| P=0.004 ** (e) (e) P=0.044 * | |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) P=0.056 | |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) | |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 54
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.13 0/41.56 0/44.30 0/32.01 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 4.8% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 715 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.151N P=0.202N P=0.178N P=0.772N |(e) (e) (e) (e) |
|POLY 3 | P=0.095N P=0.240N P=0.226N P=0.303N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.105N P=0.240N P=0.231N P=0.269N |(e) (e) (e) (e) |
|POLY 6 | P=0.080N P=0.236N P=0.217N P=0.367N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.146N P=0.221N P=0.195N P=0.603N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.061N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.08 0/41.56 3/44.30 1/32.26 |1/44.06 0/47.49 0/47.22 1/45.95 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 6.8% 3.1% |2.3% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/22 (5%) 0/27 (0%) 3/31 (10%) 0/2 (0%) |1/32 (3%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 662 |729 (T) --- --- 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.090 P=0.459N P=0.433 P=0.396 |P=0.597 P=0.466N P=0.471N P=0.751N |
|POLY 3 | P=0.327 P=0.502N P=0.324 P=0.698 |P=0.594 P=0.485N P=0.486N P=0.751N |
|POLY 1.5 | P=0.396 P=0.503N P=0.315 P=0.730 |P=0.595 P=0.489N P=0.489N P=0.752N |
|POLY 6 | P=0.233 P=0.499N P=0.339 P=0.638 |P=0.592 P=0.482N P=0.484N P=0.752N |
|LOGISTIC REGRESSION| P=0.209 (e) P=0.433 P=0.624 |P=0.597 (e) (e) P=0.756N |
|COCH-ARM / FISHERS | P=0.469 P=0.500N P=0.309 P=0.753N |P=0.598 P=0.495N P=0.495N P=0.747N |
|ORDER RESTRICTED | P=0.276 (e) (e) (e) |P=0.383N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 55
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 42/50 (84%) 45/50 (90%) 41/50 (82%) |47/49 (96%) 45/50 (90%) 40/50 (80%) 45/50 (90%) |
|POLY-3 RATE (b) | 45/48.70 42/47.82 45/49.59 41/47.15 |47/48.77 45/49.03 40/49.34 45/49.48 |
|POLY-3 PERCENT (g) | 92.4% 87.8% 90.7% 87.0% |96.4% 91.8% 81.1% 91.0% |
|TERMINAL (d) | 22/22 (100%) 25/27 (93%) 29/31 (94%) 2/2 (100%) |32/32 (100%) 36/38 (95%) 30/37 (81%) 33/34 (97%) |
|FIRST INCIDENCE | 425 344 486 487 |358 613 528 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.123N P=0.054N P<0.001 ** |P=0.325N P=0.059N P=0.020N* P=0.264N |
|POLY 3 | P=0.273N P=0.323N P=0.528N P=0.266N |P=0.191N P=0.285N P=0.015N* P=0.236N |
|POLY 1.5 | P=0.238N P=0.304N P=0.577N P=0.227N |P=0.197N P=0.255N P=0.015N* P=0.230N |
|POLY 6 | P=0.354N P=0.342N P=0.439N P=0.365N |P=0.187N P=0.336N P=0.015N* P=0.247N |
|LOGISTIC REGRESSION| P=0.256N P=0.300N P=0.623N P=0.204N |P=0.202N P=0.160N P=0.018N* P=0.225N |
|COCH-ARM / FISHERS | P=0.211N P=0.277N P=0.630N P=0.194N |P=0.208N P=0.226N P=0.015N* P=0.226N |
|ORDER RESTRICTED | P=0.269N (e) (e) (e) |P=0.051N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 9/50 (18%) 4/50 (8%) |0/49 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 6/42.09 2/41.62 9/44.96 4/33.63 |0/44.06 1/47.49 1/47.33 2/46.80 |
|POLY-3 PERCENT (g) | 14.3% 4.8% 20.0% 11.9% |0.0% 2.1% 2.1% 4.3% |
|TERMINAL (d) | 5/22 (23%) 1/27 (4%) 7/31 (23%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 725 715 543 488 |--- 729 (T) 701 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.038 * P=0.083N P=0.536 P=0.092 |P=0.157 P=0.534 P=0.515 P=0.259 |
|POLY 3 | P=0.421 P=0.135N P=0.335 P=0.516N |P=0.164 P=0.515 P=0.514 P=0.251 |
|POLY 1.5 | P=0.513 P=0.136N P=0.312 P=0.442N |P=0.162 P=0.511 P=0.511 P=0.248 |
|POLY 6 | P=0.286 P=0.127N P=0.373 P=0.623 |P=0.164 P=0.518 P=0.517 P=0.252 |
|LOGISTIC REGRESSION| P=0.386 P=0.091N P=0.369 P=0.595N |P=0.110 P=0.534 P=0.501 P=0.106 |
|COCH-ARM / FISHERS | P=0.516N P=0.134N P=0.288 P=0.370N |P=0.155 P=0.505 P=0.505 P=0.253 |
|ORDER RESTRICTED | P=0.305 (e) (e) (e) |P=0.130 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 56
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 7/50 (14%) 1/50 (2%) |1/49 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.76 3/41.56 7/44.30 1/32.09 |1/44.06 1/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 2.3% 7.2% 15.8% 3.1% |2.3% 2.1% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 3/27 (11%) 7/31 (23%) 0/2 (0%) |1/32 (3%) 1/38 (3%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 495 729 (T) 729 (T) 708 |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.061 P=0.358 P=0.075 P=0.634 |P=0.228N P=0.723N P=0.471N P=0.488N |
|POLY 3 | P=0.317 P=0.294 P=0.033 * P=0.693 |P=0.231N P=0.744N P=0.486N P=0.492N |
|POLY 1.5 | P=0.444 P=0.297 P=0.032 * P=0.727 |P=0.232N P=0.748N P=0.489N P=0.493N |
|POLY 6 | P=0.155 P=0.297 P=0.037 * P=0.629 |P=0.231N P=0.741N P=0.484N P=0.494N |
|LOGISTIC REGRESSION| P=0.282 P=0.308 P=0.036 * P=0.678N |P=0.228N P=0.723N (e) (e) |
|COCH-ARM / FISHERS | P=0.580 P=0.309 P=0.030 * P=0.753N |P=0.233N P=0.747N P=0.495N P=0.495N |
|ORDER RESTRICTED | P=0.157 (e) (e) (e) |P=0.243N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.42 2/42.67 0/44.30 1/32.71 |0/44.06 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 2.4% 4.7% 0.0% 3.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 632 344 --- 487 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.592N P=0.486 P=0.505N P=0.704 |(e) (e) (e) (e) |
|POLY 3 | P=0.515N P=0.502 P=0.491N P=0.700 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.513N P=0.500 P=0.495N P=0.731 |(e) (e) (e) (e) |
|POLY 6 | P=0.509N P=0.508 P=0.484N P=0.639 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.422N P=0.628 P=0.521N P=0.658N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.500N P=0.753N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.443N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 57
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 43/50 (86%) 44/50 (88%) 43/50 (86%) |48/49 (98%) 50/50 (100%) 49/50 (98%) 49/50 (98%) |
|POLY-3 RATE (b) | 39/46.94 43/46.79 44/48.53 43/46.78 |48/48.98 50/50.00 49/49.90 49/50.00 |
|POLY-3 PERCENT (g) | 83.1% 91.9% 90.7% 91.9% |98.0% 100.0% 98.2% 98.0% |
|TERMINAL (d) | 21/22 (96%) 27/27 (100%) 31/31 (100%) 2/2 (100%) |32/32 (100%) 38/38 (100%) 37/37 (100%) 33/34 (97%) |
|FIRST INCIDENCE | 506 373 486 488 |358 609 528 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.475N P=0.198N P<0.001 ** |P=0.526N P=0.208N P=0.218N P=0.472N |
|POLY 3 | P=0.133 P=0.137 P=0.193 P=0.133 |P=0.543N P=0.504 P=0.751 P=0.762N |
|POLY 1.5 | P=0.168 P=0.164 P=0.172 P=0.171 |P=0.543N P=0.500 P=0.753 P=0.759 |
|POLY 6 | P=0.089 P=0.110 P=0.219 P=0.090 |P=0.542N P=0.513 P=0.747 P=0.760N |
|LOGISTIC REGRESSION| P=0.050 P=0.140 P=0.181 P=0.052 |P=0.543N P=0.481 P=0.750 P=0.762N |
|COCH-ARM / FISHERS | P=0.205 P=0.218 P=0.143 P=0.218 |P=0.543N P=0.495 P=0.747 P=0.747 |
|ORDER RESTRICTED | P=0.088 (e) (e) (e) |P=0.527N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/49 (0%) 5/50 (10%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.76 0/41.56 1/44.30 2/32.81 |0/44.06 5/48.19 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.3% 6.1% |0.0% 10.4% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 2/38 (5%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 495 --- 729 (T) 507 |--- 609 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.120 P=0.508N P=0.725N P=0.372 |P=0.201N P=0.049 * (e) (e) |
|POLY 3 | P=0.199 P=0.506N P=0.753N P=0.409 |P=0.171N P=0.039 * (e) (e) |
|POLY 1.5 | P=0.221 P=0.505N P=0.757N P=0.453 |P=0.176N P=0.037 * (e) (e) |
|POLY 6 | P=0.181 P=0.504N P=0.745N P=0.338 |P=0.169N P=0.041 * (e) (e) |
|LOGISTIC REGRESSION| P=0.334 P=0.363N P=0.735 P=0.674 |P=0.207N P=0.025 * (e) (e) |
|COCH-ARM / FISHERS | P=0.247 P=0.500N P=0.753N P=0.500 |P=0.195N P=0.030 * (e) (e) |
|ORDER RESTRICTED | P=0.151 (e) (e) (e) |P=0.081N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 58
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 4/49 (8%) 10/49 (20%) 17/50 (34%) |2/50 (4%) 2/50 (4%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 7/43.39 4/41.59 10/44.53 17/38.13 |2/44.94 2/47.91 2/47.42 4/46.24 |
|POLY-3 PERCENT (g) | 16.1% 9.6% 22.5% 44.6% |4.5% 4.2% 4.2% 8.7% |
|TERMINAL (d) | 1/22 (5%) 1/27 (4%) 6/31 (19%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 582 698 494 487 |430 609 679 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.222N P=0.494 P<0.001 ** |P=0.223 P=0.656N P=0.660N P=0.346 |
|POLY 3 | P<0.001 ** P=0.284N P=0.315 P=0.003 ** |P=0.225 P=0.671N P=0.674N P=0.350 |
|POLY 1.5 | P<0.001 ** P=0.282N P=0.300 P=0.007 ** |P=0.226 P=0.678N P=0.680N P=0.348 |
|POLY 6 | P<0.001 ** P=0.281N P=0.341 P<0.001 ** |P=0.223 P=0.665N P=0.670N P=0.350 |
|LOGISTIC REGRESSION| P=0.002 ** P=0.275N P=0.279 P=0.031 * |P=0.167 P=0.533 P=0.586 P=0.272 |
|COCH-ARM / FISHERS | P=0.002 ** P=0.274N P=0.282 P=0.017 * |P=0.221 P=0.691N P=0.691N P=0.339 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.287 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 6/49 (12%) 8/49 (16%) 12/50 (24%) |4/50 (8%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 8/43.57 6/42.59 8/43.86 12/35.75 |4/45.54 2/47.91 2/47.53 3/46.13 |
|POLY-3 PERCENT (g) | 18.4% 14.1% 18.2% 33.6% |8.8% 4.2% 4.2% 6.5% |
|TERMINAL (d) | 1/22 (5%) 0/27 (0%) 4/31 (13%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 582 610 669 537 |430 609 644 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.361N P=0.415N P=0.002 ** |P=0.479N P=0.300N P=0.307N P=0.494N |
|POLY 3 | P=0.051 P=0.403N P=0.603N P=0.095 |P=0.483N P=0.314N P=0.318N P=0.493N |
|POLY 1.5 | P=0.076 P=0.407N P=0.603 P=0.149 |P=0.480N P=0.321N P=0.323N P=0.492N |
|POLY 6 | P=0.029 * P=0.389N P=0.584N P=0.040 * |P=0.487N P=0.310N P=0.315N P=0.498N |
|LOGISTIC REGRESSION| P=0.093 P=0.399N P=0.606N P=0.171 |P=0.577 P=0.543N P=0.507N P=0.602N |
|COCH-ARM / FISHERS | P=0.116 P=0.403N P=0.590 P=0.227 |P=0.479N P=0.339N P=0.339N P=0.500N |
|ORDER RESTRICTED | P=0.043 * (e) (e) (e) |P=0.352N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 59
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 1/49 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 1/41.71 1/43.40 3/32.76 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 2.3% 9.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 590 726 621 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.500 P=0.566 P=0.021 * |(e) (e) (e) (e) |
|POLY 3 | P=0.036 * P=0.498 P=0.506 P=0.080 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.044 * P=0.496 P=0.501 P=0.097 |(e) (e) (e) (e) |
|POLY 6 | P=0.030 * P=0.504 P=0.515 P=0.057 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.059 P=0.535 P=0.549 P=0.079 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.055 P=0.495 P=0.495 P=0.121 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.020 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/49 (2%) 8/49 (16%) 8/50 (16%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/43.11 1/41.36 8/43.86 8/34.69 |0/44.12 1/47.91 1/47.41 2/45.97 |
|POLY-3 PERCENT (g) | 9.3% 2.4% 18.2% 23.1% |0.0% 2.1% 2.1% 4.4% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 4/31 (13%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 582 698 669 529 |--- 609 679 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.178N P=0.319 P=0.014 * |P=0.156 P=0.521 P=0.523 P=0.254 |
|POLY 3 | P=0.014 * P=0.191N P=0.183 P=0.086 |P=0.160 P=0.516 P=0.514 P=0.246 |
|POLY 1.5 | P=0.023 * P=0.190N P=0.176 P=0.125 |P=0.159 P=0.511 P=0.510 P=0.244 |
|POLY 6 | P=0.007 ** P=0.189N P=0.199 P=0.043 * |P=0.159 P=0.521 P=0.518 P=0.246 |
|LOGISTIC REGRESSION| P=0.030 * P=0.181N P=0.176 P=0.217 |P=0.128 P=0.385 P=0.478 P=0.240 |
|COCH-ARM / FISHERS | P=0.041 * P=0.187N P=0.168 P=0.178 |P=0.153 P=0.500 P=0.500 P=0.247 |
|ORDER RESTRICTED | P=0.018 * (e) (e) (e) |P=0.126 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 60
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 3/49 (6%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/43.49 2/42.19 3/43.62 3/33.08 |0/44.12 1/47.91 1/47.53 1/45.76 |
|POLY-3 PERCENT (g) | 11.5% 4.7% 6.9% 9.1% |0.0% 2.1% 2.1% 2.2% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 549 610 691 569 |--- 609 644 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.452 P=0.222N P=0.268N P=0.530 |P=0.392 P=0.521 P=0.527 P=0.512 |
|POLY 3 | P=0.455N P=0.228N P=0.354N P=0.513N |P=0.395 P=0.516 P=0.515 P=0.507 |
|POLY 1.5 | P=0.417N P=0.226N P=0.361N P=0.436N |P=0.394 P=0.511 P=0.510 P=0.506 |
|POLY 6 | P=0.498N P=0.225N P=0.340N P=0.641N |P=0.392 P=0.521 P=0.518 P=0.506 |
|LOGISTIC REGRESSION| P=0.315N P=0.192N P=0.389N P=0.271N |P=0.331 P=0.385 P=0.438 P=0.512 |
|COCH-ARM / FISHERS | P=0.369N P=0.218N P=0.369N P=0.357N |P=0.384 P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.372N (e) (e) (e) |P=0.335 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 4/49 (8%) 7/50 (14%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 5/43.17 5/42.18 4/43.53 7/33.63 |0/44.12 0/47.49 2/47.88 3/45.97 |
|POLY-3 PERCENT (g) | 11.6% 11.9% 9.2% 20.8% |0.0% 0.0% 4.2% 6.5% |
|TERMINAL (d) | 1/22 (5%) 0/27 (0%) 3/31 (10%) 1/2 (50%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 495 673 691 549 |--- --- 633 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.565N P=0.358N P=0.010 * |P=0.029 * (e) P=0.267 P=0.136 |
|POLY 3 | P=0.194 P=0.616 P=0.495N P=0.216 |P=0.028 * (e) P=0.256 P=0.126 |
|POLY 1.5 | P=0.241 P=0.618 P=0.504N P=0.290 |P=0.028 * (e) P=0.250 P=0.125 |
|POLY 6 | P=0.147 P=0.626 P=0.476N P=0.120 |P=0.027 * (e) P=0.261 P=0.126 |
|LOGISTIC REGRESSION| P=0.207 P=0.630 P=0.514N P=0.277 |P=0.023 * (e) P=0.152 P=0.126 |
|COCH-ARM / FISHERS | P=0.305 P=0.630N P=0.513N P=0.380 |P=0.028 * (e) P=0.247 P=0.121 |
|ORDER RESTRICTED | P=0.166 (e) (e) (e) |P=0.041 * (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 61
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 5/49 (10%) 15/50 (30%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 5/44.20 15/37.26 |0/44.12 2/47.90 2/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 11.3% 40.3% |0.0% 4.2% 4.2% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 2/31 (7%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 2/37 (5%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 486 488 |--- 613 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.066 P<0.001 ** |P=0.494N P=0.268 P=0.271 (e) |
|POLY 3 | P<0.001 ** (e) P=0.034 * P<0.001 ** |P=0.482N P=0.256 P=0.253 (e) |
|POLY 1.5 | P<0.001 ** (e) P=0.032 * P<0.001 ** |P=0.486N P=0.250 P=0.248 (e) |
|POLY 6 | P<0.001 ** (e) P=0.039 * P<0.001 ** |P=0.484N P=0.261 P=0.256 (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.029 * P<0.001 ** |P=0.505N P=0.190 P=0.271 (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.027 * P<0.001 ** |P=0.500N P=0.247 P=0.247 (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.282N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) 4/50 (8%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.28 0/41.56 1/43.38 4/33.09 |1/44.49 0/47.49 0/47.22 1/45.95 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 2.3% 12.1% |2.3% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 676 --- 729 (T) 529 |624 --- --- 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.511N P=0.711N P=0.021 * |P=0.605 P=0.487N P=0.483N P=0.745N |
|POLY 3 | P=0.025 * P=0.503N P=0.755N P=0.113 |P=0.591 P=0.487N P=0.488N P=0.753N |
|POLY 1.5 | P=0.028 * P=0.503N P=0.760N P=0.143 |P=0.592 P=0.491N P=0.491N P=0.754N |
|POLY 6 | P=0.023 * P=0.501N P=0.747N P=0.074 |P=0.589 P=0.485N P=0.487N P=0.755N |
|LOGISTIC REGRESSION| P=0.030 * P=0.500N P=0.758N P=0.146 |P=0.539 P=0.594N P=0.586N P=0.734 |
|COCH-ARM / FISHERS | P=0.034 * P=0.500N P=0.747 P=0.181 |P=0.595 P=0.500N P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.011 * (e) (e) (e) |P=0.387N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 62
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |
|POLY-3 RATE (b) | 0/42.08 2/43.03 0/44.30 0/32.01 | |
|POLY-3 PERCENT (g) | 0.0% 4.7% 0.0% 0.0% | |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) | |
|FIRST INCIDENCE | --- 373 --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.409N P=0.233 (e) (e) | |
|POLY 3 | P=0.427N P=0.242 (e) (e) | |
|POLY 1.5 | P=0.419N P=0.239 (e) (e) | |
|POLY 6 | P=0.452N P=0.248 (e) (e) | |
|LOGISTIC REGRESSION| P=0.469N P=0.420 (e) (e) | |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) | |
|ORDER RESTRICTED | P=0.310N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 6/50 (12%) 7/50 (14%) | |
|POLY-3 RATE (b) | 6/43.97 5/42.89 6/45.54 7/33.81 | |
|POLY-3 PERCENT (g) | 13.6% 11.7% 13.2% 20.7% | |
|TERMINAL (d) | 0/22 (0%) 3/27 (11%) 2/31 (7%) 1/2 (50%) | |
|FIRST INCIDENCE | 495 484 494 555 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.045 * P=0.446N P=0.495N P=0.049 * | |
|POLY 3 | P=0.233 P=0.518N P=0.596N P=0.303 | |
|POLY 1.5 | P=0.297 P=0.514N P=0.608N P=0.395 | |
|POLY 6 | P=0.168 P=0.516N P=0.574N P=0.176 | |
|LOGISTIC REGRESSION| P=0.504 P=0.447N P=0.564 P=0.575 | |
|COCH-ARM / FISHERS | P=0.384 P=0.500N P=0.620N P=0.500 | |
|ORDER RESTRICTED | P=0.271 (e) (e) (e) | |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 63
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 12/50 (24%) 14/50 (28%) 22/50 (44%) | |
|POLY-3 RATE (b) | 15/46.34 12/45.11 14/48.12 22/41.48 | |
|POLY-3 PERCENT (g) | 32.4% 26.6% 29.1% 53.0% | |
|TERMINAL (d) | 2/22 (9%) 5/27 (19%) 4/31 (13%) 1/2 (50%) | |
|FIRST INCIDENCE | 425 344 486 487 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.277N P=0.328N P<0.001 ** | |
|POLY 3 | P=0.017 * P=0.353N P=0.451N P=0.035 * | |
|POLY 1.5 | P=0.026 * P=0.345N P=0.474N P=0.061 | |
|POLY 6 | P=0.009 ** P=0.358N P=0.414N P=0.012 * | |
|LOGISTIC REGRESSION| P=0.373 P=0.257N P=0.543 P=0.567N | |
|COCH-ARM / FISHERS | P=0.042 * P=0.326N P=0.500N P=0.107 | |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 44/48 (92%) 42/48 (88%) 47/48 (98%) 46/48 (96%) |49/50 (98%) 48/49 (98%) 44/46 (96%) 49/50 (98%) |
|POLY-3 RATE (b) | 44/46.94 42/45.61 47/47.53 46/47.71 |49/49.98 48/49.00 44/45.30 49/50.00 |
|POLY-3 PERCENT (g) | 93.7% 92.1% 98.9% 96.4% |98.0% 98.0% 97.1% 98.0% |
|TERMINAL (d) | 22/22 (100%) 25/26 (96%) 31/31 (100%) 1/1 (100%) |32/32 (100%) 36/37 (97%) 33/33 (100%) 33/34 (97%) |
|FIRST INCIDENCE | 425 373 486 487 |288 609 609 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.193N P=0.108N P<0.001 ** |P=0.483N P=0.128N P=0.126N P=0.405N |
|POLY 3 | P=0.220 P=0.542N P=0.182 P=0.445 |P=0.617N P=0.754N P=0.658N P=0.758N |
|POLY 1.5 | P=0.176 P=0.488N P=0.177 P=0.392 |P=0.606N P=0.755N P=0.578N P=0.759N |
|POLY 6 | P=0.286 P=0.553N P=0.209 P=0.539 |P=0.627N P=0.751N P=0.749N P=0.756N |
|LOGISTIC REGRESSION| P=0.062 P=0.470N P=0.193 P=0.424 |P=0.562N P=0.747 P=0.390N P=0.762N |
|COCH-ARM / FISHERS | P=0.132 P=0.370N P=0.181 P=0.339 |P=0.589N P=0.747N P=0.468N P=0.753N |
|ORDER RESTRICTED | P=0.172 (e) (e) (e) |P=0.669N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 64
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Ectopic Parathyroid Gland |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 1/48 (2%) 0/48 (0%) 4/48 (8%) |0/50 (0%) 0/49 (0%) 0/46 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/40.99 1/39.93 0/42.48 4/30.98 |0/44.12 0/46.49 0/43.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 2.5% 0.0% 12.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 1/26 (4%) 0/31 (0%) 0/1 (0%) |0/32 (0%) 0/37 (0%) 0/33 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 624 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.533 (e) P=0.004 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.009 ** P=0.495 (e) P=0.032 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.010 * P=0.496 (e) P=0.043 * |(e) (e) (e) (e) |
|POLY 6 | P=0.011 * P=0.496 (e) P=0.018 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.005 ** P=0.533 (e) P=0.020 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.013 * P=0.500 (e) P=0.059 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Ultimobranchial Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 2/44.89 1/32.35 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 3.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 543 634 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113 (e) P=0.277 P=0.388 |(e) (e) (e) (e) |
|POLY 3 | P=0.152 (e) P=0.252 P=0.448 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.195 (e) P=0.245 P=0.473 |(e) (e) (e) (e) |
|POLY 6 | P=0.101 (e) P=0.263 P=0.406 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.296 (e) P=0.214 P=0.536 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.246 (e) P=0.247 P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.191 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 65
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 8/50 (16%) 8/50 (16%) 5/50 (10%) |34/50 (68%) 11/50 (22%) 13/50 (26%) 8/50 (16%) |
|POLY-3 RATE (b) | 17/45.18 8/41.93 8/44.90 5/33.78 |34/47.78 11/47.99 13/47.64 8/46.28 |
|POLY-3 PERCENT (g) | 37.6% 19.1% 17.8% 14.8% |71.2% 22.9% 27.3% 17.3% |
|TERMINAL (d) | 6/22 (27%) 7/27 (26%) 6/31 (19%) 0/2 (0%) |23/32 (72%) 8/38 (21%) 11/37 (30%) 6/34 (18%) |
|FIRST INCIDENCE | 495 624 543 487 |430 613 633 638 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.217N P=0.021N* P=0.010N* P=0.516N |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 3 | P=0.012N* P=0.043N* P=0.028N* P=0.021N* |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P=0.007N** P=0.039N* P=0.029N* P=0.008N** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P=0.024N* P=0.047N* P=0.025N* P=0.080N |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.008N** P=0.034N* P=0.034N* P=0.004N** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P=0.004N** P=0.032N* P=0.032N* P=0.004N** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|ORDER RESTRICTED | P=0.012N* (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 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) | 1/42.08 2/41.56 0/44.30 0/32.01 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 2.4% 4.8% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 2/27 (7%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.362N P=0.572 P=0.432N P=0.934N |(e) (e) (e) (e) |
|POLY 3 | P=0.202N P=0.496 P=0.490N P=0.554N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.198N P=0.495 P=0.495N P=0.527N |(e) (e) (e) (e) |
|POLY 6 | P=0.210N P=0.501 P=0.481N P=0.598N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.362N P=0.572 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.226N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 66
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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) | 0/42.08 0/41.56 0/44.30 0/32.01 |0/44.12 2/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.2% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 2/38 (5%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.399N P=0.277 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.384N P=0.254 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.389N P=0.249 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.382N P=0.258 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.277 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.405N P=0.247 (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.255N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/3 (33%) 0/5 (0%) 1/2 (50%) 1/3 (33%) |0/0 (0%) 0/0 (0%) 3/3 (100%) 2/3 (67%) |
|POLY-3 RATE (b) | 1/2.67 0/2.63 1/1.53 1/2.60 |0/0.00 0/0.00 3/3.00 2/2.84 |
|POLY-3 PERCENT (g) | 37.5% 0.0% 65.4% 38.5% |0.0% 0.0% 100.0% 70.5% |
|TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) |0/0 (0%) 0/0 (0%) 3/3 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 676 --- 691 691 |--- --- 729 (T) 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.242 P=0.482N P=0.696N P=0.396 |P=0.190 (e) (e) P=0.500 |
|POLY 3 | P=0.574 P=0.504N P=0.650 P=0.768 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.536 P=0.455N P=0.659 P=0.764 |(e) (e) (e) (e) |
|POLY 6 | P=0.621 P=0.575N P=0.636 P=0.774 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.565 P=0.585N P=0.625 P=0.806 |P=0.660N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.472 P=0.375N P=0.700 P=0.800N |P=0.500N (e) (e) P=1.000 |
|ORDER RESTRICTED | P=0.355 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 67
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Trachea |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 8/50 (16%) 3/50 (6%) |0/50 (0%) 4/50 (8%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.40 1/42.18 8/45.58 3/33.29 |0/44.12 4/48.04 2/47.22 1/45.76 |
|POLY-3 PERCENT (g) | 4.7% 2.4% 17.6% 9.0% |0.0% 8.3% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 4/31 (13%) 0/2 (0%) |0/32 (0%) 2/38 (5%) 2/37 (5%) 1/34 (3%) |
|FIRST INCIDENCE | 681 526 486 487 |--- 609 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.031 * P=0.482N P=0.110 P=0.195 |P=0.576N P=0.084 P=0.271 P=0.512 |
|POLY 3 | P=0.112 P=0.502N P=0.057 P=0.391 |P=0.552N P=0.072 P=0.253 P=0.507 |
|POLY 1.5 | P=0.172 P=0.503N P=0.052 P=0.444 |P=0.558N P=0.068 P=0.248 P=0.506 |
|POLY 6 | P=0.050 P=0.496N P=0.067 P=0.304 |P=0.553N P=0.075 P=0.256 P=0.506 |
|LOGISTIC REGRESSION| P=0.318 P=0.470N P=0.044 * P=0.589 |P=0.575N P=0.051 P=0.271 P=0.512 |
|COCH-ARM / FISHERS | P=0.256 P=0.500N P=0.046 * P=0.500 |P=0.577N P=0.059 P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.092 (e) (e) (e) |P=0.172 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/43.42 0/41.56 2/44.45 2/32.47 |1/44.12 1/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 6.9% 0.0% 4.5% 6.2% |2.3% 2.1% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |1/32 (3%) 1/38 (3%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 495 --- 691 639 |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.358 P=0.123N P=0.437N P=0.546 |P=0.228N P=0.723N P=0.471N P=0.488N |
|POLY 3 | P=0.543 P=0.126N P=0.489N P=0.629N |P=0.233N P=0.744N P=0.486N P=0.493N |
|POLY 1.5 | P=0.582 P=0.124N P=0.495N P=0.568N |P=0.234N P=0.749N P=0.490N P=0.494N |
|POLY 6 | P=0.502 P=0.126N P=0.476N P=0.623 |P=0.232N P=0.740N P=0.484N P=0.494N |
|LOGISTIC REGRESSION| P=0.508N P=0.075N P=0.547N P=0.358N |P=0.228N P=0.723N (e) (e) |
|COCH-ARM / FISHERS | P=0.578N P=0.121N P=0.500N P=0.500N |P=0.235N P=0.753N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.379N (e) (e) (e) |P=0.244N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/21/03 EXPERIMENT: 88138 TEST: 03 Page 68
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |12/50 (24%) 20/50 (40%) 20/50 (40%) 20/50 (40%) |
|POLY-3 RATE (b) | |12/44.72 20/48.06 20/47.84 20/46.41 |
|POLY-3 PERCENT (g) | |26.8% 41.6% 41.8% 43.1% |
|TERMINAL (d) | |8/32 (25%) 16/38 (42%) 16/37 (43%) 17/34 (50%) |
|FIRST INCIDENCE | |634 633 644 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.108 P=0.175 P=0.158 P=0.095 |
|POLY 3 | |P=0.110 P=0.099 P=0.096 P=0.077 |
|POLY 1.5 | |P=0.110 P=0.088 P=0.086 P=0.076 |
|POLY 6 | |P=0.101 P=0.105 P=0.101 P=0.072 |
|LOGISTIC REGRESSION| |P=0.100 P=0.108 P=0.104 P=0.078 |
|COCH-ARM / FISHERS | |P=0.098 P=0.066 P=0.066 P=0.066 |
|ORDER RESTRICTED | |P=0.084 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus: Serosa |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | |0/44.12 2/47.63 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | |0.0% 4.2% 0.0% 0.0% |
|TERMINAL (d) | |0/32 (0%) 1/38 (3%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | |--- 693 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.409N P=0.270 (e) (e) |
|POLY 3 | |P=0.384N P=0.255 (e) (e) |
|POLY 1.5 | |P=0.389N P=0.249 (e) (e) |
|POLY 6 | |P=0.381N P=0.259 (e) (e) |
|LOGISTIC REGRESSION| |P=0.402N P=0.246 (e) (e) |
|COCH-ARM / FISHERS | |P=0.405N P=0.247 (e) (e) |
|ORDER RESTRICTED | |P=0.255N (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).