TDMS Study 05203-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 08 TIME: 09:36:38
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62340D
PATHOLOGIST: HEATH, JAMES E. CAS: 88-72-2
------------------------------------------------------------------------------------------------------------------------------------
RATS, FINAL#1; CORE STUDY
REASONS FOR REMOVAL: 25022 Accidently Killed
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 PPM
INCLUDE 002 0 PPM
INCLUDE 003 625 PPM
INCLUDE 004 625 PPM
INCLUDE 005 1250 PPM
INCLUDE 006 1250 PPM
INCLUDE 007 2000 PPM
INCLUDE 008 2000 PPM
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 08 TIME: 09:36:38
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62340D
PATHOLOGIST: HEATH, JAMES E. CAS: 88-72-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF O-NITROTOLUENE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
Degeneration Fatty
Hyperplasia Diffuse
Hyperplasia Focal
Adrenal Medulla Hyperplasia
Bone Marrow Hyperplasia
Bone: Cranium Osteopetrosis
Brain Compression
Epididymis Atypia Cellular
Eye Cataract
Eye: Retina Degeneration
Heart Cardiomyopathy
Islets, Pancreatic Hyperplasia
Pigmentation
Kidney Cyst
Nephropathy
Kidney: Renal Tubule Degeneration Hyaline
Pigmentation
Liver Angiectasis
Atrophy
Basophilic Focus
Clear Cell Focus
Degeneration Cystic
Eosinophilic Focus
Hematopoietic Cell Proliferation
Hemorrhage
Hepatodiaphragmatic Nodule
Infiltration Cellular Mixed Cell
Mixed Cell Focus
Necrosis Focal
Liver: Bile Duct Hyperplasia
Liver: Centrilobular Necrosis
Liver: Kupffer Cell Pigmentation
Lung Infiltration Cellular Histiocyte
Lung: Alveolar Epithelium Hyperplasia
Lymph Node, Mandibular Hyperplasia Lymphoid
Pigmentation
Lymph Node, Mediastinal Pigmentation
Lymph Node, Mesenteric Hemorrhage
Pigmentation
Mammary Gland Dilatation
Mesentery Accessory Spleen
Nose Foreign Body
Inflammation Chronic
Nose: Respiratory Epithelium Hyperplasia
Pancreas Atrophy
Pancreas: Acinus Hyperplasia Focal
Peritoneum: Mesothelium Hyperplasia
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 08 TIME: 09:36:38
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62340D
PATHOLOGIST: HEATH, JAMES E. CAS: 88-72-2
Pituitary Gland: Pars Distalis Angiectasis
Cyst
Cytoplasmic Alteration
Hyperplasia Focal
Pituitary Gland: Pars Intermedia Cyst
Preputial Gland Atrophy
Inflammation Chronic
Prostate Inflammation Chronic
Prostate: Ventral Hyperplasia
Salivary Glands Atrophy
Spleen Fibrosis
Hematopoietic Cell Proliferation
Pigmentation
Stomach, Forestomach Edema
Stomach, Forestomach: Epithelium Hyperplasia
Stomach, Glandular Erosion
Ulcer
Testes Angiectasis
Testes: Germinal Epithelium Atrophy
Testes: Interstitial Cell Hyperplasia
Thyroid Gland Ultimobranchial Cyst
Thyroid Gland: C-Cell Hyperplasia
Thyroid Gland: Follicle Cyst
Urinary Bladder Fibrosis
Inflammation Chronic
Urinary Bladder: Transitional Epithelium
Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia Focal
Adrenal Medulla Hyperplasia
Bone Marrow Hyperplasia
Bone: Cranium Osteopetrosis
Bone: Femur Osteopetrosis
Clitoral Gland Atrophy
Heart Cardiomyopathy
Kidney Nephropathy
Kidney: Renal Tubule Pigmentation
Liver Basophilic Focus
Clear Cell Focus
Degeneration Cystic
Eosinophilic Focus
Infiltration Cellular Mixed Cell
Mixed Cell Focus
Necrosis Focal
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte Vacuolization Cytoplasmic
Liver: Kupffer Cell Pigmentation
Lung Infiltration Cellular Histiocyte
Lung: Alveolar Epithelium Hyperplasia
Lymph Node, Mandibular Hyperplasia Lymphoid
Mammary Gland Dilatation
Hyperplasia
Mesentery: Fat Necrosis
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 08 TIME: 09:36:38
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62340D
PATHOLOGIST: HEATH, JAMES E. CAS: 88-72-2
Nose Foreign Body
Inflammation Chronic
Ovary Angiectasis
Pancreas Atrophy
Salivary Glands Atrophy
Spleen Hematopoietic Cell Proliferation
Pigmentation
Stomach, Forestomach: Epithelium Hyperplasia
Thyroid Gland: C-Cell Hyperplasia
Uterus Hydrometra
===============================================================
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/60 (22%) 12/60 (20%) 13/60 (22%) 10/60 (17%) |8/60 (13%) 10/60 (17%) 8/60 (13%) 10/59 (17%) |
|POLY-3 RATE (b) | 13/54.52 12/45.64 13/39.21 10/27.12 |8/57.34 10/55.69 8/54.16 10/52.97 |
|POLY-3 PERCENT (g) | 23.8% 26.3% 33.2% 36.9% |14.0% 18.0% 14.8% 18.9% |
|TERMINAL (d) | 9/39 (23%) 6/18 (33%) 2/3 (67%) 0/0 (0%) |6/47 (13%) 10/47 (21%) 4/39 (10%) 6/32 (19%) |
|FIRST INCIDENCE | 640 615 523 391 |620 729 (T) 685 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.086 P<0.001 ** P<0.001 ** |P=0.141 P=0.394 P=0.465 P=0.169 |
|POLY 3 | P=0.104 P=0.480 P=0.225 P=0.185 |P=0.328 P=0.373 P=0.558 P=0.330 |
|POLY 1.5 | P=0.339 P=0.568 P=0.367 P=0.467 |P=0.357 P=0.385 P=0.578 P=0.356 |
|POLY 6 | P=0.011 * P=0.357 P=0.093 P=0.032 * |P=0.284 P=0.359 P=0.533 P=0.288 |
|LOGISTIC REGRESSION| P=0.049 * P=0.343 P=0.218 P=0.200 |P=0.297 P=0.376 P=0.570 P=0.338 |
|COCH-ARM / FISHERS | P=0.303N P=0.500N P=0.588N P=0.322N |P=0.389 P=0.399 P=0.605N P=0.384 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Fatty |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/60 (27%) 10/60 (17%) 11/60 (18%) 4/60 (7%) |13/60 (22%) 11/60 (18%) 17/60 (28%) 11/59 (19%) |
|POLY-3 RATE (b) | 16/54.85 10/46.77 11/37.61 4/23.65 |13/57.31 11/55.97 17/54.55 11/53.70 |
|POLY-3 PERCENT (g) | 29.2% 21.4% 29.3% 16.9% |22.7% 19.7% 31.2% 20.5% |
|TERMINAL (d) | 13/39 (33%) 1/18 (6%) 1/3 (33%) 0/0 (0%) |10/47 (21%) 9/47 (19%) 11/39 (28%) 5/32 (16%) |
|FIRST INCIDENCE | 537 378 519 391 |674 684 656 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.450 P<0.001 ** P=0.005 ** |P=0.202 P=0.423N P=0.135 P=0.446 |
|POLY 3 | P=0.277N P=0.251N P=0.588 P=0.225N |P=0.470 P=0.435N P=0.212 P=0.480N |
|POLY 1.5 | P=0.063N P=0.191N P=0.403N P=0.046N* |P=0.502 P=0.424N P=0.233 P=0.454N |
|POLY 6 | P=0.396 P=0.356N P=0.331 P=0.539 |P=0.415 P=0.448N P=0.188 P=0.525N |
|LOGISTIC REGRESSION| P=0.301N P=0.183N P=0.385 P=0.490N |P=0.455 P=0.435N P=0.199 P=0.451N |
|COCH-ARM / FISHERS | P=0.004N** P=0.134N P=0.191N P=0.003N** |P=0.530N P=0.410N P=0.264 P=0.428N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 3/60 (5%) |3/60 (5%) 1/60 (2%) 0/60 (0%) 1/59 (2%) |
|POLY-3 RATE (b) | 0/53.85 0/44.05 1/35.13 3/23.64 |3/56.86 1/55.92 0/53.74 1/52.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.9% 12.7% |5.3% 1.8% 0.0% 1.9% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |3/47 (6%) 0/47 (0%) 0/39 (0%) 1/32 (3%) |
|FIRST INCIDENCE | --- --- 628 439 |729 (T) 669 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** (e) P=0.362 P=0.067 |P=0.196N P=0.309N P=0.156N P=0.450N |
|POLY 3 | P=0.016 * (e) P=0.418 P=0.038 * |P=0.139N P=0.312N P=0.130N P=0.336N |
|POLY 1.5 | P=0.014 * (e) P=0.453 P=0.062 |P=0.136N P=0.310N P=0.126N P=0.324N |
|POLY 6 | P=0.033 * (e) P=0.371 P=0.022 * |P=0.142N P=0.314N P=0.136N P=0.357N |
|LOGISTIC REGRESSION| P=0.094 (e) P=0.536 P=0.646 |P=0.148N P=0.308N (e) P=0.450N |
|COCH-ARM / FISHERS | P=0.021 * (e) P=0.500 P=0.122 |P=0.133N P=0.309N P=0.122N P=0.316N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/60 (10%) 2/60 (3%) 6/60 (10%) 3/60 (5%) |9/60 (15%) 6/60 (10%) 14/60 (23%) 15/59 (25%) |
|POLY-3 RATE (b) | 6/53.85 2/44.85 6/36.07 3/23.32 |9/57.10 6/56.48 14/54.43 15/54.35 |
|POLY-3 PERCENT (g) | 11.1% 4.5% 16.6% 12.9% |15.8% 10.6% 25.7% 27.6% |
|TERMINAL (d) | 6/39 (15%) 0/18 (0%) 1/3 (33%) 0/0 (0%) |7/47 (15%) 4/47 (9%) 11/39 (28%) 8/32 (25%) |
|FIRST INCIDENCE | 729 (T) 589 502 404 |674 531 569 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.424N P<0.001 ** P=0.012 * |P=0.004 ** P=0.301N P=0.085 P=0.032 * |
|POLY 3 | P=0.348 P=0.202N P=0.337 P=0.558 |P=0.021 * P=0.298N P=0.143 P=0.097 |
|POLY 1.5 | P=0.528 P=0.170N P=0.458 P=0.493N |P=0.024 * P=0.295N P=0.156 P=0.107 |
|POLY 6 | P=0.191 P=0.254N P=0.194 P=0.302 |P=0.016 * P=0.302N P=0.126 P=0.082 |
|LOGISTIC REGRESSION| P=0.248 P=0.222N P=0.122 P=0.595 |P=0.026 * P=0.290N P=0.135 P=0.118 |
|COCH-ARM / FISHERS | P=0.324N P=0.136N P=0.619N P=0.245N |P=0.028 * P=0.291N P=0.177 P=0.117 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 2/60 (3%) 2/60 (3%) 0/60 (0%) |6/60 (10%) 7/60 (12%) 6/60 (10%) 7/59 (12%) |
|POLY-3 RATE (b) | 3/54.09 2/44.41 2/35.74 0/21.46 |6/56.86 7/55.80 6/53.99 7/53.24 |
|POLY-3 PERCENT (g) | 5.6% 4.5% 5.6% 0.0% |10.6% 12.6% 11.1% 13.2% |
|TERMINAL (d) | 1/39 (3%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |6/47 (13%) 6/47 (13%) 3/39 (8%) 4/32 (13%) |
|FIRST INCIDENCE | 674 658 519 --- |729 (T) 702 707 488 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.368 P=0.594 P=0.342 P=1.000N |P=0.215 P=0.498 P=0.492 P=0.266 |
|POLY 3 | P=0.374N P=0.588N P=0.670 P=0.352N |P=0.409 P=0.486 P=0.583 P=0.450 |
|POLY 1.5 | P=0.204N P=0.549N P=0.603N P=0.228N |P=0.431 P=0.492 P=0.598 P=0.469 |
|POLY 6 | P=0.610 P=0.643N P=0.557 P=0.520N |P=0.372 P=0.479 P=0.564 P=0.416 |
|LOGISTIC REGRESSION| P=0.257N P=0.609N P=0.568N P=0.804N |P=0.398 P=0.470 P=0.541 P=0.478 |
|COCH-ARM / FISHERS | P=0.085N P=0.500N P=0.500N P=0.122N |P=0.453 P=0.500 P=0.619N P=0.487 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/60 (12%) 4/60 (7%) 2/60 (3%) 0/59 (0%) |8/60 (13%) 2/60 (3%) 3/60 (5%) 3/58 (5%) |
|POLY-3 RATE (b) | 7/54.16 4/44.85 2/35.88 0/21.19 |8/57.12 2/55.80 3/53.91 3/52.12 |
|POLY-3 PERCENT (g) | 12.9% 8.9% 5.6% 0.0% |14.0% 3.6% 5.6% 5.8% |
|TERMINAL (d) | 5/39 (13%) 3/18 (17%) 0/3 (0%) 0/0 (0%) |5/47 (11%) 1/47 (2%) 1/39 (3%) 2/32 (6%) |
|FIRST INCIDENCE | 674 428 519 --- |691 702 706 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.581N P=0.565 P=0.533 P=1.000N |P=0.178N P=0.057N P=0.171N P=0.252N |
|POLY 3 | P=0.054N P=0.379N P=0.226N P=0.139N |P=0.089N P=0.051N P=0.120N P=0.133N |
|POLY 1.5 | P=0.015N* P=0.324N P=0.150N P=0.046N* |P=0.085N P=0.050N P=0.112N P=0.122N |
|POLY 6 | P=0.214N P=0.468N P=0.367N P=0.361N |P=0.099N P=0.053N P=0.132N P=0.153N |
|LOGISTIC REGRESSION| P=0.032N* P=0.378N P=0.199N P=0.714N |P=0.106N P=0.053N P=0.125N P=0.161N |
|COCH-ARM / FISHERS | P=0.003N** P=0.264N P=0.081N P=0.007N** |P=0.081N P=0.047N* P=0.102N P=0.113N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 25/60 (42%) 43/60 (72%) 45/60 (75%) |2/60 (3%) 7/60 (12%) 15/60 (25%) 24/60 (40%) |
|POLY-3 RATE (b) | 2/53.85 25/53.76 43/51.12 45/49.76 |2/57.70 7/56.53 15/57.71 24/57.29 |
|POLY-3 PERCENT (g) | 3.7% 46.5% 84.1% 90.4% |3.5% 12.4% 26.0% 41.9% |
|TERMINAL (d) | 2/39 (5%) 4/18 (22%) 3/3 (100%) 0/0 (0%) |1/47 (2%) 5/47 (11%) 5/39 (13%) 9/33 (27%) |
|FIRST INCIDENCE | 729 (T) 378 384 391 |401 505 370 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.086 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.076 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=0.078 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.075 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.090 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=0.081 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |2/60 (3%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 0/44.05 0/34.77 0/21.46 |2/56.90 1/55.69 1/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |3.5% 1.8% 1.9% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 1/47 (2%) 1/39 (3%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |719 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.200N P=0.509N P=0.574N P=0.326N |
|POLY 3 | (e) (e) (e) (e) |P=0.145N P=0.507N P=0.520N P=0.252N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.140N P=0.504N P=0.511N P=0.245N |
|POLY 6 | (e) (e) (e) (e) |P=0.152N P=0.511N P=0.531N P=0.265N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.179N P=0.513N P=0.549N P=0.282N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.135N P=0.500N P=0.500N P=0.248N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |1/60 (2%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/53.85 0/44.05 0/34.77 0/21.46 |1/56.86 0/55.69 0/53.74 2/54.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |1.8% 0.0% 0.0% 3.7% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.258 P=0.500N P=0.537N P=0.456 |
|POLY 3 | (e) (e) (e) (e) |P=0.280 P=0.504N P=0.511N P=0.484 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.283 P=0.502N P=0.507N P=0.492 |
|POLY 6 | (e) (e) (e) (e) |P=0.275 P=0.506N P=0.518N P=0.469 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.303 (e) (e) P=0.523 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.287 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone: Cranium |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 2/60 (3%) |2/60 (3%) 6/60 (10%) 6/60 (10%) 10/60 (17%) |
|POLY-3 RATE (b) | 0/53.85 1/44.05 0/34.77 2/22.37 |2/56.86 6/55.69 6/53.91 10/54.41 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 8.9% |3.5% 10.8% 11.1% 18.4% |
|TERMINAL (d) | 0/39 (0%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |2/47 (4%) 6/47 (13%) 4/39 (10%) 6/33 (18%) |
|FIRST INCIDENCE | --- 729 (T) --- 581 |729 (T) 729 (T) 706 586 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.346 (e) P=0.003 ** |P=0.002 ** P=0.135 P=0.089 P=0.004 ** |
|POLY 3 | P=0.122 P=0.460 (e) P=0.111 |P=0.010 * P=0.128 P=0.118 P=0.012 * |
|POLY 1.5 | P=0.118 P=0.478 (e) P=0.154 |P=0.011 * P=0.132 P=0.125 P=0.013 * |
|POLY 6 | P=0.166 P=0.435 (e) P=0.078 |P=0.007 ** P=0.125 P=0.110 P=0.009 ** |
|LOGISTIC REGRESSION| P=0.031 * P=0.346 (e) P=0.139 |P=0.009 ** P=0.135 P=0.102 P=0.016 * |
|COCH-ARM / FISHERS | P=0.146 P=0.500 (e) P=0.248 |P=0.013 * P=0.136 P=0.136 P=0.015 * |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone: Femur |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |8/60 (13%) 9/60 (15%) 13/60 (22%) 16/60 (27%) |
|POLY-3 RATE (b) | 0/53.85 0/44.05 0/34.77 0/21.46 |8/58.22 9/55.69 13/54.05 16/55.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |13.7% 16.2% 24.1% 28.7% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |5/47 (11%) 9/47 (19%) 11/39 (28%) 9/33 (27%) |
|FIRST INCIDENCE | --- --- --- --- |453 729 (T) 672 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.002 ** P=0.495 P=0.090 P=0.015 * |
|POLY 3 | (e) (e) (e) (e) |P=0.016 * P=0.461 P=0.123 P=0.040 * |
|POLY 1.5 | (e) (e) (e) (e) |P=0.020 * P=0.477 P=0.140 P=0.047 * |
|POLY 6 | (e) (e) (e) (e) |P=0.012 * P=0.442 P=0.104 P=0.031 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.024 * P=0.508 P=0.166 P=0.083 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.024 * P=0.500 P=0.168 P=0.054 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/60 (10%) 3/60 (5%) 2/60 (3%) 1/60 (2%) |6/60 (10%) 10/60 (17%) 5/60 (8%) 3/60 (5%) |
|POLY-3 RATE (b) | 6/55.95 3/44.99 2/35.61 1/21.88 |6/56.98 10/56.79 5/54.34 3/53.36 |
|POLY-3 PERCENT (g) | 10.7% 6.7% 5.6% 4.6% |10.5% 17.6% 9.2% 5.6% |
|TERMINAL (d) | 1/39 (3%) 0/18 (0%) 1/3 (33%) 0/0 (0%) |5/47 (11%) 5/47 (11%) 2/39 (5%) 2/33 (6%) |
|FIRST INCIDENCE | 441 639 391 608 |700 531 636 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.573 P=0.477N P=0.591N P=0.686 |P=0.246N P=0.210 P=0.602N P=0.435N |
|POLY 3 | P=0.181N P=0.361N P=0.329N P=0.367N |P=0.130N P=0.208 P=0.533N P=0.277N |
|POLY 1.5 | P=0.081N P=0.308N P=0.232N P=0.186N |P=0.116N P=0.209 P=0.519N P=0.261N |
|POLY 6 | P=0.391N P=0.440N P=0.488N P=0.613N |P=0.157N P=0.207 P=0.550N P=0.306N |
|LOGISTIC REGRESSION| P=0.006N** P=0.094N P=0.024N* P=0.010N* |P=0.109N P=0.212 P=0.522N P=0.369N |
|COCH-ARM / FISHERS | P=0.026N* P=0.245N P=0.136N P=0.057N |P=0.102N P=0.211 P=0.500N P=0.245N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Hydrocephalus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 1/60 (2%) 1/60 (2%) 2/60 (3%) |2/60 (3%) 4/60 (7%) 0/60 (0%) 3/60 (5%) |
|POLY-3 RATE (b) | 3/54.87 1/44.05 1/35.61 2/23.01 |2/56.86 4/56.85 0/53.74 3/53.48 |
|POLY-3 PERCENT (g) | 5.5% 2.3% 2.8% 8.7% |3.5% 7.0% 0.0% 5.6% |
|TERMINAL (d) | 0/39 (0%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |2/47 (4%) 1/47 (2%) 0/39 (0%) 2/33 (6%) |
|FIRST INCIDENCE | 533 729 (T) 391 421 |729 (T) 531 --- 691 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.282 P=0.484N P=0.579N P=0.367 |P=0.483 P=0.332 P=0.280N P=0.354 |
|POLY 3 | P=0.589N P=0.388N P=0.470N P=0.492 |P=0.556N P=0.338 P=0.250N P=0.472 |
|POLY 1.5 | P=0.503N P=0.350N P=0.396N P=0.654 |P=0.544N P=0.338 P=0.245N P=0.486 |
|POLY 6 | P=0.580 P=0.445N P=0.578N P=0.309 |P=0.553 P=0.338 P=0.258N P=0.449 |
|LOGISTIC REGRESSION| P=0.091N P=0.240N P=0.076N P=0.099N |P=0.504N P=0.356 (e) P=0.427 |
|COCH-ARM / FISHERS | P=0.392N P=0.309N P=0.309N P=0.500N |P=0.529N P=0.340 P=0.248N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/59 (2%) 3/57 (5%) 6/54 (11%) 25/53 (47%) |
|POLY-3 RATE (b) | |1/55.90 3/53.54 6/49.21 25/48.82 |
|POLY-3 PERCENT (g) | |1.8% 5.6% 12.2% 51.2% |
|TERMINAL (d) | |0/46 (0%) 1/45 (2%) 2/36 (6%) 17/32 (53%) |
|FIRST INCIDENCE | |719 582 569 603 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P<0.001 ** P=0.293 P=0.041 * P<0.001 ** |
|POLY 3 | |P<0.001 ** P=0.291 P=0.039 * P<0.001 ** |
|POLY 1.5 | |P<0.001 ** P=0.292 P=0.041 * P<0.001 ** |
|POLY 6 | |P<0.001 ** P=0.290 P=0.037 * P<0.001 ** |
|LOGISTIC REGRESSION| |P<0.001 ** P=0.305 P=0.053 P<0.001 ** |
|COCH-ARM / FISHERS | |P<0.001 ** P=0.296 P=0.044 * P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/59 (3%) 4/57 (7%) 4/54 (7%) 2/53 (4%) |
|POLY-3 RATE (b) | |2/56.01 4/52.95 4/48.18 2/48.25 |
|POLY-3 PERCENT (g) | |3.6% 7.6% 8.3% 4.2% |
|TERMINAL (d) | |1/46 (2%) 3/45 (7%) 4/36 (11%) 1/32 (3%) |
|FIRST INCIDENCE | |691 708 729 (T) 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.404 P=0.326 P=0.242 P=0.609 |
|POLY 3 | |P=0.489 P=0.313 P=0.271 P=0.639 |
|POLY 1.5 | |P=0.506 P=0.317 P=0.282 P=0.647 |
|POLY 6 | |P=0.460 P=0.308 P=0.258 P=0.624 |
|LOGISTIC REGRESSION| |P=0.522 P=0.313 P=0.254 P=0.686 |
|COCH-ARM / FISHERS | |P=0.520 P=0.323 P=0.298 P=0.649 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |5/59 (8%) 1/57 (2%) 4/54 (7%) 1/53 (2%) |
|POLY-3 RATE (b) | |5/56.01 1/52.86 4/48.26 1/47.50 |
|POLY-3 PERCENT (g) | |8.9% 1.9% 8.3% 2.1% |
|TERMINAL (d) | |4/46 (9%) 1/45 (2%) 3/36 (8%) 1/32 (3%) |
|FIRST INCIDENCE | |691 729 (T) 708 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.255N P=0.112N P=0.635N P=0.199N |
|POLY 3 | |P=0.183N P=0.117N P=0.592N P=0.145N |
|POLY 1.5 | |P=0.175N P=0.115N P=0.577N P=0.137N |
|POLY 6 | |P=0.197N P=0.119N P=0.610N P=0.159N |
|LOGISTIC REGRESSION| |P=0.215N P=0.118N P=0.615N P=0.163N |
|COCH-ARM / FISHERS | |P=0.167N P=0.111N P=0.556N P=0.130N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |4/59 (7%) 4/57 (7%) 6/54 (11%) 5/53 (9%) |
|POLY-3 RATE (b) | |4/56.13 4/52.86 6/49.51 5/47.98 |
|POLY-3 PERCENT (g) | |7.1% 7.6% 12.1% 10.4% |
|TERMINAL (d) | |2/46 (4%) 4/45 (9%) 2/36 (6%) 4/32 (13%) |
|FIRST INCIDENCE | |691 729 (T) 523 586 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.186 P=0.624 P=0.287 P=0.324 |
|POLY 3 | |P=0.251 P=0.609 P=0.295 P=0.403 |
|POLY 1.5 | |P=0.265 P=0.615 P=0.304 P=0.418 |
|POLY 6 | |P=0.227 P=0.602 P=0.283 P=0.379 |
|LOGISTIC REGRESSION| |P=0.291 P=0.612 P=0.359 P=0.432 |
|COCH-ARM / FISHERS | |P=0.279 P=0.622 P=0.316 P=0.432 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Atypia Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 39/60 (65%) 32/60 (53%) 27/59 (46%) 21/60 (35%) | |
|POLY-3 RATE (b) | 39/57.69 32/51.29 27/44.28 21/34.23 | |
|POLY-3 PERCENT (g) | 67.6% 62.4% 61.0% 61.4% | |
|TERMINAL (d) | 25/39 (64%) 14/18 (78%) 2/3 (67%) 0/0 (0%) | |
|FIRST INCIDENCE | 533 378 384 404 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.031 * P<0.001 ** P<0.001 ** | |
|POLY 3 | P=0.244N P=0.350N P=0.306N P=0.347N | |
|POLY 1.5 | P=0.029N* P=0.230N P=0.128N P=0.044N* | |
|POLY 6 | P=0.255 P=0.578N P=0.534 P=0.242 | |
|LOGISTIC REGRESSION| P=0.137N P=0.232N P=0.195N P=0.350N | |
|COCH-ARM / FISHERS | P<0.001N** P=0.133N P=0.027N* P<0.001N** | |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/59 (0%) 0/60 (0%) | |
|POLY-3 RATE (b) | 0/53.85 2/44.40 0/34.22 0/21.46 | |
|POLY-3 PERCENT (g) | 0.0% 4.5% 0.0% 0.0% | |
|TERMINAL (d) | 0/39 (0%) 1/18 (6%) 0/3 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | --- 632 --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.443 P=0.127 (e) (e) | |
|POLY 3 | P=0.620 P=0.198 (e) (e) | |
|POLY 1.5 | P=0.565N P=0.215 (e) (e) | |
|POLY 6 | P=0.429 P=0.175 (e) (e) | |
|LOGISTIC REGRESSION| P=0.702 P=0.211 (e) (e) | |
|COCH-ARM / FISHERS | P=0.383N P=0.248 (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 1/1 (100%) 1/2 (50%) 1/1 (100%) |1/3 (33%) 2/3 (67%) 1/2 (50%) 1/1 (100%) |
|POLY-3 RATE (b) | 0/2.00 1/1.00 1/1.15 1/1.00 |1/3.00 2/2.90 1/1.92 1/1.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 86.6% 100.0% |33.3% 68.9% 52.1% 100.0% |
|TERMINAL (d) | 0/2 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |1/3 (33%) 2/2 (100%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 621 581 512 |729 (T) 729 (T) 672 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * P=0.357 P=0.376 P=0.186 |P=0.081 P=0.309 P=0.484 P=0.473 |
|POLY 3 | P=0.013 * P=1.000N P=0.362 P=1.000N |P=0.300 P=0.486 P=0.661 P=0.500 |
|POLY 1.5 | P=0.045 * P=1.000N P=0.415 P=1.000N |P=0.305 P=0.493 P=0.666 P=0.500 |
|POLY 6 | P=0.004 ** P=1.000N P=0.325 P=1.000N |P=0.290 P=0.472 P=0.653 P=0.500 |
|LOGISTIC REGRESSION| P=0.119 (e) P=0.651 (e) |P=0.698 P=0.309 P=0.775N (e) |
|COCH-ARM / FISHERS | P=0.145 P=0.333 P=0.500 P=0.333 |P=0.273 P=0.500 P=0.700 P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/2 (50%) 1/1 (100%) 1/2 (50%) 1/1 (100%) |2/3 (67%) 2/3 (67%) 1/2 (50%) 1/1 (100%) |
|POLY-3 RATE (b) | 1/2.00 1/1.00 1/1.15 1/1.00 |2/3.00 2/2.90 1/1.92 1/1.00 |
|POLY-3 PERCENT (g) | 50.0% 100.0% 86.6% 100.0% |66.7% 68.9% 52.1% 100.0% |
|TERMINAL (d) | 1/2 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |2/3 (67%) 2/2 (100%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 621 581 512 |729 (T) 729 (T) 672 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * P=0.357 P=0.376 P=0.186 |P=0.117 P=0.581 P=0.484 P=0.473 |
|POLY 3 | P=0.406 P=0.614 P=0.658 P=0.614 |P=0.537 P=0.753 P=0.689N P=0.691 |
|POLY 1.5 | P=0.421 P=0.614 P=0.703 P=0.614 |P=0.540 P=0.757 P=0.679N P=0.691 |
|POLY 6 | P=0.401 P=0.614 P=0.625 P=0.614 |P=0.532 P=0.745 P=0.707N P=0.691 |
|LOGISTIC REGRESSION| P=0.214 (e) P=0.800 (e) |P=0.606N P=0.581 P=0.631N (e) |
|COCH-ARM / FISHERS | P=0.460 P=0.667 P=0.833N P=0.667 |P=0.554 P=0.800N P=0.700N P=0.750 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 40/60 (67%) 43/60 (72%) 43/60 (72%) 37/60 (62%) |22/60 (37%) 16/60 (27%) 13/60 (22%) 13/60 (22%) |
|POLY-3 RATE (b) | 40/57.01 43/54.24 43/51.92 37/45.30 |22/57.45 16/55.69 13/53.91 13/54.37 |
|POLY-3 PERCENT (g) | 70.2% 79.3% 82.8% 81.7% |38.3% 28.7% 24.1% 23.9% |
|TERMINAL (d) | 27/39 (69%) 15/18 (83%) 3/3 (100%) 0/0 (0%) |19/47 (40%) 16/47 (34%) 11/39 (28%) 8/33 (24%) |
|FIRST INCIDENCE | 533 428 298 391 |620 729 (T) 706 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.244N P=0.164N P=0.162N P=0.300N |
|POLY 3 | P=0.050 P=0.176 P=0.078 P=0.113 |P=0.045N* P=0.189N P=0.078N P=0.073N |
|POLY 1.5 | P=0.270 P=0.246 P=0.158 P=0.376 |P=0.038N* P=0.177N P=0.066N P=0.062N |
|POLY 6 | P<0.001 ** P=0.097 P=0.025 * P=0.011 * |P=0.059N P=0.206N P=0.097N P=0.096N |
|LOGISTIC REGRESSION| P=0.234 P=0.159 P=0.114 P=0.468 |P=0.082N P=0.192N P=0.100N P=0.088N |
|COCH-ARM / FISHERS | P=0.294N P=0.346 P=0.346 P=0.352N |P=0.032N* P=0.163N P=0.054N P=0.054N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |0/60 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/54.06 0/44.05 0/34.77 2/22.58 |0/56.86 0/54.87 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 3.7% 0.0% 0.0% 8.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 674 --- --- 519 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.074 P=0.392N P=0.649N P=0.036 * |(e) (e) (e) (e) |
|POLY 3 | P=0.607 P=0.286N P=0.347N P=0.380 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.564 P=0.264N P=0.296N P=0.521 |(e) (e) (e) (e) |
|POLY 6 | P=0.607N P=0.321N P=0.425N P=0.240 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.484 P=0.291N P=0.420N P=0.612 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.567 P=0.248N P=0.248N P=0.691N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |0/60 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 1/53.85 0/44.05 0/34.77 2/22.65 |0/56.86 0/54.87 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 1.9% 0.0% 0.0% 8.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 483 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030 * P=0.654N P=0.952N P=0.055 |(e) (e) (e) (e) |
|POLY 3 | P=0.344 P=0.540N P=0.583N P=0.252 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.291 P=0.522N P=0.548N P=0.351 |(e) (e) (e) (e) |
|POLY 6 | P=0.493 P=0.565N P=0.632N P=0.163 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.281 (e) (e) P=0.531 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.287 P=0.500N P=0.500N P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 3/60 (5%) 2/60 (3%) |0/60 (0%) 1/59 (2%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 1/44.05 3/35.98 2/22.60 |0/56.86 1/54.87 1/53.83 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 8.3% 8.9% |0.0% 1.8% 1.9% 0.0% |
|TERMINAL (d) | 0/39 (0%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 1/47 (2%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 729 (T) 502 534 |--- 729 (T) 707 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.346 P=0.029 * P=0.048 * |P=0.603 P=0.500 P=0.476 (e) |
|POLY 3 | P=0.022 * P=0.460 P=0.065 P=0.111 |P=0.635N P=0.493 P=0.489 (e) |
|POLY 1.5 | P=0.044 * P=0.478 P=0.085 P=0.155 |P=0.626N P=0.494 P=0.494 (e) |
|POLY 6 | P=0.012 * P=0.435 P=0.045 * P=0.079 |P=0.611 P=0.491 P=0.483 (e) |
|LOGISTIC REGRESSION| P=0.068 P=0.346 P=0.160 P=0.361 |P=0.638N P=0.500 P=0.498 (e) |
|COCH-ARM / FISHERS | P=0.111 P=0.500 P=0.122 P=0.248 |P=0.616N P=0.496 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |2/60 (3%) 0/59 (0%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 0/44.05 0/34.77 1/22.20 |2/56.86 0/54.87 1/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.5% |3.5% 0.0% 1.9% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |2/47 (4%) 0/47 (0%) 1/39 (3%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- 464 |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.157 (e) (e) P=0.446 |P=0.215N P=0.239N P=0.565N P=0.319N |
|POLY 3 | P=0.270 (e) (e) P=0.349 |P=0.163N P=0.246N P=0.520N P=0.252N |
|POLY 1.5 | P=0.203 (e) (e) P=0.413 |P=0.160N P=0.244N P=0.511N P=0.245N |
|POLY 6 | P=0.454 (e) (e) P=0.286 |P=0.168N P=0.247N P=0.531N P=0.265N |
|LOGISTIC REGRESSION| P=0.366 (e) (e) P=0.944 |P=0.215N (e) P=0.565N (e) |
|COCH-ARM / FISHERS | P=0.188 (e) (e) P=0.500 |P=0.157N P=0.252N P=0.500N P=0.248N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |2/60 (3%) 1/59 (2%) 1/60 (2%) 1/60 (2%) |
|POLY-3 RATE (b) | 0/53.85 1/44.05 0/34.77 0/21.46 |2/56.86 1/54.87 1/53.74 1/53.86 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |3.5% 1.8% 1.9% 1.9% |
|TERMINAL (d) | 0/39 (0%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |2/47 (4%) 1/47 (2%) 1/39 (3%) 0/33 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |729 (T) 729 (T) 729 (T) 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500 P=0.346 (e) (e) |P=0.453N P=0.500N P=0.565N P=0.581N |
|POLY 3 | P=0.710 P=0.460 (e) (e) |P=0.372N P=0.512N P=0.520N P=0.519N |
|POLY 1.5 | P=0.651N P=0.478 (e) (e) |P=0.366N P=0.510N P=0.511N P=0.509N |
|POLY 6 | P=0.619 P=0.435 (e) (e) |P=0.384N P=0.515N P=0.531N P=0.535N |
|LOGISTIC REGRESSION| (e) P=0.346 (e) (e) |P=0.350N P=0.500N P=0.565N P=0.476N |
|COCH-ARM / FISHERS | P=0.517N P=0.500 (e) (e) |P=0.357N P=0.506N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 56/60 (93%) 59/60 (98%) 56/60 (93%) 56/60 (93%) |53/60 (88%) 45/59 (76%) 48/60 (80%) 52/60 (87%) |
|POLY-3 RATE (b) | 56/59.40 59/59.65 56/58.13 56/57.43 |53/59.05 45/58.03 48/58.04 52/57.51 |
|POLY-3 PERCENT (g) | 94.3% 98.9% 96.3% 97.5% |89.8% 77.6% 82.7% 90.4% |
|TERMINAL (d) | 37/39 (95%) 18/18 (100%) 3/3 (100%) 0/0 (0%) |43/47 (92%) 36/47 (77%) 34/39 (87%) 32/33 (97%) |
|FIRST INCIDENCE | 441 378 298 359 |401 429 370 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.003 ** P=0.119N P=0.327 P=0.008 ** |
|POLY 3 | P=0.281 P=0.167 P=0.460 P=0.320 |P=0.379 P=0.058N P=0.191N P=0.580 |
|POLY 1.5 | P=0.448 P=0.172 P=0.522 P=0.443 |P=0.452 P=0.060N P=0.170N P=0.591N |
|POLY 6 | P=0.146 P=0.166 P=0.390 P=0.233 |P=0.271 P=0.058N P=0.239N P=0.452 |
|LOGISTIC REGRESSION| P=0.502 P=0.178 P=0.530 P=0.612 |P=0.459 P=0.073N P=0.199N P=0.613 |
|COCH-ARM / FISHERS | P=0.400N P=0.182 P=0.641N P=0.641N |P=0.532 P=0.068N P=0.159N P=0.500N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 3/60 (5%) 0/60 (0%) 1/60 (2%) |9/60 (15%) 10/59 (17%) 4/60 (7%) 11/60 (18%) |
|POLY-3 RATE (b) | 3/54.07 3/46.16 0/34.77 1/21.81 |9/57.02 10/55.10 4/54.17 11/53.64 |
|POLY-3 PERCENT (g) | 5.6% 6.5% 0.0% 4.6% |15.8% 18.2% 7.4% 20.5% |
|TERMINAL (d) | 2/39 (5%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |7/47 (15%) 8/47 (17%) 2/39 (5%) 9/33 (27%) |
|FIRST INCIDENCE | 673 378 --- 632 |691 695 636 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.595N P=0.484 P=0.578N P=0.046 * |P=0.222 P=0.492 P=0.200N P=0.144 |
|POLY 3 | P=0.295N P=0.587 P=0.219N P=0.629N |P=0.456 P=0.467 P=0.139N P=0.346 |
|POLY 1.5 | P=0.182N P=0.622 P=0.170N P=0.485N |P=0.482 P=0.474 P=0.131N P=0.374 |
|POLY 6 | P=0.487N P=0.531 P=0.305N P=0.544 |P=0.414 P=0.461 P=0.151N P=0.300 |
|LOGISTIC REGRESSION| P=0.024N* P=0.382N P=0.333N P=0.647 |P=0.390 P=0.459 P=0.141N P=0.234 |
|COCH-ARM / FISHERS | P=0.095N P=0.660N P=0.122N P=0.309N |P=0.511 P=0.484 P=0.120N P=0.404 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 3/60 (5%) 0/60 (0%) 2/60 (3%) |0/60 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 1/54.15 3/45.27 0/34.77 2/22.62 |0/56.86 0/54.87 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 1.9% 6.6% 0.0% 8.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 649 465 --- 419 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.103 P=0.186 P=0.677N P=0.060 |(e) (e) (e) (e) |
|POLY 3 | P=0.341 P=0.245 P=0.584N P=0.250 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.428 P=0.271 P=0.548N P=0.351 |(e) (e) (e) (e) |
|POLY 6 | P=0.259 P=0.210 P=0.633N P=0.162 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.426N P=0.465 P=0.512N P=0.766 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.569 P=0.309 P=0.500N P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |2/60 (3%) 0/59 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 1/44.07 1/34.97 0/21.46 |2/57.62 0/54.87 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 2.9% 0.0% |3.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 726 676 --- |453 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.080 P=0.372 P=0.273 (e) |P=0.079N P=0.240N P=0.262N P=0.276N |
|POLY 3 | P=0.383 P=0.460 P=0.417 (e) |P=0.066N P=0.249N P=0.254N P=0.255N |
|POLY 1.5 | P=0.502 P=0.478 P=0.453 (e) |P=0.066N P=0.246N P=0.247N P=0.247N |
|POLY 6 | P=0.245 P=0.435 P=0.370 (e) |P=0.065N P=0.251N P=0.262N P=0.269N |
|LOGISTIC REGRESSION| P=0.221 P=0.376 P=0.412 (e) |P=0.052N P=0.222N P=0.173N P=0.229N |
|COCH-ARM / FISHERS | P=0.618N P=0.500 P=0.500 (e) |P=0.067N P=0.252N P=0.248N P=0.248N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 12/60 (20%) 14/60 (23%) 9/60 (15%) |9/60 (15%) 10/59 (17%) 7/60 (12%) 17/60 (28%) |
|POLY-3 RATE (b) | 5/54.15 12/47.60 14/38.40 9/26.90 |9/57.47 10/55.18 7/54.34 17/53.97 |
|POLY-3 PERCENT (g) | 9.2% 25.2% 36.5% 33.5% |15.7% 18.1% 12.9% 31.5% |
|TERMINAL (d) | 3/39 (8%) 3/18 (17%) 2/3 (67%) 0/0 (0%) |6/47 (13%) 7/47 (15%) 4/39 (10%) 14/33 (42%) |
|FIRST INCIDENCE | 673 428 527 463 |620 695 636 639 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P=0.008 ** P=0.488 P=0.527N P=0.008 ** |
|POLY 3 | P<0.001 ** P=0.027 * P<0.001 ** P=0.013 * |P=0.039 * P=0.462 P=0.441N P=0.038 * |
|POLY 1.5 | P=0.014 * P=0.038 * P=0.005 ** P=0.050 |P=0.047 * P=0.471 P=0.422N P=0.047 * |
|POLY 6 | P<0.001 ** P=0.016 * P<0.001 ** P=0.002 ** |P=0.029 * P=0.452 P=0.467N P=0.026 * |
|LOGISTIC REGRESSION| P=0.014 * P=0.077 P<0.001 ** P=0.136 |P=0.037 * P=0.473 P=0.408N P=0.034 * |
|COCH-ARM / FISHERS | P=0.183 P=0.057 P=0.022 * P=0.197 |P=0.059 P=0.484 P=0.395N P=0.060 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 2/60 (3%) |2/60 (3%) 3/59 (5%) 4/60 (7%) 4/60 (7%) |
|POLY-3 RATE (b) | 0/53.85 1/44.14 2/35.32 2/22.83 |2/56.86 3/54.92 4/53.74 4/53.75 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 5.7% 8.8% |3.5% 5.5% 7.4% 7.4% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |2/47 (4%) 2/47 (4%) 4/39 (10%) 1/33 (3%) |
|FIRST INCIDENCE | --- 707 636 483 |729 (T) 716 729 (T) 663 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.387 P=0.071 P=0.142 |P=0.114 P=0.495 P=0.255 P=0.225 |
|POLY 3 | P=0.039 * P=0.461 P=0.159 P=0.112 |P=0.207 P=0.484 P=0.312 P=0.312 |
|POLY 1.5 | P=0.061 P=0.478 P=0.190 P=0.156 |P=0.221 P=0.488 P=0.323 P=0.325 |
|POLY 6 | P=0.030 * P=0.435 P=0.125 P=0.079 |P=0.186 P=0.481 P=0.298 P=0.292 |
|LOGISTIC REGRESSION| P=0.089 P=0.431 P=0.176 P=0.658 |P=0.182 P=0.479 P=0.255 P=0.318 |
|COCH-ARM / FISHERS | P=0.123 P=0.500 P=0.248 P=0.248 |P=0.234 P=0.492 P=0.340 P=0.340 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 4/60 (7%) |0/60 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 1/53.94 1/44.45 1/34.92 4/24.16 |0/56.86 0/54.87 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 1.9% 2.3% 2.9% 16.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 707 616 691 419 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.668 P=0.370 P=0.012 * |(e) (e) (e) (e) |
|POLY 3 | P=0.045 * P=0.716 P=0.654 P=0.043 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.051 P=0.736 P=0.704 P=0.083 |(e) (e) (e) (e) |
|POLY 6 | P=0.054 P=0.684 P=0.579 P=0.019 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.151 P=0.755N P=0.596 P=0.543 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.080 P=0.752N P=0.752N P=0.182 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 38/60 (63%) 22/60 (37%) 21/60 (35%) 25/60 (42%) |51/60 (85%) 56/59 (95%) 60/60 (100%) 54/60 (90%) |
|POLY-3 RATE (b) | 38/54.87 22/47.62 21/41.49 25/37.78 |51/58.27 56/57.66 60/60.00 54/58.46 |
|POLY-3 PERCENT (g) | 69.3% 46.2% 50.6% 66.2% |87.5% 97.1% 100.0% 92.4% |
|TERMINAL (d) | 34/39 (87%) 12/18 (67%) 3/3 (100%) 0/0 (0%) |44/47 (94%) 47/47 (100%) 39/39 (100%) 31/33 (94%) |
|FIRST INCIDENCE | 441 428 483 391 |401 495 370 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.300 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.162 P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.269N P=0.010N* P=0.037N* P=0.463N |P=0.130 P=0.042 * P=0.004 ** P=0.275 |
|POLY 1.5 | P=0.088N P=0.005N** P=0.010N* P=0.135N |P=0.134 P=0.048 * P=0.003 ** P=0.282 |
|POLY 6 | P=0.409 P=0.025N* P=0.167N P=0.238 |P=0.124 P=0.042 * P=0.007 ** P=0.266 |
|LOGISTIC REGRESSION| P=0.296 P=0.089N P=0.386N P=0.516 |P=0.095 P=0.038 * P<0.001 ** P=0.196 |
|COCH-ARM / FISHERS | P=0.015N* P=0.003N** P=0.002N** P=0.014N* |P=0.144 P=0.067 P<0.001 ** P=0.291 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 29/60 (48%) 29/60 (48%) 34/60 (57%) 31/60 (52%) |16/60 (27%) 30/59 (51%) 28/60 (47%) 33/60 (55%) |
|POLY-3 RATE (b) | 29/54.06 29/49.14 34/48.88 31/41.29 |16/57.01 30/55.01 28/55.80 33/54.91 |
|POLY-3 PERCENT (g) | 53.6% 59.0% 69.6% 75.1% |28.1% 54.5% 50.2% 60.1% |
|TERMINAL (d) | 26/39 (67%) 13/18 (72%) 2/3 (67%) 0/0 (0%) |15/47 (32%) 28/47 (60%) 22/39 (56%) 22/33 (67%) |
|FIRST INCIDENCE | 705 559 298 391 |691 708 432 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.006 ** P=0.003 ** P<0.001 ** |
|POLY 3 | P=0.006 ** P=0.357 P=0.060 P=0.018 * |P<0.001 ** P=0.003 ** P=0.011 * P<0.001 ** |
|POLY 1.5 | P=0.047 * P=0.449 P=0.114 P=0.105 |P<0.001 ** P=0.004 ** P=0.014 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.248 P=0.020 * P<0.001 ** |P<0.001 ** P=0.002 ** P=0.009 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.009 ** P=0.079 P=0.056 P=0.022 * |P<0.001 ** P=0.003 ** P=0.012 * P<0.001 ** |
|COCH-ARM / FISHERS | P=0.295 P=0.572N P=0.232 P=0.428 |P=0.003 ** P=0.006 ** P=0.018 * P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 3/60 (5%) 1/60 (2%) 2/60 (3%) |0/60 (0%) 0/59 (0%) 1/60 (2%) 2/60 (3%) |
|POLY-3 RATE (b) | 3/53.85 3/44.14 1/34.77 2/22.48 |0/56.86 0/54.87 1/53.74 2/53.58 |
|POLY-3 PERCENT (g) | 5.6% 6.8% 2.9% 8.9% |0.0% 0.0% 1.9% 3.7% |
|TERMINAL (d) | 3/39 (8%) 2/18 (11%) 1/3 (33%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 1/39 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 707 729 (T) 502 |--- --- 729 (T) 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.308 P=0.333 P=0.027 * |P=0.041 * (e) P=0.463 P=0.193 |
|POLY 3 | P=0.572 P=0.567 P=0.472N P=0.491 |P=0.057 (e) P=0.489 P=0.225 |
|POLY 1.5 | P=0.458N P=0.610 P=0.397N P=0.653 |P=0.060 (e) P=0.493 P=0.231 |
|POLY 6 | P=0.438 P=0.503 P=0.581N P=0.306 |P=0.053 (e) P=0.482 P=0.214 |
|LOGISTIC REGRESSION| P=0.117 P=0.369 P=0.333 P=0.393 |P=0.059 (e) P=0.463 P=0.242 |
|COCH-ARM / FISHERS | P=0.288N P=0.660N P=0.309N P=0.500N |P=0.062 (e) P=0.500 P=0.248 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/60 (12%) 18/60 (30%) 29/60 (48%) 24/60 (40%) |5/60 (8%) 12/59 (20%) 25/60 (42%) 32/60 (53%) |
|POLY-3 RATE (b) | 7/53.98 18/46.38 29/44.55 24/35.61 |5/56.86 12/55.96 25/55.67 32/55.68 |
|POLY-3 PERCENT (g) | 13.0% 38.8% 65.1% 67.4% |8.8% 21.4% 44.9% 57.5% |
|TERMINAL (d) | 5/39 (13%) 10/18 (56%) 2/3 (67%) 0/0 (0%) |5/47 (11%) 7/47 (15%) 15/39 (39%) 18/33 (55%) |
|FIRST INCIDENCE | 705 555 432 404 |729 (T) 505 569 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.062 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.052 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.052 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.052 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.053 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.053 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 6/60 (10%) 2/60 (3%) 2/60 (3%) |0/60 (0%) 2/59 (3%) 1/60 (2%) 3/60 (5%) |
|POLY-3 RATE (b) | 0/53.85 6/46.68 2/35.10 2/22.80 |0/56.86 2/55.54 1/54.22 3/53.81 |
|POLY-3 PERCENT (g) | 0.0% 12.9% 5.7% 8.8% |0.0% 3.6% 1.8% 5.6% |
|TERMINAL (d) | 0/39 (0%) 1/18 (6%) 1/3 (33%) 0/0 (0%) |0/47 (0%) 1/47 (2%) 0/39 (0%) 2/33 (6%) |
|FIRST INCIDENCE | --- 471 637 419 |--- 505 586 586 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.019 * P=0.008 ** P=0.016 * P=0.088 |P=0.071 P=0.240 P=0.489 P=0.084 |
|POLY 3 | P=0.077 P=0.010 * P=0.158 P=0.112 |P=0.089 P=0.232 P=0.491 P=0.110 |
|POLY 1.5 | P=0.202 P=0.012 * P=0.189 P=0.156 |P=0.094 P=0.233 P=0.494 P=0.115 |
|POLY 6 | P=0.014 * P=0.007 ** P=0.124 P=0.079 |P=0.081 P=0.232 P=0.485 P=0.102 |
|LOGISTIC REGRESSION| P=0.512N P=0.057 P=0.102 P=0.668 |P=0.111 P=0.241 P=0.556 P=0.131 |
|COCH-ARM / FISHERS | P=0.467 P=0.014 * P=0.248 P=0.248 |P=0.100 P=0.244 P=0.500 P=0.122 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 2/60 (3%) 2/60 (3%) |0/60 (0%) 1/59 (2%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/53.85 0/44.05 2/35.71 2/22.80 |0/56.86 1/54.87 1/53.82 0/53.33 |
|POLY-3 PERCENT (g) | 3.7% 0.0% 5.6% 8.8% |0.0% 1.8% 1.9% 0.0% |
|TERMINAL (d) | 2/39 (5%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 1/47 (2%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) --- 581 471 |--- 729 (T) 709 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.025 * P=0.420N P=0.238 P=0.121 |P=0.591 P=0.500 P=0.461 (e) |
|POLY 3 | P=0.291 P=0.285N P=0.538 P=0.384 |P=0.635N P=0.493 P=0.489 (e) |
|POLY 1.5 | P=0.331 P=0.263N P=0.608 P=0.523 |P=0.626N P=0.494 P=0.494 (e) |
|POLY 6 | P=0.293 P=0.319N P=0.438 P=0.243 |P=0.612 P=0.491 P=0.483 (e) |
|LOGISTIC REGRESSION| P=0.443 (e) P=0.658 P=0.724 |P=0.641N P=0.500 P=0.496 (e) |
|COCH-ARM / FISHERS | P=0.431 P=0.248N P=0.691N P=0.691N |P=0.616N P=0.496 P=0.500 (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 8/60 (13%) 8/60 (13%) 5/60 (8%) |9/60 (15%) 13/59 (22%) 10/60 (17%) 7/60 (12%) |
|POLY-3 RATE (b) | 5/54.30 8/45.26 8/38.20 5/24.50 |9/57.19 13/54.92 10/54.16 7/53.60 |
|POLY-3 PERCENT (g) | 9.2% 17.7% 20.9% 20.4% |15.7% 23.7% 18.5% 13.1% |
|TERMINAL (d) | 3/39 (8%) 4/18 (22%) 0/3 (0%) 0/0 (0%) |7/47 (15%) 12/47 (26%) 6/39 (15%) 5/33 (15%) |
|FIRST INCIDENCE | 649 567 483 463 |674 716 685 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.041 * P=0.005 ** P<0.001 ** |P=0.489 P=0.236 P=0.349 P=0.551 |
|POLY 3 | P=0.062 P=0.172 P=0.102 P=0.186 |P=0.315N P=0.206 P=0.449 P=0.448N |
|POLY 1.5 | P=0.209 P=0.216 P=0.163 P=0.360 |P=0.284N P=0.215 P=0.470 P=0.422N |
|POLY 6 | P=0.008 ** P=0.119 P=0.047 * P=0.068 |P=0.371N P=0.197 P=0.421 P=0.494N |
|LOGISTIC REGRESSION| P=0.233 P=0.163 P=0.286 P=0.492 |P=0.389N P=0.203 P=0.433 P=0.498N |
|COCH-ARM / FISHERS | P=0.521N P=0.279 P=0.279 P=0.628N |P=0.252N P=0.226 P=0.500 P=0.395N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 5/60 (8%) 11/60 (18%) 20/60 (33%) |15/60 (25%) 11/59 (19%) 6/60 (10%) 12/60 (20%) |
|POLY-3 RATE (b) | 1/53.85 5/44.90 11/39.75 20/33.67 |15/56.86 11/55.25 6/54.69 12/53.99 |
|POLY-3 PERCENT (g) | 1.9% 11.1% 27.7% 59.4% |26.4% 19.9% 11.0% 22.2% |
|TERMINAL (d) | 1/39 (3%) 3/18 (17%) 0/3 (0%) 0/0 (0%) |15/47 (32%) 8/47 (17%) 4/39 (10%) 8/33 (24%) |
|FIRST INCIDENCE | 729 (T) 600 502 359 |729 (T) 669 370 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.021 * P<0.001 ** P<0.001 ** |P=0.519N P=0.259N P=0.067N P=0.460 |
|POLY 3 | P<0.001 ** P=0.066 P<0.001 ** P<0.001 ** |P=0.219N P=0.279N P=0.031N* P=0.387N |
|POLY 1.5 | P<0.001 ** P=0.081 P<0.001 ** P<0.001 ** |P=0.203N P=0.275N P=0.028N* P=0.359N |
|POLY 6 | P<0.001 ** P=0.049 * P<0.001 ** P<0.001 ** |P=0.249N P=0.280N P=0.036N* P=0.435N |
|LOGISTIC REGRESSION| P<0.001 ** P=0.066 P=0.009 ** P<0.001 ** |P=0.236N P=0.294N P=0.031N* P=0.531N |
|COCH-ARM / FISHERS | P<0.001 ** P=0.103 P=0.002 ** P<0.001 ** |P=0.188N P=0.269N P=0.026N* P=0.331N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 7/60 (12%) 12/60 (20%) 6/60 (10%) |6/60 (10%) 9/59 (15%) 11/60 (18%) 28/60 (47%) |
|POLY-3 RATE (b) | 5/53.85 7/45.16 12/38.87 6/24.76 |6/56.86 9/54.87 11/53.92 28/54.73 |
|POLY-3 PERCENT (g) | 9.3% 15.5% 30.9% 24.2% |10.6% 16.4% 20.4% 51.2% |
|TERMINAL (d) | 5/39 (13%) 4/18 (22%) 1/3 (33%) 0/0 (0%) |6/47 (13%) 9/47 (19%) 9/39 (23%) 18/33 (55%) |
|FIRST INCIDENCE | 729 (T) 600 523 519 |729 (T) 729 (T) 706 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.062 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.288 P=0.073 P<0.001 ** |
|POLY 3 | P=0.007 ** P=0.264 P=0.008 ** P=0.103 |P<0.001 ** P=0.265 P=0.119 P<0.001 ** |
|POLY 1.5 | P=0.053 P=0.313 P=0.020 * P=0.237 |P<0.001 ** P=0.271 P=0.131 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.201 P=0.002 ** P=0.031 * |P<0.001 ** P=0.259 P=0.106 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.009 ** P=0.193 P=0.012 * P=0.066 |P<0.001 ** P=0.288 P=0.079 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.305 P=0.381 P=0.057 P=0.500 |P<0.001 ** P=0.279 P=0.148 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 4/60 (7%) 6/60 (10%) 6/60 (10%) |0/60 (0%) 1/59 (2%) 3/60 (5%) 5/60 (8%) |
|POLY-3 RATE (b) | 3/54.55 4/44.97 6/36.79 6/24.93 |0/56.86 1/54.87 3/54.61 5/53.90 |
|POLY-3 PERCENT (g) | 5.5% 8.9% 16.3% 24.1% |0.0% 1.8% 5.5% 9.3% |
|TERMINAL (d) | 1/39 (3%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 1/47 (2%) 2/39 (5%) 1/33 (3%) |
|FIRST INCIDENCE | 537 603 581 421 |--- 729 (T) 370 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.260 P=0.011 * P<0.001 ** |P=0.003 ** P=0.500 P=0.102 P=0.018 * |
|POLY 3 | P=0.013 * P=0.397 P=0.096 P=0.034 * |P=0.006 ** P=0.493 P=0.113 P=0.027 * |
|POLY 1.5 | P=0.040 * P=0.442 P=0.147 P=0.090 |P=0.007 ** P=0.494 P=0.116 P=0.029 * |
|POLY 6 | P=0.003 ** P=0.336 P=0.050 P=0.010 * |P=0.005 ** P=0.491 P=0.108 P=0.024 * |
|LOGISTIC REGRESSION| P=0.073 P=0.549 P=0.227 P=0.397 |P=0.009 ** P=0.500 P=0.156 P=0.035 * |
|COCH-ARM / FISHERS | P=0.150 P=0.500 P=0.245 P=0.245 |P=0.008 ** P=0.496 P=0.122 P=0.029 * |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Regeneration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |1/60 (2%) 2/59 (3%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 0/44.05 0/34.77 0/21.46 |1/56.88 2/54.96 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |1.8% 3.6% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 1/47 (2%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |726 708 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.211N P=0.493 P=0.541N P=0.575N |
|POLY 3 | (e) (e) (e) (e) |P=0.169N P=0.488 P=0.511N P=0.513N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.163N P=0.491 P=0.507N P=0.507N |
|POLY 6 | (e) (e) (e) (e) |P=0.177N P=0.486 P=0.518N P=0.523N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.177N P=0.487 P=0.529N P=0.554N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.157N P=0.494 P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 53/60 (88%) 37/60 (62%) 7/60 (12%) 0/60 (0%) |7/60 (12%) 2/59 (3%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 53/58.86 37/50.92 7/36.67 0/21.46 |7/56.90 2/54.87 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 90.1% 72.7% 19.1% 0.0% |12.3% 3.6% 0.0% 0.0% |
|TERMINAL (d) | 35/39 (90%) 16/18 (89%) 1/3 (33%) 0/0 (0%) |5/47 (11%) 2/47 (4%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 441 428 519 --- |722 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224N P=0.070 P=0.266N P=0.169N |P=0.002N** P=0.087N P=0.020N* P=0.031N* |
|POLY 3 | P<0.001N** P=0.008N** P<0.001N** P<0.001N** |P<0.001N** P=0.090N P=0.010N* P=0.011N* |
|POLY 1.5 | P<0.001N** P=0.002N** P<0.001N** P<0.001N** |P<0.001N** P=0.088N P=0.009N** P=0.009N** |
|POLY 6 | P<0.001N** P=0.049N* P<0.001N** P<0.001N** |P<0.001N** P=0.092N P=0.012N* P=0.013N* |
|LOGISTIC REGRESSION| P<0.001N** P=0.013N* P<0.001N** P<0.001N** |P=0.002N** P=0.092N P=0.017N* P=0.025N* |
|COCH-ARM / FISHERS | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |P<0.001N** P=0.085N P=0.006N** P=0.006N** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 3/60 (5%) 8/60 (13%) 5/60 (8%) |3/60 (5%) 0/59 (0%) 2/60 (3%) 2/60 (3%) |
|POLY-3 RATE (b) | 1/53.86 3/44.97 8/37.93 5/24.77 |3/57.16 0/54.87 2/54.05 2/53.92 |
|POLY-3 PERCENT (g) | 1.9% 6.7% 21.1% 20.2% |5.3% 0.0% 3.7% 3.7% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 727 621 515 396 |674 --- 672 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.154 P<0.001 ** P=0.003 ** |P=0.561 P=0.131N P=0.553N P=0.579N |
|POLY 3 | P<0.001 ** P=0.245 P=0.003 ** P=0.016 * |P=0.531N P=0.127N P=0.525N P=0.526N |
|POLY 1.5 | P=0.005 ** P=0.271 P=0.007 ** P=0.038 * |P=0.524N P=0.125N P=0.515N P=0.513N |
|POLY 6 | P<0.001 ** P=0.211 P<0.001 ** P=0.006 ** |P=0.543N P=0.129N P=0.539N P=0.548N |
|LOGISTIC REGRESSION| P=0.059 P=0.317 P=0.018 * P=0.401 |P=0.495N P=0.122N P=0.490N P=0.471N |
|COCH-ARM / FISHERS | P=0.044 * P=0.309 P=0.016 * P=0.103 |P=0.517N P=0.125N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 2/60 (3%) 1/60 (2%) 1/60 (2%) |4/60 (7%) 2/59 (3%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 4/54.62 2/44.73 1/35.16 1/22.27 |4/58.16 2/55.71 1/53.86 0/53.33 |
|POLY-3 PERCENT (g) | 7.3% 4.5% 2.8% 4.5% |6.9% 3.6% 1.9% 0.0% |
|TERMINAL (d) | 1/39 (3%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 640 499 616 419 |453 531 698 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.499 P=0.586N P=0.629N P=0.530 |P=0.031N* P=0.352N P=0.217N P=0.088N |
|POLY 3 | P=0.260N P=0.433N P=0.340N P=0.518N |P=0.025N* P=0.358N P=0.204N P=0.073N |
|POLY 1.5 | P=0.159N P=0.389N P=0.263N P=0.350N |P=0.023N* P=0.353N P=0.194N P=0.068N |
|POLY 6 | P=0.425N P=0.500N P=0.462N P=0.592 |P=0.029N* P=0.363N P=0.218N P=0.083N |
|LOGISTIC REGRESSION| P=0.054N P=0.271N P=0.221N P=0.163N |P=0.013N* P=0.290N P=0.124N P=0.048N* |
|COCH-ARM / FISHERS | P=0.082N P=0.340N P=0.182N P=0.182N |P=0.022N* P=0.348N P=0.182N P=0.059N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 0/60 (0%) 1/60 (2%) 3/60 (5%) |3/60 (5%) 0/59 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 4/54.70 0/44.05 1/34.92 3/23.54 |3/57.85 0/54.87 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 7.3% 0.0% 2.9% 12.7% |5.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 533 --- 691 419 |453 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.076 P=0.146N P=0.719N P=0.116 |P=0.031N* P=0.128N P=0.145N P=0.155N |
|POLY 3 | P=0.588N P=0.094N P=0.344N P=0.386 |P=0.022N* P=0.129N P=0.134N P=0.135N |
|POLY 1.5 | P=0.546N P=0.078N P=0.265N P=0.572 |P=0.022N* P=0.127N P=0.128N P=0.128N |
|POLY 6 | P=0.594N P=0.123N P=0.467N P=0.203 |P=0.023N* P=0.132N P=0.141N P=0.147N |
|LOGISTIC REGRESSION| P=0.382N P=0.047N* P=0.246N P=0.308N |P=0.017N* P=0.105N P=0.079N P=0.103N |
|COCH-ARM / FISHERS | P=0.476N P=0.059N P=0.182N P=0.500N |P=0.024N* P=0.125N P=0.122N P=0.122N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |2/60 (3%) 2/60 (3%) 2/60 (3%) 1/60 (2%) |
|POLY-3 RATE (b) | 3/54.48 0/44.05 1/35.24 0/21.46 |2/56.95 2/55.69 2/54.37 1/53.33 |
|POLY-3 PERCENT (g) | 5.5% 0.0% 2.8% 0.0% |3.5% 3.6% 3.7% 1.9% |
|TERMINAL (d) | 1/39 (3%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 2/47 (4%) 1/39 (3%) 1/33 (3%) |
|FIRST INCIDENCE | 537 --- 589 --- |707 729 (T) 525 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.405N P=0.222N P=0.723 P=0.699N |P=0.482N P=0.688 P=0.646 P=0.611N |
|POLY 3 | P=0.154N P=0.162N P=0.472N P=0.354N |P=0.393N P=0.685 P=0.677 P=0.523N |
|POLY 1.5 | P=0.100N P=0.142N P=0.397N P=0.229N |P=0.381N P=0.689 P=0.684 P=0.512N |
|POLY 6 | P=0.252N P=0.196N P=0.577N P=0.522N |P=0.413N P=0.681 P=0.666 P=0.542N |
|LOGISTIC REGRESSION| P=0.063N P=0.095N P=0.276N P=0.213N |P=0.358N P=0.684 P=0.662N P=0.558N |
|COCH-ARM / FISHERS | P=0.063N P=0.122N P=0.309N P=0.122N |P=0.367N P=0.691N P=0.691N P=0.500N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 25/60 (42%) 42/60 (70%) 40/60 (67%) 22/60 (37%) |52/60 (87%) 54/60 (90%) 53/60 (88%) 55/60 (92%) |
|POLY-3 RATE (b) | 25/56.21 42/54.40 40/48.45 22/34.97 |52/58.74 54/58.37 53/57.43 55/58.34 |
|POLY-3 PERCENT (g) | 44.5% 77.2% 82.6% 62.9% |88.5% 92.5% 92.3% 94.3% |
|TERMINAL (d) | 16/39 (41%) 12/18 (67%) 2/3 (67%) 0/0 (0%) |42/47 (89%) 45/47 (96%) 38/39 (97%) 33/33 (100%) |
|FIRST INCIDENCE | 537 465 483 391 |453 495 370 488 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.393 P=0.053 P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P=0.065 |P=0.155 P=0.331 P=0.346 P=0.205 |
|POLY 1.5 | P=0.086 P<0.001 ** P<0.001 ** P=0.306 |P=0.201 P=0.355 P=0.414 P=0.240 |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P=0.004 ** |P=0.100 P=0.305 P=0.263 P=0.155 |
|LOGISTIC REGRESSION| P=0.043 * P<0.001 ** P<0.001 ** P=0.392 |P=0.150 P=0.325 P=0.339 P=0.187 |
|COCH-ARM / FISHERS | P=0.224N P=0.002 ** P=0.005 ** P=0.354N |P=0.259 P=0.389 P=0.500 P=0.279 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 8/60 (13%) 3/60 (5%) 7/60 (12%) |6/60 (10%) 14/60 (23%) 16/60 (27%) 9/60 (15%) |
|POLY-3 RATE (b) | 2/53.86 8/44.77 3/35.85 7/26.13 |6/57.38 14/55.77 16/54.23 9/54.15 |
|POLY-3 PERCENT (g) | 3.7% 17.9% 8.4% 26.8% |10.5% 25.1% 29.5% 16.6% |
|TERMINAL (d) | 1/39 (3%) 4/18 (22%) 0/3 (0%) 0/0 (0%) |3/47 (6%) 13/47 (28%) 14/39 (36%) 5/33 (15%) |
|FIRST INCIDENCE | 727 589 589 421 |620 708 656 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.003 ** P=0.062 P<0.001 ** |P=0.063 P=0.044 * P=0.006 ** P=0.139 |
|POLY 3 | P=0.014 * P=0.022 * P=0.325 P=0.007 ** |P=0.198 P=0.035 * P=0.010 * P=0.250 |
|POLY 1.5 | P=0.047 * P=0.032 * P=0.398 P=0.022 * |P=0.229 P=0.038 * P=0.012 * P=0.270 |
|POLY 6 | P=0.002 ** P=0.013 * P=0.236 P<0.001 ** |P=0.152 P=0.031 * P=0.007 ** P=0.219 |
|LOGISTIC REGRESSION| P=0.046 * P=0.009 ** P=0.365 P=0.341 |P=0.184 P=0.037 * P=0.011 * P=0.286 |
|COCH-ARM / FISHERS | P=0.172 P=0.047 * P=0.500 P=0.081 |P=0.268 P=0.042 * P=0.016 * P=0.291 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/58 (3%) 0/59 (0%) 0/58 (0%) 0/59 (0%) |1/60 (2%) 3/60 (5%) 0/59 (0%) 4/59 (7%) |
|POLY-3 RATE (b) | 2/51.94 0/43.05 0/33.39 0/21.19 |1/56.89 3/55.69 0/52.74 4/52.68 |
|POLY-3 PERCENT (g) | 3.9% 0.0% 0.0% 0.0% |1.8% 5.4% 0.0% 7.6% |
|TERMINAL (d) | 2/38 (5%) 0/17 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 3/47 (6%) 0/38 (0%) 3/32 (9%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |722 729 (T) --- 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.407N P=0.428N P=0.835N P=1.000N |P=0.106 P=0.303 P=0.546N P=0.104 |
|POLY 3 | P=0.102N P=0.282N P=0.347N P=0.458N |P=0.173 P=0.298 P=0.515N P=0.157 |
|POLY 1.5 | P=0.078N P=0.259N P=0.296N P=0.350N |P=0.181 P=0.302 P=0.510N P=0.166 |
|POLY 6 | P=0.149N P=0.317N P=0.425N P=0.589N |P=0.160 P=0.295 P=0.522N P=0.144 |
|LOGISTIC REGRESSION| P=0.407N (e) (e) (e) |P=0.165 P=0.291 P=0.523N P=0.166 |
|COCH-ARM / FISHERS | P=0.067N P=0.244N P=0.248N P=0.244N |P=0.192 P=0.309 P=0.504N P=0.177 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/58 (3%) 2/59 (3%) 1/58 (2%) 1/59 (2%) |4/60 (7%) 4/60 (7%) 1/59 (2%) 4/59 (7%) |
|POLY-3 RATE (b) | 2/52.72 2/43.94 1/33.39 1/21.84 |4/56.86 4/56.01 1/52.96 4/52.50 |
|POLY-3 PERCENT (g) | 3.8% 4.6% 3.0% 4.6% |7.0% 7.1% 1.9% 7.6% |
|TERMINAL (d) | 1/38 (3%) 0/17 (0%) 1/3 (33%) 0/0 (0%) |4/47 (9%) 2/47 (4%) 0/38 (0%) 3/32 (9%) |
|FIRST INCIDENCE | 441 555 729 (T) 512 |729 (T) 669 672 685 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.294 P=0.572 P=0.577 P=0.657 |P=0.505 P=0.636 P=0.243N P=0.440 |
|POLY 3 | P=0.608 P=0.626 P=0.650N P=0.659 |P=0.469N P=0.634 P=0.202N P=0.598 |
|POLY 1.5 | P=0.461N P=0.659 P=0.587N P=0.647N |P=0.455N P=0.637 P=0.195N P=0.615 |
|POLY 6 | P=0.482 P=0.577 P=0.690 P=0.497 |P=0.491N P=0.631 P=0.212N P=0.569 |
|LOGISTIC REGRESSION| P=0.199N P=0.481N P=0.461N P=0.202N |P=0.480N P=0.633 P=0.204N P=0.516 |
|COCH-ARM / FISHERS | P=0.297N P=0.684N P=0.500N P=0.494N |P=0.439N P=0.641N P=0.187N P=0.632 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/58 (5%) 4/59 (7%) 3/58 (5%) 2/59 (3%) |3/60 (5%) 5/60 (8%) 6/59 (10%) 15/59 (25%) |
|POLY-3 RATE (b) | 3/52.26 4/44.04 3/35.12 2/22.54 |3/56.95 5/55.69 6/53.05 15/54.29 |
|POLY-3 PERCENT (g) | 5.7% 9.1% 8.5% 8.9% |5.3% 9.0% 11.3% 27.6% |
|TERMINAL (d) | 2/38 (5%) 2/17 (12%) 0/3 (0%) 0/0 (0%) |2/47 (4%) 5/47 (11%) 4/38 (11%) 5/32 (16%) |
|FIRST INCIDENCE | 640 534 391 359 |707 729 (T) 672 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.038 * P=0.216 P=0.212 P=0.093 |P<0.001 ** P=0.354 P=0.170 P<0.001 ** |
|POLY 3 | P=0.351 P=0.408 P=0.471 P=0.502 |P<0.001 ** P=0.345 P=0.210 P<0.001 ** |
|POLY 1.5 | P=0.535 P=0.453 P=0.556 P=0.664 |P<0.001 ** P=0.351 P=0.221 P<0.001 ** |
|POLY 6 | P=0.173 P=0.344 P=0.354 P=0.314 |P<0.001 ** P=0.339 P=0.197 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.249N P=0.501 P=0.543N P=0.566N |P<0.001 ** P=0.336 P=0.204 P=0.002 ** |
|COCH-ARM / FISHERS | P=0.340N P=0.510 P=0.660N P=0.492N |P<0.001 ** P=0.359 P=0.237 P=0.002 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/58 (16%) 2/59 (3%) 6/58 (10%) 12/59 (20%) |31/60 (52%) 33/60 (55%) 30/59 (51%) 30/59 (51%) |
|POLY-3 RATE (b) | 9/52.29 2/43.72 6/35.59 12/29.09 |31/57.80 33/58.76 30/56.46 30/54.77 |
|POLY-3 PERCENT (g) | 17.2% 4.6% 16.9% 41.3% |53.6% 56.2% 53.1% 54.8% |
|TERMINAL (d) | 6/38 (16%) 0/17 (0%) 2/3 (67%) 0/0 (0%) |28/47 (60%) 25/47 (53%) 19/38 (50%) 20/32 (63%) |
|FIRST INCIDENCE | 673 616 483 404 |453 429 432 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.211N P=0.019 * P<0.001 ** |P=0.074 P=0.421 P=0.275 P=0.073 |
|POLY 3 | P=0.024 * P=0.052N P=0.594N P=0.021 * |P=0.520 P=0.465 P=0.554N P=0.527 |
|POLY 1.5 | P=0.051 P=0.038N* P=0.458N P=0.092 |P=0.488N P=0.451 P=0.548N P=0.565 |
|POLY 6 | P=0.008 ** P=0.082N P=0.432 P=0.002 ** |P=0.454 P=0.482 P=0.562N P=0.465 |
|LOGISTIC REGRESSION| P=0.136 P=0.069N P=0.609N P=0.366 |P=0.444N P=0.430 P=0.545N P=0.506 |
|COCH-ARM / FISHERS | P=0.131 P=0.025N* P=0.291N P=0.331 |P=0.435N P=0.427 P=0.537N P=0.537N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 3/60 (5%) 1/60 (2%) 2/60 (3%) |1/60 (2%) 1/60 (2%) 1/60 (2%) 3/60 (5%) |
|POLY-3 RATE (b) | 2/54.21 3/45.38 1/35.03 2/22.93 |1/56.86 1/55.69 1/53.74 3/53.33 |
|POLY-3 PERCENT (g) | 3.7% 6.6% 2.9% 8.7% |1.8% 1.8% 1.9% 5.6% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 1/47 (2%) 1/39 (3%) 3/33 (9%) |
|FIRST INCIDENCE | 631 378 658 359 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.108 P=0.326 P=0.591 P=0.174 |P=0.094 P=0.761 P=0.720 P=0.189 |
|POLY 3 | P=0.403 P=0.420 P=0.644N P=0.384 |P=0.160 P=0.756 P=0.748 P=0.283 |
|POLY 1.5 | P=0.521 P=0.456 P=0.583N P=0.524 |P=0.167 P=0.758 P=0.753 P=0.294 |
|POLY 6 | P=0.285 P=0.368 P=0.698 P=0.242 |P=0.149 P=0.754 P=0.741 P=0.265 |
|LOGISTIC REGRESSION| P=0.206N P=0.686N P=0.630N P=0.483N |P=0.094 P=0.761 P=0.720 P=0.189 |
|COCH-ARM / FISHERS | P=0.452N P=0.500 P=0.500N P=0.691N |P=0.173 P=0.752N P=0.752N P=0.309 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/60 (10%) 9/60 (15%) 3/60 (5%) 8/60 (13%) |6/60 (10%) 1/60 (2%) 1/60 (2%) 3/60 (5%) |
|POLY-3 RATE (b) | 6/54.93 9/46.72 3/35.57 8/26.15 |6/57.66 1/55.69 1/53.74 3/53.33 |
|POLY-3 PERCENT (g) | 10.9% 19.3% 8.4% 30.6% |10.4% 1.8% 1.9% 5.6% |
|TERMINAL (d) | 1/39 (3%) 3/18 (17%) 0/3 (0%) 0/0 (0%) |3/47 (6%) 1/47 (2%) 1/39 (3%) 3/33 (9%) |
|FIRST INCIDENCE | 631 378 637 359 |453 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.064 P=0.358 P<0.001 ** |P=0.277N P=0.065N P=0.096N P=0.419N |
|POLY 3 | P=0.107 P=0.184 P=0.490N P=0.045 * |P=0.168N P=0.064N P=0.070N P=0.284N |
|POLY 1.5 | P=0.246 P=0.230 P=0.376N P=0.139 |P=0.163N P=0.061N P=0.065N P=0.265N |
|POLY 6 | P=0.026 * P=0.127 P=0.615 P=0.009 ** |P=0.176N P=0.066N P=0.077N P=0.315N |
|LOGISTIC REGRESSION| P=0.462 P=0.415 P=0.412N P=0.445 |P=0.158N P=0.054N P=0.050N P=0.229N |
|COCH-ARM / FISHERS | P=0.521 P=0.291 P=0.245N P=0.389 |P=0.158N P=0.057N P=0.057N P=0.245N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 2/59 (3%) 1/58 (2%) |0/59 (0%) 0/58 (0%) 0/59 (0%) 0/59 (0%) |
|POLY-3 RATE (b) | 1/54.18 0/44.05 2/35.06 1/21.62 |0/55.98 0/53.87 0/52.74 0/52.53 |
|POLY-3 PERCENT (g) | 1.9% 0.0% 5.7% 4.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/46 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 640 --- 603 463 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.086 P=0.594N P=0.265 P=0.481 |(e) (e) (e) (e) |
|POLY 3 | P=0.251 P=0.541N P=0.356 P=0.537 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.307 P=0.523N P=0.414 P=0.640 |(e) (e) (e) (e) |
|POLY 6 | P=0.223 P=0.567N P=0.283 P=0.414 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.560 P=0.450N P=0.574 P=0.649N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.422 P=0.500N P=0.494 P=0.744 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 6/60 (10%) 3/59 (5%) 2/58 (3%) |5/59 (8%) 3/58 (5%) 4/59 (7%) 5/59 (8%) |
|POLY-3 RATE (b) | 2/54.46 6/47.12 3/34.76 2/22.29 |5/55.98 3/54.10 4/53.37 5/52.62 |
|POLY-3 PERCENT (g) | 3.7% 12.7% 8.6% 9.0% |8.9% 5.6% 7.5% 9.5% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 1/3 (33%) 0/0 (0%) |5/47 (11%) 2/46 (4%) 3/38 (8%) 4/33 (12%) |
|FIRST INCIDENCE | 537 378 603 439 |729 (T) 669 525 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.055 P=0.072 P=0.048 * P=0.277 |P=0.295 P=0.369N P=0.617N P=0.407 |
|POLY 3 | P=0.198 P=0.093 P=0.310 P=0.374 |P=0.461 P=0.376N P=0.530N P=0.590 |
|POLY 1.5 | P=0.401 P=0.111 P=0.385 P=0.510 |P=0.480 P=0.373N P=0.517N P=0.609 |
|POLY 6 | P=0.054 P=0.071 P=0.219 P=0.237 |P=0.431 P=0.380N P=0.548N P=0.557 |
|LOGISTIC REGRESSION| P=0.158N P=0.422 P=0.391 P=0.423N |P=0.467 P=0.380N P=0.506N P=0.441 |
|COCH-ARM / FISHERS | P=0.410N P=0.136 P=0.492 P=0.678 |P=0.499 P=0.368N P=0.500N P=0.629N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 3/60 (5%) 0/59 (0%) 0/58 (0%) |0/59 (0%) 4/58 (7%) 1/59 (2%) 3/59 (5%) |
|POLY-3 RATE (b) | 3/54.18 3/44.52 0/34.26 0/20.87 |0/55.98 4/54.19 1/52.74 3/53.10 |
|POLY-3 PERCENT (g) | 5.5% 6.7% 0.0% 0.0% |0.0% 7.4% 1.9% 5.7% |
|TERMINAL (d) | 2/39 (5%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 2/46 (4%) 1/38 (3%) 1/33 (3%) |
|FIRST INCIDENCE | 640 641 --- --- |--- 669 729 (T) 639 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.576N P=0.356 P=0.551N P=0.993N |P=0.142 P=0.062 P=0.458 P=0.093 |
|POLY 3 | P=0.141N P=0.568 P=0.223N P=0.359N |P=0.192 P=0.057 P=0.488 P=0.110 |
|POLY 1.5 | P=0.064N P=0.611 P=0.174N P=0.236N |P=0.204 P=0.058 P=0.493 P=0.115 |
|POLY 6 | P=0.351N P=0.506 P=0.308N P=0.524N |P=0.175 P=0.057 P=0.481 P=0.103 |
|LOGISTIC REGRESSION| P=0.182N P=0.579 P=0.254N P=0.647N |P=0.220 P=0.061 P=0.458 P=0.132 |
|COCH-ARM / FISHERS | P=0.025N* P=0.660N P=0.125N P=0.128N |P=0.217 P=0.057 P=0.500 P=0.122 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/57 (5%) 10/47 (21%) 1/46 (2%) 1/43 (2%) |40/60 (67%) 30/60 (50%) 29/59 (49%) 24/60 (40%) |
|POLY-3 RATE (b) | 3/53.07 10/37.48 1/25.69 1/16.32 |40/58.61 30/57.85 29/56.30 24/55.71 |
|POLY-3 PERCENT (g) | 5.7% 26.7% 3.9% 6.1% |68.3% 51.9% 51.5% 43.1% |
|TERMINAL (d) | 1/39 (3%) 2/16 (13%) 0/2 (0%) 0/0 (0%) |32/47 (68%) 24/47 (51%) 19/39 (49%) 15/33 (46%) |
|FIRST INCIDENCE | 441 378 676 655 |401 505 370 488 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.126 P=0.004 ** P=0.708N P=0.506 |P=0.204N P=0.075N P=0.246N P=0.192N |
|POLY 3 | P=0.390 P=0.005 ** P=0.577N P=0.664 |P=0.005N** P=0.050N P=0.047N* P=0.004N** |
|POLY 1.5 | P=0.384N P=0.008 ** P=0.496N P=0.586N |P=0.004N** P=0.049N* P=0.042N* P=0.003N** |
|POLY 6 | P=0.058 P=0.003 ** P=0.678N P=0.504 |P=0.009N** P=0.052N P=0.056N P=0.007N** |
|LOGISTIC REGRESSION| P=0.153N P=0.049 * P=0.242N P=0.293N |P=0.004N** P=0.050N P=0.042N* P=0.004N** |
|COCH-ARM / FISHERS | P=0.100N P=0.015 * P=0.394N P=0.422N |P=0.003N** P=0.048N* P=0.040N* P=0.003N** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/57 (4%) 0/47 (0%) 0/46 (0%) 0/43 (0%) |0/60 (0%) 1/60 (2%) 0/59 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/51.98 0/34.89 0/25.48 0/16.05 |0/56.86 1/55.69 0/53.53 0/53.33 |
|POLY-3 PERCENT (g) | 3.9% 0.0% 0.0% 0.0% |0.0% 1.8% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/16 (0%) 0/2 (0%) 0/0 (0%) |0/47 (0%) 1/47 (2%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 727 --- --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.423N P=0.431N P=0.874N P=1.000N |P=0.573N P=0.500 (e) (e) |
|POLY 3 | P=0.145N P=0.333N P=0.413N P=0.515N |P=0.527N P=0.496 (e) (e) |
|POLY 1.5 | P=0.109N P=0.310N P=0.356N P=0.419N |P=0.523N P=0.498 (e) (e) |
|POLY 6 | P=0.210N P=0.366N P=0.493N P=0.622N |P=0.533N P=0.494 (e) (e) |
|LOGISTIC REGRESSION| P=0.412N P=0.425N P=0.870N (e) |(e) P=0.500 (e) (e) |
|COCH-ARM / FISHERS | P=0.089N P=0.298N P=0.304N P=0.322N |P=0.517N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/57 (11%) 2/47 (4%) 2/46 (4%) 2/43 (5%) |14/60 (23%) 36/60 (60%) 30/59 (51%) 19/60 (32%) |
|POLY-3 RATE (b) | 6/53.30 2/35.18 2/26.32 2/17.40 |14/56.90 36/57.70 30/55.17 19/54.26 |
|POLY-3 PERCENT (g) | 11.3% 5.7% 7.6% 11.5% |24.6% 62.4% 54.4% 35.0% |
|TERMINAL (d) | 2/39 (5%) 1/16 (6%) 0/2 (0%) 0/0 (0%) |13/47 (28%) 29/47 (62%) 23/39 (59%) 12/33 (36%) |
|FIRST INCIDENCE | 533 650 597 419 |719 495 523 663 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.221 P=0.377N P=0.633 P=0.383 |P=0.033 * P<0.001 ** P<0.001 ** P=0.031 * |
|POLY 3 | P=0.422N P=0.307N P=0.458N P=0.631 |P=0.250 P<0.001 ** P<0.001 ** P=0.159 |
|POLY 1.5 | P=0.281N P=0.261N P=0.346N P=0.467N |P=0.304 P<0.001 ** P<0.001 ** P=0.181 |
|POLY 6 | P=0.594 P=0.376N P=0.610N P=0.412 |P=0.174 P<0.001 ** P<0.001 ** P=0.127 |
|LOGISTIC REGRESSION| P=0.129N P=0.152N P=0.158N P=0.080N |P=0.258 P<0.001 ** P<0.001 ** P=0.081 |
|COCH-ARM / FISHERS | P=0.147N P=0.207N P=0.216N P=0.246N |P=0.373 P<0.001 ** P=0.002 ** P=0.207 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Accessory Spleen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/16 (19%) 0/6 (0%) 0/5 (0%) 3/4 (75%) |2/9 (22%) 0/1 (0%) 1/3 (33%) 1/3 (33%) |
|POLY-3 RATE (b) | 3/14.77 0/3.54 0/3.58 3/3.26 |2/8.24 0/1.00 1/3.00 1/3.00 |
|POLY-3 PERCENT (g) | 20.3% 0.0% 0.0% 92.1% |24.3% 0.0% 33.3% 33.3% |
|TERMINAL (d) | 2/11 (18%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |1/7 (14%) 0/1 (0%) 1/3 (33%) 1/3 (33%) |
|FIRST INCIDENCE | 586 --- --- 404 |620 --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * P=0.536N P=0.590N P=0.064 |P=0.556 P=0.421N P=0.717N P=0.735N |
|POLY 3 | P=0.026 * P=0.457N P=0.451N P=0.022 * |P=0.463 P=0.754N P=0.666 P=0.666 |
|POLY 1.5 | P=0.039 * P=0.406N P=0.415N P=0.027 * |P=0.451 P=0.758N P=0.657 P=0.657 |
|POLY 6 | P=0.013 * P=0.519N P=0.514N P=0.019 * |P=0.471 P=0.751N P=0.673 P=0.673 |
|LOGISTIC REGRESSION| P=0.330 P=0.359N P=0.350N P=0.648 |P=0.405 P=0.808N P=0.645 P=0.645 |
|COCH-ARM / FISHERS | P=0.086 P=0.364N P=0.421N P=0.061 |P=0.420 P=0.800N P=0.618 P=0.618 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/16 (19%) 0/6 (0%) 0/5 (0%) 0/4 (0%) |0/9 (0%) 0/1 (0%) 0/3 (0%) 0/3 (0%) |
|POLY-3 RATE (b) | 3/14.29 0/3.54 0/3.58 0/1.11 |0/7.86 0/1.00 0/3.00 0/3.00 |
|POLY-3 PERCENT (g) | 21.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/11 (27%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/7 (0%) 0/1 (0%) 0/3 (0%) 0/3 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000N P=1.000N P=1.000N P=1.000N |(e) (e) (e) (e) |
|POLY 3 | P=0.201N P=0.448N P=0.441N P=0.662N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.158N P=0.400N P=0.410N P=0.580N |(e) (e) (e) (e) |
|POLY 6 | P=0.271N P=0.507N P=0.502N P=0.731N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=1.000N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.122N P=0.364N P=0.421N P=0.491N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/16 (81%) 3/6 (50%) 5/5 (100%) 1/4 (25%) |7/9 (78%) 1/1 (100%) 2/3 (67%) 0/3 (0%) |
|POLY-3 RATE (b) | 13/16.00 3/4.45 5/5.00 1/1.86 |7/8.62 1/1.00 2/3.00 0/3.00 |
|POLY-3 PERCENT (g) | 81.3% 67.5% 100.0% 53.9% |81.3% 100.0% 66.7% 0.0% |
|TERMINAL (d) | 8/11 (73%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |6/7 (86%) 1/1 (100%) 2/3 (67%) 0/3 (0%) |
|FIRST INCIDENCE | 537 615 597 463 |453 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060 P=0.587N P=0.086 P=0.579 |P=0.008N** P=0.594N P=0.318N P=0.024N* |
|POLY 3 | P=0.510 P=0.509N P=0.380 P=0.525N |P=0.007N** P=0.822 P=0.608N P=0.007N** |
|POLY 1.5 | P=0.445N P=0.376N P=0.380 P=0.264N |P=0.010N* P=0.796 P=0.622N P=0.010N* |
|POLY 6 | P=0.332 P=0.611N P=0.380 P=0.752N |P=0.004N** P=0.856 P=0.582N P=0.003N** |
|LOGISTIC REGRESSION| P=0.527N P=0.344N (e) P=0.251N |P=0.028N* P=0.808 P=0.645N P=0.051N |
|COCH-ARM / FISHERS | P=0.103N P=0.176N P=0.421 P=0.061N |P=0.028N* P=0.800 P=0.618N P=0.045N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/60 (15%) 13/60 (22%) 10/60 (17%) 11/60 (18%) |2/60 (3%) 0/60 (0%) 0/60 (0%) 7/60 (12%) |
|POLY-3 RATE (b) | 9/54.19 13/46.28 10/37.61 11/27.62 |2/56.86 0/55.69 0/53.74 7/53.42 |
|POLY-3 PERCENT (g) | 16.6% 28.1% 26.6% 39.8% |3.5% 0.0% 0.0% 13.1% |
|TERMINAL (d) | 6/39 (15%) 5/18 (28%) 0/3 (0%) 0/0 (0%) |2/47 (4%) 0/47 (0%) 0/39 (0%) 6/33 (18%) |
|FIRST INCIDENCE | 691 567 299 439 |729 (T) --- --- 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** |P=0.003 ** P=0.239N P=0.280N P=0.026 * |
|POLY 3 | P=0.022 * P=0.124 P=0.189 P=0.028 * |P=0.010 * P=0.242N P=0.250N P=0.067 |
|POLY 1.5 | P=0.116 P=0.169 P=0.310 P=0.118 |P=0.010 * P=0.240N P=0.245N P=0.074 |
|POLY 6 | P<0.001 ** P=0.077 P=0.077 P=0.003 ** |P=0.009 ** P=0.245N P=0.258N P=0.056 |
|LOGISTIC REGRESSION| P=0.013 * P=0.090 P=0.166 P=0.032 * |P=0.004 ** (e) (e) P=0.029 * |
|COCH-ARM / FISHERS | P=0.446 P=0.240 P=0.500 P=0.404 |P=0.012 * P=0.248N P=0.248N P=0.081 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 0/44.05 2/36.63 0/21.46 |0/56.86 0/55.69 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 5.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- 299 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.428 (e) P=0.235 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.173 (e) P=0.165 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.264 (e) P=0.195 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.101 (e) P=0.129 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.429 (e) P=0.248 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/60 (15%) 9/60 (15%) 8/60 (13%) 9/60 (15%) |2/60 (3%) 1/60 (2%) 2/60 (3%) 8/60 (13%) |
|POLY-3 RATE (b) | 9/54.34 9/45.95 8/36.44 9/26.51 |2/56.86 1/55.69 2/53.96 8/54.10 |
|POLY-3 PERCENT (g) | 16.6% 19.6% 22.0% 34.0% |3.5% 1.8% 3.7% 14.8% |
|TERMINAL (d) | 6/39 (15%) 3/18 (17%) 0/3 (0%) 0/0 (0%) |2/47 (4%) 1/47 (2%) 1/39 (3%) 5/33 (15%) |
|FIRST INCIDENCE | 663 615 576 432 |729 (T) 729 (T) 672 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.138 P<0.001 ** P<0.001 ** |P=0.003 ** P=0.500N P=0.634 P=0.018 * |
|POLY 3 | P=0.080 P=0.448 P=0.359 P=0.088 |P=0.007 ** P=0.507N P=0.674 P=0.039 * |
|POLY 1.5 | P=0.231 P=0.515 P=0.509 P=0.259 |P=0.007 ** P=0.504N P=0.682 P=0.043 * |
|POLY 6 | P=0.013 * P=0.355 P=0.186 P=0.016 * |P=0.006 ** P=0.511N P=0.664 P=0.033 * |
|LOGISTIC REGRESSION| P=0.023 * P=0.439 P=0.131 P=0.109 |P=0.008 ** P=0.500N P=0.679 P=0.044 * |
|COCH-ARM / FISHERS | P=0.509N P=0.601N P=0.500N P=0.601N |P=0.009 ** P=0.500N P=0.691N P=0.047 * |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/60 (10%) 5/60 (8%) 7/60 (12%) 8/60 (13%) |2/60 (3%) 0/60 (0%) 0/60 (0%) 3/60 (5%) |
|POLY-3 RATE (b) | 6/54.35 5/44.98 7/36.38 8/25.89 |2/56.86 0/55.69 0/53.74 3/53.42 |
|POLY-3 PERCENT (g) | 11.0% 11.1% 19.2% 30.9% |3.5% 0.0% 0.0% 5.6% |
|TERMINAL (d) | 4/39 (10%) 3/18 (17%) 0/3 (0%) 0/0 (0%) |2/47 (4%) 0/47 (0%) 0/39 (0%) 2/33 (6%) |
|FIRST INCIDENCE | 631 567 576 432 |729 (T) --- --- 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.348 P=0.002 ** P<0.001 ** |P=0.218 P=0.239N P=0.280N P=0.353 |
|POLY 3 | P=0.028 * P=0.620 P=0.223 P=0.044 * |P=0.307 P=0.242N P=0.250N P=0.472 |
|POLY 1.5 | P=0.082 P=0.572N P=0.332 P=0.139 |P=0.312 P=0.240N P=0.245N P=0.486 |
|POLY 6 | P=0.006 ** P=0.537 P=0.113 P=0.008 ** |P=0.301 P=0.245N P=0.258N P=0.448 |
|LOGISTIC REGRESSION| P=0.014 * P=0.620N P=0.133 P=0.144 |P=0.248 (e) (e) P=0.393 |
|COCH-ARM / FISHERS | P=0.259 P=0.500N P=0.500 P=0.389 |P=0.317 P=0.248N P=0.248N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 1/60 (2%) 1/60 (2%) 1/60 (2%) |0/60 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) |
|POLY-3 RATE (b) | 2/53.95 1/44.05 1/34.83 1/22.25 |0/56.86 0/55.69 1/53.74 1/53.68 |
|POLY-3 PERCENT (g) | 3.7% 2.3% 2.9% 4.5% |0.0% 0.0% 1.9% 1.9% |
|TERMINAL (d) | 1/39 (3%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 1/39 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 705 729 (T) 714 432 |--- --- 729 (T) 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.088 P=0.725 P=0.401 P=0.460 |P=0.157 (e) P=0.463 P=0.496 |
|POLY 3 | P=0.597N P=0.570N P=0.644N P=0.658 |P=0.175 (e) P=0.489 P=0.489 |
|POLY 1.5 | P=0.486N P=0.539N P=0.583N P=0.650N |P=0.180 (e) P=0.493 P=0.494 |
|POLY 6 | P=0.575 P=0.614N P=0.697 P=0.496 |P=0.165 (e) P=0.482 P=0.479 |
|LOGISTIC REGRESSION| P=0.542 P=0.683N P=0.607 P=0.668N |P=0.192 (e) P=0.463 P=0.509 |
|COCH-ARM / FISHERS | P=0.359N P=0.500N P=0.500N P=0.500N |P=0.185 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/60 (0%) 0/59 (0%) 0/60 (0%) 2/60 (3%) |
|POLY-3 RATE (b) | |0/56.86 0/54.87 0/53.74 2/53.85 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 0.0% 3.7% |
|TERMINAL (d) | |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | |--- --- --- 603 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.046 * (e) (e) P=0.210 |
|POLY 3 | |P=0.050 (e) (e) P=0.226 |
|POLY 1.5 | |P=0.052 (e) (e) P=0.232 |
|POLY 6 | |P=0.049 * (e) (e) P=0.216 |
|LOGISTIC REGRESSION| |P=0.056 (e) (e) P=0.252 |
|COCH-ARM / FISHERS | |P=0.054 (e) (e) P=0.248 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |9/60 (15%) 8/59 (14%) 11/60 (18%) 6/60 (10%) |
|POLY-3 RATE (b) | |9/56.86 8/54.87 11/54.11 6/53.51 |
|POLY-3 PERCENT (g) | |15.8% 14.6% 20.3% 11.2% |
|TERMINAL (d) | |9/47 (19%) 8/47 (17%) 9/39 (23%) 4/33 (12%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 656 706 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.430 P=0.500N P=0.247 P=0.558N |
|POLY 3 | |P=0.379N P=0.532N P=0.356 P=0.334N |
|POLY 1.5 | |P=0.351N P=0.525N P=0.376 P=0.313N |
|POLY 6 | |P=0.429N P=0.539N P=0.332 P=0.372N |
|LOGISTIC REGRESSION| |P=0.525N P=0.500N P=0.296 P=0.501N |
|COCH-ARM / FISHERS | |P=0.321N P=0.515N P=0.404 P=0.291N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/60 (18%) 14/60 (23%) 7/60 (12%) 4/60 (7%) |13/60 (22%) 10/59 (17%) 7/60 (12%) 4/60 (7%) |
|POLY-3 RATE (b) | 11/54.55 14/47.68 7/37.42 4/24.34 |13/57.73 10/54.98 7/54.58 4/53.61 |
|POLY-3 PERCENT (g) | 20.2% 29.4% 18.7% 16.4% |22.5% 18.2% 12.8% 7.5% |
|TERMINAL (d) | 9/39 (23%) 3/18 (17%) 1/3 (33%) 0/0 (0%) |11/47 (23%) 9/47 (19%) 4/39 (10%) 2/33 (6%) |
|FIRST INCIDENCE | 537 428 512 404 |401 702 569 685 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.028 * P=0.024 * P=0.048 * |P=0.049N* P=0.326N P=0.210N P=0.081N |
|POLY 3 | P=0.435N P=0.196 P=0.537N P=0.472N |P=0.012N* P=0.369N P=0.136N P=0.024N* |
|POLY 1.5 | P=0.135N P=0.250 P=0.391N P=0.213N |P=0.010N* P=0.358N P=0.126N P=0.020N* |
|POLY 6 | P=0.226 P=0.134 P=0.467 P=0.386 |P=0.016N* P=0.378N P=0.149N P=0.031N* |
|LOGISTIC REGRESSION| P=0.085N P=0.293 P=0.490N P=0.221N |P=0.010N* P=0.343N P=0.103N P=0.018N* |
|COCH-ARM / FISHERS | P=0.014N* P=0.327 P=0.222N P=0.048N* |P=0.008N** P=0.338N P=0.110N P=0.017N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 2/60 (3%) 3/60 (5%) 4/60 (7%) |1/60 (2%) 1/59 (2%) 2/60 (3%) 2/60 (3%) |
|POLY-3 RATE (b) | 1/53.85 2/44.45 3/35.94 4/23.50 |1/56.86 1/54.87 2/53.74 2/53.33 |
|POLY-3 PERCENT (g) | 1.9% 4.5% 8.4% 17.0% |1.8% 1.8% 3.7% 3.8% |
|TERMINAL (d) | 1/39 (3%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 1/47 (2%) 2/39 (5%) 2/33 (6%) |
|FIRST INCIDENCE | 729 (T) 616 483 495 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.299 P=0.038 * P<0.001 ** |P=0.188 P=0.761 P=0.435 P=0.378 |
|POLY 3 | P=0.021 * P=0.434 P=0.183 P=0.041 * |P=0.279 P=0.753 P=0.480 P=0.478 |
|POLY 1.5 | P=0.040 * P=0.463 P=0.231 P=0.081 |P=0.291 P=0.754 P=0.489 P=0.489 |
|POLY 6 | P=0.013 * P=0.392 P=0.128 P=0.018 * |P=0.260 P=0.751 P=0.469 P=0.459 |
|LOGISTIC REGRESSION| P=0.034 * P=0.439 P=0.311 P=0.064 |P=0.188 P=0.761 P=0.435 P=0.378 |
|COCH-ARM / FISHERS | P=0.100 P=0.500 P=0.309 P=0.182 |P=0.303 P=0.748 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Peritoneum: Mesothelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/3 (33%) 1/21 (5%) 4/33 (12%) 2/46 (4%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 1/3.00 1/15.80 4/21.29 2/16.95 |0/0.00 0/0.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 33.3% 6.3% 18.8% 11.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/3 (33%) 1/6 (17%) 1/2 (50%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 519 414 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.605N P=0.054 P=0.167 |(e) (e) (e) (e) |
|POLY 3 | P=0.566N P=0.339N P=0.584N P=0.450N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.366N P=0.313N P=0.512N P=0.301N |(e) (e) (e) (e) |
|POLY 6 | P=0.652 P=0.387N P=0.716N P=0.771N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.494N P=0.605N P=0.609N P=0.447N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.196N P=0.239N P=0.370N P=0.176N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/59 (5%) 0/60 (0%) 7/58 (12%) 2/59 (3%) |6/59 (10%) 5/60 (8%) 4/60 (7%) 4/60 (7%) |
|POLY-3 RATE (b) | 3/53.10 0/44.05 7/35.67 2/21.91 |6/55.90 5/56.38 4/53.83 4/53.81 |
|POLY-3 PERCENT (g) | 5.7% 0.0% 19.6% 9.1% |10.7% 8.9% 7.4% 7.4% |
|TERMINAL (d) | 3/39 (8%) 0/18 (0%) 1/3 (33%) 0/0 (0%) |4/46 (9%) 4/47 (9%) 3/39 (8%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) --- 502 562 |722 495 707 663 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.286N P<0.001 ** P=0.010 * |P=0.458N P=0.492N P=0.481N P=0.560N |
|POLY 3 | P=0.064 P=0.157N P=0.048 * P=0.487 |P=0.294N P=0.494N P=0.395N P=0.395N |
|POLY 1.5 | P=0.154 P=0.138N P=0.082 P=0.651 |P=0.279N P=0.491N P=0.380N P=0.378N |
|POLY 6 | P=0.021 * P=0.189N P=0.021 * P=0.304 |P=0.320N P=0.498N P=0.414N P=0.423N |
|LOGISTIC REGRESSION| P=0.068 (e) P=0.069 P=0.300 |P=0.275N P=0.486N P=0.447N P=0.406N |
|COCH-ARM / FISHERS | P=0.377 P=0.119N P=0.154 P=0.500N |P=0.261N P=0.488N P=0.361N P=0.361N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/59 (3%) 6/60 (10%) 3/58 (5%) 4/59 (7%) |22/59 (37%) 20/60 (33%) 22/60 (37%) 24/60 (40%) |
|POLY-3 RATE (b) | 2/53.10 6/45.99 3/34.37 4/23.65 |22/58.70 20/55.91 22/54.98 24/55.82 |
|POLY-3 PERCENT (g) | 3.8% 13.1% 8.7% 16.9% |37.5% 35.8% 40.0% 43.0% |
|TERMINAL (d) | 2/39 (5%) 2/18 (11%) 0/3 (0%) 0/0 (0%) |14/46 (30%) 18/47 (38%) 17/39 (44%) 15/33 (46%) |
|FIRST INCIDENCE | 729 (T) 499 569 391 |401 695 569 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.035 * P=0.051 P=0.012 * |P=0.050 P=0.419N P=0.350 P=0.120 |
|POLY 3 | P=0.075 P=0.093 P=0.315 P=0.092 |P=0.257 P=0.502N P=0.466 P=0.340 |
|POLY 1.5 | P=0.177 P=0.112 P=0.388 P=0.173 |P=0.301 P=0.461N P=0.520 P=0.390 |
|POLY 6 | P=0.021 * P=0.069 P=0.226 P=0.040 * |P=0.196 P=0.547N P=0.402 P=0.270 |
|LOGISTIC REGRESSION| P=0.439 P=0.177 P=0.339 P=0.597 |P=0.339 P=0.389N P=0.523N P=0.552 |
|COCH-ARM / FISHERS | P=0.410 P=0.142 P=0.492 P=0.340 |P=0.357 P=0.398N P=0.548N P=0.454 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/59 (2%) 0/60 (0%) 1/58 (2%) 4/59 (7%) |0/59 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 1/53.11 0/44.05 1/33.73 4/23.90 |0/55.86 0/55.69 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 1.9% 0.0% 3.0% 16.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/46 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 727 --- 616 391 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.648N P=0.446 P=0.026 * |(e) (e) (e) (e) |
|POLY 3 | P=0.034 * P=0.537N P=0.650 P=0.043 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.031 * P=0.519N P=0.699 P=0.083 |(e) (e) (e) (e) |
|POLY 6 | P=0.058 P=0.563N P=0.575 P=0.019 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.200 P=0.628N P=0.716 P=0.773 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.043 * P=0.496N P=0.748 P=0.182 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/59 (15%) 13/60 (22%) 13/58 (22%) 10/59 (17%) |12/59 (20%) 6/60 (10%) 12/60 (20%) 9/60 (15%) |
|POLY-3 RATE (b) | 9/54.07 13/47.89 13/37.46 10/26.80 |12/56.75 6/55.69 12/55.08 9/54.58 |
|POLY-3 PERCENT (g) | 16.7% 27.2% 34.7% 37.3% |21.2% 10.8% 21.8% 16.5% |
|TERMINAL (d) | 5/39 (13%) 4/18 (22%) 0/3 (0%) 0/0 (0%) |9/46 (20%) 6/47 (13%) 8/39 (21%) 4/33 (12%) |
|FIRST INCIDENCE | 555 428 523 439 |401 729 (T) 569 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.029 * P<0.001 ** P<0.001 ** |P=0.344 P=0.099N P=0.430 P=0.585N |
|POLY 3 | P=0.012 * P=0.146 P=0.042 * P=0.050 |P=0.470N P=0.106N P=0.558 P=0.350N |
|POLY 1.5 | P=0.091 P=0.189 P=0.093 P=0.176 |P=0.447N P=0.101N P=0.577 P=0.327N |
|POLY 6 | P<0.001 ** P=0.098 P=0.011 * P=0.007 ** |P=0.508N P=0.111N P=0.538 P=0.391N |
|LOGISTIC REGRESSION| P=0.123 P=0.309 P=0.073 P=0.265 |P=0.414N P=0.094N P=0.554N P=0.266N |
|COCH-ARM / FISHERS | P=0.453 P=0.254 P=0.226 P=0.500 |P=0.424N P=0.093N P=0.572N P=0.301N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 0/60 (0%) 0/58 (0%) 0/59 (0%) |0/59 (0%) 2/60 (3%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.10 0/44.05 0/33.33 0/20.93 |0/55.86 2/55.69 1/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 3.6% 1.9% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/46 (0%) 2/47 (4%) 1/39 (3%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.581N P=0.243 P=0.467 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.513N P=0.237 P=0.492 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.500N P=0.239 P=0.497 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.533N P=0.235 P=0.486 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.243 P=0.467 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.486N P=0.252 P=0.504 (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 1/60 (2%) 1/58 (2%) 0/59 (0%) |3/59 (5%) 1/60 (2%) 1/60 (2%) 1/60 (2%) |
|POLY-3 RATE (b) | 0/53.10 1/44.05 1/33.33 0/20.93 |3/56.07 1/55.69 1/53.74 1/53.33 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 3.0% 0.0% |5.4% 1.8% 1.9% 1.9% |
|TERMINAL (d) | 0/39 (0%) 1/18 (6%) 1/3 (33%) 0/0 (0%) |2/46 (4%) 1/47 (2%) 1/39 (3%) 1/33 (3%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |674 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.025 * P=0.346 P=0.048 * (e) |P=0.276N P=0.305N P=0.362N P=0.413N |
|POLY 3 | P=0.379 P=0.463 P=0.411 (e) |P=0.200N P=0.308N P=0.321N P=0.324N |
|POLY 1.5 | P=0.498 P=0.481 P=0.448 (e) |P=0.194N P=0.305N P=0.312N P=0.312N |
|POLY 6 | P=0.241 P=0.437 P=0.362 (e) |P=0.209N P=0.313N P=0.334N P=0.345N |
|LOGISTIC REGRESSION| (e) P=0.346 P=0.048 * (e) |P=0.217N P=0.303N P=0.316N P=0.323N |
|COCH-ARM / FISHERS | P=0.620N P=0.504 P=0.496 (e) |P=0.188N P=0.303N P=0.303N P=0.303N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/60 (12%) 9/59 (15%) 35/58 (60%) 41/56 (73%) | |
|POLY-3 RATE (b) | 7/54.53 9/44.60 35/44.73 41/44.77 | |
|POLY-3 PERCENT (g) | 12.8% 20.2% 78.2% 91.6% | |
|TERMINAL (d) | 2/39 (5%) 1/17 (6%) 2/3 (67%) 0/0 (0%) | |
|FIRST INCIDENCE | 663 615 384 391 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.069 P<0.001 ** P<0.001 ** | |
|POLY 3 | P<0.001 ** P=0.238 P<0.001 ** P<0.001 ** | |
|POLY 1.5 | P<0.001 ** P=0.298 P<0.001 ** P<0.001 ** | |
|POLY 6 | P<0.001 ** P=0.167 P<0.001 ** P<0.001 ** | |
|LOGISTIC REGRESSION| P<0.001 ** P=0.234 P<0.001 ** P<0.001 ** | |
|COCH-ARM / FISHERS | P<0.001 ** P=0.381 P<0.001 ** P<0.001 ** | |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 4/59 (7%) 1/58 (2%) 0/56 (0%) | |
|POLY-3 RATE (b) | 1/54.18 4/44.16 1/33.09 0/19.41 | |
|POLY-3 PERCENT (g) | 1.9% 9.1% 3.0% 0.0% | |
|TERMINAL (d) | 0/39 (0%) 1/17 (6%) 0/3 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | 640 569 714 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.257 P=0.071 P=0.447 P=0.993N | |
|POLY 3 | P=0.536 P=0.124 P=0.640 P=0.668N | |
|POLY 1.5 | P=0.425N P=0.145 P=0.692 P=0.605N | |
|POLY 6 | P=0.235 P=0.099 P=0.560 P=0.727N | |
|LOGISTIC REGRESSION| P=0.440N P=0.221 P=0.688 P=0.723N | |
|COCH-ARM / FISHERS | P=0.189N P=0.177 P=0.744 P=0.517N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 40/60 (67%) 43/59 (73%) 36/58 (62%) 27/56 (48%) | |
|POLY-3 RATE (b) | 40/56.29 43/54.04 36/48.32 27/36.46 | |
|POLY-3 PERCENT (g) | 71.1% 79.6% 74.5% 74.1% | |
|TERMINAL (d) | 29/39 (74%) 12/17 (71%) 1/3 (33%) 0/0 (0%) | |
|FIRST INCIDENCE | 537 378 384 391 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |
|POLY 3 | P=0.423 P=0.196 P=0.427 P=0.467 | |
|POLY 1.5 | P=0.214N P=0.234 P=0.569 P=0.299N | |
|POLY 6 | P=0.063 P=0.155 P=0.253 P=0.087 | |
|LOGISTIC REGRESSION| P=0.447N P=0.115 P=0.387 P=0.239 | |
|COCH-ARM / FISHERS | P=0.011N* P=0.295 P=0.371N P=0.034N* | |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 24/60 (40%) 14/59 (24%) 18/60 (30%) 9/60 (15%) | |
|POLY-3 RATE (b) | 24/57.24 14/47.02 18/42.91 9/26.13 | |
|POLY-3 PERCENT (g) | 41.9% 29.8% 41.9% 34.4% | |
|TERMINAL (d) | 16/39 (41%) 3/18 (17%) 1/3 (33%) 0/0 (0%) | |
|FIRST INCIDENCE | 441 569 299 404 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.556 P<0.001 ** P<0.001 ** | |
|POLY 3 | P=0.387N P=0.138N P=0.581 P=0.356N | |
|POLY 1.5 | P=0.092N P=0.087N P=0.384N P=0.062N | |
|POLY 6 | P=0.253 P=0.228N P=0.315 P=0.291 | |
|LOGISTIC REGRESSION| P=0.028N* P=0.040N* P=0.084N P=0.166N | |
|COCH-ARM / FISHERS | P=0.004N** P=0.044N* P=0.169N P=0.002N** | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate: Ventral |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/60 (30%) 3/59 (5%) 9/60 (15%) 1/60 (2%) | |
|POLY-3 RATE (b) | 18/54.46 3/43.99 9/36.50 1/22.10 | |
|POLY-3 PERCENT (g) | 33.1% 6.8% 24.7% 4.5% | |
|TERMINAL (d) | 15/39 (39%) 2/18 (11%) 2/3 (67%) 0/0 (0%) | |
|FIRST INCIDENCE | 631 559 512 519 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.031 * P=0.034N* P<0.001 ** P=0.412 | |
|POLY 3 | P=0.009N** P<0.001N** P=0.269N P=0.020N* | |
|POLY 1.5 | P<0.001N** P<0.001N** P=0.130N P<0.001N** | |
|POLY 6 | P=0.083N P=0.004N** P=0.552N P=0.234N | |
|LOGISTIC REGRESSION| P=0.293N P=0.005N** P=0.402 P=0.451N | |
|COCH-ARM / FISHERS | P<0.001N** P<0.001N** P=0.040N* P<0.001N** | |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 18/59 (31%) 43/60 (72%) |2/60 (3%) 3/60 (5%) 9/60 (15%) 48/60 (80%) |
|POLY-3 RATE (b) | 0/53.85 2/45.52 18/39.87 43/49.52 |2/57.25 3/56.31 9/54.39 48/56.66 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 45.2% 86.8% |3.5% 5.3% 16.6% 84.7% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 1/3 (33%) 0/0 (0%) |1/47 (2%) 1/47 (2%) 6/39 (15%) 30/33 (91%) |
|FIRST INCIDENCE | --- 378 483 359 |620 582 636 586 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.234 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.489 P=0.017 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.202 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.493 P=0.021 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.218 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.496 P=0.024 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.181 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.489 P=0.019 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.560 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.519 P=0.028 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.248 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.500 P=0.027 * P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/60 (10%) 6/60 (10%) 9/60 (15%) 7/60 (12%) |1/60 (2%) 0/59 (0%) 1/60 (2%) 0/59 (0%) |
|POLY-3 RATE (b) | 6/54.06 6/44.47 9/37.78 7/25.26 |1/56.86 0/54.87 1/53.74 0/52.53 |
|POLY-3 PERCENT (g) | 11.1% 13.5% 23.8% 27.7% |1.8% 0.0% 1.9% 0.0% |
|TERMINAL (d) | 5/39 (13%) 3/18 (17%) 1/3 (33%) 0/0 (0%) |1/47 (2%) 0/47 (0%) 1/39 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 674 615 483 419 |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.170 P<0.001 ** P<0.001 ** |P=0.456N P=0.500N P=0.720 P=0.571N |
|POLY 3 | P=0.027 * P=0.480 P=0.094 P=0.084 |P=0.393N P=0.507N P=0.748 P=0.516N |
|POLY 1.5 | P=0.099 P=0.543 P=0.161 P=0.219 |P=0.389N P=0.506N P=0.753 P=0.510N |
|POLY 6 | P=0.004 ** P=0.388 P=0.039 * P=0.020 * |P=0.401N P=0.509N P=0.741 P=0.526N |
|LOGISTIC REGRESSION| P=0.011 * P=0.310 P=0.109 P=0.091 |P=0.456N (e) P=0.720 (e) |
|COCH-ARM / FISHERS | P=0.342 P=0.619N P=0.291 P=0.500 |P=0.384N P=0.504N P=0.752N P=0.504N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/60 (12%) 33/60 (55%) 38/60 (63%) 47/60 (78%) |22/60 (37%) 38/59 (64%) 48/60 (80%) 48/59 (81%) |
|POLY-3 RATE (b) | 7/54.65 33/55.13 38/50.69 47/51.81 |22/57.71 38/57.66 48/57.83 48/57.03 |
|POLY-3 PERCENT (g) | 12.8% 59.9% 75.0% 90.7% |38.1% 65.9% 83.0% 84.2% |
|TERMINAL (d) | 2/39 (5%) 7/18 (39%) 2/3 (67%) 0/0 (0%) |20/47 (43%) 32/47 (68%) 34/39 (87%) 27/33 (82%) |
|FIRST INCIDENCE | 537 378 384 391 |401 495 370 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** 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=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** 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=0.002 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/59 (0%) 0/60 (0%) 0/59 (0%) |
|POLY-3 RATE (b) | 0/53.85 2/45.20 0/34.77 0/21.46 |0/56.86 0/54.87 0/53.74 0/52.53 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 428 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.578N P=0.199 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.622 P=0.201 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.563N P=0.217 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.429 P=0.179 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.142N P=0.447 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.382N P=0.248 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 47
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |2/60 (3%) 0/59 (0%) 0/60 (0%) 0/59 (0%) |
|POLY-3 RATE (b) | 0/53.85 0/44.05 0/34.77 0/21.46 |2/57.00 0/54.87 0/53.74 0/52.53 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |3.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |706 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.090N P=0.258N P=0.281N P=0.315N |
|POLY 3 | (e) (e) (e) (e) |P=0.067N P=0.246N P=0.251N P=0.256N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.067N P=0.244N P=0.245N P=0.249N |
|POLY 6 | (e) (e) (e) (e) |P=0.067N P=0.248N P=0.259N P=0.269N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.070N P=0.243N P=0.244N P=0.249N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.068N P=0.252N P=0.248N P=0.252N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/60 (15%) 8/60 (13%) 13/60 (22%) 16/60 (27%) |36/60 (60%) 44/59 (75%) 43/60 (72%) 46/59 (78%) |
|POLY-3 RATE (b) | 9/55.67 8/45.57 13/40.79 16/31.89 |36/56.99 44/57.32 43/55.99 46/57.01 |
|POLY-3 PERCENT (g) | 16.2% 17.6% 31.9% 50.2% |63.2% 76.8% 76.8% 80.7% |
|TERMINAL (d) | 4/39 (10%) 4/18 (22%) 1/3 (33%) 0/0 (0%) |34/47 (72%) 36/47 (77%) 32/39 (82%) 26/33 (79%) |
|FIRST INCIDENCE | 441 378 298 359 |707 495 525 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.240 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.087 P=0.007 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.532 P=0.058 P<0.001 ** |P=0.023 * P=0.079 P=0.077 P=0.026 * |
|POLY 1.5 | P=0.003 ** P=0.598N P=0.117 P=0.009 ** |P=0.026 * P=0.072 P=0.093 P=0.026 * |
|POLY 6 | P<0.001 ** P=0.419 P=0.017 * P<0.001 ** |P=0.020 * P=0.093 P=0.063 P=0.026 * |
|LOGISTIC REGRESSION| P=0.295 P=0.428N P=0.574N P=0.581N |P=0.011 * P=0.046 * P=0.033 * P=0.010 * |
|COCH-ARM / FISHERS | P=0.033 * P=0.500N P=0.240 P=0.088 |P=0.032 * P=0.067 P=0.124 P=0.027 * |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 48
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/59 (7%) 2/60 (3%) 0/60 (0%) 1/60 (2%) |0/59 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 4/54.87 2/44.75 0/34.77 1/21.93 |0/56.07 0/54.87 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 7.3% 4.5% 0.0% 4.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 533 499 --- 589 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.333N P=0.457N P=0.146N P=0.673 |(e) (e) (e) (e) |
|POLY 3 | P=0.149N P=0.435N P=0.146N P=0.524N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.091N P=0.388N P=0.100N P=0.352N |(e) (e) (e) (e) |
|POLY 6 | P=0.261N P=0.506N P=0.234N P=0.584 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.005N** P=0.101N P=0.004N** P=0.012N* |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.049N* P=0.332N P=0.057N P=0.177N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/59 (3%) 2/60 (3%) 1/60 (2%) 1/60 (2%) |1/59 (2%) 1/59 (2%) 0/60 (0%) 1/60 (2%) |
|POLY-3 RATE (b) | 2/53.49 2/44.75 1/34.97 1/22.27 |1/56.07 1/55.10 0/53.74 1/53.67 |
|POLY-3 PERCENT (g) | 3.7% 4.5% 2.9% 4.5% |1.8% 1.8% 0.0% 1.9% |
|TERMINAL (d) | 0/38 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 640 499 676 421 |729 (T) 669 --- 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.291 P=0.539 P=0.658 P=0.520 |P=0.578N P=0.758 P=0.537N P=0.717 |
|POLY 3 | P=0.601N P=0.628 P=0.640N P=0.660 |P=0.535N P=0.757 P=0.508N P=0.751 |
|POLY 1.5 | P=0.455N P=0.661 P=0.578N P=0.646N |P=0.530N P=0.758 P=0.503N P=0.757 |
|POLY 6 | P=0.491 P=0.576 P=0.700 P=0.496 |P=0.541N P=0.755 P=0.515N P=0.739 |
|LOGISTIC REGRESSION| P=0.194N P=0.574N P=0.536N P=0.243N |P=0.507N P=0.759N (e) P=0.745N |
|COCH-ARM / FISHERS | P=0.296N P=0.684N P=0.494N P=0.494N |P=0.524N P=0.752N P=0.496N P=0.748N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 49
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/59 (10%) 2/60 (3%) 1/60 (2%) 2/60 (3%) |5/59 (8%) 3/59 (5%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 6/55.74 2/44.75 1/35.20 2/23.11 |5/56.61 3/55.89 1/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 10.8% 4.5% 2.8% 8.7% |8.8% 5.4% 1.9% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |3/47 (6%) 1/47 (2%) 1/39 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 533 499 603 391 |620 429 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.416N P=0.237N P=0.193N P=0.652 |P=0.017N* P=0.368N P=0.148N P=0.064N |
|POLY 3 | P=0.181N P=0.218N P=0.176N P=0.543N |P=0.009N** P=0.365N P=0.115N P=0.037N* |
|POLY 1.5 | P=0.109N P=0.175N P=0.110N P=0.330N |P=0.008N** P=0.361N P=0.108N P=0.034N* |
|POLY 6 | P=0.300N P=0.290N P=0.302N P=0.461 |P=0.011N* P=0.370N P=0.126N P=0.044N* |
|LOGISTIC REGRESSION| P<0.001N** P=0.015N* P=0.003N** P<0.001N** |P=0.006N** P=0.326N P=0.099N P=0.030N* |
|COCH-ARM / FISHERS | P=0.055N P=0.131N P=0.054N P=0.131N |P=0.008N** P=0.358N P=0.100N P=0.027N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/59 (7%) 2/60 (3%) 7/60 (12%) 7/60 (12%) |1/60 (2%) 1/59 (2%) 1/60 (2%) 3/60 (5%) |
|POLY-3 RATE (b) | 4/52.89 2/45.66 7/37.75 7/25.69 |1/56.90 1/55.05 1/54.08 3/53.72 |
|POLY-3 PERCENT (g) | 7.6% 4.4% 18.5% 27.3% |1.8% 1.8% 1.9% 5.6% |
|TERMINAL (d) | 3/38 (8%) 0/18 (0%) 1/3 (33%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 720 378 502 463 |719 684 636 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.571N P=0.002 ** P<0.001 ** |P=0.126 P=0.747 P=0.724 P=0.216 |
|POLY 3 | P=0.010 * P=0.407N P=0.109 P=0.034 * |P=0.163 P=0.753 P=0.749 P=0.286 |
|POLY 1.5 | P=0.026 * P=0.371N P=0.168 P=0.097 |P=0.169 P=0.754 P=0.754 P=0.296 |
|POLY 6 | P=0.003 ** P=0.465N P=0.054 P=0.008 ** |P=0.153 P=0.752 P=0.743 P=0.269 |
|LOGISTIC REGRESSION| P=0.255 P=0.179N P=0.246 P=0.173 |P=0.185 P=0.761 P=0.746N P=0.309 |
|COCH-ARM / FISHERS | P=0.094 P=0.332N P=0.274 P=0.274 |P=0.175 P=0.748 P=0.752N P=0.309 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 50
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/59 (2%) 2/60 (3%) 0/60 (0%) 3/60 (5%) |2/60 (3%) 0/59 (0%) 1/60 (2%) 1/60 (2%) |
|POLY-3 RATE (b) | 1/53.15 2/45.20 0/34.77 3/23.41 |2/56.86 0/54.87 1/53.86 1/53.57 |
|POLY-3 PERCENT (g) | 1.9% 4.4% 0.0% 12.8% |3.5% 0.0% 1.9% 1.9% |
|TERMINAL (d) | 0/38 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |2/47 (4%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 649 428 --- 421 |729 (T) --- 698 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.050 P=0.404 P=0.677N P=0.030 * |P=0.514N P=0.239N P=0.554N P=0.596N |
|POLY 3 | P=0.183 P=0.444 P=0.581N P=0.109 |P=0.440N P=0.246N P=0.519N P=0.521N |
|POLY 1.5 | P=0.208 P=0.472 P=0.545N P=0.179 |P=0.436N P=0.244N P=0.511N P=0.511N |
|POLY 6 | P=0.184 P=0.403 P=0.630N P=0.059 |P=0.447N P=0.247N P=0.529N P=0.538N |
|LOGISTIC REGRESSION| P=0.542N P=0.742 P=0.510N P=0.697 |P=0.434N (e) P=0.524N P=0.506N |
|COCH-ARM / FISHERS | P=0.281 P=0.506 P=0.496N P=0.316 |P=0.431N P=0.252N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | |
|POLY-3 RATE (b) | 0/53.85 0/44.05 0/34.77 2/22.78 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 8.8% | |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | --- --- --- 404 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * (e) (e) P=0.081 | |
|POLY 3 | P=0.085 (e) (e) P=0.112 | |
|POLY 1.5 | P=0.057 (e) (e) P=0.156 | |
|POLY 6 | P=0.197 (e) (e) P=0.079 | |
|LOGISTIC REGRESSION| P=0.148 (e) (e) P=0.676 | |
|COCH-ARM / FISHERS | P=0.053 (e) (e) P=0.248 | |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 51
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/60 (22%) 21/60 (35%) 12/60 (20%) 19/60 (32%) | |
|POLY-3 RATE (b) | 13/56.48 21/50.73 12/38.79 19/33.26 | |
|POLY-3 PERCENT (g) | 23.0% 41.4% 30.9% 57.1% | |
|TERMINAL (d) | 5/39 (13%) 5/18 (28%) 1/3 (33%) 0/0 (0%) | |
|FIRST INCIDENCE | 441 471 502 391 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.004 ** P=0.006 ** P<0.001 ** | |
|POLY 3 | P=0.003 ** P=0.031 * P=0.270 P<0.001 ** | |
|POLY 1.5 | P=0.037 * P=0.046 * P=0.434 P=0.015 * | |
|POLY 6 | P<0.001 ** P=0.017 * P=0.114 P<0.001 ** | |
|LOGISTIC REGRESSION| P=0.346 P=0.221 P=0.570N P=0.523 | |
|COCH-ARM / FISHERS | P=0.293 P=0.078 P=0.500N P=0.151 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/60 (17%) 14/60 (23%) 13/60 (22%) 31/60 (52%) | |
|POLY-3 RATE (b) | 10/57.13 14/49.66 13/42.49 31/42.05 | |
|POLY-3 PERCENT (g) | 17.5% 28.2% 30.6% 73.7% | |
|TERMINAL (d) | 2/39 (5%) 2/18 (11%) 0/3 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | 533 428 384 391 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.071 P=0.032 * P<0.001 ** | |
|POLY 3 | P<0.001 ** P=0.138 P=0.099 P<0.001 ** | |
|POLY 1.5 | P<0.001 ** P=0.181 P=0.174 P<0.001 ** | |
|POLY 6 | P<0.001 ** P=0.090 P=0.038 * P<0.001 ** | |
|LOGISTIC REGRESSION| P=0.292 P=0.490N P=0.172N P=0.578 | |
|COCH-ARM / FISHERS | P<0.001 ** P=0.247 P=0.322 P<0.001 ** | |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 52
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/56 (0%) 0/54 (0%) 0/55 (0%) 0/55 (0%) |1/57 (2%) 0/55 (0%) 2/58 (3%) 2/58 (3%) |
|POLY-3 RATE (b) | 0/50.79 0/39.13 0/31.66 0/19.60 |1/54.00 0/52.04 2/51.74 2/51.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |1.9% 0.0% 3.9% 3.9% |
|TERMINAL (d) | 0/38 (0%) 0/16 (0%) 0/3 (0%) 0/0 (0%) |0/45 (0%) 0/44 (0%) 2/37 (5%) 2/31 (7%) |
|FIRST INCIDENCE | --- --- --- --- |706 --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.136 P=0.516N P=0.443 P=0.385 |
|POLY 3 | (e) (e) (e) (e) |P=0.206 P=0.507N P=0.485 P=0.482 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.216 P=0.507N P=0.494 P=0.494 |
|POLY 6 | (e) (e) (e) (e) |P=0.191 P=0.508N P=0.473 P=0.462 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.164 P=0.508N P=0.473 P=0.446 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.226 P=0.509N P=0.507 P=0.507 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Ultimobranchial Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 1/60 (2%) 2/60 (3%) 3/60 (5%) |1/60 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/52.85 1/44.23 2/35.43 3/23.44 |1/56.86 1/55.69 1/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 5.6% 12.8% |1.8% 1.8% 1.9% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 1/47 (2%) 1/39 (3%) 0/33 (0%) |
|FIRST INCIDENCE | --- 684 581 471 |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.397 P=0.091 P=0.037 * |P=0.387N P=0.761 P=0.720 P=0.571N |
|POLY 3 | P=0.016 * P=0.465 P=0.163 P=0.039 * |P=0.320N P=0.756 P=0.748 P=0.513N |
|POLY 1.5 | P=0.024 * P=0.482 P=0.193 P=0.064 |P=0.313N P=0.758 P=0.753 P=0.507N |
|POLY 6 | P=0.015 * P=0.440 P=0.128 P=0.023 * |P=0.333N P=0.754 P=0.741 P=0.523N |
|LOGISTIC REGRESSION| P=0.066 P=0.482 P=0.230 P=0.422 |P=0.387N P=0.761 P=0.720 (e) |
|COCH-ARM / FISHERS | P=0.052 P=0.504 P=0.252 P=0.125 |P=0.304N P=0.752N P=0.752N P=0.500N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 53
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/59 (17%) 11/60 (18%) 9/60 (15%) 7/60 (12%) |22/60 (37%) 24/60 (40%) 22/60 (37%) 9/60 (15%) |
|POLY-3 RATE (b) | 10/53.36 11/47.38 9/37.48 7/26.22 |22/58.02 24/56.54 22/54.03 9/54.03 |
|POLY-3 PERCENT (g) | 18.7% 23.2% 24.0% 26.7% |37.9% 42.5% 40.7% 16.7% |
|TERMINAL (d) | 8/38 (21%) 3/18 (17%) 1/3 (33%) 0/0 (0%) |17/47 (36%) 21/47 (45%) 19/39 (49%) 6/33 (18%) |
|FIRST INCIDENCE | 649 499 384 404 |620 505 698 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.101 P<0.001 ** P<0.001 ** |P=0.104N P=0.417 P=0.297 P=0.068N |
|POLY 3 | P=0.234 P=0.380 P=0.367 P=0.318 |P=0.010N* P=0.381 P=0.456 P=0.009N** |
|POLY 1.5 | P=0.516 P=0.440 P=0.517 P=0.589 |P=0.007N** P=0.401 P=0.508 P=0.007N** |
|POLY 6 | P=0.047 * P=0.298 P=0.189 P=0.094 |P=0.020N* P=0.352 P=0.387 P=0.015N* |
|LOGISTIC REGRESSION| P=0.464N P=0.495 P=0.332 P=0.565N |P=0.012N* P=0.403 P=0.449 P=0.008N** |
|COCH-ARM / FISHERS | P=0.199N P=0.517 P=0.484N P=0.288N |P=0.005N** P=0.426 P=0.575N P=0.006N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/59 (5%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 2/60 (3%) 1/60 (2%) 1/60 (2%) |
|POLY-3 RATE (b) | 3/52.85 2/44.05 0/34.77 0/21.46 |0/56.86 2/55.79 1/53.74 1/53.33 |
|POLY-3 PERCENT (g) | 5.7% 4.5% 0.0% 0.0% |0.0% 3.6% 1.9% 1.9% |
|TERMINAL (d) | 3/38 (8%) 2/18 (11%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 1/47 (2%) 1/39 (3%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- 705 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.673N P=0.542 P=0.738N P=1.000N |P=0.334 P=0.233 P=0.463 P=0.429 |
|POLY 3 | P=0.100N P=0.582N P=0.213N P=0.346N |P=0.402 P=0.233 P=0.489 P=0.487 |
|POLY 1.5 | P=0.051N P=0.542N P=0.165N P=0.223N |P=0.417 P=0.235 P=0.493 P=0.493 |
|POLY 6 | P=0.237N P=0.638N P=0.297N P=0.516N |P=0.378 P=0.232 P=0.482 P=0.477 |
|LOGISTIC REGRESSION| P=0.673N P=0.542 (e) (e) |P=0.378 P=0.234 P=0.463 P=0.429 |
|COCH-ARM / FISHERS | P=0.024N* P=0.492N P=0.119N P=0.119N |P=0.433 P=0.248 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 54
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) |2/2 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.00 1/1.00 |2/2.00 0/0.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% |100.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- 544 |706 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 2/59 (3%) |0/60 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 0/44.05 1/35.30 2/21.50 |0/56.86 0/54.87 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.8% 9.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- 564 581 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.446 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.049 * (e) P=0.419 P=0.107 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.045 * (e) P=0.454 P=0.150 |(e) (e) (e) (e) |
|POLY 6 | P=0.089 (e) P=0.372 P=0.075 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.030 * (e) P=0.660 P=0.051 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.060 (e) P=0.500 P=0.244 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 55
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/59 (0%) |0/60 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 0/44.05 2/35.22 0/20.74 |0/56.86 0/54.87 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 5.7% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 1/3 (33%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- 597 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030 * (e) P=0.030 * (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.174 (e) P=0.159 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.263 (e) P=0.190 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.105 (e) P=0.124 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.165 (e) P=0.154 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.425 (e) P=0.248 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 2/60 (3%) 3/59 (5%) |0/60 (0%) 0/59 (0%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 2/44.07 2/35.16 3/22.48 |0/56.86 0/54.87 1/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 4.5% 5.7% 13.4% |0.0% 0.0% 1.9% 0.0% |
|TERMINAL (d) | 0/39 (0%) 1/18 (6%) 1/3 (33%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 1/39 (3%) 0/33 (0%) |
|FIRST INCIDENCE | --- 726 616 439 |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.103 P=0.024 * P=0.010 * |P=0.496 (e) P=0.463 (e) |
|POLY 3 | P=0.020 * P=0.196 P=0.159 P=0.035 * |P=0.528 (e) P=0.489 (e) |
|POLY 1.5 | P=0.036 * P=0.214 P=0.189 P=0.059 |P=0.540 (e) P=0.493 (e) |
|POLY 6 | P=0.014 * P=0.172 P=0.124 P=0.021 * |P=0.506 (e) P=0.482 (e) |
|LOGISTIC REGRESSION| P=0.014 * P=0.109 P=0.130 P=0.278 |(e) (e) P=0.463 (e) |
|COCH-ARM / FISHERS | P=0.087 P=0.248 P=0.248 P=0.119 |P=0.551 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 56
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |7/60 (12%) 6/59 (10%) 1/60 (2%) 3/60 (5%) |
|POLY-3 RATE (b) | |7/56.86 6/54.87 1/53.74 3/53.57 |
|POLY-3 PERCENT (g) | |12.3% 10.9% 1.9% 5.6% |
|TERMINAL (d) | |7/47 (15%) 6/47 (13%) 1/39 (3%) 2/33 (6%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.113N P=0.500N P=0.057N P=0.324N |
|POLY 3 | |P=0.049N* P=0.527N P=0.038N* P=0.185N |
|POLY 1.5 | |P=0.045N* P=0.521N P=0.035N* P=0.173N |
|POLY 6 | |P=0.055N P=0.533N P=0.042N* P=0.207N |
|LOGISTIC REGRESSION| |P=0.081N P=0.500N P=0.057N P=0.237N |
|COCH-ARM / FISHERS | |P=0.041N* P=0.513N P=0.031N* P=0.161N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |8/60 (13%) 6/59 (10%) 9/60 (15%) 8/60 (13%) |
|POLY-3 RATE (b) | |8/57.01 6/54.92 9/54.22 8/53.81 |
|POLY-3 PERCENT (g) | |14.0% 10.9% 16.6% 14.9% |
|TERMINAL (d) | |7/47 (15%) 5/47 (11%) 6/39 (15%) 7/33 (21%) |
|FIRST INCIDENCE | |691 716 656 586 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.182 P=0.395N P=0.357 P=0.334 |
|POLY 3 | |P=0.391 P=0.417N P=0.455 P=0.558 |
|POLY 1.5 | |P=0.417 P=0.410N P=0.474 P=0.581 |
|POLY 6 | |P=0.347 P=0.424N P=0.432 P=0.515 |
|LOGISTIC REGRESSION| |P=0.349 P=0.422N P=0.435 P=0.523 |
|COCH-ARM / FISHERS | |P=0.443 P=0.402N P=0.500 P=0.605N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 57
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/60 (3%) 1/59 (2%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | |2/57.70 1/54.87 1/54.61 0/53.33 |
|POLY-3 PERCENT (g) | |3.5% 1.8% 1.8% 0.0% |
|TERMINAL (d) | |1/47 (2%) 1/47 (2%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | |401 729 (T) 370 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.165N P=0.500N P=0.523N P=0.278N |
|POLY 3 | |P=0.145N P=0.517N P=0.519N P=0.256N |
|POLY 1.5 | |P=0.140N P=0.513N P=0.511N P=0.247N |
|POLY 6 | |P=0.153N P=0.521N P=0.530N P=0.269N |
|LOGISTIC REGRESSION| |P=0.102N P=0.484N P=0.340N P=0.235N |
|COCH-ARM / FISHERS | |P=0.134N P=0.506N P=0.500N P=0.248N |
|=================================================================================================================================|
(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).