TDMS Study 05203-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 08 TIME: 09:33:11
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 PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 08 TIME: 09:33:11
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
Rats(FISCHER 344)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Brain
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Liver
Lung
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 08 TIME: 09:33:11
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 Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom
Fibroma
Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Fibrosarcoma
Keratoacanthoma
Lipoma
Testes Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma
Carcinoma or Adenoma
Thyroid Gland: Follicular Cell Carcinoma or Adenoma
All Organs Hemangioma
Hemangiosarcoma or Hemangioma
Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Mesothelioma: Benign, Malignant, NOS
Mesothelioma: Malignant
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Mammary Gland Carcinoma or Adenoma
Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 08 TIME: 09:33:11
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
Mesentery Lipoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Fibroma
Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Fibrosarcoma
Thyroid Gland: C-Cell Adenoma
Uterus Polyp Stromal
Sarcoma Stromal or Polyp Stromal
All Organs Hemangioma
Hemangiosarcoma or Hemangioma
Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant and Benign Tumors
===============================================================
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 1
Statistical Analysis of Primary Tumors 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |2/60 (3%) 0/60 (0%) 0/60 (0%) 1/59 (2%) |
|POLY-3 RATE (b) | 0/53.85 0/44.05 0/34.77 1/22.19 |2/56.86 0/55.69 0/53.74 1/52.49 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.5% |3.5% 0.0% 0.0% 1.9% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |2/47 (4%) 0/47 (0%) 0/39 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- 471 |729 (T) --- --- 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.156 (e) (e) P=0.441 |P=0.417N P=0.239N P=0.280N P=0.611N |
|POLY 3 | P=0.271 (e) (e) P=0.349 |P=0.343N P=0.242N P=0.250N P=0.528N |
|POLY 1.5 | P=0.203 (e) (e) P=0.412 |P=0.343N P=0.240N P=0.245N P=0.517N |
|POLY 6 | P=0.454 (e) (e) P=0.286 |P=0.343N P=0.245N P=0.258N P=0.546N |
|LOGISTIC REGRESSION| P=0.359 (e) (e) P=0.931 |P=0.359N (e) (e) P=0.533N |
|COCH-ARM / FISHERS | P=0.188 (e) (e) P=0.500 |P=0.342N P=0.248N P=0.248N P=0.506N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 4/60 (7%) 6/60 (10%) 2/59 (3%) |2/60 (3%) 0/60 (0%) 0/60 (0%) 1/58 (2%) |
|POLY-3 RATE (b) | 2/53.85 4/45.15 6/36.81 2/22.52 |2/56.95 0/55.69 0/53.74 1/52.47 |
|POLY-3 PERCENT (g) | 3.7% 8.9% 16.3% 8.9% |3.5% 0.0% 0.0% 1.9% |
|TERMINAL (d) | 2/39 (5%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 0/47 (0%) 0/39 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) 567 531 471 |707 --- --- 603 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.139 P<0.001 ** P=0.119 |P=0.393N P=0.246N P=0.274N P=0.578N |
|POLY 3 | P=0.064 P=0.261 P=0.048 * P=0.380 |P=0.348N P=0.243N P=0.251N P=0.528N |
|POLY 1.5 | P=0.189 P=0.294 P=0.077 P=0.518 |P=0.347N P=0.241N P=0.245N P=0.520N |
|POLY 6 | P=0.012 * P=0.218 P=0.024 * P=0.241 |P=0.348N P=0.245N P=0.259N P=0.545N |
|LOGISTIC REGRESSION| P=0.243 P=0.317 P=0.068 P=0.716 |P=0.333N P=0.241N P=0.251N P=0.498N |
|COCH-ARM / FISHERS | P=0.482 P=0.340 P=0.136 P=0.684 |P=0.345N P=0.248N P=0.248N P=0.513N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 2
Statistical Analysis of Primary Tumors 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 Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/59 (0%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) |
|POLY-3 RATE (b) | 2/53.85 0/44.05 0/34.77 0/21.19 |0/56.86 0/55.69 0/53.74 0/52.03 |
|POLY-3 PERCENT (g) | 3.7% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.403N P=0.420N P=0.840N P=1.000N |(e) (e) (e) (e) |
|POLY 3 | P=0.104N P=0.285N P=0.345N P=0.466N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.080N P=0.263N P=0.295N P=0.358N |(e) (e) (e) (e) |
|POLY 6 | P=0.151N P=0.319N P=0.423N P=0.594N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.403N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.068N P=0.248N P=0.248N P=0.252N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 4/60 (7%) 6/60 (10%) 2/59 (3%) |2/60 (3%) 0/60 (0%) 0/60 (0%) 1/58 (2%) |
|POLY-3 RATE (b) | 4/53.85 4/45.15 6/36.81 2/22.52 |2/56.95 0/55.69 0/53.74 1/52.47 |
|POLY-3 PERCENT (g) | 7.4% 8.9% 16.3% 8.9% |3.5% 0.0% 0.0% 1.9% |
|TERMINAL (d) | 4/39 (10%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 0/47 (0%) 0/39 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) 567 531 471 |707 --- --- 603 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.316 P=0.003 ** P=0.119 |P=0.393N P=0.246N P=0.274N P=0.578N |
|POLY 3 | P=0.220 P=0.543 P=0.170 P=0.584 |P=0.348N P=0.243N P=0.251N P=0.528N |
|POLY 1.5 | P=0.435 P=0.588 P=0.245 P=0.560N |P=0.347N P=0.241N P=0.245N P=0.520N |
|POLY 6 | P=0.068 P=0.479 P=0.094 P=0.370 |P=0.348N P=0.245N P=0.259N P=0.545N |
|LOGISTIC REGRESSION| P=0.391 P=0.566 P=0.169 P=0.734 |P=0.333N P=0.241N P=0.251N P=0.498N |
|COCH-ARM / FISHERS | P=0.356N P=0.641N P=0.372 P=0.348N |P=0.345N P=0.248N P=0.248N P=0.513N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 3
Statistical Analysis of Primary Tumors 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/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 3/59 (5%) 2/58 (3%) 1/56 (2%) |12/59 (20%) 9/57 (16%) 3/54 (6%) 3/53 (6%) |
|POLY-3 RATE (b) | 2/53.85 3/44.40 2/33.95 1/20.14 |12/55.88 9/52.86 3/48.18 3/47.50 |
|POLY-3 PERCENT (g) | 3.7% 6.8% 5.9% 5.0% |21.5% 17.0% 6.2% 6.3% |
|TERMINAL (d) | 2/39 (5%) 1/17 (6%) 0/3 (0%) 0/0 (0%) |11/46 (24%) 9/45 (20%) 3/36 (8%) 3/32 (9%) |
|FIRST INCIDENCE | 729 (T) 465 519 471 |726 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.182 P=0.282 P=0.209 P=0.441 |P=0.015N* P=0.333N P=0.040N* P=0.065N |
|POLY 3 | P=0.420 P=0.413 P=0.519 P=0.634 |P=0.005N** P=0.366N P=0.025N* P=0.027N* |
|POLY 1.5 | P=0.571N P=0.449 P=0.591 P=0.674N |P=0.004N** P=0.358N P=0.023N* P=0.024N* |
|POLY 6 | P=0.242 P=0.362 P=0.416 P=0.476 |P=0.006N** P=0.374N P=0.029N* P=0.033N* |
|LOGISTIC REGRESSION| P=0.245N P=0.616 P=0.648 P=0.869N |P=0.016N* P=0.357N P=0.043N* P=0.065N |
|COCH-ARM / FISHERS | P=0.339N P=0.492 P=0.678 P=0.526N |P=0.004N** P=0.347N P=0.019N* P=0.021N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 2/59 (3%) 0/58 (0%) 1/56 (2%) |2/59 (3%) 4/57 (7%) 3/54 (6%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/53.89 2/43.50 0/33.03 1/19.91 |2/55.90 4/53.62 3/48.27 0/47.50 |
|POLY-3 PERCENT (g) | 3.7% 4.6% 0.0% 5.0% |3.6% 7.5% 6.2% 0.0% |
|TERMINAL (d) | 1/39 (3%) 1/17 (6%) 0/3 (0%) 0/0 (0%) |1/46 (2%) 2/45 (4%) 2/36 (6%) 0/32 (0%) |
|FIRST INCIDENCE | 720 600 --- 581 |719 505 706 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.193 P=0.458 P=0.844N P=0.169 |P=0.275N P=0.327 P=0.402 P=0.327N |
|POLY 3 | P=0.473N P=0.614 P=0.358N P=0.631 |P=0.229N P=0.319 P=0.434 P=0.275N |
|POLY 1.5 | P=0.359N P=0.647 P=0.306N P=0.676N |P=0.216N P=0.321 P=0.444 P=0.269N |
|POLY 6 | P=0.621N P=0.563 P=0.439N P=0.473 |P=0.251N P=0.317 P=0.421 P=0.285N |
|LOGISTIC REGRESSION| P=0.631 P=0.618 P=0.694N P=0.636 |P=0.196N P=0.334 P=0.416 P=0.295N |
|COCH-ARM / FISHERS | P=0.246N P=0.684 P=0.256N P=0.526N |P=0.202N P=0.323 P=0.458 P=0.275N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 4
Statistical Analysis of Primary Tumors 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/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 5/59 (8%) 2/58 (3%) 2/56 (4%) |14/59 (24%) 13/57 (23%) 6/54 (11%) 3/53 (6%) |
|POLY-3 RATE (b) | 4/53.89 5/44.84 2/33.95 2/20.64 |14/55.92 13/53.62 6/48.27 3/47.50 |
|POLY-3 PERCENT (g) | 7.4% 11.2% 5.9% 9.7% |25.0% 24.3% 12.4% 6.3% |
|TERMINAL (d) | 3/39 (8%) 2/17 (12%) 0/3 (0%) 0/0 (0%) |12/46 (26%) 11/45 (24%) 5/36 (14%) 3/32 (9%) |
|FIRST INCIDENCE | 720 465 519 471 |719 505 706 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.076 P=0.194 P=0.284 P=0.067 |P=0.010N* P=0.528N P=0.126N P=0.031N* |
|POLY 3 | P=0.542 P=0.387 P=0.559N P=0.551 |P=0.003N** P=0.550N P=0.083N P=0.009N** |
|POLY 1.5 | P=0.398N P=0.433 P=0.469N P=0.592N |P=0.002N** P=0.546N P=0.075N P=0.008N** |
|POLY 6 | P=0.323 P=0.322 P=0.633 P=0.343 |P=0.004N** P=0.554N P=0.094N P=0.012N* |
|LOGISTIC REGRESSION| P=0.266N P=0.538 P=0.585N P=0.607 |P=0.004N** P=0.564N P=0.121N P=0.029N* |
|COCH-ARM / FISHERS | P=0.182N P=0.489 P=0.356N P=0.373N |P=0.002N** P=0.541N P=0.065N P=0.007N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large: Colon/Rectum |
| Polyp Adenomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |0/60 (0%) 2/60 (3%) 0/60 (0%) 1/60 (2%) |
|POLY-3 RATE (b) | 1/53.85 0/44.05 0/34.77 1/22.27 |0/56.86 2/55.69 0/53.74 1/53.33 |
|POLY-3 PERCENT (g) | 1.9% 0.0% 0.0% 4.5% |0.0% 3.6% 0.0% 1.9% |
|TERMINAL (d) | 1/39 (3%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 2/47 (4%) 0/39 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) --- --- 419 |--- 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.295 P=0.654N P=0.952N P=0.475 |P=0.414 P=0.239 (e) P=0.429 |
|POLY 3 | P=0.667 P=0.540N P=0.583N P=0.545 |P=0.483 P=0.233 (e) P=0.487 |
|POLY 1.5 | P=0.621 P=0.522N P=0.548N P=0.649 |P=0.496 P=0.235 (e) P=0.493 |
|POLY 6 | P=0.675N P=0.565N P=0.632N P=0.419 |P=0.463 P=0.231 (e) P=0.477 |
|LOGISTIC REGRESSION| P=0.566N (e) (e) P=0.766N |(e) P=0.239 (e) P=0.429 |
|COCH-ARM / FISHERS | P=0.618 P=0.500N P=0.500N P=0.752N |P=0.510 P=0.248 (e) P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 5
Statistical Analysis of Primary Tumors 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |1/60 (2%) 1/59 (2%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/53.95 0/44.05 0/34.77 0/21.46 |1/56.86 1/54.87 1/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 3.7% 0.0% 0.0% 0.0% |1.8% 1.8% 1.9% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 1/47 (2%) 1/39 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 705 --- --- --- |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.360N P=0.401N P=0.739N P=1.000N |P=0.387N P=0.761 P=0.720 P=0.571N |
|POLY 3 | P=0.103N P=0.285N P=0.346N P=0.464N |P=0.319N P=0.753 P=0.748 P=0.513N |
|POLY 1.5 | P=0.079N P=0.263N P=0.296N P=0.355N |P=0.312N P=0.754 P=0.753 P=0.507N |
|POLY 6 | P=0.151N P=0.320N P=0.424N P=0.593N |P=0.332N P=0.751 P=0.741 P=0.523N |
|LOGISTIC REGRESSION| P=0.249N P=0.341N P=0.557N P=0.986N |P=0.387N P=0.761 P=0.720 (e) |
|COCH-ARM / FISHERS | P=0.067N P=0.248N P=0.248N P=0.248N |P=0.303N P=0.748 P=0.752N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/59 (0%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 2/44.05 0/34.77 0/21.46 |0/56.86 0/54.87 1/54.37 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 4.5% 0.0% 0.0% |0.0% 0.0% 1.8% 0.0% |
|TERMINAL (d) | 0/39 (0%) 2/18 (11%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- --- 525 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.232 P=0.091 (e) (e) |P=0.550 (e) P=0.497 (e) |
|POLY 3 | P=0.622 P=0.196 (e) (e) |P=0.526 (e) P=0.491 (e) |
|POLY 1.5 | P=0.564N P=0.214 (e) (e) |P=0.539 (e) P=0.495 (e) |
|POLY 6 | P=0.430 P=0.172 (e) (e) |P=0.503 (e) P=0.486 (e) |
|LOGISTIC REGRESSION| (e) P=0.091 (e) (e) |P=0.553 (e) P=0.579 (e) |
|COCH-ARM / FISHERS | P=0.382N P=0.248 (e) (e) |P=0.551 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 6
Statistical Analysis of Primary Tumors 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 |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |1/60 (2%) 1/59 (2%) 2/60 (3%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/53.95 2/44.05 0/34.77 0/21.46 |1/56.86 1/54.87 2/54.37 0/53.33 |
|POLY-3 PERCENT (g) | 3.7% 4.5% 0.0% 0.0% |1.8% 1.8% 3.7% 0.0% |
|TERMINAL (d) | 1/39 (3%) 2/18 (11%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 1/47 (2%) 1/39 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 705 729 (T) --- --- |729 (T) 729 (T) 525 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.605 P=0.414 P=0.739N P=1.000N |P=0.480N P=0.761 P=0.455 P=0.571N |
|POLY 3 | P=0.219N P=0.618 P=0.346N P=0.464N |P=0.421N P=0.753 P=0.484 P=0.513N |
|POLY 1.5 | P=0.123N P=0.653 P=0.296N P=0.355N |P=0.410N P=0.754 P=0.491 P=0.507N |
|POLY 6 | P=0.430N P=0.565 P=0.424N P=0.593N |P=0.441N P=0.751 P=0.475 P=0.523N |
|LOGISTIC REGRESSION| P=0.632N P=0.481 P=0.557N P=0.986N |P=0.378N P=0.761 P=0.543 (e) |
|COCH-ARM / FISHERS | P=0.063N P=0.691N P=0.248N P=0.248N |P=0.398N P=0.748 P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 3/60 (5%) 3/60 (5%) 7/60 (12%) |1/60 (2%) 0/59 (0%) 1/60 (2%) 6/60 (10%) |
|POLY-3 RATE (b) | 2/53.94 3/44.45 3/35.90 7/25.88 |1/56.86 0/54.87 1/53.74 6/53.62 |
|POLY-3 PERCENT (g) | 3.7% 6.8% 8.4% 27.1% |1.8% 0.0% 1.9% 11.2% |
|TERMINAL (d) | 1/39 (3%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 0/47 (0%) 1/39 (3%) 4/33 (12%) |
|FIRST INCIDENCE | 707 621 615 391 |729 (T) --- 729 (T) 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.242 P=0.090 P<0.001 ** |P=0.002 ** P=0.500N P=0.720 P=0.024 * |
|POLY 3 | P=0.007 ** P=0.413 P=0.325 P=0.006 ** |P=0.005 ** P=0.507N P=0.748 P=0.048 * |
|POLY 1.5 | P=0.015 * P=0.452 P=0.398 P=0.021 * |P=0.006 ** P=0.506N P=0.753 P=0.053 |
|POLY 6 | P=0.003 ** P=0.359 P=0.237 P<0.001 ** |P=0.005 ** P=0.509N P=0.741 P=0.042 * |
|LOGISTIC REGRESSION| P=0.041 * P=0.369 P=0.405 P=0.263 |P=0.004 ** (e) P=0.720 P=0.040 * |
|COCH-ARM / FISHERS | P=0.045 * P=0.500 P=0.500 P=0.081 |P=0.007 ** P=0.504N P=0.752N P=0.057 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 7
Statistical Analysis of Primary Tumors 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 |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 3/60 (5%) 3/60 (5%) 8/60 (13%) |1/60 (2%) 0/59 (0%) 1/60 (2%) 6/60 (10%) |
|POLY-3 RATE (b) | 3/53.94 3/44.45 3/35.90 8/26.50 |1/56.86 0/54.87 1/53.74 6/53.62 |
|POLY-3 PERCENT (g) | 5.6% 6.8% 8.4% 30.2% |1.8% 0.0% 1.9% 11.2% |
|TERMINAL (d) | 2/39 (5%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 0/47 (0%) 1/39 (3%) 4/33 (12%) |
|FIRST INCIDENCE | 707 621 615 391 |729 (T) --- 729 (T) 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.355 P=0.111 P<0.001 ** |P=0.002 ** P=0.500N P=0.720 P=0.024 * |
|POLY 3 | P=0.009 ** P=0.570 P=0.466 P=0.007 ** |P=0.005 ** P=0.507N P=0.748 P=0.048 * |
|POLY 1.5 | P=0.018 * P=0.612 P=0.552 P=0.025 * |P=0.006 ** P=0.506N P=0.753 P=0.053 |
|POLY 6 | P=0.004 ** P=0.507 P=0.350 P<0.001 ** |P=0.005 ** P=0.509N P=0.741 P=0.042 * |
|LOGISTIC REGRESSION| P=0.041 * P=0.504 P=0.510 P=0.229 |P=0.004 ** (e) P=0.720 P=0.040 * |
|COCH-ARM / FISHERS | P=0.052 P=0.660N P=0.660N P=0.102 |P=0.007 ** P=0.504N P=0.752N P=0.057 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 3/60 (5%) 3/60 (5%) 8/60 (13%) |1/60 (2%) 0/59 (0%) 1/60 (2%) 6/60 (10%) |
|POLY-3 RATE (b) | 3/53.94 3/44.45 3/35.90 8/26.50 |1/56.86 0/54.87 1/53.74 6/53.62 |
|POLY-3 PERCENT (g) | 5.6% 6.8% 8.4% 30.2% |1.8% 0.0% 1.9% 11.2% |
|TERMINAL (d) | 2/39 (5%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 0/47 (0%) 1/39 (3%) 4/33 (12%) |
|FIRST INCIDENCE | 707 621 615 391 |729 (T) --- 729 (T) 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.355 P=0.111 P<0.001 ** |P=0.002 ** P=0.500N P=0.720 P=0.024 * |
|POLY 3 | P=0.009 ** P=0.570 P=0.466 P=0.007 ** |P=0.005 ** P=0.507N P=0.748 P=0.048 * |
|POLY 1.5 | P=0.018 * P=0.612 P=0.552 P=0.025 * |P=0.006 ** P=0.506N P=0.753 P=0.053 |
|POLY 6 | P=0.004 ** P=0.507 P=0.350 P<0.001 ** |P=0.005 ** P=0.509N P=0.741 P=0.042 * |
|LOGISTIC REGRESSION| P=0.041 * P=0.504 P=0.510 P=0.229 |P=0.004 ** (e) P=0.720 P=0.040 * |
|COCH-ARM / FISHERS | P=0.052 P=0.660N P=0.660N P=0.102 |P=0.007 ** P=0.504N P=0.752N P=0.057 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 8
Statistical Analysis of Primary Tumors 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 |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 5/60 (8%) 1/60 (2%) 2/60 (3%) |1/60 (2%) 2/60 (3%) 0/60 (0%) 3/60 (5%) |
|POLY-3 RATE (b) | 1/53.85 5/44.71 1/34.77 2/22.99 |1/56.86 2/55.79 0/53.74 3/53.33 |
|POLY-3 PERCENT (g) | 1.9% 11.2% 2.9% 8.7% |1.8% 3.6% 0.0% 5.6% |
|TERMINAL (d) | 1/39 (3%) 2/18 (11%) 1/3 (33%) 0/0 (0%) |1/47 (2%) 1/47 (2%) 0/39 (0%) 3/33 (9%) |
|FIRST INCIDENCE | 729 (T) 639 729 (T) 419 |729 (T) 705 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.017 * P=0.160 P=0.185 |P=0.176 P=0.493 P=0.537N P=0.189 |
|POLY 3 | P=0.237 P=0.066 P=0.654 P=0.254 |P=0.258 P=0.493 P=0.511N P=0.283 |
|POLY 1.5 | P=0.397 P=0.081 P=0.703 P=0.354 |P=0.267 P=0.496 P=0.507N P=0.294 |
|POLY 6 | P=0.095 P=0.049 * P=0.577 P=0.165 |P=0.244 P=0.490 P=0.518N P=0.265 |
|LOGISTIC REGRESSION| P=0.304 P=0.049 * P=0.160 P=0.782N |P=0.205 P=0.492 (e) P=0.189 |
|COCH-ARM / FISHERS | P=0.506N P=0.103 P=0.752N P=0.500 |P=0.277 P=0.500 P=0.500N P=0.309 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 5/60 (8%) 1/60 (2%) 2/60 (3%) |1/60 (2%) 2/60 (3%) 0/60 (0%) 4/60 (7%) |
|POLY-3 RATE (b) | 2/53.85 5/44.71 1/34.77 2/22.99 |1/56.86 2/55.79 0/53.74 4/53.33 |
|POLY-3 PERCENT (g) | 3.7% 11.2% 2.9% 8.7% |1.8% 3.6% 0.0% 7.5% |
|TERMINAL (d) | 2/39 (5%) 2/18 (11%) 1/3 (33%) 0/0 (0%) |1/47 (2%) 1/47 (2%) 0/39 (0%) 4/33 (12%) |
|FIRST INCIDENCE | 729 (T) 639 729 (T) 419 |729 (T) 705 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.007 ** P=0.042 * P=0.256 P=0.185 |P=0.071 P=0.493 P=0.537N P=0.090 |
|POLY 3 | P=0.390 P=0.149 P=0.644N P=0.386 |P=0.126 P=0.493 P=0.511N P=0.161 |
|POLY 1.5 | P=0.566 P=0.178 P=0.583N P=0.525 |P=0.132 P=0.496 P=0.507N P=0.170 |
|POLY 6 | P=0.195 P=0.115 P=0.697 P=0.244 |P=0.117 P=0.490 P=0.518N P=0.146 |
|LOGISTIC REGRESSION| P=0.398 P=0.107 P=0.256 P=0.703N |P=0.086 P=0.492 (e) P=0.090 |
|COCH-ARM / FISHERS | P=0.341N P=0.219 P=0.500N P=0.691N |P=0.139 P=0.500 P=0.500N P=0.182 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 9
Statistical Analysis of Primary Tumors 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 |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 1/60 (2%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/53.85 0/44.05 0/34.77 0/21.46 |0/56.86 0/55.69 1/53.82 2/53.98 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 1.9% 3.7% |
|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 | --- --- --- --- |--- --- 709 586 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.049 * (e) P=0.461 P=0.221 |
|POLY 3 | (e) (e) (e) (e) |P=0.057 (e) P=0.489 P=0.226 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.059 (e) P=0.494 P=0.232 |
|POLY 6 | (e) (e) (e) (e) |P=0.054 (e) P=0.483 P=0.217 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.066 (e) P=0.496 P=0.247 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.061 (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 |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 7/60 (12%) 10/60 (17%) 2/60 (3%) |23/60 (38%) 47/60 (78%) 52/60 (87%) 56/60 (93%) |
|POLY-3 RATE (b) | 0/53.85 7/44.88 10/38.12 2/22.15 |23/57.50 47/57.31 52/56.73 56/58.22 |
|POLY-3 PERCENT (g) | 0.0% 15.6% 26.2% 9.0% |40.0% 82.0% 91.7% 96.2% |
|TERMINAL (d) | 0/39 (0%) 4/18 (22%) 1/3 (33%) 0/0 (0%) |18/47 (38%) 39/47 (83%) 36/39 (92%) 33/33 (100%) |
|FIRST INCIDENCE | --- 621 576 608 |620 505 525 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.004 ** P<0.001 ** P=0.110 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.022 * P=0.005 ** P<0.001 ** P=0.154 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P=0.077 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.002 ** P=0.003 ** P<0.001 ** P=0.030 * |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.250 P=0.006 ** P<0.001 ** P=0.248 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 10
Statistical Analysis of Primary Tumors 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 |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 7/60 (12%) 10/60 (17%) 2/60 (3%) |23/60 (38%) 47/60 (78%) 52/60 (87%) 56/60 (93%) |
|POLY-3 RATE (b) | 0/53.85 7/44.88 10/38.12 2/22.15 |23/57.50 47/57.31 52/56.73 56/58.22 |
|POLY-3 PERCENT (g) | 0.0% 15.6% 26.2% 9.0% |40.0% 82.0% 91.7% 96.2% |
|TERMINAL (d) | 0/39 (0%) 4/18 (22%) 1/3 (33%) 0/0 (0%) |18/47 (38%) 39/47 (83%) 36/39 (92%) 33/33 (100%) |
|FIRST INCIDENCE | --- 621 576 608 |620 505 525 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.004 ** P<0.001 ** P=0.110 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.022 * P=0.005 ** P<0.001 ** P=0.154 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P=0.077 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.002 ** P=0.003 ** P<0.001 ** P=0.030 * |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.250 P=0.006 ** P<0.001 ** P=0.248 |P<0.001 ** P<0.001 ** 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 |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 7/60 (12%) 10/60 (17%) 2/60 (3%) |23/60 (38%) 47/60 (78%) 52/60 (87%) 57/60 (95%) |
|POLY-3 RATE (b) | 0/53.85 7/44.88 10/38.12 2/22.15 |23/57.50 47/57.31 52/56.73 57/58.70 |
|POLY-3 PERCENT (g) | 0.0% 15.6% 26.2% 9.0% |40.0% 82.0% 91.7% 97.1% |
|TERMINAL (d) | 0/39 (0%) 4/18 (22%) 1/3 (33%) 0/0 (0%) |18/47 (38%) 39/47 (83%) 36/39 (92%) 33/33 (100%) |
|FIRST INCIDENCE | --- 621 576 608 |620 505 525 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.004 ** P<0.001 ** P=0.110 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.022 * P=0.005 ** P<0.001 ** P=0.154 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P=0.077 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.002 ** P=0.003 ** P<0.001 ** P=0.030 * |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.250 P=0.006 ** P<0.001 ** P=0.248 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 11
Statistical Analysis of Primary Tumors 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 |
| Lipoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/53.85 1/44.07 0/34.77 0/21.46 |0/56.86 0/55.69 0/53.74 2/53.33 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |0.0% 0.0% 0.0% 3.8% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 2/33 (6%) |
|FIRST INCIDENCE | --- 726 --- --- |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.515 P=0.372 (e) (e) |P=0.031 * (e) (e) P=0.165 |
|POLY 3 | P=0.710 P=0.460 (e) (e) |P=0.050 (e) (e) P=0.224 |
|POLY 1.5 | P=0.651N P=0.478 (e) (e) |P=0.051 (e) (e) P=0.231 |
|POLY 6 | P=0.619 P=0.435 (e) (e) |P=0.048 * (e) (e) P=0.213 |
|LOGISTIC REGRESSION| P=0.559 P=0.376 (e) (e) |(e) (e) (e) P=0.165 |
|COCH-ARM / FISHERS | P=0.517N P=0.500 (e) (e) |P=0.053 (e) (e) P=0.248 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/59 (19%) 9/60 (15%) 3/58 (5%) 9/59 (15%) |19/59 (32%) 32/60 (53%) 26/60 (43%) 20/60 (33%) |
|POLY-3 RATE (b) | 11/55.19 9/45.97 3/33.77 9/26.33 |19/56.21 32/57.45 26/54.81 20/55.23 |
|POLY-3 PERCENT (g) | 19.9% 19.6% 8.9% 34.2% |33.8% 55.7% 47.4% 36.2% |
|TERMINAL (d) | 6/39 (15%) 3/18 (17%) 1/3 (33%) 0/0 (0%) |16/46 (35%) 25/47 (53%) 19/39 (49%) 10/33 (30%) |
|FIRST INCIDENCE | 441 569 621 391 |691 531 636 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.296 P=0.525 P<0.001 ** |P=0.147 P=0.020 * P=0.044 * P=0.156 |
|POLY 3 | P=0.390 P=0.581N P=0.149N P=0.155 |P=0.484N P=0.014 * P=0.100 P=0.473 |
|POLY 1.5 | P=0.471N P=0.497N P=0.072N P=0.401 |P=0.439N P=0.014 * P=0.116 P=0.500 |
|POLY 6 | P=0.153 P=0.501 P=0.324N P=0.030 * |P=0.494 P=0.014 * P=0.083 P=0.425 |
|LOGISTIC REGRESSION| P=0.455N P=0.345N P=0.055N P=0.367N |P=0.511N P=0.013 * P=0.075 P=0.446 |
|COCH-ARM / FISHERS | P=0.209N P=0.387N P=0.023N* P=0.403N |P=0.396N P=0.016 * P=0.144 P=0.526 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 12
Statistical Analysis of Primary Tumors 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | |
|POLY-3 RATE (b) | 2/53.85 0/43.44 0/34.77 0/21.46 | |
|POLY-3 PERCENT (g) | 3.7% 0.0% 0.0% 0.0% | |
|TERMINAL (d) | 2/39 (5%) 0/18 (0%) 0/3 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | 729 (T) --- --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.403N P=0.420N P=0.840N P=1.000N | |
|POLY 3 | P=0.104N P=0.288N P=0.345N P=0.463N | |
|POLY 1.5 | P=0.080N P=0.267N P=0.295N P=0.355N | |
|POLY 6 | P=0.151N P=0.321N P=0.423N P=0.593N | |
|LOGISTIC REGRESSION| P=0.403N (e) (e) (e) | |
|COCH-ARM / FISHERS | 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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/53.85 0/44.05 0/34.77 1/21.88 |0/56.86 1/55.69 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 3.7% 0.0% 0.0% 4.6% |0.0% 1.8% 0.0% 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) --- --- 608 |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.232 P=0.420N P=0.840N P=0.068 |P=0.573N P=0.500 (e) (e) |
|POLY 3 | P=0.382N P=0.285N P=0.345N P=0.654 |P=0.528N P=0.496 (e) (e) |
|POLY 1.5 | P=0.362N P=0.263N P=0.295N P=0.652N |P=0.523N P=0.498 (e) (e) |
|POLY 6 | P=0.379N P=0.319N P=0.423N P=0.492 |P=0.535N P=0.494 (e) (e) |
|LOGISTIC REGRESSION| P=0.548 (e) (e) P=0.517 |(e) P=0.500 (e) (e) |
|COCH-ARM / FISHERS | P=0.339N P=0.248N P=0.248N P=0.500N |P=0.517N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 13
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/60 (12%) 3/60 (5%) 1/60 (2%) 1/60 (2%) |0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 7/54.46 3/44.62 1/35.30 1/21.88 |0/56.86 1/55.69 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 12.9% 6.7% 2.8% 4.6% |0.0% 1.8% 0.0% 0.0% |
|TERMINAL (d) | 5/39 (13%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 1/47 (2%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 537 616 564 608 |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.487 P=0.497N P=0.592N P=0.390 |P=0.573N P=0.500 (e) (e) |
|POLY 3 | P=0.053N P=0.252N P=0.114N P=0.291N |P=0.528N P=0.496 (e) (e) |
|POLY 1.5 | P=0.022N* P=0.208N P=0.068N P=0.126N |P=0.523N P=0.498 (e) (e) |
|POLY 6 | P=0.142N P=0.323N P=0.217N P=0.560N |P=0.535N P=0.494 (e) (e) |
|LOGISTIC REGRESSION| P=0.087N P=0.236N P=0.086N P=0.609N |(e) P=0.500 (e) (e) |
|COCH-ARM / FISHERS | P=0.007N** P=0.161N P=0.031N* P=0.031N* |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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 46/60 (77%) 52/60 (87%) 59/60 (98%) |3/60 (5%) 3/60 (5%) 18/60 (30%) 20/60 (33%) |
|POLY-3 RATE (b) | 5/54.01 46/54.11 52/54.03 59/59.12 |3/56.86 3/55.69 18/55.07 20/54.21 |
|POLY-3 PERCENT (g) | 9.3% 85.0% 96.2% 99.8% |5.3% 5.4% 32.7% 36.9% |
|TERMINAL (d) | 3/39 (8%) 15/18 (83%) 3/3 (100%) 0/0 (0%) |3/47 (6%) 3/47 (6%) 15/39 (39%) 14/33 (42%) |
|FIRST INCIDENCE | 705 465 432 391 |729 (T) 729 (T) 432 663 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.663 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.652 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=0.656 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.647 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.663 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=0.660N P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 14
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 47/60 (78%) 55/60 (92%) 59/60 (98%) |3/60 (5%) 3/60 (5%) 21/60 (35%) 22/60 (37%) |
|POLY-3 RATE (b) | 5/54.01 47/54.49 55/55.72 59/59.12 |3/56.86 3/55.69 21/55.86 22/54.21 |
|POLY-3 PERCENT (g) | 9.3% 86.3% 98.7% 99.8% |5.3% 5.4% 37.6% 40.6% |
|TERMINAL (d) | 3/39 (8%) 15/18 (83%) 3/3 (100%) 0/0 (0%) |3/47 (6%) 3/47 (6%) 16/39 (41%) 16/33 (49%) |
|FIRST INCIDENCE | 705 465 384 391 |729 (T) 729 (T) 432 663 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.663 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.652 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=0.656 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.647 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.663 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=0.660N 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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 7/60 (12%) 17/60 (28%) 20/60 (33%) |0/60 (0%) 0/60 (0%) 4/60 (7%) 3/60 (5%) |
|POLY-3 RATE (b) | 0/53.85 7/45.87 17/40.23 20/33.65 |0/56.86 0/55.69 4/54.54 3/53.33 |
|POLY-3 PERCENT (g) | 0.0% 15.3% 42.3% 59.4% |0.0% 0.0% 7.3% 5.6% |
|TERMINAL (d) | 0/39 (0%) 1/18 (6%) 1/3 (33%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 2/39 (5%) 3/33 (9%) |
|FIRST INCIDENCE | --- 569 384 439 |--- --- 569 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P=0.011 * (e) P=0.052 P=0.067 |
|POLY 3 | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P=0.018 * (e) P=0.056 P=0.109 |
|POLY 1.5 | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P=0.020 * (e) P=0.058 P=0.114 |
|POLY 6 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P=0.015 * (e) P=0.054 P=0.100 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |P=0.024 * (e) P=0.074 P=0.067 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P=0.023 * (e) P=0.059 P=0.122 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 15
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 2/44.40 0/34.77 0/21.46 |0/56.86 0/55.69 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 4.5% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 632 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.443 P=0.127 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.622 P=0.198 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.564N P=0.215 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.430 P=0.175 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.702 P=0.211 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.382N P=0.248 (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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 3/60 (5%) 1/60 (2%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 5/54.46 3/44.62 1/35.30 0/21.46 |0/56.86 0/55.69 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 9.2% 6.7% 2.8% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/39 (8%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 537 616 564 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.464N P=0.612 P=0.661N P=0.699N |(e) (e) (e) (e) |
|POLY 3 | P=0.079N P=0.470N P=0.238N P=0.218N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.029N* P=0.419N P=0.170N P=0.101N |(e) (e) (e) (e) |
|POLY 6 | P=0.240N P=0.543N P=0.358N P=0.427N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.043N* P=0.412N P=0.141N P=0.234N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.008N** P=0.359N P=0.103N P=0.029N* |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 16
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Lipoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 4/60 (7%) 13/60 (22%) 13/60 (22%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 4/44.88 13/39.45 13/29.03 |0/56.86 0/55.69 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 0.0% 8.9% 33.0% 44.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 569 502 414 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.020 * P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P=0.041 * P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.049 * P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.032 * P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.057 P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.059 P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 55/60 (92%) 53/60 (88%) 51/60 (85%) 46/60 (77%) | |
|POLY-3 RATE (b) | 55/58.31 53/56.59 51/52.86 46/49.88 | |
|POLY-3 PERCENT (g) | 94.3% 93.7% 96.5% 92.2% | |
|TERMINAL (d) | 38/39 (97%) 18/18 (100%) 3/3 (100%) 0/0 (0%) | |
|FIRST INCIDENCE | 533 465 483 404 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |
|POLY 3 | P=0.453N P=0.610N P=0.457 P=0.475N | |
|POLY 1.5 | P=0.113N P=0.503N P=0.638N P=0.146N | |
|POLY 6 | P=0.234 P=0.646 P=0.271 P=0.541 | |
|LOGISTIC REGRESSION| P=0.021 * P=0.433 P=0.049 * P=0.141 | |
|COCH-ARM / FISHERS | P=0.011N* P=0.381N P=0.197N P=0.022N* | |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 17
Statistical Analysis of Primary Tumors 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/59 (17%) 6/60 (10%) 0/60 (0%) 1/60 (2%) |9/60 (15%) 6/60 (10%) 3/60 (5%) 5/60 (8%) |
|POLY-3 RATE (b) | 10/53.92 6/44.05 0/34.77 1/22.29 |9/56.86 6/56.38 3/55.36 5/53.82 |
|POLY-3 PERCENT (g) | 18.6% 13.6% 0.0% 4.5% |15.8% 10.6% 5.4% 9.3% |
|TERMINAL (d) | 6/38 (16%) 6/18 (33%) 0/3 (0%) 0/0 (0%) |9/47 (19%) 5/47 (11%) 0/39 (0%) 3/33 (9%) |
|FIRST INCIDENCE | 533 729 (T) --- 404 |729 (T) 495 370 663 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.571N P=0.480 P=0.183N P=0.652 |P=0.220N P=0.289N P=0.109N P=0.410N |
|POLY 3 | P=0.006N** P=0.352N P=0.010N* P=0.147N |P=0.109N P=0.296N P=0.068N P=0.227N |
|POLY 1.5 | P<0.001N** P=0.278N P=0.004N** P=0.037N* |P=0.103N P=0.294N P=0.066N P=0.212N |
|POLY 6 | P=0.044N* P=0.474N P=0.040N* P=0.438N |P=0.121N P=0.300N P=0.073N P=0.255N |
|LOGISTIC REGRESSION| P=0.033N* P=0.466N P=0.010N* P=0.056N |P=0.080N P=0.296N P=0.046N* P=0.268N |
|COCH-ARM / FISHERS | P<0.001N** P=0.200N P<0.001N** P=0.004N** |P=0.096N P=0.291N P=0.063N P=0.197N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 4/60 (7%) 0/60 (0%) 1/60 (2%) |1/60 (2%) 3/60 (5%) 3/60 (5%) 1/60 (2%) |
|POLY-3 RATE (b) | 0/52.85 4/44.20 0/34.77 1/21.81 |1/56.86 3/55.69 3/53.74 1/53.42 |
|POLY-3 PERCENT (g) | 0.0% 9.1% 0.0% 4.6% |1.8% 5.4% 5.6% 1.9% |
|TERMINAL (d) | 0/38 (0%) 3/18 (17%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 3/47 (6%) 3/39 (8%) 0/33 (0%) |
|FIRST INCIDENCE | --- 691 --- 632 |729 (T) 729 (T) 729 (T) 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.009 ** (e) P=0.046 * |P=0.446 P=0.306 P=0.241 P=0.693 |
|POLY 3 | P=0.323 P=0.042 * (e) P=0.350 |P=0.556 P=0.299 P=0.286 P=0.746 |
|POLY 1.5 | P=0.477 P=0.050 (e) P=0.414 |P=0.567N P=0.302 P=0.294 P=0.753 |
|POLY 6 | P=0.157 P=0.031 * (e) P=0.285 |P=0.523 P=0.295 P=0.275 P=0.735 |
|LOGISTIC REGRESSION| P=0.053 P=0.017 * (e) P=0.349 |P=0.479 P=0.306 P=0.241 P=0.741 |
|COCH-ARM / FISHERS | P=0.503N P=0.061 (e) P=0.504 |P=0.548N P=0.309 P=0.309 P=0.752N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 18
Statistical Analysis of Primary Tumors 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 |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/59 (17%) 10/60 (17%) 0/60 (0%) 2/60 (3%) |10/60 (17%) 9/60 (15%) 6/60 (10%) 6/60 (10%) |
|POLY-3 RATE (b) | 10/53.92 10/44.20 0/34.77 2/22.64 |10/56.86 9/56.38 6/55.36 6/53.90 |
|POLY-3 PERCENT (g) | 18.6% 22.6% 0.0% 8.8% |17.6% 16.0% 10.8% 11.1% |
|TERMINAL (d) | 6/38 (16%) 9/18 (50%) 0/3 (0%) 0/0 (0%) |10/47 (21%) 8/47 (17%) 3/39 (8%) 3/33 (9%) |
|FIRST INCIDENCE | 533 691 --- 404 |729 (T) 495 370 663 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.103 P=0.072 P=0.183N P=0.177 |P=0.305N P=0.499N P=0.323N P=0.447N |
|POLY 3 | P=0.029N* P=0.403 P=0.010N* P=0.269N |P=0.142N P=0.508N P=0.226N P=0.244N |
|POLY 1.5 | P=0.005N** P=0.498 P=0.004N** P=0.090N |P=0.131N P=0.504N P=0.219N P=0.227N |
|POLY 6 | P=0.206N P=0.273 P=0.040N* P=0.598N |P=0.162N P=0.513N P=0.238N P=0.273N |
|LOGISTIC REGRESSION| P=0.242N P=0.244 P=0.010N* P=0.227N |P=0.111N P=0.513N P=0.186N P=0.290N |
|COCH-ARM / FISHERS | P<0.001N** P=0.580N P<0.001N** P=0.014N* |P=0.120N P=0.500N P=0.211N P=0.211N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/59 (2%) 1/60 (2%) 1/60 (2%) 1/60 (2%) |0/60 (0%) 0/60 (0%) 2/60 (3%) 1/60 (2%) |
|POLY-3 RATE (b) | 1/52.85 1/44.14 1/34.86 1/22.11 |0/56.86 0/55.69 2/54.19 1/53.41 |
|POLY-3 PERCENT (g) | 1.9% 2.3% 2.9% 4.5% |0.0% 0.0% 3.7% 1.9% |
|TERMINAL (d) | 1/38 (3%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 1/39 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 707 706 512 |--- --- 597 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035 * P=0.608 P=0.270 P=0.372 |P=0.129 (e) P=0.212 P=0.425 |
|POLY 3 | P=0.418 P=0.719 P=0.659 P=0.547 |P=0.154 (e) P=0.227 P=0.488 |
|POLY 1.5 | P=0.487 P=0.740 P=0.708 P=0.652 |P=0.162 (e) P=0.232 P=0.494 |
|POLY 6 | P=0.364 P=0.686 P=0.583 P=0.420 |P=0.141 (e) P=0.221 P=0.477 |
|LOGISTIC REGRESSION| P=0.269 P=0.660 P=0.440 P=0.831 |P=0.179 (e) P=0.262 P=0.495 |
|COCH-ARM / FISHERS | P=0.597N P=0.748N P=0.748N P=0.748N |P=0.170 (e) P=0.248 P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 19
Statistical Analysis of Primary Tumors 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 |
| Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 0/59 (0%) |0/60 (0%) 0/59 (0%) 1/60 (2%) 1/60 (2%) |
|POLY-3 RATE (b) | 1/53.85 2/44.05 1/35.04 0/20.74 |0/56.86 0/54.87 1/53.74 1/53.33 |
|POLY-3 PERCENT (g) | 1.9% 4.5% 2.9% 0.0% |0.0% 0.0% 1.9% 1.9% |
|TERMINAL (d) | 1/39 (3%) 2/18 (11%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 1/39 (3%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 656 --- |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.125 P=0.242 P=0.392 P=1.000N |P=0.131 (e) P=0.463 P=0.429 |
|POLY 3 | P=0.630 P=0.431 P=0.656 P=0.658N |P=0.174 (e) P=0.489 P=0.487 |
|POLY 1.5 | P=0.440N P=0.462 P=0.704 P=0.594N |P=0.180 (e) P=0.493 P=0.493 |
|POLY 6 | P=0.424 P=0.387 P=0.581 P=0.721N |P=0.163 (e) P=0.482 P=0.477 |
|LOGISTIC REGRESSION| P=0.324 P=0.242 P=0.633 (e) |(e) (e) P=0.463 P=0.429 |
|COCH-ARM / FISHERS | P=0.252N P=0.500 P=0.752N P=0.504N |P=0.186 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |11/60 (18%) 7/60 (12%) 15/60 (25%) 16/60 (27%) |
|POLY-3 RATE (b) | |11/56.86 7/56.18 15/54.46 16/54.81 |
|POLY-3 PERCENT (g) | |19.3% 12.5% 27.5% 29.2% |
|TERMINAL (d) | |11/47 (23%) 6/47 (13%) 13/39 (33%) 9/33 (27%) |
|FIRST INCIDENCE | |729 (T) 582 523 586 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.006 ** P=0.221N P=0.114 P=0.041 * |
|POLY 3 | |P=0.043 * P=0.229N P=0.212 P=0.159 |
|POLY 1.5 | |P=0.049 * P=0.226N P=0.229 P=0.175 |
|POLY 6 | |P=0.034 * P=0.232N P=0.190 P=0.135 |
|LOGISTIC REGRESSION| |P=0.040 * P=0.237N P=0.183 P=0.143 |
|COCH-ARM / FISHERS | |P=0.058 P=0.222N P=0.253 P=0.191 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 20
Statistical Analysis of Primary Tumors 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 |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |11/60 (18%) 8/60 (13%) 15/60 (25%) 17/60 (28%) |
|POLY-3 RATE (b) | |11/56.86 8/56.18 15/54.46 17/54.81 |
|POLY-3 PERCENT (g) | |19.3% 14.2% 27.5% 31.0% |
|TERMINAL (d) | |11/47 (23%) 7/47 (15%) 13/39 (33%) 10/33 (30%) |
|FIRST INCIDENCE | |729 (T) 582 523 586 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.004 ** P=0.308N P=0.114 P=0.024 * |
|POLY 3 | |P=0.032 * P=0.318N P=0.212 P=0.113 |
|POLY 1.5 | |P=0.038 * P=0.314N P=0.229 P=0.126 |
|POLY 6 | |P=0.025 * P=0.322N P=0.190 P=0.093 |
|LOGISTIC REGRESSION| |P=0.029 * P=0.329N P=0.183 P=0.097 |
|COCH-ARM / FISHERS | |P=0.045 * P=0.309N P=0.253 P=0.140 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 2/60 (3%) |1/60 (2%) 1/60 (2%) 0/60 (0%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/53.85 2/44.73 0/34.77 2/22.99 |1/56.90 1/55.69 0/53.74 2/53.68 |
|POLY-3 PERCENT (g) | 0.0% 4.5% 0.0% 8.7% |1.8% 1.8% 0.0% 3.7% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 1/47 (2%) 0/39 (0%) 1/33 (3%) |
|FIRST INCIDENCE | --- 534 --- 359 |719 729 (T) --- 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058 P=0.168 (e) P=0.171 |P=0.316 P=0.751 P=0.554N P=0.411 |
|POLY 3 | P=0.142 P=0.199 (e) P=0.113 |P=0.384 P=0.756 P=0.511N P=0.480 |
|POLY 1.5 | P=0.172 P=0.216 (e) P=0.156 |P=0.392 P=0.758 P=0.507N P=0.490 |
|POLY 6 | P=0.131 P=0.177 (e) P=0.079 |P=0.373 P=0.753 P=0.518N P=0.463 |
|LOGISTIC REGRESSION| P=0.570 P=0.307 (e) P=0.913 |P=0.399 P=0.755 P=0.514N P=0.514 |
|COCH-ARM / FISHERS | P=0.248 P=0.248 (e) P=0.248 |P=0.399 P=0.752N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 21
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 2/60 (3%) |2/60 (3%) 1/60 (2%) 0/60 (0%) 3/60 (5%) |
|POLY-3 RATE (b) | 0/53.85 2/44.73 0/34.77 2/22.99 |2/56.90 1/55.69 0/53.74 3/53.68 |
|POLY-3 PERCENT (g) | 0.0% 4.5% 0.0% 8.7% |3.5% 1.8% 0.0% 5.6% |
|TERMINAL (d) | 0/39 (0%) 0/18 (0%) 0/3 (0%) 0/0 (0%) |1/47 (2%) 1/47 (2%) 0/39 (0%) 2/33 (6%) |
|FIRST INCIDENCE | --- 534 --- 359 |719 729 (T) --- 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058 P=0.168 (e) P=0.171 |P=0.293 P=0.509N P=0.291N P=0.369 |
|POLY 3 | P=0.142 P=0.199 (e) P=0.113 |P=0.388 P=0.507N P=0.251N P=0.474 |
|POLY 1.5 | P=0.172 P=0.216 (e) P=0.156 |P=0.396 P=0.504N P=0.245N P=0.487 |
|POLY 6 | P=0.131 P=0.177 (e) P=0.079 |P=0.377 P=0.511N P=0.258N P=0.452 |
|LOGISTIC REGRESSION| P=0.570 P=0.307 (e) P=0.913 |P=0.387 P=0.513N P=0.262N P=0.492 |
|COCH-ARM / FISHERS | P=0.248 P=0.248 (e) P=0.248 |P=0.404 P=0.500N 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 3/60 (5%) 0/60 (0%) 2/60 (3%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/53.85 3/44.73 0/34.77 2/22.90 |0/56.86 0/55.69 0/53.74 2/53.76 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 0.0% 8.7% |0.0% 0.0% 0.0% 3.7% |
|TERMINAL (d) | 0/39 (0%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 632 --- 439 |--- --- --- 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027 * P=0.049 * (e) P=0.151 |P=0.045 * (e) (e) P=0.208 |
|POLY 3 | P=0.158 P=0.090 (e) P=0.112 |P=0.050 (e) (e) P=0.225 |
|POLY 1.5 | P=0.220 P=0.102 (e) P=0.156 |P=0.051 (e) (e) P=0.231 |
|POLY 6 | P=0.107 P=0.075 (e) P=0.079 |P=0.048 * (e) (e) P=0.216 |
|LOGISTIC REGRESSION| P=0.431 P=0.116 (e) P=0.756 |P=0.056 (e) (e) P=0.253 |
|COCH-ARM / FISHERS | P=0.345 P=0.122 (e) P=0.248 |P=0.053 (e) (e) P=0.248 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 22
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 3/60 (5%) 1/60 (2%) 2/60 (3%) |0/60 (0%) 0/60 (0%) 1/60 (2%) 2/60 (3%) |
|POLY-3 RATE (b) | 1/53.85 3/44.73 1/34.83 2/22.90 |0/56.86 0/55.69 1/53.74 2/53.76 |
|POLY-3 PERCENT (g) | 1.9% 6.7% 2.9% 8.7% |0.0% 0.0% 1.9% 3.7% |
|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 | 729 (T) 632 714 439 |--- --- 729 (T) 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * P=0.131 P=0.252 P=0.151 |P=0.045 * (e) P=0.463 P=0.208 |
|POLY 3 | P=0.232 P=0.243 P=0.654 P=0.254 |P=0.057 (e) P=0.489 P=0.225 |
|POLY 1.5 | P=0.334 P=0.270 P=0.704 P=0.353 |P=0.059 (e) P=0.493 P=0.231 |
|POLY 6 | P=0.144 P=0.208 P=0.578 P=0.165 |P=0.053 (e) P=0.482 P=0.216 |
|LOGISTIC REGRESSION| P=0.363 P=0.266 P=0.378 P=0.803 |P=0.064 (e) P=0.463 P=0.253 |
|COCH-ARM / FISHERS | P=0.506 P=0.309 P=0.752N P=0.500 |P=0.061 (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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 1/54.45 2/44.58 0/34.77 0/21.46 |0/56.86 0/55.69 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 1.8% 4.5% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 1/18 (6%) 0/3 (0%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 537 567 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.479N P=0.397 P=0.561N P=0.699N |(e) (e) (e) (e) |
|POLY 3 | P=0.432N P=0.431 P=0.585N P=0.655N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.276N P=0.462 P=0.549N P=0.591N |(e) (e) (e) (e) |
|POLY 6 | P=0.686N P=0.388 P=0.634N P=0.718N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.095N P=0.655 P=0.292N P=0.233N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.158N P=0.500 P=0.500N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 23
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 30/60 (50%) 21/60 (35%) 3/60 (5%) 3/60 (5%) |21/60 (35%) 6/60 (10%) 4/60 (7%) 5/60 (8%) |
|POLY-3 RATE (b) | 30/57.49 21/49.12 3/35.21 3/23.66 |21/59.04 6/56.70 4/54.59 5/55.15 |
|POLY-3 PERCENT (g) | 52.2% 42.8% 8.5% 12.7% |35.6% 10.6% 7.3% 9.1% |
|TERMINAL (d) | 16/39 (41%) 7/18 (39%) 0/3 (0%) 0/0 (0%) |11/47 (23%) 3/47 (6%) 1/39 (3%) 1/33 (3%) |
|FIRST INCIDENCE | 533 465 676 419 |453 429 523 488 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491N P=0.264 P=0.184N P=0.316 |P<0.001N** P=0.003N** P=0.002N** P=0.008N** |
|POLY 3 | P<0.001N** P=0.214N P<0.001N** P=0.003N** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.132N P<0.001N** P<0.001N** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P=0.002N** P=0.387N P<0.001N** P=0.177N |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.085N P<0.001N** P<0.001N** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.070N P<0.001N** P<0.001N** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 20/60 (33%) 29/60 (48%) 44/60 (73%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/53.85 20/49.25 29/46.48 44/50.51 |0/56.86 0/55.69 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 3.7% 40.6% 62.4% 87.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 5/18 (28%) 1/3 (33%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 428 432 359 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 24
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 20/60 (33%) 29/60 (48%) 44/60 (73%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/53.85 20/49.25 29/46.48 44/50.51 |0/56.86 0/55.69 0/53.74 0/53.33 |
|POLY-3 PERCENT (g) | 3.7% 40.6% 62.4% 87.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 5/18 (28%) 1/3 (33%) 0/0 (0%) |0/47 (0%) 0/47 (0%) 0/39 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 428 432 359 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 60/60 (100%) 58/60 (97%) 55/60 (92%) 59/60 (98%) |47/60 (78%) 57/60 (95%) 59/60 (98%) 59/60 (98%) |
|POLY-3 RATE (b) | 60/60.00 58/58.34 55/55.51 59/59.12 |47/57.65 57/59.20 59/59.48 59/59.30 |
|POLY-3 PERCENT (g) | 100.0% 99.4% 99.1% 99.8% |81.5% 96.3% 99.2% 99.5% |
|TERMINAL (d) | 39/39 (100%) 18/18 (100%) 3/3 (100%) 0/0 (0%) |41/47 (87%) 45/47 (96%) 39/39 (100%) 33/33 (100%) |
|FIRST INCIDENCE | 441 465 432 391 |620 495 370 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.032 * P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.799N P=0.996N P=0.974N P=1.000N |P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.424N P=0.613N P=0.195N P=0.970N |P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=1.000N P=1.000N P=1.000N P=1.000N |P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.003 ** (e) (e) (e) |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.252N P=0.248N P=0.029N* P=0.500N |P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 08 Page 25
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 37/60 (62%) 47/60 (78%) 42/60 (70%) 51/60 (85%) |24/60 (40%) 16/60 (27%) 18/60 (30%) 20/60 (33%) |
|POLY-3 RATE (b) | 37/58.10 47/56.24 42/51.38 51/54.25 |24/59.08 16/57.37 18/56.09 20/56.38 |
|POLY-3 PERCENT (g) | 63.7% 83.6% 81.8% 94.0% |40.6% 27.9% 32.1% 35.5% |
|TERMINAL (d) | 21/39 (54%) 14/18 (78%) 2/3 (67%) 0/0 (0%) |13/47 (28%) 12/47 (26%) 11/39 (28%) 10/33 (30%) |
|FIRST INCIDENCE | 533 378 384 359 |453 429 523 488 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.327 P=0.124N P=0.387N P=0.438 |
|POLY 3 | P<0.001 ** P=0.010 * P=0.023 * P<0.001 ** |P=0.369N P=0.104N P=0.224N P=0.353N |
|POLY 1.5 | P<0.001 ** P=0.019 * P=0.064 P<0.001 ** |P=0.340N P=0.096N P=0.200N P=0.319N |
|POLY 6 | P<0.001 ** P=0.004 ** P=0.005 ** P<0.001 ** |P=0.423N P=0.120N P=0.262N P=0.416N |
|LOGISTIC REGRESSION| P=0.009 ** P=0.052 P=0.129 P=0.139 |P=0.251N P=0.075N P=0.139N P=0.210N |
|COCH-ARM / FISHERS | P=0.009 ** P=0.036 * P=0.221 P=0.003 ** |P=0.309N P=0.087N P=0.169N P=0.285N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 625 PPM 1250 PPM 2000 PPM |0 PPM 625 PPM 1250 PPM 2000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 60/60 (100%) 60/60 (100%) 57/60 (95%) 60/60 (100%)|54/60 (90%) 58/60 (97%) 60/60 (100%) 60/60 (100%) |
|POLY-3 RATE (b) | 60/60.00 60/60.00 57/57.21 60/60.00 |54/59.17 58/60.00 60/60.00 60/60.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 99.6% 100.0% |91.3% 96.7% 100.0% 100.0% |
|TERMINAL (d) | 39/39 (100%) 18/18 (100%) 3/3 (100%) 0/0 (0%) |42/47 (89%) 45/47 (96%) 39/39 (100%) 33/33 (100%) |
|FIRST INCIDENCE | 441 378 384 359 |453 429 370 464 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** (e) |P<0.001 ** P=0.268 P=0.009 ** P<0.001 ** |
|POLY 3 | P=1.000N (e) P=1.000N (e) |P=0.003 ** P=0.195 P=0.026 * P=0.026 * |
|POLY 1.5 | P=0.688N (e) P=0.669N (e) |P=0.002 ** P=0.173 P=0.021 * P=0.021 * |
|POLY 6 | P=1.000N (e) P=1.000N (e) |P=0.003 ** P=0.209 P=0.030 * P=0.030 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P<0.001 ** P=0.126 P=0.013 * P=0.014 * |
|COCH-ARM / FISHERS | P=0.357N (e) P=0.122N (e) |P<0.001 ** P=0.136 P=0.014 * P=0.014 * |
|=================================================================================================================================|
(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).