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: 09:39:10
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; CONTROL + 2000 & 5000PPM STOP GROUPS
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 009 2000 PPM(STOP)
INCLUDE 010 5000 PPM(STOP)
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 08 TIME: 09:39:10
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
Hypertrophy Focal
Adrenal Medulla Hyperplasia
Bone Marrow Hyperplasia
Brain Compression
Epididymis Atypia Cellular
Heart Cardiomyopathy
Thrombosis
Islets, Pancreatic Hyperplasia
Pigmentation
Kidney Cyst
Hydronephrosis
Inflammation Chronic
Nephropathy
Kidney: Renal Tubule Pigmentation
Liver Angiectasis
Atrophy
Basophilic Focus
Clear Cell Focus
Degeneration Cystic
Eosinophilic Focus
Hematopoietic Cell Proliferation
Hepatodiaphragmatic Nodule
Infiltration Cellular Mixed Cell
Mixed Cell Focus
Necrosis Focal
Liver: Bile Duct Hyperplasia
Liver: Centrilobular Necrosis
Liver: Hepatocyte Vacuolization Cytoplasmic
Lung Congestion
Hemorrhage
Infiltration Cellular Histiocyte
Lung: Alveolar Epithelium Hyperplasia
Lymph Node, Mandibular Hemorrhage
Hyperplasia Lymphoid
Pigmentation
Lymph Node, Mediastinal Hemorrhage
Pigmentation
Lymph Node, Mesenteric Ectasia
Hemorrhage
Hyperplasia Lymphoid
Lymph Node: Pancreatic Hyperplasia
Mesentery: Fat Necrosis
Nose Foreign Body
Inflammation Chronic
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 08 TIME: 09:39:10
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: Respiratory Epithelium Hyperplasia
Pancreas Atrophy
Pancreas: Acinus Hyperplasia Focal
Peritoneum: Mesothelium Hyperplasia
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
Testes: Germinal Epithelium Atrophy
Testes: Interstitial Cell Hyperplasia
Thymus Cyst
Thyroid Gland Ultimobranchial Cyst
Thyroid Gland: C-Cell Hyperplasia
===============================================================
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/60 (22%) 14/60 (23%) 9/60 (15%) |
|POLY-3 RATE (b) | 13/54.52 14/43.80 9/25.12 |
|POLY-3 PERCENT (g) | 23.8% 32.0% 35.8% |
|TERMINAL (d) | 9/39 (23%) 2/11 (18%) 0/0 (0%) |
|FIRST INCIDENCE | 640 419 359 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.009 ** P<0.001 ** |
|POLY 3 | P=0.156 P=0.251 P=0.225 |
|POLY 1.5 | P=0.443 P=0.350 P=0.523 |
|POLY 6 | P=0.024 * P=0.141 P=0.053 |
|LOGISTIC REGRESSION| P=0.505N P=0.451 P=0.456 |
|COCH-ARM / FISHERS | P=0.194N P=0.500 P=0.240N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Fatty |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 16/60 (27%) 14/60 (23%) 12/60 (20%) |
|POLY-3 RATE (b) | 16/54.85 14/42.46 12/26.34 |
|POLY-3 PERCENT (g) | 29.2% 33.0% 45.6% |
|TERMINAL (d) | 13/39 (33%) 2/11 (18%) 0/0 (0%) |
|FIRST INCIDENCE | 537 502 359 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.015 * P<0.001 ** |
|POLY 3 | P=0.124 P=0.428 P=0.134 |
|POLY 1.5 | P=0.387 P=0.562 P=0.423 |
|POLY 6 | P=0.018 * P=0.265 P=0.020 * |
|LOGISTIC REGRESSION| P=0.133 P=0.428 P=0.171 |
|COCH-ARM / FISHERS | P=0.233N P=0.417N P=0.259N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/53.85 0/38.63 2/20.85 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 9.6% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.049 * (e) P=0.143 |
|POLY 3 | P=0.084 (e) P=0.106 |
|POLY 1.5 | P=0.065 (e) P=0.147 |
|POLY 6 | P=0.173 (e) P=0.077 |
|LOGISTIC REGRESSION| P=0.352 (e) P=0.852 |
|COCH-ARM / FISHERS | P=0.092 (e) P=0.248 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/60 (10%) 4/60 (7%) 6/60 (10%) |
|POLY-3 RATE (b) | 6/53.85 4/39.90 6/23.27 |
|POLY-3 PERCENT (g) | 11.1% 10.0% 25.8% |
|TERMINAL (d) | 6/39 (15%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 531 359 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.282 P<0.001 ** |
|POLY 3 | P=0.159 P=0.564N P=0.132 |
|POLY 1.5 | P=0.277 P=0.482N P=0.298 |
|POLY 6 | P=0.086 P=0.585 P=0.042 * |
|LOGISTIC REGRESSION| P=0.304 P=0.627N P=0.393 |
|COCH-ARM / FISHERS | P=0.542 P=0.372N P=0.619N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/60 (5%) 3/60 (5%) 2/60 (3%) |
|POLY-3 RATE (b) | 3/54.09 3/39.00 2/20.56 |
|POLY-3 PERCENT (g) | 5.6% 7.7% 9.7% |
|TERMINAL (d) | 1/39 (3%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | 674 658 485 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.009 ** P=0.194 P=0.076 |
|POLY 3 | P=0.374 P=0.505 P=0.459 |
|POLY 1.5 | P=0.530 P=0.573 P=0.626 |
|POLY 6 | P=0.237 P=0.410 P=0.294 |
|LOGISTIC REGRESSION| P=0.305 P=0.397 P=0.682 |
|COCH-ARM / FISHERS | P=0.419N P=0.660N P=0.500N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/60 (12%) 3/60 (5%) 1/60 (2%) |
|POLY-3 RATE (b) | 7/54.16 3/39.44 1/19.92 |
|POLY-3 PERCENT (g) | 12.9% 7.6% 5.0% |
|TERMINAL (d) | 5/39 (13%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 674 499 540 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.327 P=0.544 P=0.338 |
|POLY 3 | P=0.203N P=0.318N P=0.328N |
|POLY 1.5 | P=0.084N P=0.243N P=0.146N |
|POLY 6 | P=0.430N P=0.438N P=0.579N |
|LOGISTIC REGRESSION| P=0.350N P=0.365N P=0.744N |
|COCH-ARM / FISHERS | P=0.023N* P=0.161N P=0.031N* |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/60 (3%) 37/60 (62%) 33/60 (55%) |
|POLY-3 RATE (b) | 2/53.85 37/52.90 33/41.18 |
|POLY-3 PERCENT (g) | 3.7% 69.9% 80.1% |
|TERMINAL (d) | 2/39 (5%) 4/11 (36%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 260 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Brain |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/60 (10%) 2/60 (3%) 1/60 (2%) |
|POLY-3 RATE (b) | 6/55.95 2/39.16 1/19.86 |
|POLY-3 PERCENT (g) | 10.7% 5.1% 5.0% |
|TERMINAL (d) | 1/39 (3%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 441 658 567 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.641 P=0.410N P=0.692 |
|POLY 3 | P=0.229N P=0.282N P=0.405N |
|POLY 1.5 | P=0.111N P=0.212N P=0.211N |
|POLY 6 | P=0.418N P=0.391N P=0.624 |
|LOGISTIC REGRESSION| P=0.025N* P=0.053N P=0.016N* |
|COCH-ARM / FISHERS | P=0.040N* P=0.136N P=0.057N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Brain |
| Hydrocephalus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/60 (5%) 2/60 (3%) 1/60 (2%) |
|POLY-3 RATE (b) | 3/54.87 2/38.89 1/19.71 |
|POLY-3 PERCENT (g) | 5.5% 5.1% 5.1% |
|TERMINAL (d) | 0/39 (0%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | 533 658 621 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.194 P=0.549 P=0.395 |
|POLY 3 | P=0.599N P=0.650N P=0.659N |
|POLY 1.5 | P=0.419N P=0.588N P=0.513N |
|POLY 6 | P=0.523 P=0.611 P=0.523 |
|LOGISTIC REGRESSION| P=0.524N P=0.493N P=0.455N |
|COCH-ARM / FISHERS | P=0.240N P=0.500N P=0.309N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Epididymis |
| Atypia Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 39/60 (65%) 24/60 (40%) 28/58 (48%) |
|POLY-3 RATE (b) | 39/57.69 24/46.73 28/38.71 |
|POLY-3 PERCENT (g) | 67.6% 51.4% 72.3% |
|TERMINAL (d) | 25/39 (64%) 5/11 (46%) 0/0 (0%) |
|FIRST INCIDENCE | 533 420 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.056 P<0.001 ** |
|POLY 3 | P=0.435 P=0.060N P=0.389 |
|POLY 1.5 | P=0.325N P=0.022N* P=0.375N |
|POLY 6 | P=0.106 P=0.184N P=0.064 |
|LOGISTIC REGRESSION| P=0.087N P=0.025N* P=0.029N* |
|COCH-ARM / FISHERS | P=0.070N P=0.005N** P=0.050N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Epididymis |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/58 (0%) |
|POLY-3 RATE (b) | 0/53.85 2/39.12 0/18.38 |
|POLY-3 PERCENT (g) | 0.0% 5.1% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 658 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.239 P=0.104 (e) |
|POLY 3 | P=0.350 P=0.175 (e) |
|POLY 1.5 | P=0.519 P=0.200 (e) |
|POLY 6 | P=0.167 P=0.146 (e) |
|LOGISTIC REGRESSION| P=0.604 P=0.196 (e) |
|COCH-ARM / FISHERS | P=0.622N P=0.248 (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 40/60 (67%) 39/60 (65%) 46/60 (77%) |
|POLY-3 RATE (b) | 40/57.01 39/50.36 46/49.91 |
|POLY-3 PERCENT (g) | 70.2% 77.5% 92.2% |
|TERMINAL (d) | 27/39 (69%) 10/11 (91%) 0/0 (0%) |
|FIRST INCIDENCE | 533 275 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.250 P=0.002 ** |
|POLY 1.5 | P=0.010 * P=0.414 P=0.013 * |
|POLY 6 | P<0.001 ** P=0.094 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.003 ** P=0.244 P=0.022 * |
|COCH-ARM / FISHERS | P=0.121 P=0.500N P=0.156 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 4/60 (7%) 1/60 (2%) |
|POLY-3 RATE (b) | 1/53.85 4/39.86 1/20.00 |
|POLY-3 PERCENT (g) | 1.9% 10.0% 5.0% |
|TERMINAL (d) | 1/39 (3%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 589 501 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.037 * P=0.032 * P=0.365 |
|POLY 3 | P=0.191 P=0.104 P=0.522 |
|POLY 1.5 | P=0.377 P=0.132 P=0.630 |
|POLY 6 | P=0.062 P=0.074 P=0.407 |
|LOGISTIC REGRESSION| P=0.509 P=0.148 P=0.806 |
|COCH-ARM / FISHERS | P=0.540N P=0.182 P=0.752N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/60 (3%) 2/60 (3%) 10/60 (17%) |
|POLY-3 RATE (b) | 2/54.06 2/39.49 10/27.60 |
|POLY-3 PERCENT (g) | 3.7% 5.1% 36.2% |
|TERMINAL (d) | 1/39 (3%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 674 537 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.424 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.575 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.627 P=0.002 ** |
|POLY 6 | P<0.001 ** P=0.501 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.313 P=0.696N P=0.556N |
|COCH-ARM / FISHERS | P=0.004 ** P=0.691N P=0.015 * |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 11/60 (18%) |
|POLY-3 RATE (b) | 1/53.85 0/38.63 11/28.01 |
|POLY-3 PERCENT (g) | 1.9% 0.0% 39.3% |
|TERMINAL (d) | 1/39 (3%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.750N P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.565N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.537N P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.601N P<0.001 ** |
|LOGISTIC REGRESSION| P=0.043 * (e) P=0.508 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.002 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/53.85 1/38.85 2/20.63 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 9.7% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 670 464 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * P=0.349 P=0.086 |
|POLY 3 | P=0.072 P=0.436 P=0.105 |
|POLY 1.5 | P=0.084 P=0.463 P=0.146 |
|POLY 6 | P=0.085 P=0.400 P=0.077 |
|LOGISTIC REGRESSION| P=0.183 P=0.469 P=0.449 |
|COCH-ARM / FISHERS | P=0.161 P=0.500 P=0.248 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 3/60 (5%) |
|POLY-3 RATE (b) | 0/53.85 0/38.63 3/21.15 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 14.2% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.004 ** |
|POLY 3 | P=0.026 * (e) P=0.034 * |
|POLY 1.5 | P=0.019 * (e) P=0.056 |
|POLY 6 | P=0.064 (e) P=0.021 * |
|LOGISTIC REGRESSION| P=0.095 (e) P=0.307 |
|COCH-ARM / FISHERS | P=0.033 * (e) P=0.122 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 4/60 (7%) |
|POLY-3 RATE (b) | 0/53.85 2/38.89 4/21.75 |
|POLY-3 PERCENT (g) | 0.0% 5.1% 18.4% |
|TERMINAL (d) | 0/39 (0%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | --- 658 464 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.068 P=0.002 ** |
|POLY 3 | P=0.007 ** P=0.174 P=0.011 * |
|POLY 1.5 | P=0.012 * P=0.199 P=0.022 * |
|POLY 6 | P=0.006 ** P=0.145 P=0.006 ** |
|LOGISTIC REGRESSION| P=0.020 * P=0.132 P=0.096 |
|COCH-ARM / FISHERS | P=0.043 * P=0.248 P=0.059 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 56/60 (93%) 60/60 (100%) 60/60 (100%) |
|POLY-3 RATE (b) | 56/59.40 60/60.00 60/60.00 |
|POLY-3 PERCENT (g) | 94.3% 100.0% 100.0% |
|TERMINAL (d) | 37/39 (95%) 11/11 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 441 260 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.032 * P=0.077 P=0.077 |
|POLY 1.5 | P=0.028 * P=0.068 P=0.068 |
|POLY 6 | P=0.043 * P=0.098 P=0.098 |
|LOGISTIC REGRESSION| P=0.085 P=0.093 P=0.338 |
|COCH-ARM / FISHERS | P=0.027 * P=0.059 P=0.059 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/60 (5%) 2/60 (3%) 1/60 (2%) |
|POLY-3 RATE (b) | 3/54.07 2/38.94 1/20.03 |
|POLY-3 PERCENT (g) | 5.6% 5.1% 5.0% |
|TERMINAL (d) | 2/39 (5%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 673 658 485 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.155 P=0.430 P=0.404 |
|POLY 3 | P=0.588N P=0.643N P=0.652N |
|POLY 1.5 | P=0.412N P=0.584N P=0.507N |
|POLY 6 | P=0.535 P=0.622 P=0.532 |
|LOGISTIC REGRESSION| P=0.681 P=0.650 P=0.735N |
|COCH-ARM / FISHERS | P=0.240N P=0.500N P=0.309N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 2/60 (3%) 1/60 (2%) |
|POLY-3 RATE (b) | 1/54.15 2/40.12 1/19.92 |
|POLY-3 PERCENT (g) | 1.9% 5.0% 5.0% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 649 420 540 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.355 P=0.414 P=0.336 |
|POLY 3 | P=0.337 P=0.398 P=0.520 |
|POLY 1.5 | P=0.454 P=0.441 P=0.629 |
|POLY 6 | P=0.237 P=0.340 P=0.405 |
|LOGISTIC REGRESSION| P=0.286N P=0.691N P=0.875 |
|COCH-ARM / FISHERS | P=0.613N P=0.500 P=0.752N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/53.85 0/38.63 2/21.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 9.5% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 316 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.074 (e) P=0.200 |
|POLY 3 | P=0.083 (e) P=0.106 |
|POLY 1.5 | P=0.065 (e) P=0.148 |
|POLY 6 | P=0.170 (e) P=0.077 |
|LOGISTIC REGRESSION| P=0.384 (e) P=0.994 |
|COCH-ARM / FISHERS | P=0.092 (e) P=0.248 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/60 (8%) 18/60 (30%) 6/60 (10%) |
|POLY-3 RATE (b) | 5/54.15 18/43.30 6/23.35 |
|POLY-3 PERCENT (g) | 9.2% 41.6% 25.7% |
|TERMINAL (d) | 3/39 (8%) 5/11 (46%) 0/0 (0%) |
|FIRST INCIDENCE | 673 523 391 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.004 ** P<0.001 ** P=0.089 |
|POLY 1.5 | P=0.086 P<0.001 ** P=0.213 |
|POLY 6 | P<0.001 ** P<0.001 ** P=0.028 * |
|LOGISTIC REGRESSION| P=0.131 P<0.001 ** P=0.486 |
|COCH-ARM / FISHERS | P=0.493N P=0.002 ** P=0.500 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 2/60 (3%) 1/60 (2%) |
|POLY-3 RATE (b) | 1/53.85 2/39.35 1/19.92 |
|POLY-3 PERCENT (g) | 1.9% 5.1% 5.0% |
|TERMINAL (d) | 1/39 (3%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 595 540 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.094 P=0.247 P=0.314 |
|POLY 3 | P=0.335 P=0.394 P=0.521 |
|POLY 1.5 | P=0.454 P=0.438 P=0.630 |
|POLY 6 | P=0.234 P=0.336 P=0.406 |
|LOGISTIC REGRESSION| P=0.538 P=0.480 P=0.715 |
|COCH-ARM / FISHERS | P=0.613N P=0.500 P=0.752N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 3/60 (5%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/53.85 3/39.98 2/20.85 |
|POLY-3 PERCENT (g) | 0.0% 7.5% 9.6% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 502 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.042 * P=0.054 P=0.151 |
|POLY 3 | P=0.046 * P=0.076 P=0.106 |
|POLY 1.5 | P=0.096 P=0.092 P=0.147 |
|POLY 6 | P=0.021 * P=0.058 P=0.077 |
|LOGISTIC REGRESSION| P=0.602 P=0.209 P=0.756 |
|COCH-ARM / FISHERS | P=0.266 P=0.122 P=0.248 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 3/60 (5%) |
|POLY-3 RATE (b) | 1/53.94 0/38.63 3/21.43 |
|POLY-3 PERCENT (g) | 1.9% 0.0% 14.0% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 707 --- 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * P=0.701N P=0.027 * |
|POLY 3 | P=0.114 P=0.565N P=0.096 |
|POLY 1.5 | P=0.105 P=0.537N P=0.161 |
|POLY 6 | P=0.180 P=0.602N P=0.055 |
|LOGISTIC REGRESSION| P=0.325 P=0.630N P=0.615 |
|COCH-ARM / FISHERS | P=0.153 P=0.500N P=0.309 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 38/60 (63%) 31/60 (52%) 17/60 (28%) |
|POLY-3 RATE (b) | 38/54.87 31/47.22 17/30.44 |
|POLY-3 PERCENT (g) | 69.3% 65.7% 55.9% |
|TERMINAL (d) | 34/39 (87%) 8/11 (73%) 0/0 (0%) |
|FIRST INCIDENCE | 441 260 316 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.133N P=0.425N P=0.147N |
|POLY 1.5 | P=0.009N** P=0.277N P=0.010N* |
|POLY 6 | P=0.482 P=0.559 P=0.526 |
|LOGISTIC REGRESSION| P=0.374N P=0.424 P=0.592N |
|COCH-ARM / FISHERS | P<0.001N** P=0.134N P<0.001N** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 29/60 (48%) 30/60 (50%) 34/60 (57%) |
|POLY-3 RATE (b) | 29/54.06 30/48.25 34/42.40 |
|POLY-3 PERCENT (g) | 53.6% 62.2% 80.2% |
|TERMINAL (d) | 26/39 (67%) 9/11 (82%) 0/0 (0%) |
|FIRST INCIDENCE | 705 370 316 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.002 ** P=0.240 P=0.003 ** |
|POLY 1.5 | P=0.022 * P=0.337 P=0.026 * |
|POLY 6 | P<0.001 ** P=0.136 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.018 * P=0.118 P=0.027 * |
|COCH-ARM / FISHERS | P=0.202 P=0.500 P=0.232 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/60 (5%) 6/60 (10%) 3/60 (5%) |
|POLY-3 RATE (b) | 3/53.85 6/39.38 3/20.96 |
|POLY-3 PERCENT (g) | 5.6% 15.2% 14.3% |
|TERMINAL (d) | 3/39 (8%) 4/11 (36%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 569 547 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.005 ** P=0.003 ** |
|POLY 3 | P=0.114 P=0.117 P=0.261 |
|POLY 1.5 | P=0.284 P=0.164 P=0.418 |
|POLY 6 | P=0.029 * P=0.070 P=0.141 |
|LOGISTIC REGRESSION| P=0.025 * P=0.039 * P=0.197 |
|COCH-ARM / FISHERS | P=0.529N P=0.245 P=0.660N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/60 (12%) 15/60 (25%) 13/60 (22%) |
|POLY-3 RATE (b) | 7/53.98 15/42.08 13/26.74 |
|POLY-3 PERCENT (g) | 13.0% 35.7% 48.6% |
|TERMINAL (d) | 5/39 (13%) 4/11 (36%) 0/0 (0%) |
|FIRST INCIDENCE | 705 569 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.007 ** P<0.001 ** |
|POLY 1.5 | P=0.006 ** P=0.017 * P=0.010 * |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.004 ** P=0.002 ** |
|COCH-ARM / FISHERS | P=0.139 P=0.049 * P=0.110 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 2/39.46 0/19.33 |
|POLY-3 PERCENT (g) | 0.0% 5.1% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 523 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.459 P=0.144 (e) |
|POLY 3 | P=0.360 P=0.177 (e) |
|POLY 1.5 | P=0.529 P=0.201 (e) |
|POLY 6 | P=0.172 P=0.148 (e) |
|LOGISTIC REGRESSION| P=0.668N P=0.316 (e) |
|COCH-ARM / FISHERS | P=0.613N P=0.248 (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 11/60 (18%) 6/60 (10%) |
|POLY-3 RATE (b) | 0/53.85 11/43.80 6/22.67 |
|POLY-3 PERCENT (g) | 0.0% 25.1% 26.5% |
|TERMINAL (d) | 0/39 (0%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | --- 260 359 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.003 ** P<0.001 ** P=0.003 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.422 P=0.013 * P=0.011 * |
|COCH-ARM / FISHERS | P=0.090 P<0.001 ** P=0.014 * |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/60 (3%) 2/60 (3%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/53.85 2/39.41 0/19.33 |
|POLY-3 PERCENT (g) | 3.7% 5.1% 0.0% |
|TERMINAL (d) | 2/39 (5%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 499 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.623 P=0.362 P=1.000N |
|POLY 3 | P=0.542N P=0.576 P=0.485N |
|POLY 1.5 | P=0.333N P=0.628 P=0.373N |
|POLY 6 | P=0.578 P=0.501 P=0.603N |
|LOGISTIC REGRESSION| P=0.427N P=0.677 (e) |
|COCH-ARM / FISHERS | P=0.173N P=0.691N P=0.248N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/60 (8%) 10/60 (17%) 4/60 (7%) |
|POLY-3 RATE (b) | 5/54.30 10/41.36 4/21.85 |
|POLY-3 PERCENT (g) | 9.2% 24.2% 18.3% |
|TERMINAL (d) | 3/39 (8%) 3/11 (27%) 0/0 (0%) |
|FIRST INCIDENCE | 649 555 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.003 ** P=0.003 ** |
|POLY 3 | P=0.085 P=0.043 * P=0.273 |
|POLY 1.5 | P=0.304 P=0.072 P=0.473 |
|POLY 6 | P=0.009 ** P=0.020 * P=0.124 |
|LOGISTIC REGRESSION| P=0.346 P=0.071 P=0.613 |
|COCH-ARM / FISHERS | P=0.369N P=0.135 P=0.500N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 15/60 (25%) 33/60 (55%) |
|POLY-3 RATE (b) | 1/53.85 15/45.26 33/40.91 |
|POLY-3 PERCENT (g) | 1.9% 33.1% 80.7% |
|TERMINAL (d) | 1/39 (3%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 370 359 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.002 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/60 (8%) 12/60 (20%) 8/60 (13%) |
|POLY-3 RATE (b) | 5/53.85 12/42.23 8/24.64 |
|POLY-3 PERCENT (g) | 9.3% 28.4% 32.5% |
|TERMINAL (d) | 5/39 (13%) 2/11 (18%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 499 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.006 ** P=0.014 * P=0.022 * |
|POLY 1.5 | P=0.047 * P=0.026 * P=0.075 |
|POLY 6 | P<0.001 ** P=0.006 ** P=0.005 ** |
|LOGISTIC REGRESSION| P=0.110 P=0.026 * P=0.189 |
|COCH-ARM / FISHERS | P=0.331 P=0.057 P=0.279 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/60 (5%) 2/60 (3%) 3/60 (5%) |
|POLY-3 RATE (b) | 3/54.55 2/39.14 3/21.22 |
|POLY-3 PERCENT (g) | 5.5% 5.1% 14.1% |
|TERMINAL (d) | 1/39 (3%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 537 595 471 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * P=0.525 P=0.055 |
|POLY 3 | P=0.278 P=0.645N P=0.261 |
|POLY 1.5 | P=0.372 P=0.585N P=0.417 |
|POLY 6 | P=0.222 P=0.620 P=0.142 |
|LOGISTIC REGRESSION| P=0.551 P=0.507N P=0.738N |
|COCH-ARM / FISHERS | P=0.581 P=0.500N P=0.660N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 53/60 (88%) 6/60 (10%) 1/60 (2%) |
|POLY-3 RATE (b) | 53/58.86 6/39.55 1/20.18 |
|POLY-3 PERCENT (g) | 90.1% 15.2% 5.0% |
|TERMINAL (d) | 35/39 (90%) 3/11 (27%) 0/0 (0%) |
|FIRST INCIDENCE | 441 595 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002N** P<0.001N** P=0.361N |
|POLY 3 | P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P<0.001N** P<0.001N** |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 9/60 (15%) 3/60 (5%) |
|POLY-3 RATE (b) | 1/53.86 9/41.86 3/21.34 |
|POLY-3 PERCENT (g) | 1.9% 21.5% 14.1% |
|TERMINAL (d) | 0/39 (0%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | 727 420 417 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P=0.026 * |
|POLY 3 | P=0.012 * P=0.002 ** P=0.096 |
|POLY 1.5 | P=0.083 P=0.004 ** P=0.161 |
|POLY 6 | P<0.001 ** P<0.001 ** P=0.055 |
|LOGISTIC REGRESSION| P=0.450 P=0.016 * P=0.456 |
|COCH-ARM / FISHERS | P=0.435 P=0.008 ** P=0.309 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/60 (7%) 1/60 (2%) 6/60 (10%) |
|POLY-3 RATE (b) | 4/54.62 1/39.26 6/24.22 |
|POLY-3 PERCENT (g) | 7.3% 2.6% 24.8% |
|TERMINAL (d) | 1/39 (3%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 640 523 316 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** P=0.437N P=0.008 ** |
|POLY 3 | P=0.089 P=0.296N P=0.059 |
|POLY 1.5 | P=0.122 P=0.242N P=0.146 |
|POLY 6 | P=0.075 P=0.381N P=0.018 * |
|LOGISTIC REGRESSION| P=0.350N P=0.133N P=0.196N |
|COCH-ARM / FISHERS | P=0.232 P=0.182N P=0.372 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/60 (7%) 0/60 (0%) 2/60 (3%) |
|POLY-3 RATE (b) | 4/54.70 0/38.63 2/20.94 |
|POLY-3 PERCENT (g) | 7.3% 0.0% 9.6% |
|TERMINAL (d) | 1/39 (3%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 533 --- 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.381 P=0.213N P=0.338 |
|POLY 3 | P=0.452N P=0.121N P=0.550 |
|POLY 1.5 | P=0.382N P=0.091N P=0.584N |
|POLY 6 | P=0.489N P=0.174N P=0.351 |
|LOGISTIC REGRESSION| P=0.166N P=0.056N P=0.185N |
|COCH-ARM / FISHERS | P=0.307N P=0.059N P=0.340N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 1/60 (2%) |
|POLY-3 RATE (b) | 0/53.85 2/38.63 1/20.24 |
|POLY-3 PERCENT (g) | 0.0% 5.2% 4.9% |
|TERMINAL (d) | 0/39 (0%) 2/11 (18%) 0/0 (0%) |
|FIRST INCIDENCE | --- 729 (T) 316 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.034 * P=0.034 * P=0.493 |
|POLY 3 | P=0.149 P=0.173 P=0.338 |
|POLY 1.5 | P=0.234 P=0.199 P=0.402 |
|POLY 6 | P=0.088 P=0.143 P=0.281 |
|LOGISTIC REGRESSION| P=0.455 P=0.034 * (e) |
|COCH-ARM / FISHERS | P=0.444 P=0.248 P=0.500 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/60 (5%) 3/60 (5%) 4/60 (7%) |
|POLY-3 RATE (b) | 3/54.48 3/39.29 4/21.81 |
|POLY-3 PERCENT (g) | 5.5% 7.6% 18.3% |
|TERMINAL (d) | 1/39 (3%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | 537 534 362 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.262 P=0.015 * |
|POLY 3 | P=0.123 P=0.505 P=0.135 |
|POLY 1.5 | P=0.207 P=0.573 P=0.255 |
|POLY 6 | P=0.075 P=0.410 P=0.061 |
|LOGISTIC REGRESSION| P=0.355 P=0.650 P=0.641 |
|COCH-ARM / FISHERS | P=0.427 P=0.660N P=0.500 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 25/60 (42%) 23/60 (38%) 15/60 (25%) |
|POLY-3 RATE (b) | 25/56.21 23/45.45 15/28.55 |
|POLY-3 PERCENT (g) | 44.5% 50.6% 52.5% |
|TERMINAL (d) | 16/39 (41%) 4/11 (36%) 0/0 (0%) |
|FIRST INCIDENCE | 537 419 316 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.002 ** P<0.001 ** |
|POLY 3 | P=0.258 P=0.336 P=0.328 |
|POLY 1.5 | P=0.386N P=0.491 P=0.405N |
|POLY 6 | P=0.028 * P=0.177 P=0.053 |
|LOGISTIC REGRESSION| P=0.506 P=0.436 P=0.608 |
|COCH-ARM / FISHERS | P=0.031N* P=0.426N P=0.040N* |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/60 (3%) 15/60 (25%) 29/60 (48%) |
|POLY-3 RATE (b) | 2/53.86 15/42.70 29/39.41 |
|POLY-3 PERCENT (g) | 3.7% 35.1% 73.6% |
|TERMINAL (d) | 1/39 (3%) 4/11 (36%) 0/0 (0%) |
|FIRST INCIDENCE | 727 420 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/58 (3%) 1/58 (2%) 0/59 (0%) |
|POLY-3 RATE (b) | 2/51.94 1/38.10 0/19.21 |
|POLY-3 PERCENT (g) | 3.9% 2.6% 0.0% |
|TERMINAL (d) | 2/38 (5%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 658 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.765 P=0.651 P=1.000N |
|POLY 3 | P=0.392N P=0.605N P=0.479N |
|POLY 1.5 | P=0.251N P=0.561N P=0.367N |
|POLY 6 | P=0.602N P=0.663N P=0.600N |
|LOGISTIC REGRESSION| P=0.661N P=0.700N (e) |
|COCH-ARM / FISHERS | P=0.158N P=0.500N P=0.244N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/58 (3%) 4/58 (7%) 3/59 (5%) |
|POLY-3 RATE (b) | 2/52.72 4/38.98 3/20.96 |
|POLY-3 PERCENT (g) | 3.8% 10.3% 14.3% |
|TERMINAL (d) | 1/38 (3%) 2/11 (18%) 0/0 (0%) |
|FIRST INCIDENCE | 441 502 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.008 ** P=0.095 P=0.050 |
|POLY 3 | P=0.103 P=0.213 P=0.179 |
|POLY 1.5 | P=0.209 P=0.262 P=0.294 |
|POLY 6 | P=0.045 * P=0.157 P=0.098 |
|LOGISTIC REGRESSION| P=0.533 P=0.468 P=0.754N |
|COCH-ARM / FISHERS | P=0.476 P=0.340 P=0.508 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/58 (5%) 5/58 (9%) 3/59 (5%) |
|POLY-3 RATE (b) | 3/52.26 5/38.86 3/21.38 |
|POLY-3 PERCENT (g) | 5.7% 12.9% 14.0% |
|TERMINAL (d) | 2/38 (5%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | 640 615 391 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.043 * P=0.044 * |
|POLY 3 | P=0.158 P=0.212 P=0.275 |
|POLY 1.5 | P=0.320 P=0.268 P=0.434 |
|POLY 6 | P=0.058 P=0.149 P=0.149 |
|LOGISTIC REGRESSION| P=0.410 P=0.208 P=0.693N |
|COCH-ARM / FISHERS | P=0.540N P=0.358 P=0.652N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/58 (16%) 5/58 (9%) 5/59 (8%) |
|POLY-3 RATE (b) | 9/52.29 5/39.91 5/22.30 |
|POLY-3 PERCENT (g) | 17.2% 12.5% 22.4% |
|TERMINAL (d) | 6/38 (16%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | 673 370 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.381 P<0.001 ** |
|POLY 3 | P=0.519 P=0.373N P=0.431 |
|POLY 1.5 | P=0.415N P=0.291N P=0.521N |
|POLY 6 | P=0.335 P=0.501N P=0.181 |
|LOGISTIC REGRESSION| P=0.480N P=0.266N P=0.456 |
|COCH-ARM / FISHERS | P=0.169N P=0.197N P=0.187N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/60 (3%) 4/60 (7%) 9/60 (15%) |
|POLY-3 RATE (b) | 2/54.21 4/40.70 9/24.48 |
|POLY-3 PERCENT (g) | 3.7% 9.8% 36.8% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 631 370 419 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.126 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.219 P<0.001 ** |
|POLY 1.5 | P=0.002 ** P=0.267 P=0.003 ** |
|POLY 6 | P<0.001 ** P=0.162 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.032 * P=0.595 P=0.009 ** |
|COCH-ARM / FISHERS | P=0.015 * P=0.340 P=0.027 * |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/60 (10%) 13/60 (22%) 13/60 (22%) |
|POLY-3 RATE (b) | 6/54.93 13/43.19 13/28.14 |
|POLY-3 PERCENT (g) | 10.9% 30.1% 46.2% |
|TERMINAL (d) | 1/39 (3%) 2/11 (18%) 0/0 (0%) |
|FIRST INCIDENCE | 631 370 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.015 * P<0.001 ** |
|POLY 1.5 | P=0.004 ** P=0.030 * P=0.006 ** |
|POLY 6 | P<0.001 ** P=0.006 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.173 P=0.102 P=0.283 |
|COCH-ARM / FISHERS | P=0.080 P=0.066 P=0.066 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/59 (3%) |
|POLY-3 RATE (b) | 0/53.85 0/38.63 2/20.37 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 9.8% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 419 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.028 * (e) P=0.094 |
|POLY 3 | P=0.084 (e) P=0.103 |
|POLY 1.5 | P=0.064 (e) P=0.144 |
|POLY 6 | P=0.173 (e) P=0.076 |
|LOGISTIC REGRESSION| P=0.222 (e) P=0.551 |
|COCH-ARM / FISHERS | P=0.090 (e) P=0.244 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/60 (3%) 4/60 (7%) 4/59 (7%) |
|POLY-3 RATE (b) | 2/54.46 4/39.99 4/21.49 |
|POLY-3 PERCENT (g) | 3.7% 10.0% 18.6% |
|TERMINAL (d) | 0/39 (0%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | 537 499 502 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.103 P=0.014 * |
|POLY 3 | P=0.048 * P=0.211 P=0.076 |
|POLY 1.5 | P=0.104 P=0.261 P=0.148 |
|POLY 6 | P=0.021 * P=0.153 P=0.036 * |
|LOGISTIC REGRESSION| P=0.361 P=0.462 P=0.508 |
|COCH-ARM / FISHERS | P=0.299 P=0.340 P=0.332 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/59 (3%) |
|POLY-3 RATE (b) | 0/53.85 0/38.63 2/20.12 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 9.9% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 540 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.010 * (e) P=0.036 * |
|POLY 3 | P=0.085 (e) P=0.103 |
|POLY 1.5 | P=0.064 (e) P=0.143 |
|POLY 6 | P=0.178 (e) P=0.075 |
|LOGISTIC REGRESSION| P=0.088 (e) P=0.241 |
|COCH-ARM / FISHERS | P=0.090 (e) P=0.244 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 0/59 (0%) |
|POLY-3 RATE (b) | 3/54.18 0/38.63 0/19.00 |
|POLY-3 PERCENT (g) | 5.5% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 640 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.469N P=0.352N P=1.000N |
|POLY 3 | P=0.121N P=0.192N P=0.383N |
|POLY 1.5 | P=0.079N P=0.158N P=0.252N |
|POLY 6 | P=0.194N P=0.250N P=0.537N |
|LOGISTIC REGRESSION| P=0.220N P=0.200N P=0.643N |
|COCH-ARM / FISHERS | P=0.061N P=0.122N P=0.125N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/16 (0%) 0/18 (0%) 2/16 (13%) |
|POLY-3 RATE (b) | 0/13.11 0/10.69 2/6.39 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 31.3% |
|TERMINAL (d) | 0/4 (0%) 0/2 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 581 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** |
|POLY 3 | P=0.055 (e) P=0.105 |
|POLY 1.5 | P=0.052 (e) P=0.148 |
|POLY 6 | P=0.066 (e) P=0.071 |
|LOGISTIC REGRESSION| P=0.028 * (e) P=0.081 |
|COCH-ARM / FISHERS | P=0.083 (e) P=0.242 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Mammary Gland |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/57 (5%) 3/51 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/53.07 3/32.38 1/16.57 |
|POLY-3 PERCENT (g) | 5.7% 9.3% 6.0% |
|TERMINAL (d) | 1/39 (3%) 2/11 (18%) 0/0 (0%) |
|FIRST INCIDENCE | 441 658 567 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.151 P=0.269 P=0.560 |
|POLY 3 | P=0.480 P=0.425 P=0.663 |
|POLY 1.5 | P=0.531N P=0.502 P=0.563N |
|POLY 6 | P=0.281 P=0.330 P=0.503 |
|LOGISTIC REGRESSION| P=0.538N P=0.638 P=0.218N |
|COCH-ARM / FISHERS | P=0.281N P=0.606 P=0.360N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/57 (4%) 0/51 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/51.98 0/32.12 0/16.04 |
|POLY-3 PERCENT (g) | 3.9% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 727 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.705N P=0.544N P=1.000N |
|POLY 3 | P=0.254N P=0.355N P=0.515N |
|POLY 1.5 | P=0.183N P=0.314N P=0.407N |
|POLY 6 | P=0.362N P=0.413N P=0.622N |
|LOGISTIC REGRESSION| P=0.693N P=0.534N (e) |
|COCH-ARM / FISHERS | P=0.153N P=0.276N P=0.281N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/57 (11%) 1/51 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 6/53.30 1/32.12 4/19.18 |
|POLY-3 PERCENT (g) | 11.3% 3.1% 20.9% |
|TERMINAL (d) | 2/39 (5%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | 533 729 (T) 391 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.076 P=0.324N P=0.117 |
|POLY 3 | P=0.454 P=0.189N P=0.293 |
|POLY 1.5 | P=0.555 P=0.133N P=0.498 |
|POLY 6 | P=0.371 P=0.284N P=0.137 |
|LOGISTIC REGRESSION| P=0.245N P=0.078N P=0.103N |
|COCH-ARM / FISHERS | P=0.439N P=0.076N P=0.457N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Mesentery |
| Accessory Spleen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/16 (19%) 0/1 (0%) 0/3 (0%) |
|POLY-3 RATE (b) | 3/14.77 0/1.00 0/1.72 |
|POLY-3 PERCENT (g) | 20.3% 0.0% 0.0% |
|TERMINAL (d) | 2/11 (18%) 0/1 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 586 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.525N P=0.473N P=0.889N |
|POLY 3 | P=0.448N P=0.789N P=0.623N |
|POLY 1.5 | P=0.375N P=0.792N P=0.575N |
|POLY 6 | P=0.588N P=0.784N P=0.690N |
|LOGISTIC REGRESSION| P=0.318N P=0.849N P=0.510N |
|COCH-ARM / FISHERS | P=0.357N P=0.824N P=0.578N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Mesentery |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/16 (19%) 0/1 (0%) 0/3 (0%) |
|POLY-3 RATE (b) | 3/14.29 0/1.00 0/1.72 |
|POLY-3 PERCENT (g) | 21.0% 0.0% 0.0% |
|TERMINAL (d) | 3/11 (27%) 0/1 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.876N P=0.718N P=1.000N |
|POLY 3 | P=0.440N P=0.786N P=0.617N |
|POLY 1.5 | P=0.370N P=0.791N P=0.571N |
|POLY 6 | P=0.577N P=0.778N P=0.686N |
|LOGISTIC REGRESSION| P=0.876N (e) (e) |
|COCH-ARM / FISHERS | P=0.357N P=0.824N P=0.578N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/16 (81%) 1/1 (100%) 0/3 (0%) |
|POLY-3 RATE (b) | 13/16.00 1/1.00 0/1.72 |
|POLY-3 PERCENT (g) | 81.3% 100.0% 0.0% |
|TERMINAL (d) | 8/11 (73%) 1/1 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 537 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.249N P=0.231N P=0.681N |
|POLY 3 | P=0.108N P=0.796 P=0.106N |
|POLY 1.5 | P=0.021N* P=0.796 P=0.033N* |
|POLY 6 | P=0.513N P=0.796 P=0.336N |
|LOGISTIC REGRESSION| P=0.021N* P=0.231N P=0.028N* |
|COCH-ARM / FISHERS | P=0.011N* P=0.824 P=0.021N* |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/60 (15%) 14/60 (23%) 5/60 (8%) |
|POLY-3 RATE (b) | 9/54.19 14/44.17 5/22.72 |
|POLY-3 PERCENT (g) | 16.6% 31.7% 22.0% |
|TERMINAL (d) | 6/39 (15%) 3/11 (27%) 0/0 (0%) |
|FIRST INCIDENCE | 691 370 316 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.002 ** P=0.003 ** |
|POLY 3 | P=0.162 P=0.062 P=0.420 |
|POLY 1.5 | P=0.505 P=0.101 P=0.533N |
|POLY 6 | P=0.017 * P=0.028 * P=0.176 |
|LOGISTIC REGRESSION| P=0.225N P=0.234 P=0.692 |
|COCH-ARM / FISHERS | P=0.139N P=0.177 P=0.197N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/60 (15%) 10/60 (17%) 2/60 (3%) |
|POLY-3 RATE (b) | 9/54.34 10/41.18 2/20.80 |
|POLY-3 PERCENT (g) | 16.6% 24.3% 9.6% |
|TERMINAL (d) | 6/39 (15%) 3/11 (27%) 0/0 (0%) |
|FIRST INCIDENCE | 663 419 316 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.014 * P=0.013 * P=0.141 |
|POLY 3 | P=0.574 P=0.251 P=0.371N |
|POLY 1.5 | P=0.208N P=0.350 P=0.154N |
|POLY 6 | P=0.167 P=0.142 P=0.558 |
|LOGISTIC REGRESSION| P=0.328N P=0.272 P=0.330N |
|COCH-ARM / FISHERS | P=0.024N* P=0.500 P=0.027N* |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/60 (10%) 7/60 (12%) 3/60 (5%) |
|POLY-3 RATE (b) | 6/54.35 7/40.25 3/21.51 |
|POLY-3 PERCENT (g) | 11.0% 17.4% 14.0% |
|TERMINAL (d) | 4/39 (10%) 2/11 (18%) 0/0 (0%) |
|FIRST INCIDENCE | 631 567 316 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.041 * P=0.042 * |
|POLY 3 | P=0.338 P=0.283 P=0.513 |
|POLY 1.5 | P=0.525N P=0.370 P=0.529N |
|POLY 6 | P=0.114 P=0.184 P=0.281 |
|LOGISTIC REGRESSION| P=0.569N P=0.282 P=0.403N |
|COCH-ARM / FISHERS | P=0.192N P=0.500 P=0.245N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/53.95 0/38.63 0/19.33 |
|POLY-3 PERCENT (g) | 3.7% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 705 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.674N P=0.515N P=1.000N |
|POLY 3 | P=0.221N P=0.319N P=0.486N |
|POLY 1.5 | P=0.159N P=0.282N P=0.373N |
|POLY 6 | P=0.319N P=0.374N P=0.604N |
|LOGISTIC REGRESSION| P=0.530N P=0.422N P=0.975N |
|COCH-ARM / FISHERS | P=0.137N P=0.248N P=0.248N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/60 (18%) 11/60 (18%) 9/60 (15%) |
|POLY-3 RATE (b) | 11/54.55 11/41.89 9/24.84 |
|POLY-3 PERCENT (g) | 20.2% 26.3% 36.2% |
|TERMINAL (d) | 9/39 (23%) 3/11 (27%) 0/0 (0%) |
|FIRST INCIDENCE | 537 420 359 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.019 * P<0.001 ** |
|POLY 3 | P=0.104 P=0.323 P=0.132 |
|POLY 1.5 | P=0.313 P=0.434 P=0.365 |
|POLY 6 | P=0.018 * P=0.195 P=0.027 * |
|LOGISTIC REGRESSION| P=0.311 P=0.422 P=0.364 |
|COCH-ARM / FISHERS | P=0.356N P=0.593N P=0.404N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 6/60 (10%) 3/60 (5%) |
|POLY-3 RATE (b) | 1/53.85 6/39.76 3/21.04 |
|POLY-3 PERCENT (g) | 1.9% 15.1% 14.3% |
|TERMINAL (d) | 1/39 (3%) 2/11 (18%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 502 359 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.002 ** P=0.002 ** |
|POLY 3 | P=0.026 * P=0.022 * P=0.095 |
|POLY 1.5 | P=0.096 P=0.034 * P=0.160 |
|POLY 6 | P=0.004 ** P=0.012 * P=0.054 |
|LOGISTIC REGRESSION| P=0.065 P=0.018 * P=0.284 |
|COCH-ARM / FISHERS | P=0.366 P=0.057 P=0.309 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Peritoneum: Mesothelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/3 (33%) 3/47 (6%) 0/54 (0%) |
|POLY-3 RATE (b) | 1/3.00 3/30.85 0/16.55 |
|POLY-3 PERCENT (g) | 33.3% 9.7% 0.0% |
|TERMINAL (d) | 1/3 (33%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 684 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.232 P=0.155 P=1.000N |
|POLY 3 | P=0.078N P=0.371N P=0.045N* |
|POLY 1.5 | P=0.029N* P=0.327N P=0.016N* |
|POLY 6 | P=0.269N P=0.453N P=0.266N |
|LOGISTIC REGRESSION| P=0.544N P=0.559N (e) |
|COCH-ARM / FISHERS | P=0.019N* P=0.226N P=0.053N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/59 (5%) 4/57 (7%) 4/59 (7%) |
|POLY-3 RATE (b) | 3/53.10 4/38.39 4/22.02 |
|POLY-3 PERCENT (g) | 5.7% 10.4% 18.2% |
|TERMINAL (d) | 3/39 (8%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 592 391 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.088 P=0.019 * |
|POLY 3 | P=0.104 P=0.331 P=0.141 |
|POLY 1.5 | P=0.201 P=0.393 P=0.262 |
|POLY 6 | P=0.049 * P=0.252 P=0.065 |
|LOGISTIC REGRESSION| P=0.420 P=0.315 P=0.717 |
|COCH-ARM / FISHERS | P=0.453 P=0.481 P=0.500 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/59 (3%) 3/57 (5%) 6/59 (10%) |
|POLY-3 RATE (b) | 2/53.10 3/38.82 6/22.92 |
|POLY-3 PERCENT (g) | 3.8% 7.7% 26.2% |
|TERMINAL (d) | 2/39 (5%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 370 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.195 P<0.001 ** |
|POLY 3 | P=0.012 * P=0.362 P=0.013 * |
|POLY 1.5 | P=0.025 * P=0.414 P=0.037 * |
|POLY 6 | P=0.007 ** P=0.292 P=0.004 ** |
|LOGISTIC REGRESSION| P=0.237 P=0.623 P=0.197 |
|COCH-ARM / FISHERS | P=0.093 P=0.484 P=0.136 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/59 (2%) 1/57 (2%) 42/59 (71%) |
|POLY-3 RATE (b) | 1/53.11 1/38.31 42/49.79 |
|POLY-3 PERCENT (g) | 1.9% 2.6% 84.4% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 727 275 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.628 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.683 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.715 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.632 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.515N P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.743 P<0.001 ** |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/59 (15%) 9/57 (16%) 15/59 (25%) |
|POLY-3 RATE (b) | 9/54.07 9/39.84 15/28.59 |
|POLY-3 PERCENT (g) | 16.7% 22.6% 52.5% |
|TERMINAL (d) | 5/39 (13%) 3/11 (27%) 0/0 (0%) |
|FIRST INCIDENCE | 555 523 359 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.044 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.326 P<0.001 ** |
|POLY 1.5 | P=0.008 ** P=0.426 P=0.011 * |
|POLY 6 | P<0.001 ** P=0.207 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.029 * P=0.446 P=0.083 |
|COCH-ARM / FISHERS | P=0.089 P=0.570 P=0.126 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/59 (0%) 1/57 (2%) 2/59 (3%) |
|POLY-3 RATE (b) | 0/53.10 1/37.70 2/20.12 |
|POLY-3 PERCENT (g) | 0.0% 2.7% 9.9% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 637 540 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** P=0.380 P=0.046 * |
|POLY 3 | P=0.072 P=0.433 P=0.104 |
|POLY 1.5 | P=0.085 P=0.459 P=0.146 |
|POLY 6 | P=0.087 P=0.398 P=0.076 |
|LOGISTIC REGRESSION| P=0.130 P=0.531 P=0.248 |
|COCH-ARM / FISHERS | P=0.163 P=0.491 P=0.248 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Preputial Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/60 (12%) 38/60 (63%) 54/59 (92%) |
|POLY-3 RATE (b) | 7/54.53 38/51.02 54/55.43 |
|POLY-3 PERCENT (g) | 12.8% 74.5% 97.4% |
|TERMINAL (d) | 2/39 (5%) 4/11 (36%) 0/0 (0%) |
|FIRST INCIDENCE | 663 420 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 40/60 (67%) 33/60 (55%) 14/59 (24%) |
|POLY-3 RATE (b) | 40/56.29 33/50.22 14/28.29 |
|POLY-3 PERCENT (g) | 71.1% 65.7% 49.5% |
|TERMINAL (d) | 29/39 (74%) 8/11 (73%) 0/0 (0%) |
|FIRST INCIDENCE | 537 419 359 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.043N* P=0.342N P=0.041N* |
|POLY 1.5 | P<0.001N** P=0.239N P<0.001N** |
|POLY 6 | P=0.475N P=0.529N P=0.520N |
|LOGISTIC REGRESSION| P=0.009N** P=0.372N P=0.130N |
|COCH-ARM / FISHERS | P<0.001N** P=0.131N P<0.001N** |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 24/60 (40%) 17/60 (28%) 8/60 (13%) |
|POLY-3 RATE (b) | 24/57.24 17/43.71 8/25.13 |
|POLY-3 PERCENT (g) | 41.9% 38.9% 31.8% |
|TERMINAL (d) | 16/39 (41%) 3/11 (27%) 0/0 (0%) |
|FIRST INCIDENCE | 441 420 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.062 P=0.015 * |
|POLY 3 | P=0.262N P=0.459N P=0.290N |
|POLY 1.5 | P=0.038N* P=0.294N P=0.045N* |
|POLY 6 | P=0.366 P=0.481 P=0.401 |
|LOGISTIC REGRESSION| P=0.011N* P=0.183N P=0.004N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.124N P<0.001N** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Prostate: Ventral |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 18/60 (30%) 4/60 (7%) 1/60 (2%) |
|POLY-3 RATE (b) | 18/54.46 4/39.09 1/20.15 |
|POLY-3 PERCENT (g) | 33.1% 10.2% 5.0% |
|TERMINAL (d) | 15/39 (39%) 2/11 (18%) 0/0 (0%) |
|FIRST INCIDENCE | 631 621 412 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.634 P=0.336N P=0.497 |
|POLY 3 | P<0.001N** P=0.009N** P=0.033N* |
|POLY 1.5 | P<0.001N** P=0.003N** P=0.002N** |
|POLY 6 | P=0.016N* P=0.036N* P=0.269N |
|LOGISTIC REGRESSION| P=0.063N P=0.078N P=0.236N |
|COCH-ARM / FISHERS | P<0.001N** P<0.001N** P<0.001N** |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 16/58 (28%) 49/59 (83%) |
|POLY-3 RATE (b) | 0/53.85 16/43.40 49/53.51 |
|POLY-3 PERCENT (g) | 0.0% 36.9% 91.6% |
|TERMINAL (d) | 0/39 (0%) 3/11 (27%) 0/0 (0%) |
|FIRST INCIDENCE | --- 502 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/60 (10%) 14/60 (23%) 27/60 (45%) |
|POLY-3 RATE (b) | 6/54.06 14/40.92 27/35.21 |
|POLY-3 PERCENT (g) | 11.1% 34.2% 76.7% |
|TERMINAL (d) | 5/39 (13%) 6/11 (55%) 0/0 (0%) |
|FIRST INCIDENCE | 674 531 384 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.006 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.014 * P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.042 * P<0.001 ** |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/60 (12%) 36/60 (60%) 35/60 (58%) |
|POLY-3 RATE (b) | 7/54.65 36/53.67 35/44.61 |
|POLY-3 PERCENT (g) | 12.8% 67.1% 78.5% |
|TERMINAL (d) | 2/39 (5%) 4/11 (36%) 0/0 (0%) |
|FIRST INCIDENCE | 537 260 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.155 P<0.001 ** P=0.107 |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/60 (15%) 4/60 (7%) 7/60 (12%) |
|POLY-3 RATE (b) | 9/55.67 4/39.82 7/23.88 |
|POLY-3 PERCENT (g) | 16.2% 10.1% 29.3% |
|TERMINAL (d) | 4/39 (10%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | 441 523 316 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.618N P=0.002 ** |
|POLY 3 | P=0.281 P=0.293N P=0.185 |
|POLY 1.5 | P=0.446 P=0.208N P=0.422 |
|POLY 6 | P=0.154 P=0.429N P=0.053 |
|LOGISTIC REGRESSION| P=0.387N P=0.098N P=0.306N |
|COCH-ARM / FISHERS | P=0.401N P=0.120N P=0.395N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/59 (7%) 2/60 (3%) 0/60 (0%) |
|POLY-3 RATE (b) | 4/54.87 2/39.21 0/19.33 |
|POLY-3 PERCENT (g) | 7.3% 5.1% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 533 567 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.341N P=0.549N P=0.397N |
|POLY 3 | P=0.250N P=0.500N P=0.308N |
|POLY 1.5 | P=0.114N P=0.426N P=0.169N |
|POLY 6 | P=0.510N P=0.599N P=0.490N |
|LOGISTIC REGRESSION| P=0.007N** P=0.125N P=0.002N** |
|COCH-ARM / FISHERS | P=0.041N* P=0.332N P=0.057N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/59 (3%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/53.49 1/38.89 0/19.33 |
|POLY-3 PERCENT (g) | 3.7% 2.6% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 640 658 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.754N P=0.713N P=0.992N |
|POLY 3 | P=0.398N P=0.608N P=0.484N |
|POLY 1.5 | P=0.253N P=0.560N P=0.370N |
|POLY 6 | P=0.612N P=0.670N P=0.603N |
|LOGISTIC REGRESSION| P=0.230N P=0.470N P=0.327N |
|COCH-ARM / FISHERS | P=0.158N P=0.494N P=0.244N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/59 (10%) 4/60 (7%) 1/60 (2%) |
|POLY-3 RATE (b) | 6/55.74 4/39.79 1/19.92 |
|POLY-3 PERCENT (g) | 10.8% 10.1% 5.0% |
|TERMINAL (d) | 0/38 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 533 523 540 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.580 P=0.585 P=0.614N |
|POLY 3 | P=0.389N P=0.587N P=0.403N |
|POLY 1.5 | P=0.171N P=0.491N P=0.207N |
|POLY 6 | P=0.546 P=0.542 P=0.624 |
|LOGISTIC REGRESSION| P=0.010N* P=0.131N P<0.001N** |
|COCH-ARM / FISHERS | P=0.043N* P=0.361N P=0.054N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/59 (7%) 7/60 (12%) 3/60 (5%) |
|POLY-3 RATE (b) | 4/52.89 7/40.35 3/21.73 |
|POLY-3 PERCENT (g) | 7.6% 17.4% 13.8% |
|TERMINAL (d) | 3/38 (8%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | 720 470 316 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.010 * P=0.069 |
|POLY 3 | P=0.176 P=0.132 P=0.368 |
|POLY 1.5 | P=0.403 P=0.184 P=0.556 |
|POLY 6 | P=0.043 * P=0.080 P=0.199 |
|LOGISTIC REGRESSION| P=0.591 P=0.127 P=0.511N |
|COCH-ARM / FISHERS | P=0.375N P=0.274 P=0.491N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Testes |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/53.85 2/39.99 0/19.33 |
|POLY-3 PERCENT (g) | 0.0% 5.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 420 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.649 P=0.213 (e) |
|POLY 3 | P=0.360 P=0.179 (e) |
|POLY 1.5 | P=0.529 P=0.202 (e) |
|POLY 6 | P=0.173 P=0.150 (e) |
|LOGISTIC REGRESSION| P=0.281N P=0.527 (e) |
|COCH-ARM / FISHERS | P=0.613N P=0.248 (e) |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/60 (22%) 18/60 (30%) 53/60 (88%) |
|POLY-3 RATE (b) | 13/56.48 18/44.43 53/56.31 |
|POLY-3 PERCENT (g) | 23.0% 40.5% 94.1% |
|TERMINAL (d) | 5/39 (13%) 4/11 (36%) 0/0 (0%) |
|FIRST INCIDENCE | 441 499 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.002 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.045 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.089 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.016 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.257 P=0.033 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.202 P<0.001 ** |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/60 (17%) 15/60 (25%) 4/60 (7%) |
|POLY-3 RATE (b) | 10/57.13 15/45.16 4/22.04 |
|POLY-3 PERCENT (g) | 17.5% 33.2% 18.2% |
|TERMINAL (d) | 2/39 (5%) 2/11 (18%) 0/0 (0%) |
|FIRST INCIDENCE | 533 370 359 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.040 * P=0.014 * P=0.169 |
|POLY 3 | P=0.212 P=0.053 P=0.586 |
|POLY 1.5 | P=0.471N P=0.094 P=0.344N |
|POLY 6 | P=0.018 * P=0.022 * P=0.289 |
|LOGISTIC REGRESSION| P=0.004N** P=0.576N P=0.007N** |
|COCH-ARM / FISHERS | P=0.055N P=0.184 P=0.077N |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/56 (0%) 2/56 (4%) 1/56 (2%) |
|POLY-3 RATE (b) | 0/50.79 2/37.22 1/18.18 |
|POLY-3 PERCENT (g) | 0.0% 5.4% 5.5% |
|TERMINAL (d) | 0/38 (0%) 0/10 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 523 636 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.103 P=0.208 P=0.007 ** |
|POLY 3 | P=0.144 P=0.176 P=0.333 |
|POLY 1.5 | P=0.228 P=0.200 P=0.398 |
|POLY 6 | P=0.089 P=0.148 P=0.277 |
|LOGISTIC REGRESSION| P=0.593 P=0.456 P=0.296 |
|COCH-ARM / FISHERS | P=0.444 P=0.248 P=0.500 |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Ultimobranchial Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/59 (0%) 4/60 (7%) 3/60 (5%) |
|POLY-3 RATE (b) | 0/52.85 4/40.07 3/21.83 |
|POLY-3 PERCENT (g) | 0.0% 10.0% 13.7% |
|TERMINAL (d) | 0/38 (0%) 1/11 (9%) 0/0 (0%) |
|FIRST INCIDENCE | --- 555 299 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** P=0.016 * P=0.079 |
|POLY 3 | P=0.016 * P=0.034 * P=0.036 * |
|POLY 1.5 | P=0.044 * P=0.044 * P=0.059 |
|POLY 6 | P=0.005 ** P=0.023 * P=0.022 * |
|LOGISTIC REGRESSION| P=0.530 P=0.081 P=0.892 |
|COCH-ARM / FISHERS | P=0.170 P=0.061 P=0.125 |
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/59 (17%) 9/60 (15%) 6/60 (10%) |
|POLY-3 RATE (b) | 10/53.36 9/41.81 6/23.38 |
|POLY-3 PERCENT (g) | 18.7% 21.5% 25.7% |
|TERMINAL (d) | 8/38 (21%) 3/11 (27%) 0/0 (0%) |
|FIRST INCIDENCE | 649 419 362 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.062 P<0.001 ** |
|POLY 3 | P=0.323 P=0.469 P=0.370 |
|POLY 1.5 | P=0.515N P=0.573 P=0.558N |
|POLY 6 | P=0.109 P=0.326 P=0.133 |
|LOGISTIC REGRESSION| P=0.413N P=0.606N P=0.643N |
|COCH-ARM / FISHERS | P=0.168N P=0.484N P=0.200N |
|=================================================================================================================================|
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 |
|Dose | 0 PPM 2000 PPM 5000 PPM |
| | (STOP) (STOP) |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/59 (5%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 3/52.85 0/38.63 0/19.33 |
|POLY-3 PERCENT (g) | 5.7% 0.0% 0.0% |
|TERMINAL (d) | 3/38 (8%) 0/11 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.543N P=0.403N P=1.000N |
|POLY 3 | P=0.115N P=0.186N P=0.373N |
|POLY 1.5 | P=0.075N P=0.153N P=0.242N |
|POLY 6 | P=0.185N P=0.241N P=0.531N |
|LOGISTIC REGRESSION| P=0.543N (e) (e) |
|COCH-ARM / FISHERS | P=0.058N P=0.119N P=0.119N |
|=================================================================================================================================|
(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).