TDMS Study 05205-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst P-NITROTOLUENE DATE: 01/04/01
EXPERIMENT: 05205 TEST: 07 TIME: 08:00:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62537D
PATHOLOGIST: HEATH, JAMES E. CAS: 99-99-0
------------------------------------------------------------------------------------------------------------------------------------
Final#2/Rats
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst P-NITROTOLUENE DATE: 01/04/01
EXPERIMENT: 05205 TEST: 07 TIME: 08:00:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62537D
PATHOLOGIST: HEATH, JAMES E. CAS: 99-99-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF P-NITROTOLUENE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
Eye: Retina Degeneration
Kidney Nephropathy
Kidney: Renal Tubule Hyaline Droplet
Hyperplasia Oncocytic
Pigmentation
Liver Basophilic Focus
Clear Cell Focus
Degeneration Cystic
Eosinophilic Focus
Mixed Cell Focus
Liver: Bile Duct Hyperplasia
Lung Hemorrhage
Infiltration Cellular Histiocyte
Lymph Node, Mandibular Pigmentation
Lymph Node, Mesenteric Pigmentation
Mammary Gland Hyperplasia
Mesentery: Fat Necrosis
Nose: Respiratory Epithelium Hyperplasia
Pancreas Atrophy
Preputial Gland Inflammation Chronic
Prostate Inflammation Chronic
Prostate: Epithelium Hyperplasia
Spleen Hematopoietic Cell Proliferation
Pigmentation
Stomach, Glandular Erosion
Testes: Germinal Epithelium Atrophy
Testes: Interstitial Cell Hyperplasia
Thyroid Gland Ultimobranchial Cyst
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Degeneration Fatty
Hypertrophy Focal
Adrenal Medulla Hyperplasia
Bone Marrow Infiltration Cellular Histiocyte
Bone: Femur Osteopetrosis
Kidney Mineralization
Kidney: Renal Tubule Hyaline Droplet
Hyperplasia Oncocytic
Pigmentation
Kidney: Transitional Epithelium Hyperplasia
Liver Eosinophilic Focus
Hepatodiaphragmatic Nodule
Infiltration Cellular Mixed Cell
Liver: Bile Duct Hyperplasia
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst P-NITROTOLUENE DATE: 01/04/01
EXPERIMENT: 05205 TEST: 07 TIME: 08:00:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62537D
PATHOLOGIST: HEATH, JAMES E. CAS: 99-99-0
Lung Infiltration Cellular Histiocyte
Lymph Node: Pancreatic Pigmentation
Mammary Gland Hyperplasia
Nose Inflammation Chronic
Pituitary Gland: Pars Distalis Cyst
Spleen Hematopoietic Cell Proliferation
Pigmentation
Thyroid Gland: C-Cell Hyperplasia
Uterus Prolapse
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 4/50 (8%) 11/50 (22%) 13/50 (26%) |10/50 (20%) 6/50 (12%) 9/50 (18%) 5/50 (10%) |
|POLY-3 RATE (b) | 8/45.64 4/45.60 11/47.96 13/46.71 |10/46.11 6/46.63 9/47.21 5/48.20 |
|POLY-3 PERCENT (g) | 17.5% 8.8% 22.9% 27.8% |21.7% 12.9% 19.1% 10.4% |
|TERMINAL (d) | 6/31 (19%) 3/38 (8%) 7/38 (18%) 12/40 (30%) |9/39 (23%) 4/37 (11%) 8/39 (21%) 4/41 (10%) |
|FIRST INCIDENCE | 592 516 659 682 |676 639 675 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.101 P=0.120N P=0.467 P=0.343 |P=0.129N P=0.238N P=0.497N P=0.113N |
|POLY 3 | P=0.044 * P=0.177N P=0.348 P=0.175 |P=0.134N P=0.198N P=0.477N P=0.110N |
|POLY 1.5 | P=0.042 * P=0.177N P=0.331 P=0.170 |P=0.143N P=0.201N P=0.485N P=0.117N |
|POLY 6 | P=0.048 * P=0.175N P=0.370 P=0.183 |P=0.127N P=0.197N P=0.475N P=0.104N |
|LOGISTIC REGRESSION| P=0.046 * P=0.178N P=0.320 P=0.189 |P=0.130N P=0.201N P=0.478N P=0.106N |
|COCH-ARM / FISHERS | P=0.041 * P=0.178N P=0.306 P=0.163 |P=0.158N P=0.207N P=0.500N P=0.131N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Fatty |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 9/50 (18%) 9/50 (18%) 8/50 (16%) |11/50 (22%) 19/50 (38%) 9/50 (18%) 10/50 (20%) |
|POLY-3 RATE (b) | 13/46.51 9/45.21 9/48.16 8/46.76 |11/45.99 19/46.33 9/47.85 10/48.20 |
|POLY-3 PERCENT (g) | 28.0% 19.9% 18.7% 17.1% |23.9% 41.0% 18.8% 20.8% |
|TERMINAL (d) | 4/31 (13%) 8/38 (21%) 6/38 (16%) 6/40 (15%) |10/39 (26%) 16/37 (43%) 8/39 (21%) 8/41 (20%) |
|FIRST INCIDENCE | 591 659 621 693 |708 724 387 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091N P=0.169N P=0.158N P=0.098N |P=0.148N P=0.048 * P=0.402N P=0.448N |
|POLY 3 | P=0.145N P=0.255N P=0.205N P=0.157N |P=0.149N P=0.060 P=0.363N P=0.452N |
|POLY 1.5 | P=0.151N P=0.245N P=0.216N P=0.158N |P=0.164N P=0.061 P=0.375N P=0.469N |
|POLY 6 | P=0.140N P=0.270N P=0.196N P=0.156N |P=0.136N P=0.057 P=0.359N P=0.435N |
|LOGISTIC REGRESSION| P=0.149N P=0.233N P=0.264N P=0.158N |P=0.152N P=0.054 P=0.392N P=0.428N |
|COCH-ARM / FISHERS | P=0.160N P=0.235N P=0.235N P=0.163N |P=0.194N P=0.063 P=0.402N P=0.500N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |5/50 (10%) 8/50 (16%) 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/44.85 3/44.95 1/47.38 0/46.53 |5/45.91 8/46.31 3/47.00 3/48.05 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 2.1% 0.0% |10.9% 17.3% 6.4% 6.2% |
|TERMINAL (d) | 0/31 (0%) 3/38 (8%) 1/38 (3%) 0/40 (0%) |5/39 (13%) 7/37 (19%) 3/39 (8%) 2/41 (5%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |729 (T) 724 729 (T) 728 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309N P=0.159 P=0.541 (e) |P=0.130N P=0.246 P=0.355N P=0.329N |
|POLY 3 | P=0.350N P=0.119 P=0.511 (e) |P=0.135N P=0.281 P=0.344N P=0.332N |
|POLY 1.5 | P=0.356N P=0.119 P=0.507 (e) |P=0.141N P=0.280 P=0.348N P=0.341N |
|POLY 6 | P=0.340N P=0.120 P=0.516 (e) |P=0.129N P=0.280 P=0.342N P=0.324N |
|LOGISTIC REGRESSION| (e) P=0.159 P=0.541 (e) |P=0.120N P=0.272 P=0.355N P=0.306N |
|COCH-ARM / FISHERS | P=0.366N P=0.121 P=0.500 (e) |P=0.154N P=0.277 P=0.357N P=0.357N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.85 0/44.95 0/47.38 0/46.53 |0/45.91 0/46.28 2/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |0.0% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 1/31 (3%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |0/39 (0%) 0/37 (0%) 2/39 (5%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.279N P=0.459N P=0.459N P=0.449N |P=0.608 (e) P=0.238 (e) |
|POLY 3 | P=0.307N P=0.500N P=0.489N P=0.493N |P=0.619 (e) P=0.243 (e) |
|POLY 1.5 | P=0.306N P=0.500N P=0.493N P=0.496N |P=0.610 (e) P=0.241 (e) |
|POLY 6 | P=0.309N P=0.498N P=0.484N P=0.488N |P=0.627 (e) P=0.243 (e) |
|LOGISTIC REGRESSION| P=0.279N (e) (e) (e) |(e) (e) P=0.238 (e) |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |4/50 (8%) 14/50 (28%) 7/50 (14%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/45.02 2/44.95 3/47.96 2/46.53 |4/45.91 14/46.92 7/47.00 2/48.05 |
|POLY-3 PERCENT (g) | 4.4% 4.5% 6.3% 4.3% |8.7% 29.8% 14.9% 4.2% |
|TERMINAL (d) | 1/31 (3%) 2/38 (5%) 1/38 (3%) 2/40 (5%) |4/39 (10%) 11/37 (30%) 7/39 (18%) 2/41 (5%) |
|FIRST INCIDENCE | 687 729 (T) 621 729 (T) |729 (T) 577 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.541N P=0.638N P=0.557 P=0.617N |P=0.060N P=0.008 ** P=0.259 P=0.314N |
|POLY 3 | P=0.589 P=0.693 P=0.529 P=0.682N |P=0.053N P=0.009 ** P=0.275 P=0.317N |
|POLY 1.5 | P=0.580 P=0.694 P=0.517 P=0.687N |P=0.059N P=0.008 ** P=0.271 P=0.324N |
|POLY 6 | P=0.584N P=0.694N P=0.544 P=0.675N |P=0.048N* P=0.009 ** P=0.275 P=0.310N |
|LOGISTIC REGRESSION| P=0.573 P=0.692N P=0.456 P=0.676N |P=0.059N P=0.010 * P=0.259 P=0.314N |
|COCH-ARM / FISHERS | P=0.569 P=0.691N P=0.500 P=0.691N |P=0.076N P=0.009 ** P=0.262 P=0.339N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/49 (6%) 3/50 (6%) 3/50 (6%) |3/49 (6%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.32 3/43.95 3/47.38 3/46.62 |3/44.91 2/46.61 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 4.4% 6.8% 6.3% 6.4% |6.7% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 1/31 (3%) 3/37 (8%) 3/38 (8%) 2/40 (5%) |3/38 (8%) 1/37 (3%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 592 729 (T) 729 (T) 707 |729 (T) 639 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.533 P=0.562 P=0.577 P=0.580 |P=0.035N* P=0.508N P=0.116N P=0.108N |
|POLY 3 | P=0.461 P=0.486 P=0.520 P=0.513 |P=0.036N* P=0.483N P=0.111N P=0.107N |
|POLY 1.5 | P=0.453 P=0.488 P=0.512 P=0.507 |P=0.036N* P=0.486N P=0.112N P=0.110N |
|POLY 6 | P=0.474 P=0.485 P=0.530 P=0.522 |P=0.035N* P=0.481N P=0.110N P=0.104N |
|LOGISTIC REGRESSION| P=0.462 P=0.491 P=0.489 P=0.493 |P=0.037N* P=0.488N (e) (e) |
|COCH-ARM / FISHERS | P=0.441 P=0.490 P=0.500 P=0.500 |P=0.038N* P=0.490N P=0.117N P=0.117N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 7/50 (14%) 3/50 (6%) 3/50 (6%) |4/50 (8%) 3/50 (6%) 6/50 (12%) 7/50 (14%) |
|POLY-3 RATE (b) | 4/46.37 7/46.50 3/47.60 3/47.89 |4/47.10 3/46.31 6/48.95 7/48.99 |
|POLY-3 PERCENT (g) | 8.6% 15.1% 6.3% 6.3% |8.5% 6.5% 12.3% 14.3% |
|TERMINAL (d) | 0/31 (0%) 3/38 (8%) 1/38 (3%) 0/40 (0%) |2/39 (5%) 2/37 (5%) 0/39 (0%) 3/41 (7%) |
|FIRST INCIDENCE | 504 592 679 496 |497 724 387 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223N P=0.297 P=0.441N P=0.482N |P=0.172 P=0.513N P=0.391 P=0.302 |
|POLY 3 | P=0.242N P=0.263 P=0.486N P=0.482N |P=0.154 P=0.509N P=0.394 P=0.285 |
|POLY 1.5 | P=0.249N P=0.262 P=0.491N P=0.490N |P=0.146 P=0.505N P=0.386 P=0.276 |
|POLY 6 | P=0.232N P=0.267 P=0.479N P=0.472N |P=0.164 P=0.516N P=0.402 P=0.295 |
|LOGISTIC REGRESSION| P=0.363N P=0.248 P=0.658N P=0.623N |P=0.055 P=0.516N P=0.217 P=0.143 |
|COCH-ARM / FISHERS | P=0.260N P=0.262 P=0.500N P=0.500N |P=0.132 P=0.500N P=0.370 P=0.262 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone Marrow |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 5/50 (10%) |
|POLY-3 RATE (b) | 0/44.85 0/44.95 0/47.38 0/46.53 |0/45.91 1/46.28 1/47.00 5/48.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 2.1% 10.4% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |0/39 (0%) 1/37 (3%) 1/39 (3%) 5/41 (12%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.007 ** P=0.489 P=0.500 P=0.038 * |
|POLY 3 | (e) (e) (e) (e) |P=0.006 ** P=0.502 P=0.505 P=0.035 * |
|POLY 1.5 | (e) (e) (e) (e) |P=0.006 ** P=0.501 P=0.503 P=0.033 * |
|POLY 6 | (e) (e) (e) (e) |P=0.006 ** P=0.501 P=0.505 P=0.036 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.489 P=0.500 P=0.038 * |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.006 ** P=0.500 P=0.500 P=0.028 * |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone: Cranium |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |12/49 (24%) 12/50 (24%) 11/50 (22%) 11/50 (22%) |
|POLY-3 RATE (b) | 1/44.95 0/44.95 0/47.38 0/46.53 |12/44.91 12/46.79 11/47.48 11/48.77 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |26.7% 25.7% 23.2% 22.6% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |12/38 (32%) 11/37 (30%) 9/39 (23%) 9/41 (22%) |
|FIRST INCIDENCE | 704 --- --- --- |729 (T) 577 655 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.292N P=0.489N P=0.475N P=0.480N |P=0.337N P=0.568 P=0.470N P=0.418N |
|POLY 3 | P=0.307N P=0.500N P=0.489N P=0.493N |P=0.349N P=0.548N P=0.439N P=0.410N |
|POLY 1.5 | P=0.306N P=0.500N P=0.494N P=0.496N |P=0.374N P=0.556N P=0.453N P=0.436N |
|POLY 6 | P=0.308N P=0.499N P=0.485N P=0.489N |P=0.322N P=0.542N P=0.426N P=0.383N |
|LOGISTIC REGRESSION| P=0.305N P=0.500N P=0.502N P=0.499N |P=0.362N P=0.562N P=0.449N P=0.423N |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.414N P=0.570N P=0.478N P=0.478N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Bone: Femur |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |19/49 (39%) 14/50 (28%) 10/50 (20%) 6/50 (12%) |
|POLY-3 RATE (b) | 2/44.85 1/44.95 0/47.38 0/46.53 |19/47.24 14/46.66 10/47.03 6/48.44 |
|POLY-3 PERCENT (g) | 4.5% 2.2% 0.0% 0.0% |40.2% 30.0% 21.3% 12.4% |
|TERMINAL (d) | 2/31 (7%) 1/38 (3%) 0/38 (0%) 0/40 (0%) |13/38 (34%) 12/37 (32%) 9/39 (23%) 5/41 (12%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |380 659 721 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.078N P=0.429N P=0.195N P=0.184N |P<0.001N** P=0.231N P=0.041N* P=0.003N** |
|POLY 3 | P=0.098N P=0.499N P=0.225N P=0.229N |P<0.001N** P=0.206N P=0.036N* P<0.001N** |
|POLY 1.5 | P=0.099N P=0.500N P=0.230N P=0.233N |P<0.001N** P=0.194N P=0.034N* P<0.001N** |
|POLY 6 | P=0.097N P=0.497N P=0.219N P=0.224N |P<0.001N** P=0.223N P=0.041N* P<0.001N** |
|LOGISTIC REGRESSION| P=0.078N P=0.429N (e) (e) |P<0.001N** P=0.179N P=0.035N* P=0.004N** |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |P<0.001N** P=0.178N P=0.033N* P=0.002N** |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Brain |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 7/50 (14%) 4/50 (8%) |4/50 (8%) 6/50 (12%) 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 5/45.44 3/46.18 7/48.01 4/46.53 |4/46.58 6/46.72 3/47.20 3/48.69 |
|POLY-3 PERCENT (g) | 11.0% 6.5% 14.6% 8.6% |8.6% 12.8% 6.4% 6.2% |
|TERMINAL (d) | 2/31 (7%) 0/38 (0%) 5/38 (13%) 4/40 (10%) |3/39 (8%) 4/37 (11%) 2/39 (5%) 1/41 (2%) |
|FIRST INCIDENCE | 639 515 627 729 (T) |504 639 676 532 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.449N P=0.339N P=0.495 P=0.382N |P=0.269N P=0.354 P=0.497N P=0.468N |
|POLY 3 | P=0.533N P=0.347N P=0.419 P=0.485N |P=0.276N P=0.372 P=0.493N P=0.476N |
|POLY 1.5 | P=0.539N P=0.351N P=0.403 P=0.491N |P=0.284N P=0.371 P=0.495N P=0.484N |
|POLY 6 | P=0.526N P=0.341N P=0.437 P=0.477N |P=0.268N P=0.372 P=0.493N P=0.468N |
|LOGISTIC REGRESSION| P=0.550 P=0.362N P=0.361 P=0.483N |P=0.344N P=0.364 P=0.521N P=0.629N |
|COCH-ARM / FISHERS | P=0.549N P=0.357N P=0.380 P=0.500N |P=0.299N P=0.370 P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Brain |
| Hydrocephalus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 4/50 (8%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/44.85 2/45.83 2/47.75 2/46.53 |1/45.91 4/46.72 1/47.20 1/48.20 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 4.2% 4.3% |2.2% 8.6% 2.1% 2.1% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 2/40 (5%) |1/39 (3%) 2/37 (5%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 515 659 729 (T) |729 (T) 639 676 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.281 P=0.239 P=0.269 P=0.296 |P=0.352N P=0.177 P=0.758N P=0.750N |
|POLY 3 | P=0.258 P=0.242 P=0.251 P=0.245 |P=0.352N P=0.184 P=0.754N P=0.750N |
|POLY 1.5 | P=0.251 P=0.240 P=0.246 P=0.242 |P=0.359N P=0.182 P=0.756N P=0.753N |
|POLY 6 | P=0.268 P=0.246 P=0.259 P=0.251 |P=0.345N P=0.186 P=0.753N P=0.746N |
|LOGISTIC REGRESSION| P=0.200 P=0.195 P=0.201 P=0.296 |P=0.390N P=0.180 P=0.761 P=0.764 |
|COCH-ARM / FISHERS | P=0.242 P=0.247 P=0.247 P=0.247 |P=0.373N P=0.181 P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | |2/45.91 0/46.28 0/47.00 1/47.44 |
|POLY-3 PERCENT (g) | |4.4% 0.0% 0.0% 2.1% |
|TERMINAL (d) | |2/39 (5%) 0/37 (0%) 0/39 (0%) 1/41 (2%) |
|FIRST INCIDENCE | |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.444N P=0.250N P=0.238N P=0.483N |
|POLY 3 | |P=0.467N P=0.235N P=0.232N P=0.489N |
|POLY 1.5 | |P=0.467N P=0.236N P=0.234N P=0.495N |
|POLY 6 | |P=0.466N P=0.236N P=0.231N P=0.482N |
|LOGISTIC REGRESSION| |P=0.444N (e) (e) P=0.483N |
|COCH-ARM / FISHERS | |P=0.466N P=0.247N P=0.247N P=0.508N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 5/50 (10%) 4/50 (8%) 6/49 (12%) |
|POLY-3 RATE (b) | |3/45.91 5/46.28 4/47.00 6/48.05 |
|POLY-3 PERCENT (g) | |6.5% 10.8% 8.5% 12.5% |
|TERMINAL (d) | |3/39 (8%) 5/37 (14%) 4/39 (10%) 5/41 (12%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 532 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.264 P=0.326 P=0.500 P=0.269 |
|POLY 3 | |P=0.251 P=0.361 P=0.513 P=0.266 |
|POLY 1.5 | |P=0.238 P=0.360 P=0.509 P=0.253 |
|POLY 6 | |P=0.266 P=0.360 P=0.514 P=0.278 |
|LOGISTIC REGRESSION| |P=0.239 P=0.326 P=0.500 P=0.218 |
|COCH-ARM / FISHERS | |P=0.215 P=0.357 P=0.500 P=0.233 |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 3/50 (6%) 2/50 (4%) 2/49 (4%) |
|POLY-3 RATE (b) | |2/45.91 3/46.40 2/47.00 2/47.44 |
|POLY-3 PERCENT (g) | |4.4% 6.5% 4.3% 4.2% |
|TERMINAL (d) | |2/39 (5%) 2/37 (5%) 2/39 (5%) 2/41 (5%) |
|FIRST INCIDENCE | |729 (T) 701 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.492N P=0.483 P=0.695 P=0.677N |
|POLY 3 | |P=0.509N P=0.505 P=0.685N P=0.682N |
|POLY 1.5 | |P=0.518N P=0.503 P=0.688N P=0.689N |
|POLY 6 | |P=0.501N P=0.505 P=0.685N P=0.675N |
|LOGISTIC REGRESSION| |P=0.490N P=0.502 P=0.695 P=0.677N |
|COCH-ARM / FISHERS | |P=0.532N P=0.500 P=0.691N P=0.684 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Epididymis |
| Atypia Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 37/50 (74%) 36/49 (73%) 35/50 (70%) 42/50 (84%) | |
|POLY-3 RATE (b) | 37/47.09 36/46.93 35/48.13 42/48.22 | |
|POLY-3 PERCENT (g) | 78.6% 76.7% 72.7% 87.1% | |
|TERMINAL (d) | 26/31 (84%) 30/38 (79%) 29/38 (76%) 36/40 (90%) | |
|FIRST INCIDENCE | 591 490 659 496 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.398N P=0.134N P=0.076N P=0.304N | |
|POLY 3 | P=0.151 P=0.512N P=0.329N P=0.190 | |
|POLY 1.5 | P=0.145 P=0.529N P=0.357N P=0.179 | |
|POLY 6 | P=0.161 P=0.498N P=0.308N P=0.207 | |
|LOGISTIC REGRESSION| P=0.201 P=0.540N P=0.205N P=0.223 | |
|COCH-ARM / FISHERS | P=0.135 P=0.567N P=0.412N P=0.163 | |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/3 (33%) 2/2 (100%) 1/1 (100%) 1/1 (100%) |1/2 (50%) 0/0 (0%) 3/3 (100%) 1/1 (100%) |
|POLY-3 RATE (b) | 1/2.99 2/2.00 1/1.00 1/1.00 |1/2.00 0/0.00 3/3.00 1/1.00 |
|POLY-3 PERCENT (g) | 33.5% 100.0% 100.0% 100.0% |50.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 1/2 (50%) 2/2 (100%) 1/1 (100%) 0/0 (0%) |1/2 (50%) 0/0 (0%) 3/3 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 591 |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.121 P=0.500 P=0.638 P=0.543 |P=0.314 P=1.000 P=0.419 P=0.638 |
|POLY 3 | P=0.225 P=0.282 P=0.501 P=0.501 |(e) (e) P=0.412 P=0.614 |
|POLY 1.5 | P=0.224 P=0.281 P=0.501 P=0.501 |(e) (e) P=0.412 P=0.614 |
|POLY 6 | P=0.226 P=0.283 P=0.502 P=0.502 |(e) (e) P=0.412 P=0.614 |
|LOGISTIC REGRESSION| P=0.326 P=0.500 P=0.638 (e) |P=0.314 (e) P=0.419 P=0.638 |
|COCH-ARM / FISHERS | P=0.214 P=0.300 P=0.500 P=0.500 |P=0.298 P=1.000 P=0.400 P=0.667 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/3 (0%) 2/2 (100%) 1/1 (100%) 0/1 (0%) |1/2 (50%) 0/0 (0%) 3/3 (100%) 1/1 (100%) |
|POLY-3 RATE (b) | 0/2.99 2/2.00 1/1.00 0/0.53 |1/2.00 0/0.00 3/3.00 1/1.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 0.0% |50.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/2 (0%) 2/2 (100%) 1/1 (100%) 0/0 (0%) |1/2 (50%) 0/0 (0%) 3/3 (100%) 1/1 (100%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.256 P=0.193 P=0.362 (e) |P=0.314 P=1.000N P=0.419 P=0.638 |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** (e) |(e) (e) P=0.412 P=0.614 |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** (e) |(e) (e) P=0.412 P=0.614 |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** (e) |(e) (e) P=0.412 P=0.614 |
|LOGISTIC REGRESSION| (e) P=0.193 P=0.362 (e) |P=0.314 (e) P=0.419 P=0.638 |
|COCH-ARM / FISHERS | P=0.595 P=0.100 P=0.250 (e) |P=0.298 P=1.000 P=0.400 P=0.667 |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 31/50 (62%) 35/50 (70%) 29/50 (58%) |13/50 (26%) 10/50 (20%) 11/50 (22%) 8/50 (16%) |
|POLY-3 RATE (b) | 29/47.19 31/45.93 35/49.38 29/47.61 |13/46.58 10/46.90 11/47.03 8/48.05 |
|POLY-3 PERCENT (g) | 61.5% 67.5% 70.9% 60.9% |27.9% 21.3% 23.4% 16.7% |
|TERMINAL (d) | 22/31 (71%) 27/38 (71%) 26/38 (68%) 25/40 (63%) |11/39 (28%) 9/37 (24%) 10/39 (26%) 8/41 (20%) |
|FIRST INCIDENCE | 378 592 523 595 |591 528 721 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.149N P=0.340N P=0.551 P=0.153N |P=0.119N P=0.363N P=0.403N P=0.134N |
|POLY 3 | P=0.476N P=0.343 P=0.218 P=0.563N |P=0.139N P=0.309N P=0.396N P=0.142N |
|POLY 1.5 | P=0.509N P=0.370 P=0.184 P=0.576N |P=0.146N P=0.311N P=0.398N P=0.148N |
|POLY 6 | P=0.419N P=0.329 P=0.275 P=0.528N |P=0.133N P=0.313N P=0.403N P=0.138N |
|LOGISTIC REGRESSION| P=0.448N P=0.413 P=0.162 P=0.532N |P=0.128N P=0.312N P=0.379N P=0.134N |
|COCH-ARM / FISHERS | P=0.539 P=0.419 P=0.149 P=0.580N |P=0.159N P=0.318N P=0.408N P=0.163N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Heart |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.85 0/44.95 0/47.38 0/46.53 |0/45.91 0/46.28 3/47.20 0/48.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 6.4% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |0/39 (0%) 0/37 (0%) 2/39 (5%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 676 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.556 (e) P=0.124 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.567 (e) P=0.124 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.558 (e) P=0.122 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.577 (e) P=0.125 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.542 (e) P=0.122 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.539 (e) P=0.121 (e) |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/49 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.85 2/44.95 3/46.77 1/46.53 |0/45.91 0/46.28 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 4.5% 4.5% 6.4% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/31 (7%) 2/38 (5%) 2/38 (5%) 1/40 (3%) |0/39 (0%) 0/37 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 679 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326N P=0.620N P=0.578 P=0.411N |(e) (e) (e) (e) |
|POLY 3 | P=0.386N P=0.693N P=0.519 P=0.487N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.394N P=0.693N P=0.508 P=0.493N |(e) (e) (e) (e) |
|POLY 6 | P=0.375N P=0.691N P=0.534 P=0.479N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.370N P=0.620N P=0.528 P=0.411N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.691N P=0.490 P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.85 4/44.95 3/47.38 1/46.53 |1/46.58 0/46.28 0/47.00 2/48.08 |
|POLY-3 PERCENT (g) | 0.0% 8.9% 6.3% 2.2% |2.2% 0.0% 0.0% 4.2% |
|TERMINAL (d) | 0/31 (0%) 4/38 (11%) 3/38 (8%) 1/40 (3%) |0/39 (0%) 0/37 (0%) 0/39 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |504 --- --- 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.509N P=0.091 P=0.159 P=0.551 |P=0.265 P=0.496N P=0.496N P=0.524 |
|POLY 3 | P=0.573N P=0.060 P=0.129 P=0.507 |P=0.251 P=0.501N P=0.498N P=0.511 |
|POLY 1.5 | P=0.583N P=0.061 P=0.125 P=0.504 |P=0.249 P=0.501N P=0.499N P=0.507 |
|POLY 6 | P=0.558N P=0.061 P=0.134 P=0.512 |P=0.253 P=0.503N P=0.499N P=0.514 |
|LOGISTIC REGRESSION| (e) P=0.091 P=0.159 P=0.551 |P=0.177 P=0.540N P=0.568N P=0.380 |
|COCH-ARM / FISHERS | P=0.596 P=0.059 P=0.121 P=0.500 |P=0.246 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/44.85 1/45.18 0/47.38 1/46.53 |2/45.99 0/46.28 0/47.00 2/48.05 |
|POLY-3 PERCENT (g) | 2.2% 2.2% 0.0% 2.2% |4.4% 0.0% 0.0% 4.2% |
|TERMINAL (d) | 1/31 (3%) 0/38 (0%) 0/38 (0%) 1/40 (3%) |1/39 (3%) 0/37 (0%) 0/39 (0%) 2/41 (5%) |
|FIRST INCIDENCE | 729 (T) 668 --- 729 (T) |708 --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.571N P=0.741N P=0.459N P=0.704N |P=0.521 P=0.248N P=0.242N P=0.673N |
|POLY 3 | P=0.609N P=0.759N P=0.489N P=0.752N |P=0.507 P=0.236N P=0.232N P=0.678N |
|POLY 1.5 | P=0.612N P=0.760N P=0.493N P=0.756N |P=0.504 P=0.236N P=0.234N P=0.683N |
|POLY 6 | P=0.607N P=0.757N P=0.484N P=0.747N |P=0.510 P=0.236N P=0.232N P=0.673N |
|LOGISTIC REGRESSION| P=0.612N P=0.762N (e) P=0.704N |P=0.520 P=0.236N P=0.232N P=0.673N |
|COCH-ARM / FISHERS | P=0.616N P=0.753N P=0.500N P=0.753N |P=0.500 P=0.247N P=0.247N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |15/50 (30%) 21/50 (42%) 32/50 (64%) 40/50 (80%) |
|POLY-3 RATE (b) | 0/44.85 0/44.95 0/47.38 0/46.53 |15/46.25 21/46.87 32/47.88 40/48.89 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |32.4% 44.8% 66.8% 81.8% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |13/39 (33%) 18/37 (49%) 29/39 (74%) 36/41 (88%) |
|FIRST INCIDENCE | --- --- --- --- |655 629 633 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P<0.001 ** P=0.116 P<0.001 ** P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) |P<0.001 ** P=0.154 P<0.001 ** P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) |P<0.001 ** P=0.152 P<0.001 ** P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) |P<0.001 ** P=0.153 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P<0.001 ** P=0.149 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P<0.001 ** P=0.149 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 37/50 (74%) 31/50 (62%) 18/50 (36%) |11/50 (22%) 12/50 (24%) 7/50 (14%) 11/50 (22%) |
|POLY-3 RATE (b) | 28/46.81 37/48.28 31/47.93 18/46.71 |11/46.62 12/47.30 7/47.33 11/48.77 |
|POLY-3 PERCENT (g) | 59.8% 76.6% 64.7% 38.5% |23.6% 25.4% 14.8% 22.6% |
|TERMINAL (d) | 19/31 (61%) 29/38 (76%) 27/38 (71%) 17/40 (43%) |9/39 (23%) 8/37 (22%) 6/39 (15%) 9/41 (22%) |
|FIRST INCIDENCE | 591 490 668 682 |574 528 639 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.294 P=0.399N P=0.004N** |P=0.396N P=0.462 P=0.216N P=0.540N |
|POLY 3 | P=0.002N** P=0.055 P=0.389 P=0.028N* |P=0.424N P=0.516 P=0.206N P=0.548N |
|POLY 1.5 | P=0.002N** P=0.051 P=0.375 P=0.030N* |P=0.438N P=0.511 P=0.209N P=0.565N |
|POLY 6 | P=0.002N** P=0.061 P=0.398 P=0.028N* |P=0.410N P=0.518 P=0.206N P=0.533N |
|LOGISTIC REGRESSION| P=0.002N** P=0.045 * P=0.497 P=0.020N* |P=0.463N P=0.502 P=0.208N P=0.595N |
|COCH-ARM / FISHERS | P=0.004N** P=0.046 * P=0.342 P=0.035N* |P=0.465N P=0.500 P=0.218N P=0.595N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 23/50 (46%) 27/50 (54%) 18/50 (36%) |8/50 (16%) 41/50 (82%) 49/50 (98%) 46/50 (92%) |
|POLY-3 RATE (b) | 2/45.05 23/46.41 27/47.41 18/46.91 |8/45.91 41/47.91 49/49.97 46/49.04 |
|POLY-3 PERCENT (g) | 4.4% 49.6% 57.0% 38.4% |17.4% 85.6% 98.1% 93.8% |
|TERMINAL (d) | 1/31 (3%) 20/38 (53%) 26/38 (68%) 16/40 (40%) |8/39 (21%) 32/37 (87%) 39/39 (100%) 41/41 (100%) |
|FIRST INCIDENCE | 679 515 724 676 |729 (T) 577 387 532 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.032 * P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.004 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.004 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.006 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.009 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.005 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia Oncocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 2/50 (4%) 4/50 (8%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/44.85 0/44.95 0/47.38 3/46.53 |0/45.91 2/46.28 4/47.00 6/48.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.5% |0.0% 4.3% 8.5% 12.5% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 3/40 (8%) |0/39 (0%) 2/37 (5%) 4/39 (10%) 6/41 (15%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.016 * (e) (e) P=0.169 |P=0.011 * P=0.227 P=0.063 P=0.020 * |
|POLY 3 | P=0.012 * (e) (e) P=0.125 |P=0.009 ** P=0.239 P=0.063 P=0.018 * |
|POLY 1.5 | P=0.011 * (e) (e) P=0.123 |P=0.008 ** P=0.239 P=0.063 P=0.017 * |
|POLY 6 | P=0.012 * (e) (e) P=0.130 |P=0.010 * P=0.239 P=0.063 P=0.019 * |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.169 |(e) P=0.227 P=0.063 P=0.020 * |
|COCH-ARM / FISHERS | P=0.012 * (e) (e) P=0.121 |P=0.008 ** P=0.247 P=0.059 P=0.013 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 28/50 (56%) 47/50 (94%) 46/50 (92%) |9/50 (18%) 43/50 (86%) 49/50 (98%) 50/50 (100%) |
|POLY-3 RATE (b) | 10/47.05 28/47.57 47/48.99 46/48.72 |9/48.05 43/49.64 49/49.15 50/50.00 |
|POLY-3 PERCENT (g) | 21.3% 58.9% 95.9% 94.4% |18.7% 86.6% 99.7% 100.0% |
|TERMINAL (d) | 2/31 (7%) 21/38 (55%) 37/38 (97%) 39/40 (98%) |5/39 (13%) 31/37 (84%) 39/39 (100%) 41/41 (100%) |
|FIRST INCIDENCE | 504 515 627 496 |497 387 633 532 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.85 1/44.95 0/47.38 0/46.53 |3/45.99 0/46.28 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |6.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 1/38 (3%) 0/38 (0%) 0/40 (0%) |2/39 (5%) 0/37 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |708 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.537N P=0.541 (e) (e) |P=0.046N* P=0.131N P=0.125N P=0.113N |
|POLY 3 | P=0.562N P=0.500 (e) (e) |P=0.045N* P=0.118N P=0.115N P=0.111N |
|POLY 1.5 | P=0.564N P=0.500 (e) (e) |P=0.045N* P=0.118N P=0.116N P=0.114N |
|POLY 6 | P=0.559N P=0.502 (e) (e) |P=0.045N* P=0.118N P=0.115N P=0.109N |
|LOGISTIC REGRESSION| (e) P=0.541 (e) (e) |P=0.044N* P=0.119N P=0.116N P=0.111N |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.047N* P=0.121N P=0.121N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.85 1/44.95 0/47.38 1/46.53 |1/45.91 0/46.28 1/47.00 2/48.25 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 2.2% |2.2% 0.0% 2.1% 4.2% |
|TERMINAL (d) | 0/31 (0%) 1/38 (3%) 0/38 (0%) 1/40 (3%) |1/39 (3%) 0/37 (0%) 1/39 (3%) 1/41 (2%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |729 (T) --- 729 (T) 676 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.448 P=0.541 (e) P=0.551 |P=0.267 P=0.511N P=0.762 P=0.517 |
|POLY 3 | P=0.416 P=0.500 (e) P=0.507 |P=0.260 P=0.498N P=0.755N P=0.517 |
|POLY 1.5 | P=0.412 P=0.500 (e) P=0.504 |P=0.256 P=0.499N P=0.757N P=0.511 |
|POLY 6 | P=0.423 P=0.502 (e) P=0.512 |P=0.265 P=0.499N P=0.755N P=0.524 |
|LOGISTIC REGRESSION| (e) P=0.541 (e) P=0.551 |P=0.255 (e) P=0.762 P=0.502 |
|COCH-ARM / FISHERS | P=0.405 P=0.500 (e) P=0.500 |P=0.247 P=0.500N P=0.753N P=0.500 |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 39/50 (78%) 42/50 (84%) 45/50 (90%) |44/50 (88%) 41/50 (82%) 49/50 (98%) 46/50 (92%) |
|POLY-3 RATE (b) | 31/46.13 39/47.77 42/48.25 45/48.21 |44/48.41 41/47.20 49/49.84 46/49.46 |
|POLY-3 PERCENT (g) | 67.2% 81.7% 87.0% 93.4% |90.9% 86.9% 98.3% 93.0% |
|TERMINAL (d) | 26/31 (84%) 33/38 (87%) 37/38 (97%) 40/40 (100%)|37/39 (95%) 37/37 (100%) 39/39 (100%) 39/41 (95%) |
|FIRST INCIDENCE | 504 515 627 497 |497 629 387 532 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.092 P=0.410 P=0.221 P=0.131 |P=0.493 P=0.493N P=0.191 P=0.563N |
|POLY 3 | P<0.001 ** P=0.074 P=0.013 * P<0.001 ** |P=0.239 P=0.374N P=0.100 P=0.494 |
|POLY 1.5 | P<0.001 ** P=0.067 P=0.012 * P<0.001 ** |P=0.193 P=0.327N P=0.080 P=0.453 |
|POLY 6 | P<0.001 ** P=0.090 P=0.015 * P<0.001 ** |P=0.287 P=0.457N P=0.121 P=0.522 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.051 P=0.039 * P<0.001 ** |P=0.272 P=0.206N P=0.074 P=0.552 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.063 P=0.012 * P<0.001 ** |P=0.132 P=0.288N P=0.056 P=0.370 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 27/50 (54%) 30/50 (60%) 32/50 (64%) |12/50 (24%) 11/50 (22%) 18/50 (36%) 10/50 (20%) |
|POLY-3 RATE (b) | 20/44.85 27/44.95 30/47.41 32/47.17 |12/45.91 11/46.28 18/47.48 10/48.44 |
|POLY-3 PERCENT (g) | 44.6% 60.1% 63.3% 67.8% |26.1% 23.8% 37.9% 20.6% |
|TERMINAL (d) | 20/31 (65%) 27/38 (71%) 29/38 (76%) 30/40 (75%) |12/39 (31%) 11/37 (30%) 16/39 (41%) 9/41 (22%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 724 595 |729 (T) 729 (T) 655 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.096 P=0.375 P=0.158 P=0.131 |P=0.361N P=0.560N P=0.134 P=0.351N |
|POLY 3 | P=0.019 * P=0.097 P=0.049 * P=0.016 * |P=0.369N P=0.491N P=0.158 P=0.350N |
|POLY 1.5 | P=0.015 * P=0.104 P=0.043 * P=0.014 * |P=0.397N P=0.493N P=0.150 P=0.370N |
|POLY 6 | P=0.027 * P=0.093 P=0.059 P=0.022 * |P=0.338N P=0.493N P=0.165 P=0.330N |
|LOGISTIC REGRESSION| P=0.033 * P=0.375 (e) P=0.029 * |P=0.362N P=0.560N P=0.144 P=0.341N |
|COCH-ARM / FISHERS | P=0.013 * P=0.115 P=0.036 * P=0.014 * |P=0.445N P=0.500N P=0.138 P=0.405N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 5/50 (10%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.85 3/45.21 5/47.38 1/46.53 |0/45.91 0/46.28 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 0.0% 6.6% 10.6% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 2/38 (5%) 5/38 (13%) 1/40 (3%) |0/39 (0%) 0/37 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 659 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.566 P=0.148 P=0.053 P=0.551 |(e) (e) (e) (e) |
|POLY 3 | P=0.506 P=0.120 P=0.035 * P=0.507 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.494 P=0.120 P=0.034 * P=0.504 |(e) (e) (e) (e) |
|POLY 6 | P=0.525 P=0.122 P=0.038 * P=0.512 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.511 P=0.121 P=0.053 P=0.551 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.477 P=0.121 P=0.028 * P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 5/50 (10%) 19/50 (38%) |1/50 (2%) 2/50 (4%) 7/50 (14%) 9/50 (18%) |
|POLY-3 RATE (b) | 5/45.18 5/45.18 5/47.41 19/46.67 |1/46.58 2/46.28 7/47.75 9/48.67 |
|POLY-3 PERCENT (g) | 11.1% 11.1% 10.6% 40.7% |2.2% 4.3% 14.7% 18.5% |
|TERMINAL (d) | 4/31 (13%) 4/38 (11%) 4/38 (11%) 18/40 (45%) |0/39 (0%) 2/37 (5%) 4/39 (10%) 6/41 (15%) |
|FIRST INCIDENCE | 639 668 724 693 |504 729 (T) 633 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.530N P=0.505N P=0.007 ** |P=0.004 ** P=0.490 P=0.039 * P=0.015 * |
|POLY 3 | P<0.001 ** P=0.630N P=0.600N P<0.001 ** |P=0.002 ** P=0.498 P=0.033 * P=0.010 * |
|POLY 1.5 | P<0.001 ** P=0.630N P=0.611N P<0.001 ** |P=0.002 ** P=0.499 P=0.032 * P=0.009 ** |
|POLY 6 | P<0.001 ** P=0.628N P=0.586N P<0.001 ** |P=0.002 ** P=0.495 P=0.034 * P=0.011 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.628N P=0.580N P=0.002 ** |P<0.001 ** P=0.483 P=0.024 * P=0.005 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.630N P=0.630N P<0.001 ** |P=0.002 ** P=0.500 P=0.030 * P=0.008 ** |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 7/50 (14%) 10/50 (20%) |3/50 (6%) 7/50 (14%) 14/50 (28%) 12/50 (24%) |
|POLY-3 RATE (b) | 6/45.69 4/45.91 7/47.41 10/46.67 |3/46.05 7/46.81 14/47.88 12/49.04 |
|POLY-3 PERCENT (g) | 13.1% 8.7% 14.8% 21.4% |6.5% 15.0% 29.2% 24.5% |
|TERMINAL (d) | 2/31 (7%) 2/38 (5%) 6/38 (16%) 9/40 (23%) |2/39 (5%) 5/37 (14%) 10/39 (26%) 8/41 (20%) |
|FIRST INCIDENCE | 592 581 724 693 |693 577 655 532 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.161 P=0.320N P=0.600N P=0.357 |P=0.019 * P=0.152 P=0.005 ** P=0.021 * |
|POLY 3 | P=0.092 P=0.366N P=0.528 P=0.218 |P=0.013 * P=0.164 P=0.004 ** P=0.015 * |
|POLY 1.5 | P=0.090 P=0.368N P=0.518 P=0.214 |P=0.011 * P=0.162 P=0.003 ** P=0.013 * |
|POLY 6 | P=0.096 P=0.362N P=0.540 P=0.226 |P=0.016 * P=0.164 P=0.004 ** P=0.017 * |
|LOGISTIC REGRESSION| P=0.090 P=0.373N P=0.520 P=0.223 |P=0.009 ** P=0.160 P=0.004 ** P=0.011 * |
|COCH-ARM / FISHERS | P=0.086 P=0.370N P=0.500 P=0.207 |P=0.009 ** P=0.159 P=0.003 ** P=0.011 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) 2/50 (4%) |41/50 (82%) 33/50 (66%) 43/50 (86%) 49/50 (98%) |
|POLY-3 RATE (b) | 3/44.95 2/45.18 4/47.50 2/46.71 |41/46.92 33/46.84 43/49.06 49/49.78 |
|POLY-3 PERCENT (g) | 6.7% 4.4% 8.4% 4.3% |87.4% 70.5% 87.6% 98.4% |
|TERMINAL (d) | 2/31 (7%) 1/38 (3%) 2/38 (5%) 1/40 (3%) |38/39 (97%) 30/37 (81%) 37/39 (95%) 41/41 (100%) |
|FIRST INCIDENCE | 704 668 704 682 |504 639 387 532 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.397N P=0.443N P=0.597 P=0.412N |P=0.017 * P=0.077N P=0.396 P=0.088 |
|POLY 3 | P=0.457N P=0.498N P=0.530 P=0.483N |P=0.003 ** P=0.030N* P=0.614 P=0.024 * |
|POLY 1.5 | P=0.466N P=0.499N P=0.518 P=0.490N |P=0.002 ** P=0.037N* P=0.528 P=0.015 * |
|POLY 6 | P=0.444N P=0.494N P=0.545 P=0.471N |P=0.006 ** P=0.024N* P=0.582N P=0.044 * |
|LOGISTIC REGRESSION| P=0.459N P=0.498N P=0.550 P=0.482N |P=0.004 ** P=0.027N* P=0.531 P=0.029 * |
|COCH-ARM / FISHERS | P=0.479N P=0.500N P=0.500 P=0.500N |P<0.001 ** P=0.055N P=0.393 P=0.008 ** |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 10/50 (20%) 2/50 (4%) 3/50 (6%) |4/50 (8%) 3/50 (6%) 5/50 (10%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/44.85 10/45.83 2/47.75 3/46.53 |4/46.51 3/46.28 5/47.00 3/48.05 |
|POLY-3 PERCENT (g) | 2.2% 21.8% 4.2% 6.5% |8.6% 6.5% 10.6% 6.2% |
|TERMINAL (d) | 1/31 (3%) 8/38 (21%) 1/38 (3%) 3/40 (8%) |2/39 (5%) 3/37 (8%) 5/39 (13%) 3/41 (7%) |
|FIRST INCIDENCE | 729 (T) 515 627 729 (T) |591 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.327N P=0.012 * P=0.554 P=0.400 |P=0.443N P=0.520N P=0.499 P=0.474N |
|POLY 3 | P=0.394N P=0.004 ** P=0.522 P=0.319 |P=0.459N P=0.503N P=0.507 P=0.482N |
|POLY 1.5 | P=0.408N P=0.004 ** P=0.513 P=0.313 |P=0.467N P=0.501N P=0.506 P=0.488N |
|POLY 6 | P=0.374N P=0.005 ** P=0.533 P=0.327 |P=0.453N P=0.508N P=0.502 P=0.479N |
|LOGISTIC REGRESSION| P=0.427N P=0.005 ** P=0.478 P=0.400 |P=0.458N P=0.500N P=0.504 P=0.517N |
|COCH-ARM / FISHERS | P=0.430N P=0.004 ** P=0.500 P=0.309 |P=0.482N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.32 1/45.31 0/47.38 0/46.53 |1/45.91 0/46.28 1/47.19 1/48.27 |
|POLY-3 PERCENT (g) | 4.4% 2.2% 0.0% 0.0% |2.2% 0.0% 2.1% 2.1% |
|TERMINAL (d) | 1/31 (3%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |1/39 (3%) 0/37 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 592 627 --- --- |729 (T) --- 679 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.093N P=0.484N P=0.213N P=0.212N |P=0.556 P=0.511N P=0.758 P=0.747N |
|POLY 3 | P=0.098N P=0.500N P=0.227N P=0.231N |P=0.554 P=0.498N P=0.754N P=0.749N |
|POLY 1.5 | P=0.099N P=0.500N P=0.231N P=0.234N |P=0.548 P=0.499N P=0.756N P=0.753N |
|POLY 6 | P=0.098N P=0.498N P=0.223N P=0.227N |P=0.560 P=0.499N P=0.753N P=0.745N |
|LOGISTIC REGRESSION| P=0.125N P=0.512N P=0.286N P=0.261N |P=0.519 (e) P=0.762 P=0.756 |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |P=0.539 P=0.500N P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 44/50 (88%) 42/50 (84%) 42/50 (84%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 45/47.65 44/47.39 42/49.08 42/48.08 |3/45.91 1/46.28 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 94.4% 92.9% 85.6% 87.4% |6.5% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 31/31 (100%) 38/38 (100%) 37/38 (97%) 36/40 (90%) |3/39 (8%) 1/37 (3%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 592 516 523 595 |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004N** P=0.054N P=0.014N* P=0.010N* |P=0.041N* P=0.324N P=0.121N P=0.112N |
|POLY 3 | P=0.103N P=0.549N P=0.114N P=0.177N |P=0.042N* P=0.302N P=0.115N P=0.111N |
|POLY 1.5 | P=0.141N P=0.506N P=0.163N P=0.209N |P=0.042N* P=0.303N P=0.116N P=0.114N |
|POLY 6 | P=0.064N P=0.677N P=0.082N P=0.149N |P=0.042N* P=0.303N P=0.114N P=0.108N |
|LOGISTIC REGRESSION| P=0.076N P=0.618N P=0.089N P=0.136N |P=0.041N* P=0.324N (e) (e) |
|COCH-ARM / FISHERS | P=0.211N P=0.500N P=0.277N P=0.277N |P=0.044N* P=0.309N P=0.121N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.94 1/45.41 1/47.58 2/47.90 |2/46.49 0/46.28 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 4.4% 2.2% 2.1% 4.2% |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |0/39 (0%) 0/37 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 504 592 679 496 |574 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.563 P=0.508N P=0.482N P=0.691 |P=0.111N P=0.237N P=0.235N P=0.225N |
|POLY 3 | P=0.573 P=0.504N P=0.488N P=0.679N |P=0.114N P=0.238N P=0.235N P=0.230N |
|POLY 1.5 | P=0.566 P=0.502N P=0.493N P=0.684N |P=0.114N P=0.237N P=0.235N P=0.232N |
|POLY 6 | P=0.581 P=0.504N P=0.481N P=0.671N |P=0.113N P=0.240N P=0.236N P=0.228N |
|LOGISTIC REGRESSION| P=0.373 P=0.557N P=0.728N P=0.620 |P=0.136N P=0.248N P=0.263N P=0.311N |
|COCH-ARM / FISHERS | P=0.556 P=0.500N P=0.500N P=0.691N |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/45.45 0/44.95 1/47.38 1/46.62 |2/45.99 1/46.31 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 6.6% 0.0% 2.1% 2.2% |4.4% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 1/38 (3%) 0/40 (0%) |1/39 (3%) 0/37 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 591 --- 729 (T) 707 |708 724 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.266N P=0.117N P=0.265N P=0.277N |P=0.096N P=0.506N P=0.242N P=0.227N |
|POLY 3 | P=0.288N P=0.121N P=0.291N P=0.296N |P=0.099N P=0.498N P=0.232N P=0.228N |
|POLY 1.5 | P=0.291N P=0.120N P=0.296N P=0.300N |P=0.100N P=0.498N P=0.234N P=0.231N |
|POLY 6 | P=0.284N P=0.121N P=0.284N P=0.290N |P=0.098N P=0.499N P=0.232N P=0.225N |
|LOGISTIC REGRESSION| P=0.311N P=0.122N P=0.340N P=0.325N |P=0.095N P=0.498N P=0.232N P=0.228N |
|COCH-ARM / FISHERS | P=0.296N P=0.121N P=0.309N P=0.309N |P=0.101N P=0.500N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/45.84 0/44.95 0/47.38 1/46.93 |2/45.99 3/47.01 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 8.7% 0.0% 0.0% 2.1% |4.4% 6.4% 0.0% 0.0% |
|TERMINAL (d) | 1/31 (3%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |1/39 (3%) 1/37 (3%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 378 --- --- 617 |708 528 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.112N P=0.056N P=0.052N P=0.156N |P=0.070N P=0.492 P=0.242N P=0.227N |
|POLY 3 | P=0.118N P=0.063N P=0.056N P=0.172N |P=0.068N P=0.510 P=0.232N P=0.228N |
|POLY 1.5 | P=0.120N P=0.062N P=0.058N P=0.176N |P=0.069N P=0.507 P=0.234N P=0.231N |
|POLY 6 | P=0.117N P=0.063N P=0.054N P=0.165N |P=0.067N P=0.512 P=0.232N P=0.225N |
|LOGISTIC REGRESSION| P=0.176N P=0.064N P=0.108N P=0.230N |P=0.085N P=0.490 P=0.232N P=0.228N |
|COCH-ARM / FISHERS | P=0.125N P=0.059N P=0.059N P=0.181N |P=0.073N P=0.500 P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/46.07 0/44.95 3/47.41 0/46.53 |1/45.91 0/46.28 2/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 10.9% 0.0% 6.3% 0.0% |2.2% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 2/31 (7%) 0/38 (0%) 2/38 (5%) 0/40 (0%) |1/39 (3%) 0/37 (0%) 2/39 (5%) 0/41 (0%) |
|FIRST INCIDENCE | 378 --- 724 --- |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033N* P=0.029N* P=0.278N P=0.025N* |P=0.444N P=0.511N P=0.500 P=0.490N |
|POLY 3 | P=0.038N* P=0.033N* P=0.341N P=0.030N* |P=0.447N P=0.498N P=0.508 P=0.491N |
|POLY 1.5 | P=0.040N* P=0.032N* P=0.348N P=0.030N* |P=0.452N P=0.499N P=0.506 P=0.494N |
|POLY 6 | P=0.037N* P=0.033N* P=0.331N P=0.028N* |P=0.442N P=0.499N P=0.509 P=0.488N |
|LOGISTIC REGRESSION| P=0.055N P=0.033N* P=0.460N P=0.043N* |P=0.444N (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.044N* P=0.028N* P=0.357N P=0.028N* |P=0.461N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 40/50 (80%) 43/50 (86%) 45/50 (90%) |44/50 (88%) 35/50 (70%) 39/50 (78%) 31/50 (62%) |
|POLY-3 RATE (b) | 36/48.06 40/48.45 43/49.14 45/48.24 |44/48.54 35/47.46 39/49.46 31/49.22 |
|POLY-3 PERCENT (g) | 74.9% 82.6% 87.5% 93.3% |90.7% 73.8% 78.9% 63.0% |
|TERMINAL (d) | 23/31 (74%) 31/38 (82%) 33/38 (87%) 38/40 (95%) |36/39 (92%) 31/37 (84%) 30/39 (77%) 26/41 (63%) |
|FIRST INCIDENCE | 378 515 621 591 |497 528 387 532 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.430 P=0.452N P=0.562 P=0.541 |P=0.004N** P=0.082N P=0.214N P=0.004N** |
|POLY 3 | P=0.006 ** P=0.244 P=0.082 P=0.009 ** |P=0.002N** P=0.022N* P=0.084N P<0.001N** |
|POLY 1.5 | P=0.007 ** P=0.238 P=0.074 P=0.011 * |P=0.002N** P=0.020N* P=0.100N P<0.001N** |
|POLY 6 | P=0.007 ** P=0.270 P=0.104 P=0.009 ** |P<0.001N** P=0.027N* P=0.074N P<0.001N** |
|LOGISTIC REGRESSION| P=0.020 * P=0.242 P=0.100 P=0.028 * |P=0.003N** P=0.015N* P=0.122N P<0.001N** |
|COCH-ARM / FISHERS | P=0.013 * P=0.241 P=0.070 P=0.020 * |P=0.006N** P=0.024N* P=0.143N P=0.002N** |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 5/50 (10%) 4/50 (8%) |4/50 (8%) 5/50 (10%) 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/44.85 2/45.21 5/47.38 4/46.53 |4/46.42 5/46.28 4/47.16 1/48.05 |
|POLY-3 PERCENT (g) | 6.7% 4.4% 10.6% 8.6% |8.6% 10.8% 8.5% 2.1% |
|TERMINAL (d) | 3/31 (10%) 1/38 (3%) 5/38 (13%) 4/40 (10%) |3/39 (8%) 5/37 (14%) 3/39 (8%) 1/41 (2%) |
|FIRST INCIDENCE | 729 (T) 659 729 (T) 729 (T) |574 729 (T) 687 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.428 P=0.426N P=0.472 P=0.638 |P=0.098N P=0.472 P=0.641 P=0.168N |
|POLY 3 | P=0.343 P=0.496N P=0.387 P=0.520 |P=0.101N P=0.498 P=0.634N P=0.169N |
|POLY 1.5 | P=0.333 P=0.498N P=0.375 P=0.512 |P=0.104N P=0.500 P=0.637N P=0.172N |
|POLY 6 | P=0.356 P=0.491N P=0.402 P=0.533 |P=0.097N P=0.493 P=0.635N P=0.166N |
|LOGISTIC REGRESSION| P=0.367 P=0.497N P=0.472 P=0.638 |P=0.104N P=0.503 P=0.642 P=0.194N |
|COCH-ARM / FISHERS | P=0.320 P=0.500N P=0.357 P=0.500 |P=0.112N P=0.500 P=0.643N P=0.181N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/48 (10%) 2/49 (4%) 2/49 (4%) 4/49 (8%) |4/50 (8%) 3/50 (6%) 2/48 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 5/42.87 2/43.95 2/47.02 4/45.67 |4/46.11 3/46.60 2/45.44 4/48.05 |
|POLY-3 PERCENT (g) | 11.7% 4.6% 4.3% 8.8% |8.7% 6.4% 4.4% 8.3% |
|TERMINAL (d) | 5/30 (17%) 2/37 (5%) 2/38 (5%) 4/40 (10%) |3/39 (8%) 1/37 (3%) 1/38 (3%) 3/41 (7%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |676 675 687 728 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.386N P=0.138N P=0.130N P=0.323N |P=0.558N P=0.520N P=0.349N P=0.613N |
|POLY 3 | P=0.490N P=0.205N P=0.180N P=0.460N |P=0.575 P=0.494N P=0.344N P=0.620N |
|POLY 1.5 | P=0.498N P=0.207N P=0.191N P=0.472N |P=0.568 P=0.496N P=0.348N P=0.628N |
|POLY 6 | P=0.479N P=0.202N P=0.167N P=0.442N |P=0.576N P=0.494N P=0.342N P=0.614N |
|LOGISTIC REGRESSION| P=0.386N P=0.138N P=0.130N P=0.323N |P=0.571 P=0.498N P=0.349N P=0.613N |
|COCH-ARM / FISHERS | P=0.510N P=0.209N P=0.209N P=0.487N |P=0.555 P=0.500N P=0.359N P=0.643N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/48 (6%) 4/49 (8%) 3/49 (6%) 4/49 (8%) |3/50 (6%) 1/50 (2%) 3/48 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/43.33 4/44.60 3/47.02 4/45.67 |3/45.97 1/46.28 3/45.28 1/48.20 |
|POLY-3 PERCENT (g) | 6.9% 9.0% 6.4% 8.8% |6.5% 2.2% 6.6% 2.1% |
|TERMINAL (d) | 2/30 (7%) 3/37 (8%) 3/38 (8%) 4/40 (10%) |2/39 (5%) 1/37 (3%) 3/38 (8%) 0/41 (0%) |
|FIRST INCIDENCE | 591 515 729 (T) 729 (T) |712 729 (T) 729 (T) 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.567N P=0.579 P=0.567N P=0.632 |P=0.292N P=0.321N P=0.652 P=0.287N |
|POLY 3 | P=0.494 P=0.516 P=0.624N P=0.529 |P=0.298N P=0.303N P=0.655 P=0.289N |
|POLY 1.5 | P=0.485 P=0.514 P=0.635N P=0.521 |P=0.305N P=0.303N P=0.651 P=0.295N |
|POLY 6 | P=0.507 P=0.520 P=0.611N P=0.540 |P=0.291N P=0.304N P=0.657 P=0.283N |
|LOGISTIC REGRESSION| P=0.469 P=0.507 P=0.662N P=0.524 |P=0.293N P=0.304N P=0.655 P=0.295N |
|COCH-ARM / FISHERS | P=0.472 P=0.512 P=0.651N P=0.512 |P=0.315N P=0.309N P=0.641 P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 1/49 (2%) 2/49 (4%) 2/49 (4%) |2/50 (4%) 4/50 (8%) 1/48 (2%) 7/50 (14%) |
|POLY-3 RATE (b) | 4/43.03 1/43.95 2/47.02 2/46.06 |2/46.11 4/46.50 1/45.28 7/48.05 |
|POLY-3 PERCENT (g) | 9.3% 2.3% 4.3% 4.3% |4.3% 8.6% 2.2% 14.6% |
|TERMINAL (d) | 2/30 (7%) 1/37 (3%) 2/38 (5%) 0/40 (0%) |1/39 (3%) 2/37 (5%) 1/38 (3%) 6/41 (15%) |
|FIRST INCIDENCE | 704 729 (T) 729 (T) 676 |676 675 729 (T) 728 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.273N P=0.141N P=0.253N P=0.269N |P=0.073 P=0.322 P=0.503N P=0.098 |
|POLY 3 | P=0.319N P=0.172N P=0.297N P=0.306N |P=0.060 P=0.341 P=0.506N P=0.089 |
|POLY 1.5 | P=0.327N P=0.172N P=0.309N P=0.316N |P=0.058 P=0.340 P=0.509N P=0.086 |
|POLY 6 | P=0.309N P=0.170N P=0.284N P=0.292N |P=0.061 P=0.340 P=0.506N P=0.092 |
|LOGISTIC REGRESSION| P=0.319N P=0.165N P=0.270N P=0.322N |P=0.066 P=0.339 P=0.511N P=0.095 |
|COCH-ARM / FISHERS | P=0.336N P=0.175N P=0.329N P=0.329N |P=0.056 P=0.339 P=0.515N P=0.080 |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/48 (38%) 14/49 (29%) 30/49 (61%) 26/49 (53%) |27/50 (54%) 22/50 (44%) 24/48 (50%) 25/50 (50%) |
|POLY-3 RATE (b) | 18/44.39 14/45.27 30/48.16 26/47.51 |27/47.24 22/47.38 24/45.51 25/48.84 |
|POLY-3 PERCENT (g) | 40.6% 30.9% 62.3% 54.7% |57.2% 46.4% 52.7% 51.2% |
|TERMINAL (d) | 14/30 (47%) 11/37 (30%) 24/38 (63%) 23/40 (58%) |23/39 (59%) 18/37 (49%) 22/38 (58%) 22/41 (54%) |
|FIRST INCIDENCE | 504 515 627 496 |504 528 676 532 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113 P=0.120N P=0.121 P=0.370 |P=0.349N P=0.287N P=0.385N P=0.324N |
|POLY 3 | P=0.023 * P=0.231N P=0.026 * P=0.122 |P=0.421N P=0.199N P=0.413N P=0.351N |
|POLY 1.5 | P=0.019 * P=0.233N P=0.021 * P=0.108 |P=0.444N P=0.203N P=0.414N P=0.374N |
|POLY 6 | P=0.030 * P=0.223N P=0.036 * P=0.142 |P=0.400N P=0.198N P=0.421N P=0.331N |
|LOGISTIC REGRESSION| P=0.018 * P=0.234N P=0.025 * P=0.095 |P=0.399N P=0.199N P=0.357N P=0.358N |
|COCH-ARM / FISHERS | P=0.015 * P=0.236N P=0.016 * P=0.091 |P=0.490N P=0.212N P=0.423N P=0.421N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.18 1/44.95 3/47.58 2/46.53 |0/45.91 1/46.28 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 2.2% 2.2% 6.3% 4.3% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 1/38 (3%) 2/38 (5%) 2/40 (5%) |0/39 (0%) 1/37 (3%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 639 729 (T) 679 729 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.389 P=0.743N P=0.359 P=0.564 |P=0.556N P=0.489 (e) (e) |
|POLY 3 | P=0.341 P=0.760 P=0.324 P=0.510 |P=0.563N P=0.502 (e) (e) |
|POLY 1.5 | P=0.335 P=0.760 P=0.317 P=0.506 |P=0.564N P=0.501 (e) (e) |
|POLY 6 | P=0.351 P=0.760 P=0.333 P=0.517 |P=0.562N P=0.501 (e) (e) |
|LOGISTIC REGRESSION| P=0.330 P=0.762 P=0.278 P=0.496 |(e) P=0.489 (e) (e) |
|COCH-ARM / FISHERS | P=0.324 P=0.753N P=0.309 P=0.500 |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) 5/50 (10%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 7/46.46 3/44.97 5/47.60 3/46.70 |0/45.91 1/46.28 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 15.1% 6.7% 10.5% 6.4% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 1/31 (3%) 2/38 (5%) 3/38 (8%) 2/40 (5%) |0/39 (0%) 1/37 (3%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 504 724 679 685 |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.132N P=0.135N P=0.295N P=0.125N |P=0.556N P=0.489 (e) (e) |
|POLY 3 | P=0.169N P=0.171N P=0.362N P=0.155N |P=0.563N P=0.502 (e) (e) |
|POLY 1.5 | P=0.173N P=0.165N P=0.369N P=0.157N |P=0.564N P=0.501 (e) (e) |
|POLY 6 | P=0.163N P=0.176N P=0.355N P=0.152N |P=0.562N P=0.501 (e) (e) |
|LOGISTIC REGRESSION| P=0.192N P=0.160N P=0.465N P=0.185N |(e) P=0.489 (e) (e) |
|COCH-ARM / FISHERS | P=0.179N P=0.159N P=0.380N P=0.159N |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |2/49 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/44.85 2/44.95 3/47.87 1/46.53 |2/45.11 1/46.29 1/47.00 1/48.08 |
|POLY-3 PERCENT (g) | 8.9% 4.5% 6.3% 2.2% |4.4% 2.2% 2.1% 2.1% |
|TERMINAL (d) | 4/31 (13%) 2/38 (5%) 1/38 (3%) 1/40 (3%) |1/38 (3%) 0/37 (0%) 1/39 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 621 729 (T) |676 728 729 (T) 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.115N P=0.246N P=0.406N P=0.111N |P=0.383N P=0.511N P=0.491N P=0.472N |
|POLY 3 | P=0.150N P=0.336N P=0.465N P=0.168N |P=0.395N P=0.491N P=0.486N P=0.478N |
|POLY 1.5 | P=0.155N P=0.337N P=0.479N P=0.173N |P=0.398N P=0.491N P=0.488N P=0.483N |
|POLY 6 | P=0.144N P=0.333N P=0.446N P=0.160N |P=0.391N P=0.493N P=0.486N P=0.474N |
|LOGISTIC REGRESSION| P=0.148N P=0.246N P=0.487N P=0.111N |P=0.391N P=0.491N P=0.489N P=0.494N |
|COCH-ARM / FISHERS | P=0.162N P=0.339N P=0.500N P=0.181N |P=0.404N P=0.492N P=0.492N P=0.492N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |2/49 (4%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.85 3/44.95 1/47.38 0/46.53 |2/45.59 3/46.72 1/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 6.7% 6.7% 2.1% 0.0% |4.4% 6.4% 2.1% 0.0% |
|TERMINAL (d) | 3/31 (10%) 3/38 (8%) 1/38 (3%) 0/40 (0%) |1/38 (3%) 1/37 (3%) 1/39 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |497 639 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.032N* P=0.566N P=0.235N P=0.080N |P=0.097N P=0.497 P=0.494N P=0.229N |
|POLY 3 | P=0.048N* P=0.661N P=0.286N P=0.112N |P=0.096N P=0.511 P=0.489N P=0.226N |
|POLY 1.5 | P=0.049N* P=0.662N P=0.294N P=0.115N |P=0.097N P=0.510 P=0.490N P=0.228N |
|POLY 6 | P=0.045N* P=0.659N P=0.276N P=0.108N |P=0.094N P=0.512 P=0.490N P=0.223N |
|LOGISTIC REGRESSION| P=0.032N* P=0.566N P=0.235N (e) |P=0.126N P=0.487 P=0.536N P=0.351N |
|COCH-ARM / FISHERS | P=0.052N P=0.661N P=0.309N P=0.121N |P=0.101N P=0.510 P=0.492N P=0.242N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/14 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) |0/4 (0%) 0/8 (0%) 1/3 (33%) 3/11 (27%) |
|POLY-3 RATE (b) | 0/11.17 0/6.08 0/6.69 0/4.69 |0/2.87 0/6.69 1/2.81 3/10.10 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 35.6% 29.7% |
|TERMINAL (d) | 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%) |0/2 (0%) 0/4 (0%) 1/2 (50%) 3/7 (43%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.113 (e) P=0.500 P=0.395 |
|POLY 3 | (e) (e) (e) (e) |P=0.115 (e) P=0.496 P=0.407 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.105 (e) P=0.478 P=0.385 |
|POLY 6 | (e) (e) (e) (e) |P=0.118 (e) P=0.509 P=0.420 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.500 P=0.395 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.083 (e) P=0.429 P=0.363 |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/14 (0%) 0/7 (0%) 0/7 (0%) 0/5 (0%) |1/4 (25%) 2/8 (25%) 1/3 (33%) 4/11 (36%) |
|POLY-3 RATE (b) | 0/11.17 0/6.08 0/6.69 0/4.69 |1/2.87 2/7.02 1/2.81 4/10.63 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |34.9% 28.5% 35.6% 37.6% |
|TERMINAL (d) | 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%) |1/2 (50%) 1/4 (25%) 1/2 (50%) 2/7 (29%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 639 729 (T) 639 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.340 P=0.666 P=0.807 P=0.444 |
|POLY 3 | (e) (e) (e) (e) |P=0.495 P=0.692N P=0.772 P=0.700 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.462 P=0.712N P=0.747 P=0.661 |
|POLY 6 | (e) (e) (e) (e) |P=0.516 P=0.669N P=0.774N P=0.723N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.443 P=0.729N P=0.807 P=0.673 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.380 P=0.745N P=0.714 P=0.593 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/14 (14%) 0/7 (0%) 1/7 (14%) 1/5 (20%) |0/4 (0%) 0/8 (0%) 1/3 (33%) 4/11 (36%) |
|POLY-3 RATE (b) | 2/11.31 0/6.08 1/6.69 1/4.69 |0/2.87 0/6.69 1/2.81 4/10.10 |
|POLY-3 PERCENT (g) | 17.7% 0.0% 15.0% 21.3% |0.0% 0.0% 35.6% 39.6% |
|TERMINAL (d) | 0/4 (0%) 0/4 (0%) 1/4 (25%) 1/3 (33%) |0/2 (0%) 0/4 (0%) 1/2 (50%) 4/7 (57%) |
|FIRST INCIDENCE | 695 --- 729 (T) 729 (T) |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.522N P=0.218N P=0.469N P=0.499N |P=0.047 * (e) P=0.500 P=0.277 |
|POLY 3 | P=0.539 P=0.377N P=0.690N P=0.701 |P=0.046 * (e) P=0.496 P=0.302 |
|POLY 1.5 | P=0.523 P=0.384N P=0.708N P=0.683 |P=0.041 * (e) P=0.478 P=0.279 |
|POLY 6 | P=0.555 P=0.371N P=0.669N P=0.718 |P=0.046 * (e) P=0.509 P=0.314 |
|LOGISTIC REGRESSION| P=0.593 P=0.363N P=0.643N P=0.738 |(e) (e) P=0.500 P=0.277 |
|COCH-ARM / FISHERS | P=0.495 P=0.433N P=0.726 P=0.624 |P=0.035 * (e) P=0.429 P=0.242 |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/14 (7%) 0/7 (0%) 2/7 (29%) 0/5 (0%) |0/4 (0%) 2/8 (25%) 0/3 (0%) 2/11 (18%) |
|POLY-3 RATE (b) | 1/11.33 0/6.08 2/6.81 0/4.69 |0/2.87 2/6.69 0/2.81 2/10.25 |
|POLY-3 PERCENT (g) | 8.8% 0.0% 29.4% 0.0% |0.0% 29.9% 0.0% 19.5% |
|TERMINAL (d) | 0/4 (0%) 0/4 (0%) 0/4 (0%) 0/3 (0%) |0/2 (0%) 2/4 (50%) 0/2 (0%) 1/7 (14%) |
|FIRST INCIDENCE | 687 --- 704 --- |--- 729 (T) --- 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.431N P=0.500N P=0.549 P=0.485N |P=0.500 P=0.390 (e) P=0.380 |
|POLY 3 | P=0.674N P=0.625N P=0.310 P=0.679N |P=0.586 P=0.436 (e) P=0.541 |
|POLY 1.5 | P=0.660 P=0.629N P=0.288 P=0.688N |P=0.556 P=0.422 (e) P=0.522 |
|POLY 6 | P=0.660N P=0.622N P=0.338 P=0.672N |P=0.607 P=0.447 (e) P=0.555 |
|LOGISTIC REGRESSION| P=0.668 P=0.632N P=0.312 P=0.700N |P=0.559 P=0.390 (e) P=0.547 |
|COCH-ARM / FISHERS | P=0.624 P=0.667N P=0.247 P=0.737N |P=0.490 P=0.424 (e) P=0.524 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 28/45 (62%) 22/48 (46%) 27/43 (63%) 26/36 (72%) |42/50 (84%) 42/50 (84%) 45/50 (90%) 29/50 (58%) |
|POLY-3 RATE (b) | 28/42.99 22/46.41 27/42.98 26/34.63 |42/47.65 42/48.82 45/48.51 29/49.24 |
|POLY-3 PERCENT (g) | 65.1% 47.4% 62.8% 75.1% |88.2% 86.0% 92.8% 58.9% |
|TERMINAL (d) | 18/29 (62%) 16/38 (42%) 19/34 (56%) 20/28 (71%) |36/39 (92%) 31/37 (84%) 38/39 (97%) 24/41 (59%) |
|FIRST INCIDENCE | 504 490 523 617 |504 528 633 532 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.441 P=0.043N* P=0.249N P=0.425N |P<0.001N** P=0.446 P=0.325 P=0.003N** |
|POLY 3 | P=0.085 P=0.067N P=0.500N P=0.240 |P<0.001N** P=0.497N P=0.324 P<0.001N** |
|POLY 1.5 | P=0.083 P=0.071N P=0.542N P=0.238 |P<0.001N** P=0.546N P=0.302 P<0.001N** |
|POLY 6 | P=0.094 P=0.064N P=0.452N P=0.253 |P<0.001N** P=0.435N P=0.343 P<0.001N** |
|LOGISTIC REGRESSION| P=0.087 P=0.085N P=0.565 P=0.264 |P<0.001N** P=0.567N P=0.439 P<0.001N** |
|COCH-ARM / FISHERS | P=0.085 P=0.084N P=0.566 P=0.239 |P<0.001N** P=0.607N P=0.277 P=0.004N** |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/6 (67%) 18/18 (100%) 7/7 (100%) 9/10 (90%) |5/5 (100%) 1/1 (100%) 3/3 (100%) 0/0 (0%) |
|POLY-3 RATE (b) | 4/5.50 18/18.00 7/7.00 9/9.83 |5/5.00 1/1.00 3/3.00 0/0.00 |
|POLY-3 PERCENT (g) | 72.7% 100.0% 100.0% 91.6% |100.0% 100.0% 100.0% 0.0% |
|TERMINAL (d) | 3/3 (100%) 13/13 (100%) 4/4 (100%) 8/8 (100%) |4/4 (100%) 1/1 (100%) 3/3 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 695 515 676 693 |591 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.333N P=0.113 P=0.358 P=0.737N |(e) (e) (e) (e) |
|POLY 3 | P=0.577 P=0.061 P=0.252 P=0.398 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.523 P=0.041 * P=0.212 P=0.358 |(e) (e) (e) (e) |
|POLY 6 | P=0.637 P=0.122 P=0.333 P=0.461 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.562 P=0.032 * P=0.298 P=0.586 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.454 P=0.054 P=0.192 P=0.304 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) 9/50 (18%) 1/50 (2%) |3/50 (6%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 5/45.02 6/44.95 9/47.97 1/46.53 |3/45.91 2/46.49 2/47.00 2/48.05 |
|POLY-3 PERCENT (g) | 11.1% 13.4% 18.8% 2.2% |6.5% 4.3% 4.3% 4.2% |
|TERMINAL (d) | 4/31 (13%) 6/38 (16%) 7/38 (18%) 1/40 (3%) |3/39 (8%) 1/37 (3%) 2/39 (5%) 2/41 (5%) |
|FIRST INCIDENCE | 687 729 (T) 621 729 (T) |729 (T) 675 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.061N P=0.625N P=0.308 P=0.061N |P=0.402N P=0.521N P=0.500N P=0.477N |
|POLY 3 | P=0.094N P=0.499 P=0.230 P=0.094N |P=0.416N P=0.494N P=0.489N P=0.479N |
|POLY 1.5 | P=0.101N P=0.500 P=0.215 P=0.097N |P=0.421N P=0.496N P=0.493N P=0.487N |
|POLY 6 | P=0.085N P=0.501 P=0.250 P=0.089N |P=0.410N P=0.493N P=0.488N P=0.473N |
|LOGISTIC REGRESSION| P=0.091N P=0.527 P=0.220 P=0.085N |P=0.403N P=0.497N P=0.500N P=0.477N |
|COCH-ARM / FISHERS | P=0.113N P=0.500 P=0.194 P=0.102N |P=0.431N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 8/50 (16%) 8/50 (16%) 3/50 (6%) |5/50 (10%) 4/50 (8%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 7/46.18 8/45.21 8/47.77 3/46.53 |5/46.51 4/46.51 2/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 15.2% 17.7% 16.8% 6.5% |10.8% 8.6% 4.3% 0.0% |
|TERMINAL (d) | 5/31 (16%) 7/38 (18%) 7/38 (18%) 3/40 (8%) |3/39 (8%) 2/37 (5%) 2/39 (5%) 0/41 (0%) |
|FIRST INCIDENCE | 378 659 621 729 (T) |591 675 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058N P=0.588N P=0.580N P=0.091N |P=0.015N* P=0.518N P=0.221N P=0.032N* |
|POLY 3 | P=0.105N P=0.482 P=0.528 P=0.154N |P=0.014N* P=0.500N P=0.212N P=0.028N* |
|POLY 1.5 | P=0.109N P=0.488 P=0.516 P=0.157N |P=0.014N* P=0.499N P=0.213N P=0.029N* |
|POLY 6 | P=0.098N P=0.483 P=0.547 P=0.148N |P=0.013N* P=0.504N P=0.214N P=0.027N* |
|LOGISTIC REGRESSION| P=0.114N P=0.499 P=0.421 P=0.181N |P=0.016N* P=0.500N P=0.218N P=0.037N* |
|COCH-ARM / FISHERS | P=0.113N P=0.500 P=0.500 P=0.159N |P=0.016N* P=0.500N P=0.218N P=0.028N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) 5/50 (10%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/45.36 6/44.95 5/47.38 0/46.53 |1/45.91 0/46.28 3/47.00 1/48.05 |
|POLY-3 PERCENT (g) | 11.0% 13.4% 10.6% 0.0% |2.2% 0.0% 6.4% 2.1% |
|TERMINAL (d) | 3/31 (10%) 6/38 (16%) 5/38 (13%) 0/40 (0%) |1/39 (3%) 0/37 (0%) 3/39 (8%) 1/41 (2%) |
|FIRST INCIDENCE | 639 729 (T) 729 (T) --- |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.013N* P=0.610 P=0.516N P=0.022N* |P=0.493 P=0.511N P=0.305 P=0.751N |
|POLY 3 | P=0.022N* P=0.494 P=0.603N P=0.028N* |P=0.493 P=0.498N P=0.314 P=0.750N |
|POLY 1.5 | P=0.023N* P=0.497 P=0.613N P=0.029N* |P=0.484 P=0.499N P=0.311 P=0.754N |
|POLY 6 | P=0.020N* P=0.491 P=0.591N P=0.027N* |P=0.501 P=0.499N P=0.314 P=0.747N |
|LOGISTIC REGRESSION| P=0.020N* P=0.505 P=0.597N P=0.033N* |P=0.493 (e) P=0.305 P=0.751N |
|COCH-ARM / FISHERS | P=0.026N* P=0.500 P=0.630N P=0.028N* |P=0.469 P=0.500N P=0.309 P=0.753N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.85 4/44.95 1/47.38 0/46.53 |0/45.91 2/46.51 1/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 0.0% 8.9% 2.1% 0.0% |0.0% 4.3% 2.1% 0.0% |
|TERMINAL (d) | 0/31 (0%) 4/38 (11%) 1/38 (3%) 0/40 (0%) |0/39 (0%) 0/37 (0%) 1/39 (3%) 0/41 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |--- 675 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.238N P=0.091 P=0.541 (e) |P=0.443N P=0.240 P=0.500 (e) |
|POLY 3 | P=0.277N P=0.060 P=0.511 (e) |P=0.444N P=0.240 P=0.505 (e) |
|POLY 1.5 | P=0.284N P=0.061 P=0.507 (e) |P=0.450N P=0.239 P=0.503 (e) |
|POLY 6 | P=0.267N P=0.061 P=0.516 (e) |P=0.439N P=0.241 P=0.505 (e) |
|LOGISTIC REGRESSION| (e) P=0.091 P=0.541 (e) |P=0.460N P=0.237 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.296N P=0.059 P=0.500 (e) |P=0.461N P=0.247 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |9/50 (18%) 11/50 (22%) 3/50 (6%) 6/50 (12%) |
|POLY-3 RATE (b) | |9/46.12 11/46.31 3/47.20 6/48.20 |
|POLY-3 PERCENT (g) | |19.5% 23.8% 6.4% 12.5% |
|TERMINAL (d) | |7/39 (18%) 10/37 (27%) 2/39 (5%) 5/41 (12%) |
|FIRST INCIDENCE | |695 724 676 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.096N P=0.360 P=0.067N P=0.257N |
|POLY 3 | |P=0.098N P=0.404 P=0.054N P=0.257N |
|POLY 1.5 | |P=0.104N P=0.405 P=0.056N P=0.268N |
|POLY 6 | |P=0.093N P=0.399 P=0.053N P=0.247N |
|LOGISTIC REGRESSION| |P=0.091N P=0.399 P=0.056N P=0.247N |
|COCH-ARM / FISHERS | |P=0.117N P=0.402 P=0.061N P=0.288N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 18/50 (36%) 16/49 (33%) 7/50 (14%) |3/50 (6%) 1/50 (2%) 8/50 (16%) 4/50 (8%) |
|POLY-3 RATE (b) | 12/45.82 18/45.83 16/46.86 7/47.39 |3/45.97 1/46.28 8/47.60 4/48.27 |
|POLY-3 PERCENT (g) | 26.2% 39.3% 34.2% 14.8% |6.5% 2.2% 16.8% 8.3% |
|TERMINAL (d) | 8/31 (26%) 16/38 (42%) 14/38 (37%) 5/40 (13%) |2/39 (5%) 1/37 (3%) 6/39 (15%) 3/41 (7%) |
|FIRST INCIDENCE | 504 516 659 591 |712 729 (T) 639 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.021N* P=0.296 P=0.463 P=0.076N |P=0.281 P=0.321N P=0.109 P=0.532 |
|POLY 3 | P=0.047N* P=0.130 P=0.271 P=0.132N |P=0.271 P=0.303N P=0.110 P=0.526 |
|POLY 1.5 | P=0.055N P=0.133 P=0.255 P=0.141N |P=0.259 P=0.303N P=0.106 P=0.517 |
|POLY 6 | P=0.038N* P=0.130 P=0.294 P=0.119N |P=0.284 P=0.304N P=0.113 P=0.536 |
|LOGISTIC REGRESSION| P=0.057N P=0.137 P=0.287 P=0.157N |P=0.252 P=0.304N P=0.104 P=0.522 |
|COCH-ARM / FISHERS | P=0.069N P=0.138 P=0.232 P=0.154N |P=0.240 P=0.309N P=0.100 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/49 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.85 2/44.95 2/46.58 1/46.53 |0/45.91 0/46.28 1/47.00 1/48.05 |
|POLY-3 PERCENT (g) | 2.2% 4.5% 4.3% 2.2% |0.0% 0.0% 2.1% 2.1% |
|TERMINAL (d) | 1/31 (3%) 2/38 (5%) 2/38 (5%) 1/40 (3%) |0/39 (0%) 0/37 (0%) 1/39 (3%) 1/41 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.479N P=0.571 P=0.571 P=0.704N |P=0.250 (e) P=0.500 P=0.510 |
|POLY 3 | P=0.539N P=0.501 P=0.513 P=0.752N |P=0.249 (e) P=0.505 P=0.509 |
|POLY 1.5 | P=0.546N P=0.500 P=0.505 P=0.756N |P=0.245 (e) P=0.503 P=0.506 |
|POLY 6 | P=0.529N P=0.503 P=0.524 P=0.747N |P=0.254 (e) P=0.505 P=0.512 |
|LOGISTIC REGRESSION| P=0.479N P=0.571 P=0.571 P=0.704N |(e) (e) P=0.500 P=0.510 |
|COCH-ARM / FISHERS | P=0.556N P=0.500 P=0.492 P=0.753N |P=0.236 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 2/47 (4%) 1/49 (2%) 1/45 (2%) |4/50 (8%) 5/50 (10%) 7/50 (14%) 7/50 (14%) |
|POLY-3 RATE (b) | 1/43.32 2/42.88 1/46.38 1/42.20 |4/46.69 5/46.31 7/47.19 7/48.27 |
|POLY-3 PERCENT (g) | 2.3% 4.7% 2.2% 2.4% |8.6% 10.8% 14.8% 14.5% |
|TERMINAL (d) | 1/30 (3%) 2/38 (5%) 1/37 (3%) 1/37 (3%) |2/39 (5%) 3/37 (8%) 6/39 (15%) 6/41 (15%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |574 724 679 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.481N P=0.583 P=0.715N P=0.715N |P=0.240 P=0.482 P=0.269 P=0.295 |
|POLY 3 | P=0.536N P=0.496 P=0.745N P=0.755 |P=0.217 P=0.495 P=0.267 P=0.281 |
|POLY 1.5 | P=0.541N P=0.495 P=0.749N P=0.751 |P=0.210 P=0.498 P=0.267 P=0.275 |
|POLY 6 | P=0.528N P=0.500 P=0.740N P=0.761 |P=0.224 P=0.488 P=0.264 P=0.285 |
|LOGISTIC REGRESSION| P=0.481N P=0.583 P=0.715N P=0.715N |P=0.207 P=0.499 P=0.257 P=0.238 |
|COCH-ARM / FISHERS | P=0.550N P=0.492 P=0.747N P=0.736 |P=0.194 P=0.500 P=0.262 P=0.262 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 8/47 (17%) 7/49 (14%) 8/45 (18%) |22/50 (44%) 13/50 (26%) 18/50 (36%) 6/50 (12%) |
|POLY-3 RATE (b) | 4/43.32 8/43.29 7/46.96 8/42.75 |22/48.45 13/46.77 18/48.22 6/48.05 |
|POLY-3 PERCENT (g) | 9.2% 18.5% 14.9% 18.7% |45.4% 27.8% 37.3% 12.5% |
|TERMINAL (d) | 4/30 (13%) 7/38 (18%) 5/37 (14%) 6/37 (16%) |16/39 (41%) 10/37 (27%) 15/39 (39%) 6/41 (15%) |
|FIRST INCIDENCE | 729 (T) 611 621 595 |380 659 387 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.297 P=0.296 P=0.377 P=0.281 |P<0.001N** P=0.077N P=0.285N P<0.001N** |
|POLY 3 | P=0.207 P=0.175 P=0.309 P=0.169 |P<0.001N** P=0.056N P=0.274N P<0.001N** |
|POLY 1.5 | P=0.193 P=0.171 P=0.295 P=0.159 |P<0.001N** P=0.052N P=0.271N P<0.001N** |
|POLY 6 | P=0.229 P=0.182 P=0.328 P=0.184 |P<0.001N** P=0.062N P=0.287N P<0.001N** |
|LOGISTIC REGRESSION| P=0.189 P=0.175 P=0.297 P=0.164 |P<0.001N** P=0.048N* P=0.299N P<0.001N** |
|COCH-ARM / FISHERS | P=0.175 P=0.167 P=0.274 P=0.147 |P<0.001N** P=0.046N* P=0.270N P<0.001N** |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 5/47 (11%) 9/49 (18%) 7/45 (16%) |10/50 (20%) 12/50 (24%) 8/50 (16%) 7/50 (14%) |
|POLY-3 RATE (b) | 4/43.42 5/42.88 9/47.19 7/42.20 |10/46.97 12/46.64 8/48.39 7/48.05 |
|POLY-3 PERCENT (g) | 9.2% 11.7% 19.1% 16.6% |21.3% 25.7% 16.5% 14.6% |
|TERMINAL (d) | 3/30 (10%) 5/38 (13%) 6/37 (16%) 7/37 (19%) |8/39 (21%) 8/37 (22%) 5/39 (13%) 7/41 (17%) |
|FIRST INCIDENCE | 704 729 (T) 621 729 (T) |380 675 387 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.262 P=0.633 P=0.203 P=0.385 |P=0.141N P=0.371 P=0.396N P=0.263N |
|POLY 3 | P=0.173 P=0.492 P=0.150 P=0.243 |P=0.151N P=0.397 P=0.371N P=0.279N |
|POLY 1.5 | P=0.164 P=0.490 P=0.139 P=0.236 |P=0.158N P=0.399 P=0.380N P=0.286N |
|POLY 6 | P=0.187 P=0.497 P=0.164 P=0.256 |P=0.145N P=0.395 P=0.364N P=0.273N |
|LOGISTIC REGRESSION| P=0.178 P=0.530 P=0.130 P=0.296 |P=0.189N P=0.407 P=0.454N P=0.314N |
|COCH-ARM / FISHERS | P=0.152 P=0.486 P=0.124 P=0.225 |P=0.170N P=0.405 P=0.398N P=0.298N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/49 (0%) 0/45 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.32 0/42.88 0/46.38 0/42.20 |0/45.91 0/46.28 2/47.28 2/48.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.2% 4.2% |
|TERMINAL (d) | 0/30 (0%) 0/38 (0%) 0/37 (0%) 0/37 (0%) |0/39 (0%) 0/37 (0%) 1/39 (3%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 655 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.098 (e) P=0.245 P=0.249 |
|POLY 3 | (e) (e) (e) (e) |P=0.094 (e) P=0.244 P=0.248 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.091 (e) P=0.242 P=0.244 |
|POLY 6 | (e) (e) (e) (e) |P=0.097 (e) P=0.245 P=0.251 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.086 (e) P=0.229 P=0.249 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.086 (e) P=0.247 P=0.247 |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 39/49 (80%) 45/50 (90%) 45/50 (90%) | |
|POLY-3 RATE (b) | 39/48.40 39/46.73 45/49.41 45/48.10 | |
|POLY-3 PERCENT (g) | 80.6% 83.5% 91.1% 93.6% | |
|TERMINAL (d) | 24/31 (77%) 32/38 (84%) 35/38 (92%) 39/40 (98%) | |
|FIRST INCIDENCE | 504 581 523 591 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.478N P=0.197N P=0.479N P=0.368N | |
|POLY 3 | P=0.020 * P=0.460 P=0.107 P=0.045 * | |
|POLY 1.5 | P=0.027 * P=0.490 P=0.100 P=0.059 | |
|POLY 6 | P=0.015 * P=0.427 P=0.109 P=0.032 * | |
|LOGISTIC REGRESSION| P=0.060 P=0.552 P=0.127 P=0.116 | |
|COCH-ARM / FISHERS | P=0.039 * P=0.521 P=0.086 P=0.086 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 29/50 (58%) 24/50 (48%) 18/50 (36%) | |
|POLY-3 RATE (b) | 27/48.20 29/47.37 24/49.16 18/47.19 | |
|POLY-3 PERCENT (g) | 56.0% 61.2% 48.8% 38.1% | |
|TERMINAL (d) | 14/31 (45%) 24/38 (63%) 17/38 (45%) 15/40 (38%) | |
|FIRST INCIDENCE | 378 490 523 617 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005N** P=0.431N P=0.155N P=0.016N* | |
|POLY 3 | P=0.020N* P=0.378 P=0.305N P=0.058N | |
|POLY 1.5 | P=0.020N* P=0.395 P=0.322N P=0.056N | |
|POLY 6 | P=0.019N* P=0.360 P=0.285N P=0.059N | |
|LOGISTIC REGRESSION| P=0.021N* P=0.420 P=0.432N P=0.055N | |
|COCH-ARM / FISHERS | P=0.020N* P=0.420 P=0.345N P=0.054N | |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Prostate: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 11/50 (22%) 7/50 (14%) 1/50 (2%) | |
|POLY-3 RATE (b) | 12/45.44 11/45.31 7/47.38 1/46.53 | |
|POLY-3 PERCENT (g) | 26.4% 24.3% 14.8% 2.2% | |
|TERMINAL (d) | 8/31 (26%) 10/38 (26%) 7/38 (18%) 1/40 (3%) | |
|FIRST INCIDENCE | 639 627 729 (T) 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.331N P=0.075N P<0.001N** | |
|POLY 3 | P<0.001N** P=0.503N P=0.128N P<0.001N** | |
|POLY 1.5 | P<0.001N** P=0.501N P=0.137N P<0.001N** | |
|POLY 6 | P<0.001N** P=0.502N P=0.118N P<0.001N** | |
|LOGISTIC REGRESSION| P<0.001N** P=0.493N P=0.105N P<0.001N** | |
|COCH-ARM / FISHERS | P<0.001N** P=0.500N P=0.154N P<0.001N** | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/45.32 0/44.95 0/47.38 1/46.53 |1/45.91 0/46.28 0/47.00 2/48.25 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 2.2% |2.2% 0.0% 0.0% 4.2% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 1/40 (3%) |1/39 (3%) 0/37 (0%) 0/39 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 591 --- --- 729 (T) |729 (T) --- --- 676 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.617 P=0.508N P=0.496N P=0.732N |P=0.263 P=0.511N P=0.500N P=0.517 |
|POLY 3 | P=0.601 P=0.502N P=0.491N P=0.755N |P=0.252 P=0.498N P=0.495N P=0.517 |
|POLY 1.5 | P=0.598 P=0.501N P=0.495N P=0.757N |P=0.250 P=0.499N P=0.497N P=0.511 |
|POLY 6 | P=0.604 P=0.502N P=0.487N P=0.751N |P=0.255 P=0.499N P=0.495N P=0.524 |
|LOGISTIC REGRESSION| P=0.559 P=0.536N P=0.648N P=0.739 |P=0.247 (e) (e) P=0.502 |
|COCH-ARM / FISHERS | P=0.595 P=0.500N P=0.500N P=0.753N |P=0.246 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/45.18 0/44.95 0/47.38 0/46.53 |1/45.91 1/46.28 0/47.00 0/47.05 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% |2.2% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 1/31 (3%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |1/39 (3%) 1/37 (3%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 639 --- --- --- |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.102N P=0.222N P=0.208N P=0.207N |P=0.231N P=0.750 P=0.500N P=0.495N |
|POLY 3 | P=0.112N P=0.238N P=0.227N P=0.231N |P=0.236N P=0.759N P=0.495N P=0.495N |
|POLY 1.5 | P=0.113N P=0.238N P=0.231N P=0.233N |P=0.237N P=0.759N P=0.497N P=0.498N |
|POLY 6 | P=0.112N P=0.238N P=0.222N P=0.227N |P=0.236N P=0.759N P=0.495N P=0.492N |
|LOGISTIC REGRESSION| P=0.122N P=0.238N P=0.259N P=0.247N |P=0.231N P=0.750 (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.238N P=0.753N P=0.500N P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/44.85 0/44.95 0/47.38 0/46.53 |1/45.91 2/46.28 0/47.00 2/47.27 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 4.3% 0.0% 4.2% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |1/39 (3%) 2/37 (5%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) --- 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.487 P=0.482 P=0.500N P=0.513 |
|POLY 3 | (e) (e) (e) (e) |P=0.478 P=0.503 P=0.495N P=0.510 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.472 P=0.502 P=0.497N P=0.504 |
|POLY 6 | (e) (e) (e) (e) |P=0.483 P=0.502 P=0.495N P=0.516 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.476 P=0.482 (e) P=0.493 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.462 P=0.500 P=0.500N P=0.492 |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin: Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 0/50 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/44.85 0/44.95 0/47.38 0/46.53 |1/45.91 3/46.28 0/47.00 1/47.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 6.5% 0.0% 2.1% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |1/39 (3%) 3/37 (8%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.396N P=0.286 P=0.500N P=0.756N |
|POLY 3 | (e) (e) (e) (e) |P=0.404N P=0.308 P=0.495N P=0.755N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.408N P=0.308 P=0.497N P=0.758N |
|POLY 6 | (e) (e) (e) (e) |P=0.400N P=0.308 P=0.495N P=0.752N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.396N P=0.286 (e) P=0.756N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.416N P=0.309 P=0.500N P=0.747 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 2/50 (4%) 4/50 (8%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/44.85 4/45.21 2/47.38 4/47.00 |1/45.99 1/46.28 1/47.20 1/48.05 |
|POLY-3 PERCENT (g) | 6.7% 8.9% 4.2% 8.5% |2.2% 2.2% 2.1% 2.1% |
|TERMINAL (d) | 3/31 (10%) 3/38 (8%) 2/38 (5%) 3/40 (8%) |0/39 (0%) 1/37 (3%) 0/39 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 729 (T) 659 729 (T) 591 |708 729 (T) 676 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.571N P=0.594 P=0.407N P=0.617 |P=0.611N P=0.752 P=0.760 P=0.747N |
|POLY 3 | P=0.508 P=0.504 P=0.475N P=0.525 |P=0.622N P=0.759N P=0.755N P=0.751N |
|POLY 1.5 | P=0.497 P=0.502 P=0.485N P=0.515 |P=0.626N P=0.759N P=0.757N P=0.754N |
|POLY 6 | P=0.524 P=0.510 P=0.463N P=0.542 |P=0.619N P=0.760N P=0.754N P=0.748N |
|LOGISTIC REGRESSION| P=0.500 P=0.506 P=0.407N P=0.511 |P=0.632N P=0.761N P=0.756 P=0.754N |
|COCH-ARM / FISHERS | P=0.481 P=0.500 P=0.500N P=0.500 |P=0.634 P=0.753N P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 13/50 (26%) 19/50 (38%) 25/50 (50%) |26/50 (52%) 26/50 (52%) 45/50 (90%) 43/50 (86%) |
|POLY-3 RATE (b) | 9/46.50 13/46.86 19/48.19 25/48.55 |26/48.05 26/46.57 45/49.41 43/49.75 |
|POLY-3 PERCENT (g) | 19.4% 27.8% 39.4% 51.5% |54.1% 55.8% 91.1% 86.4% |
|TERMINAL (d) | 4/31 (13%) 8/38 (21%) 14/38 (37%) 21/40 (53%) |21/39 (54%) 23/37 (62%) 38/39 (97%) 37/41 (90%) |
|FIRST INCIDENCE | 504 592 621 496 |497 659 387 532 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.339 P=0.084 P=0.010 * |P<0.001 ** P=0.487 P<0.001 ** P=0.003 ** |
|POLY 3 | P<0.001 ** P=0.239 P=0.025 * P<0.001 ** |P<0.001 ** P=0.516 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.236 P=0.024 * P<0.001 ** |P<0.001 ** P=0.546 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.247 P=0.028 * P<0.001 ** |P<0.001 ** P=0.470 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.230 P=0.019 * P<0.001 ** |P<0.001 ** P=0.564N P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.235 P=0.022 * P<0.001 ** |P<0.001 ** P=0.579N P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 12/50 (24%) 24/50 (48%) 38/50 (76%) |24/50 (48%) 32/50 (64%) 45/50 (90%) 48/50 (96%) |
|POLY-3 RATE (b) | 9/45.81 12/46.18 24/49.13 38/48.85 |24/47.40 32/47.20 45/48.44 48/49.39 |
|POLY-3 PERCENT (g) | 19.7% 26.0% 48.9% 77.8% |50.6% 67.8% 92.9% 97.2% |
|TERMINAL (d) | 5/31 (16%) 9/38 (24%) 18/38 (47%) 32/40 (80%) |19/39 (49%) 28/37 (76%) 38/39 (97%) 41/41 (100%) |
|FIRST INCIDENCE | 591 515 523 497 |504 629 639 532 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.446 P=0.013 * P<0.001 ** |P<0.001 ** P=0.057 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.317 P=0.002 ** P<0.001 ** |P<0.001 ** P=0.064 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.316 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.069 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.322 P=0.003 ** P<0.001 ** |P<0.001 ** P=0.057 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.312 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.082 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.312 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.079 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.18 2/45.80 1/47.48 0/46.53 |1/45.91 1/46.55 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 4.3% 4.4% 2.1% 0.0% |2.2% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |1/39 (3%) 0/37 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 378 581 704 --- |729 (T) 659 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.122N P=0.682 P=0.483N P=0.240N |P=0.227N P=0.754 P=0.500N P=0.490N |
|POLY 3 | P=0.124N P=0.691 P=0.490N P=0.235N |P=0.234N P=0.757N P=0.495N P=0.491N |
|POLY 1.5 | P=0.125N P=0.691 P=0.495N P=0.237N |P=0.235N P=0.758N P=0.497N P=0.494N |
|POLY 6 | P=0.122N P=0.694 P=0.484N P=0.232N |P=0.233N P=0.757N P=0.495N P=0.488N |
|LOGISTIC REGRESSION| P=0.205N P=0.699 P=0.726 P=0.355N |P=0.244N P=0.761 (e) (e) |
|COCH-ARM / FISHERS | P=0.125N P=0.691N P=0.500N P=0.247N |P=0.236N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/46.57 1/45.44 1/47.48 1/46.67 |2/46.71 0/46.28 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 8.6% 2.2% 2.1% 2.1% |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |0/39 (0%) 0/37 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 378 581 704 693 |504 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.127N P=0.186N P=0.164N P=0.172N |P=0.114N P=0.237N P=0.243N P=0.230N |
|POLY 3 | P=0.130N P=0.186N P=0.173N P=0.178N |P=0.113N P=0.239N P=0.236N P=0.231N |
|POLY 1.5 | P=0.132N P=0.184N P=0.176N P=0.179N |P=0.114N P=0.238N P=0.236N P=0.233N |
|POLY 6 | P=0.128N P=0.187N P=0.169N P=0.175N |P=0.113N P=0.241N P=0.237N P=0.230N |
|LOGISTIC REGRESSION| P=0.206N P=0.165N P=0.364N P=0.239N |P=0.150N P=0.254N P=0.276N P=0.377N |
|COCH-ARM / FISHERS | P=0.134N P=0.181N P=0.181N P=0.181N |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.35 2/45.80 3/48.08 2/46.76 |3/46.66 2/46.65 1/47.19 0/48.05 |
|POLY-3 PERCENT (g) | 4.4% 4.4% 6.2% 4.3% |6.4% 4.3% 2.1% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |1/39 (3%) 0/37 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 591 581 627 693 |504 659 679 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.580N P=0.691 P=0.543 P=0.659N |P=0.059N P=0.505N P=0.311N P=0.115N |
|POLY 3 | P=0.585 P=0.690N P=0.527 P=0.683N |P=0.059N P=0.500N P=0.301N P=0.114N |
|POLY 1.5 | P=0.578 P=0.692N P=0.516 P=0.687N |P=0.060N P=0.500N P=0.303N P=0.115N |
|POLY 6 | P=0.589N P=0.687N P=0.541 P=0.675N |P=0.058N P=0.501N P=0.302N P=0.112N |
|LOGISTIC REGRESSION| P=0.490 P=0.681 P=0.385 P=0.672 |P=0.081N P=0.519N P=0.342N P=0.172N |
|COCH-ARM / FISHERS | P=0.569 P=0.691N P=0.500 P=0.691N |P=0.062N P=0.500N P=0.309N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/46.43 1/45.41 0/47.38 2/47.31 |0/45.91 2/46.42 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 10.8% 2.2% 0.0% 4.2% |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |0/39 (0%) 0/37 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 378 592 --- 496 |--- 701 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.152N P=0.106N P=0.030N* P=0.195N |P=0.391N P=0.245 (e) (e) |
|POLY 3 | P=0.156N P=0.106N P=0.029N* P=0.209N |P=0.394N P=0.240 (e) (e) |
|POLY 1.5 | P=0.159N P=0.105N P=0.030N* P=0.213N |P=0.398N P=0.239 (e) (e) |
|POLY 6 | P=0.154N P=0.107N P=0.028N* P=0.203N |P=0.392N P=0.240 (e) (e) |
|LOGISTIC REGRESSION| P=0.250N P=0.098N P=0.071N P=0.284N |P=0.401N P=0.239 (e) (e) |
|COCH-ARM / FISHERS | P=0.165N P=0.102N P=0.028N* P=0.218N |P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.68 0/44.95 0/47.38 1/46.67 |0/45.91 0/46.28 0/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 2.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 0/40 (0%) |0/39 (0%) 0/37 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 591 --- --- 693 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.449N P=0.249N P=0.230N P=0.488N |(e) (e) (e) (e) |
|POLY 3 | P=0.456N P=0.241N P=0.229N P=0.493N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.458N P=0.239N P=0.232N P=0.496N |(e) (e) (e) (e) |
|POLY 6 | P=0.454N P=0.242N P=0.226N P=0.488N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.532N P=0.255N P=0.353N P=0.566N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.461N P=0.247N P=0.247N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 11/50 (22%) 8/50 (16%) 30/50 (60%) | |
|POLY-3 RATE (b) | 7/45.70 11/45.44 8/47.84 30/48.52 | |
|POLY-3 PERCENT (g) | 15.3% 24.2% 16.7% 61.8% | |
|TERMINAL (d) | 3/31 (10%) 9/38 (24%) 6/38 (16%) 25/40 (63%) | |
|FIRST INCIDENCE | 591 659 659 496 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.328 P=0.589N P<0.001 ** | |
|POLY 3 | P<0.001 ** P=0.211 P=0.538 P<0.001 ** | |
|POLY 1.5 | P<0.001 ** P=0.214 P=0.524 P<0.001 ** | |
|POLY 6 | P<0.001 ** P=0.210 P=0.555 P<0.001 ** | |
|LOGISTIC REGRESSION| P<0.001 ** P=0.218 P=0.497 P<0.001 ** | |
|COCH-ARM / FISHERS | P<0.001 ** P=0.218 P=0.500 P<0.001 ** | |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 15/50 (30%) 7/50 (14%) 23/50 (46%) | |
|POLY-3 RATE (b) | 7/45.64 15/46.91 7/48.24 23/47.66 | |
|POLY-3 PERCENT (g) | 15.3% 32.0% 14.5% 48.3% | |
|TERMINAL (d) | 4/31 (13%) 10/38 (26%) 4/38 (11%) 20/40 (50%) | |
|FIRST INCIDENCE | 591 515 627 591 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.099 P=0.494N P=0.006 ** | |
|POLY 3 | P<0.001 ** P=0.049 * P=0.570N P<0.001 ** | |
|POLY 1.5 | P<0.001 ** P=0.046 * P=0.587N P<0.001 ** | |
|POLY 6 | P<0.001 ** P=0.053 P=0.548N P<0.001 ** | |
|LOGISTIC REGRESSION| P<0.001 ** P=0.045 * P=0.575 P<0.001 ** | |
|COCH-ARM / FISHERS | P<0.001 ** P=0.045 * P=0.613N P<0.001 ** | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/47 (0%) 2/44 (5%) 0/46 (0%) |0/48 (0%) 1/48 (2%) 0/45 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.95 0/42.44 2/42.16 0/42.53 |0/43.91 1/44.40 0/42.41 1/48.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 0.0% |0.0% 2.3% 0.0% 2.1% |
|TERMINAL (d) | 0/31 (0%) 0/36 (0%) 2/36 (6%) 0/36 (0%) |0/37 (0%) 1/36 (3%) 0/36 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.619 (e) P=0.272 (e) |P=0.430 P=0.495 (e) P=0.520 |
|POLY 3 | P=0.594 (e) P=0.228 (e) |P=0.428 P=0.502 (e) P=0.518 |
|POLY 1.5 | P=0.589 (e) P=0.222 (e) |P=0.423 P=0.502 (e) P=0.514 |
|POLY 6 | P=0.602 (e) P=0.235 (e) |P=0.433 P=0.502 (e) P=0.521 |
|LOGISTIC REGRESSION| (e) (e) P=0.272 (e) |(e) P=0.495 (e) P=0.520 |
|COCH-ARM / FISHERS | P=0.581 (e) P=0.221 (e) |P=0.414 P=0.500 (e) P=0.510 |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Ultimobranchial Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.85 0/44.95 0/47.38 2/47.22 |0/45.91 0/46.28 1/47.28 2/48.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.2% |0.0% 0.0% 2.1% 4.2% |
|TERMINAL (d) | 0/31 (0%) 0/38 (0%) 0/38 (0%) 1/40 (3%) |0/39 (0%) 0/37 (0%) 0/39 (0%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- --- 496 |--- --- 655 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.053 (e) (e) P=0.270 |P=0.079 (e) P=0.509 P=0.249 |
|POLY 3 | P=0.048 * (e) (e) P=0.249 |P=0.075 (e) P=0.506 P=0.248 |
|POLY 1.5 | P=0.047 * (e) (e) P=0.244 |P=0.073 (e) P=0.504 P=0.244 |
|POLY 6 | P=0.049 * (e) (e) P=0.255 |P=0.077 (e) P=0.507 P=0.251 |
|LOGISTIC REGRESSION| P=0.026 * (e) (e) P=0.171 |P=0.066 (e) P=0.479 P=0.249 |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |P=0.070 (e) P=0.500 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 8/50 (16%) 3/50 (6%) 7/50 (14%) |16/50 (32%) 14/50 (28%) 13/50 (26%) 8/50 (16%) |
|POLY-3 RATE (b) | 7/45.69 8/45.18 3/47.38 7/46.53 |16/46.04 14/46.40 13/47.33 8/48.38 |
|POLY-3 PERCENT (g) | 15.3% 17.7% 6.3% 15.0% |34.8% 30.2% 27.5% 16.5% |
|TERMINAL (d) | 3/31 (10%) 7/38 (18%) 3/38 (8%) 7/40 (18%) |15/39 (39%) 12/37 (32%) 12/39 (31%) 7/41 (17%) |
|FIRST INCIDENCE | 639 668 729 (T) 729 (T) |695 702 639 639 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.319N P=0.602 P=0.111N P=0.454N |P=0.024N* P=0.476N P=0.326N P=0.037N* |
|POLY 3 | P=0.438N P=0.491 P=0.143N P=0.599N |P=0.024N* P=0.402N P=0.296N P=0.034N* |
|POLY 1.5 | P=0.445N P=0.495 P=0.148N P=0.604N |P=0.028N* P=0.405N P=0.308N P=0.039N* |
|POLY 6 | P=0.431N P=0.486 P=0.138N P=0.594N |P=0.020N* P=0.404N P=0.289N P=0.030N* |
|LOGISTIC REGRESSION| P=0.413N P=0.502 P=0.154N P=0.588N |P=0.022N* P=0.414N P=0.305N P=0.033N* |
|COCH-ARM / FISHERS | P=0.457N P=0.500 P=0.159N P=0.613N |P=0.037N* P=0.414N P=0.330N P=0.050N |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.85 2/44.95 1/47.41 0/46.53 |0/45.91 1/46.28 1/47.00 0/48.05 |
|POLY-3 PERCENT (g) | 0.0% 4.5% 2.1% 0.0% |0.0% 2.2% 2.1% 0.0% |
|TERMINAL (d) | 0/31 (0%) 2/38 (5%) 0/38 (0%) 0/40 (0%) |0/39 (0%) 1/37 (3%) 1/39 (3%) 0/41 (0%) |
|FIRST INCIDENCE | --- 729 (T) 724 --- |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.412N P=0.284 P=0.543 (e) |P=0.579N P=0.489 P=0.500 (e) |
|POLY 3 | P=0.447N P=0.238 P=0.511 (e) |P=0.582N P=0.502 P=0.505 (e) |
|POLY 1.5 | P=0.453N P=0.238 P=0.507 (e) |P=0.586N P=0.501 P=0.503 (e) |
|POLY 6 | P=0.438N P=0.239 P=0.517 (e) |P=0.578N P=0.501 P=0.505 (e) |
|LOGISTIC REGRESSION| P=0.431N P=0.284 P=0.522 (e) |(e) P=0.489 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.461N P=0.247 P=0.500 (e) |P=0.595N P=0.500 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus |
| Prolapse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | |0/45.91 0/46.28 0/47.00 2/48.77 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 0.0% 4.1% |
|TERMINAL (d) | |0/39 (0%) 0/37 (0%) 0/39 (0%) 0/41 (0%) |
|FIRST INCIDENCE | |--- --- --- 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.051 (e) (e) P=0.256 |
|POLY 3 | |P=0.048 * (e) (e) P=0.251 |
|POLY 1.5 | |P=0.047 * (e) (e) P=0.246 |
|POLY 6 | |P=0.049 * (e) (e) P=0.257 |
|LOGISTIC REGRESSION| |P=0.020 * (e) (e) P=0.120 |
|COCH-ARM / FISHERS | |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 01/04/01 EXPERIMENT: 05205 TEST: 07 Page 47
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |5/50 (10%) 10/50 (20%) 13/50 (26%) 19/50 (38%) |
|POLY-3 RATE (b) | |5/45.91 10/46.28 13/47.16 19/48.20 |
|POLY-3 PERCENT (g) | |10.9% 21.6% 27.6% 39.4% |
|TERMINAL (d) | |5/39 (13%) 10/37 (27%) 12/39 (31%) 17/41 (42%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 687 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P<0.001 ** P=0.104 P=0.032 * P=0.002 ** |
|POLY 3 | |P<0.001 ** P=0.132 P=0.036 * P<0.001 ** |
|POLY 1.5 | |P<0.001 ** P=0.132 P=0.035 * P<0.001 ** |
|POLY 6 | |P<0.001 ** P=0.131 P=0.036 * P<0.001 ** |
|LOGISTIC REGRESSION| |P<0.001 ** P=0.104 P=0.033 * P=0.002 ** |
|COCH-ARM / FISHERS | |P<0.001 ** P=0.131 P=0.033 * P<0.001 ** |
|=================================================================================================================================|
(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).
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