TDMS Study 05205-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst P-NITROTOLUENE DATE: 02/08/00
EXPERIMENT: 05205 TEST: 08 TIME: 09:33:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62537D
PATHOLOGIST: FARNELL, D. CAS: 99-99-0
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FINAL#1 CHRONIC STUDY FOR MICE
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: 02/08/00
EXPERIMENT: 05205 TEST: 08 TIME: 09:33:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62537D
PATHOLOGIST: FARNELL, D. CAS: 99-99-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF P-NITROTOLUENE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Cytoplasmic Alteration Focal
Intestine Small, Ileum: Peyer's Patch Hyperplasia Lymphoid
Intestine Small, Jejunum: Peyer's Patch
Hyperplasia Lymphoid
Liver Basophilic Focus
Liver: Hepatocyte Syncytial Alteration Focal
Lung Hemorrhage
Infiltration Cellular Mixed Cell
Lung: Alveolar Epithelium Bronchiolization
Hyperplasia
Parathyroid Gland Cyst
Testes: Germinal Epithelium Degeneration
Thyroid Gland Degeneration Cystic Focal
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Kidney Nephropathy
Liver: Hepatocyte, Centrilobular Vacuolization Cytoplasmic
Lung: Alveolar Epithelium Bronchiolization
Lymph Node, Mesenteric Hyperplasia Lymphoid
Spleen Hematopoietic Cell Proliferation
Stomach, Forestomach Diverticulum
Thyroid Gland Degeneration Cystic Focal
===============================================================
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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) | 0/49 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.1% 0.0% 0.0% |0.0% 2.0% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 2/46 (4%) 0/45 (0%) 0/42 (0%) |0/46 (0%) 1/47 (2%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.420N P=0.243 (e) (e) |P=0.559N P=0.504 (e) (e) |
|POLY 3 | P=0.407N P=0.241 (e) (e) |P=0.569N P=0.499 (e) (e) |
|POLY 1.5 | P=0.405N P=0.241 (e) (e) |P=0.569N P=0.499 (e) (e) |
|POLY 6 | P=0.410N P=0.242 (e) (e) |P=0.569N P=0.500 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.243 (e) (e) |(e) P=0.504 (e) (e) |
|COCH-ARM / FISHERS | P=0.402N P=0.253 (e) (e) |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 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 5/50 (10%) 9/49 (18%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.1% 10.3% 18.9% 4.2% |0.0% 2.0% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 5/46 (11%) 9/45 (20%) 2/42 (5%) |0/46 (0%) 1/47 (2%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 717 729 (T) 729 (T) 729 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.432 P=0.109 P=0.010 * P=0.471 |P=0.559N P=0.504 (e) (e) |
|POLY 3 | P=0.461 P=0.106 P=0.008 ** P=0.497 |P=0.569N P=0.499 (e) (e) |
|POLY 1.5 | P=0.476 P=0.106 P=0.008 ** P=0.502 |P=0.569N P=0.499 (e) (e) |
|POLY 6 | P=0.439 P=0.106 P=0.007 ** P=0.490 |P=0.569N P=0.500 (e) (e) |
|LOGISTIC REGRESSION| P=0.439 P=0.107 P=0.009 ** P=0.493 |(e) P=0.504 (e) (e) |
|COCH-ARM / FISHERS | P=0.492 P=0.107 P=0.008 ** P=0.508 |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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) | 4/49 (8%) 0/50 (0%) 0/49 (0%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.3% 0.0% 0.0% 8.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/45 (9%) 0/46 (0%) 0/45 (0%) 4/42 (10%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.370 P=0.061N P=0.064N P=0.605 |(e) (e) (e) (e) |
|POLY 3 | P=0.404 P=0.058N P=0.061N P=0.639 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.407 P=0.059N P=0.061N P=0.639N |(e) (e) (e) (e) |
|POLY 6 | P=0.400 P=0.058N P=0.063N P=0.629 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.370 (e) (e) P=0.605 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.409 P=0.056N P=0.059N P=0.631N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex: Capsule |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 6/50 (12%) 1/49 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.1% 12.3% 2.1% 2.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/45 (2%) 6/46 (13%) 1/45 (2%) 1/42 (2%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.290N P=0.062 P=0.761 P=0.746 |(e) (e) (e) (e) |
|POLY 3 | P=0.267N P=0.059 P=0.759 P=0.759 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.262N P=0.059 P=0.760 P=0.759N |(e) (e) (e) (e) |
|POLY 6 | P=0.275N P=0.060 P=0.757 P=0.755 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.290N P=0.062 P=0.761 P=0.746 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.258N P=0.059 P=0.753N P=0.747N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 0/45 (0%) 2/49 (4%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| |2.0% 0.0% 4.2% 0.0% |
|TERMINAL (d) | |1/46 (2%) 0/42 (0%) 1/42 (2%) 0/47 (0%) |
|FIRST INCIDENCE | |729 (T) --- 625 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.456N P=0.518N P=0.474 P=0.496N |
|POLY 3 | |P=0.463N P=0.522N P=0.486 P=0.508N |
|POLY 1.5 | |P=0.465N P=0.522N P=0.488 P=0.509N |
|POLY 6 | |P=0.459N P=0.522N P=0.484 P=0.506N |
|LOGISTIC REGRESSION| |P=0.429N (e) P=0.561 (e) |
|COCH-ARM / FISHERS | |P=0.463N P=0.526N P=0.492 P=0.510N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 4/45 (9%) 3/49 (6%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| |2.0% 9.1% 6.4% 4.3% |
|TERMINAL (d) | |1/46 (2%) 4/42 (10%) 3/42 (7%) 2/47 (4%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.563 P=0.154 P=0.274 P=0.508 |
|POLY 3 | |P=0.537 P=0.146 P=0.288 P=0.485 |
|POLY 1.5 | |P=0.534 P=0.147 P=0.292 P=0.484 |
|POLY 6 | |P=0.545 P=0.146 P=0.285 P=0.490 |
|LOGISTIC REGRESSION| |P=0.563 P=0.154 P=0.274 P=0.508 |
|COCH-ARM / FISHERS | |P=0.539 P=0.150 P=0.301 P=0.485 |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 3/50 (6%) |4/50 (8%) 2/50 (4%) 1/50 (2%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 4.1% 2.1% 6.2% 6.3% |8.1% 4.1% 2.1% 12.2% |
|TERMINAL (d) | 2/46 (4%) 1/46 (2%) 3/45 (7%) 2/42 (5%) |4/46 (9%) 2/47 (4%) 1/43 (2%) 6/49 (12%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 681 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.266 P=0.500N P=0.490 P=0.463 |P=0.229 P=0.327N P=0.201N P=0.410 |
|POLY 3 | P=0.293 P=0.501N P=0.495 P=0.489 |P=0.203 P=0.340N P=0.188N P=0.370 |
|POLY 1.5 | P=0.298 P=0.502N P=0.498 P=0.494 |P=0.202 P=0.340N P=0.185N P=0.367 |
|POLY 6 | P=0.285 P=0.500N P=0.490 P=0.482 |P=0.205 P=0.339N P=0.191N P=0.377 |
|LOGISTIC REGRESSION| P=0.291 P=0.500N P=0.490 P=0.498 |P=0.229 P=0.327N P=0.201N P=0.410 |
|COCH-ARM / FISHERS | P=0.302 P=0.500N P=0.500 P=0.500 |P=0.205 P=0.339N P=0.181N P=0.370 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Heart |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.1% 2.0% 0.0% 0.0% |2.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/46 (2%) 0/46 (0%) 0/45 (0%) 0/42 (0%) |1/46 (2%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 665 689 --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.109N P=0.498N P=0.247N P=0.257N |P=0.302N P=0.496N P=0.513N P=0.487N |
|POLY 3 | P=0.102N P=0.502N P=0.241N P=0.245N |P=0.307N P=0.501N P=0.506N P=0.500N |
|POLY 1.5 | P=0.101N P=0.502N P=0.239N P=0.241N |P=0.306N P=0.501N P=0.504N P=0.501N |
|POLY 6 | P=0.103N P=0.501N P=0.244N P=0.250N |P=0.309N P=0.500N P=0.507N P=0.498N |
|LOGISTIC REGRESSION| P=0.099N P=0.481N P=0.245N P=0.227N |P=0.302N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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: Epicardium |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 0/42 (0%) |2/46 (4%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.114N P=0.234N P=0.253N P=0.225N |
|POLY 3 | (e) (e) (e) (e) |P=0.114N P=0.238N P=0.244N P=0.238N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.114N P=0.238N P=0.241N P=0.239N |
|POLY 6 | (e) (e) (e) (e) |P=0.115N P=0.238N P=0.246N P=0.235N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.114N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.247N 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 |
|=================================================================================================================================|
| |
|Intestine Small, Ileum: Peyer's Patch |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/48 (0%) 3/49 (6%) |2/49 (4%) 0/48 (0%) 0/48 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 6.4% |4.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 3/42 (7%) |2/46 (4%) 0/47 (0%) 0/41 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** (e) (e) P=0.106 |P=0.116N P=0.234N P=0.264N P=0.225N |
|POLY 3 | P=0.011 * (e) (e) P=0.116 |P=0.114N P=0.241N P=0.250N P=0.235N |
|POLY 1.5 | P=0.011 * (e) (e) P=0.119 |P=0.113N P=0.241N P=0.247N P=0.235N |
|POLY 6 | P=0.011 * (e) (e) P=0.112 |P=0.115N P=0.239N P=0.254N P=0.233N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.106 |P=0.116N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.012 * (e) (e) P=0.125 |P=0.114N P=0.253N P=0.253N P=0.242N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum: Peyer's Patch |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/48 (0%) 2/49 (4%) |1/49 (2%) 0/48 (0%) 0/48 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.2% |2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 2/42 (5%) |1/46 (2%) 0/47 (0%) 0/42 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.040 * (e) (e) P=0.219 |P=0.303N P=0.496N P=0.518N P=0.487N |
|POLY 3 | P=0.045 * (e) (e) P=0.233 |P=0.305N P=0.503N P=0.509N P=0.498N |
|POLY 1.5 | P=0.046 * (e) (e) P=0.237 |P=0.304N P=0.503N P=0.507N P=0.498N |
|POLY 6 | P=0.044 * (e) (e) P=0.229 |P=0.307N P=0.502N P=0.511N P=0.496N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.219 |P=0.303N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.253 |P=0.304N P=0.505N P=0.505N P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/49 (4%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.1% 4.2% 4.1% 0.0% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 2/46 (4%) 2/46 (4%) 2/45 (4%) 0/42 (0%) |0/46 (0%) 0/47 (0%) 1/43 (2%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.183N P=0.694 P=0.687 P=0.259N |P=0.698 (e) P=0.487 (e) |
|POLY 3 | P=0.170N P=0.686 P=0.690 P=0.244N |P=0.696 (e) P=0.497 (e) |
|POLY 1.5 | P=0.167N P=0.685 P=0.692 P=0.241N |P=0.694 (e) P=0.500 (e) |
|POLY 6 | P=0.176N P=0.687 P=0.686 P=0.248N |P=0.700 (e) P=0.494 (e) |
|LOGISTIC REGRESSION| P=0.183N P=0.694 P=0.687 (e) |(e) (e) P=0.487 (e) |
|COCH-ARM / FISHERS | P=0.162N P=0.684 P=0.691N P=0.247N |P=0.697 (e) P=0.505 (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.1% 0.0% 2.1% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/46 (4%) 0/46 (0%) 1/45 (2%) 0/42 (0%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 665 --- 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.096N P=0.123N P=0.317N P=0.138N |(e) (e) (e) (e) |
|POLY 3 | P=0.086N P=0.124N P=0.311N P=0.125N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.085N P=0.124N P=0.308N P=0.122N |(e) (e) (e) (e) |
|POLY 6 | P=0.087N P=0.124N P=0.316N P=0.129N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.084N P=0.119N P=0.305N P=0.115N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.086N P=0.125N P=0.309N P=0.121N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |1/49 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.1% 0.0% 4.2% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 0/42 (0%) |1/46 (2%) 0/47 (0%) 2/43 (5%) 0/49 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.449N P=0.496N P=0.476 P=0.487N |
|POLY 3 | (e) (e) (e) (e) |P=0.457N P=0.498N P=0.495 P=0.498N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.458N P=0.498N P=0.500 P=0.498N |
|POLY 6 | (e) (e) (e) (e) |P=0.454N P=0.499N P=0.490 P=0.496N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.449N (e) P=0.476 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.457N P=0.495N P=0.508 P=0.495N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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) | 46/50 (92%) 49/49 (100%) 47/50 (94%) 43/50 (86%) |11/49 (22%) 7/50 (14%) 9/50 (18%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 92.0% 100.0% 96.0% 88.3% |22.5% 14.3% 18.7% 6.1% |
|TERMINAL (d) | 42/46 (91%) 46/46 (100%) 45/45 (100%) 38/42 (91%) |9/46 (20%) 6/47 (13%) 6/43 (14%) 3/49 (6%) |
|FIRST INCIDENCE | 453 280 625 505 |654 664 669 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.526 P=0.268 P=0.368 P=0.510 |P=0.025N* P=0.213N P=0.461N P=0.019N* |
|POLY 3 | P=0.120N P=0.063 P=0.330 P=0.387N |P=0.025N* P=0.215N P=0.418N P=0.020N* |
|POLY 1.5 | P=0.084N P=0.063 P=0.407 P=0.327N |P=0.025N* P=0.211N P=0.404N P=0.019N* |
|POLY 6 | P=0.199N P=0.063 P=0.226 P=0.478N |P=0.025N* P=0.219N P=0.433N P=0.019N* |
|LOGISTIC REGRESSION| P=0.059N (e) P=0.520 P=0.297N |P=0.023N* P=0.179N P=0.365N P=0.018N* |
|COCH-ARM / FISHERS | P=0.057N P=0.061 P=0.500 P=0.262N |P=0.024N* P=0.204N P=0.382N P=0.018N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 1/50 (2%) 4/50 (8%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.1% 0.0% |0.0% 2.0% 8.4% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 0/42 (0%) |0/46 (0%) 0/47 (0%) 2/43 (5%) 0/49 (0%) |
|FIRST INCIDENCE | --- --- 693 --- |--- 680 714 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.684 (e) P=0.492 (e) |P=0.603 P=0.500 P=0.060 (e) |
|POLY 3 | P=0.683 (e) P=0.499 (e) |P=0.595 P=0.502 P=0.059 (e) |
|POLY 1.5 | P=0.689 (e) P=0.499 (e) |P=0.592 P=0.503 P=0.061 (e) |
|POLY 6 | P=0.675 (e) P=0.497 (e) |P=0.601 P=0.503 P=0.057 (e) |
|LOGISTIC REGRESSION| P=0.696 (e) P=0.487 (e) |P=0.607 P=0.578 P=0.062 (e) |
|COCH-ARM / FISHERS | P=0.695 (e) P=0.500 (e) |P=0.596 P=0.505 P=0.061 (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.0% 2.1% 4.1% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/46 (2%) 1/46 (2%) 2/45 (4%) 0/42 (0%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.392N P=0.761 P=0.492 P=0.518N |(e) (e) (e) (e) |
|POLY 3 | P=0.375N P=0.755 P=0.497 P=0.505N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.370N P=0.755 P=0.499 P=0.503N |(e) (e) (e) (e) |
|POLY 6 | P=0.382N P=0.756 P=0.493 P=0.509N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.392N P=0.761 P=0.492 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.365N P=0.747 P=0.500 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 |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 0/50 (0%) 2/50 (4%) |2/49 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 10.2% 10.3% 0.0% 4.2% |4.1% 6.1% 0.0% 0.0% |
|TERMINAL (d) | 5/46 (11%) 5/46 (11%) 0/45 (0%) 2/42 (5%) |2/46 (4%) 3/47 (6%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.096N P=0.630 P=0.036N* P=0.255N |P=0.071N P=0.510 P=0.253N P=0.225N |
|POLY 3 | P=0.081N P=0.628 P=0.032N* P=0.228N |P=0.072N P=0.504 P=0.241N P=0.235N |
|POLY 1.5 | P=0.080N P=0.627 P=0.031N* P=0.223N |P=0.071N P=0.506 P=0.238N P=0.235N |
|POLY 6 | P=0.084N P=0.629 P=0.033N* P=0.236N |P=0.071N P=0.503 P=0.244N P=0.233N |
|LOGISTIC REGRESSION| P=0.096N P=0.630 (e) P=0.255N |P=0.071N P=0.510 (e) (e) |
|COCH-ARM / FISHERS | P=0.079N P=0.630N P=0.028N* P=0.218N |P=0.071N P=0.510 P=0.242N P=0.242N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 7/50 (14%) 9/50 (18%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.2% 12.3% 14.5% 18.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/46 (9%) 6/46 (13%) 7/45 (16%) 9/42 (21%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058 P=0.370 P=0.249 P=0.085 |(e) (e) (e) (e) |
|POLY 3 | P=0.079 P=0.368 P=0.256 P=0.106 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.084 P=0.367 P=0.260 P=0.111 |(e) (e) (e) (e) |
|POLY 6 | P=0.072 P=0.370 P=0.250 P=0.099 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.058 P=0.370 P=0.249 P=0.085 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.088 P=0.370 P=0.262 P=0.117 |(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) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 6/50 (12%) |0/49 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.1% 6.0% 4.1% 12.5% |0.0% 6.1% 0.0% 0.0% |
|TERMINAL (d) | 3/46 (7%) 2/46 (4%) 1/45 (2%) 5/42 (12%) |0/46 (0%) 3/47 (6%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) 280 625 625 |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.126 P=0.661 P=0.510N P=0.205 |P=0.303N P=0.125 (e) (e) |
|POLY 3 | P=0.144 P=0.654N P=0.501N P=0.233 |P=0.311N P=0.121 (e) (e) |
|POLY 1.5 | P=0.148 P=0.657N P=0.500N P=0.238 |P=0.310N P=0.121 (e) (e) |
|POLY 6 | P=0.140 P=0.652N P=0.504N P=0.226 |P=0.310N P=0.120 (e) (e) |
|LOGISTIC REGRESSION| P=0.156 P=0.613N P=0.505N P=0.243 |(e) P=0.125 (e) (e) |
|COCH-ARM / FISHERS | P=0.151 P=0.661N P=0.500N P=0.243 |P=0.308N P=0.125 (e) (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 30/50 (60%) 26/50 (52%) 33/50 (66%) |40/49 (82%) 41/50 (82%) 39/50 (78%) 39/50 (78%) |
|POLY-3 ADJUSTED (b)| 60.3% 61.5% 53.2% 68.4% |81.8% 82.7% 78.9% 78.0% |
|TERMINAL (d) | 27/46 (59%) 30/46 (65%) 25/45 (56%) 29/42 (69%) |38/46 (83%) 40/47 (85%) 34/43 (79%) 38/49 (78%) |
|FIRST INCIDENCE | 453 729 (T) 597 625 |654 487 456 276 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.150 P=0.576 P=0.322N P=0.181 |P=0.238N P=0.583 P=0.454 P=0.287N |
|POLY 3 | P=0.260 P=0.533 P=0.306N P=0.263 |P=0.318N P=0.556 P=0.456N P=0.414N |
|POLY 1.5 | P=0.287 P=0.543 P=0.291N P=0.294 |P=0.325N P=0.569 P=0.441N P=0.418N |
|POLY 6 | P=0.228 P=0.526 P=0.328N P=0.230 |P=0.305N P=0.535 P=0.481N P=0.408N |
|LOGISTIC REGRESSION| P=0.268 P=0.572 P=0.274N P=0.304 |P=0.328N P=0.571 P=0.420N P=0.418N |
|COCH-ARM / FISHERS | P=0.322 P=0.581N P=0.273N P=0.339 |P=0.331N P=0.584 P=0.421N P=0.421N |
|=================================================================================================================================|
| | | |
| | 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%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.0% 2.1% 4.1% 6.3% |0.0% 2.0% 0.0% 0.0% |
|TERMINAL (d) | 1/46 (2%) 1/46 (2%) 2/45 (4%) 3/42 (7%) |0/46 (0%) 1/47 (2%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.139 P=0.761 P=0.492 P=0.274 |P=0.559N P=0.504 (e) (e) |
|POLY 3 | P=0.158 P=0.760 P=0.497 P=0.296 |P=0.569N P=0.502 (e) (e) |
|POLY 1.5 | P=0.162 P=0.759 P=0.499 P=0.300 |P=0.567N P=0.502 (e) (e) |
|POLY 6 | P=0.153 P=0.760 P=0.493 P=0.289 |P=0.569N P=0.501 (e) (e) |
|LOGISTIC REGRESSION| P=0.139 P=0.761 P=0.492 P=0.274 |(e) P=0.504 (e) (e) |
|COCH-ARM / FISHERS | P=0.165 P=0.753N P=0.500 P=0.309 |P=0.565N P=0.505 (e) (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 4/50 (8%) 3/50 (6%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 8.1% 6.2% 8.3% 6.3% |0.0% 4.1% 0.0% 2.0% |
|TERMINAL (d) | 3/46 (7%) 3/46 (7%) 4/45 (9%) 3/42 (7%) |0/46 (0%) 2/47 (4%) 0/43 (0%) 1/49 (2%) |
|FIRST INCIDENCE | 453 729 (T) 729 (T) 729 (T) |--- 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.513N P=0.502N P=0.632 P=0.542N |P=0.551 P=0.243 (e) P=0.513 |
|POLY 3 | P=0.485N P=0.510N P=0.629 P=0.523N |P=0.539 P=0.239 (e) P=0.502 |
|POLY 1.5 | P=0.475N P=0.508N P=0.635 P=0.514N |P=0.539 P=0.240 (e) P=0.502 |
|POLY 6 | P=0.498N P=0.511N P=0.620 P=0.536N |P=0.541 P=0.239 (e) P=0.504 |
|LOGISTIC REGRESSION| P=0.454N P=0.468N P=0.635 P=0.464N |(e) P=0.243 (e) P=0.513 |
|COCH-ARM / FISHERS | P=0.463N P=0.500N P=0.643N P=0.500N |P=0.543 P=0.253 (e) P=0.505 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Syncytial Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 13/50 (26%) 17/50 (34%) 33/50 (66%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.1% 26.7% 34.5% 66.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/46 (4%) 13/46 (28%) 15/45 (33%) 28/42 (67%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 597 505 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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, Centrilobular |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 6.1% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 0/42 (0%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 3/49 (6%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.014 * (e) (e) P=0.133 |
|POLY 3 | (e) (e) (e) (e) |P=0.011 * (e) (e) P=0.121 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.011 * (e) (e) P=0.121 |
|POLY 6 | (e) (e) (e) (e) |P=0.011 * (e) (e) P=0.123 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.133 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.012 * (e) (e) P=0.125 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.0% 0.0% 4.1% |0.0% 0.0% 0.0% 2.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 1/42 (2%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 1/49 (2%) |
|FIRST INCIDENCE | --- 711 --- 505 |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.132 P=0.500 (e) P=0.232 |P=0.208 (e) (e) P=0.513 |
|POLY 3 | P=0.138 P=0.500 (e) P=0.234 |P=0.199 (e) (e) P=0.500 |
|POLY 1.5 | P=0.139 P=0.499 (e) P=0.236 |P=0.198 (e) (e) P=0.499 |
|POLY 6 | P=0.135 P=0.501 (e) P=0.231 |P=0.201 (e) (e) P=0.502 |
|LOGISTIC REGRESSION| P=0.121 P=0.503 (e) P=0.221 |(e) (e) (e) P=0.513 |
|COCH-ARM / FISHERS | P=0.140 P=0.500 (e) P=0.247 |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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) | 0/50 (0%) 7/50 (14%) 4/50 (8%) 1/50 (2%) |1/50 (2%) 5/50 (10%) 2/50 (4%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 14.4% 8.2% 2.1% |2.0% 10.2% 4.2% 10.2% |
|TERMINAL (d) | 0/46 (0%) 7/46 (15%) 3/45 (7%) 0/42 (0%) |1/46 (2%) 4/47 (9%) 2/43 (5%) 5/49 (10%) |
|FIRST INCIDENCE | --- 729 (T) 689 597 |729 (T) 680 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.465N P=0.009 ** P=0.062 P=0.496 |P=0.176 P=0.110 P=0.476 P=0.119 |
|POLY 3 | P=0.433N P=0.008 ** P=0.060 P=0.496 |P=0.152 P=0.102 P=0.490 P=0.102 |
|POLY 1.5 | P=0.426N P=0.008 ** P=0.060 P=0.498 |P=0.151 P=0.102 P=0.494 P=0.101 |
|POLY 6 | P=0.444N P=0.008 ** P=0.059 P=0.494 |P=0.156 P=0.103 P=0.487 P=0.105 |
|LOGISTIC REGRESSION| P=0.416N P=0.009 ** P=0.063 P=0.479 |P=0.155 P=0.104 P=0.476 P=0.119 |
|COCH-ARM / FISHERS | P=0.420N P=0.006 ** P=0.059 P=0.500 |P=0.154 P=0.102 P=0.500 P=0.102 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 2.1% 2.1% |0.0% 0.0% 4.2% 0.0% |
|TERMINAL (d) | 0/46 (0%) 1/46 (2%) 1/45 (2%) 0/42 (0%) |0/46 (0%) 0/47 (0%) 1/43 (2%) 0/49 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 597 |--- --- 625 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.366 P=0.500 P=0.496 P=0.496 |P=0.597 (e) P=0.228 (e) |
|POLY 3 | P=0.378 P=0.499 P=0.498 P=0.496 |P=0.597 (e) P=0.233 (e) |
|POLY 1.5 | P=0.381 P=0.499 P=0.499 P=0.498 |P=0.594 (e) P=0.234 (e) |
|POLY 6 | P=0.372 P=0.500 P=0.496 P=0.494 |P=0.604 (e) P=0.232 (e) |
|LOGISTIC REGRESSION| P=0.381 P=0.500 P=0.496 P=0.479 |P=0.650 (e) P=0.298 (e) |
|COCH-ARM / FISHERS | P=0.384 P=0.500 P=0.500 P=0.500 |P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.2% |0.0% 2.0% 0.0% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 1/42 (2%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- --- --- 681 |--- 487 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.042 * (e) (e) P=0.225 |P=0.571N P=0.500 (e) (e) |
|POLY 3 | P=0.044 * (e) (e) P=0.232 |P=0.568N P=0.502 (e) (e) |
|POLY 1.5 | P=0.045 * (e) (e) P=0.235 |P=0.568N P=0.501 (e) (e) |
|POLY 6 | P=0.044 * (e) (e) P=0.229 |P=0.567N P=0.503 (e) (e) |
|LOGISTIC REGRESSION| P=0.047 * (e) (e) P=0.245 |P=0.245N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |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 |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Bronchiolization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 20/50 (40%) 30/50 (60%) 48/50 (96%) |0/50 (0%) 33/50 (66%) 41/50 (82%) 49/50 (98%) |
|POLY-3 ADJUSTED (b)| 0.0% 41.0% 61.9% 96.7% |0.0% 67.2% 83.7% 99.9% |
|TERMINAL (d) | 0/46 (0%) 20/46 (44%) 30/45 (67%) 41/42 (98%) |0/46 (0%) 32/47 (68%) 37/43 (86%) 49/49 (100%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 505 |--- 664 534 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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) | 1/50 (2%) 1/50 (2%) 4/50 (8%) 6/50 (12%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.0% 2.1% 8.3% 12.6% |4.1% 2.0% 4.2% 2.0% |
|TERMINAL (d) | 1/46 (2%) 1/46 (2%) 4/45 (9%) 6/42 (14%) |2/46 (4%) 1/47 (2%) 2/43 (5%) 1/49 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.761 P=0.174 P=0.045 * |P=0.427N P=0.492N P=0.670 P=0.478N |
|POLY 3 | P=0.012 * P=0.760 P=0.176 P=0.052 |P=0.445N P=0.502N P=0.683 P=0.500N |
|POLY 1.5 | P=0.012 * P=0.759 P=0.178 P=0.054 |P=0.447N P=0.501N P=0.687 P=0.502N |
|POLY 6 | P=0.011 * P=0.760 P=0.173 P=0.049 * |P=0.442N P=0.501N P=0.680 P=0.496N |
|LOGISTIC REGRESSION| P=0.009 ** P=0.761 P=0.174 P=0.045 * |P=0.427N P=0.492N P=0.670 P=0.478N |
|COCH-ARM / FISHERS | P=0.013 * P=0.753N P=0.181 P=0.056 |P=0.444N P=0.500N P=0.691N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.0% 0.0% 0.0% 0.0% |0.0% 2.0% 4.2% 0.0% |
|TERMINAL (d) | 1/46 (2%) 0/46 (0%) 0/45 (0%) 0/42 (0%) |0/46 (0%) 1/47 (2%) 2/43 (5%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.316N P=0.500N P=0.504N P=0.518N |P=0.601N P=0.504 P=0.224 (e) |
|POLY 3 | P=0.303N P=0.501N P=0.502N P=0.505N |P=0.616N P=0.499 P=0.231 (e) |
|POLY 1.5 | P=0.304N P=0.501N P=0.501N P=0.503N |P=0.618N P=0.499 P=0.233 (e) |
|POLY 6 | P=0.302N P=0.500N P=0.504N P=0.509N |P=0.611N P=0.500 P=0.229 (e) |
|LOGISTIC REGRESSION| P=0.316N (e) (e) (e) |(e) P=0.504 P=0.224 (e) |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.616N P=0.500 P=0.247 (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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, Bronchial |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 2.1% 0.0% |0.0% 0.0% 6.3% 2.0% |
|TERMINAL (d) | 0/46 (0%) 1/46 (2%) 1/45 (2%) 0/42 (0%) |0/46 (0%) 0/47 (0%) 3/43 (7%) 1/49 (2%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.615N P=0.500 P=0.496 (e) |P=0.263 (e) P=0.110 P=0.513 |
|POLY 3 | P=0.602N P=0.499 P=0.498 (e) |P=0.247 (e) P=0.114 P=0.500 |
|POLY 1.5 | P=0.598N P=0.499 P=0.499 (e) |P=0.245 (e) P=0.116 P=0.499 |
|POLY 6 | P=0.607N P=0.500 P=0.496 (e) |P=0.253 (e) P=0.112 P=0.502 |
|LOGISTIC REGRESSION| (e) P=0.500 P=0.496 (e) |(e) (e) P=0.110 P=0.513 |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.247 (e) P=0.121 P=0.500 |
|=================================================================================================================================|
| | | |
| | 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) | 1/48 (2%) 0/50 (0%) 1/45 (2%) 1/48 (2%) |0/50 (0%) 1/48 (2%) 2/48 (4%) 0/47 (0%) |
|POLY-3 ADJUSTED (b)| 2.1% 0.0% 2.3% 2.2% |0.0% 2.1% 4.4% 0.0% |
|TERMINAL (d) | 1/45 (2%) 0/46 (0%) 1/41 (2%) 1/40 (3%) |0/46 (0%) 1/45 (2%) 2/41 (5%) 0/46 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.504 P=0.496N P=0.741 P=0.735 |P=0.615N P=0.496 P=0.214 (e) |
|POLY 3 | P=0.523 P=0.493N P=0.743 P=0.753 |P=0.630N P=0.491 P=0.222 (e) |
|POLY 1.5 | P=0.529 P=0.493N P=0.745 P=0.756 |P=0.632N P=0.491 P=0.224 (e) |
|POLY 6 | P=0.516 P=0.493N P=0.739 P=0.747 |P=0.625N P=0.491 P=0.220 (e) |
|LOGISTIC REGRESSION| P=0.504 (e) P=0.741 P=0.735 |(e) P=0.496 P=0.214 (e) |
|COCH-ARM / FISHERS | P=0.534 P=0.490N P=0.736 P=0.753N |P=0.630N P=0.490 P=0.237 (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/49 (0%) 1/49 (2%) |0/48 (0%) 1/49 (2%) 2/49 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 2.1% |0.0% 2.1% 4.3% 4.1% |
|TERMINAL (d) | 0/46 (0%) 1/46 (2%) 0/44 (0%) 0/42 (0%) |0/46 (0%) 1/46 (2%) 1/42 (2%) 2/49 (4%) |
|FIRST INCIDENCE | --- 729 (T) --- 689 |--- 729 (T) 716 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.387 P=0.500 (e) P=0.487 |P=0.178 P=0.500 P=0.225 P=0.253 |
|POLY 3 | P=0.398 P=0.496 (e) P=0.493 |P=0.166 P=0.501 P=0.233 P=0.244 |
|POLY 1.5 | P=0.400 P=0.495 (e) P=0.494 |P=0.166 P=0.502 P=0.237 P=0.244 |
|POLY 6 | P=0.395 P=0.496 (e) P=0.491 |P=0.168 P=0.500 P=0.230 P=0.245 |
|LOGISTIC REGRESSION| P=0.403 P=0.500 (e) P=0.499 |P=0.168 P=0.500 P=0.236 P=0.253 |
|COCH-ARM / FISHERS | P=0.402 P=0.495 (e) P=0.495 |P=0.168 P=0.505 P=0.253 P=0.258 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/49 (2%) |2/48 (4%) 5/49 (10%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.1% |4.2% 10.4% 0.0% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/44 (0%) 1/42 (2%) |2/46 (4%) 5/46 (11%) 0/42 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.187 (e) (e) P=0.482 |P=0.050N P=0.217 P=0.259N P=0.225N |
|POLY 3 | P=0.195 (e) (e) P=0.492 |P=0.048N* P=0.219 P=0.242N P=0.231N |
|POLY 1.5 | P=0.196 (e) (e) P=0.494 |P=0.047N* P=0.221 P=0.238N P=0.231N |
|POLY 6 | P=0.193 (e) (e) P=0.489 |P=0.048N* P=0.216 P=0.246N P=0.230N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.482 |P=0.050N P=0.217 (e) (e) |
|COCH-ARM / FISHERS | P=0.197 (e) (e) P=0.495 |P=0.048N* P=0.226 P=0.242N P=0.237N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.2% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 625 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.598 (e) P=0.233 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.597 (e) P=0.233 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.594 (e) P=0.235 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.604 (e) P=0.232 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.662 (e) P=0.311 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/6 (17%) 1/7 (14%) 1/8 (13%) 2/5 (40%) |0/3 (0%) 2/3 (67%) 1/4 (25%) 1/7 (14%) |
|POLY-3 ADJUSTED (b)| 16.7% 14.4% 13.5% 40.0% |0.0% 66.7% 25.3% 14.3% |
|TERMINAL (d) | 0/5 (0%) 0/5 (0%) 0/5 (0%) 2/5 (40%) |0/2 (0%) 2/3 (67%) 0/2 (0%) 1/7 (14%) |
|FIRST INCIDENCE | 665 280 597 729 (T) |--- 729 (T) 714 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.338 P=0.760 P=0.753 P=0.487 |P=0.462N P=0.309 P=0.496 P=0.748 |
|POLY 3 | P=0.268 P=0.728N P=0.715N P=0.431 |P=0.427N P=0.185 P=0.572 P=0.678 |
|POLY 1.5 | P=0.270 P=0.727N P=0.706N P=0.431 |P=0.449N P=0.172 P=0.565 P=0.671 |
|POLY 6 | P=0.266 P=0.730N P=0.727N P=0.431 |P=0.392N P=0.209 P=0.584 P=0.689 |
|LOGISTIC REGRESSION| P=0.151 (e) P=0.382N P=0.487 |P=0.425N P=0.309 P=0.564 P=0.748 |
|COCH-ARM / FISHERS | P=0.263 P=0.731N P=0.692N P=0.424 |P=0.474N P=0.200 P=0.571 P=0.700 |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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%) 4/7 (57%) 4/8 (50%) 2/5 (40%) |1/3 (33%) 1/3 (33%) 1/4 (25%) 1/7 (14%) |
|POLY-3 ADJUSTED (b)| 69.5% 66.7% 57.5% 40.0% |36.7% 33.3% 25.3% 14.3% |
|TERMINAL (d) | 4/5 (80%) 4/5 (80%) 4/5 (80%) 2/5 (40%) |1/2 (50%) 1/3 (33%) 0/2 (0%) 1/7 (14%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 714 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.130N P=0.773 P=0.773 P=0.270N |P=0.332N P=0.691N P=0.758 P=0.460N |
|POLY 3 | P=0.226N P=0.690N P=0.557N P=0.367N |P=0.334N P=0.743N P=0.678N P=0.538N |
|POLY 1.5 | P=0.242N P=0.673N P=0.516N P=0.381N |P=0.341N P=0.751N P=0.687N P=0.550N |
|POLY 6 | P=0.206N P=0.684N P=0.620N P=0.342N |P=0.323N P=0.727N P=0.664N P=0.519N |
|LOGISTIC REGRESSION| P=0.130N P=0.773 P=0.773 P=0.270N |P=0.281N P=0.691N P=0.685N P=0.460N |
|COCH-ARM / FISHERS | P=0.266N P=0.587N P=0.471N P=0.392N |P=0.333N P=0.800N P=0.714N P=0.533N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Nose: Sinus |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.0% 4.1% 4.1% 4.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/46 (2%) 2/46 (4%) 2/45 (4%) 1/42 (2%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 721 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.386 P=0.500 P=0.492 P=0.469 |(e) (e) (e) (e) |
|POLY 3 | P=0.410 P=0.499 P=0.497 P=0.491 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.417 P=0.498 P=0.499 P=0.495 |(e) (e) (e) (e) |
|POLY 6 | P=0.400 P=0.500 P=0.493 P=0.484 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.392 P=0.500 P=0.492 P=0.481 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.423 P=0.500 P=0.500 P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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: Sinus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.0% 6.2% 6.2% 4.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/46 (2%) 3/46 (7%) 3/45 (7%) 1/42 (2%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 721 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.434 P=0.306 P=0.298 P=0.469 |(e) (e) (e) (e) |
|POLY 3 | P=0.460 P=0.305 P=0.302 P=0.491 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.469 P=0.304 P=0.304 P=0.495 |(e) (e) (e) (e) |
|POLY 6 | P=0.448 P=0.306 P=0.298 P=0.484 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.440 P=0.306 P=0.298 P=0.481 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.477 P=0.309 P=0.309 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 |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/48 (2%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| |2.1% 4.1% 0.0% 0.0% |
|TERMINAL (d) | |1/45 (2%) 2/47 (4%) 0/43 (0%) 0/48 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.183N P=0.515 P=0.509N P=0.487N |
|POLY 3 | |P=0.188N P=0.510 P=0.499N P=0.497N |
|POLY 1.5 | |P=0.187N P=0.512 P=0.496N P=0.498N |
|POLY 6 | |P=0.188N P=0.509 P=0.502N P=0.496N |
|LOGISTIC REGRESSION| |P=0.183N P=0.515 (e) (e) |
|COCH-ARM / FISHERS | |P=0.185N P=0.515 P=0.490N P=0.495N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |12/48 (25%) 14/50 (28%) 13/50 (26%) 13/49 (27%) |
|POLY-3 ADJUSTED (b)| |25.3% 28.1% 27.1% 27.1% |
|TERMINAL (d) | |12/45 (27%) 12/47 (26%) 11/43 (26%) 13/48 (27%) |
|FIRST INCIDENCE | |729 (T) 487 669 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.530N P=0.457 P=0.450 P=0.574 |
|POLY 3 | |P=0.497 P=0.465 P=0.514 P=0.514 |
|POLY 1.5 | |P=0.498 P=0.462 P=0.526 P=0.513 |
|POLY 6 | |P=0.504 P=0.471 P=0.503 P=0.524 |
|LOGISTIC REGRESSION| |P=0.509 P=0.499 P=0.491 P=0.574 |
|COCH-ARM / FISHERS | |P=0.514 P=0.458 P=0.547 P=0.524 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Ovary |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/48 (2%) 2/50 (4%) 5/50 (10%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| |2.1% 4.1% 10.5% 0.0% |
|TERMINAL (d) | |1/45 (2%) 2/47 (4%) 4/43 (9%) 0/48 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 716 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.386N P=0.515 P=0.096 P=0.487N |
|POLY 3 | |P=0.401N P=0.510 P=0.103 P=0.497N |
|POLY 1.5 | |P=0.403N P=0.512 P=0.107 P=0.498N |
|POLY 6 | |P=0.395N P=0.509 P=0.100 P=0.496N |
|LOGISTIC REGRESSION| |P=0.398N P=0.515 P=0.100 (e) |
|COCH-ARM / FISHERS | |P=0.398N P=0.515 P=0.112 P=0.495N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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: Acinus |
| Atrophy Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/49 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.1% 0.0% |4.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 1/45 (2%) 0/42 (0%) |2/46 (4%) 0/47 (0%) 0/42 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.684 (e) P=0.496 (e) |P=0.115N P=0.234N P=0.259N P=0.225N |
|POLY 3 | P=0.683 (e) P=0.498 (e) |P=0.112N P=0.235N P=0.245N P=0.235N |
|POLY 1.5 | P=0.688 (e) P=0.499 (e) |P=0.112N P=0.235N P=0.242N P=0.235N |
|POLY 6 | P=0.675 (e) P=0.496 (e) |P=0.113N P=0.236N P=0.249N P=0.233N |
|LOGISTIC REGRESSION| (e) (e) P=0.496 (e) |P=0.115N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.114N P=0.242N P=0.247N P=0.242N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |3/49 (6%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.0% 0.0% 2.1% 0.0% |6.2% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 1/46 (2%) 0/46 (0%) 1/45 (2%) 0/42 (0%) |3/46 (7%) 0/47 (0%) 1/42 (2%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.424N P=0.500N P=0.757 P=0.518N |P=0.085N P=0.118N P=0.338N P=0.111N |
|POLY 3 | P=0.410N P=0.501N P=0.758 P=0.505N |P=0.083N P=0.118N P=0.319N P=0.117N |
|POLY 1.5 | P=0.407N P=0.501N P=0.759 P=0.503N |P=0.084N P=0.117N P=0.314N P=0.117N |
|POLY 6 | P=0.413N P=0.500N P=0.756 P=0.509N |P=0.083N P=0.118N P=0.324N P=0.115N |
|LOGISTIC REGRESSION| P=0.424N (e) P=0.757 (e) |P=0.085N (e) P=0.338N (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.500N P=0.753N P=0.500N |P=0.085N P=0.117N P=0.309N P=0.117N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/45 (0%) 0/44 (0%) 3/50 (6%) |0/49 (0%) 0/48 (0%) 1/44 (2%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 6.3% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/41 (0%) 0/39 (0%) 3/42 (7%) |0/45 (0%) 0/45 (0%) 1/37 (3%) 0/47 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * (e) (e) P=0.113 |P=0.692 (e) P=0.461 (e) |
|POLY 3 | P=0.013 * (e) (e) P=0.121 |P=0.691 (e) P=0.472 (e) |
|POLY 1.5 | P=0.014 * (e) (e) P=0.124 |P=0.688 (e) P=0.474 (e) |
|POLY 6 | P=0.013 * (e) (e) P=0.118 |P=0.697 (e) P=0.469 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.113 |(e) (e) P=0.461 (e) |
|COCH-ARM / FISHERS | P=0.015 * (e) (e) P=0.129 |P=0.689 (e) P=0.473 (e) |
|=================================================================================================================================|
| | | |
| | 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) | 2/46 (4%) 1/49 (2%) 1/49 (2%) 0/45 (0%) |0/45 (0%) 0/49 (0%) 1/49 (2%) 0/45 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 2.1% 2.1% 0.0% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 2/43 (5%) 1/46 (2%) 1/45 (2%) 0/40 (0%) |0/41 (0%) 0/46 (0%) 1/43 (2%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.164N P=0.476N P=0.484N P=0.254N |P=0.702 (e) P=0.510 (e) |
|POLY 3 | P=0.159N P=0.472N P=0.478N P=0.245N |P=0.705 (e) P=0.512 (e) |
|POLY 1.5 | P=0.158N P=0.474N P=0.477N P=0.243N |P=0.701 (e) P=0.514 (e) |
|POLY 6 | P=0.161N P=0.471N P=0.480N P=0.247N |P=0.711 (e) P=0.511 (e) |
|LOGISTIC REGRESSION| P=0.164N P=0.476N P=0.484N (e) |(e) (e) P=0.510 (e) |
|COCH-ARM / FISHERS | P=0.155N P=0.476N P=0.476N P=0.253N |P=0.695 (e) P=0.521 (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 0/49 (0%) 0/49 (0%) 0/45 (0%) |4/45 (9%) 2/49 (4%) 3/49 (6%) 0/45 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |9.1% 4.2% 6.4% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) 0/45 (0%) 0/40 (0%) |4/41 (10%) 2/46 (4%) 3/43 (7%) 0/45 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.052N P=0.285N P=0.474N P=0.052N |
|POLY 3 | (e) (e) (e) (e) |P=0.056N P=0.300N P=0.466N P=0.057N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.057N P=0.300N P=0.462N P=0.059N |
|POLY 6 | (e) (e) (e) (e) |P=0.054N P=0.299N P=0.469N P=0.056N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.052N P=0.285N P=0.474N (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.059N P=0.299N P=0.452N P=0.058N |
|=================================================================================================================================|
| | | |
| | 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) | 0/46 (0%) 1/49 (2%) 0/49 (0%) 0/45 (0%) |0/45 (0%) 2/49 (4%) 0/49 (0%) 0/45 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 0.0% |0.0% 4.2% 0.0% 0.0% |
|TERMINAL (d) | 0/43 (0%) 1/46 (2%) 0/45 (0%) 0/40 (0%) |0/41 (0%) 2/46 (4%) 0/43 (0%) 0/45 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.582N P=0.513 (e) (e) |P=0.393N P=0.264 (e) (e) |
|POLY 3 | P=0.572N P=0.516 (e) (e) |P=0.406N P=0.256 (e) (e) |
|POLY 1.5 | P=0.572N P=0.515 (e) (e) |P=0.407N P=0.256 (e) (e) |
|POLY 6 | P=0.573N P=0.517 (e) (e) |P=0.403N P=0.257 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.513 (e) (e) |(e) P=0.264 (e) (e) |
|COCH-ARM / FISHERS | P=0.574N P=0.516 (e) (e) |P=0.407N P=0.269 (e) (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 31/50 (62%) 32/50 (64%) 28/50 (56%) | |
|POLY-3 ADJUSTED (b)| 57.2% 63.4% 65.3% 57.3% | |
|TERMINAL (d) | 28/46 (61%) 30/46 (65%) 30/45 (67%) 24/42 (57%) | |
|FIRST INCIDENCE | 729 (T) 689 597 585 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.359 P=0.338 P=0.225 P=0.389 | |
|POLY 3 | P=0.492N P=0.341 P=0.272 P=0.579 | |
|POLY 1.5 | P=0.487N P=0.334 P=0.274 P=0.580N | |
|POLY 6 | P=0.504N P=0.352 P=0.263 P=0.574 | |
|LOGISTIC REGRESSION| P=0.526 P=0.339 P=0.230 P=0.538 | |
|COCH-ARM / FISHERS | P=0.490N P=0.342 P=0.270 P=0.580N | |
|=================================================================================================================================|
| | | |
| | 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) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 6.1% 4.1% 2.1% 0.0% | |
|TERMINAL (d) | 3/46 (7%) 2/46 (4%) 1/45 (2%) 0/42 (0%) | |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.071N P=0.500N P=0.313N P=0.138N | |
|POLY 3 | P=0.064N P=0.501N P=0.309N P=0.124N | |
|POLY 1.5 | P=0.063N P=0.502N P=0.307N P=0.122N | |
|POLY 6 | P=0.066N P=0.500N P=0.313N P=0.128N | |
|LOGISTIC REGRESSION| P=0.071N P=0.500N P=0.313N (e) | |
|COCH-ARM / FISHERS | P=0.062N P=0.500N P=0.309N P=0.121N | |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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: Subcutaneous Tissue |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.1% 0.0% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 0/42 (0%) |0/46 (0%) 2/47 (4%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.396N P=0.243 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.407N P=0.236 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.407N P=0.237 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.405N P=0.237 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.243 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.1% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/46 (2%) 0/46 (0%) 0/45 (0%) 0/42 (0%) |0/46 (0%) 0/47 (0%) 0/42 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 721 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123N P=0.242N P=0.247N P=0.260N |(e) (e) (e) (e) |
|POLY 3 | P=0.113N P=0.238N P=0.240N P=0.244N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.113N P=0.239N P=0.238N P=0.241N |(e) (e) (e) (e) |
|POLY 6 | P=0.113N P=0.238N P=0.242N P=0.248N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.117N P=0.238N P=0.240N P=0.245N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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%) 15/50 (30%) 10/50 (20%) 11/50 (22%) |2/49 (4%) 7/50 (14%) 11/49 (22%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 18.1% 30.8% 20.2% 22.8% |4.1% 14.3% 22.6% 8.2% |
|TERMINAL (d) | 8/46 (17%) 15/46 (33%) 6/45 (13%) 7/42 (17%) |0/46 (0%) 6/47 (13%) 5/42 (12%) 4/49 (8%) |
|FIRST INCIDENCE | 453 729 (T) 597 625 |682 680 456 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.439 P=0.122 P=0.482 P=0.334 |P=0.418 P=0.090 P=0.010 * P=0.364 |
|POLY 3 | P=0.506 P=0.110 P=0.498 P=0.376 |P=0.380 P=0.081 P=0.007 ** P=0.341 |
|POLY 1.5 | P=0.518 P=0.112 P=0.498 P=0.386 |P=0.381 P=0.083 P=0.007 ** P=0.341 |
|POLY 6 | P=0.493 P=0.109 P=0.498 P=0.365 |P=0.385 P=0.080 P=0.007 ** P=0.342 |
|LOGISTIC REGRESSION| P=0.537N P=0.123 P=0.584 P=0.446 |P=0.459 P=0.096 P=0.029 * P=0.354 |
|COCH-ARM / FISHERS | P=0.534 P=0.121 P=0.500 P=0.402 |P=0.395 P=0.085 P=0.007 ** P=0.349 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |5/49 (10%) 9/50 (18%) 4/49 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 6.1% 4.1% 2.1% 2.1% |10.3% 18.4% 8.6% 4.1% |
|TERMINAL (d) | 3/46 (7%) 2/46 (4%) 1/45 (2%) 1/42 (2%) |5/46 (11%) 9/47 (19%) 4/42 (10%) 2/49 (4%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223N P=0.500N P=0.313N P=0.338N |P=0.067N P=0.206 P=0.557N P=0.193N |
|POLY 3 | P=0.206N P=0.501N P=0.309N P=0.315N |P=0.074N P=0.198 P=0.522N P=0.212N |
|POLY 1.5 | P=0.203N P=0.502N P=0.307N P=0.311N |P=0.074N P=0.201 P=0.514N P=0.213N |
|POLY 6 | P=0.210N P=0.500N P=0.313N P=0.322N |P=0.072N P=0.197 P=0.531N P=0.209N |
|LOGISTIC REGRESSION| P=0.223N P=0.500N P=0.313N P=0.338N |P=0.067N P=0.206 P=0.557N P=0.193N |
|COCH-ARM / FISHERS | P=0.199N P=0.500N P=0.309N P=0.309N |P=0.073N P=0.205 P=0.500N P=0.210N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Diverticulum |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 5/50 (10%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.1% 0.0% |0.0% 10.2% 2.1% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 1/45 (2%) 0/42 (0%) |0/46 (0%) 5/47 (11%) 1/43 (2%) 0/49 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.684 (e) P=0.496 (e) |P=0.231N P=0.036 * P=0.487 (e) |
|POLY 3 | P=0.683 (e) P=0.498 (e) |P=0.238N P=0.032 * P=0.497 (e) |
|POLY 1.5 | P=0.688 (e) P=0.499 (e) |P=0.238N P=0.032 * P=0.500 (e) |
|POLY 6 | P=0.675 (e) P=0.496 (e) |P=0.236N P=0.031 * P=0.494 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.496 (e) |(e) P=0.036 * P=0.487 (e) |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.237N P=0.030 * P=0.505 (e) |
|=================================================================================================================================|
| | | |
| | 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) | 3/50 (6%) 5/50 (10%) 0/50 (0%) 2/50 (4%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.0% 10.0% 0.0% 4.1% |0.0% 4.1% 0.0% 0.0% |
|TERMINAL (d) | 2/46 (4%) 3/46 (7%) 0/45 (0%) 0/42 (0%) |0/46 (0%) 2/47 (4%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 453 280 --- 597 |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.247N P=0.360 P=0.126N P=0.524N |P=0.396N P=0.243 (e) (e) |
|POLY 3 | P=0.230N P=0.359 P=0.124N P=0.514N |P=0.406N P=0.239 (e) (e) |
|POLY 1.5 | P=0.226N P=0.358 P=0.122N P=0.508N |P=0.405N P=0.240 (e) (e) |
|POLY 6 | P=0.235N P=0.361 P=0.127N P=0.520N |P=0.406N P=0.239 (e) (e) |
|LOGISTIC REGRESSION| P=0.166N P=0.309 P=0.137N P=0.419N |(e) P=0.243 (e) (e) |
|COCH-ARM / FISHERS | P=0.221N P=0.357 P=0.121N P=0.500N |P=0.402N P=0.253 (e) (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) | |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 6.0% 2.1% | |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 0/42 (0%) | |
|FIRST INCIDENCE | --- --- 597 625 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.240 (e) P=0.124 P=0.492 | |
|POLY 3 | P=0.236 (e) P=0.122 P=0.496 | |
|POLY 1.5 | P=0.241 (e) P=0.121 P=0.498 | |
|POLY 6 | P=0.229 (e) P=0.123 P=0.493 | |
|LOGISTIC REGRESSION| P=0.202 (e) P=0.039 * P=0.493 | |
|COCH-ARM / FISHERS | P=0.247 (e) P=0.121 P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thymus |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/40 (0%) 0/44 (0%) 0/45 (0%) |1/48 (2%) 2/49 (4%) 0/47 (0%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.1% 4.2% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/39 (0%) 0/40 (0%) 0/39 (0%) |1/45 (2%) 2/46 (4%) 0/42 (0%) 0/45 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.193N P=0.508 P=0.514N P=0.500N |
|POLY 3 | (e) (e) (e) (e) |P=0.198N P=0.504 P=0.510N P=0.510N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.198N P=0.505 P=0.508N P=0.510N |
|POLY 6 | (e) (e) (e) (e) |P=0.198N P=0.504 P=0.511N P=0.508N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.193N P=0.508 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.196N P=0.508 P=0.505N P=0.511N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/47 (6%) 3/40 (8%) 1/44 (2%) 0/45 (0%) |1/48 (2%) 1/49 (2%) 2/47 (4%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| 6.5% 7.7% 2.3% 0.0% |2.1% 2.1% 4.4% 0.0% |
|TERMINAL (d) | 3/44 (7%) 3/39 (8%) 1/40 (3%) 0/39 (0%) |0/45 (0%) 1/46 (2%) 2/42 (5%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |707 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.063N P=0.606 P=0.340N P=0.143N |P=0.369N P=0.758N P=0.479 P=0.492N |
|POLY 3 | P=0.057N P=0.583 P=0.332N P=0.131N |P=0.383N P=0.758N P=0.482 P=0.510N |
|POLY 1.5 | P=0.055N P=0.582 P=0.330N P=0.129N |P=0.384N P=0.757N P=0.486 P=0.510N |
|POLY 6 | P=0.059N P=0.585 P=0.336N P=0.135N |P=0.380N P=0.759N P=0.479 P=0.508N |
|LOGISTIC REGRESSION| P=0.063N P=0.606 P=0.340N (e) |P=0.382N P=0.754N P=0.489 P=0.498N |
|COCH-ARM / FISHERS | P=0.054N P=0.582 P=0.334N P=0.129N |P=0.381N P=0.747N P=0.492 P=0.511N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 0/40 (0%) 0/44 (0%) 1/45 (2%) |0/48 (0%) 0/49 (0%) 2/47 (4%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 2.3% |0.0% 0.0% 4.4% 0.0% |
|TERMINAL (d) | 1/44 (2%) 0/39 (0%) 0/40 (0%) 1/39 (3%) |0/45 (0%) 0/46 (0%) 2/42 (5%) 0/45 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 729 (T) |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.575 P=0.524N P=0.519N P=0.735 |P=0.591 (e) P=0.223 (e) |
|POLY 3 | P=0.589 P=0.533N P=0.515N P=0.745 |P=0.585 (e) P=0.226 (e) |
|POLY 1.5 | P=0.592 P=0.534N P=0.514N P=0.748 |P=0.582 (e) P=0.229 (e) |
|POLY 6 | P=0.586 P=0.532N P=0.517N P=0.741 |P=0.592 (e) P=0.225 (e) |
|LOGISTIC REGRESSION| P=0.575 (e) (e) P=0.735 |(e) (e) P=0.223 (e) |
|COCH-ARM / FISHERS | P=0.594 P=0.540N P=0.516N P=0.742 |P=0.585 (e) P=0.242 (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 9/50 (18%) 13/49 (27%) 15/49 (31%) |18/50 (36%) 27/50 (54%) 29/49 (59%) 22/50 (44%) |
|POLY-3 ADJUSTED (b)| 20.4% 18.1% 27.4% 31.8% |36.5% 55.3% 59.9% 44.8% |
|TERMINAL (d) | 10/46 (22%) 8/46 (17%) 13/44 (30%) 13/41 (32%) |17/46 (37%) 27/47 (57%) 25/42 (60%) 22/49 (45%) |
|FIRST INCIDENCE | 729 (T) 280 729 (T) 597 |654 729 (T) 456 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047 * P=0.500N P=0.273 P=0.110 |P=0.444 P=0.064 P=0.011 * P=0.360 |
|POLY 3 | P=0.071 P=0.484N P=0.288 P=0.150 |P=0.335 P=0.046 * P=0.015 * P=0.261 |
|POLY 1.5 | P=0.076 P=0.490N P=0.294 P=0.156 |P=0.329 P=0.048 * P=0.015 * P=0.259 |
|POLY 6 | P=0.065 P=0.481N P=0.276 P=0.142 |P=0.354 P=0.044 * P=0.015 * P=0.272 |
|LOGISTIC REGRESSION| P=0.085 P=0.481N P=0.273 P=0.147 |P=0.338 P=0.052 P=0.022 * P=0.271 |
|COCH-ARM / FISHERS | P=0.081 P=0.500N P=0.298 P=0.163 |P=0.347 P=0.054 P=0.017 * P=0.270 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) |1/50 (2%) 3/50 (6%) 1/49 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 0.0% |2.0% 6.1% 2.1% 0.0% |
|TERMINAL (d) | 0/46 (0%) 1/46 (2%) 0/44 (0%) 0/41 (0%) |1/46 (2%) 3/47 (6%) 1/42 (2%) 0/49 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.586N P=0.500 (e) (e) |P=0.193N P=0.313 P=0.741 P=0.487N |
|POLY 3 | P=0.573N P=0.499 (e) (e) |P=0.202N P=0.304 P=0.749 P=0.500N |
|POLY 1.5 | P=0.572N P=0.499 (e) (e) |P=0.203N P=0.304 P=0.752 P=0.501N |
|POLY 6 | P=0.574N P=0.500 (e) (e) |P=0.199N P=0.305 P=0.747 P=0.498N |
|LOGISTIC REGRESSION| (e) P=0.500 (e) (e) |P=0.193N P=0.313 P=0.741 (e) |
|COCH-ARM / FISHERS | P=0.571N P=0.500 (e) (e) |P=0.201N P=0.309 P=0.747 P=0.500N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/6 (17%) 1/13 (8%) 0/8 (0%) 2/8 (25%) |0/3 (0%) 0/6 (0%) 1/7 (14%) 0/6 (0%) |
|POLY-3 ADJUSTED (b)| 16.7% 7.7% 0.0% 26.2% |0.0% 0.0% 14.3% 0.0% |
|TERMINAL (d) | 1/6 (17%) 1/13 (8%) 0/8 (0%) 2/7 (29%) |0/3 (0%) 0/6 (0%) 1/7 (14%) 0/6 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.307 P=0.582N P=0.443N P=0.558 |P=0.765 (e) P=0.669 (e) |
|POLY 3 | P=0.340 P=0.580N P=0.442N P=0.588 |P=0.760 (e) P=0.663 (e) |
|POLY 1.5 | P=0.344 P=0.580N P=0.442N P=0.595 |P=0.760 (e) P=0.663 (e) |
|POLY 6 | P=0.334 P=0.580N P=0.442N P=0.577 |P=0.760 (e) P=0.663 (e) |
|LOGISTIC REGRESSION| P=0.307 P=0.582N (e) P=0.558 |(e) (e) P=0.669 (e) |
|COCH-ARM / FISHERS | P=0.346 P=0.544N P=0.429N P=0.615 |P=0.771 (e) P=0.700 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/6 (83%) 13/13 (100%) 8/8 (100%) 6/8 (75%) |3/3 (100%) 6/6 (100%) 6/7 (86%) 6/6 (100%) |
|POLY-3 ADJUSTED (b)| 83.3% 100.0% 100.0% 75.0% |100.0% 100.0% 85.7% 100.0% |
|TERMINAL (d) | 5/6 (83%) 13/13 (100%) 8/8 (100%) 5/7 (71%) |3/3 (100%) 6/6 (100%) 6/7 (86%) 6/6 (100%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 625 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.547N P=0.346 P=0.443 P=0.653 |P=0.765 (e) P=0.669N (e) |
|POLY 3 | P=0.215N P=0.341 P=0.442 P=0.604N |P=0.760 (e) P=0.663N (e) |
|POLY 1.5 | P=0.215N P=0.341 P=0.442 P=0.604N |P=0.760 (e) P=0.663N (e) |
|POLY 6 | P=0.215N P=0.341 P=0.442 P=0.604N |P=0.760 (e) P=0.663N (e) |
|LOGISTIC REGRESSION| P=0.547N P=0.346 P=0.443 (e) |P=0.765 (e) P=0.669N (e) |
|COCH-ARM / FISHERS | P=0.219N P=0.316 P=0.429 P=0.615N |P=0.771 (e) P=0.700N (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 0/50 (0%) 4/50 (8%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| |2.0% 0.0% 8.4% 6.1% |
|TERMINAL (d) | |1/46 (2%) 0/47 (0%) 3/43 (7%) 3/49 (6%) |
|FIRST INCIDENCE | |729 (T) --- 716 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.127 P=0.496N P=0.164 P=0.328 |
|POLY 3 | |P=0.111 P=0.501N P=0.171 P=0.305 |
|POLY 1.5 | |P=0.109 P=0.501N P=0.174 P=0.304 |
|POLY 6 | |P=0.114 P=0.500N P=0.169 P=0.310 |
|LOGISTIC REGRESSION| |P=0.116 (e) P=0.167 P=0.328 |
|COCH-ARM / FISHERS | |P=0.111 P=0.500N P=0.181 P=0.309 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| |4.0% 0.0% 0.0% 2.0% |
|TERMINAL (d) | |1/46 (2%) 0/47 (0%) 0/43 (0%) 1/49 (2%) |
|FIRST INCIDENCE | |629 --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.455N P=0.240N P=0.254N P=0.488N |
|POLY 3 | |P=0.461N P=0.240N P=0.245N P=0.503N |
|POLY 1.5 | |P=0.461N P=0.239N P=0.242N P=0.503N |
|POLY 6 | |P=0.462N P=0.241N P=0.249N P=0.500N |
|LOGISTIC REGRESSION| |P=0.428N P=0.163N P=0.156N P=0.468N |
|COCH-ARM / FISHERS | |P=0.461N P=0.247N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 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 |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |19/50 (38%) 21/50 (42%) 23/50 (46%) 25/50 (50%) |
|POLY-3 ADJUSTED (b)| |38.7% 42.2% 48.0% 51.0% |
|TERMINAL (d) | |19/46 (41%) 19/47 (40%) 22/43 (51%) 25/49 (51%) |
|FIRST INCIDENCE | |729 (T) 487 682 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.182 P=0.453 P=0.181 P=0.230 |
|POLY 3 | |P=0.115 P=0.441 P=0.236 P=0.154 |
|POLY 1.5 | |P=0.114 P=0.431 P=0.249 P=0.150 |
|POLY 6 | |P=0.122 P=0.456 P=0.226 P=0.167 |
|LOGISTIC REGRESSION| |P=0.120 P=0.425 P=0.207 P=0.230 |
|COCH-ARM / FISHERS | |P=0.124 P=0.419 P=0.272 P=0.157 |
|=================================================================================================================================|
| | | |
| | 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) | |47/50 (94%) 45/50 (90%) 44/50 (88%) 49/50 (98%) |
|POLY-3 ADJUSTED (b)| |94.7% 92.1% 90.5% 98.0% |
|TERMINAL (d) | |44/46 (96%) 45/47 (96%) 41/43 (95%) 48/49 (98%) |
|FIRST INCIDENCE | |654 729 (T) 534 276 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.562 P=0.229N P=0.620N P=0.510N |
|POLY 3 | |P=0.250 P=0.453N P=0.332N P=0.360 |
|POLY 1.5 | |P=0.233 P=0.413N P=0.294N P=0.334 |
|POLY 6 | |P=0.281 P=0.505N P=0.380N P=0.403 |
|LOGISTIC REGRESSION| |P=0.133 P=0.316N P=0.438N P=0.281 |
|COCH-ARM / FISHERS | |P=0.220 P=0.357N P=0.243N P=0.309 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(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.
(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).