TDMS Study 05203-09 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 09 TIME: 10:12:19
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62340D
PATHOLOGIST: FARNELL, D. CAS: 88-72-2
------------------------------------------------------------------------------------------------------------------------------------
MICE, FINAL#1
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 O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 09 TIME: 10:12:19
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62340D
PATHOLOGIST: FARNELL, D. CAS: 88-72-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF O-NITROTOLUENE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Cytoplasmic Alteration Focal
Heart Infiltration Cellular Mixed Cell
Inflammation Chronic Focal
Mineralization
Kidney Congestion
Cyst
Inflammation
Nephropathy
Kidney: Renal Tubule Accumulation, Hyaline Droplet
Dilatation
Necrosis
Pigmentation
Liver Angiectasis
Basophilic Focus
Clear Cell Focus
Eosinophilic Focus
Infiltration Cellular Mixed Cell
Necrosis
Liver: Hepatocyte Fatty Change Diffuse
Syncytial Alteration Focal
Vacuolization Cytoplasmic Diffuse
Vacuolization Cytoplasmic Focal
Liver: Hepatocyte, Centrilobular Depletion Glycogen
Fatty Change
Liver: Oval Cell Hyperplasia
Lung Congestion
Hemorrhage
Hyperplasia
Infiltration Cellular Mixed Cell
Lymph Node, Mediastinal Hemorrhage
Mesentery Inflammation Chronic
Mesentery: Artery Inflammation Chronic
Mesentery: Fat Necrosis
Preputial Gland Degeneration Cystic
Inflammation Chronic
Prostate Inflammation Chronic
Skeletal Muscle Hemorrhage Focal
Skin: Subcutaneous Tissue Edema
Hemorrhage Focal
Inflammation Chronic Focal
Spleen Depletion Cellular
Hematopoietic Cell Proliferation
Stomach, Forestomach Inflammation Focal
Ulcer
Stomach, Forestomach: Epithelium Hyperplasia
Stomach, Glandular Erosion
Inflammation Focal
Thymus Atrophy
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 09 TIME: 10:12:19
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62340D
PATHOLOGIST: FARNELL, D. CAS: 88-72-2
Cyst
Thyroid Gland Degeneration Cystic Focal
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Bone Hyperostosis
Clitoral Gland Degeneration Cystic
Inflammation Chronic
Heart Inflammation Chronic Focal
Kidney Hyperplasia Lymphoid
Nephropathy
Kidney: Renal Tubule Accumulation, Hyaline Droplet
Casts Protein
Pigmentation
Liver Angiectasis
Basophilic Focus
Clear Cell Focus
Eosinophilic Focus
Infiltration Cellular Mixed Cell
Mixed Cell Focus
Necrosis
Liver: Hepatocyte Necrosis Focal
Vacuolization Cytoplasmic Focal
Liver: Oval Cell Hyperplasia
Lung Infiltration Cellular Mixed Cell
Lymph Node, Mediastinal Hemorrhage
Hyperplasia Lymphoid
Lymph Node, Mesenteric Hyperplasia
Lymph Node: Renal Hyperplasia
Mesentery: Fat Necrosis
Nose: Mucosa, Glands Dilatation Focal
Ovary Cyst
Skin: Subcutaneous Tissue Edema
Spleen Hematopoietic Cell Proliferation
Hyperplasia Lymphoid
Stomach, Forestomach: Epithelium Hyperplasia
Stomach, Glandular Inflammation Focal
Thymus Hyperplasia Lymphoid
Thyroid Gland Degeneration Cystic Focal
Thyroid Gland: Follicle Cyst
Uterus Hydrometra
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/58 (0%) 0/60 (0%) |2/59 (3%) 0/59 (0%) 1/58 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/56.99 1/49.97 0/22.81 0/9.13 |2/56.26 0/53.27 1/55.51 0/39.77 |
|POLY-3 PERCENT (g) | 0.0% 2.0% 0.0% 0.0% |3.6% 0.0% 1.8% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 0/46 (0%) 1/47 (2%) 0/5 (0%) |
|FIRST INCIDENCE | --- 641 --- --- |299 --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.814 P=0.460 (e) (e) |P=0.331N P=0.255N P=0.523N P=0.439N |
|POLY 3 | P=0.603 P=0.474 (e) (e) |P=0.207N P=0.250N P=0.505N P=0.322N |
|POLY 1.5 | P=0.702 P=0.485 (e) (e) |P=0.199N P=0.246N P=0.504N P=0.279N |
|POLY 6 | P=0.485 P=0.460 (e) (e) |P=0.238N P=0.254N P=0.509N P=0.396N |
|LOGISTIC REGRESSION| P=0.911N P=0.537 (e) (e) |P=0.144N P=0.170N P=0.734N P=0.142N |
|COCH-ARM / FISHERS | P=0.568N P=0.500 (e) (e) |P=0.187N P=0.248N P=0.506N P=0.244N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/58 (0%) 0/60 (0%) |0/59 (0%) 0/59 (0%) 2/58 (3%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/56.99 2/49.65 0/22.81 0/9.13 |0/55.32 0/53.27 2/55.51 0/39.77 |
|POLY-3 PERCENT (g) | 0.0% 4.0% 0.0% 0.0% |0.0% 0.0% 3.6% 0.0% |
|TERMINAL (d) | 0/52 (0%) 2/34 (6%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 2/47 (4%) 0/5 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.380 P=0.151 (e) (e) |P=0.265 (e) P=0.217 (e) |
|POLY 3 | P=0.392 P=0.208 (e) (e) |P=0.383 (e) P=0.238 (e) |
|POLY 1.5 | P=0.631 P=0.221 (e) (e) |P=0.489 (e) P=0.238 (e) |
|POLY 6 | P=0.166 P=0.194 (e) (e) |P=0.255 (e) P=0.236 (e) |
|LOGISTIC REGRESSION| (e) P=0.151 (e) (e) |(e) (e) P=0.217 (e) |
|COCH-ARM / FISHERS | P=0.406N P=0.248 (e) (e) |P=0.598 (e) P=0.244 (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/60 (12%) 2/60 (3%) 0/58 (0%) 0/60 (0%) |0/59 (0%) 1/59 (2%) 0/58 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 7/56.99 2/49.65 0/22.81 0/9.13 |0/55.32 1/53.27 0/55.51 0/39.77 |
|POLY-3 PERCENT (g) | 12.3% 4.0% 0.0% 0.0% |0.0% 1.9% 0.0% 0.0% |
|TERMINAL (d) | 7/52 (14%) 2/34 (6%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 1/46 (2%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.345N P=0.224N P=1.000N P=1.000N |P=0.830N P=0.476 (e) (e) |
|POLY 3 | P=0.019N* P=0.119N P=0.133N P=0.381N |P=0.562N P=0.492 (e) (e) |
|POLY 1.5 | P=0.006N** P=0.101N P=0.046N* P=0.136N |P=0.568N P=0.495 (e) (e) |
|POLY 6 | P=0.052N P=0.145N P=0.348N P=0.573N |P=0.595N P=0.489 (e) (e) |
|LOGISTIC REGRESSION| P=0.345N P=0.224N (e) (e) |(e) P=0.476 (e) (e) |
|COCH-ARM / FISHERS | P=0.002N** P=0.081N P=0.007N** P=0.006N** |P=0.565N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/56 (0%) 0/60 (0%) |2/59 (3%) 0/57 (0%) 0/58 (0%) 0/59 (0%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 0/22.24 0/9.13 |2/55.32 0/51.53 0/55.51 0/38.97 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |3.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |2/52 (4%) 0/45 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.206N P=0.271N P=0.261N P=0.793N |
|POLY 3 | (e) (e) (e) (e) |P=0.091N P=0.254N P=0.237N P=0.323N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.104N P=0.251N P=0.237N P=0.280N |
|POLY 6 | (e) (e) (e) (e) |P=0.083N P=0.257N P=0.240N P=0.397N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.206N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.257N P=0.252N P=0.248N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Hyperostosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 0/23.48 0/9.13 |0/56.31 0/54.01 0/57.18 2/40.62 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.9% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.024 * (e) (e) P=0.163 |
|POLY 3 | (e) (e) (e) (e) |P=0.038 * (e) (e) P=0.174 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.202 |
|POLY 6 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.138 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.079 (e) (e) P=0.316 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.248 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 0/60 (0%) |0/60 (0%) 0/58 (0%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/56.99 2/50.17 1/24.00 0/9.13 |0/56.31 0/53.22 1/57.18 0/39.77 |
|POLY-3 PERCENT (g) | 0.0% 4.0% 4.2% 0.0% |0.0% 0.0% 1.8% 0.0% |
|TERMINAL (d) | 0/52 (0%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 1/47 (2%) 0/5 (0%) |
|FIRST INCIDENCE | --- 572 569 --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.098 P=0.179 P=0.217 (e) |P=0.527 (e) P=0.480 (e) |
|POLY 3 | P=0.199 P=0.211 P=0.352 (e) |P=0.518 (e) P=0.503 (e) |
|POLY 1.5 | P=0.429 P=0.222 P=0.414 (e) |P=0.609 (e) P=0.503 (e) |
|POLY 6 | P=0.101 P=0.197 P=0.288 (e) |P=0.413 (e) P=0.500 (e) |
|LOGISTIC REGRESSION| P=0.800 P=0.273 P=0.656 (e) |(e) (e) P=0.480 (e) |
|COCH-ARM / FISHERS | P=0.461N P=0.248 P=0.500 (e) |P=0.695 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 3/60 (5%) 2/60 (3%) 0/60 (0%) |1/60 (2%) 0/58 (0%) 2/60 (3%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/56.99 3/50.40 2/25.02 0/9.13 |1/56.85 0/53.22 2/57.82 2/40.51 |
|POLY-3 PERCENT (g) | 0.0% 6.0% 8.0% 0.0% |1.8% 0.0% 3.5% 4.9% |
|TERMINAL (d) | 0/52 (0%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 542 410 --- |562 --- 553 583 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.095 P=0.081 P=0.211 (e) |P=0.128 P=0.507N P=0.497 P=0.379 |
|POLY 3 | P=0.075 P=0.099 P=0.115 (e) |P=0.162 P=0.513N P=0.506 P=0.386 |
|POLY 1.5 | P=0.301 P=0.108 P=0.159 (e) |P=0.199 P=0.510N P=0.506 P=0.439 |
|POLY 6 | P=0.022 * P=0.090 P=0.081 (e) |P=0.132 P=0.517N P=0.501 P=0.309 |
|LOGISTIC REGRESSION| P=0.279N P=0.148 P=0.586 (e) |P=0.387 P=0.498N P=0.321 P=0.632 |
|COCH-ARM / FISHERS | P=0.409N P=0.122 P=0.248 (e) |P=0.250 P=0.508N P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 2/58 (3%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 0/23.48 0/9.13 |0/56.31 2/53.22 0/57.18 0/39.77 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 3.8% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 2/46 (4%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.735N P=0.212 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.443N P=0.225 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.427N P=0.228 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.498N P=0.222 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.212 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.403N P=0.239 (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |11/58 (19%) 4/57 (7%) 5/57 (9%) 2/58 (3%) |
|POLY-3 RATE (b) | |11/54.31 4/51.20 5/54.26 2/38.56 |
|POLY-3 PERCENT (g) | |20.3% 7.8% 9.2% 5.2% |
|TERMINAL (d) | |11/50 (22%) 4/44 (9%) 5/45 (11%) 0/5 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 685 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.425N P=0.078N P=0.128N P=0.461 |
|POLY 3 | |P=0.024N* P=0.059N P=0.087N P=0.041N* |
|POLY 1.5 | |P=0.015N* P=0.056N P=0.087N P=0.019N* |
|POLY 6 | |P=0.041N* P=0.064N P=0.092N P=0.113N |
|LOGISTIC REGRESSION| |P=0.199N P=0.078N P=0.128N P=0.437N |
|COCH-ARM / FISHERS | |P=0.009N** P=0.051N P=0.095N P=0.008N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/58 (5%) 2/57 (4%) 0/57 (0%) 0/58 (0%) |
|POLY-3 RATE (b) | |3/54.31 2/51.20 0/54.26 0/38.28 |
|POLY-3 PERCENT (g) | |5.5% 3.9% 0.0% 0.0% |
|TERMINAL (d) | |3/50 (6%) 2/44 (5%) 0/45 (0%) 0/5 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.140N P=0.558N P=0.141N P=0.679N |
|POLY 3 | |P=0.044N* P=0.527N P=0.120N P=0.195N |
|POLY 1.5 | |P=0.042N* P=0.520N P=0.120N P=0.155N |
|POLY 6 | |P=0.049N* P=0.535N P=0.122N P=0.272N |
|LOGISTIC REGRESSION| |P=0.140N P=0.558N (e) (e) |
|COCH-ARM / FISHERS | |P=0.040N* P=0.508N P=0.125N P=0.122N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/58 (5%) 2/57 (4%) 0/57 (0%) 1/58 (2%) |
|POLY-3 RATE (b) | |3/54.31 2/51.20 0/54.26 1/38.39 |
|POLY-3 PERCENT (g) | |5.5% 3.9% 0.0% 2.6% |
|TERMINAL (d) | |3/50 (6%) 2/44 (5%) 0/45 (0%) 0/5 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) --- 702 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.583N P=0.558N P=0.141N P=0.452 |
|POLY 3 | |P=0.174N P=0.527N P=0.120N P=0.438N |
|POLY 1.5 | |P=0.173N P=0.520N P=0.120N P=0.373N |
|POLY 6 | |P=0.176N P=0.535N P=0.122N P=0.542N |
|LOGISTIC REGRESSION| |P=0.413N P=0.558N (e) P=0.715 |
|COCH-ARM / FISHERS | |P=0.164N P=0.508N P=0.125N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 3/60 (5%) 1/60 (2%) |0/60 (0%) 1/60 (2%) 1/59 (2%) 0/58 (0%) |
|POLY-3 RATE (b) | 0/56.99 1/49.65 3/25.42 1/9.97 |0/56.31 1/54.01 1/56.26 0/38.16 |
|POLY-3 PERCENT (g) | 0.0% 2.0% 11.8% 10.0% |0.0% 1.9% 1.8% 0.0% |
|TERMINAL (d) | 0/52 (0%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 1/46 (2%) 1/47 (2%) 0/5 (0%) |
|FIRST INCIDENCE | --- 729 (T) 492 391 |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.415 P=0.060 P=0.396 |P=0.539 P=0.476 P=0.480 (e) |
|POLY 3 | P=0.031 * P=0.473 P=0.039 * P=0.280 |P=0.600 P=0.492 P=0.500 (e) |
|POLY 1.5 | P=0.069 P=0.484 P=0.063 P=0.349 |P=0.646N P=0.495 P=0.500 (e) |
|POLY 6 | P=0.060 P=0.458 P=0.023 * P=0.246 |P=0.498 P=0.488 P=0.497 (e) |
|LOGISTIC REGRESSION| P=0.618 P=0.415 P=0.351 P=0.945 |(e) P=0.476 P=0.480 (e) |
|COCH-ARM / FISHERS | P=0.351 P=0.500 P=0.122 P=0.500 |P=0.603N P=0.500 P=0.496 (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 4/60 (7%) 1/60 (2%) |0/60 (0%) 0/60 (0%) 0/59 (0%) 2/58 (3%) |
|POLY-3 RATE (b) | 1/56.99 0/49.65 4/26.06 1/10.01 |0/56.31 0/54.01 0/56.26 2/38.84 |
|POLY-3 PERCENT (g) | 1.8% 0.0% 15.4% 10.0% |0.0% 0.0% 0.0% 5.2% |
|TERMINAL (d) | 1/52 (2%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) --- 410 358 |--- --- --- 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.585N P=0.017 * P=0.467 |P=0.014 * (e) (e) P=0.100 |
|POLY 3 | P=0.071 P=0.527N P=0.044 * P=0.407 |P=0.037 * (e) (e) P=0.166 |
|POLY 1.5 | P=0.113 P=0.516N P=0.085 P=0.543 |P=0.039 * (e) (e) P=0.194 |
|POLY 6 | P=0.184 P=0.542N P=0.020 * P=0.330 |P=0.046 * (e) (e) P=0.131 |
|LOGISTIC REGRESSION| P=0.447N (e) P=0.451 P=0.983N |P=0.071 (e) (e) P=0.282 |
|COCH-ARM / FISHERS | P=0.444 P=0.500N P=0.182 P=0.752N |P=0.044 * (e) (e) P=0.239 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 1/60 (2%) |0/60 (0%) 0/60 (0%) 0/59 (0%) 0/58 (0%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 2/24.86 1/10.01 |0/56.31 0/54.01 0/56.26 0/38.16 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 8.1% 10.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- 410 358 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.040 * (e) P=0.143 P=0.467 |(e) (e) (e) (e) |
|POLY 3 | P=0.081 (e) P=0.115 P=0.280 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.077 (e) P=0.158 P=0.349 |(e) (e) (e) (e) |
|POLY 6 | P=0.262 (e) P=0.080 P=0.246 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.586N (e) P=0.553 P=0.952 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.246 (e) P=0.248 P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/58 (0%) 2/59 (3%) 0/58 (0%) 0/60 (0%) |2/59 (3%) 1/56 (2%) 0/58 (0%) 0/59 (0%) |
|POLY-3 RATE (b) | 0/55.68 2/49.71 0/22.83 0/9.13 |2/55.85 1/52.43 0/55.37 0/38.93 |
|POLY-3 PERCENT (g) | 0.0% 4.0% 0.0% 0.0% |3.6% 1.9% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |2/52 (4%) 1/46 (2%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 641 --- --- |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.432 P=0.174 (e) (e) |P=0.238N P=0.543N P=0.261N P=0.793N |
|POLY 3 | P=0.397 P=0.213 (e) (e) |P=0.100N P=0.522N P=0.240N P=0.326N |
|POLY 1.5 | P=0.637 P=0.225 (e) (e) |P=0.102N P=0.519N P=0.239N P=0.282N |
|POLY 6 | P=0.169 P=0.199 (e) (e) |P=0.105N P=0.527N P=0.244N P=0.401N |
|LOGISTIC REGRESSION| P=0.776 P=0.250 (e) (e) |P=0.238N P=0.543N (e) (e) |
|COCH-ARM / FISHERS | P=0.400N P=0.252 (e) (e) |P=0.101N P=0.520N P=0.252N P=0.248N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/58 (9%) 3/59 (5%) 0/58 (0%) 0/60 (0%) |2/59 (3%) 3/56 (5%) 3/58 (5%) 1/59 (2%) |
|POLY-3 RATE (b) | 5/55.68 3/49.39 0/22.83 0/9.13 |2/55.85 3/52.43 3/55.37 1/39.11 |
|POLY-3 PERCENT (g) | 9.0% 6.1% 0.0% 0.0% |3.6% 5.7% 5.4% 2.6% |
|TERMINAL (d) | 5/52 (10%) 3/34 (9%) 0/0 (0%) 0/0 (0%) |2/52 (4%) 3/46 (7%) 3/47 (6%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |729 (T) 729 (T) 729 (T) 685 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.736N P=0.600N P=1.000N P=1.000N |P=0.232 P=0.444 P=0.454 P=0.447 |
|POLY 3 | P=0.131N P=0.425N P=0.207N P=0.439N |P=0.500N P=0.471 P=0.496 P=0.619N |
|POLY 1.5 | P=0.036N* P=0.390N P=0.097N P=0.208N |P=0.426N P=0.475 P=0.498 P=0.564N |
|POLY 6 | P=0.359N P=0.470N P=0.413N P=0.597N |P=0.511 P=0.465 P=0.488 P=0.698N |
|LOGISTIC REGRESSION| P=0.736N P=0.600N (e) (e) |P=0.428 P=0.444 P=0.454 P=0.724 |
|COCH-ARM / FISHERS | P=0.007N** P=0.349N P=0.029N* P=0.026N* |P=0.338N P=0.475 P=0.492 P=0.500N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/58 (3%) 4/59 (7%) 1/58 (2%) 1/60 (2%) |2/59 (3%) 0/56 (0%) 2/58 (3%) 1/59 (2%) |
|POLY-3 RATE (b) | 2/55.68 4/49.39 1/23.22 1/9.97 |2/55.93 0/52.43 2/55.37 1/39.46 |
|POLY-3 PERCENT (g) | 3.6% 8.1% 4.3% 10.0% |3.6% 0.0% 3.6% 2.5% |
|TERMINAL (d) | 2/52 (4%) 4/34 (12%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 0/46 (0%) 2/47 (4%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 619 392 |710 --- 729 (T) 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.166 P=0.041 * P=0.378 |P=0.348 P=0.266N P=0.655 P=0.620 |
|POLY 3 | P=0.315 P=0.285 P=0.661 P=0.483 |P=0.580 P=0.252N P=0.690 P=0.617N |
|POLY 1.5 | P=0.570 P=0.311 P=0.648N P=0.663 |P=0.571N P=0.250N P=0.691 P=0.562N |
|POLY 6 | P=0.165 P=0.252 P=0.499 P=0.374 |P=0.516 P=0.256N P=0.683 P=0.695N |
|LOGISTIC REGRESSION| P=0.120 P=0.166 P=0.631 P=0.986 |P=0.549N P=0.251N P=0.687 P=0.509N |
|COCH-ARM / FISHERS | P=0.224N P=0.348 P=0.500N P=0.487N |P=0.525N P=0.261N P=0.684 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Fibrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/58 (0%) 2/59 (3%) 0/58 (0%) 0/60 (0%) |0/59 (0%) 1/56 (2%) 0/58 (0%) 0/59 (0%) |
|POLY-3 RATE (b) | 0/55.68 2/50.01 0/22.83 0/9.13 |0/55.85 1/52.43 0/55.37 0/38.93 |
|POLY-3 PERCENT (g) | 0.0% 4.0% 0.0% 0.0% |0.0% 1.9% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 1/46 (2%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 526 --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.601 P=0.187 (e) (e) |P=0.830N P=0.476 (e) (e) |
|POLY 3 | P=0.397 P=0.215 (e) (e) |P=0.561N P=0.487 (e) (e) |
|POLY 1.5 | P=0.637 P=0.226 (e) (e) |P=0.566N P=0.489 (e) (e) |
|POLY 6 | P=0.170 P=0.200 (e) (e) |P=0.600N P=0.484 (e) (e) |
|LOGISTIC REGRESSION| P=0.676N P=0.284 (e) (e) |(e) P=0.476 (e) (e) |
|COCH-ARM / FISHERS | P=0.400N P=0.252 (e) (e) |P=0.565N P=0.487 (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/58 (2%) 3/59 (5%) 0/58 (0%) 0/60 (0%) |0/59 (0%) 4/56 (7%) 1/58 (2%) 0/59 (0%) |
|POLY-3 RATE (b) | 1/55.68 3/49.39 0/22.83 0/9.13 |0/55.85 4/52.43 1/55.37 0/38.93 |
|POLY-3 PERCENT (g) | 1.8% 6.1% 0.0% 0.0% |0.0% 7.6% 1.8% 0.0% |
|TERMINAL (d) | 1/52 (2%) 3/34 (9%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 4/46 (9%) 1/47 (2%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.331 P=0.169 P=1.000N P=1.000N |P=0.561 P=0.049 * P=0.480 (e) |
|POLY 3 | P=0.535 P=0.265 P=0.650N P=0.719N |P=0.424N P=0.054 P=0.498 (e) |
|POLY 1.5 | P=0.422N P=0.285 P=0.587N P=0.649N |P=0.360N P=0.055 P=0.499 (e) |
|POLY 6 | P=0.235 P=0.239 P=0.714N P=0.753N |P=0.550N P=0.052 P=0.495 (e) |
|LOGISTIC REGRESSION| P=0.331 P=0.169 (e) (e) |(e) P=0.049 * P=0.480 (e) |
|COCH-ARM / FISHERS | P=0.149N P=0.316 P=0.500N P=0.492N |P=0.293N P=0.053 P=0.496 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/58 (0%) 1/59 (2%) 3/58 (5%) 0/60 (0%) |0/59 (0%) 0/56 (0%) 0/58 (0%) 1/59 (2%) |
|POLY-3 RATE (b) | 0/55.68 1/49.43 3/24.80 0/9.13 |0/55.85 0/52.43 0/55.37 1/39.35 |
|POLY-3 PERCENT (g) | 0.0% 2.0% 12.1% 0.0% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 717 410 --- |--- --- --- 608 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029 * P=0.428 P=0.026 * (e) |P=0.152 (e) (e) P=0.431 |
|POLY 3 | P=0.056 P=0.476 P=0.039 * (e) |P=0.164 (e) (e) P=0.432 |
|POLY 1.5 | P=0.173 P=0.488 P=0.063 (e) |P=0.180 (e) (e) P=0.464 |
|POLY 6 | P=0.063 P=0.461 P=0.023 * (e) |P=0.180 (e) (e) P=0.385 |
|LOGISTIC REGRESSION| P=0.554N P=0.467 P=0.390 (e) |P=0.277 (e) (e) P=0.575 |
|COCH-ARM / FISHERS | P=0.625N P=0.504 P=0.122 (e) |P=0.202 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 56/58 (97%) 53/59 (90%) 34/58 (59%) 18/60 (30%) |9/59 (15%) 14/56 (25%) 10/58 (17%) 11/59 (19%) |
|POLY-3 RATE (b) | 56/56.97 53/55.78 34/42.74 18/24.25 |9/55.85 14/55.01 10/56.60 11/43.33 |
|POLY-3 PERCENT (g) | 98.3% 95.0% 79.5% 74.2% |16.1% 25.5% 17.7% 25.4% |
|TERMINAL (d) | 52/52 (100%) 34/34 (100%) 0/0 (0%) 0/0 (0%) |9/52 (17%) 10/46 (22%) 6/47 (13%) 0/5 (0%) |
|FIRST INCIDENCE | 592 451 303 345 |729 (T) 312 553 409 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.002 ** P=0.120 P=0.430 P<0.001 ** |
|POLY 3 | P<0.001N** P=0.289N P<0.001N** P<0.001N** |P=0.262 P=0.164 P=0.513 P=0.189 |
|POLY 1.5 | P<0.001N** P=0.168N P<0.001N** P<0.001N** |P=0.368 P=0.159 P=0.508 P=0.282 |
|POLY 6 | P=0.014N* P=0.618N P=0.018N* P=0.463N |P=0.150 P=0.164 P=0.508 P=0.087 |
|LOGISTIC REGRESSION| P=0.428N P=0.560N P=0.067N P=0.759N |P=0.300N P=0.139 P=0.479 P=0.452 |
|COCH-ARM / FISHERS | P<0.001N** P=0.141N P<0.001N** P<0.001N** |P=0.517 P=0.142 P=0.484 P=0.403 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/58 (3%) 0/59 (0%) 0/58 (0%) 0/60 (0%) |0/59 (0%) 0/56 (0%) 0/58 (0%) 1/59 (2%) |
|POLY-3 RATE (b) | 2/56.14 0/49.39 0/22.83 0/9.13 |0/55.85 0/52.43 0/55.37 1/39.26 |
|POLY-3 PERCENT (g) | 3.6% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 2.6% |
|TERMINAL (d) | 1/52 (2%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 592 --- --- --- |--- --- --- 640 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.536N P=0.308N P=0.921N P=1.000N |P=0.127 (e) (e) P=0.386 |
|POLY 3 | P=0.152N P=0.267N P=0.459N P=0.600N |P=0.164 (e) (e) P=0.432 |
|POLY 1.5 | P=0.116N P=0.252N P=0.353N P=0.458N |P=0.180 (e) (e) P=0.464 |
|POLY 6 | P=0.199N P=0.288N P=0.588N P=0.677N |P=0.180 (e) (e) P=0.384 |
|LOGISTIC REGRESSION| P=0.108N P=0.200N P=0.285N P=0.822N |P=0.257 (e) (e) P=0.546 |
|COCH-ARM / FISHERS | P=0.113N P=0.244N P=0.248N P=0.239N |P=0.202 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/58 (0%) 0/59 (0%) 2/58 (3%) 0/60 (0%) |0/59 (0%) 1/56 (2%) 0/58 (0%) 1/59 (2%) |
|POLY-3 RATE (b) | 0/55.68 0/49.39 2/24.24 0/9.13 |0/55.85 1/52.99 0/55.37 1/39.11 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 8.3% 0.0% |0.0% 1.9% 0.0% 2.6% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- 410 --- |--- 553 --- 685 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225 (e) P=0.165 (e) |P=0.298 P=0.500 (e) P=0.278 |
|POLY 3 | P=0.167 (e) P=0.114 (e) |P=0.328 P=0.490 (e) P=0.431 |
|POLY 1.5 | P=0.236 (e) P=0.158 (e) |P=0.364 P=0.490 (e) P=0.463 |
|POLY 6 | P=0.317 (e) P=0.080 (e) |P=0.317 P=0.488 (e) P=0.383 |
|LOGISTIC REGRESSION| P=0.425N (e) P=0.563 (e) |P=0.512 P=0.463 (e) P=0.446 |
|COCH-ARM / FISHERS | P=0.600 (e) P=0.248 (e) |P=0.409 P=0.487 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/58 (2%) 2/59 (3%) 5/58 (9%) 3/60 (5%) |1/59 (2%) 3/56 (5%) 2/58 (3%) 10/59 (17%) |
|POLY-3 RATE (b) | 1/55.68 2/49.40 5/25.11 3/11.71 |1/55.85 3/53.25 2/55.86 10/42.75 |
|POLY-3 PERCENT (g) | 1.8% 4.1% 19.9% 25.6% |1.8% 5.6% 3.6% 23.4% |
|TERMINAL (d) | 1/52 (2%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 1/46 (2%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 726 526 368 |729 (T) 553 624 444 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.361 P<0.001 ** P=0.070 |P<0.001 ** P=0.280 P=0.486 P<0.001 ** |
|POLY 3 | P=0.007 ** P=0.459 P=0.016 * P=0.057 |P<0.001 ** P=0.289 P=0.500 P<0.001 ** |
|POLY 1.5 | P=0.022 * P=0.479 P=0.037 * P=0.111 |P<0.001 ** P=0.289 P=0.500 P=0.002 ** |
|POLY 6 | P=0.013 * P=0.432 P=0.006 ** P=0.038 * |P<0.001 ** P=0.287 P=0.496 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.087 P=0.382 P=0.026 * P=0.859 |P=0.011 * P=0.280 P=0.460 P=0.017 * |
|COCH-ARM / FISHERS | P=0.229 P=0.506 P=0.103 P=0.322 |P<0.001 ** P=0.290 P=0.494 P=0.004 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/58 (0%) 0/59 (0%) 0/58 (0%) 0/60 (0%) |6/59 (10%) 8/56 (14%) 7/58 (12%) 6/59 (10%) |
|POLY-3 RATE (b) | 0/55.68 0/49.39 0/22.83 0/9.13 |6/55.85 8/52.43 7/55.59 6/42.55 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |10.7% 15.3% 12.6% 14.1% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |6/52 (12%) 8/46 (17%) 6/47 (13%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 673 403 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.014 * P=0.297 P=0.428 P=0.061 |
|POLY 3 | (e) (e) (e) (e) |P=0.411 P=0.340 P=0.496 P=0.425 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.514 P=0.346 P=0.498 P=0.520 |
|POLY 6 | (e) (e) (e) (e) |P=0.276 P=0.330 P=0.485 P=0.282 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.400N P=0.297 P=0.479 P=0.400N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.474N P=0.348 P=0.487 P=0.619N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/58 (0%) 1/59 (2%) 4/58 (7%) 0/60 (0%) |0/59 (0%) 0/56 (0%) 0/58 (0%) 1/59 (2%) |
|POLY-3 RATE (b) | 0/55.68 1/50.09 4/25.36 0/9.13 |0/55.85 0/52.43 0/55.37 1/39.60 |
|POLY-3 PERCENT (g) | 0.0% 2.0% 15.8% 0.0% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 485 497 --- |--- --- --- 507 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * P=0.490 P=0.020 * (e) |P=0.194 (e) (e) P=0.493 |
|POLY 3 | P=0.024 * P=0.479 P=0.013 * (e) |P=0.164 (e) (e) P=0.433 |
|POLY 1.5 | P=0.110 P=0.490 P=0.025 * (e) |P=0.180 (e) (e) P=0.465 |
|POLY 6 | P=0.028 * P=0.465 P=0.006 ** (e) |P=0.178 (e) (e) P=0.386 |
|LOGISTIC REGRESSION| P=0.213N P=0.489 P=0.238 (e) |P=0.267 (e) (e) P=0.576 |
|COCH-ARM / FISHERS | P=0.600 P=0.504 P=0.059 (e) |P=0.202 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/58 (0%) 1/59 (2%) 0/58 (0%) 2/60 (3%) |0/59 (0%) 0/56 (0%) 1/58 (2%) 0/59 (0%) |
|POLY-3 RATE (b) | 0/55.68 1/49.43 0/22.83 2/10.89 |0/55.85 0/52.43 1/55.43 0/38.93 |
|POLY-3 PERCENT (g) | 0.0% 2.0% 0.0% 18.4% |0.0% 0.0% 1.8% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 717 --- 297 |--- --- 715 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * P=0.428 (e) P=0.133 |P=0.540 (e) P=0.480 (e) |
|POLY 3 | P=0.118 P=0.476 (e) P=0.079 |P=0.510 (e) P=0.498 (e) |
|POLY 1.5 | P=0.082 P=0.488 (e) P=0.115 |P=0.604 (e) P=0.499 (e) |
|POLY 6 | P=0.237 P=0.461 (e) P=0.065 |P=0.407 (e) P=0.495 (e) |
|LOGISTIC REGRESSION| P=0.477 P=0.467 (e) P=0.838 |P=0.655 (e) P=0.498 (e) |
|COCH-ARM / FISHERS | P=0.145 P=0.504 (e) P=0.256 |P=0.695 (e) P=0.496 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/58 (2%) 6/59 (10%) 32/58 (55%) 35/60 (58%) |0/59 (0%) 1/56 (2%) 3/58 (5%) 35/59 (59%) |
|POLY-3 RATE (b) | 1/56.01 6/50.19 32/41.46 35/38.67 |0/55.85 1/52.45 3/55.97 35/50.78 |
|POLY-3 PERCENT (g) | 1.8% 12.0% 77.2% 90.5% |0.0% 1.9% 5.4% 68.9% |
|TERMINAL (d) | 0/52 (0%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 1/47 (2%) 0/5 (0%) |
|FIRST INCIDENCE | 637 641 365 297 |--- 723 624 444 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.027 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.476 P=0.122 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.042 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.487 P=0.120 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.049 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.489 P=0.120 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.034 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.485 P=0.118 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.068 P<0.001 ** P=0.014 * |P<0.001 ** P=0.486 P=0.087 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.060 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.487 P=0.119 P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/59 (0%) 2/57 (4%) 1/60 (2%) |0/60 (0%) 1/59 (2%) 0/59 (0%) 3/60 (5%) |
|POLY-3 RATE (b) | 1/56.99 0/49.39 2/23.64 1/9.98 |0/56.31 1/53.32 0/56.29 3/40.47 |
|POLY-3 PERCENT (g) | 1.8% 0.0% 8.5% 10.0% |0.0% 1.9% 0.0% 7.4% |
|TERMINAL (d) | 1/52 (2%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 1/46 (2%) 0/47 (0%) 1/5 (20%) |
|FIRST INCIDENCE | 729 (T) --- 569 386 |--- 729 (T) --- 590 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.585N P=0.002 ** P=0.401 |P=0.002 ** P=0.476 (e) P=0.010 * |
|POLY 3 | P=0.266 P=0.528N P=0.247 P=0.406 |P=0.033 * P=0.489 (e) P=0.072 |
|POLY 1.5 | P=0.252 P=0.517N P=0.343 P=0.542 |P=0.037 * P=0.492 (e) P=0.092 |
|POLY 6 | P=0.532 P=0.542N P=0.161 P=0.330 |P=0.037 * P=0.486 (e) P=0.050 |
|LOGISTIC REGRESSION| P=0.437 (e) P=0.230 P=0.982 |P=0.043 * P=0.476 (e) P=0.103 |
|COCH-ARM / FISHERS | P=0.500 P=0.504N P=0.481 P=0.752N |P=0.045 * P=0.496 (e) P=0.122 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 6/59 (10%) 4/57 (7%) 0/60 (0%) |1/60 (2%) 6/59 (10%) 2/59 (3%) 6/60 (10%) |
|POLY-3 RATE (b) | 0/56.99 6/49.39 4/24.68 0/9.13 |1/56.31 6/53.32 2/56.82 6/41.81 |
|POLY-3 PERCENT (g) | 0.0% 12.2% 16.2% 0.0% |1.8% 11.3% 3.5% 14.4% |
|TERMINAL (d) | 0/52 (0%) 6/34 (18%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 6/46 (13%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 729 (T) 553 --- |729 (T) 729 (T) 624 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.004 ** P<0.001 ** (e) |P<0.001 ** P=0.042 * P=0.490 P=0.003 ** |
|POLY 3 | P=0.007 ** P=0.010 * P=0.011 * (e) |P=0.056 P=0.049 * P=0.503 P=0.023 * |
|POLY 1.5 | P=0.163 P=0.012 * P=0.023 * (e) |P=0.076 P=0.051 P=0.502 P=0.036 * |
|POLY 6 | P<0.001 ** P=0.008 ** P=0.006 ** (e) |P=0.039 * P=0.047 * P=0.500 P=0.011 * |
|LOGISTIC REGRESSION| P=0.010 * P=0.004 ** P=0.050 (e) |P=0.117 P=0.042 * P=0.453 P=0.076 |
|COCH-ARM / FISHERS | P=0.294N P=0.013 * P=0.053 (e) |P=0.114 P=0.054 P=0.494 P=0.057 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 2/59 (3%) 0/57 (0%) 0/60 (0%) |1/60 (2%) 0/59 (0%) 2/59 (3%) 4/60 (7%) |
|POLY-3 RATE (b) | 3/56.99 2/49.39 0/22.81 0/9.13 |1/56.31 0/53.32 2/56.29 4/40.49 |
|POLY-3 PERCENT (g) | 5.3% 4.1% 0.0% 0.0% |1.8% 0.0% 3.6% 9.9% |
|TERMINAL (d) | 3/52 (6%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 0/46 (0%) 2/47 (4%) 2/5 (40%) |
|FIRST INCIDENCE | 729 (T) 728 --- --- |729 (T) --- 729 (T) 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.819 P=0.673 P=1.000N P=1.000N |P<0.001 ** P=0.524N P=0.465 P<0.001 ** |
|POLY 3 | P=0.278N P=0.564N P=0.348N P=0.533N |P=0.023 * P=0.511N P=0.500 P=0.099 |
|POLY 1.5 | P=0.115N P=0.540N P=0.232N P=0.350N |P=0.029 * P=0.508N P=0.500 P=0.133 |
|POLY 6 | P=0.540N P=0.596N P=0.513N P=0.641N |P=0.019 * P=0.514N P=0.495 P=0.061 |
|LOGISTIC REGRESSION| P=0.815N P=0.668N (e) (e) |P=0.015 * (e) P=0.465 P=0.077 |
|COCH-ARM / FISHERS | P=0.041N* P=0.508N P=0.132N P=0.122N |P=0.041 * P=0.504N P=0.494 P=0.182 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Congestion Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 1/59 (2%) 0/57 (0%) 0/60 (0%) |1/60 (2%) 2/59 (3%) 1/59 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/57.46 1/49.85 0/22.81 0/9.13 |1/56.31 2/53.34 1/56.29 0/39.77 |
|POLY-3 PERCENT (g) | 3.5% 2.0% 0.0% 0.0% |1.8% 3.8% 1.8% 0.0% |
|TERMINAL (d) | 1/52 (2%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 1/46 (2%) 1/47 (2%) 0/5 (0%) |
|FIRST INCIDENCE | 592 592 --- --- |729 (T) 723 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.709N P=0.591N P=0.921N P=1.000N |P=0.644N P=0.458 P=0.739 P=0.927N |
|POLY 3 | P=0.328N P=0.549N P=0.464N P=0.603N |P=0.324N P=0.481 P=0.760 P=0.567N |
|POLY 1.5 | P=0.179N P=0.530N P=0.361N P=0.464N |P=0.289N P=0.486 P=0.760N P=0.536N |
|POLY 6 | P=0.531N P=0.573N P=0.590N P=0.679N |P=0.401N P=0.476 P=0.757 P=0.615N |
|LOGISTIC REGRESSION| P=0.067N P=0.442N P=0.296N P=0.826N |P=0.575N P=0.469 P=0.739 (e) |
|COCH-ARM / FISHERS | P=0.103N P=0.506N P=0.261N P=0.248N |P=0.248N P=0.494 P=0.748 P=0.500N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 14/59 (24%) 1/57 (2%) 1/60 (2%) |2/60 (3%) 3/59 (5%) 6/59 (10%) 28/60 (47%) |
|POLY-3 RATE (b) | 3/57.33 14/50.61 1/23.34 1/9.93 |2/56.31 3/53.32 6/56.51 28/46.93 |
|POLY-3 PERCENT (g) | 5.2% 27.7% 4.3% 10.1% |3.6% 5.6% 10.6% 59.7% |
|TERMINAL (d) | 2/52 (4%) 10/34 (29%) 0/0 (0%) 0/0 (0%) |2/52 (4%) 3/46 (7%) 5/47 (11%) 3/5 (60%) |
|FIRST INCIDENCE | 637 559 564 427 |729 (T) 729 (T) 673 516 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P=0.308 P=0.058 |P<0.001 ** P=0.444 P=0.111 P<0.001 ** |
|POLY 3 | P=0.052 P<0.001 ** P=0.628N P=0.530 |P<0.001 ** P=0.475 P=0.136 P<0.001 ** |
|POLY 1.5 | P=0.514N P=0.002 ** P=0.491N P=0.626N |P<0.001 ** P=0.481 P=0.136 P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P=0.554 P=0.400 |P<0.001 ** P=0.468 P=0.132 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.073 P=0.002 ** P=0.685N P=0.968N |P<0.001 ** P=0.444 P=0.134 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.025N* P=0.003 ** P=0.329N P=0.309N |P<0.001 ** P=0.492 P=0.131 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hyperplasia Focal Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/59 (0%) 0/57 (0%) 0/60 (0%) |2/60 (3%) 5/59 (8%) 2/59 (3%) 1/60 (2%) |
|POLY-3 RATE (b) | 0/56.99 0/49.39 0/22.81 0/9.13 |2/56.31 5/53.32 2/56.29 1/39.88 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |3.6% 9.4% 3.6% 2.5% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |2/52 (4%) 5/46 (11%) 2/47 (4%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) 702 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.341 P=0.171 P=0.658 P=0.375 |
|POLY 3 | (e) (e) (e) (e) |P=0.349N P=0.196 P=0.693 P=0.616N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.288N P=0.201 P=0.693N P=0.562N |
|POLY 6 | (e) (e) (e) (e) |P=0.454N P=0.190 P=0.688 P=0.694N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.503 P=0.171 P=0.658 P=0.646 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.222N P=0.213 P=0.684 P=0.500N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/60 (75%) 40/59 (68%) 24/57 (42%) 29/60 (48%) |45/60 (75%) 38/59 (64%) 37/59 (63%) 43/60 (72%) |
|POLY-3 RATE (b) | 45/58.16 40/54.36 24/36.94 29/33.58 |45/56.92 38/55.59 37/57.30 43/52.85 |
|POLY-3 PERCENT (g) | 77.4% 73.6% 65.0% 86.4% |79.1% 68.4% 64.6% 81.4% |
|TERMINAL (d) | 41/52 (79%) 27/34 (79%) 0/0 (0%) 0/0 (0%) |42/52 (81%) 33/46 (72%) 32/47 (68%) 4/5 (80%) |
|FIRST INCIDENCE | 592 451 365 312 |592 312 624 403 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.037 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.407N P=0.273N P<0.001 ** |
|POLY 3 | P=0.345 P=0.399N P=0.121N P=0.211 |P=0.371 P=0.136N P=0.061N P=0.473 |
|POLY 1.5 | P=0.139N P=0.321N P=0.009N** P=0.338N |P=0.482 P=0.134N P=0.068N P=0.570N |
|POLY 6 | P=0.024 * P=0.510N P=0.512 P=0.024 * |P=0.229 P=0.152N P=0.066N P=0.257 |
|LOGISTIC REGRESSION| P=0.189 P=0.481N P=0.377N P=0.311 |P=0.190 P=0.189N P=0.070N P=0.178 |
|COCH-ARM / FISHERS | P<0.001N** P=0.253N P<0.001N** P=0.002N** |P=0.478N P=0.145N P=0.106N P=0.418N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/59 (0%) 0/57 (0%) 0/60 (0%) |0/60 (0%) 0/59 (0%) 1/59 (2%) 3/60 (5%) |
|POLY-3 RATE (b) | 2/57.33 0/49.39 0/22.81 0/9.13 |0/56.31 0/53.32 1/56.45 3/40.20 |
|POLY-3 PERCENT (g) | 3.5% 0.0% 0.0% 0.0% |0.0% 0.0% 1.8% 7.5% |
|TERMINAL (d) | 1/52 (2%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 1/5 (20%) |
|FIRST INCIDENCE | 637 --- --- --- |--- --- 690 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.570N P=0.312N P=0.995N P=1.000N |P<0.001 ** (e) P=0.493 P=0.004 ** |
|POLY 3 | P=0.157N P=0.272N P=0.464N P=0.603N |P=0.012 * (e) P=0.500 P=0.072 |
|POLY 1.5 | P=0.120N P=0.258N P=0.360N P=0.464N |P=0.015 * (e) P=0.500 P=0.092 |
|POLY 6 | P=0.204N P=0.291N P=0.590N P=0.679N |P=0.012 * (e) P=0.498 P=0.049 * |
|LOGISTIC REGRESSION| P=0.222N P=0.224N P=0.531N P=0.985N |P=0.012 * (e) P=0.481 P=0.040 * |
|COCH-ARM / FISHERS | P=0.117N P=0.252N P=0.261N P=0.248N |P=0.021 * (e) P=0.496 P=0.122 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 15/59 (25%) 27/57 (47%) 30/60 (50%) |3/60 (5%) 0/59 (0%) 2/59 (3%) 13/60 (22%) |
|POLY-3 RATE (b) | 1/56.99 15/52.33 27/38.30 30/34.75 |3/56.77 0/53.32 2/56.29 13/44.33 |
|POLY-3 PERCENT (g) | 1.8% 28.7% 70.5% 86.3% |5.3% 0.0% 3.6% 29.3% |
|TERMINAL (d) | 1/52 (2%) 4/34 (12%) 0/0 (0%) 0/0 (0%) |2/52 (4%) 0/46 (0%) 2/47 (4%) 1/5 (20%) |
|FIRST INCIDENCE | 729 (T) 526 419 297 |592 --- 729 (T) 444 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.139N P=0.532N P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.131N P=0.504N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.128N P=0.502N P=0.002 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.135N P=0.513N P<0.001 ** |
|LOGISTIC REGRESSION| P=0.004 ** P<0.001 ** P<0.001 ** P=0.110 |P<0.001 ** P=0.119N P=0.522N P=0.021 * |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.125N P=0.508N P=0.007 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Fatty Change Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/59 (0%) 0/57 (0%) 0/60 (0%) |0/60 (0%) 2/59 (3%) 0/59 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/57.95 0/49.39 0/22.81 0/9.13 |0/56.31 2/54.68 0/56.29 0/39.77 |
|POLY-3 PERCENT (g) | 3.5% 0.0% 0.0% 0.0% |0.0% 3.7% 0.0% 0.0% |
|TERMINAL (d) | 1/52 (2%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 263 --- --- --- |--- 266 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.232N P=0.286N P=0.503N P=0.500N |P=0.443N P=0.238 (e) (e) |
|POLY 3 | P=0.159N P=0.275N P=0.466N P=0.604N |P=0.444N P=0.231 (e) (e) |
|POLY 1.5 | P=0.121N P=0.261N P=0.363N P=0.466N |P=0.428N P=0.233 (e) (e) |
|POLY 6 | P=0.206N P=0.293N P=0.591N P=0.679N |P=0.499N P=0.229 (e) (e) |
|LOGISTIC REGRESSION| P<0.001N** P=0.187N P=0.033N* P<0.001N** |P=0.419N P=0.307 (e) (e) |
|COCH-ARM / FISHERS | P=0.117N P=0.252N P=0.261N P=0.248N |P=0.405N P=0.244 (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/59 (0%) 0/57 (0%) 0/60 (0%) |0/60 (0%) 0/59 (0%) 0/59 (0%) 6/60 (10%) |
|POLY-3 RATE (b) | 2/56.99 0/49.39 0/22.81 0/9.13 |0/56.31 0/53.32 0/56.29 6/41.82 |
|POLY-3 PERCENT (g) | 3.5% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 14.4% |
|TERMINAL (d) | 2/52 (4%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.620N P=0.336N P=1.000 P=1.000N |P<0.001 ** (e) (e) P=0.003 ** |
|POLY 3 | P=0.156N P=0.271N P=0.462N P=0.602N |P<0.001 ** (e) (e) P=0.006 ** |
|POLY 1.5 | P=0.120N P=0.258N P=0.359N P=0.463N |P<0.001 ** (e) (e) P=0.009 ** |
|POLY 6 | P=0.201N P=0.288N P=0.589N P=0.679N |P<0.001 ** (e) (e) P=0.003 ** |
|LOGISTIC REGRESSION| P=0.620N (e) (e) (e) |P<0.001 ** (e) (e) P=0.029 * |
|COCH-ARM / FISHERS | P=0.117N P=0.252N P=0.261N P=0.248N |P<0.001 ** (e) (e) P=0.014 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Syncytial Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/60 (27%) 26/59 (44%) 43/57 (75%) 39/60 (65%) |0/60 (0%) 0/59 (0%) 0/59 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 16/57.33 26/52.31 43/48.12 39/42.22 |0/56.31 0/53.32 0/56.29 0/39.77 |
|POLY-3 PERCENT (g) | 27.9% 49.7% 89.4% 92.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 15/52 (29%) 18/34 (53%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 637 463 303 277 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.021 * P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.002 ** P=0.018 * P<0.001 ** P=0.088 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.036 * P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/60 (17%) 4/59 (7%) 0/57 (0%) 0/60 (0%) |0/60 (0%) 2/59 (3%) 0/59 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 10/56.99 4/49.39 0/22.81 0/9.13 |0/56.31 2/53.32 0/56.29 0/39.77 |
|POLY-3 PERCENT (g) | 17.6% 8.1% 0.0% 0.0% |0.0% 3.8% 0.0% 0.0% |
|TERMINAL (d) | 10/52 (19%) 4/34 (12%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 2/46 (4%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.375N P=0.269N P=1.000N P=1.000N |P=0.735N P=0.212 (e) (e) |
|POLY 3 | P=0.010N* P=0.125N P=0.065N P=0.311N |P=0.446N P=0.226 (e) (e) |
|POLY 1.5 | P=0.002N** P=0.104N P=0.013N* P=0.068N |P=0.430N P=0.229 (e) (e) |
|POLY 6 | P=0.050N P=0.157N P=0.271N P=0.548N |P=0.502N P=0.222 (e) (e) |
|LOGISTIC REGRESSION| P=0.375N P=0.269N (e) (e) |(e) P=0.212 (e) (e) |
|COCH-ARM / FISHERS | P<0.001N** P=0.081N P<0.001N** P<0.001N** |P=0.405N P=0.244 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 5/59 (8%) 2/57 (4%) 1/60 (2%) |1/60 (2%) 2/59 (3%) 2/59 (3%) 9/60 (15%) |
|POLY-3 RATE (b) | 4/57.45 5/49.39 2/23.87 1/9.97 |1/56.31 2/53.32 2/56.51 9/43.00 |
|POLY-3 PERCENT (g) | 7.0% 10.1% 8.4% 10.0% |1.8% 3.8% 3.5% 20.9% |
|TERMINAL (d) | 3/52 (6%) 5/34 (15%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 2/46 (4%) 1/47 (2%) 1/5 (20%) |
|FIRST INCIDENCE | 596 729 (T) 560 393 |729 (T) 729 (T) 673 516 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** P=0.266 P=0.057 P=0.358 |P<0.001 ** P=0.457 P=0.475 P<0.001 ** |
|POLY 3 | P=0.410 P=0.407 P=0.582 P=0.572 |P<0.001 ** P=0.481 P=0.501 P=0.002 ** |
|POLY 1.5 | P=0.424N P=0.443 P=0.568N P=0.518N |P<0.001 ** P=0.486 P=0.501 P=0.004 ** |
|POLY 6 | P=0.226 P=0.362 P=0.369 P=0.421 |P<0.001 ** P=0.475 P=0.497 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.444 P=0.398 P=0.672N P=0.807N |P=0.003 ** P=0.457 P=0.493 P=0.021 * |
|COCH-ARM / FISHERS | P=0.082N P=0.489 P=0.364N P=0.182N |P<0.001 ** P=0.494 P=0.494 P=0.008 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte, Centrilobular |
| Depletion Glycogen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/59 (2%) 0/57 (0%) 3/60 (5%) |0/60 (0%) 0/59 (0%) 0/59 (0%) 1/60 (2%) |
|POLY-3 RATE (b) | 0/56.99 1/49.39 0/22.81 3/11.81 |0/56.31 0/53.32 0/56.29 1/40.30 |
|POLY-3 PERCENT (g) | 0.0% 2.0% 0.0% 25.4% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/52 (0%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 277 |--- --- --- 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.415 (e) P=0.093 |P=0.186 (e) (e) P=0.481 |
|POLY 3 | P=0.043 * P=0.472 (e) P=0.022 * |P=0.165 (e) (e) P=0.435 |
|POLY 1.5 | P=0.023 * P=0.483 (e) P=0.038 * |P=0.180 (e) (e) P=0.466 |
|POLY 6 | P=0.121 P=0.457 (e) P=0.016 * |P=0.177 (e) (e) P=0.388 |
|LOGISTIC REGRESSION| P=0.475 P=0.415 (e) P=0.675 |P=0.252 (e) (e) P=0.584 |
|COCH-ARM / FISHERS | P=0.045 * P=0.496 (e) P=0.122 |P=0.200 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte, Centrilobular |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 2/59 (3%) 5/57 (9%) 2/60 (3%) |2/60 (3%) 0/59 (0%) 2/59 (3%) 0/60 (0%) |
|POLY-3 RATE (b) | 1/57.04 2/50.32 5/25.85 2/10.85 |2/57.56 0/53.32 2/56.35 0/39.77 |
|POLY-3 PERCENT (g) | 1.8% 4.0% 19.3% 18.4% |3.5% 0.0% 3.6% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 1/47 (2%) 0/5 (0%) |
|FIRST INCIDENCE | 719 542 451 358 |483 --- 715 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.423 P=0.002 ** P=0.149 |P=0.405N P=0.246N P=0.680 P=0.256N |
|POLY 3 | P=0.013 * P=0.457 P=0.015 * P=0.158 |P=0.322N P=0.255N P=0.686 P=0.328N |
|POLY 1.5 | P=0.045 * P=0.473 P=0.035 * P=0.252 |P=0.287N P=0.250N P=0.689 P=0.283N |
|POLY 6 | P=0.019 * P=0.436 P=0.006 ** P=0.117 |P=0.404N P=0.261N P=0.678 P=0.403N |
|LOGISTIC REGRESSION| P=0.363N P=0.561 P=0.306 P=0.933 |P=0.186N P=0.175N P=0.543 P=0.143N |
|COCH-ARM / FISHERS | P=0.373 P=0.494 P=0.092 P=0.500 |P=0.248N P=0.252N P=0.684 P=0.248N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Oval Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/59 (0%) 0/57 (0%) 2/60 (3%) |0/60 (0%) 0/59 (0%) 0/59 (0%) 4/60 (7%) |
|POLY-3 RATE (b) | 0/56.99 0/49.39 0/22.81 2/10.89 |0/56.31 0/53.32 0/56.29 4/41.83 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 18.4% |0.0% 0.0% 0.0% 9.6% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- 354 |--- --- --- 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.034 * (e) (e) P=0.202 |P=0.002 ** (e) (e) P=0.044 * |
|POLY 3 | P=0.149 (e) (e) P=0.077 |P=0.002 ** (e) (e) P=0.033 * |
|POLY 1.5 | P=0.045 * (e) (e) P=0.112 |P=0.002 ** (e) (e) P=0.044 * |
|POLY 6 | P=0.506 (e) (e) P=0.063 |P=0.003 ** (e) (e) P=0.020 * |
|LOGISTIC REGRESSION| P=0.446 (e) (e) P=0.845 |P=0.011 * (e) (e) P=0.127 |
|COCH-ARM / FISHERS | P=0.048 * (e) (e) P=0.248 |P=0.003 ** (e) (e) P=0.059 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 1/60 (2%) |1/60 (2%) 2/60 (3%) 1/59 (2%) 1/57 (2%) |
|POLY-3 RATE (b) | 0/56.99 1/50.40 1/24.12 1/9.96 |1/56.31 2/54.68 1/56.37 1/37.60 |
|POLY-3 PERCENT (g) | 0.0% 2.0% 4.2% 10.0% |1.8% 3.7% 1.8% 2.7% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 463 517 405 |729 (T) 608 701 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.043 * P=0.497 P=0.417 P=0.304 |P=0.412 P=0.477 P=0.743 P=0.300 |
|POLY 3 | P=0.139 P=0.476 P=0.353 P=0.280 |P=0.563 P=0.490 P=0.760N P=0.663 |
|POLY 1.5 | P=0.163 P=0.486 P=0.415 P=0.348 |P=0.590N P=0.493 P=0.760N P=0.706 |
|POLY 6 | P=0.221 P=0.462 P=0.288 P=0.246 |P=0.504 P=0.486 P=0.758 P=0.591 |
|LOGISTIC REGRESSION| P=0.466N P=0.482 P=0.736 P=0.940 |P=0.528N P=0.518 P=0.761 P=0.585 |
|COCH-ARM / FISHERS | P=0.384 P=0.500 P=0.500 P=0.500 |P=0.549N P=0.500 P=0.748 P=0.739 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 5/60 (8%) |2/60 (3%) 1/60 (2%) 1/59 (2%) 2/57 (4%) |
|POLY-3 RATE (b) | 1/57.95 0/49.65 1/24.35 5/13.49 |2/56.32 1/54.01 1/56.26 2/37.88 |
|POLY-3 PERCENT (g) | 1.7% 0.0% 4.1% 37.1% |3.6% 1.9% 1.8% 5.3% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 1/46 (2%) 1/47 (2%) 0/5 (0%) |
|FIRST INCIDENCE | 263 --- 365 277 |725 729 (T) 729 (T) 671 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.500N P=0.758 P=0.034 * |P=0.124 P=0.545N P=0.537N P=0.158 |
|POLY 3 | P=0.014 * P=0.531N P=0.548 P=0.005 ** |P=0.450 P=0.515N P=0.500N P=0.543 |
|POLY 1.5 | P=0.005 ** P=0.518N P=0.650 P=0.016 * |P=0.487 P=0.509N P=0.500N P=0.607 |
|POLY 6 | P=0.077 P=0.546N P=0.422 P=0.003 ** |P=0.432 P=0.522N P=0.506N P=0.443 |
|LOGISTIC REGRESSION| P=0.446N (e) P=0.602N P=0.532N |P=0.374 P=0.533N P=0.526N P=0.482 |
|COCH-ARM / FISHERS | P=0.012 * P=0.500N P=0.752N P=0.103 |P=0.536 P=0.500N P=0.506N P=0.671 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 1/60 (2%) |1/60 (2%) 0/60 (0%) 0/59 (0%) 0/57 (0%) |
|POLY-3 RATE (b) | 0/56.99 2/49.65 0/23.48 1/10.00 |1/56.31 0/54.01 0/56.26 0/37.46 |
|POLY-3 PERCENT (g) | 0.0% 4.0% 0.0% 10.0% |1.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 2/34 (6%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 371 |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047 * P=0.151 (e) P=0.441 |P=0.473N P=0.524N P=0.520N P=0.927N |
|POLY 3 | P=0.201 P=0.208 (e) P=0.280 |P=0.250N P=0.508N P=0.500N P=0.578N |
|POLY 1.5 | P=0.288 P=0.221 (e) P=0.349 |P=0.282N P=0.505N P=0.500N P=0.547N |
|POLY 6 | P=0.150 P=0.194 (e) P=0.246 |P=0.236N P=0.512N P=0.503N P=0.625N |
|LOGISTIC REGRESSION| P=0.273 P=0.151 (e) P=0.950 |P=0.473N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.539 P=0.248 (e) P=0.500 |P=0.312N P=0.500N P=0.504N P=0.513N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia Focal Histiocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 2/60 (3%) 0/59 (0%) 0/57 (0%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 0/23.48 0/9.13 |0/56.31 2/54.01 0/56.26 0/37.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 3.7% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 2/46 (4%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.735N P=0.212 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.455N P=0.228 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.440N P=0.232 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.512N P=0.224 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.212 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.416N P=0.248 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |1/60 (2%) 1/60 (2%) 2/59 (3%) 1/57 (2%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 0/23.48 0/9.13 |1/56.38 1/54.01 2/56.26 1/37.66 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |1.8% 1.9% 3.6% 2.7% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 1/46 (2%) 2/47 (4%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |710 729 (T) 729 (T) 677 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.158 P=0.734 P=0.463 P=0.435 |
|POLY 3 | (e) (e) (e) (e) |P=0.416 P=0.751 P=0.499 P=0.663 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.489 P=0.754 P=0.500 P=0.706 |
|POLY 6 | (e) (e) (e) (e) |P=0.337 P=0.746 P=0.493 P=0.592 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.381 P=0.753 P=0.497 P=0.697 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.573 P=0.752N P=0.494 P=0.739 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 4/60 (7%) 9/60 (15%) 3/60 (5%) |0/60 (0%) 0/60 (0%) 0/59 (0%) 9/57 (16%) |
|POLY-3 RATE (b) | 0/56.99 4/50.86 9/28.99 3/11.56 |0/56.31 0/54.01 0/56.26 9/40.48 |
|POLY-3 PERCENT (g) | 0.0% 7.9% 31.1% 26.0% |0.0% 0.0% 0.0% 22.2% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 526 410 391 |--- --- --- 507 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.042 * P<0.001 ** P=0.004 ** |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.048 * P<0.001 ** P=0.021 * |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 1.5 | P=0.002 ** P=0.054 P<0.001 ** P=0.037 * |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.043 * P<0.001 ** P=0.016 * |P<0.001 ** (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P=0.559 P=0.088 P=0.035 * P=0.541 |P<0.001 ** (e) (e) P=0.005 ** |
|COCH-ARM / FISHERS | P=0.191 P=0.059 P<0.001 ** P=0.122 |P<0.001 ** (e) (e) P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 3/60 (5%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 0/59 (0%) 0/57 (0%) |
|POLY-3 RATE (b) | 0/56.99 3/49.65 0/23.48 0/9.13 |0/56.31 0/54.01 0/56.26 0/37.46 |
|POLY-3 PERCENT (g) | 0.0% 6.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 3/34 (9%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.165 P=0.058 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.276 P=0.097 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.599 P=0.106 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.058 P=0.086 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.058 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.312N P=0.122 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/60 (2%) 3/60 (5%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 3/60 (5%) |
|POLY-3 RATE (b) | 1/57.04 1/49.65 3/25.25 0/9.13 |0/56.31 0/54.01 0/57.18 3/40.79 |
|POLY-3 PERCENT (g) | 1.8% 2.0% 11.9% 0.0% |0.0% 0.0% 0.0% 7.4% |
|TERMINAL (d) | 0/52 (0%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 719 729 (T) 523 --- |--- --- --- 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * P=0.667 P=0.031 * P=1.000N |P=0.002 ** (e) (e) P=0.039 * |
|POLY 3 | P=0.191 P=0.729 P=0.110 P=0.721N |P=0.010 * (e) (e) P=0.073 |
|POLY 1.5 | P=0.371 P=0.743 P=0.178 P=0.654N |P=0.010 * (e) (e) P=0.093 |
|POLY 6 | P=0.212 P=0.710 P=0.060 P=0.754N |P=0.012 * (e) (e) P=0.051 |
|LOGISTIC REGRESSION| P=0.748 P=0.703 P=0.441 (e) |P=0.024 * (e) (e) P=0.156 |
|COCH-ARM / FISHERS | P=0.409N P=0.752N P=0.309 P=0.500N |P=0.012 * (e) (e) P=0.122 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 0/23.48 0/9.13 |0/56.31 0/54.01 0/57.18 2/40.20 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 629 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.005 ** (e) (e) P=0.049 * |
|POLY 3 | (e) (e) (e) (e) |P=0.038 * (e) (e) P=0.172 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.201 |
|POLY 6 | (e) (e) (e) (e) |P=0.047 * (e) (e) P=0.136 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.051 (e) (e) P=0.202 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.248 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 2/55 (4%) 0/56 (0%) 0/53 (0%) |0/53 (0%) 0/58 (0%) 1/57 (2%) 1/57 (2%) |
|POLY-3 RATE (b) | 1/56.99 2/46.32 0/21.95 0/7.99 |0/50.24 0/53.22 1/54.43 1/38.05 |
|POLY-3 PERCENT (g) | 1.8% 4.3% 0.0% 0.0% |0.0% 0.0% 1.8% 2.6% |
|TERMINAL (d) | 1/52 (2%) 2/32 (6%) 0/0 (0%) 0/0 (0%) |0/46 (0%) 0/46 (0%) 0/46 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- 715 640 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.568 P=0.334 P=1.000N P=1.000N |P=0.075 (e) P=0.480 P=0.386 |
|POLY 3 | P=0.649 P=0.428 P=0.659N P=0.733N |P=0.157 (e) P=0.516 P=0.446 |
|POLY 1.5 | P=0.432N P=0.446 P=0.599N P=0.671N |P=0.194 (e) P=0.516 P=0.478 |
|POLY 6 | P=0.442 P=0.406 P=0.720N P=0.762N |P=0.130 (e) P=0.513 P=0.398 |
|LOGISTIC REGRESSION| P=0.568 P=0.334 (e) (e) |P=0.253 (e) P=0.515 P=0.574 |
|COCH-ARM / FISHERS | P=0.206N P=0.467 P=0.517N P=0.531N |P=0.243 (e) P=0.518 P=0.518 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/55 (0%) 1/56 (2%) 0/53 (0%) |3/53 (6%) 1/58 (2%) 2/57 (4%) 4/57 (7%) |
|POLY-3 RATE (b) | 0/56.99 0/46.32 1/22.67 0/7.99 |3/50.70 1/53.22 2/54.37 4/38.36 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.4% 0.0% |5.9% 1.9% 3.7% 10.4% |
|TERMINAL (d) | 0/52 (0%) 0/32 (0%) 0/0 (0%) 0/0 (0%) |2/46 (4%) 1/46 (2%) 2/46 (4%) 2/5 (40%) |
|FIRST INCIDENCE | --- --- 476 --- |592 729 (T) 729 (T) 583 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.463 (e) P=0.455 (e) |P=0.011 * P=0.309N P=0.495N P=0.018 * |
|POLY 3 | P=0.411 (e) P=0.343 (e) |P=0.227 P=0.288N P=0.468N P=0.353 |
|POLY 1.5 | P=0.406 (e) P=0.403 (e) |P=0.260 P=0.283N P=0.466N P=0.438 |
|POLY 6 | P=0.634 (e) P=0.282 (e) |P=0.210 P=0.295N P=0.477N P=0.239 |
|LOGISTIC REGRESSION| P=0.674N (e) P=0.757 (e) |P=0.228 P=0.266N P=0.483N P=0.404 |
|COCH-ARM / FISHERS | P=0.681 (e) P=0.483 (e) |P=0.313 P=0.276N P=0.465N P=0.541 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/55 (2%) 0/56 (0%) 0/53 (0%) |6/53 (11%) 2/58 (3%) 2/57 (4%) 2/57 (4%) |
|POLY-3 RATE (b) | 0/56.99 1/46.32 0/21.95 0/7.99 |6/50.24 2/53.41 2/54.37 2/37.96 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |11.9% 3.7% 3.7% 5.3% |
|TERMINAL (d) | 0/52 (0%) 1/32 (3%) 0/0 (0%) 0/0 (0%) |6/46 (13%) 1/46 (2%) 2/46 (4%) 0/5 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |729 (T) 679 729 (T) 688 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.784 P=0.403 (e) (e) |P=0.573 P=0.141N P=0.135N P=0.262 |
|POLY 3 | P=0.587 P=0.459 (e) (e) |P=0.137N P=0.115N P=0.110N P=0.245N |
|POLY 1.5 | P=0.690 P=0.469 (e) (e) |P=0.122N P=0.113N P=0.110N P=0.174N |
|POLY 6 | P=0.467 P=0.446 (e) (e) |P=0.156N P=0.118N P=0.114N P=0.382N |
|LOGISTIC REGRESSION| (e) P=0.403 (e) (e) |P=0.316N P=0.119N P=0.135N P=0.662 |
|COCH-ARM / FISHERS | P=0.583N P=0.478 (e) (e) |P=0.101N P=0.108N P=0.113N P=0.113N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/3 (0%) 0/4 (0%) 0/7 (0%) 0/1 (0%) |0/6 (0%) 0/3 (0%) 2/10 (20%) 0/11 (0%) |
|POLY-3 RATE (b) | 0/2.88 0/3.68 0/2.49 0/0.16 |0/5.98 0/2.59 2/9.43 0/7.61 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 21.2% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |0/5 (0%) 0/2 (0%) 1/5 (20%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 624 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.382 (e) P=0.246 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.586 (e) P=0.335 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.665N (e) P=0.343 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.438 (e) P=0.321 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.567N (e) P=0.658 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.601N (e) P=0.375 (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/3 (0%) 0/4 (0%) 0/7 (0%) 0/1 (0%) |0/6 (0%) 0/3 (0%) 2/10 (20%) 1/11 (9%) |
|POLY-3 RATE (b) | 0/2.88 0/3.68 0/2.49 0/0.16 |0/5.98 0/2.59 2/9.05 1/8.10 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 22.1% 12.3% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |0/5 (0%) 0/2 (0%) 2/5 (40%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) 583 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.031 * (e) P=0.227 P=0.421 |
|POLY 3 | (e) (e) (e) (e) |P=0.321 (e) P=0.323 P=0.562 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.384 (e) P=0.337 P=0.590 |
|POLY 6 | (e) (e) (e) (e) |P=0.228 (e) P=0.301 P=0.511 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.479 (e) P=0.227 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.452 (e) P=0.375 P=0.647 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/12 (25%) 2/12 (17%) 2/42 (5%) 0/38 (0%) |1/11 (9%) 0/9 (0%) 0/9 (0%) 2/34 (6%) |
|POLY-3 RATE (b) | 3/11.54 2/10.90 2/18.55 0/6.18 |1/10.98 0/7.77 0/7.77 2/24.95 |
|POLY-3 PERCENT (g) | 26.0% 18.4% 10.8% 0.0% |9.1% 0.0% 0.0% 8.0% |
|TERMINAL (d) | 3/11 (27%) 1/7 (14%) 0/0 (0%) 0/0 (0%) |1/10 (10%) 0/6 (0%) 0/5 (0%) 0/4 (0%) |
|FIRST INCIDENCE | 729 (T) 717 492 --- |729 (T) --- --- 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.198 P=0.675 P=0.160 P=1.000N |P=0.169 P=0.602N P=0.638N P=0.366 |
|POLY 3 | P=0.107N P=0.528N P=0.255N P=0.272N |P=0.545 P=0.568N P=0.568N P=0.716N |
|POLY 1.5 | P=0.014N* P=0.515N P=0.122N P=0.048N* |P=0.576 P=0.556N P=0.556N P=0.673N |
|POLY 6 | P=0.507N P=0.550N P=0.576N P=0.580N |P=0.492 P=0.584N P=0.586N P=0.716 |
|LOGISTIC REGRESSION| P=0.359N P=0.634N P=0.432N (e) |P=0.392N (e) (e) P=0.294N |
|COCH-ARM / FISHERS | P=0.003N** P=0.500N P=0.067N P=0.011N* |P=0.609 P=0.550N P=0.550N P=0.578N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/12 (25%) 1/12 (8%) 0/42 (0%) 0/38 (0%) |0/11 (0%) 0/9 (0%) 1/9 (11%) 0/34 (0%) |
|POLY-3 RATE (b) | 3/12.00 1/10.85 0/17.23 0/6.18 |0/10.98 0/7.77 1/7.77 0/23.82 |
|POLY-3 PERCENT (g) | 25.0% 9.2% 0.0% 0.0% |0.0% 0.0% 12.9% 0.0% |
|TERMINAL (d) | 2/11 (18%) 1/7 (14%) 0/0 (0%) 0/0 (0%) |0/10 (0%) 0/6 (0%) 1/5 (20%) 0/4 (0%) |
|FIRST INCIDENCE | 592 729 (T) --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.626N P=0.451N P=0.942N P=1.000N |P=0.579 (e) P=0.362 (e) |
|POLY 3 | P=0.008N** P=0.333N P=0.035N* P=0.286N |P=0.678N (e) P=0.431 (e) |
|POLY 1.5 | P<0.001N** P=0.316N P=0.008N** P=0.052N |P=0.642N (e) P=0.444 (e) |
|POLY 6 | P=0.086N P=0.362N P=0.212N P=0.583N |P=0.627 (e) P=0.412 (e) |
|LOGISTIC REGRESSION| P=0.126N P=0.245N P=0.138N P=0.823N |(e) (e) P=0.362 (e) |
|COCH-ARM / FISHERS | P=0.003N** P=0.295N P=0.009N** P=0.011N* |P=0.601N (e) P=0.450 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/12 (50%) 1/12 (8%) 1/42 (2%) 0/38 (0%) |6/11 (55%) 5/9 (56%) 4/9 (44%) 0/34 (0%) |
|POLY-3 RATE (b) | 6/11.54 1/11.00 1/17.81 0/6.18 |6/10.98 5/7.77 4/8.70 0/23.82 |
|POLY-3 PERCENT (g) | 52.0% 9.1% 5.6% 0.0% |54.6% 64.4% 46.0% 0.0% |
|TERMINAL (d) | 6/11 (55%) 0/7 (0%) 0/0 (0%) 0/0 (0%) |6/10 (60%) 5/6 (83%) 2/5 (40%) 0/4 (0%) |
|FIRST INCIDENCE | 729 (T) 690 544 --- |729 (T) 729 (T) 553 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.628N P=0.131N P=0.358 P=1.000N |P=0.076N P=0.343 P=0.566 P=0.081N |
|POLY 3 | P<0.001N** P=0.029N* P<0.001N** P=0.060N |P<0.001N** P=0.521 P=0.527N P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.028N* P<0.001N** P<0.001N** |P<0.001N** P=0.581 P=0.514N P<0.001N** |
|POLY 6 | P<0.001N** P=0.033N* P=0.062N P=0.497N |P<0.001N** P=0.432 P=0.551N P<0.001N** |
|LOGISTIC REGRESSION| P=0.076N P=0.052N P=0.491N (e) |P<0.001N** P=0.343 P=0.298N (e) |
|COCH-ARM / FISHERS | P<0.001N** P=0.034N* P<0.001N** P<0.001N** |P<0.001N** P=0.658 P=0.500N P<0.001N** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Mucosa, Glands |
| Dilatation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 3/59 (5%) 1/57 (2%) |
|POLY-3 RATE (b) | 0/56.99 1/49.65 0/23.48 0/9.13 |0/56.31 0/54.01 3/56.29 1/38.13 |
|POLY-3 PERCENT (g) | 0.0% 2.0% 0.0% 0.0% |0.0% 0.0% 5.3% 2.6% |
|TERMINAL (d) | 0/52 (0%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 3/47 (6%) 0/5 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- --- 729 (T) 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.791 P=0.415 (e) (e) |P=0.012 * (e) P=0.104 P=0.230 |
|POLY 3 | P=0.604 P=0.473 (e) (e) |P=0.107 (e) P=0.120 P=0.424 |
|POLY 1.5 | P=0.705 P=0.484 (e) (e) |P=0.159 (e) P=0.120 P=0.455 |
|POLY 6 | P=0.483 P=0.458 (e) (e) |P=0.060 (e) P=0.117 P=0.379 |
|LOGISTIC REGRESSION| (e) P=0.415 (e) (e) |P=0.061 (e) P=0.104 P=0.423 |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.234 (e) P=0.119 P=0.487 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/59 (5%) 2/56 (4%) 1/56 (2%) 0/56 (0%) |
|POLY-3 RATE (b) | |3/55.31 2/51.28 1/53.29 0/36.99 |
|POLY-3 PERCENT (g) | |5.4% 3.9% 1.9% 0.0% |
|TERMINAL (d) | |3/51 (6%) 1/45 (2%) 1/44 (2%) 0/5 (0%) |
|FIRST INCIDENCE | |729 (T) 721 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.283N P=0.554N P=0.360N P=0.684N |
|POLY 3 | |P=0.094N P=0.534N P=0.319N P=0.208N |
|POLY 1.5 | |P=0.082N P=0.529N P=0.319N P=0.167N |
|POLY 6 | |P=0.122N P=0.541N P=0.325N P=0.285N |
|LOGISTIC REGRESSION| |P=0.231N P=0.552N P=0.360N (e) |
|COCH-ARM / FISHERS | |P=0.067N P=0.525N P=0.329N P=0.132N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |12/59 (20%) 18/56 (32%) 13/56 (23%) 11/56 (20%) |
|POLY-3 RATE (b) | |12/55.77 18/51.50 13/53.94 11/40.00 |
|POLY-3 PERCENT (g) | |21.5% 35.0% 24.1% 27.5% |
|TERMINAL (d) | |11/51 (22%) 17/45 (38%) 10/44 (23%) 1/5 (20%) |
|FIRST INCIDENCE | |592 660 671 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P<0.001 ** P=0.073 P=0.368 P<0.001 ** |
|POLY 3 | |P=0.425 P=0.090 P=0.462 P=0.335 |
|POLY 1.5 | |P=0.501N P=0.098 P=0.462 P=0.471 |
|POLY 6 | |P=0.242 P=0.080 P=0.450 P=0.168 |
|LOGISTIC REGRESSION| |P=0.381 P=0.090 P=0.455 P=0.378 |
|COCH-ARM / FISHERS | |P=0.327N P=0.110 P=0.441 P=0.556N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/59 (2%) 2/56 (4%) 0/56 (0%) 1/56 (2%) |
|POLY-3 RATE (b) | |1/55.31 2/52.40 0/53.29 1/37.40 |
|POLY-3 PERCENT (g) | |1.8% 3.8% 0.0% 2.7% |
|TERMINAL (d) | |1/51 (2%) 0/45 (0%) 0/44 (0%) 0/5 (0%) |
|FIRST INCIDENCE | |729 (T) 343 --- 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.620 P=0.475 P=0.529N P=0.489 |
|POLY 3 | |P=0.535N P=0.481 P=0.507N P=0.666 |
|POLY 1.5 | |P=0.530N P=0.483 P=0.507N P=0.707 |
|POLY 6 | |P=0.548N P=0.478 P=0.511N P=0.598 |
|LOGISTIC REGRESSION| |P=0.380N P=0.499 (e) P=0.767 |
|COCH-ARM / FISHERS | |P=0.513N P=0.480 P=0.513N P=0.739 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/59 (0%) 0/56 (0%) 2/56 (4%) 0/56 (0%) |
|POLY-3 RATE (b) | |0/55.31 0/51.25 2/53.29 0/36.99 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 3.8% 0.0% |
|TERMINAL (d) | |0/51 (0%) 0/45 (0%) 2/44 (5%) 0/5 (0%) |
|FIRST INCIDENCE | |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.260 (e) P=0.207 (e) |
|POLY 3 | |P=0.367 (e) P=0.229 (e) |
|POLY 1.5 | |P=0.474 (e) P=0.230 (e) |
|POLY 6 | |P=0.245 (e) P=0.226 (e) |
|LOGISTIC REGRESSION| |(e) (e) P=0.207 (e) |
|COCH-ARM / FISHERS | |P=0.586 (e) P=0.235 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 0/59 (0%) 0/59 (0%) 0/58 (0%) |0/60 (0%) 2/57 (4%) 1/58 (2%) 1/57 (2%) |
|POLY-3 RATE (b) | 0/56.29 0/49.39 0/23.21 0/8.80 |0/56.31 2/52.86 1/55.63 1/38.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 3.8% 1.8% 2.6% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 660 661 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.275 P=0.223 P=0.507 P=0.421 |
|POLY 3 | (e) (e) (e) (e) |P=0.347 P=0.224 P=0.498 P=0.424 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.411 P=0.225 P=0.497 P=0.455 |
|POLY 6 | (e) (e) (e) (e) |P=0.280 P=0.222 P=0.496 P=0.379 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.559 P=0.229 P=0.449 P=0.560 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.488 P=0.235 P=0.492 P=0.487 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/59 (2%) 1/59 (2%) 0/59 (0%) 0/58 (0%) |2/60 (3%) 1/57 (2%) 0/58 (0%) 0/57 (0%) |
|POLY-3 RATE (b) | 1/56.29 1/49.54 0/23.21 0/8.80 |2/56.31 1/52.60 0/55.37 0/37.73 |
|POLY-3 PERCENT (g) | 1.8% 2.0% 0.0% 0.0% |3.6% 1.9% 0.0% 0.0% |
|TERMINAL (d) | 1/52 (2%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |2/52 (4%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 690 --- --- |729 (T) 712 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.880 P=0.678 P=1.000N P=1.000N |P=0.235N P=0.537N P=0.261N P=0.793N |
|POLY 3 | P=0.605N P=0.731 P=0.650N P=0.723N |P=0.103N P=0.524N P=0.241N P=0.335N |
|POLY 1.5 | P=0.369N P=0.744 P=0.587N P=0.656N |P=0.106N P=0.521N P=0.241N P=0.292N |
|POLY 6 | P=0.802 P=0.714 P=0.714N P=0.756N |P=0.106N P=0.527N P=0.244N P=0.408N |
|LOGISTIC REGRESSION| P=0.875N P=0.745 (e) (e) |P=0.160N P=0.527N (e) (e) |
|COCH-ARM / FISHERS | P=0.238N P=0.752N P=0.500N P=0.504N |P=0.105N P=0.519N P=0.256N P=0.261N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 1/59 (2%) 0/59 (0%) 0/58 (0%) |2/60 (3%) 0/57 (0%) 0/58 (0%) 0/57 (0%) |
|POLY-3 RATE (b) | 0/56.29 1/49.54 0/23.21 0/8.80 |2/56.31 0/52.53 0/55.37 0/37.73 |
|POLY-3 PERCENT (g) | 0.0% 2.0% 0.0% 0.0% |3.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |2/52 (4%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 690 --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.804 P=0.440 (e) (e) |P=0.205N P=0.266N P=0.261N P=0.793N |
|POLY 3 | P=0.605 P=0.475 (e) (e) |P=0.095N P=0.253N P=0.241N P=0.335N |
|POLY 1.5 | P=0.703 P=0.486 (e) (e) |P=0.108N P=0.251N P=0.241N P=0.292N |
|POLY 6 | P=0.485 P=0.460 (e) (e) |P=0.086N P=0.256N P=0.244N P=0.408N |
|LOGISTIC REGRESSION| P=0.914 P=0.506 (e) (e) |P=0.205N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.570N P=0.500 (e) (e) |P=0.119N P=0.261N P=0.256N P=0.261N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 36
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/53 (4%) 1/50 (2%) 0/50 (0%) 0/46 (0%) |0/58 (0%) 1/58 (2%) 0/53 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 2/51.28 1/41.29 0/19.25 0/6.89 |0/55.19 1/53.17 0/50.37 0/35.53 |
|POLY-3 PERCENT (g) | 3.9% 2.4% 0.0% 0.0% |0.0% 1.9% 0.0% 0.0% |
|TERMINAL (d) | 2/47 (4%) 1/29 (3%) 0/0 (0%) 0/0 (0%) |0/51 (0%) 1/46 (2%) 0/42 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.849N P=0.666N P=1.000N P=1.000N |P=0.836N P=0.479 (e) (e) |
|POLY 3 | P=0.359N P=0.575N P=0.476N P=0.622N |P=0.580N P=0.493 (e) (e) |
|POLY 1.5 | P=0.197N P=0.553N P=0.369N P=0.497N |P=0.585N P=0.495 (e) (e) |
|POLY 6 | P=0.574N P=0.599N P=0.603N P=0.688N |P=0.613N P=0.489 (e) (e) |
|LOGISTIC REGRESSION| P=0.849N P=0.666N (e) (e) |(e) P=0.479 (e) (e) |
|COCH-ARM / FISHERS | P=0.114N P=0.522N P=0.262N P=0.284N |P=0.583N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/53 (0%) 0/50 (0%) 0/50 (0%) 0/46 (0%) |1/58 (2%) 4/58 (7%) 3/53 (6%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/51.28 0/41.29 0/19.25 0/6.89 |1/55.19 4/53.17 3/50.48 0/35.53 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |1.8% 7.5% 5.9% 0.0% |
|TERMINAL (d) | 0/47 (0%) 0/29 (0%) 0/0 (0%) 0/0 (0%) |1/51 (2%) 4/46 (9%) 2/42 (5%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 701 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.421 P=0.151 P=0.251 P=0.925N |
|POLY 3 | (e) (e) (e) (e) |P=0.449N P=0.169 P=0.274 P=0.585N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.361N P=0.173 P=0.276 P=0.554N |
|POLY 6 | (e) (e) (e) (e) |P=0.538 P=0.164 P=0.269 P=0.628N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.587 P=0.151 P=0.271 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.266N P=0.182 P=0.276 P=0.523N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 37
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/53 (0%) 0/50 (0%) 0/50 (0%) 1/46 (2%) |1/58 (2%) 1/58 (2%) 2/53 (4%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/51.28 0/41.29 0/19.25 1/7.80 |1/55.19 1/53.17 2/50.37 0/35.53 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 12.8% |1.8% 1.9% 4.0% 0.0% |
|TERMINAL (d) | 0/47 (0%) 0/29 (0%) 0/0 (0%) 0/0 (0%) |1/51 (2%) 1/46 (2%) 2/42 (5%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- 326 |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.188 (e) (e) P=0.486 |P=0.534 P=0.738 P=0.432 P=0.925N |
|POLY 3 | P=0.404 (e) (e) P=0.267 |P=0.514N P=0.752 P=0.468 P=0.585N |
|POLY 1.5 | P=0.182 (e) (e) P=0.327 |P=0.460N P=0.755 P=0.470 P=0.554N |
|POLY 6 | P=0.775 (e) (e) P=0.237 |P=0.578 P=0.748 P=0.462 P=0.628N |
|LOGISTIC REGRESSION| P=0.881 (e) (e) (e) |P=0.534 P=0.738 P=0.432 (e) |
|COCH-ARM / FISHERS | P=0.182 (e) (e) P=0.465 |P=0.395N P=0.752N P=0.466 P=0.523N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 28/60 (47%) 27/59 (46%) 16/59 (27%) 1/60 (2%) | |
|POLY-3 RATE (b) | 28/57.40 27/53.68 16/31.46 1/9.95 | |
|POLY-3 PERCENT (g) | 48.8% 50.3% 50.9% 10.1% | |
|TERMINAL (d) | 26/52 (50%) 16/34 (47%) 0/0 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | 637 460 451 414 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.082 P<0.001 ** P=0.189 | |
|POLY 3 | P=0.385N P=0.512 P=0.513 P=0.119N | |
|POLY 1.5 | P=0.003N** P=0.559 P=0.237N P<0.001N** | |
|POLY 6 | P=0.125 P=0.452 P=0.091 P=0.545N | |
|LOGISTIC REGRESSION| P=0.192N P=0.526 P=0.103 P=0.916 | |
|COCH-ARM / FISHERS | P<0.001N** P=0.534N P=0.021N* P<0.001N** | |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 38
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 5/59 (8%) 1/59 (2%) 0/60 (0%) | |
|POLY-3 RATE (b) | 1/56.99 5/49.73 1/23.64 0/9.13 | |
|POLY-3 PERCENT (g) | 1.8% 10.1% 4.2% 0.0% | |
|TERMINAL (d) | 1/52 (2%) 2/34 (6%) 0/0 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | 729 (T) 641 517 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.036 * P=0.045 * P=0.417 P=1.000N | |
|POLY 3 | P=0.196 P=0.075 P=0.545 P=0.721N | |
|POLY 1.5 | P=0.583N P=0.085 P=0.647 P=0.654N | |
|POLY 6 | P=0.029 * P=0.064 P=0.421 P=0.754N | |
|LOGISTIC REGRESSION| P=0.435 P=0.077 P=0.867 (e) | |
|COCH-ARM / FISHERS | P=0.135N P=0.100 P=0.748 P=0.500N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/59 (2%) 7/57 (12%) 4/58 (7%) | |
|POLY-3 RATE (b) | 0/56.99 1/48.73 7/25.95 4/12.11 | |
|POLY-3 PERCENT (g) | 0.0% 2.1% 27.0% 33.0% | |
|TERMINAL (d) | 0/52 (0%) 1/34 (3%) 0/0 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | --- 729 (T) 410 403 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.415 P<0.001 ** P<0.001 ** | |
|POLY 3 | P<0.001 ** P=0.469 P<0.001 ** P=0.005 ** | |
|POLY 1.5 | P<0.001 ** P=0.481 P<0.001 ** P=0.011 * | |
|POLY 6 | P<0.001 ** P=0.454 P<0.001 ** P=0.004 ** | |
|LOGISTIC REGRESSION| P=0.281 P=0.415 P=0.085 P=0.376 | |
|COCH-ARM / FISHERS | P=0.032 * P=0.496 P=0.005 ** P=0.055 | |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 39
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | |
|POLY-3 RATE (b) | 2/56.99 1/49.66 1/24.29 0/9.13 | |
|POLY-3 PERCENT (g) | 3.5% 2.0% 4.1% 0.0% | |
|TERMINAL (d) | 2/52 (4%) 0/34 (0%) 0/0 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | 729 (T) 728 419 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.593 P=0.642N P=0.490 P=1.000N | |
|POLY 3 | P=0.555N P=0.548N P=0.667 P=0.602N | |
|POLY 1.5 | P=0.338N P=0.527N P=0.645N P=0.463N | |
|POLY 6 | P=0.690N P=0.573N P=0.504 P=0.679N | |
|LOGISTIC REGRESSION| P=0.407N P=0.627N P=0.569N (e) | |
|COCH-ARM / FISHERS | P=0.153N P=0.500N P=0.500N P=0.248N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skeletal Muscle |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/6 (0%) 2/35 (6%) 2/47 (4%) |0/2 (0%) 0/3 (0%) 0/3 (0%) 0/18 (0%) |
|POLY-3 RATE (b) | 0/1.00 0/4.38 2/16.35 2/8.91 |0/1.98 0/2.44 0/2.14 0/12.26 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 12.2% 22.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |0/1 (0%) 0/2 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 556 376 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.011 * P=0.139 |(e) (e) (e) (e) |
|POLY 3 | P=0.328 (e) P=0.959 P=0.940 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.400 (e) P=0.968 P=0.981 |(e) (e) (e) (e) |
|POLY 6 | P=0.371 (e) P=0.917 P=0.534 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.608 (e) P=0.862 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.652 (e) P=0.944 P=0.958 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 40
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin: Artery, Subcutaneous Tissue |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/57.46 0/49.65 0/23.48 0/9.13 |0/56.31 0/54.01 0/57.18 0/39.77 |
|POLY-3 PERCENT (g) | 3.5% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/52 (2%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 592 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.536N P=0.308N P=0.921N P=1.000N |(e) (e) (e) (e) |
|POLY 3 | P=0.155N P=0.272N P=0.458N P=0.603N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.118N P=0.257N P=0.352N P=0.464N |(e) (e) (e) (e) |
|POLY 6 | P=0.203N P=0.291N P=0.587N P=0.679N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.120N P=0.204N P=0.301N P=0.826N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.248N P=0.248N P=0.248N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 3/60 (5%) 14/60 (23%) 22/60 (37%) |0/60 (0%) 1/60 (2%) 2/60 (3%) 4/60 (7%) |
|POLY-3 RATE (b) | 0/56.99 3/50.60 14/31.58 22/27.65 |0/56.31 1/54.26 2/57.29 4/41.32 |
|POLY-3 PERCENT (g) | 0.0% 5.9% 44.3% 79.6% |0.0% 1.8% 3.5% 9.7% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 1/47 (2%) 0/5 (0%) |
|FIRST INCIDENCE | --- 542 451 277 |--- 660 701 548 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.088 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.485 P=0.223 P=0.022 * |
|POLY 3 | P<0.001 ** P=0.100 P<0.001 ** P<0.001 ** |P=0.010 * P=0.493 P=0.242 P=0.032 * |
|POLY 1.5 | P<0.001 ** P=0.108 P<0.001 ** P<0.001 ** |P=0.014 * P=0.495 P=0.242 P=0.044 * |
|POLY 6 | P<0.001 ** P=0.091 P<0.001 ** P<0.001 ** |P=0.007 ** P=0.489 P=0.238 P=0.019 * |
|LOGISTIC REGRESSION| P=0.006 ** P=0.156 P=0.002 ** P=0.046 * |P=0.042 * P=0.512 P=0.240 P=0.106 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.122 P<0.001 ** P<0.001 ** |P=0.022 * P=0.500 P=0.248 P=0.059 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 41
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 2/60 (3%) |1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 1/24.01 2/10.80 |1/57.02 0/54.01 0/57.18 0/39.77 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.2% 18.5% |1.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- 566 391 |483 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** (e) P=0.254 P=0.093 |P=0.308N P=0.503N P=0.493N P=0.507N |
|POLY 3 | P=0.073 (e) P=0.352 P=0.077 |P=0.247N P=0.511N P=0.499N P=0.570N |
|POLY 1.5 | P=0.034 * (e) P=0.414 P=0.112 |P=0.278N P=0.507N P=0.498N P=0.537N |
|POLY 6 | P=0.311 (e) P=0.288 P=0.063 |P=0.234N P=0.516N P=0.503N P=0.618N |
|LOGISTIC REGRESSION| P=0.341 (e) P=0.663 P=0.787 |P=0.297N P=0.432N P=0.802N P=0.447N |
|COCH-ARM / FISHERS | P=0.070 (e) P=0.500 P=0.248 |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 2/60 (3%) |2/60 (3%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|POLY-3 RATE (b) | 0/56.99 1/49.70 1/24.29 2/10.79 |2/57.02 0/54.01 0/57.18 1/39.84 |
|POLY-3 PERCENT (g) | 0.0% 2.0% 4.1% 18.5% |3.5% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 717 419 392 |483 --- --- 710 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.428 P=0.490 P=0.057 |P=0.675 P=0.255N P=0.247N P=0.628 |
|POLY 3 | P=0.061 P=0.473 P=0.353 P=0.077 |P=0.412N P=0.250N P=0.237N P=0.620N |
|POLY 1.5 | P=0.056 P=0.485 P=0.416 P=0.112 |P=0.441N P=0.246N P=0.236N P=0.564N |
|POLY 6 | P=0.145 P=0.458 P=0.289 P=0.063 |P=0.375N P=0.255N P=0.241N P=0.699N |
|LOGISTIC REGRESSION| P=0.517 P=0.461 P=0.783 P=0.777 |P=0.393N P=0.204N P=0.334N P=0.426N |
|COCH-ARM / FISHERS | P=0.153 P=0.500 P=0.500 P=0.248 |P=0.461N P=0.248N P=0.248N P=0.500N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 42
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/58 (0%) 0/60 (0%) |0/59 (0%) 0/57 (0%) 2/58 (3%) 0/57 (0%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 0/22.92 0/9.13 |0/55.32 0/53.12 2/55.37 0/37.66 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 3.6% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 2/47 (4%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.265 (e) P=0.217 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.370 (e) P=0.238 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.477 (e) P=0.238 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.246 (e) P=0.235 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.217 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.590 (e) P=0.244 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 7/60 (12%) 2/58 (3%) 0/60 (0%) |0/59 (0%) 0/57 (0%) 0/58 (0%) 1/57 (2%) |
|POLY-3 RATE (b) | 1/57.46 7/54.11 2/24.17 0/9.13 |0/55.32 0/53.12 0/55.37 1/38.44 |
|POLY-3 PERCENT (g) | 1.7% 12.9% 8.3% 0.0% |0.0% 0.0% 0.0% 2.6% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 592 460 492 --- |--- --- --- 444 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.178 P=0.029 * P=0.178 P=1.000N |P=0.199 (e) (e) P=0.500 |
|POLY 3 | P=0.071 P=0.025 * P=0.251 P=0.722N |P=0.161 (e) (e) P=0.429 |
|POLY 1.5 | P=0.463 P=0.028 * P=0.346 P=0.654N |P=0.176 (e) (e) P=0.460 |
|POLY 6 | P=0.005 ** P=0.022 * P=0.164 P=0.754N |P=0.173 (e) (e) P=0.383 |
|LOGISTIC REGRESSION| P<0.001N** P=0.179 P=0.748N P=0.816N |P=0.211 (e) (e) P=0.508 |
|COCH-ARM / FISHERS | P=0.117N P=0.031 * P=0.487 P=0.500N |P=0.196 (e) (e) P=0.491 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 43
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/60 (22%) 24/60 (40%) 49/58 (84%) 60/60 (100%)|11/59 (19%) 19/57 (33%) 21/58 (36%) 54/57 (95%) |
|POLY-3 RATE (b) | 13/57.88 24/53.66 49/51.53 60/60.00 |11/56.65 19/55.13 21/57.18 54/54.87 |
|POLY-3 PERCENT (g) | 22.5% 44.7% 95.1% 100.0% |19.4% 34.5% 36.7% 98.4% |
|TERMINAL (d) | 10/52 (19%) 11/34 (32%) 0/0 (0%) 0/0 (0%) |8/52 (15%) 14/46 (30%) 15/47 (32%) 5/5 (100%) |
|FIRST INCIDENCE | 596 451 365 277 |483 497 553 409 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.044 * P=0.025 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.056 P=0.031 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.056 P=0.030 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.054 P=0.030 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.026 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.054 P=0.019 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.024 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.055 P=0.027 * P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 3/60 (5%) 0/58 (0%) 0/60 (0%) |8/59 (14%) 5/57 (9%) 4/58 (7%) 2/57 (4%) |
|POLY-3 RATE (b) | 2/56.99 3/49.65 0/22.92 0/9.13 |8/55.40 5/53.12 4/55.37 2/37.66 |
|POLY-3 PERCENT (g) | 3.5% 6.0% 0.0% 0.0% |14.4% 9.4% 7.2% 5.3% |
|TERMINAL (d) | 2/52 (4%) 3/34 (9%) 0/0 (0%) 0/0 (0%) |7/52 (14%) 5/46 (11%) 4/47 (9%) 2/5 (40%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |710 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491 P=0.312 P=1.000N P=1.000N |P=0.532 P=0.361N P=0.234N P=0.254 |
|POLY 3 | P=0.589N P=0.438 P=0.461N P=0.602N |P=0.085N P=0.306N P=0.180N P=0.152N |
|POLY 1.5 | P=0.252N P=0.465 P=0.358N P=0.463N |P=0.061N P=0.301N P=0.180N P=0.095N |
|POLY 6 | P=0.461 P=0.405 P=0.588N P=0.679N |P=0.131N P=0.316N P=0.187N P=0.284N |
|LOGISTIC REGRESSION| P=0.491 P=0.312 (e) (e) |P=0.535N P=0.328N P=0.205N P=0.490 |
|COCH-ARM / FISHERS | P=0.075N P=0.500 P=0.256N P=0.248N |P=0.038N* P=0.302N P=0.189N P=0.053N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 44
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 3/58 (5%) 1/60 (2%) |1/60 (2%) 2/58 (3%) 1/58 (2%) 0/59 (0%) |
|POLY-3 RATE (b) | 0/56.99 1/50.39 3/24.43 1/10.06 |1/56.85 2/53.22 1/55.63 0/38.93 |
|POLY-3 PERCENT (g) | 0.0% 2.0% 12.3% 9.9% |1.8% 3.8% 1.8% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 2/46 (4%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 469 492 297 |562 729 (T) 661 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.008 ** P=0.493 P=0.019 * P=0.497 |P=0.457N P=0.468 P=0.753N P=0.522N |
|POLY 3 | P=0.031 * P=0.475 P=0.036 * P=0.281 |P=0.331N P=0.477 P=0.756 P=0.573N |
|POLY 1.5 | P=0.068 P=0.486 P=0.059 P=0.349 |P=0.295N P=0.482 P=0.756 P=0.540N |
|POLY 6 | P=0.063 P=0.462 P=0.022 * P=0.246 |P=0.413N P=0.470 P=0.752 P=0.621N |
|LOGISTIC REGRESSION| P=0.324N P=0.487 P=0.267 P=0.734 |P=0.209N P=0.494 P=0.665 P=0.418N |
|COCH-ARM / FISHERS | P=0.351 P=0.500 P=0.116 P=0.500 |P=0.251N P=0.487 P=0.744 P=0.504N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 3/58 (5%) 1/60 (2%) |1/60 (2%) 1/58 (2%) 1/58 (2%) 0/59 (0%) |
|POLY-3 RATE (b) | 0/56.99 1/49.65 3/24.55 1/10.06 |1/56.85 1/53.22 1/55.59 0/38.93 |
|POLY-3 PERCENT (g) | 0.0% 2.0% 12.2% 9.9% |1.8% 1.9% 1.8% 0.0% |
|TERMINAL (d) | 0/52 (0%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 1/46 (2%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 729 (T) 470 302 |562 729 (T) 673 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.415 P=0.023 * P=0.493 |P=0.480N P=0.743 P=0.758N P=0.522N |
|POLY 3 | P=0.031 * P=0.473 P=0.036 * P=0.281 |P=0.380N P=0.746 P=0.755 P=0.573N |
|POLY 1.5 | P=0.068 P=0.484 P=0.060 P=0.349 |P=0.352N P=0.749 P=0.756 P=0.540N |
|POLY 6 | P=0.060 P=0.458 P=0.022 * P=0.246 |P=0.451N P=0.741 P=0.752 P=0.621N |
|LOGISTIC REGRESSION| P=0.666N P=0.415 P=0.332 P=0.765 |P=0.258N P=0.762 P=0.672 P=0.418N |
|COCH-ARM / FISHERS | P=0.351 P=0.500 P=0.116 P=0.500 |P=0.315N P=0.744 P=0.744 P=0.504N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 45
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 5/60 (8%) 6/58 (10%) 3/60 (5%) |1/60 (2%) 4/58 (7%) 6/58 (10%) 1/59 (2%) |
|POLY-3 RATE (b) | 2/56.99 5/50.71 6/26.13 3/11.83 |1/56.85 4/53.22 6/55.84 1/39.09 |
|POLY-3 PERCENT (g) | 3.5% 9.9% 23.0% 25.4% |1.8% 7.5% 10.7% 2.6% |
|TERMINAL (d) | 2/52 (4%) 2/34 (6%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 4/46 (9%) 4/47 (9%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 469 497 297 |562 729 (T) 661 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.111 P<0.001 ** P=0.080 |P=0.101 P=0.152 P=0.056 P=0.608 |
|POLY 3 | P=0.007 ** P=0.173 P=0.016 * P=0.098 |P=0.344 P=0.161 P=0.055 P=0.670 |
|POLY 1.5 | P=0.053 P=0.192 P=0.041 * P=0.198 |P=0.489 P=0.165 P=0.055 P=0.713 |
|POLY 6 | P=0.003 ** P=0.152 P=0.005 ** P=0.061 |P=0.176 P=0.155 P=0.053 P=0.597 |
|LOGISTIC REGRESSION| P=0.585N P=0.242 P=0.166 P=0.692N |P=0.545 P=0.172 P=0.039 * P=0.710N |
|COCH-ARM / FISHERS | P=0.498 P=0.219 P=0.125 P=0.500 |P=0.505N P=0.172 P=0.052 P=0.748 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/57 (0%) 0/54 (0%) 2/53 (4%) 0/55 (0%) |1/58 (2%) 0/57 (0%) 0/57 (0%) 0/52 (0%) |
|POLY-3 RATE (b) | 0/54.72 0/45.09 2/22.05 0/8.47 |1/55.73 0/53.12 0/54.48 0/34.63 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 9.1% 0.0% |1.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- 539 --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.046 * (e) P=0.032 * (e) |P=0.473N P=0.524N P=0.520N P=0.927N |
|POLY 3 | P=0.163 (e) P=0.105 (e) |P=0.254N P=0.510N P=0.505N P=0.591N |
|POLY 1.5 | P=0.229 (e) P=0.145 (e) |P=0.287N P=0.507N P=0.503N P=0.559N |
|POLY 6 | P=0.307 (e) P=0.075 (e) |P=0.242N P=0.514N P=0.508N P=0.636N |
|LOGISTIC REGRESSION| P=0.738 (e) P=0.340 (e) |P=0.473N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.589 (e) P=0.230 (e) |P=0.317N P=0.504N P=0.504N P=0.527N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 46
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/57 (0%) 1/54 (2%) 0/53 (0%) 1/55 (2%) |0/58 (0%) 0/57 (0%) 0/57 (0%) 2/52 (4%) |
|POLY-3 RATE (b) | 0/54.72 1/45.72 0/20.99 1/9.27 |0/55.73 0/53.12 0/54.48 2/35.27 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 10.8% |0.0% 0.0% 0.0% 5.7% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 526 --- 422 |--- --- --- 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.049 * P=0.486 (e) P=0.100 |P=0.012 * (e) (e) P=0.093 |
|POLY 3 | P=0.272 P=0.464 (e) P=0.277 |P=0.033 * (e) (e) P=0.152 |
|POLY 1.5 | P=0.250 P=0.475 (e) P=0.343 |P=0.034 * (e) (e) P=0.178 |
|POLY 6 | P=0.358 P=0.451 (e) P=0.244 |P=0.042 * (e) (e) P=0.120 |
|LOGISTIC REGRESSION| P=0.718N P=0.517 (e) P=0.922 |P=0.078 (e) (e) P=0.274 |
|COCH-ARM / FISHERS | P=0.400 P=0.486 (e) P=0.491 |P=0.039 * (e) (e) P=0.221 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/57 (0%) 0/54 (0%) 0/53 (0%) 0/55 (0%) |0/58 (0%) 1/57 (2%) 2/57 (4%) 1/52 (2%) |
|POLY-3 RATE (b) | 0/54.72 0/45.09 0/20.99 0/8.47 |0/55.73 1/53.14 2/54.75 1/35.12 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 1.9% 3.7% 2.9% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 723 673 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.113 P=0.476 P=0.227 P=0.461 |
|POLY 3 | (e) (e) (e) (e) |P=0.192 P=0.491 P=0.234 P=0.411 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.253 P=0.493 P=0.235 P=0.442 |
|POLY 6 | (e) (e) (e) (e) |P=0.134 P=0.487 P=0.230 P=0.367 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.401 P=0.489 P=0.219 P=0.592 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.335 P=0.496 P=0.243 P=0.473 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 47
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular: Glands |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/57 (0%) 0/54 (0%) 0/53 (0%) 0/55 (0%) |0/58 (0%) 0/57 (0%) 2/57 (4%) 0/52 (0%) |
|POLY-3 RATE (b) | 0/54.72 0/45.09 0/20.99 0/8.47 |0/55.73 0/53.12 2/54.86 0/34.63 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 3.7% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 1/47 (2%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 624 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.403 (e) P=0.234 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.349 (e) P=0.234 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.456 (e) P=0.235 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.235 (e) P=0.231 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.620 (e) P=0.201 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.574 (e) P=0.243 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/57 (0%) 3/52 (6%) 3/45 (7%) 6/54 (11%) |1/57 (2%) 0/56 (0%) 0/55 (0%) 1/44 (2%) |
|POLY-3 RATE (b) | 0/54.72 3/44.32 3/19.41 6/13.03 |1/54.56 0/50.95 0/53.44 1/30.20 |
|POLY-3 PERCENT (g) | 0.0% 6.8% 15.5% 46.0% |1.8% 0.0% 0.0% 3.3% |
|TERMINAL (d) | 0/51 (0%) 0/29 (0%) 0/0 (0%) 0/0 (0%) |0/50 (0%) 0/44 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 469 410 368 |562 --- --- 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.113 P=0.025 * P<0.001 ** |P=0.552 P=0.507N P=0.493N P=0.704 |
|POLY 3 | P<0.001 ** P=0.086 P=0.024 * P<0.001 ** |P=0.522 P=0.514N P=0.504N P=0.618 |
|POLY 1.5 | P<0.001 ** P=0.093 P=0.040 * P<0.001 ** |P=0.531 P=0.510N P=0.504N P=0.658 |
|POLY 6 | P<0.001 ** P=0.077 P=0.015 * P<0.001 ** |P=0.550 P=0.518N P=0.506N P=0.557 |
|LOGISTIC REGRESSION| P=0.477N P=0.138 P=0.315 P=0.429 |P=0.609 P=0.458N P=0.692N P=0.726N |
|COCH-ARM / FISHERS | P=0.013 * P=0.105 P=0.083 P=0.011 * |P=0.545 P=0.504N P=0.509N P=0.684 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 48
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/57 (7%) 3/52 (6%) 1/45 (2%) 0/54 (0%) |1/57 (2%) 0/56 (0%) 0/55 (0%) 0/44 (0%) |
|POLY-3 RATE (b) | 4/54.72 3/42.49 1/18.06 0/7.95 |1/54.02 0/50.95 0/53.44 0/29.79 |
|POLY-3 PERCENT (g) | 7.3% 7.1% 5.5% 0.0% |1.9% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/51 (8%) 1/29 (3%) 0/0 (0%) 0/0 (0%) |1/50 (2%) 0/44 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 690 556 --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.343 P=0.547 P=0.321 P=1.000N |P=0.467N P=0.525N P=0.512N P=0.923N |
|POLY 3 | P=0.480N P=0.634N P=0.589N P=0.498N |P=0.263N P=0.512N P=0.502N P=0.613N |
|POLY 1.5 | P=0.189N P=0.598N P=0.439N P=0.292N |P=0.298N P=0.509N P=0.503N P=0.585N |
|POLY 6 | P=0.605 P=0.626 P=0.561 P=0.622N |P=0.243N P=0.515N P=0.504N P=0.652N |
|LOGISTIC REGRESSION| P=0.741 P=0.617 P=0.851 (e) |P=0.467N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.033N* P=0.552N P=0.264N P=0.066N |P=0.333N P=0.504N P=0.509N P=0.564N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/57 (2%) 0/52 (0%) 0/45 (0%) 0/54 (0%) |5/57 (9%) 0/56 (0%) 2/55 (4%) 1/44 (2%) |
|POLY-3 RATE (b) | 1/54.72 0/42.29 0/17.51 0/7.95 |5/54.09 0/50.95 2/53.44 1/29.87 |
|POLY-3 PERCENT (g) | 1.8% 0.0% 0.0% 0.0% |9.2% 0.0% 3.7% 3.4% |
|TERMINAL (d) | 1/51 (2%) 0/29 (0%) 0/0 (0%) 0/0 (0%) |4/50 (8%) 0/44 (0%) 2/47 (4%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |710 --- 729 (T) 710 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.908N P=0.613N P=1.000N P=1.000N |P=0.535N P=0.047N* P=0.248N P=0.577 |
|POLY 3 | P=0.431N P=0.551N P=0.685N P=0.728N |P=0.177N P=0.037N* P=0.223N P=0.297N |
|POLY 1.5 | P=0.322N P=0.537N P=0.630N P=0.664N |P=0.171N P=0.035N* P=0.224N P=0.234N |
|POLY 6 | P=0.555N P=0.568N P=0.737N P=0.758N |P=0.187N P=0.039N* P=0.226N P=0.404N |
|LOGISTIC REGRESSION| P=0.908N (e) (e) (e) |P=0.362N P=0.040N* P=0.227N P=0.643N |
|COCH-ARM / FISHERS | P=0.317N P=0.523N P=0.559N P=0.514N |P=0.161N P=0.030N* P=0.234N P=0.174N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 49
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/59 (17%) 11/59 (19%) 3/59 (5%) 0/59 (0%) |14/60 (23%) 16/59 (27%) 16/58 (28%) 13/53 (25%) |
|POLY-3 RATE (b) | 10/56.49 11/50.78 3/24.59 0/9.00 |14/56.77 16/53.03 16/56.04 13/37.85 |
|POLY-3 PERCENT (g) | 17.7% 21.7% 12.2% 0.0% |24.7% 30.2% 28.6% 34.3% |
|TERMINAL (d) | 9/52 (17%) 6/33 (18%) 0/0 (0%) 0/0 (0%) |13/52 (25%) 15/45 (33%) 12/46 (26%) 2/5 (40%) |
|FIRST INCIDENCE | 596 485 548 --- |592 723 624 581 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.043 * P=0.179 P=0.007 ** P=1.000N |P<0.001 ** P=0.255 P=0.300 P<0.001 ** |
|POLY 3 | P=0.413N P=0.393 P=0.401N P=0.312N |P=0.212 P=0.333 P=0.400 P=0.218 |
|POLY 1.5 | P=0.040N* P=0.439 P=0.172N P=0.068N |P=0.334 P=0.356 P=0.398 P=0.352 |
|POLY 6 | P=0.286 P=0.338 P=0.479 P=0.548N |P=0.099 P=0.304 P=0.388 P=0.085 |
|LOGISTIC REGRESSION| P=0.163N P=0.510 P=0.682N P=0.873N |P=0.074 P=0.319 P=0.391 P=0.087 |
|COCH-ARM / FISHERS | P<0.001N** P=0.500 P=0.037N* P<0.001N** |P=0.511 P=0.396 P=0.375 P=0.528 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 0/59 (0%) 0/59 (0%) 0/59 (0%) |2/60 (3%) 1/59 (2%) 0/58 (0%) 0/53 (0%) |
|POLY-3 RATE (b) | 0/56.04 0/48.65 0/23.02 0/9.00 |2/57.02 1/53.01 0/55.26 0/35.48 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |3.5% 1.9% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/33 (0%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 1/45 (2%) 0/46 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |483 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.178N P=0.535N P=0.249N P=0.445N |
|POLY 3 | (e) (e) (e) (e) |P=0.107N P=0.525N P=0.245N P=0.353N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.111N P=0.518N P=0.243N P=0.311N |
|POLY 6 | (e) (e) (e) (e) |P=0.111N P=0.534N P=0.249N P=0.423N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.091N P=0.477N P=0.341N P=0.182N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.112N P=0.506N P=0.256N P=0.280N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 50
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/59 (0%) 0/59 (0%) 0/59 (0%) 0/59 (0%) |0/60 (0%) 1/59 (2%) 0/58 (0%) 2/53 (4%) |
|POLY-3 RATE (b) | 0/56.04 0/48.65 0/23.02 0/9.00 |0/56.31 1/53.01 0/55.26 2/36.16 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 1.9% 0.0% 5.5% |
|TERMINAL (d) | 0/52 (0%) 0/33 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 1/45 (2%) 0/46 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) --- 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.032 * P=0.471 (e) P=0.129 |
|POLY 3 | (e) (e) (e) (e) |P=0.095 P=0.488 (e) P=0.153 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.104 P=0.491 (e) P=0.178 |
|POLY 6 | (e) (e) (e) (e) |P=0.098 P=0.484 (e) P=0.122 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.141 P=0.471 (e) P=0.254 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.119 P=0.496 (e) P=0.218 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/14 (36%) 0/9 (0%) 0/2 (0%) 0/0 (0%) |0/8 (0%) 0/4 (0%) 0/0 (0%) 0/2 (0%) |
|POLY-3 RATE (b) | 5/13.46 0/8.83 0/0.81 0/0.00 |0/8.00 0/4.00 0/0.00 0/1.86 |
|POLY-3 PERCENT (g) | 37.2% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 5/12 (42%) 0/8 (0%) 0/0 (0%) 0/0 (0%) |0/8 (0%) 0/4 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.152N P=0.062N P=1.000N P=1.000N |(e) (e) (e) (e) |
|POLY 3 | (e) P=0.051N P=0.632N (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) P=0.053N P=0.550N (e) |(e) (e) (e) (e) |
|POLY 6 | (e) P=0.049N* P=0.714N (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.152N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.106N P=0.059N P=0.458N P=1.000 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 51
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/14 (71%) 9/9 (100%) 1/2 (50%) 0/0 (0%) |8/8 (100%) 4/4 (100%) 0/0 (0%) 2/2 (100%) |
|POLY-3 RATE (b) | 10/14.00 9/9.00 1/1.27 0/0.00 |8/8.00 4/4.00 0/0.00 2/2.00 |
|POLY-3 PERCENT (g) | 71.4% 100.0% 79.0% 0.0% |100.0% 100.0% 0.0% 100.0% |
|TERMINAL (d) | 8/12 (67%) 8/8 (100%) 0/0 (0%) 0/0 (0%) |8/8 (100%) 4/4 (100%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 592 686 596 --- |729 (T) 729 (T) --- 702 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.097 P=0.249 P=0.118 P=1.000N |(e) (e) (e) (e) |
|POLY 3 | (e) P=0.109 P=0.749 (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) P=0.109 P=0.753N (e) |(e) (e) (e) (e) |
|POLY 6 | (e) P=0.109 P=0.678 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.356 (e) P=0.903N (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.623 P=0.113 P=0.542N P=1.000 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Urethra |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 1/1 (100%) 2/2 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 1/1.00 2/2.00 |0/0.00 0/0.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% 100.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 522 368 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 52
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/60 (2%) 0/59 (0%) 2/60 (3%) 1/59 (2%) |
|POLY-3 RATE (b) | |1/56.31 0/53.96 2/57.40 1/39.06 |
|POLY-3 PERCENT (g) | |1.8% 0.0% 3.5% 2.6% |
|TERMINAL (d) | |1/52 (2%) 0/46 (0%) 1/47 (2%) 0/5 (0%) |
|FIRST INCIDENCE | |729 (T) --- 673 696 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.138 P=0.524N P=0.475 P=0.300 |
|POLY 3 | |P=0.353 P=0.509N P=0.507 P=0.672 |
|POLY 1.5 | |P=0.419 P=0.506N P=0.507 P=0.715 |
|POLY 6 | |P=0.287 P=0.512N P=0.502 P=0.600 |
|LOGISTIC REGRESSION| |P=0.383 (e) P=0.499 P=0.577 |
|COCH-ARM / FISHERS | |P=0.497 P=0.504N P=0.500 P=0.748 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/60 (2%) 1/59 (2%) 3/60 (5%) 0/59 (0%) |
|POLY-3 RATE (b) | |1/56.31 1/53.96 3/57.18 0/38.93 |
|POLY-3 PERCENT (g) | |1.8% 1.9% 5.3% 0.0% |
|TERMINAL (d) | |1/52 (2%) 1/46 (2%) 3/47 (6%) 0/5 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.379 P=0.734 P=0.271 P=0.927N |
|POLY 3 | |P=0.573N P=0.751 P=0.312 P=0.571N |
|POLY 1.5 | |P=0.498N P=0.754 P=0.312 P=0.539N |
|POLY 6 | |P=0.463 P=0.747 P=0.306 P=0.619N |
|LOGISTIC REGRESSION| |P=0.379 P=0.734 P=0.271 (e) |
|COCH-ARM / FISHERS | |P=0.413N P=0.748 P=0.309 P=0.504N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 53
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |24/60 (40%) 24/59 (41%) 22/60 (37%) 15/59 (25%) |
|POLY-3 RATE (b) | |24/56.46 24/54.03 22/57.56 15/42.49 |
|POLY-3 PERCENT (g) | |42.5% 44.4% 38.2% 35.3% |
|TERMINAL (d) | |22/52 (42%) 23/46 (50%) 19/47 (40%) 4/5 (80%) |
|FIRST INCIDENCE | |710 712 690 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P<0.001 ** P=0.358 P=0.554 P<0.001 ** |
|POLY 3 | |P=0.218N P=0.496 P=0.392N P=0.301N |
|POLY 1.5 | |P=0.109N P=0.519 P=0.393N P=0.158N |
|POLY 6 | |P=0.441N P=0.458 P=0.412N P=0.569 |
|LOGISTIC REGRESSION| |P=0.369 P=0.398 P=0.462N P=0.505 |
|COCH-ARM / FISHERS | |P=0.039N* P=0.544 P=0.426N P=0.067N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/60 (3%) 1/59 (2%) 1/60 (2%) 2/59 (3%) |
|POLY-3 RATE (b) | |2/56.85 1/53.98 1/57.29 2/39.89 |
|POLY-3 PERCENT (g) | |3.5% 1.9% 1.8% 5.0% |
|TERMINAL (d) | |1/52 (2%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | |562 723 701 583 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.282 P=0.532N P=0.514N P=0.471 |
|POLY 3 | |P=0.463 P=0.518N P=0.497N P=0.560 |
|POLY 1.5 | |P=0.501 P=0.513N P=0.496N P=0.622 |
|POLY 6 | |P=0.439 P=0.526N P=0.504N P=0.460 |
|LOGISTIC REGRESSION| |P=0.554N P=0.499N P=0.570N P=0.580N |
|COCH-ARM / FISHERS | |P=0.551 P=0.506N P=0.500N P=0.684 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 54
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |54/60 (90%) 51/59 (86%) 53/60 (88%) 37/59 (63%) |
|POLY-3 RATE (b) | |54/56.94 51/55.39 53/59.01 37/49.73 |
|POLY-3 PERCENT (g) | |94.8% 92.1% 89.8% 74.4% |
|TERMINAL (d) | |50/52 (96%) 45/46 (98%) 46/47 (98%) 5/5 (100%) |
|FIRST INCIDENCE | |592 553 553 403 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P<0.001 ** P=0.270 P=0.208 P<0.001 ** |
|POLY 3 | |P<0.001N** P=0.407N P=0.236N P<0.001N** |
|POLY 1.5 | |P<0.001N** P=0.378N P=0.301N P<0.001N** |
|POLY 6 | |P=0.003N** P=0.482N P=0.230N P=0.006N** |
|LOGISTIC REGRESSION| |P=0.076N P=0.483N P=0.255N P=0.058N |
|COCH-ARM / FISHERS | |P<0.001N** P=0.376N P=0.500N P<0.001N** |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).