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).