TDMS Study 05197-12 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest 2-BUTOXYETHANOL DATE: 02/18/98 EXPERIMENT: 05197 TEST: 12 TIME: 09:23:05 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15318 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62077D PATHOLOGIST: MILLER, RODNEY CAS: 111-76-0002 NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest 2-BUTOXYETHANOL DATE: 02/18/98 EXPERIMENT: 05197 TEST: 12 TIME: 09:23:05 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15318 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62077D PATHOLOGIST: MILLER, RODNEY CAS: 111-76-0002 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF 2-BUTOXYETHANOL =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex Hyperplasia Hypertrophy Bone Marrow Hyperplasia Heart Cardiomyopathy Islets, Pancreatic Hyperplasia Kidney Glomerulosclerosis Hydronephrosis Inflammation Chronic Nephropathy Kidney: Renal Tubule Pigmentation Liver Basophilic Focus Necrosis Liver: Kupffer Cell Pigmentation Hemosiderin Lung Infiltration Cellular Histiocyte Lung: Alveolar Epithelium Hyperplasia Nose: Olfactory Epithelium Atrophy Pancreas Atrophy Preputial Gland Inflammation Prostate Inflammation Skin: Prepuce Hyperplasia Inflammation Chronic Ulcer Spleen Hematopoietic Cell Proliferation Hyperplasia Lymphoid Pigmentation Hemosiderin Stomach, Forestomach Ulcer Stomach, Forestomach: Epithelium Hyperplasia Stomach, Glandular: Epithelium Hyperplasia Urinary Bladder Inflammation Urinary Bladder: Transitional Epithelium Ulcer =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex Degeneration Cystic Kidney Glomerulosclerosis Larynx: Squamous Epithelium Hyperplasia Liver Hematopoietic Cell Proliferation Necrosis Liver: Kupffer Cell Pigmentation Hemosiderin Lung Hemorrhage NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest 2-BUTOXYETHANOL DATE: 02/18/98 EXPERIMENT: 05197 TEST: 12 TIME: 09:23:05 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15318 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62077D PATHOLOGIST: MILLER, RODNEY CAS: 111-76-0002 Lymph Node, Bronchial Hyperplasia Nose: Olfactory Epithelium Degeneration Hyaline Nose: Respiratory Epithelium Degeneration Hyaline Ovary Cyst Spleen Hematopoietic Cell Proliferation Hyperplasia Lymphoid Pigmentation Hemosiderin Stomach, Forestomach Ulcer Stomach, Forestomach: Epithelium Hyperplasia Uterus Hyperplasia Cystic =============================================================== Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.5% | |TERMINAL (d) | 1/39 (3%) 0/39 (0%) 0/27 (0%) 0/26 (0%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 2/36 (6%) | |FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.362N P=0.500N P=0.573N P=0.581N |P=0.061 (e) (e) P=0.287 | |POLY 3 | P=0.305N P=0.490N P=0.525N P=0.526N |P=0.047 * (e) (e) P=0.242 | |POLY 1.5 | P=0.304N P=0.494N P=0.515N P=0.518N |P=0.046 * (e) (e) P=0.240 | |POLY 6 | P=0.306N P=0.488N P=0.538N P=0.536N |P=0.047 * (e) (e) P=0.246 | |LOGISTIC REGRESSION| P=0.362N (e) (e) (e) |(e) (e) (e) P=0.287 | |COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.505N P=0.500N |P=0.046 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 2.5% 0.0% |2.3% 4.6% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 0/26 (0%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 663 --- 600 --- |645 456 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.440N P=0.486N P=0.711 P=0.531N |P=0.189N P=0.491 P=0.500N P=0.485N | |POLY 3 | P=0.435N P=0.491N P=0.734 P=0.527N |P=0.188N P=0.500 P=0.506N P=0.497N | |POLY 1.5 | P=0.425N P=0.494N P=0.744 P=0.518N |P=0.189N P=0.497 P=0.507N P=0.498N | |POLY 6 | P=0.445N P=0.490N P=0.718 P=0.538N |P=0.185N P=0.506 P=0.502N P=0.494N | |LOGISTIC REGRESSION| P=0.333N P=0.550N P=0.735N P=0.492N |P=0.171N P=0.647 P=0.486N P=0.508N | |COCH-ARM / FISHERS | P=0.406N P=0.500N P=0.747 P=0.500N |P=0.188N P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 9/50 (18%) 9/49 (18%) 9/50 (18%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 11.1% 18.8% 22.0% 22.8% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 5/39 (13%) 7/39 (18%) 7/27 (26%) 9/26 (35%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) 549 502 729 (T) |715 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.035 * P=0.199 P=0.063 P=0.038 * |P=0.296N P=0.506N P=0.483N P=0.489N | |POLY 3 | P=0.114 P=0.229 P=0.140 P=0.125 |P=0.307N P=0.505N P=0.505N P=0.496N | |POLY 1.5 | P=0.144 P=0.216 P=0.159 P=0.145 |P=0.306N P=0.505N P=0.507N P=0.498N | |POLY 6 | P=0.084 P=0.240 P=0.116 P=0.103 |P=0.308N P=0.503N P=0.500N P=0.492N | |LOGISTIC REGRESSION| P=0.105 P=0.216 P=0.133 P=0.038 * |P=0.302N P=0.503N P=0.501N P=0.493N | |COCH-ARM / FISHERS | P=0.216 P=0.194 P=0.183 P=0.194 |P=0.306N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 38/50 (76%) 28/50 (56%) 27/49 (55%) 27/50 (54%) |3/50 (6%) 2/50 (4%) 6/50 (12%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 81.7% 58.7% 64.2% 62.9% |7.0% 4.8% 14.2% 11.4% | |TERMINAL (d) | 34/39 (87%) 26/39 (67%) 21/27 (78%) 19/26 (73%) |2/29 (7%) 1/31 (3%) 4/33 (12%) 5/36 (14%) | |FIRST INCIDENCE | 556 649 430 374 |721 712 627 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.271 P=0.019N* P=0.575N P=0.551 |P=0.280 P=0.482N P=0.307 P=0.472 | |POLY 3 | P=0.078N P=0.009N** P=0.038N* P=0.030N* |P=0.204 P=0.511N P=0.233 P=0.368 | |POLY 1.5 | P=0.060N P=0.014N* P=0.027N* P=0.026N* |P=0.199 P=0.511N P=0.228 P=0.363 | |POLY 6 | P=0.107N P=0.007N** P=0.075N P=0.038N* |P=0.211 P=0.506N P=0.248 P=0.377 | |LOGISTIC REGRESSION| P=0.182N P=0.006N** P=0.101N P=0.070N |P=0.213 P=0.500N P=0.239 P=0.407 | |COCH-ARM / FISHERS | P=0.033N* P=0.028N* P=0.024N* P=0.018N* |P=0.189 P=0.500N P=0.243 P=0.357 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex: Capsule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.4% 0.0% 0.0% 7.6% |0.0% 0.0% 2.4% 0.0% | |TERMINAL (d) | 2/39 (5%) 0/39 (0%) 0/27 (0%) 2/26 (8%) |0/29 (0%) 0/31 (0%) 1/33 (3%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 663 |--- --- 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.146 P=0.238N P=0.322N P=0.342 |P=0.719 (e) P=0.526 (e) | |POLY 3 | P=0.217 P=0.227N P=0.266N P=0.444 |P=0.708 (e) P=0.495 (e) | |POLY 1.5 | P=0.226 P=0.230N P=0.255N P=0.461 |P=0.703 (e) P=0.494 (e) | |POLY 6 | P=0.206 P=0.224N P=0.282N P=0.424 |P=0.713 (e) P=0.500 (e) | |LOGISTIC REGRESSION| P=0.183 (e) (e) P=0.416 |(e) (e) P=0.526 (e) | |COCH-ARM / FISHERS | P=0.245 P=0.247N P=0.253N P=0.500 |P=0.694 (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/50 (4%) 0/49 (0%) 3/49 (6%) |1/50 (2%) 3/50 (6%) 3/49 (6%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.2% 4.2% 0.0% 7.8% |2.3% 7.2% 7.3% 4.5% | |TERMINAL (d) | 0/38 (0%) 1/39 (3%) 0/27 (0%) 2/25 (8%) |1/29 (3%) 3/31 (10%) 3/33 (9%) 2/36 (6%) | |FIRST INCIDENCE | 565 681 --- 684 |731 (T) 731 (T) 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.152 P=0.524 P=0.513N P=0.216 |P=0.574 P=0.328 P=0.352 P=0.576 | |POLY 3 | P=0.200 P=0.522 P=0.523N P=0.257 |P=0.493 P=0.296 P=0.290 P=0.508 | |POLY 1.5 | P=0.214 P=0.517 P=0.513N P=0.272 |P=0.486 P=0.296 P=0.287 P=0.504 | |POLY 6 | P=0.184 P=0.525 P=0.537N P=0.239 |P=0.504 P=0.299 P=0.300 P=0.514 | |LOGISTIC REGRESSION| P=0.226 P=0.409 P=0.463N P=0.296 |P=0.574 P=0.328 P=0.352 P=0.576 | |COCH-ARM / FISHERS | P=0.239 P=0.508 P=0.500N P=0.309 |P=0.476 P=0.309 P=0.301 P=0.500 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Bone | | Fibrous Osteodystrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 0/50 (0%) 1/50 (2%) |22/50 (44%) 28/50 (56%) 25/50 (50%) 21/50 (42%) | |POLY-3 ADJUSTED (b)| 2.2% 8.5% 0.0% 2.5% |50.5% 64.4% 58.9% 46.1% | |TERMINAL (d) | 1/39 (3%) 4/39 (10%) 0/27 (0%) 0/26 (0%) |17/29 (59%) 22/31 (71%) 22/33 (67%) 17/36 (47%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 694 |649 592 627 485 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.489N P=0.179 P=0.573N P=0.685 |P=0.074N P=0.235 P=0.570 P=0.207N | |POLY 3 | P=0.382N P=0.194 P=0.524N P=0.732 |P=0.212N P=0.127 P=0.279 P=0.417N | |POLY 1.5 | P=0.364N P=0.189 P=0.513N P=0.741 |P=0.253N P=0.126 P=0.275 P=0.454N | |POLY 6 | P=0.407N P=0.197 P=0.538N P=0.721 |P=0.166N P=0.151 P=0.313 P=0.363N | |LOGISTIC REGRESSION| P=0.443N P=0.179 (e) P=0.729 |P=0.226N P=0.121 P=0.380 P=0.434N | |COCH-ARM / FISHERS | P=0.337N P=0.181 P=0.500N P=0.753N |P=0.316N P=0.159 P=0.344 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 9/49 (18%) 5/50 (10%) |2/50 (4%) 4/50 (8%) 2/50 (4%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 21.2% 12.5% |4.6% 9.1% 4.6% 9.0% | |TERMINAL (d) | 0/39 (0%) 1/39 (3%) 2/27 (7%) 3/26 (12%) |1/29 (3%) 0/31 (0%) 0/33 (0%) 2/36 (6%) | |FIRST INCIDENCE | --- 729 (T) 537 670 |715 255 72 582 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.005 ** P=0.500 P<0.001 ** P=0.015 * |P=0.386 P=0.347 P=0.680N P=0.402 | |POLY 3 | P=0.005 ** P=0.510 P<0.001 ** P=0.021 * |P=0.359 P=0.348 P=0.690N P=0.353 | |POLY 1.5 | P=0.007 ** P=0.506 P<0.001 ** P=0.024 * |P=0.352 P=0.341 P=0.693 P=0.346 | |POLY 6 | P=0.004 ** P=0.512 P<0.001 ** P=0.019 * |P=0.371 P=0.361 P=0.679N P=0.365 | |LOGISTIC REGRESSION| P=0.021 * P=0.500 P=0.004 ** P=0.022 * |P=0.302 P=0.460 P=0.525N P=0.341 | |COCH-ARM / FISHERS | P=0.017 * P=0.500 P<0.001 ** P=0.028 * |P=0.344 P=0.339 P=0.691N P=0.339 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Brain: Meninges | | Infiltration Cellular Mononuclear Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.2% 2.1% 0.0% 0.0% |4.6% 0.0% 0.0% 4.5% | |TERMINAL (d) | 1/39 (3%) 1/39 (3%) 0/27 (0%) 0/26 (0%) |1/29 (3%) 0/31 (0%) 0/33 (0%) 2/36 (6%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- |689 --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.308N P=0.762 P=0.573N P=0.581N |P=0.548 P=0.235N P=0.223N P=0.635N | |POLY 3 | P=0.251N P=0.750N P=0.525N P=0.526N |P=0.508 P=0.244N P=0.243N P=0.687N | |POLY 1.5 | P=0.245N P=0.753N P=0.515N P=0.518N |P=0.505 P=0.243N P=0.245N P=0.690N | |POLY 6 | P=0.260N P=0.747N P=0.538N P=0.536N |P=0.510 P=0.242N P=0.238N P=0.682N | |LOGISTIC REGRESSION| P=0.308N P=0.762 (e) (e) |P=0.516 P=0.242N P=0.241N P=0.679N | |COCH-ARM / FISHERS | P=0.236N P=0.753N P=0.505N P=0.500N |P=0.500 P=0.247N P=0.247N P=0.691N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 1/49 (2%) 4/50 (8%) | | |POLY-3 ADJUSTED (b)| 8.9% 8.5% 2.5% 10.1% | | |TERMINAL (d) | 4/39 (10%) 4/39 (10%) 1/27 (4%) 4/26 (15%) | | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.384 P=0.645 P=0.304N P=0.409 | | |POLY 3 | P=0.557 P=0.616N P=0.218N P=0.570 | | |POLY 1.5 | P=0.564N P=0.625N P=0.203N P=0.594 | | |POLY 6 | P=0.524 P=0.610N P=0.242N P=0.541 | | |LOGISTIC REGRESSION| P=0.384 P=0.645 P=0.304N P=0.409 | | |COCH-ARM / FISHERS | P=0.521N P=0.643N P=0.187N P=0.643N | | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Eye: Cornea | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) |1/1 (100%) 0/0 (0%) 0/0 (0%) 3/4 (75%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 100.0% 0.0% |100.0% 0.0% 0.0% 75.0% | |TERMINAL (d) | 0/1 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) |1/1 (100%) 0/0 (0%) 0/0 (0%) 1/2 (50%) | |FIRST INCIDENCE | --- --- 729 (T) --- |731 (T) --- --- 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.500 (e) P=0.500 (e) |P=0.256 (e) (e) P=0.485 | |POLY 3 | P=1.000N (e) P=1.000N (e) |P=1.000 (e) (e) P=0.749N | |POLY 1.5 | P=1.000N (e) P=1.000N (e) |P=1.000 (e) (e) P=0.749N | |POLY 6 | P=1.000N (e) P=1.000N (e) |P=1.000 (e) (e) P=0.749N | |LOGISTIC REGRESSION| P=0.250 (e) P=0.250 (e) |P=0.256 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.500 (e) P=0.500 (e) |P=0.556N (e) (e) P=0.800N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 47/50 (94%) 48/50 (96%) 47/50 (94%) 47/50 (94%) |46/50 (92%) 45/50 (90%) 44/50 (88%) 45/50 (90%) | |POLY-3 ADJUSTED (b)| 97.4% 97.3% 98.0% 99.2% |94.7% 96.3% 94.4% 94.9% | |TERMINAL (d) | 39/39 (100%) 39/39 (100%) 27/27 (100%) 26/26 (100%)|29/29 (100%) 30/31 (97%) 32/33 (97%) 36/36 (100%) | |FIRST INCIDENCE | 459 611 430 312 |521 456 72 485 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.567 P=0.006 ** P=0.004 ** |P=0.057N P=0.384N P=0.180N P=0.069N | |POLY 3 | P=0.309 P=0.774N P=0.751 P=0.557 |P=0.564N P=0.553 P=0.668N P=0.690 | |POLY 1.5 | P=0.369 P=0.671 P=0.704 P=0.515 |P=0.467N P=0.621 P=0.572N P=0.603N | |POLY 6 | P=0.331 P=0.776N P=0.880 P=0.781 |P=0.482 P=0.531 P=0.674 P=0.562 | |LOGISTIC REGRESSION| P=0.043 * P=0.477N P=0.381 P=0.150 |P=0.346N P=0.523 P=0.604N P=0.479N | |COCH-ARM / FISHERS | P=0.521N P=0.500 P=0.661N P=0.661N |P=0.437N P=0.500N P=0.370N P=0.500N | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Intestine Small, Duodenum | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/44 (0%) 1/41 (2%) |0/45 (0%) 2/49 (4%) 0/47 (0%) 0/47 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.8% |0.0% 4.7% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 0/25 (0%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- --- --- 684 |--- 472 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.170 (e) (e) P=0.461 |P=0.402N P=0.235 (e) (e) | |POLY 3 | P=0.168 (e) (e) P=0.455 |P=0.398N P=0.252 (e) (e) | |POLY 1.5 | P=0.170 (e) (e) P=0.457 |P=0.400N P=0.252 (e) (e) | |POLY 6 | P=0.166 (e) (e) P=0.451 |P=0.392N P=0.254 (e) (e) | |LOGISTIC REGRESSION| P=0.178 (e) (e) P=0.466 |P=0.419N P=0.357 (e) (e) | |COCH-ARM / FISHERS | P=0.176 (e) (e) P=0.456 |P=0.400N P=0.269 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Intestine Small, Duodenum: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/44 (0%) 1/41 (2%) |1/45 (2%) 2/49 (4%) 0/47 (0%) 2/47 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.8% |2.5% 4.8% 0.0% 4.6% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 0/25 (0%) |1/29 (3%) 1/31 (3%) 0/33 (0%) 1/36 (3%) | |FIRST INCIDENCE | --- --- --- 684 |731 (T) 472 --- 485 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.170 (e) (e) P=0.461 |P=0.513 P=0.508 P=0.474N P=0.548 | |POLY 3 | P=0.168 (e) (e) P=0.455 |P=0.492 P=0.519 P=0.493N P=0.533 | |POLY 1.5 | P=0.170 (e) (e) P=0.457 |P=0.485 P=0.521 P=0.494N P=0.526 | |POLY 6 | P=0.166 (e) (e) P=0.451 |P=0.500 P=0.521 P=0.488N P=0.541 | |LOGISTIC REGRESSION| P=0.178 (e) (e) P=0.466 |P=0.450 P=0.564 (e) P=0.483 | |COCH-ARM / FISHERS | P=0.176 (e) (e) P=0.456 |P=0.476 P=0.532 P=0.489N P=0.516 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 8 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 3/50 (6%) 2/47 (4%) 0/46 (0%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 13.2% 6.3% 5.1% 0.0% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 5/39 (13%) 2/39 (5%) 2/27 (7%) 0/25 (0%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 561 707 729 (T) --- |586 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.031N* P=0.242N P=0.263N P=0.049N* |P=0.308N P=0.505N P=0.514N P=0.500N | |POLY 3 | P=0.017N* P=0.223N P=0.187N P=0.029N* |P=0.305N P=0.507N P=0.507N P=0.498N | |POLY 1.5 | P=0.015N* P=0.230N P=0.171N P=0.026N* |P=0.305N P=0.506N P=0.508N P=0.499N | |POLY 6 | P=0.020N* P=0.220N P=0.213N P=0.033N* |P=0.305N P=0.507N P=0.503N P=0.495N | |LOGISTIC REGRESSION| P=0.017N* P=0.234N P=0.184N P=0.027N* |P=0.303N P=0.446N P=0.459N P=0.518N | |COCH-ARM / FISHERS | P=0.012N* P=0.243N P=0.155N P=0.017N* |P=0.306N P=0.500N P=0.505N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Glomerulosclerosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 11/47 (23%) 9/50 (18%) |7/50 (14%) 2/50 (4%) 8/49 (16%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 8.6% 8.3% 25.7% 21.8% |15.5% 4.7% 17.7% 16.9% | |TERMINAL (d) | 1/39 (3%) 1/39 (3%) 3/27 (11%) 5/26 (19%) |2/29 (7%) 0/31 (0%) 1/33 (3%) 2/36 (6%) | |FIRST INCIDENCE | 561 611 430 454 |376 534 408 437 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.018 * P=0.609N P=0.026 * P=0.056 |P=0.288 P=0.095N P=0.516 P=0.566 | |POLY 3 | P=0.020 * P=0.622N P=0.028 * P=0.074 |P=0.268 P=0.091N P=0.498 P=0.536 | |POLY 1.5 | P=0.026 * P=0.628N P=0.030 * P=0.086 |P=0.251 P=0.089N P=0.482 P=0.520 | |POLY 6 | P=0.014 * P=0.617N P=0.025 * P=0.062 |P=0.289 P=0.090N P=0.524 P=0.559 | |LOGISTIC REGRESSION| P=0.140 P=0.412 P=0.062 P=0.142 |P=0.167 P=0.041N* P=0.587 P=0.455 | |COCH-ARM / FISHERS | P=0.049 * P=0.643N P=0.034 * P=0.117 |P=0.223 P=0.080N P=0.483 P=0.500 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 9 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Hydronephrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 6/47 (13%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 14.6% 12.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 1/27 (4%) 1/26 (4%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 565 --- 537 596 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.012 * P=0.487N P=0.045 * P=0.072 |(e) (e) (e) (e) | |POLY 3 | P=0.011 * P=0.493N P=0.041 * P=0.076 |(e) (e) (e) (e) | |POLY 1.5 | P=0.013 * P=0.495N P=0.044 * P=0.083 |(e) (e) (e) (e) | |POLY 6 | P=0.009 ** P=0.492N P=0.037 * P=0.070 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.052 P=0.707N P=0.066 P=0.111 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.022 * P=0.500N P=0.047 * P=0.102 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/47 (4%) 4/50 (8%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 5.0% 10.0% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 2/26 (8%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- 707 563 623 |--- 534 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.010 * P=0.505 P=0.211 P=0.034 * |P=0.571N P=0.487 (e) (e) | |POLY 3 | P=0.014 * P=0.510 P=0.211 P=0.047 * |P=0.568N P=0.498 (e) (e) | |POLY 1.5 | P=0.016 * P=0.507 P=0.217 P=0.050 |P=0.569N P=0.497 (e) (e) | |POLY 6 | P=0.013 * P=0.513 P=0.202 P=0.042 * |P=0.564N P=0.501 (e) (e) | |LOGISTIC REGRESSION| P=0.026 * P=0.502 P=0.246 P=0.051 |P=0.586N P=0.597 (e) (e) | |COCH-ARM / FISHERS | P=0.022 * P=0.500 P=0.232 P=0.059 |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 10 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Metaplasia Osseous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/47 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 3/49 (6%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 4.2% 0.0% 0.0% |2.3% 2.4% 7.1% 9.1% | |TERMINAL (d) | 0/39 (0%) 1/39 (3%) 0/27 (0%) 0/26 (0%) |1/29 (3%) 1/31 (3%) 3/33 (9%) 4/36 (11%) | |FIRST INCIDENCE | --- 649 --- --- |731 (T) 731 (T) 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.474N P=0.252 (e) (e) |P=0.116 P=0.747N P=0.352 P=0.249 | |POLY 3 | P=0.430N P=0.250 (e) (e) |P=0.081 P=0.755 P=0.296 P=0.185 | |POLY 1.5 | P=0.421N P=0.245 (e) (e) |P=0.079 P=0.755 P=0.292 P=0.182 | |POLY 6 | P=0.445N P=0.253 (e) (e) |P=0.083 P=0.758 P=0.305 P=0.190 | |LOGISTIC REGRESSION| P=0.411N P=0.213 (e) (e) |P=0.116 P=0.747N P=0.352 P=0.249 | |COCH-ARM / FISHERS | P=0.407N P=0.247 (e) (e) |P=0.075 P=0.753N P=0.301 P=0.181 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/47 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 5.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 0/39 (0%) 0/27 (0%) 2/26 (8%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.155 P=0.500N P=0.573N P=0.360 |(e) (e) (e) (e) | |POLY 3 | P=0.222 P=0.490N P=0.529N P=0.455 |(e) (e) (e) (e) | |POLY 1.5 | P=0.230 P=0.494N P=0.521N P=0.469 |(e) (e) (e) (e) | |POLY 6 | P=0.214 P=0.488N P=0.540N P=0.437 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.155 (e) (e) P=0.360 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.515N P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 11 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 48/50 (96%) 45/50 (90%) 40/47 (85%) 37/50 (74%) |34/50 (68%) 39/50 (78%) 38/49 (78%) 33/50 (66%) | |POLY-3 ADJUSTED (b)| 96.7% 92.7% 91.5% 85.6% |72.3% 84.0% 84.7% 70.9% | |TERMINAL (d) | 38/39 (97%) 38/39 (97%) 27/27 (100%) 24/26 (92%) |21/29 (72%) 26/31 (84%) 31/33 (94%) 26/36 (72%) | |FIRST INCIDENCE | 374 649 430 374 |521 456 456 582 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.139 P=0.272N P=0.176 P=0.333 |P=0.066N P=0.328 P=0.528 P=0.163N | |POLY 3 | P=0.020N* P=0.311N P=0.223N P=0.037N* |P=0.352N P=0.122 P=0.106 P=0.532N | |POLY 1.5 | P=0.007N** P=0.262N P=0.125N P=0.013N* |P=0.343N P=0.129 P=0.121 P=0.521N | |POLY 6 | P=0.055N P=0.403N P=0.477N P=0.098N |P=0.359N P=0.131 P=0.096 P=0.535N | |LOGISTIC REGRESSION| P=0.023N* P=0.100N P=0.097N P=0.015N* |P=0.278N P=0.125 P=0.145 P=0.465N | |COCH-ARM / FISHERS | P<0.001N** P=0.218N P=0.066N P=0.002N** |P=0.342N P=0.184 P=0.200 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Kidney: Cortex | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) 0/47 (0%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.9% 2.1% 0.0% 15.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/39 (10%) 1/39 (3%) 0/27 (0%) 4/26 (15%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 694 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.056 P=0.179N P=0.118N P=0.165 |(e) (e) (e) (e) | |POLY 3 | P=0.126 P=0.164N P=0.080N P=0.294 |(e) (e) (e) (e) | |POLY 1.5 | P=0.136 P=0.169N P=0.075N P=0.317 |(e) (e) (e) (e) | |POLY 6 | P=0.115 P=0.161N P=0.090N P=0.268 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.075 P=0.179N (e) P=0.221 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.159 P=0.181N P=0.066N P=0.370 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 12 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/47 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.4% 4.2% 2.6% 0.0% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 2/39 (5%) 2/39 (5%) 1/27 (4%) 0/26 (0%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- 606 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.211N P=0.695 P=0.628N P=0.331N |P=0.559N P=0.495 (e) (e) | |POLY 3 | P=0.156N P=0.676N P=0.551N P=0.267N |P=0.568N P=0.497 (e) (e) | |POLY 1.5 | P=0.146N P=0.682N P=0.537N P=0.257N |P=0.570N P=0.496 (e) (e) | |POLY 6 | P=0.168N P=0.672N P=0.570N P=0.279N |P=0.564N P=0.501 (e) (e) | |LOGISTIC REGRESSION| P=0.211N P=0.695 P=0.628N (e) |P=0.578N P=0.539 (e) (e) | |COCH-ARM / FISHERS | P=0.128N P=0.691N P=0.523N P=0.247N |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/47 (6%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.8% 4.2% 7.7% 5.0% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 3/39 (8%) 2/39 (5%) 1/27 (4%) 0/26 (0%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 556 729 (T) 681 638 |--- 712 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.493N P=0.337N P=0.644 P=0.468N |P=0.562N P=0.500 (e) (e) | |POLY 3 | P=0.390N P=0.321N P=0.582N P=0.398N |P=0.569N P=0.495 (e) (e) | |POLY 1.5 | P=0.369N P=0.326N P=0.560N P=0.379N |P=0.570N P=0.495 (e) (e) | |POLY 6 | P=0.414N P=0.318N P=0.611N P=0.419N |P=0.565N P=0.498 (e) (e) | |LOGISTIC REGRESSION| P=0.345N P=0.346N P=0.550N P=0.335N |P=0.562N P=0.496 (e) (e) | |COCH-ARM / FISHERS | P=0.323N P=0.339N P=0.535N P=0.339N |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 13 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/47 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 7.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 1/26 (4%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- --- --- 613 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.007 ** (e) (e) P=0.089 |(e) (e) (e) (e) | |POLY 3 | P=0.009 ** (e) (e) P=0.099 |(e) (e) (e) (e) | |POLY 1.5 | P=0.010 * (e) (e) P=0.105 |(e) (e) (e) (e) | |POLY 6 | P=0.009 ** (e) (e) P=0.093 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.012 * (e) (e) P=0.117 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.012 * (e) (e) P=0.121 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Larynx | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/48 (0%) 1/49 (2%) |1/50 (2%) 3/50 (6%) 0/50 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.6% |2.3% 6.9% 0.0% 2.3% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 0/26 (0%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- 684 |730 534 --- 489 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.170 (e) (e) P=0.461 |P=0.396N P=0.306 P=0.481N P=0.743N | |POLY 3 | P=0.179 (e) (e) P=0.472 |P=0.409N P=0.308 P=0.505N P=0.757N | |POLY 1.5 | P=0.184 (e) (e) P=0.479 |P=0.414N P=0.303 P=0.507N P=0.761N | |POLY 6 | P=0.174 (e) (e) P=0.464 |P=0.401N P=0.320 P=0.500N P=0.752N | |LOGISTIC REGRESSION| P=0.190 (e) (e) P=0.489 |P=0.422N P=0.358 P=0.483N P=0.749 | |COCH-ARM / FISHERS | P=0.196 (e) (e) P=0.495 |P=0.416N P=0.309 P=0.500N P=0.747 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 14 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Larynx: Squamous Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/48 (0%) 0/49 (0%) |2/50 (4%) 8/50 (16%) 3/50 (6%) 5/49 (10%) | |POLY-3 ADJUSTED (b)| 0.0% 6.3% 0.0% 0.0% |4.6% 17.5% 7.0% 11.2% | |TERMINAL (d) | 0/39 (0%) 1/39 (3%) 0/27 (0%) 0/26 (0%) |2/29 (7%) 1/31 (3%) 1/33 (3%) 2/35 (6%) | |FIRST INCIDENCE | --- 670 --- --- |731 (T) 255 397 437 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.393N P=0.137 (e) (e) |P=0.460 P=0.058 P=0.546 P=0.273 | |POLY 3 | P=0.346N P=0.129 (e) (e) |P=0.427 P=0.055 P=0.498 P=0.232 | |POLY 1.5 | P=0.334N P=0.125 (e) (e) |P=0.409 P=0.050 P=0.491 P=0.222 | |POLY 6 | P=0.364N P=0.132 (e) (e) |P=0.450 P=0.066 P=0.512 P=0.246 | |LOGISTIC REGRESSION| P=0.338N P=0.113 (e) (e) |P=0.357 P=0.076 P=0.513 P=0.193 | |COCH-ARM / FISHERS | P=0.318N P=0.121 (e) (e) |P=0.388 P=0.046 * P=0.500 P=0.210 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/49 (0%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 0.0% |0.0% 2.4% 0.0% 4.5% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 1/27 (4%) 0/26 (0%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 2/36 (6%) | |FIRST INCIDENCE | --- --- 729 (T) --- |--- 712 --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.638 (e) P=0.427 (e) |P=0.166 P=0.500 (e) P=0.287 | |POLY 3 | P=0.640 (e) P=0.475 (e) |P=0.143 P=0.495 (e) P=0.242 | |POLY 1.5 | P=0.654 (e) P=0.485 (e) |P=0.142 P=0.495 (e) P=0.240 | |POLY 6 | P=0.627 (e) P=0.462 (e) |P=0.146 P=0.498 (e) P=0.246 | |LOGISTIC REGRESSION| (e) (e) P=0.427 (e) |P=0.150 P=0.496 (e) P=0.287 | |COCH-ARM / FISHERS | P=0.692 (e) P=0.495 (e) |P=0.140 P=0.500 (e) P=0.247 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 15 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 3/49 (6%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 7.5% |2.3% 0.0% 0.0% 2.3% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 0/26 (0%) |1/29 (3%) 0/31 (0%) 0/33 (0%) 1/36 (3%) | |FIRST INCIDENCE | --- --- 618 442 |731 (T) --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.014 * (e) P=0.455 P=0.099 |P=0.637 P=0.487N P=0.474N P=0.713N | |POLY 3 | P=0.015 * (e) P=0.477 P=0.100 |P=0.601 P=0.505N P=0.505N P=0.756N | |POLY 1.5 | P=0.016 * (e) P=0.486 P=0.104 |P=0.599 P=0.505N P=0.507N P=0.758N | |POLY 6 | P=0.014 * (e) P=0.465 P=0.095 |P=0.603 P=0.503N P=0.500N P=0.752N | |LOGISTIC REGRESSION| P=0.043 * (e) P=0.531 P=0.162 |P=0.637 (e) (e) P=0.713N | |COCH-ARM / FISHERS | P=0.019 * (e) P=0.495 P=0.117 |P=0.594 P=0.500N P=0.505N P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/50 (0%) 5/49 (10%) 3/49 (6%) |2/50 (4%) 1/50 (2%) 0/49 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 8.9% 0.0% 12.6% 7.7% |4.6% 2.4% 0.0% 2.3% | |TERMINAL (d) | 4/39 (10%) 0/39 (0%) 5/27 (19%) 3/26 (12%) |2/29 (7%) 1/31 (3%) 0/33 (0%) 1/36 (3%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |731 (T) 731 (T) --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.266 P=0.063N P=0.277 P=0.596 |P=0.309N P=0.477N P=0.210N P=0.424N | |POLY 3 | P=0.396 P=0.054N P=0.422 P=0.578N |P=0.363N P=0.509N P=0.242N P=0.492N | |POLY 1.5 | P=0.423 P=0.056N P=0.452 P=0.557N |P=0.365N P=0.509N P=0.245N P=0.496N | |POLY 6 | P=0.367 P=0.053N P=0.381 P=0.602N |P=0.361N P=0.505N P=0.236N P=0.486N | |LOGISTIC REGRESSION| P=0.266 (e) P=0.277 P=0.596 |P=0.309N P=0.477N (e) P=0.424N | |COCH-ARM / FISHERS | P=0.488 P=0.059N P=0.487 P=0.511N |P=0.367N P=0.500N P=0.253N P=0.500N | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 16 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Degeneration Fatty | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 4/49 (8%) 0/49 (0%) |2/50 (4%) 1/50 (2%) 1/49 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.2% 4.2% 9.8% 0.0% |4.6% 2.4% 2.4% 2.3% | |TERMINAL (d) | 1/39 (3%) 2/39 (5%) 2/27 (7%) 0/26 (0%) |0/29 (0%) 1/31 (3%) 0/33 (0%) 1/36 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 502 --- |586 731 (T) 570 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.518N P=0.500 P=0.112 P=0.581N |P=0.373N P=0.495N P=0.509N P=0.458N | |POLY 3 | P=0.462N P=0.517 P=0.149 P=0.529N |P=0.403N P=0.513N P=0.508N P=0.496N | |POLY 1.5 | P=0.436N P=0.511 P=0.160 P=0.521N |P=0.406N P=0.511N P=0.512N P=0.498N | |POLY 6 | P=0.490N P=0.521 P=0.135 P=0.537N |P=0.400N P=0.512N P=0.500N P=0.492N | |LOGISTIC REGRESSION| P=0.386N P=0.500 P=0.187 (e) |P=0.414N P=0.500N P=0.469N P=0.503N | |COCH-ARM / FISHERS | P=0.381N P=0.500 P=0.175 P=0.505N |P=0.410N P=0.500N P=0.508N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 10/50 (20%) 18/49 (37%) 12/49 (24%) |10/50 (20%) 6/50 (12%) 10/49 (20%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 30.5% 21.1% 42.2% 30.5% |22.6% 14.0% 23.1% 11.4% | |TERMINAL (d) | 12/39 (31%) 9/39 (23%) 11/27 (41%) 10/26 (39%) |6/29 (21%) 3/31 (10%) 6/33 (18%) 5/36 (14%) | |FIRST INCIDENCE | 459 670 430 663 |586 592 537 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.135 P=0.233N P=0.054 P=0.340 |P=0.104N P=0.192N P=0.516N P=0.070N | |POLY 3 | P=0.321 P=0.211N P=0.176 P=0.592 |P=0.161N P=0.225N P=0.577 P=0.129N | |POLY 1.5 | P=0.386 P=0.221N P=0.202 P=0.544N |P=0.163N P=0.223N P=0.566 P=0.130N | |POLY 6 | P=0.257 P=0.204N P=0.144 P=0.538 |P=0.161N P=0.218N P=0.601 P=0.128N | |LOGISTIC REGRESSION| P=0.382 P=0.210N P=0.209 P=0.581 |P=0.161N P=0.217N P=0.570 P=0.121N | |COCH-ARM / FISHERS | P=0.535 P=0.241N P=0.238 P=0.433N |P=0.171N P=0.207N P=0.579 P=0.131N | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 17 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/49 (4%) 2/49 (4%) |5/50 (10%) 7/50 (14%) 1/49 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.2% 2.1% 4.9% 5.1% |11.3% 15.8% 2.3% 2.3% | |TERMINAL (d) | 0/39 (0%) 1/39 (3%) 0/27 (0%) 1/26 (4%) |1/29 (3%) 2/31 (7%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 621 729 (T) 563 670 |521 456 72 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.252 P=0.751N P=0.443 P=0.424 |P=0.023N* P=0.392 P=0.102N P=0.093N | |POLY 3 | P=0.273 P=0.752N P=0.462 P=0.449 |P=0.023N* P=0.382 P=0.107N P=0.101N | |POLY 1.5 | P=0.290 P=0.754N P=0.476 P=0.463 |P=0.023N* P=0.374 P=0.108N P=0.101N | |POLY 6 | P=0.255 P=0.750N P=0.442 P=0.433 |P=0.022N* P=0.400 P=0.103N P=0.099N | |LOGISTIC REGRESSION| P=0.388 P=0.734 P=0.566 P=0.494 |P=0.024N* P=0.435 P=0.049N* P=0.106N | |COCH-ARM / FISHERS | P=0.329 P=0.753N P=0.492 P=0.492 |P=0.025N* P=0.380 P=0.107N P=0.102N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 3/50 (6%) 6/49 (12%) 6/49 (12%) |3/50 (6%) 5/50 (10%) 4/49 (8%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 13.3% 6.3% 15.0% 15.3% |6.8% 11.8% 9.5% 9.0% | |TERMINAL (d) | 5/39 (13%) 2/39 (5%) 4/27 (15%) 4/26 (15%) |1/29 (3%) 2/31 (7%) 4/33 (12%) 3/36 (8%) | |FIRST INCIDENCE | 669 621 663 663 |521 670 731 (T) 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.180 P=0.235N P=0.380 P=0.369 |P=0.550N P=0.368 P=0.536 P=0.568 | |POLY 3 | P=0.303 P=0.217N P=0.534 P=0.521 |P=0.507 P=0.333 P=0.472 P=0.503 | |POLY 1.5 | P=0.334 P=0.226N P=0.567 P=0.547 |P=0.503 P=0.337 P=0.472 P=0.501 | |POLY 6 | P=0.270 P=0.211N P=0.488 P=0.491 |P=0.514 P=0.337 P=0.478 P=0.509 | |LOGISTIC REGRESSION| P=0.283 P=0.229N P=0.476 P=0.487 |P=0.506 P=0.366 P=0.491 P=0.487 | |COCH-ARM / FISHERS | P=0.406 P=0.243N P=0.606 P=0.606 |P=0.499 P=0.357 P=0.489 P=0.500 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 18 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Karyomegaly | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 1/49 (2%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.4% 0.0% 0.0% 2.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/39 (5%) 0/39 (0%) 0/27 (0%) 1/26 (4%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.579N P=0.238N P=0.322N P=0.640N |(e) (e) (e) (e) | |POLY 3 | P=0.481N P=0.227N P=0.266N P=0.550N |(e) (e) (e) (e) | |POLY 1.5 | P=0.474N P=0.230N P=0.255N P=0.537N |(e) (e) (e) (e) | |POLY 6 | P=0.488N P=0.224N P=0.282N P=0.565N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.579N (e) (e) P=0.640N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.467N P=0.247N P=0.253N P=0.508N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 2/50 (4%) 7/49 (14%) 9/49 (18%) |2/50 (4%) 8/50 (16%) 7/49 (14%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 13.2% 4.2% 17.0% 21.3% |4.6% 18.5% 16.2% 6.6% | |TERMINAL (d) | 4/39 (10%) 0/39 (0%) 2/27 (7%) 3/26 (12%) |1/29 (3%) 3/31 (10%) 3/33 (9%) 1/36 (3%) | |FIRST INCIDENCE | 663 611 511 374 |645 592 537 529 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.034 * P=0.128N P=0.298 P=0.155 |P=0.425N P=0.063 P=0.108 P=0.547 | |POLY 3 | P=0.058 P=0.116N P=0.424 P=0.235 |P=0.462N P=0.044 * P=0.076 P=0.519 | |POLY 1.5 | P=0.065 P=0.122N P=0.452 P=0.244 |P=0.479N P=0.043 * P=0.073 P=0.510 | |POLY 6 | P=0.052 P=0.112N P=0.387 P=0.224 |P=0.439N P=0.048 * P=0.085 P=0.530 | |LOGISTIC REGRESSION| P=0.166 P=0.163N P=0.480 P=0.346 |P=0.507N P=0.046 * P=0.076 P=0.483 | |COCH-ARM / FISHERS | P=0.085 P=0.134N P=0.484 P=0.274 |P=0.502N P=0.046 * P=0.075 P=0.500 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 19 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Liver: Kupffer Cell | | Pigmentation Hemosiderin | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 8/49 (16%) 30/49 (61%) |0/50 (0%) 5/50 (10%) 25/49 (51%) 44/50 (88%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 19.5% 69.9% |0.0% 11.5% 54.1% 92.2% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 4/27 (15%) 16/26 (62%) |0/29 (0%) 1/31 (3%) 15/33 (46%) 34/36 (94%) | |FIRST INCIDENCE | --- --- 567 374 |--- 369 408 489 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.002 ** P<0.001 ** |P<0.001 ** P=0.039 * P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.002 ** P<0.001 ** |P<0.001 ** P=0.031 * P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.003 ** P<0.001 ** |P<0.001 ** P=0.030 * P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.002 ** P<0.001 ** |P<0.001 ** P=0.034 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.004 ** P<0.001 ** |P<0.001 ** P=0.044 * P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.003 ** P<0.001 ** |P<0.001 ** P=0.028 * P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Liver: Oval Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/49 (4%) 3/49 (6%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 2.1% 5.0% 7.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 0/39 (0%) 2/27 (7%) 3/26 (12%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) 681 729 (T) 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.074 P=0.747N P=0.372 P=0.173 |(e) (e) (e) (e) | |POLY 3 | P=0.122 P=0.749N P=0.457 P=0.256 |(e) (e) (e) (e) | |POLY 1.5 | P=0.133 P=0.753N P=0.473 P=0.268 |(e) (e) (e) (e) | |POLY 6 | P=0.110 P=0.745N P=0.433 P=0.241 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.095 P=0.765N P=0.372 P=0.173 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.159 P=0.753N P=0.492 P=0.301 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 20 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 5/50 (10%) 5/49 (10%) 3/50 (6%) |10/50 (20%) 2/50 (4%) 6/50 (12%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 11.0% 10.6% 12.6% 7.5% |22.9% 4.8% 13.8% 13.6% | |TERMINAL (d) | 4/39 (10%) 5/39 (13%) 4/27 (15%) 1/26 (4%) |7/29 (24%) 2/31 (7%) 4/33 (12%) 6/36 (17%) | |FIRST INCIDENCE | 556 729 (T) 705 614 |572 731 (T) 72 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.530N P=0.629N P=0.412 P=0.526N |P=0.218N P=0.014N* P=0.164N P=0.110N | |POLY 3 | P=0.373N P=0.607N P=0.543 P=0.426N |P=0.305N P=0.016N* P=0.205N P=0.198N | |POLY 1.5 | P=0.343N P=0.614N P=0.577 P=0.404N |P=0.312N P=0.015N* P=0.212N P=0.202N | |POLY 6 | P=0.407N P=0.604N P=0.497 P=0.450N |P=0.299N P=0.015N* P=0.189N P=0.191N | |LOGISTIC REGRESSION| P=0.368N P=0.612N P=0.532 P=0.368N |P=0.325N P=0.016N* P=0.194N P=0.177N | |COCH-ARM / FISHERS | P=0.281N P=0.630N P=0.617 P=0.357N |P=0.329N P=0.014N* P=0.207N P=0.207N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 1/50 (2%) 4/49 (8%) 4/50 (8%) |3/50 (6%) 2/50 (4%) 3/50 (6%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 13.3% 2.1% 10.1% 10.0% |7.0% 4.7% 7.1% 4.5% | |TERMINAL (d) | 5/39 (13%) 1/39 (3%) 4/27 (15%) 3/26 (12%) |2/29 (7%) 1/31 (3%) 2/33 (6%) 2/36 (6%) | |FIRST INCIDENCE | 667 729 (T) 729 (T) 604 |713 255 723 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.414 P=0.058N P=0.602N P=0.597N |P=0.378N P=0.487N P=0.605N P=0.419N | |POLY 3 | P=0.565N P=0.049N* P=0.453N P=0.449N |P=0.447N P=0.502N P=0.651 P=0.490N | |POLY 1.5 | P=0.538N P=0.052N P=0.421N P=0.424N |P=0.451N P=0.504N P=0.647 P=0.495N | |POLY 6 | P=0.542 P=0.048N* P=0.501N P=0.481N |P=0.440N P=0.497N P=0.663 P=0.483N | |LOGISTIC REGRESSION| P=0.525 P=0.049N* P=0.537N P=0.465N |P=0.456N P=0.449N P=0.645N P=0.467N | |COCH-ARM / FISHERS | P=0.483N P=0.056N P=0.383N P=0.370N |P=0.456N P=0.500N P=0.661N P=0.500N | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 21 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 1/50 (2%) 2/49 (4%) 4/50 (8%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 13.3% 2.1% 5.0% 10.1% |4.6% 4.8% 0.0% 4.5% | |TERMINAL (d) | 6/39 (15%) 1/39 (3%) 1/27 (4%) 4/26 (15%) |2/29 (7%) 2/31 (7%) 0/33 (0%) 2/36 (6%) | |FIRST INCIDENCE | 729 (T) 729 (T) 663 729 (T) |731 (T) 731 (T) --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.474 P=0.058N P=0.274N P=0.636 |P=0.477N P=0.672N P=0.210N P=0.615N | |POLY 3 | P=0.508N P=0.048N* P=0.174N P=0.453N |P=0.552N P=0.685 P=0.242N P=0.686N | |POLY 1.5 | P=0.486N P=0.051N P=0.158N P=0.426N |P=0.555N P=0.685 P=0.244N P=0.689N | |POLY 6 | P=0.533N P=0.046N* P=0.198N P=0.487N |P=0.548N P=0.690 P=0.236N P=0.680N | |LOGISTIC REGRESSION| P=0.540 P=0.058N P=0.218N P=0.636 |P=0.477N P=0.672N (e) P=0.615N | |COCH-ARM / FISHERS | P=0.444N P=0.056N P=0.141N P=0.370N |P=0.556N P=0.691N P=0.247N P=0.691N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Lung: Perivascular | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.6% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 0/26 (0%) |1/29 (3%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- --- --- --- |713 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.104N P=0.239N P=0.220N P=0.213N | |POLY 3 | (e) (e) (e) (e) |P=0.112N P=0.243N P=0.243N P=0.232N | |POLY 1.5 | (e) (e) (e) (e) |P=0.113N P=0.243N P=0.245N P=0.235N | |POLY 6 | (e) (e) (e) (e) |P=0.113N P=0.241N P=0.237N P=0.228N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.110N P=0.238N P=0.233N P=0.225N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 22 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Bronchial | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/38 (5%) 0/35 (0%) 1/33 (3%) 0/35 (0%) |1/41 (2%) 6/39 (15%) 4/41 (10%) 1/37 (3%) | |POLY-3 ADJUSTED (b)| 6.0% 0.0% 3.5% 0.0% |2.8% 17.2% 10.8% 3.0% | |TERMINAL (d) | 2/29 (7%) 0/27 (0%) 1/23 (4%) 0/18 (0%) |1/24 (4%) 5/26 (19%) 3/29 (10%) 1/27 (4%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) --- |731 (T) 647 537 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.268N P=0.254N P=0.581N P=0.348N |P=0.294N P=0.070 P=0.223 P=0.736N | |POLY 3 | P=0.229N P=0.237N P=0.555N P=0.293N |P=0.353N P=0.052 P=0.192 P=0.747 | |POLY 1.5 | P=0.221N P=0.244N P=0.551N P=0.282N |P=0.366N P=0.049 * P=0.185 P=0.743 | |POLY 6 | P=0.236N P=0.233N P=0.561N P=0.304N |P=0.333N P=0.055 P=0.205 P=0.753 | |LOGISTIC REGRESSION| P=0.268N (e) P=0.581N (e) |P=0.371N P=0.056 P=0.179 P=0.736N | |COCH-ARM / FISHERS | P=0.203N P=0.268N P=0.553N P=0.268N |P=0.384N P=0.047 * P=0.180 P=0.727 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/24 (0%) 1/26 (4%) 1/32 (3%) 1/25 (4%) |1/37 (3%) 2/38 (5%) 2/40 (5%) 1/38 (3%) | |POLY-3 ADJUSTED (b)| 0.0% 4.0% 3.8% 5.0% |3.1% 6.4% 6.0% 3.0% | |TERMINAL (d) | 0/19 (0%) 1/21 (5%) 0/16 (0%) 1/15 (7%) |1/23 (4%) 2/22 (9%) 2/28 (7%) 0/26 (0%) | |FIRST INCIDENCE | --- 729 (T) 430 729 (T) |731 (T) 731 (T) 731 (T) 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.322 P=0.520 P=0.496 P=0.453 |P=0.503N P=0.484 P=0.569 P=0.741N | |POLY 3 | P=0.341 P=0.523 P=0.534 P=0.482 |P=0.544N P=0.487 P=0.513 P=0.755N | |POLY 1.5 | P=0.355 P=0.521 P=0.545 P=0.489 |P=0.544N P=0.492 P=0.512 P=0.755N | |POLY 6 | P=0.325 P=0.525 P=0.518 P=0.474 |P=0.544N P=0.485 P=0.519 P=0.756N | |LOGISTIC REGRESSION| P=0.484 P=0.520 (e) P=0.453 |P=0.543N P=0.484 P=0.569 P=0.760N | |COCH-ARM / FISHERS | P=0.391 P=0.520 P=0.571 P=0.510 |P=0.547N P=0.510 P=0.530 P=0.747N | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 23 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/40 (0%) 0/33 (0%) 0/40 (0%) 0/37 (0%) |2/31 (6%) 2/40 (5%) 5/38 (13%) 0/34 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |7.2% 5.9% 15.5% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/25 (0%) 0/22 (0%) 0/18 (0%) |0/18 (0%) 1/25 (4%) 5/26 (19%) 0/22 (0%) | |FIRST INCIDENCE | --- --- --- --- |645 647 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.221N P=0.661N P=0.339 P=0.225N | |POLY 3 | (e) (e) (e) (e) |P=0.268N P=0.618N P=0.277 P=0.229N | |POLY 1.5 | (e) (e) (e) (e) |P=0.257N P=0.614N P=0.278 P=0.224N | |POLY 6 | (e) (e) (e) (e) |P=0.281N P=0.619N P=0.282 P=0.234N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.259N P=0.600N P=0.290 P=0.209N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.245N P=0.591N P=0.307 P=0.224N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/47 (0%) 1/43 (2%) |0/47 (0%) 0/48 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.4% 4.2% 0.0% 2.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 2/39 (5%) 0/27 (0%) 0/24 (0%) |0/28 (0%) 0/30 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 642 729 (T) --- 694 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.426N P=0.685N P=0.304N P=0.605N |(e) (e) (e) (e) | |POLY 3 | P=0.370N P=0.679N P=0.273N P=0.593N |(e) (e) (e) (e) | |POLY 1.5 | P=0.359N P=0.683N P=0.263N P=0.581N |(e) (e) (e) (e) | |POLY 6 | P=0.385N P=0.677N P=0.289N P=0.606N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.374N P=0.693N P=0.249N P=0.569N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.341N P=0.691N P=0.263N P=0.557N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 24 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/47 (2%) 0/43 (0%) |0/47 (0%) 1/48 (2%) 1/49 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.2% 6.3% 2.6% 0.0% |0.0% 2.5% 2.4% 2.3% | |TERMINAL (d) | 1/39 (3%) 2/39 (5%) 0/27 (0%) 0/24 (0%) |0/28 (0%) 1/30 (3%) 1/33 (3%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) 707 563 --- |--- 731 (T) 731 (T) 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.307N P=0.309 P=0.715 P=0.597N |P=0.433 P=0.514 P=0.533 P=0.511 | |POLY 3 | P=0.272N P=0.324 P=0.730 P=0.553N |P=0.410 P=0.501 P=0.507 P=0.517 | |POLY 1.5 | P=0.260N P=0.317 P=0.738 P=0.546N |P=0.406 P=0.500 P=0.505 P=0.515 | |POLY 6 | P=0.289N P=0.328 P=0.718 P=0.560N |P=0.417 P=0.503 P=0.512 P=0.521 | |LOGISTIC REGRESSION| P=0.239N P=0.326 P=0.755N (e) |P=0.413 P=0.514 P=0.533 P=0.516 | |COCH-ARM / FISHERS | P=0.235N P=0.309 P=0.737 P=0.538N |P=0.399 P=0.505 P=0.510 P=0.515 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 7/50 (14%) 4/47 (9%) 4/43 (9%) |1/47 (2%) 2/48 (4%) 3/49 (6%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 15.6% 14.8% 10.3% 11.5% |2.5% 4.9% 7.1% 6.8% | |TERMINAL (d) | 7/39 (18%) 7/39 (18%) 2/27 (7%) 2/24 (8%) |1/28 (4%) 2/30 (7%) 3/33 (9%) 1/36 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 681 684 |731 (T) 731 (T) 731 (T) 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.457N P=0.615 P=0.487N P=0.548N |P=0.310 P=0.524 P=0.365 P=0.368 | |POLY 3 | P=0.310N P=0.576N P=0.348N P=0.425N |P=0.265 P=0.501 P=0.317 P=0.338 | |POLY 1.5 | P=0.287N P=0.588N P=0.324N P=0.405N |P=0.259 P=0.501 P=0.314 P=0.333 | |POLY 6 | P=0.337N P=0.567N P=0.382N P=0.445N |P=0.275 P=0.505 P=0.326 P=0.347 | |LOGISTIC REGRESSION| P=0.386N P=0.615 P=0.424N P=0.481N |P=0.265 P=0.524 P=0.365 P=0.333 | |COCH-ARM / FISHERS | P=0.237N P=0.613N P=0.299N P=0.356N |P=0.249 P=0.508 P=0.324 P=0.332 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 25 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.6% 4.8% 2.4% 4.5% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/29 (0%) 2/31 (7%) 1/33 (3%) 0/36 (0%) | |FIRST INCIDENCE | --- --- --- --- |521 731 (T) 731 (T) 660 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.534N P=0.691 P=0.489N P=0.686N | |POLY 3 | (e) (e) (e) (e) |P=0.570N P=0.679 P=0.514N P=0.688N | |POLY 1.5 | (e) (e) (e) (e) |P=0.574N P=0.682 P=0.515N P=0.691N | |POLY 6 | (e) (e) (e) (e) |P=0.564N P=0.680 P=0.508N P=0.682N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.577N P=0.692N P=0.484N P=0.683 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.577N P=0.691N P=0.500N P=0.691N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/5 (100%) 2/3 (67%) 2/3 (67%) 0/1 (0%) |7/10 (70%) 3/4 (75%) 4/5 (80%) 9/9 (100%) | |POLY-3 ADJUSTED (b)| 100.0% 66.7% 78.5% 0.0% |72.3% 79.6% 82.1% 100.0% | |TERMINAL (d) | 5/5 (100%) 2/3 (67%) 2/2 (100%) 0/0 (0%) |3/5 (60%) 1/1 (100%) 3/3 (100%) 5/5 (100%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |521 456 591 529 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.815N P=0.398N P=1.000N P=1.000N |P=0.267 P=0.461N P=0.435N P=0.396 | |POLY 3 | P=0.095N P=0.392N P=0.695N P=1.000N |P=0.081 P=0.657 P=0.590 P=0.130 | |POLY 1.5 | P=0.070N P=0.392N P=0.524N P<0.001N** |P=0.079 P=0.663 P=0.584 P=0.122 | |POLY 6 | P=0.233N P=0.392N P=0.973N P=1.000N |P=0.087 P=0.640 P=0.594 P=0.149 | |LOGISTIC REGRESSION| P=0.815N P=0.398N P=1.000N (e) |P=0.056 P=0.714N P=0.513 P=0.104 | |COCH-ARM / FISHERS | P=0.061N P=0.375N P=0.375N P=0.167N |P=0.073 P=0.790N P=0.593 P=0.124 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 26 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 6/50 (12%) 2/48 (4%) 2/48 (4%) |2/50 (4%) 3/50 (6%) 1/49 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.4% 12.6% 5.1% 5.2% |4.6% 7.2% 2.4% 0.0% | |TERMINAL (d) | 1/39 (3%) 4/39 (10%) 2/27 (7%) 2/26 (8%) |1/29 (3%) 2/31 (7%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 669 681 729 (T) 729 (T) |725 723 723 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.559N P=0.151 P=0.570 P=0.565 |P=0.080N P=0.521 P=0.461N P=0.201N | |POLY 3 | P=0.445N P=0.150 P=0.643 P=0.632 |P=0.101N P=0.488 P=0.515N P=0.232N | |POLY 1.5 | P=0.418N P=0.144 P=0.660 P=0.647 |P=0.103N P=0.489 P=0.518N P=0.234N | |POLY 6 | P=0.480N P=0.153 P=0.618 P=0.614 |P=0.097N P=0.494 P=0.504N P=0.228N | |LOGISTIC REGRESSION| P=0.479N P=0.145 P=0.628 P=0.625 |P=0.092N P=0.502 P=0.489N P=0.220N | |COCH-ARM / FISHERS | P=0.366N P=0.134 P=0.676 P=0.676 |P=0.105N P=0.500 P=0.508N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 3/48 (6%) 0/48 (0%) |2/50 (4%) 4/50 (8%) 2/49 (4%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 8.8% 8.4% 7.6% 0.0% |4.6% 9.3% 4.9% 9.0% | |TERMINAL (d) | 3/39 (8%) 2/39 (5%) 3/27 (11%) 0/26 (0%) |1/29 (3%) 3/31 (10%) 2/33 (6%) 3/36 (8%) | |FIRST INCIDENCE | 642 681 729 (T) --- |621 255 731 (T) 682 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.107N P=0.625N P=0.626 P=0.117N |P=0.431 P=0.359 P=0.659N P=0.414 | |POLY 3 | P=0.071N P=0.617N P=0.576N P=0.085N |P=0.352 P=0.331 P=0.676 P=0.345 | |POLY 1.5 | P=0.062N P=0.626N P=0.551N P=0.078N |P=0.347 P=0.332 P=0.673 P=0.342 | |POLY 6 | P=0.082N P=0.611N P=0.612N P=0.093N |P=0.360 P=0.334 P=0.684 P=0.352 | |LOGISTIC REGRESSION| P=0.071N P=0.633N P=0.613N P=0.083N |P=0.342 P=0.383 P=0.680 P=0.344 | |COCH-ARM / FISHERS | P=0.047N* P=0.643N P=0.523N P=0.064N |P=0.343 P=0.339 P=0.684 P=0.339 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 27 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/48 (6%) 1/48 (2%) |6/50 (12%) 14/50 (28%) 11/49 (22%) 12/50 (24%) | |POLY-3 ADJUSTED (b)| 2.2% 4.2% 7.5% 2.6% |13.8% 33.2% 26.7% 26.9% | |TERMINAL (d) | 1/39 (3%) 2/39 (5%) 2/27 (7%) 1/26 (4%) |5/29 (17%) 12/31 (39%) 11/33 (33%) 10/36 (28%) | |FIRST INCIDENCE | 729 (T) 729 (T) 583 729 (T) |621 670 731 (T) 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.471 P=0.500 P=0.207 P=0.669 |P=0.357 P=0.051 P=0.205 P=0.194 | |POLY 3 | P=0.529 P=0.517 P=0.263 P=0.723 |P=0.201 P=0.028 * P=0.112 P=0.102 | |POLY 1.5 | P=0.554 P=0.511 P=0.276 P=0.732 |P=0.191 P=0.030 * P=0.112 P=0.099 | |POLY 6 | P=0.503 P=0.521 P=0.245 P=0.713 |P=0.219 P=0.029 * P=0.121 P=0.110 | |LOGISTIC REGRESSION| P=0.553 P=0.500 P=0.277 P=0.669 |P=0.221 P=0.034 * P=0.144 P=0.109 | |COCH-ARM / FISHERS | P=0.596N P=0.500 P=0.293 P=0.742 |P=0.182 P=0.039 * P=0.133 P=0.096 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 10/50 (20%) 5/48 (10%) 5/48 (10%) |17/50 (34%) 35/50 (70%) 26/49 (53%) 23/50 (46%) | |POLY-3 ADJUSTED (b)| 8.9% 20.9% 12.6% 12.9% |38.8% 77.3% 61.9% 51.4% | |TERMINAL (d) | 4/39 (10%) 6/39 (15%) 3/27 (11%) 3/26 (12%) |14/29 (48%) 25/31 (81%) 22/33 (67%) 21/36 (58%) | |FIRST INCIDENCE | 729 (T) 656 655 629 |621 456 570 582 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.373 P=0.089 P=0.298 P=0.291 |P=0.251N P<0.001 ** P=0.121 P=0.408 | |POLY 3 | P=0.527 P=0.092 P=0.423 P=0.407 |P=0.481 P<0.001 ** P=0.022 * P=0.160 | |POLY 1.5 | P=0.552N P=0.085 P=0.446 P=0.426 |P=0.464 P<0.001 ** P=0.023 * P=0.156 | |POLY 6 | P=0.489 P=0.099 P=0.390 P=0.388 |P=0.507 P<0.001 ** P=0.027 * P=0.171 | |LOGISTIC REGRESSION| P=0.511 P=0.088 P=0.368 P=0.383 |P=0.522 P<0.001 ** P=0.034 * P=0.187 | |COCH-ARM / FISHERS | P=0.477N P=0.074 P=0.474 P=0.474 |P=0.448 P<0.001 ** P=0.043 * P=0.154 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 28 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 0/49 (0%) 2/49 (4%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| |4.6% 0.0% 4.9% 2.3% | |TERMINAL (d) | |2/29 (7%) 0/31 (0%) 2/32 (6%) 1/35 (3%) | |FIRST INCIDENCE | |731 (T) --- 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.469N P=0.223N P=0.660N P=0.434N | |POLY 3 | |P=0.526N P=0.246N P=0.677 P=0.500N | |POLY 1.5 | |P=0.529N P=0.246N P=0.674 P=0.503N | |POLY 6 | |P=0.525N P=0.241N P=0.686 P=0.494N | |LOGISTIC REGRESSION| |P=0.469N (e) P=0.660N P=0.434N | |COCH-ARM / FISHERS | |P=0.536N P=0.253N P=0.684 P=0.508N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/50 (2%) 2/49 (4%) 2/49 (4%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| |2.3% 4.8% 4.8% 2.3% | |TERMINAL (d) | |0/29 (0%) 1/31 (3%) 0/32 (0%) 0/35 (0%) | |FIRST INCIDENCE | |713 715 537 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.524N P=0.497 P=0.516 P=0.751N | |POLY 3 | |P=0.552N P=0.486 P=0.488 P=0.761N | |POLY 1.5 | |P=0.556N P=0.486 P=0.484 P=0.759 | |POLY 6 | |P=0.545N P=0.492 P=0.498 P=0.757N | |LOGISTIC REGRESSION| |P=0.560N P=0.494 P=0.507 P=0.762N | |COCH-ARM / FISHERS | |P=0.562N P=0.492 P=0.492 P=0.747 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 29 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |11/50 (22%) 12/49 (24%) 19/49 (39%) 16/49 (33%) | |POLY-3 ADJUSTED (b)| |24.5% 28.7% 43.4% 35.6% | |TERMINAL (d) | |7/29 (24%) 8/31 (26%) 12/32 (38%) 12/35 (34%) | |FIRST INCIDENCE | |521 672 196 485 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.243 P=0.540 P=0.108 P=0.329 | |POLY 3 | |P=0.121 P=0.421 P=0.046 * P=0.177 | |POLY 1.5 | |P=0.113 P=0.434 P=0.044 * P=0.172 | |POLY 6 | |P=0.132 P=0.421 P=0.054 P=0.186 | |LOGISTIC REGRESSION| |P=0.107 P=0.459 P=0.054 P=0.166 | |COCH-ARM / FISHERS | |P=0.102 P=0.478 P=0.055 P=0.168 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/50 (2%) 0/49 (0%) 2/49 (4%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| |2.3% 0.0% 4.9% 0.0% | |TERMINAL (d) | |1/29 (3%) 0/31 (0%) 2/32 (6%) 0/35 (0%) | |FIRST INCIDENCE | |731 (T) --- 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.415N P=0.487N P=0.535 P=0.462N | |POLY 3 | |P=0.455N P=0.508N P=0.483 P=0.500N | |POLY 1.5 | |P=0.458N P=0.508N P=0.481 P=0.502N | |POLY 6 | |P=0.452N P=0.504N P=0.492 P=0.497N | |LOGISTIC REGRESSION| |P=0.415N (e) P=0.535 (e) | |COCH-ARM / FISHERS | |P=0.465N P=0.505N P=0.492 P=0.505N | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 30 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 4/50 (8%) 2/47 (4%) 4/47 (9%) |6/49 (12%) 4/50 (8%) 2/49 (4%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 22.1% 8.4% 5.1% 10.5% |14.1% 9.5% 4.8% 17.8% | |TERMINAL (d) | 9/39 (23%) 3/39 (8%) 2/27 (7%) 3/26 (12%) |5/29 (17%) 3/31 (10%) 2/33 (6%) 6/36 (17%) | |FIRST INCIDENCE | 642 681 729 (T) 670 |715 694 731 (T) 437 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.185N P=0.073N P=0.061N P=0.236N |P=0.377 P=0.339N P=0.098N P=0.529 | |POLY 3 | P=0.093N P=0.060N P=0.026N* P=0.131N |P=0.289 P=0.376N P=0.136N P=0.428 | |POLY 1.5 | P=0.084N P=0.064N P=0.022N* P=0.119N |P=0.282 P=0.374N P=0.139N P=0.418 | |POLY 6 | P=0.105N P=0.056N P=0.033N* P=0.147N |P=0.296 P=0.370N P=0.129N P=0.442 | |LOGISTIC REGRESSION| P=0.124N P=0.059N P=0.039N* P=0.150N |P=0.287 P=0.365N P=0.110N P=0.412 | |COCH-ARM / FISHERS | P=0.070N P=0.074N P=0.018N* P=0.092N |P=0.270 P=0.357N P=0.134N P=0.403 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Cytoplasmic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/47 (0%) 1/47 (2%) |1/49 (2%) 2/50 (4%) 0/49 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 2.6% |2.4% 4.8% 0.0% 4.5% | |TERMINAL (d) | 1/39 (3%) 0/39 (0%) 0/27 (0%) 0/26 (0%) |1/29 (3%) 1/31 (3%) 0/33 (0%) 1/36 (3%) | |FIRST INCIDENCE | 729 (T) --- --- 663 |731 (T) 712 --- 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.524 P=0.500N P=0.573N P=0.694 |P=0.521 P=0.515 P=0.474N P=0.562 | |POLY 3 | P=0.557 P=0.490N P=0.528N P=0.723 |P=0.481 P=0.496 P=0.503N P=0.515 | |POLY 1.5 | P=0.564 P=0.494N P=0.520N P=0.730 |P=0.478 P=0.497 P=0.504N P=0.511 | |POLY 6 | P=0.549 P=0.488N P=0.539N P=0.716 |P=0.488 P=0.499 P=0.498N P=0.521 | |LOGISTIC REGRESSION| P=0.570 (e) (e) P=0.736 |P=0.484 P=0.501 (e) P=0.511 | |COCH-ARM / FISHERS | P=0.581 P=0.500N P=0.515N P=0.737 |P=0.474 P=0.508 P=0.500N P=0.508 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 31 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/47 (0%) 0/47 (0%) |0/49 (0%) 0/50 (0%) 3/49 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 0.0% |0.0% 0.0% 7.1% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 0/26 (0%) |0/29 (0%) 0/31 (0%) 3/33 (9%) 0/36 (0%) | |FIRST INCIDENCE | --- 705 --- --- |--- --- 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.632N P=0.510 (e) (e) |P=0.593 (e) P=0.144 (e) | |POLY 3 | P=0.585N P=0.510 (e) (e) |P=0.561 (e) P=0.116 (e) | |POLY 1.5 | P=0.581N P=0.507 (e) (e) |P=0.555 (e) P=0.115 (e) | |POLY 6 | P=0.592N P=0.513 (e) (e) |P=0.567 (e) P=0.119 (e) | |LOGISTIC REGRESSION| P=0.596N P=0.500 (e) (e) |(e) (e) P=0.144 (e) | |COCH-ARM / FISHERS | P=0.578N P=0.500 (e) (e) |P=0.543 (e) P=0.121 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/46 (0%) 0/48 (0%) |1/50 (2%) 4/49 (8%) 0/48 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.3% 9.6% 0.0% 0.0% | |TERMINAL (d) | 0/38 (0%) 0/39 (0%) 0/27 (0%) 0/25 (0%) |1/29 (3%) 2/30 (7%) 0/33 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |731 (T) 604 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.108N P=0.191 P=0.474N P=0.462N | |POLY 3 | (e) (e) (e) (e) |P=0.123N P=0.168 P=0.506N P=0.500N | |POLY 1.5 | (e) (e) (e) (e) |P=0.125N P=0.167 P=0.509N P=0.502N | |POLY 6 | (e) (e) (e) (e) |P=0.118N P=0.173 P=0.500N P=0.497N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.128N P=0.168 (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.129N P=0.175 P=0.510N P=0.505N | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 32 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 1/49 (2%) 2/46 (4%) 1/48 (2%) |15/50 (30%) 15/49 (31%) 16/48 (33%) 20/49 (41%) | |POLY-3 ADJUSTED (b)| 11.3% 2.1% 5.2% 2.6% |34.6% 36.0% 37.6% 45.7% | |TERMINAL (d) | 4/38 (11%) 0/39 (0%) 1/27 (4%) 1/25 (4%) |12/29 (41%) 12/30 (40%) 13/33 (39%) 17/35 (49%) | |FIRST INCIDENCE | 669 549 563 729 (T) |649 606 544 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.174N P=0.097N P=0.345N P=0.210N |P=0.335 P=0.551N P=0.521N P=0.414 | |POLY 3 | P=0.126N P=0.088N P=0.278N P=0.138N |P=0.148 P=0.537 P=0.472 P=0.196 | |POLY 1.5 | P=0.116N P=0.093N P=0.261N P=0.127N |P=0.139 P=0.533 P=0.446 P=0.187 | |POLY 6 | P=0.138N P=0.084N P=0.305N P=0.153N |P=0.162 P=0.561 P=0.517 P=0.216 | |LOGISTIC REGRESSION| P=0.093N P=0.117N P=0.261N P=0.155N |P=0.159 P=0.543 P=0.505 P=0.213 | |COCH-ARM / FISHERS | P=0.099N P=0.102N P=0.245N P=0.107N |P=0.128 P=0.560 P=0.445 P=0.180 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/46 (0%) 0/48 (0%) |1/50 (2%) 2/49 (4%) 1/48 (2%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.3% 4.9% 2.4% 2.3% | |TERMINAL (d) | 0/38 (0%) 0/39 (0%) 0/27 (0%) 0/25 (0%) |1/29 (3%) 2/30 (7%) 0/33 (0%) 1/35 (3%) | |FIRST INCIDENCE | --- --- --- --- |731 (T) 731 (T) 544 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.480N P=0.512 P=0.756N P=0.720N | |POLY 3 | (e) (e) (e) (e) |P=0.528N P=0.482 P=0.758 P=0.761N | |POLY 1.5 | (e) (e) (e) (e) |P=0.532N P=0.483 P=0.753 P=0.758 | |POLY 6 | (e) (e) (e) (e) |P=0.521N P=0.486 P=0.756N P=0.757N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.533N P=0.512 P=0.759N P=0.720N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.537N P=0.492 P=0.742 P=0.747 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 33 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 7/49 (14%) 6/49 (12%) 8/49 (16%) | | |POLY-3 ADJUSTED (b)| 4.5% 15.1% 14.9% 20.1% | | |TERMINAL (d) | 1/39 (3%) 6/38 (16%) 3/27 (11%) 4/26 (15%) | | |FIRST INCIDENCE | 618 656 618 623 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.016 * P=0.084 P=0.063 P=0.019 * | | |POLY 3 | P=0.038 * P=0.089 P=0.102 P=0.028 * | | |POLY 1.5 | P=0.047 * P=0.086 P=0.115 P=0.033 * | | |POLY 6 | P=0.030 * P=0.090 P=0.086 P=0.024 * | | |LOGISTIC REGRESSION| P=0.042 * P=0.083 P=0.118 P=0.036 * | | |COCH-ARM / FISHERS | P=0.072 P=0.080 P=0.134 P=0.046 * | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/49 (4%) 3/48 (6%) 4/45 (9%) | | |POLY-3 ADJUSTED (b)| 0.0% 4.3% 7.3% 10.8% | | |TERMINAL (d) | 0/38 (0%) 1/38 (3%) 0/27 (0%) 1/24 (4%) | | |FIRST INCIDENCE | --- 707 537 623 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.024 * P=0.243 P=0.105 P=0.042 * | | |POLY 3 | P=0.025 * P=0.249 P=0.106 P=0.040 * | | |POLY 1.5 | P=0.028 * P=0.245 P=0.110 P=0.042 * | | |POLY 6 | P=0.023 * P=0.252 P=0.100 P=0.038 * | | |LOGISTIC REGRESSION| P=0.059 P=0.249 P=0.128 P=0.052 | | |COCH-ARM / FISHERS | P=0.036 * P=0.247 P=0.117 P=0.049 * | | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 34 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Seminal Vesicle | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 2/46 (4%) 3/46 (7%) | | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 5.2% 7.7% | | |TERMINAL (d) | 1/39 (3%) 0/39 (0%) 1/27 (4%) 0/26 (0%) | | |FIRST INCIDENCE | 729 (T) --- 705 402 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.058 P=0.500N P=0.378 P=0.232 | | |POLY 3 | P=0.075 P=0.492N P=0.447 P=0.256 | | |POLY 1.5 | P=0.078 P=0.496N P=0.459 P=0.261 | | |POLY 6 | P=0.071 P=0.489N P=0.430 P=0.251 | | |LOGISTIC REGRESSION| P=0.166 (e) P=0.414 P=0.402 | | |COCH-ARM / FISHERS | P=0.089 P=0.505N P=0.468 P=0.278 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Skin: Prepuce | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 5.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 2/26 (8%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- --- 704 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.035 * (e) P=0.441 P=0.154 |(e) (e) (e) (e) | |POLY 3 | P=0.055 (e) P=0.476 P=0.209 |(e) (e) (e) (e) | |POLY 1.5 | P=0.059 (e) P=0.485 P=0.218 |(e) (e) (e) (e) | |POLY 6 | P=0.050 (e) P=0.463 P=0.199 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.045 * (e) P=0.475 P=0.154 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.070 (e) P=0.495 P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 35 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Skin: Prepuce | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 13/49 (27%) 8/50 (16%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.4% 6.3% 30.1% 19.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/39 (5%) 1/39 (3%) 5/27 (19%) 3/26 (12%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) 656 537 596 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.005 ** P=0.510 P<0.001 ** P=0.019 * |(e) (e) (e) (e) | |POLY 3 | P=0.006 ** P=0.525 P<0.001 ** P=0.030 * |(e) (e) (e) (e) | |POLY 1.5 | P=0.008 ** P=0.516 P<0.001 ** P=0.034 * |(e) (e) (e) (e) | |POLY 6 | P=0.004 ** P=0.534 P<0.001 ** P=0.027 * |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.024 * P=0.511 P=0.003 ** P=0.033 * |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.020 * P=0.500 P=0.002 ** P=0.046 * |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Skin: Prepuce | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 11/49 (22%) 8/50 (16%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 6.3% 25.7% 19.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 1/39 (3%) 4/27 (15%) 3/26 (12%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- 656 537 596 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.131 P<0.001 ** P=0.002 ** |(e) (e) (e) (e) | |POLY 3 | P<0.001 ** P=0.129 P<0.001 ** P=0.002 ** |(e) (e) (e) (e) | |POLY 1.5 | P<0.001 ** P=0.126 P<0.001 ** P=0.002 ** |(e) (e) (e) (e) | |POLY 6 | P<0.001 ** P=0.132 P<0.001 ** P=0.002 ** |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.005 ** P=0.110 P<0.001 ** P=0.003 ** |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.004 ** P=0.121 P<0.001 ** P=0.003 ** |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 36 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 11/50 (22%) 26/48 (54%) 42/49 (86%) |24/50 (48%) 29/50 (58%) 32/49 (65%) 35/50 (70%) | |POLY-3 ADJUSTED (b)| 25.2% 22.7% 58.5% 87.8% |52.1% 61.6% 69.6% 73.4% | |TERMINAL (d) | 6/39 (15%) 6/39 (15%) 13/27 (48%) 21/26 (81%) |14/29 (48%) 16/31 (52%) 22/33 (67%) 25/36 (69%) | |FIRST INCIDENCE | 459 621 502 73 |376 255 72 489 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.465N P<0.001 ** P<0.001 ** |P=0.182 P=0.307 P=0.222 P=0.192 | |POLY 3 | P<0.001 ** P=0.483N P<0.001 ** P<0.001 ** |P=0.017 * P=0.233 P=0.059 P=0.023 * | |POLY 1.5 | P<0.001 ** P=0.487N P<0.001 ** P<0.001 ** |P=0.014 * P=0.214 P=0.054 P=0.019 * | |POLY 6 | P<0.001 ** P=0.482N P<0.001 ** P<0.001 ** |P=0.024 * P=0.282 P=0.080 P=0.033 * | |LOGISTIC REGRESSION| P<0.001 ** P=0.544 P=0.004 ** P<0.001 ** |P=0.016 * P=0.219 P=0.060 P=0.022 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.002 ** P<0.001 ** |P=0.015 * P=0.212 P=0.062 P=0.021 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 8/50 (16%) 3/48 (6%) 1/49 (2%) |6/50 (12%) 15/50 (30%) 12/49 (24%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 11.1% 17.0% 7.6% 2.6% |13.8% 35.7% 28.6% 22.6% | |TERMINAL (d) | 5/39 (13%) 8/39 (21%) 3/27 (11%) 1/26 (4%) |5/29 (17%) 14/31 (45%) 11/33 (33%) 9/36 (25%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |561 712 723 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.117N P=0.273 P=0.569N P=0.217N |P=0.500N P=0.028 * P=0.146 P=0.343 | |POLY 3 | P=0.057N P=0.308 P=0.430N P=0.138N |P=0.396 P=0.015 * P=0.076 P=0.213 | |POLY 1.5 | P=0.049N* P=0.297 P=0.406N P=0.127N |P=0.384 P=0.017 * P=0.076 P=0.210 | |POLY 6 | P=0.069N P=0.315 P=0.467N P=0.150N |P=0.418 P=0.014 * P=0.081 P=0.222 | |LOGISTIC REGRESSION| P=0.117N P=0.273 P=0.569N P=0.217N |P=0.439 P=0.020 * P=0.095 P=0.227 | |COCH-ARM / FISHERS | P=0.036N* P=0.277 P=0.381N P=0.107N |P=0.372 P=0.024 * P=0.088 P=0.207 | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 37 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Pigmentation Hemosiderin | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 6/50 (12%) 45/48 (94%) 44/49 (90%) |39/50 (78%) 44/50 (88%) 46/49 (94%) 48/50 (96%) | |POLY-3 ADJUSTED (b)| 0.0% 12.7% 95.9% 95.2% |84.3% 92.4% 98.6% 98.8% | |TERMINAL (d) | 0/39 (0%) 4/39 (10%) 27/27 (100%) 25/26 (96%) |26/29 (90%) 30/31 (97%) 33/33 (100%) 36/36 (100%) | |FIRST INCIDENCE | --- 705 430 312 |561 372 408 485 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.020 * P<0.001 ** P<0.001 ** |P=0.463 P=0.331 P=0.355 P=0.451 | |POLY 3 | P<0.001 ** P=0.018 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.162 P=0.007 ** P=0.005 ** | |POLY 1.5 | P<0.001 ** P=0.017 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.130 P=0.006 ** P=0.005 ** | |POLY 6 | P<0.001 ** P=0.019 * P<0.001 ** P<0.001 ** |P=0.002 ** P=0.246 P=0.012 * P=0.009 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.021 * P<0.001 ** P<0.001 ** |P=0.003 ** P=0.060 P=0.004 ** P=0.004 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** |P=0.004 ** P=0.143 P=0.022 * P=0.007 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 9/49 (18%) 3/48 (6%) |1/50 (2%) 7/50 (14%) 13/49 (27%) 22/50 (44%) | |POLY-3 ADJUSTED (b)| 2.2% 4.2% 21.9% 7.5% |2.3% 16.2% 29.0% 49.7% | |TERMINAL (d) | 0/39 (0%) 1/39 (3%) 5/27 (19%) 1/26 (4%) |0/29 (0%) 2/31 (7%) 7/33 (21%) 21/36 (58%) | |FIRST INCIDENCE | 459 621 457 312 |565 534 397 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.092 P=0.512 P=0.003 ** P=0.245 |P<0.001 ** P=0.038 * P=0.002 ** P<0.001 ** | |POLY 3 | P=0.109 P=0.514 P=0.004 ** P=0.257 |P<0.001 ** P=0.029 * P<0.001 ** P<0.001 ** | |POLY 1.5 | P=0.126 P=0.509 P=0.005 ** P=0.267 |P<0.001 ** P=0.028 * P<0.001 ** P<0.001 ** | |POLY 6 | P=0.092 P=0.518 P=0.003 ** P=0.245 |P<0.001 ** P=0.031 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.278 P=0.266 P=0.012 * P=0.453 |P<0.001 ** P=0.035 * P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P=0.176 P=0.500 P=0.007 ** P=0.293 |P<0.001 ** P=0.030 * P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 38 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 7/50 (14%) 16/49 (33%) 21/48 (44%) |6/50 (12%) 27/50 (54%) 42/49 (86%) 44/50 (88%) | |POLY-3 ADJUSTED (b)| 2.2% 14.7% 36.2% 50.9% |13.6% 58.3% 88.7% 90.5% | |TERMINAL (d) | 0/39 (0%) 5/39 (13%) 5/27 (19%) 17/26 (65%) |4/29 (14%) 15/31 (48%) 29/33 (88%) 33/36 (92%) | |FIRST INCIDENCE | 459 621 457 312 |565 372 397 437 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.039 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.035 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.033 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.036 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.030 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/46 (2%) 2/47 (4%) |0/48 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 2.1% 2.6% 5.3% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 1/39 (3%) 1/27 (4%) 1/26 (4%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 702 |--- 592 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.220 P=0.762 P=0.678 P=0.369 |P=0.561N P=0.505 (e) (e) | |POLY 3 | P=0.289 P=0.750N P=0.726 P=0.442 |P=0.570N P=0.502 (e) (e) | |POLY 1.5 | P=0.301 P=0.753N P=0.734 P=0.452 |P=0.570N P=0.503 (e) (e) | |POLY 6 | P=0.276 P=0.747N P=0.713 P=0.430 |P=0.568N P=0.503 (e) (e) | |LOGISTIC REGRESSION| P=0.250 P=0.762 P=0.678 P=0.419 |P=0.581N P=0.563 (e) (e) | |COCH-ARM / FISHERS | P=0.328 P=0.753N P=0.731 P=0.477 |P=0.566N P=0.510 (e) (e) | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 39 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/46 (4%) 0/47 (0%) |1/48 (2%) 1/50 (2%) 1/49 (2%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 5.0% 0.0% |2.4% 2.4% 2.3% 2.3% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 0/26 (0%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- 707 502 --- |586 534 537 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.639 P=0.505 P=0.230 (e) |P=0.629N P=0.753 P=0.748 P=0.752N | |POLY 3 | P=0.609 P=0.510 P=0.210 (e) |P=0.625N P=0.761N P=0.760N P=0.754N | |POLY 1.5 | P=0.627 P=0.507 P=0.215 (e) |P=0.627N P=0.759N P=0.760 P=0.755N | |POLY 6 | P=0.589 P=0.513 P=0.203 (e) |P=0.623N P=0.761N P=0.757N P=0.752N | |LOGISTIC REGRESSION| P=0.473N P=0.502 P=0.197 (e) |P=0.624 P=0.677N P=0.699N P=0.757 | |COCH-ARM / FISHERS | P=0.634N P=0.500 P=0.227 (e) |P=0.631N P=0.742N P=0.747N P=0.747N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 4/46 (9%) 1/47 (2%) |1/48 (2%) 0/50 (0%) 1/49 (2%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 10.0% 2.6% |2.4% 0.0% 2.4% 2.3% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 1/27 (4%) 1/26 (4%) |1/29 (3%) 0/31 (0%) 1/33 (3%) 1/36 (3%) | |FIRST INCIDENCE | --- --- 537 729 (T) |731 (T) --- 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.180 (e) P=0.045 * P=0.419 |P=0.593 P=0.487N P=0.733N P=0.713N | |POLY 3 | P=0.164 (e) P=0.046 * P=0.466 |P=0.556 P=0.500N P=0.761 P=0.752N | |POLY 1.5 | P=0.180 (e) P=0.048 * P=0.472 |P=0.551 P=0.499N P=0.760 P=0.753N | |POLY 6 | P=0.148 (e) P=0.043 * P=0.459 |P=0.559 P=0.500N P=0.758N P=0.749N | |LOGISTIC REGRESSION| P=0.304 (e) P=0.060 P=0.419 |P=0.593 (e) P=0.733N P=0.713N | |COCH-ARM / FISHERS | P=0.226 (e) P=0.049 * P=0.485 |P=0.542 P=0.490N P=0.747N P=0.747N | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 40 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Testes | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 4/50 (8%) 6/49 (12%) 4/50 (8%) | | |POLY-3 ADJUSTED (b)| 11.0% 8.4% 14.7% 9.8% | | |TERMINAL (d) | 3/39 (8%) 2/39 (5%) 3/27 (11%) 2/26 (8%) | | |FIRST INCIDENCE | 667 611 583 73 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.435 P=0.470N P=0.313 P=0.601 | | |POLY 3 | P=0.541 P=0.468N P=0.427 P=0.568N | | |POLY 1.5 | P=0.547N P=0.479N P=0.453 P=0.543N | | |POLY 6 | P=0.495 P=0.460N P=0.389 P=0.599N | | |LOGISTIC REGRESSION| P=0.369N P=0.529N P=0.479 P=0.411N | | |COCH-ARM / FISHERS | P=0.485N P=0.500N P=0.486 P=0.500N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Testes | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/49 (6%) 0/50 (0%) | | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 7.5% 0.0% | | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 2/27 (7%) 0/26 (0%) | | |FIRST INCIDENCE | --- --- 585 --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.453 (e) P=0.076 (e) | | |POLY 3 | P=0.451 (e) P=0.099 (e) | | |POLY 1.5 | P=0.477 (e) P=0.106 (e) | | |POLY 6 | P=0.424 (e) P=0.090 (e) | | |LOGISTIC REGRESSION| P=0.542 (e) P=0.115 (e) | | |COCH-ARM / FISHERS | P=0.538 (e) P=0.117 (e) | | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 41 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/43 (2%) 1/43 (2%) 1/36 (3%) 1/37 (3%) |1/46 (2%) 2/41 (5%) 0/46 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 2.5% 2.4% 3.4% 3.3% |2.5% 5.5% 0.0% 0.0% | |TERMINAL (d) | 0/36 (0%) 0/35 (0%) 0/20 (0%) 0/20 (0%) |0/27 (0%) 0/28 (0%) 0/32 (0%) 0/35 (0%) | |FIRST INCIDENCE | 642 611 704 623 |645 647 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.561 P=0.741N P=0.704 P=0.730 |P=0.180N P=0.505 P=0.500N P=0.485N | |POLY 3 | P=0.530 P=0.752N P=0.690 P=0.696 |P=0.177N P=0.460 P=0.502N P=0.491N | |POLY 1.5 | P=0.546 P=0.754N P=0.705 P=0.705 |P=0.178N P=0.458 P=0.503N P=0.491N | |POLY 6 | P=0.511 P=0.751N P=0.669 P=0.684 |P=0.174N P=0.469 P=0.497N P=0.489N | |LOGISTIC REGRESSION| P=0.613N P=0.677 P=0.738 P=0.772N |P=0.177N P=0.468 P=0.485N P=0.494N | |COCH-ARM / FISHERS | P=0.584 P=0.753N P=0.707 P=0.714 |P=0.178N P=0.456 P=0.500N P=0.489N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/43 (0%) 0/43 (0%) 0/36 (0%) 0/37 (0%) |1/46 (2%) 2/41 (5%) 1/46 (2%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.5% 5.6% 2.5% 0.0% | |TERMINAL (d) | 0/36 (0%) 0/35 (0%) 0/20 (0%) 0/20 (0%) |1/27 (4%) 2/28 (7%) 1/32 (3%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |731 (T) 731 (T) 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.190N P=0.513 P=0.724N P=0.448N | |POLY 3 | (e) (e) (e) (e) |P=0.229N P=0.459 P=0.761 P=0.489N | |POLY 1.5 | (e) (e) (e) (e) |P=0.231N P=0.457 P=0.758 P=0.490N | |POLY 6 | (e) (e) (e) (e) |P=0.225N P=0.467 P=0.755N P=0.486N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.190N P=0.513 P=0.724N (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.232N P=0.456 P=0.753N P=0.489N | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 42 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 8/48 (17%) 6/49 (12%) 5/50 (10%) |11/50 (22%) 8/50 (16%) 11/50 (22%) 11/49 (22%) | |POLY-3 ADJUSTED (b)| 11.1% 17.5% 14.9% 12.6% |25.5% 19.1% 26.1% 25.6% | |TERMINAL (d) | 5/39 (13%) 6/38 (16%) 4/27 (15%) 3/26 (12%) |9/29 (31%) 8/31 (26%) 9/33 (27%) 11/35 (31%) | |FIRST INCIDENCE | 729 (T) 656 618 684 |689 731 (T) 698 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.368 P=0.271 P=0.273 P=0.390 |P=0.467N P=0.249N P=0.472N P=0.404N | |POLY 3 | P=0.554N P=0.286 P=0.424 P=0.552 |P=0.446 P=0.327N P=0.573 P=0.594 | |POLY 1.5 | P=0.514N P=0.273 P=0.451 P=0.576 |P=0.436 P=0.326N P=0.563 P=0.585 | |POLY 6 | P=0.510 P=0.299 P=0.386 P=0.524 |P=0.459 P=0.318N P=0.596N P=0.590N | |LOGISTIC REGRESSION| P=0.521 P=0.289 P=0.375 P=0.483 |P=0.500 P=0.292N P=0.554N P=0.544N | |COCH-ARM / FISHERS | P=0.433N P=0.250 P=0.486 P=0.630N |P=0.419 P=0.306N P=0.595N P=0.574 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Tooth | | Malformation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 4/4 (100%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 100.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 3/3 (100%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 707 --- --- |--- --- --- --- | |-------------------| | | |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: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 43 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Urinary Bladder | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 5/46 (11%) 4/45 (9%) |1/47 (2%) 1/49 (2%) 0/48 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.2% 12.3% 10.6% |2.4% 2.4% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 1/39 (3%) 0/27 (0%) 2/26 (8%) |0/29 (0%) 1/31 (3%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- 707 537 623 |611 731 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.026 * P=0.243 P=0.027 * P=0.037 * |P=0.217N P=0.756N P=0.505N P=0.486N | |POLY 3 | P=0.025 * P=0.249 P=0.023 * P=0.041 * |P=0.229N P=0.759 P=0.501N P=0.488N | |POLY 1.5 | P=0.028 * P=0.245 P=0.023 * P=0.042 * |P=0.230N P=0.760N P=0.501N P=0.488N | |POLY 6 | P=0.023 * P=0.252 P=0.021 * P=0.039 * |P=0.229N P=0.758 P=0.498N P=0.487N | |LOGISTIC REGRESSION| P=0.060 P=0.249 P=0.028 * P=0.047 * |P=0.228N P=0.750N P=0.462N P=0.496N | |COCH-ARM / FISHERS | P=0.037 * P=0.247 P=0.022 * P=0.047 * |P=0.228N P=0.742N P=0.495N P=0.485N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Urinary Bladder: Transitional Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/46 (2%) 1/45 (2%) |0/47 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.2% 2.6% 2.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 1/39 (3%) 0/27 (0%) 0/26 (0%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- 681 537 623 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.425 P=0.253 P=0.487 P=0.481 |(e) (e) (e) (e) | |POLY 3 | P=0.430 P=0.249 P=0.472 P=0.465 |(e) (e) (e) (e) | |POLY 1.5 | P=0.440 P=0.245 P=0.478 P=0.468 |(e) (e) (e) (e) | |POLY 6 | P=0.419 P=0.252 P=0.464 P=0.460 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.547 P=0.235 P=0.473 P=0.515 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.465 P=0.247 P=0.479 P=0.474 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 44 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Urinary Bladder: Transitional Epithelium | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/46 (9%) 2/45 (4%) |0/47 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 9.9% 5.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 2/26 (8%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- 707 537 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.102 P=0.505 P=0.050 P=0.154 |(e) (e) (e) (e) | |POLY 3 | P=0.102 P=0.510 P=0.047 * P=0.197 |(e) (e) (e) (e) | |POLY 1.5 | P=0.110 P=0.507 P=0.048 * P=0.202 |(e) (e) (e) (e) | |POLY 6 | P=0.092 P=0.513 P=0.044 * P=0.191 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.182 P=0.502 P=0.058 P=0.154 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.135 P=0.500 P=0.049 * P=0.222 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 3/50 (6%) 1/49 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| |4.6% 7.2% 2.4% 0.0% | |TERMINAL (d) | |1/29 (3%) 2/31 (7%) 1/33 (3%) 0/36 (0%) | |FIRST INCIDENCE | |725 723 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.078N P=0.521 P=0.463N P=0.201N | |POLY 3 | |P=0.100N P=0.488 P=0.509N P=0.232N | |POLY 1.5 | |P=0.102N P=0.489 P=0.513N P=0.234N | |POLY 6 | |P=0.097N P=0.494 P=0.500N P=0.228N | |LOGISTIC REGRESSION| |P=0.089N P=0.502 P=0.477N P=0.220N | |COCH-ARM / FISHERS | |P=0.105N P=0.500 P=0.508N P=0.247N | |=================================================================================================================================| Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 45 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 2/50 (4%) 1/49 (2%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| |4.6% 4.8% 2.4% 6.8% | |TERMINAL (d) | |2/29 (7%) 1/31 (3%) 1/33 (3%) 3/36 (8%) | |FIRST INCIDENCE | |731 (T) 712 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.485 P=0.676N P=0.455N P=0.599 | |POLY 3 | |P=0.415 P=0.686 P=0.509N P=0.511 | |POLY 1.5 | |P=0.410 P=0.685 P=0.512N P=0.506 | |POLY 6 | |P=0.421 P=0.691 P=0.500N P=0.519 | |LOGISTIC REGRESSION| |P=0.440 P=0.695N P=0.455N P=0.599 | |COCH-ARM / FISHERS | |P=0.403 P=0.691N P=0.508N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 0/50 (0%) 2/49 (4%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| |4.6% 0.0% 4.7% 13.5% | |TERMINAL (d) | |1/29 (3%) 0/31 (0%) 1/33 (3%) 5/36 (14%) | |FIRST INCIDENCE | |572 --- 572 582 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.032 * P=0.240N P=0.686N P=0.197 | |POLY 3 | |P=0.019 * P=0.246N P=0.685 P=0.139 | |POLY 1.5 | |P=0.019 * P=0.244N P=0.681 P=0.137 | |POLY 6 | |P=0.020 * P=0.244N P=0.694N P=0.144 | |LOGISTIC REGRESSION| |P=0.019 * P=0.222N P=0.686N P=0.135 | |COCH-ARM / FISHERS | |P=0.019 * P=0.247N P=0.684 P=0.134 | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Poly-3 adjusted lifetime tumor incidence. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).