TDMS Study 05201-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 04/25/97 EXPERIMENT: 05201 TEST: 05 TIME: 18:43:54 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: GRUMBEIN, S. CAS: 0098-00-0000 Rats(FISCHER344) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 04/25/97 EXPERIMENT: 05201 TEST: 05 TIME: 18:43:54 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: GRUMBEIN, S. CAS: 0098-00-0000 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF FURFURYL ALCOHOL =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Adrenal Cortex Hyperplasia Hypertrophy Vacuolization Cytoplasmic Adrenal Medulla Hyperplasia Blood Vessel: Aorta Mineralization Bone Fibrous Osteodystrophy Hyperostosis Heart Cardiomyopathy Heart: Artery Mineralization Heart: Atrium Thrombosis Intestine Large, Cecum Parasite Metazoan Intestine Large, Colon Mineralization Intestine Large, Rectum Mineralization Islets, Pancreatic Hyperplasia Kidney Cyst Mineralization Nephropathy Kidney: Renal Tubule Hyperplasia Liver Angiectasis Basophilic Focus Clear Cell Focus Degeneration Cystic Eosinophilic Focus Hepatodiaphragmatic Nodule Necrosis Liver: Bile Duct Hyperplasia Liver: Centrilobular Necrosis Lung Mineralization Lung: Alveolar Epithelium Hyperplasia Lung: Artery, Mediastinum Mineralization Lymph Node, Mediastinal Hemorrhage Lymph Node: Renal Ectasia Hemorrhage Mammary Gland Galactocele Mesentery: Artery Inflammation Chronic Mineralization Mesentery: Fat Necrosis Nose Inflammation Thrombosis Nose: Glands Hyperplasia Nose: Lateral Wall Hyperplasia Metaplasia Nose: Olfactory Epithelium Atrophy NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 04/25/97 EXPERIMENT: 05201 TEST: 05 TIME: 18:43:54 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: GRUMBEIN, S. CAS: 0098-00-0000 Degeneration Hyaline Fibrosis Hyperplasia Metaplasia Nose: Respiratory Epithelium Degeneration Hyaline Hyperplasia Metaplasia Pancreas Atrophy Hyperplasia Pancreas: Artery Inflammation Mineralization Parathyroid Gland Hyperplasia Pituitary Gland: Pars Distalis Hyperplasia Preputial Gland Inflammation Chronic Prostate Hyperplasia Seminal Vesicle Mineralization Skin: Tail Inflammation Chronic Spleen Fibrosis Hematopoietic Cell Proliferation Hemorrhage Stomach, Forestomach Mineralization Stomach, Glandular Mineralization Testes Atrophy Testes: Artery Inflammation Chronic Thyroid Gland: C-Cell Hyperplasia =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Cortex Hyperplasia Vacuolization Cytoplasmic Adrenal Medulla Hyperplasia Heart Cardiomyopathy Kidney Nephropathy Kidney: Renal Tubule Hyperplasia Liver Basophilic Focus Degeneration Fatty Nose Inflammation Nose: Glands Hyperplasia Nose: Lateral Wall Hyperplasia Metaplasia Nose: Olfactory Epithelium Atrophy Degeneration Hyaline Fibrosis Hyperplasia Metaplasia Nose: Respiratory Epithelium Degeneration Hyaline Hyperplasia Metaplasia Skin: Tail Inflammation Chronic Stomach, Forestomach Necrosis Stomach, Glandular Necrosis NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 04/25/97 EXPERIMENT: 05201 TEST: 05 TIME: 18:43:54 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: GRUMBEIN, S. CAS: 0098-00-0000 Thyroid Gland: C-Cell Hyperplasia =============================================================== Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 19/50 (38%) 20/50 (40%) 24/50 (48%) |19/50 (38%) 22/50 (44%) 21/48 (44%) 23/50 (46%) | |POLY-3 ADJUSTED (b)| 42.1% 51.3% 53.9% 64.5% |45.3% 49.5% 50.2% 57.6% | |TERMINAL (d) | 4/8 (50%) 3/5 (60%) 8/9 (89%) 0/0 (0%) |15/26 (58%) 14/26 (54%) 13/22 (59%) 11/16 (69%) | |FIRST INCIDENCE | 581 477 519 421 |478 535 547 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.139 P=0.294 P<0.001 ** |P=0.013 * P=0.376 P=0.244 P=0.019 * | |POLY 3 | P=0.038 * P=0.278 P=0.203 P=0.030 * |P=0.172 P=0.431 P=0.406 P=0.176 | |POLY 1.5 | P=0.052 P=0.283 P=0.213 P=0.042 * |P=0.232 P=0.400 P=0.399 P=0.219 | |POLY 6 | P=0.016 * P=0.253 P=0.173 P=0.011 * |P=0.115 P=0.485 P=0.404 P=0.133 | |LOGISTIC REGRESSION| P=0.009 ** P=0.224 P=0.206 P=0.014 * |P=0.162 P=0.393 P=0.368 P=0.135 | |COCH-ARM / FISHERS | P=0.062 P=0.263 P=0.201 P=0.050 |P=0.322 P=0.342 P=0.354 P=0.272 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 4/50 (8%) |2/50 (4%) 4/50 (8%) 6/48 (13%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 9.2% 9.3% 3.0% 13.8% |4.9% 9.5% 14.9% 5.4% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 0/9 (0%) 0/0 (0%) |1/26 (4%) 3/26 (12%) 4/22 (18%) 2/16 (13%) | |FIRST INCIDENCE | 681 601 616 583 |652 637 522 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.044 * P=0.556 P=0.305N P=0.070 |P=0.591N P=0.353 P=0.109 P=0.547 | |POLY 3 | P=0.306 P=0.661 P=0.291N P=0.435 |P=0.441N P=0.355 P=0.128 P=0.664 | |POLY 1.5 | P=0.337 P=0.662N P=0.295N P=0.475 |P=0.407N P=0.350 P=0.129 P=0.679 | |POLY 6 | P=0.246 P=0.643 P=0.289N P=0.339 |P=0.490N P=0.361 P=0.123 P=0.640 | |LOGISTIC REGRESSION| P=0.223 P=0.606 P=0.294N P=0.328 |P=0.415N P=0.355 P=0.122 P=0.638 | |COCH-ARM / FISHERS | P=0.362 P=0.661N P=0.309N P=0.500 |P=0.370N P=0.339 P=0.121 P=0.691N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |4/50 (8%) 1/50 (2%) 0/48 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.9% 3.6% |9.7% 2.4% 0.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- 635 638 |604 679 --- 632 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.171 (e) P=0.262 P=0.362 |P=0.357N P=0.165N P=0.075N P=0.238N | |POLY 3 | P=0.354 (e) P=0.245 P=0.469 |P=0.311N P=0.172N P=0.066N P=0.207N | |POLY 1.5 | P=0.392 (e) P=0.243 P=0.487 |P=0.303N P=0.173N P=0.064N P=0.192N | |POLY 6 | P=0.267 (e) P=0.248 P=0.425 |P=0.321N P=0.172N P=0.072N P=0.229N | |LOGISTIC REGRESSION| P=0.343 (e) P=0.243 P=0.462 |P=0.283N P=0.182N P=0.069N P=0.178N | |COCH-ARM / FISHERS | P=0.419 (e) P=0.247 P=0.500 |P=0.290N P=0.181N P=0.064N P=0.181N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 4/50 (8%) 8/50 (16%) |5/50 (10%) 3/50 (6%) 3/48 (6%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 12.1% 9.3% 11.8% 26.5% |12.3% 7.1% 7.6% 20.4% | |TERMINAL (d) | 2/8 (25%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |3/26 (12%) 2/26 (8%) 2/22 (9%) 1/16 (6%) | |FIRST INCIDENCE | 599 644 666 606 |573 651 623 518 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.634N P=0.602N P=0.002 ** |P=0.024 * P=0.352N P=0.432N P=0.150 | |POLY 3 | P=0.035 * P=0.510N P=0.632N P=0.121 |P=0.064 P=0.339N P=0.375N P=0.246 | |POLY 1.5 | P=0.047 * P=0.500N P=0.632N P=0.153 |P=0.071 P=0.343N P=0.371N P=0.261 | |POLY 6 | P=0.019 * P=0.535N P=0.636N P=0.067 |P=0.057 P=0.333N P=0.388N P=0.229 | |LOGISTIC REGRESSION| P=0.007 ** P=0.546N P=0.633N P=0.049 * |P=0.069 P=0.337N P=0.373N P=0.260 | |COCH-ARM / FISHERS | P=0.059 P=0.500N P=0.643N P=0.178 |P=0.082 P=0.357N P=0.381N P=0.277 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/50 (60%) 17/50 (34%) 24/50 (48%) 19/50 (38%) |12/50 (24%) 7/50 (14%) 10/48 (21%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 70.8% 45.8% 61.9% 52.4% |28.8% 16.5% 24.5% 35.8% | |TERMINAL (d) | 6/8 (75%) 1/5 (20%) 8/9 (89%) 0/0 (0%) |7/26 (27%) 4/26 (15%) 3/22 (14%) 7/16 (44%) | |FIRST INCIDENCE | 382 560 483 472 |581 581 547 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.035 * P=0.088N P=0.173N P=0.210 |P=0.021 * P=0.158N P=0.520N P=0.121 | |POLY 3 | P=0.197N P=0.012N* P=0.249N P=0.052N |P=0.093 P=0.137N P=0.423N P=0.329 | |POLY 1.5 | P=0.149N P=0.008N** P=0.183N P=0.028N* |P=0.115 P=0.140N P=0.421N P=0.371 | |POLY 6 | P=0.382N P=0.027N* P=0.412N P=0.173N |P=0.068 P=0.137N P=0.435N P=0.271 | |LOGISTIC REGRESSION| P=0.218N P=0.007N** P=0.123N P=0.028N* |P=0.097 P=0.132N P=0.433N P=0.323 | |COCH-ARM / FISHERS | P=0.135N P=0.008N** P=0.158N P=0.022N* |P=0.149 P=0.154N P=0.447N P=0.410 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Blood Vessel: Aorta | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/2 (100%) 2/2 (100%) 2/3 (67%) 31/31 (100%)|0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 74.7% 100.0% |0.0% 100.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 686 637 692 555 |--- 679 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.466N (e) |(e) (e) (e) (e) | |POLY 3 | P=0.460 (e) P=0.712N (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.334 (e) P=0.640N (e) |(e) (e) (e) (e) | |POLY 6 | P=0.756 (e) P=0.863N (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.254 (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.263 (e) P=0.600N (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Bone | | Fibrous Osteodystrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 6/50 (12%) 34/50 (68%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 6.1% 15.5% 17.6% 84.9% |0.0% 2.4% 0.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | 665 637 635 555 |--- 679 --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.146 P=0.190 P<0.001 ** |P=0.398 P=0.518 (e) P=0.403 | |POLY 3 | P<0.001 ** P=0.204 P=0.140 P<0.001 ** |P=0.459 P=0.509 (e) P=0.484 | |POLY 1.5 | P<0.001 ** P=0.214 P=0.140 P<0.001 ** |P=0.468 P=0.506 (e) P=0.492 | |POLY 6 | P<0.001 ** P=0.182 P=0.139 P<0.001 ** |P=0.445 P=0.512 (e) P=0.473 | |LOGISTIC REGRESSION| P<0.001 ** P=0.151 P=0.136 P<0.001 ** |P=0.446 P=0.501 (e) P=0.403 | |COCH-ARM / FISHERS | P<0.001 ** P=0.218 P=0.134 P<0.001 ** |P=0.478 P=0.500 (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Bone | | Hyperostosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 5/50 (10%) 1/50 (2%) 0/50 (0%) |8/50 (16%) 14/50 (28%) 12/49 (24%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 0.0% 15.0% 3.0% 0.0% |19.4% 32.5% 28.2% 15.8% | |TERMINAL (d) | 0/8 (0%) 1/5 (20%) 0/9 (0%) 0/0 (0%) |6/26 (23%) 8/26 (31%) 2/22 (9%) 2/16 (13%) | |FIRST INCIDENCE | --- 581 693 --- |581 506 518 597 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.327N P=0.027 * P=0.513 (e) |P=0.348N P=0.132 P=0.186 P=0.576 | |POLY 3 | P=0.170N P=0.030 * P=0.507 (e) |P=0.151N P=0.129 P=0.244 P=0.446N | |POLY 1.5 | P=0.149N P=0.031 * P=0.505 (e) |P=0.125N P=0.125 P=0.237 P=0.416N | |POLY 6 | P=0.223N P=0.028 * P=0.507 (e) |P=0.189N P=0.136 P=0.251 P=0.485N | |LOGISTIC REGRESSION| P=0.177N P=0.032 * P=0.506 (e) |P=0.130N P=0.130 P=0.216 P=0.445N | |COCH-ARM / FISHERS | P=0.142N P=0.028 * P=0.500 (e) |P=0.100N P=0.114 P=0.212 P=0.387N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |2/49 (4%) 1/48 (2%) 1/48 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |5.1% 2.4% 2.6% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |2/26 (8%) 0/26 (0%) 1/22 (5%) 0/16 (0%) | |FIRST INCIDENCE | --- --- --- --- |735 (T) 651 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.297N P=0.487N P=0.559N P=0.350N | |POLY 3 | (e) (e) (e) (e) |P=0.233N P=0.485N P=0.502N P=0.249N | |POLY 1.5 | (e) (e) (e) (e) |P=0.223N P=0.492N P=0.500N P=0.240N | |POLY 6 | (e) (e) (e) (e) |P=0.247N P=0.475N P=0.509N P=0.261N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.242N P=0.486N P=0.559N (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.209N P=0.508N P=0.508N P=0.242N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |0/49 (0%) 0/48 (0%) 0/48 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 6.3% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 1/5 (20%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- 691 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.892N P=0.175 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.418N P=0.232 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.404N P=0.237 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.442N P=0.221 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.710N P=0.193 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.394N P=0.247 (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Brain | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 6.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- 616 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.591N P=0.224 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.414N P=0.235 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.400N P=0.238 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.436N P=0.227 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.433N P=0.232 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.390N P=0.247 (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/44 (2%) 5/45 (11%) 2/46 (4%) 1/45 (2%) | |POLY-3 ADJUSTED (b)| |2.8% 13.1% 5.4% 3.0% | |TERMINAL (d) | |1/24 (4%) 3/23 (13%) 2/21 (10%) 1/14 (7%) | |FIRST INCIDENCE | |735 (T) 651 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.445N P=0.104 P=0.453 P=0.638 | |POLY 3 | |P=0.283N P=0.118 P=0.520 P=0.748 | |POLY 1.5 | |P=0.267N P=0.115 P=0.523 P=0.757 | |POLY 6 | |P=0.309N P=0.122 P=0.510 P=0.733 | |LOGISTIC REGRESSION| |P=0.360N P=0.121 P=0.453 P=0.638 | |COCH-ARM / FISHERS | |P=0.252N P=0.107 P=0.517 P=0.747N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |2/44 (5%) 3/45 (7%) 1/46 (2%) 0/45 (0%) | |POLY-3 ADJUSTED (b)| |5.5% 7.9% 2.7% 0.0% | |TERMINAL (d) | |0/24 (0%) 2/23 (9%) 1/21 (5%) 0/14 (0%) | |FIRST INCIDENCE | |98 676 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.173N P=0.511 P=0.539N P=0.269N | |POLY 3 | |P=0.131N P=0.521 P=0.491N P=0.257N | |POLY 1.5 | |P=0.123N P=0.516 P=0.486N P=0.246N | |POLY 6 | |P=0.143N P=0.527 P=0.504N P=0.274N | |LOGISTIC REGRESSION| |P=0.100N P=0.414 P=0.667N P=0.278N | |COCH-ARM / FISHERS | |P=0.112N P=0.511 P=0.483N P=0.242N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Eye | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 2/3 (67%) 0/1 (0%) 1/3 (33%) |0/1 (0%) 0/0 (0%) 0/1 (0%) 0/1 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 82.3% 0.0% 66.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/1 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 477 --- 638 |--- --- --- --- | |-------------------| | | |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: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 38/50 (76%) 32/50 (64%) 40/50 (80%) 42/50 (84%) |29/50 (58%) 24/50 (48%) 23/49 (47%) 19/50 (38%) | |POLY-3 ADJUSTED (b)| 87.9% 77.8% 88.4% 94.0% |67.4% 53.8% 54.4% 49.3% | |TERMINAL (d) | 8/8 (100%) 5/5 (100%) 9/9 (100%) 0/0 (0%) |20/26 (77%) 16/26 (62%) 15/22 (68%) 12/16 (75%) | |FIRST INCIDENCE | 351 477 473 476 |581 506 589 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.525N P=0.531 P<0.001 ** |P=0.479 P=0.209N P=0.369N P=0.513N | |POLY 3 | P=0.035 * P=0.120N P=0.621 P=0.205 |P=0.137N P=0.128N P=0.141N P=0.061N | |POLY 1.5 | P=0.041 * P=0.109N P=0.542 P=0.217 |P=0.088N P=0.149N P=0.143N P=0.042N* | |POLY 6 | P=0.040 * P=0.197N P=0.711 P=0.213 |P=0.246N P=0.109N P=0.159N P=0.114N | |LOGISTIC REGRESSION| P=0.019 * P=0.102N P=0.521 P=0.155 |P=0.136N P=0.150N P=0.156N P=0.077N | |COCH-ARM / FISHERS | P=0.060 P=0.138N P=0.405 P=0.227 |P=0.052N P=0.212N P=0.184N P=0.036N* | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Heart: Artery | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 29/50 (58%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 6.1% 6.2% 6.0% 76.5% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 686 637 692 555 |--- 679 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.621 P=0.646N P<0.001 ** |P=0.645N P=0.518 (e) (e) | |POLY 3 | P<0.001 ** P=0.692 P=0.687N P<0.001 ** |P=0.608N P=0.509 (e) (e) | |POLY 1.5 | P<0.001 ** P=0.694N P=0.687N P<0.001 ** |P=0.607N P=0.506 (e) (e) | |POLY 6 | P<0.001 ** P=0.678 P=0.691N P<0.001 ** |P=0.607N P=0.512 (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** P=0.656 P=0.686N P<0.001 ** |P=0.613N P=0.501 (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.691N P=0.691N P<0.001 ** |P=0.608N P=0.500 (e) (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Heart: Atrium | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 6/50 (12%) 1/50 (2%) 3/50 (6%) |3/50 (6%) 3/50 (6%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 9.1% 18.1% 3.0% 10.5% |7.4% 7.1% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 684 490 616 521 |693 693 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.171 P=0.172 P=0.298N P=0.037 * |P=0.110N P=0.640N P=0.156N P=0.177N | |POLY 3 | P=0.494N P=0.239 P=0.294N P=0.599 |P=0.079N P=0.646N P=0.121N P=0.134N | |POLY 1.5 | P=0.454N P=0.246 P=0.296N P=0.639 |P=0.076N P=0.650N P=0.120N P=0.126N | |POLY 6 | P=0.576N P=0.220 P=0.295N P=0.495 |P=0.085N P=0.641N P=0.127N P=0.147N | |LOGISTIC REGRESSION| P=0.545N P=0.214 P=0.295N P=0.535 |P=0.083N P=0.646N P=0.123N P=0.138N | |COCH-ARM / FISHERS | P=0.424N P=0.243 P=0.309N P=0.661N |P=0.072N P=0.661N P=0.125N P=0.121N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Cecum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/46 (4%) 2/49 (4%) 8/44 (18%) 4/45 (9%) |5/49 (10%) 4/47 (9%) 8/46 (17%) 4/48 (8%) | |POLY-3 ADJUSTED (b)| 6.7% 6.3% 25.3% 14.9% |12.7% 10.0% 20.7% 10.7% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 4/9 (44%) 0/0 (0%) |4/26 (15%) 3/26 (12%) 6/22 (27%) 3/16 (19%) | |FIRST INCIDENCE | 685 477 473 497 |707 721 546 302 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.039 * P=0.633 P=0.056 P=0.082 |P=0.427 P=0.490N P=0.185 P=0.528 | |POLY 3 | P=0.267 P=0.672N P=0.047 * P=0.284 |P=0.488N P=0.486N P=0.261 P=0.530N | |POLY 1.5 | P=0.311 P=0.667N P=0.044 * P=0.312 |P=0.459N P=0.499N P=0.257 P=0.516N | |POLY 6 | P=0.171 P=0.687N P=0.051 P=0.216 |P=0.537N P=0.469N P=0.259 P=0.557N | |LOGISTIC REGRESSION| P=0.307 P=0.677N P=0.044 * P=0.313 |P=0.502N P=0.447N P=0.244 P=0.529N | |COCH-ARM / FISHERS | P=0.343 P=0.667N P=0.038 * P=0.328 |P=0.437N P=0.527N P=0.236 P=0.513N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Colon | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/48 (2%) 9/47 (19%) |0/50 (0%) 0/47 (0%) 0/48 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 3.1% 30.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/25 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- 730 580 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.545 P<0.001 ** |(e) (e) (e) (e) | |POLY 3 | P<0.001 ** (e) P=0.504 P<0.001 ** |(e) (e) (e) (e) | |POLY 1.5 | P<0.001 ** (e) P=0.502 P<0.001 ** |(e) (e) (e) (e) | |POLY 6 | P<0.001 ** (e) P=0.504 P<0.001 ** |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.521 P<0.001 ** |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.495 P<0.001 ** |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Colon | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 4/50 (8%) 6/48 (13%) 5/47 (11%) |2/50 (4%) 3/47 (6%) 2/48 (4%) 3/48 (6%) | |POLY-3 ADJUSTED (b)| 9.2% 11.9% 17.2% 17.6% |5.0% 7.6% 5.1% 8.1% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |2/26 (8%) 2/25 (8%) 2/22 (9%) 1/16 (6%) | |FIRST INCIDENCE | 591 399 492 497 |735 (T) 693 735 (T) 599 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.087 P=0.432 P=0.268 P=0.086 |P=0.287 P=0.488 P=0.635 P=0.326 | |POLY 3 | P=0.270 P=0.516 P=0.271 P=0.276 |P=0.453 P=0.494 P=0.687 P=0.463 | |POLY 1.5 | P=0.316 P=0.520 P=0.257 P=0.312 |P=0.468 P=0.487 P=0.688 P=0.474 | |POLY 6 | P=0.182 P=0.504 P=0.290 P=0.198 |P=0.430 P=0.505 P=0.681 P=0.446 | |LOGISTIC REGRESSION| P=0.368 P=0.510 P=0.239 P=0.314 |P=0.400 P=0.510 P=0.635 P=0.439 | |COCH-ARM / FISHERS | P=0.351 P=0.511 P=0.233 P=0.334 |P=0.483 P=0.470 P=0.676 P=0.480 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Rectum | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/47 (0%) 0/50 (0%) 0/48 (0%) 2/47 (4%) |0/50 (0%) 0/47 (0%) 0/47 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 7.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- --- 522 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.015 * (e) (e) P=0.135 |(e) (e) (e) (e) | |POLY 3 | P=0.032 * (e) (e) P=0.208 |(e) (e) (e) (e) | |POLY 1.5 | P=0.036 * (e) (e) P=0.226 |(e) (e) (e) (e) | |POLY 6 | P=0.026 * (e) (e) P=0.169 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.046 * (e) (e) P=0.244 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.040 * (e) (e) P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/47 (2%) 3/50 (6%) 4/48 (8%) 1/47 (2%) |4/50 (8%) 3/47 (6%) 3/47 (6%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 3.3% 9.0% 12.0% 3.8% |10.0% 7.5% 7.8% 8.2% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 1/9 (11%) 0/0 (0%) |4/26 (15%) 2/26 (8%) 3/22 (14%) 2/16 (13%) | |FIRST INCIDENCE | 735 (T) 399 585 610 |735 (T) 547 735 (T) 733 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.556 P=0.231 P=0.212 P=0.477 |P=0.449 P=0.500N P=0.594N P=0.559 | |POLY 3 | P=0.468N P=0.335 P=0.205 P=0.729 |P=0.563N P=0.500N P=0.520N P=0.548N | |POLY 1.5 | P=0.418N P=0.336 P=0.198 P=0.749 |P=0.538N P=0.511N P=0.520N P=0.529N | |POLY 6 | P=0.583N P=0.326 P=0.214 P=0.676 |P=0.599N P=0.483N P=0.527N P=0.576N | |LOGISTIC REGRESSION| P=0.407N P=0.321 P=0.200 P=0.637 |P=0.594 P=0.505N P=0.594N (e) | |COCH-ARM / FISHERS | P=0.382N P=0.332 P=0.187 P=0.753N |P=0.506N P=0.535N P=0.535N P=0.511N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |0/49 (0%) 0/48 (0%) 2/48 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 3.7% |0.0% 0.0% 5.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 1/22 (5%) 0/16 (0%) | |FIRST INCIDENCE | --- --- --- 693 |--- --- 522 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.002 ** (e) (e) P=0.035 * |P=0.714N (e) P=0.228 (e) | |POLY 3 | P=0.202 (e) (e) P=0.465 |P=0.676N (e) P=0.240 (e) | |POLY 1.5 | P=0.215 (e) (e) P=0.484 |P=0.661N (e) P=0.239 (e) | |POLY 6 | P=0.175 (e) (e) P=0.421 |P=0.697N (e) P=0.238 (e) | |LOGISTIC REGRESSION| P=0.078 (e) (e) P=0.223 |P=0.625N (e) P=0.205 (e) | |COCH-ARM / FISHERS | P=0.224 (e) (e) P=0.495 |P=0.644N (e) P=0.242 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 4/50 (8%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 3.1% 9.4% 0.0% 13.9% |0.0% 0.0% 0.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 690 694 --- 609 |--- --- --- 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.002 ** P=0.226 P=0.488N P=0.037 * |P=0.215 (e) (e) P=0.495 | |POLY 3 | P=0.110 P=0.296 P=0.495N P=0.138 |P=0.216 (e) (e) P=0.487 | |POLY 1.5 | P=0.126 P=0.304 P=0.496N P=0.162 |P=0.223 (e) (e) P=0.493 | |POLY 6 | P=0.082 P=0.276 P=0.497N P=0.094 |P=0.208 (e) (e) P=0.477 | |LOGISTIC REGRESSION| P=0.045 * P=0.239 P=0.494N P=0.120 |P=0.245 (e) (e) P=0.504 | |COCH-ARM / FISHERS | P=0.141 P=0.309 P=0.500N P=0.181 |P=0.230 (e) (e) P=0.500 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Hydronephrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/49 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.9% 0.0% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- 666 --- |--- 428 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.721 (e) P=0.258 (e) |P=0.610N P=0.504 (e) (e) | |POLY 3 | P=0.704N (e) P=0.245 (e) |P=0.603N P=0.509 (e) (e) | |POLY 1.5 | P=0.674N (e) P=0.243 (e) |P=0.604N P=0.505 (e) (e) | |POLY 6 | P=0.679 (e) P=0.247 (e) |P=0.602N P=0.514 (e) (e) | |LOGISTIC REGRESSION| P=0.788N (e) P=0.243 (e) |P=0.634N P=0.329 (e) (e) | |COCH-ARM / FISHERS | P=0.652N (e) P=0.247 (e) |P=0.606N P=0.495 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 1/49 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 3.0% 6.1% 0.0% 3.6% |4.9% 2.4% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 1/26 (4%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 536 490 --- 521 |661 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.697 P=0.480 P=0.490N P=0.758N |P=0.267N P=0.487N P=0.270N P=0.287N | |POLY 3 | P=0.628N P=0.496 P=0.498N P=0.724 |P=0.224N P=0.494N P=0.241N P=0.257N | |POLY 1.5 | P=0.610N P=0.502 P=0.497N P=0.746 |P=0.219N P=0.497N P=0.239N P=0.247N | |POLY 6 | P=0.657N P=0.481 P=0.502N P=0.666 |P=0.230N P=0.490N P=0.248N P=0.272N | |LOGISTIC REGRESSION| P=0.570N P=0.480 P=0.551N P=0.759 |P=0.227N P=0.493N P=0.240N P=0.247N | |COCH-ARM / FISHERS | P=0.594N P=0.500 P=0.500N P=0.753N |P=0.211N P=0.508N P=0.253N P=0.247N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 28/50 (56%) |0/50 (0%) 1/49 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 6.1% 6.2% 6.0% 74.7% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 686 637 692 555 |--- 679 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.621 P=0.646N P<0.001 ** |P=0.645N P=0.518 (e) (e) | |POLY 3 | P<0.001 ** P=0.692 P=0.687N P<0.001 ** |P=0.605N P=0.506 (e) (e) | |POLY 1.5 | P<0.001 ** P=0.694N P=0.687N P<0.001 ** |P=0.605N P=0.503 (e) (e) | |POLY 6 | P<0.001 ** P=0.678 P=0.691N P<0.001 ** |P=0.604N P=0.511 (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** P=0.656 P=0.686N P<0.001 ** |P=0.612N P=0.497 (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.691N P=0.691N P<0.001 ** |P=0.606N P=0.495 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 50/50 (100%) 49/50 (98%) 50/50 (100%) 50/50 (100%)|47/50 (94%) 45/49 (92%) 47/49 (96%) 47/50 (94%) | |POLY-3 ADJUSTED (b)| 100.0% 99.4% 100.0% 100.0% |98.8% 95.1% 98.3% 98.2% | |TERMINAL (d) | 8/8 (100%) 5/5 (100%) 9/9 (100%) 0/0 (0%) |26/26 (100%) 25/26 (96%) 22/22 (100%) 16/16 (100%) | |FIRST INCIDENCE | 302 399 428 347 |456 469 518 429 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.337 (e) (e) |P=0.008 ** P=0.375N P=0.277 P=0.039 * | |POLY 3 | P=0.994 P=0.990N (e) (e) |P=0.561 P=0.289N P=0.848N P=0.831N | |POLY 1.5 | P=0.855 P=0.795N (e) (e) |P=0.575 P=0.314N P=0.755N P=0.683N | |POLY 6 | P=1.000 P=1.000N (e) (e) |P=0.543 P=0.301N P=0.999N P=0.999N | |LOGISTIC REGRESSION| P=0.619 P=0.422N (e) (e) |P=0.267 P=0.296N P=0.395N P=0.583 | |COCH-ARM / FISHERS | P=0.608 P=0.500N (e) (e) |P=0.549 P=0.489N P=0.510 P=0.661N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 5/50 (10%) 2/50 (4%) 6/50 (12%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 15.1% 15.3% 6.0% 20.6% |0.0% 0.0% 0.0% 5.3% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | 617 609 688 580 |--- --- --- 658 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.486 P=0.188N P<0.001 ** |P=0.022 * (e) (e) P=0.178 | |POLY 3 | P=0.290 P=0.628 P=0.203N P=0.407 |P=0.037 * (e) (e) P=0.221 | |POLY 1.5 | P=0.334 P=0.630N P=0.206N P=0.464 |P=0.039 * (e) (e) P=0.229 | |POLY 6 | P=0.209 P=0.607 P=0.204N P=0.279 |P=0.034 * (e) (e) P=0.210 | |LOGISTIC REGRESSION| P=0.082 P=0.568 P=0.199N P=0.106 |P=0.035 * (e) (e) P=0.217 | |COCH-ARM / FISHERS | P=0.371 P=0.630N P=0.218N P=0.500 |P=0.043 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |3/50 (6%) 2/49 (4%) 3/49 (6%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 18.2% 6.3% 8.8% 14.1% |7.5% 4.9% 7.5% 13.4% | |TERMINAL (d) | 3/8 (38%) 2/5 (40%) 1/9 (11%) 0/0 (0%) |3/26 (12%) 2/26 (8%) 1/22 (5%) 3/16 (19%) | |FIRST INCIDENCE | 681 735 (T) 592 622 |735 (T) 735 (T) 679 707 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.009 ** P=0.262N P=0.225N P=0.008 ** |P=0.053 P=0.500N P=0.593 P=0.144 | |POLY 3 | P=0.537 P=0.136N P=0.216N P=0.462N |P=0.151 P=0.488N P=0.662 P=0.314 | |POLY 1.5 | P=0.578 P=0.131N P=0.224N P=0.405N |P=0.169 P=0.494N P=0.662N P=0.335 | |POLY 6 | P=0.452 P=0.154N P=0.209N P=0.605N |P=0.129 P=0.479N P=0.657 P=0.285 | |LOGISTIC REGRESSION| P=0.179 P=0.185N P=0.223N P=0.222 |P=0.088 P=0.500N P=0.638 P=0.189 | |COCH-ARM / FISHERS | P=0.587N P=0.134N P=0.243N P=0.370N |P=0.192 P=0.510N P=0.651 P=0.357 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 12/50 (24%) 27/50 (54%) 31/50 (62%) |30/50 (60%) 31/49 (63%) 34/49 (69%) 22/50 (44%) | |POLY-3 ADJUSTED (b)| 26.5% 35.0% 69.7% 77.0% |69.1% 69.4% 76.5% 54.6% | |TERMINAL (d) | 4/8 (50%) 4/5 (80%) 8/9 (89%) 0/0 (0%) |22/26 (85%) 22/26 (85%) 21/22 (96%) 12/16 (75%) | |FIRST INCIDENCE | 561 491 536 472 |478 497 522 478 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.130 P<0.001 ** P<0.001 ** |P=0.481 P=0.537 P=0.090 P=0.477 | |POLY 3 | P<0.001 ** P=0.300 P<0.001 ** P<0.001 ** |P=0.046N* P=0.584 P=0.277 P=0.110N | |POLY 1.5 | P<0.001 ** P=0.315 P<0.001 ** P<0.001 ** |P=0.029N* P=0.542 P=0.273 P=0.089N | |POLY 6 | P<0.001 ** P=0.262 P<0.001 ** P<0.001 ** |P=0.083N P=0.569N P=0.263 P=0.151N | |LOGISTIC REGRESSION| P<0.001 ** P=0.244 P<0.001 ** P<0.001 ** |P=0.053N P=0.550 P=0.245 P=0.139N | |COCH-ARM / FISHERS | P<0.001 ** P=0.312 P<0.001 ** P<0.001 ** |P=0.018N* P=0.449 P=0.222 P=0.080N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 1/50 (2%) 4/50 (8%) 0/50 (0%) |5/50 (10%) 6/49 (12%) 6/49 (12%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 15.1% 3.1% 12.0% 0.0% |12.3% 14.4% 15.1% 8.1% | |TERMINAL (d) | 2/8 (25%) 0/5 (0%) 3/9 (33%) 0/0 (0%) |4/26 (15%) 5/26 (19%) 6/22 (27%) 3/16 (19%) | |FIRST INCIDENCE | 609 686 730 --- |631 581 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.530N P=0.170N P=0.445N P=0.432N |P=0.498N P=0.505 P=0.389 P=0.604N | |POLY 3 | P=0.094N P=0.104N P=0.497N P=0.047N* |P=0.277N P=0.521 P=0.486 P=0.404N | |POLY 1.5 | P=0.077N P=0.101N P=0.492N P=0.036N* |P=0.247N P=0.511 P=0.495 P=0.380N | |POLY 6 | P=0.145N P=0.117N P=0.517N P=0.086N |P=0.323N P=0.535 P=0.463 P=0.441N | |LOGISTIC REGRESSION| P=0.308N P=0.122N P=0.476N P=0.150N |P=0.346N P=0.527 P=0.444 P=0.472N | |COCH-ARM / FISHERS | P=0.067N P=0.102N P=0.500N P=0.028N* |P=0.214N P=0.486 P=0.486 P=0.357N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.8% 0.0% |2.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |1/26 (4%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- 492 --- |735 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.644N (e) P=0.239 (e) |P=0.629N P=0.500N P=0.533N P=0.597N | |POLY 3 | P=0.703N (e) P=0.250 (e) |P=0.553N P=0.495N P=0.502N P=0.516N | |POLY 1.5 | P=0.674N (e) P=0.246 (e) |P=0.551N P=0.497N P=0.501N P=0.508N | |POLY 6 | P=0.678 (e) P=0.255 (e) |P=0.554N P=0.491N P=0.507N P=0.527N | |LOGISTIC REGRESSION| P=0.642N (e) P=0.171 (e) |P=0.629N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.652N (e) P=0.247 (e) |P=0.545N P=0.505N P=0.505N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 18/50 (36%) 12/50 (24%) 9/50 (18%) |0/50 (0%) 0/49 (0%) 1/49 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 31.7% 49.4% 33.3% 29.4% |0.0% 0.0% 2.5% 2.7% | |TERMINAL (d) | 2/8 (25%) 2/5 (40%) 2/9 (22%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 1/22 (5%) 1/16 (6%) | |FIRST INCIDENCE | 561 560 554 581 |--- --- 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.081 P=0.064 P=0.551 P=0.012 * |P=0.237 (e) P=0.467 P=0.403 | |POLY 3 | P=0.205N P=0.086 P=0.545 P=0.531N |P=0.320 (e) P=0.498 P=0.484 | |POLY 1.5 | P=0.147N P=0.092 P=0.533 P=0.450N |P=0.334 (e) P=0.499 P=0.492 | |POLY 6 | P=0.382N P=0.077 P=0.554 P=0.518 |P=0.299 (e) P=0.493 P=0.473 | |LOGISTIC REGRESSION| P=0.341N P=0.065 P=0.529 P=0.473 |(e) (e) P=0.467 P=0.403 | |COCH-ARM / FISHERS | P=0.117N P=0.093 P=0.500 P=0.402N |P=0.351 (e) P=0.495 P=0.500 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver | | Degeneration Fatty | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 9/50 (18%) 3/50 (6%) 7/50 (14%) |13/50 (26%) 9/49 (18%) 10/49 (20%) 17/50 (34%) | |POLY-3 ADJUSTED (b)| 14.2% 25.1% 8.8% 23.3% |29.6% 21.1% 23.6% 40.8% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |3/26 (12%) 1/26 (4%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 382 490 571 580 |456 628 518 438 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.190 P=0.196 P=0.358N P=0.146 |P=0.024 * P=0.228N P=0.402N P=0.140 | |POLY 3 | P=0.357 P=0.190 P=0.373N P=0.261 |P=0.048 * P=0.256N P=0.348N P=0.192 | |POLY 1.5 | P=0.424 P=0.196 P=0.361N P=0.324 |P=0.056 P=0.249N P=0.334N P=0.219 | |POLY 6 | P=0.241 P=0.179 P=0.393N P=0.154 |P=0.041 * P=0.260N P=0.373N P=0.170 | |LOGISTIC REGRESSION| P=0.529 P=0.161 P=0.399N P=0.406 |P=0.088 P=0.270N P=0.376N P=0.269 | |COCH-ARM / FISHERS | P=0.486 P=0.194 P=0.357N P=0.380 |P=0.073 P=0.251N P=0.337N P=0.257 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |3/50 (6%) 2/49 (4%) 4/49 (8%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 12.2% 6.2% 8.8% 13.9% |7.5% 4.9% 10.0% 2.7% | |TERMINAL (d) | 2/8 (25%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |3/26 (12%) 2/26 (8%) 2/22 (9%) 0/16 (0%) | |FIRST INCIDENCE | 657 571 554 526 |735 (T) 735 (T) 679 581 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.022 * P=0.469N P=0.461N P=0.009 ** |P=0.431N P=0.500N P=0.419 P=0.451N | |POLY 3 | P=0.356 P=0.340N P=0.476N P=0.572 |P=0.301N P=0.488N P=0.499 P=0.328N | |POLY 1.5 | P=0.398 P=0.334N P=0.482N P=0.617 |P=0.282N P=0.494N P=0.501 P=0.316N | |POLY 6 | P=0.271 P=0.360N P=0.472N P=0.457 |P=0.328N P=0.479N P=0.491 P=0.344N | |LOGISTIC REGRESSION| P=0.268 P=0.379N P=0.486N P=0.317 |P=0.321N P=0.500N P=0.464 P=0.335N | |COCH-ARM / FISHERS | P=0.433 P=0.339N P=0.500N P=0.643N |P=0.259N P=0.510N P=0.489 P=0.309N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/50 (8%) 6/50 (12%) |4/50 (8%) 7/49 (14%) 6/49 (12%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 3.1% 11.6% 20.1% |9.7% 16.5% 14.6% 10.4% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |2/26 (8%) 5/26 (19%) 3/22 (14%) 1/16 (6%) | |FIRST INCIDENCE | --- 490 554 522 |98 506 518 438 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.504 P=0.077 P=0.004 ** |P=0.588N P=0.269 P=0.326 P=0.499 | |POLY 3 | P=0.004 ** P=0.501 P=0.065 P=0.009 ** |P=0.433N P=0.272 P=0.364 P=0.601 | |POLY 1.5 | P=0.006 ** P=0.502 P=0.064 P=0.013 * |P=0.404N P=0.262 P=0.364 P=0.618 | |POLY 6 | P=0.002 ** P=0.494 P=0.066 P=0.005 ** |P=0.477N P=0.285 P=0.357 P=0.574 | |LOGISTIC REGRESSION| P=0.008 ** P=0.420 P=0.065 P=0.016 * |P=0.313N P=0.201 P=0.279 P=0.630N | |COCH-ARM / FISHERS | P=0.008 ** P=0.500 P=0.059 P=0.013 * |P=0.362N P=0.251 P=0.357 P=0.643N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |9/50 (18%) 13/49 (27%) 9/49 (18%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 0.0% 3.1% 5.9% 7.1% |21.7% 30.2% 21.6% 20.8% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |5/26 (19%) 8/26 (31%) 3/22 (14%) 4/16 (25%) | |FIRST INCIDENCE | --- 627 571 623 |599 497 546 478 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.105 P=0.484 P=0.250 P=0.154 |P=0.531 P=0.262 P=0.518 P=0.428 | |POLY 3 | P=0.213 P=0.498 P=0.245 P=0.205 |P=0.354N P=0.260 P=0.599N P=0.571N | |POLY 1.5 | P=0.244 P=0.501 P=0.244 P=0.224 |P=0.310N P=0.248 P=0.598N P=0.534N | |POLY 6 | P=0.153 P=0.491 P=0.247 P=0.165 |P=0.421N P=0.276 P=0.601 P=0.594 | |LOGISTIC REGRESSION| P=0.227 P=0.500 P=0.242 P=0.209 |P=0.298N P=0.237 P=0.591 P=0.553N | |COCH-ARM / FISHERS | P=0.267 P=0.500 P=0.247 P=0.247 |P=0.262N P=0.218 P=0.584 P=0.500N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 1/49 (2%) 0/49 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 6.2% 0.0% 7.2% |2.4% 2.4% 0.0% 5.4% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | --- 637 --- 601 |470 506 --- 721 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.058 P=0.219 (e) P=0.046 * |P=0.246 P=0.755N P=0.496N P=0.396 | |POLY 3 | P=0.249 P=0.235 (e) P=0.204 |P=0.293 P=0.755N P=0.506N P=0.467 | |POLY 1.5 | P=0.272 P=0.238 (e) P=0.223 |P=0.305 P=0.758N P=0.503N P=0.483 | |POLY 6 | P=0.205 P=0.227 (e) P=0.163 |P=0.277 P=0.751N P=0.512N P=0.445 | |LOGISTIC REGRESSION| P=0.207 P=0.229 (e) P=0.162 |P=0.352 P=0.654 P=0.650N P=0.506 | |COCH-ARM / FISHERS | P=0.290 P=0.247 (e) P=0.247 |P=0.321 P=0.747 P=0.505N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver | | Regeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/49 (2%) 0/49 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 3.0% 9.1% 6.0% 0.0% |0.0% 2.4% 0.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 606 604 693 --- |--- 676 --- 581 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.310N P=0.321 P=0.521 P=0.514N |P=0.441 P=0.529 (e) P=0.481 | |POLY 3 | P=0.224N P=0.305 P=0.507 P=0.537N |P=0.464 P=0.506 (e) P=0.487 | |POLY 1.5 | P=0.194N P=0.308 P=0.507 P=0.515N |P=0.472 P=0.503 (e) P=0.494 | |POLY 6 | P=0.299N P=0.295 P=0.503 P=0.586N |P=0.453 P=0.511 (e) P=0.478 | |LOGISTIC REGRESSION| P=0.200N P=0.304 P=0.509 P=0.500N |P=0.498 P=0.496 (e) P=0.499 | |COCH-ARM / FISHERS | P=0.173N P=0.309 P=0.500 P=0.500N |P=0.480 P=0.495 (e) P=0.500 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/50 (56%) 31/50 (62%) 30/50 (60%) 13/50 (26%) |6/50 (12%) 7/49 (14%) 6/49 (12%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 67.1% 75.6% 69.9% 38.7% |14.8% 16.7% 14.5% 18.0% | |TERMINAL (d) | 4/8 (50%) 3/5 (60%) 6/9 (67%) 0/0 (0%) |3/26 (12%) 3/26 (12%) 0/22 (0%) 2/16 (13%) | |FIRST INCIDENCE | 469 477 428 469 |693 651 547 518 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.445N P=0.230 P=0.503 P=0.529N |P=0.266 P=0.526 P=0.533 P=0.297 | |POLY 3 | P<0.001N** P=0.250 P=0.481 P=0.006N** |P=0.445 P=0.527 P=0.608N P=0.470 | |POLY 1.5 | P<0.001N** P=0.310 P=0.479 P=0.002N** |P=0.471 P=0.513 P=0.612N P=0.486 | |POLY 6 | P=0.009N** P=0.163 P=0.457 P=0.051N |P=0.410 P=0.546 P=0.609N P=0.447 | |LOGISTIC REGRESSION| P<0.001N** P=0.346 P=0.447 P=0.003N** |P=0.462 P=0.532 P=0.615 P=0.462 | |COCH-ARM / FISHERS | P<0.001N** P=0.342 P=0.420 P=0.002N** |P=0.503 P=0.484 P=0.606 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 17/50 (34%) 15/50 (30%) 8/50 (16%) |6/50 (12%) 6/49 (12%) 8/49 (16%) 9/50 (18%) | |POLY-3 ADJUSTED (b)| 32.3% 45.1% 37.9% 25.3% |14.4% 14.0% 18.7% 22.3% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 1/9 (11%) 0/0 (0%) |1/26 (4%) 1/26 (4%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | 382 490 428 469 |456 497 518 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.545N P=0.168 P=0.370 P=0.411 |P=0.132 P=0.586N P=0.349 P=0.194 | |POLY 3 | P=0.136N P=0.175 P=0.389 P=0.350N |P=0.189 P=0.604N P=0.403 P=0.258 | |POLY 1.5 | P=0.084N P=0.185 P=0.368 P=0.273N |P=0.208 P=0.613N P=0.397 P=0.273 | |POLY 6 | P=0.311N P=0.163 P=0.415 P=0.553N |P=0.166 P=0.589N P=0.408 P=0.241 | |LOGISTIC REGRESSION| P=0.047N* P=0.189 P=0.294 P=0.197N |P=0.300 P=0.574 P=0.314 P=0.304 | |COCH-ARM / FISHERS | P=0.059N P=0.189 P=0.326 P=0.227N |P=0.236 P=0.606 P=0.371 P=0.288 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.9% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- --- --- |456 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.339N P=0.236N P=0.263N P=0.277N | |POLY 3 | (e) (e) (e) (e) |P=0.317N P=0.233N P=0.244N P=0.259N | |POLY 1.5 | (e) (e) (e) (e) |P=0.314N P=0.234N P=0.241N P=0.249N | |POLY 6 | (e) (e) (e) (e) |P=0.320N P=0.232N P=0.251N P=0.275N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.297N P=0.278N P=0.286N P=0.235N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.308N P=0.247N P=0.253N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Lung | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 2/49 (4%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 3.1% 0.0% 0.0% |2.4% 0.0% 4.9% 8.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 2/16 (13%) | |FIRST INCIDENCE | --- 689 --- --- |470 --- 547 658 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.970N P=0.487 (e) (e) |P=0.073 P=0.500N P=0.505 P=0.217 | |POLY 3 | P=0.620N P=0.497 (e) (e) |P=0.093 P=0.496N P=0.498 P=0.273 | |POLY 1.5 | P=0.614N P=0.501 (e) (e) |P=0.102 P=0.497N P=0.500 P=0.288 | |POLY 6 | P=0.623N P=0.489 (e) (e) |P=0.082 P=0.495N P=0.493 P=0.254 | |LOGISTIC REGRESSION| P=0.759N P=0.480 (e) (e) |P=0.135 P=0.627N P=0.364 P=0.309 | |COCH-ARM / FISHERS | P=0.608N P=0.500 (e) (e) |P=0.116 P=0.500N P=0.492 P=0.309 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Lung | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 24/50 (48%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 3.1% 6.2% 6.0% 66.8% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 727 637 692 555 |--- 679 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.411 P=0.552 P<0.001 ** |P=0.645N P=0.518 (e) (e) | |POLY 3 | P<0.001 ** P=0.497 P=0.512 P<0.001 ** |P=0.608N P=0.509 (e) (e) | |POLY 1.5 | P<0.001 ** P=0.502 P=0.509 P<0.001 ** |P=0.607N P=0.506 (e) (e) | |POLY 6 | P<0.001 ** P=0.484 P=0.513 P<0.001 ** |P=0.607N P=0.512 (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** P=0.456 P=0.518 P<0.001 ** |P=0.613N P=0.501 (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 P<0.001 ** |P=0.608N P=0.500 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 7/50 (14%) 5/50 (10%) 8/50 (16%) |9/50 (18%) 16/50 (32%) 13/49 (27%) 12/50 (24%) | |POLY-3 ADJUSTED (b)| 32.9% 21.2% 14.7% 25.6% |22.2% 36.9% 30.5% 31.4% | |TERMINAL (d) | 3/8 (38%) 2/5 (40%) 2/9 (22%) 0/0 (0%) |7/26 (27%) 12/26 (46%) 5/22 (23%) 8/16 (50%) | |FIRST INCIDENCE | 490 555 646 526 |661 469 547 525 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.121 P=0.300N P=0.053N P=0.490 |P=0.170 P=0.087 P=0.169 P=0.059 | |POLY 3 | P=0.498N P=0.198N P=0.060N P=0.344N |P=0.470 P=0.104 P=0.268 P=0.250 | |POLY 1.5 | P=0.450N P=0.168N P=0.053N P=0.270N |P=0.526 P=0.097 P=0.254 P=0.281 | |POLY 6 | P=0.543 P=0.273N P=0.076N P=0.535N |P=0.393 P=0.115 P=0.282 P=0.206 | |LOGISTIC REGRESSION| P=0.529N P=0.158N P=0.049N* P=0.235N |P=0.466 P=0.098 P=0.226 P=0.181 | |COCH-ARM / FISHERS | P=0.416N P=0.154N P=0.054N P=0.227N |P=0.532N P=0.083 P=0.218 P=0.312 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Lung: Artery, Mediastinum | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 26/50 (52%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 3.1% 6.2% 6.0% 70.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 727 637 692 555 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.411 P=0.552 P<0.001 ** |(e) (e) (e) (e) | |POLY 3 | P<0.001 ** P=0.497 P=0.512 P<0.001 ** |(e) (e) (e) (e) | |POLY 1.5 | P<0.001 ** P=0.502 P=0.509 P<0.001 ** |(e) (e) (e) (e) | |POLY 6 | P<0.001 ** P=0.484 P=0.513 P<0.001 ** |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** P=0.456 P=0.518 P<0.001 ** |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 P<0.001 ** |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/45 (0%) 0/47 (0%) 0/46 (0%) 2/44 (5%) |0/43 (0%) 0/37 (0%) 1/45 (2%) 1/40 (3%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 8.1% |0.0% 0.0% 2.7% 3.2% | |TERMINAL (d) | 0/8 (0%) 0/3 (0%) 0/7 (0%) 0/0 (0%) |0/24 (0%) 0/19 (0%) 0/20 (0%) 0/13 (0%) | |FIRST INCIDENCE | --- --- --- 568 |--- --- 628 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.004 ** (e) (e) P=0.049 * |P=0.330 (e) P=0.500 P=0.495 | |POLY 3 | P=0.030 * (e) (e) P=0.194 |P=0.328 (e) P=0.512 P=0.480 | |POLY 1.5 | P=0.034 * (e) (e) P=0.215 |P=0.337 (e) P=0.513 P=0.485 | |POLY 6 | P=0.024 * (e) (e) P=0.155 |P=0.313 (e) P=0.508 P=0.471 | |LOGISTIC REGRESSION| P=0.031 * (e) (e) P=0.198 |P=0.335 (e) P=0.489 P=0.474 | |COCH-ARM / FISHERS | P=0.038 * (e) (e) P=0.242 |P=0.342 (e) P=0.511 P=0.482 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Renal | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 4/12 (33%) |0/4 (0%) 0/5 (0%) 0/8 (0%) 1/11 (9%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 45.4% |0.0% 0.0% 0.0% 10.7% | |TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/2 (0%) 0/0 (0%) |0/1 (0%) 0/1 (0%) 0/2 (0%) 0/5 (0%) | |FIRST INCIDENCE | --- --- --- 594 |--- --- --- 712 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) (e) P=0.023 * |P=0.176 (e) (e) P=0.440 | |POLY 3 | P=0.002 ** (e) (e) P=0.089 |P=0.359 (e) (e) P=0.694 | |POLY 1.5 | P=0.002 ** (e) (e) P=0.077 |P=0.362 (e) (e) P=0.694 | |POLY 6 | P=0.002 ** (e) (e) P=0.108 |P=0.356 (e) (e) P=0.697 | |LOGISTIC REGRESSION| P=0.004 ** (e) (e) P=0.077 |P=0.370 (e) (e) P=0.702 | |COCH-ARM / FISHERS | P=0.004 ** (e) (e) P=0.068 |P=0.362 (e) (e) P=0.733 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Renal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/10 (10%) 0/8 (0%) 1/10 (10%) 3/12 (25%) |0/4 (0%) 1/5 (20%) 1/8 (13%) 1/11 (9%) | |POLY-3 ADJUSTED (b)| 18.0% 0.0% 15.2% 36.1% |0.0% 22.5% 16.2% 10.8% | |TERMINAL (d) | 1/1 (100%) 0/1 (0%) 0/2 (0%) 0/0 (0%) |0/1 (0%) 1/1 (100%) 0/2 (0%) 1/5 (20%) | |FIRST INCIDENCE | 735 (T) --- 688 601 |--- 735 (T) 628 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.002 ** P=0.500N P=0.671N P=0.038 * |P=0.579N P=0.500 P=0.506 P=0.814 | |POLY 3 | P=0.130 P=0.499N P=0.734N P=0.451 |P=0.637N P=0.547 P=0.615 P=0.693 | |POLY 1.5 | P=0.133 P=0.519N P=0.748N P=0.415 |P=0.637N P=0.545 P=0.623 P=0.694 | |POLY 6 | P=0.114 P=0.466N P=0.697N P=0.515 |P=0.636N P=0.553 P=0.611 P=0.694 | |LOGISTIC REGRESSION| P=0.088 (e) P=0.634N P=0.339 |P=0.640N P=0.500 P=0.764 P=0.814 | |COCH-ARM / FISHERS | P=0.127 P=0.556N P=0.763N P=0.368 |P=0.645N P=0.556 P=0.667 P=0.733 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Galactocele | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/30 (20%) 2/25 (8%) 6/29 (21%) 7/27 (26%) |3/50 (6%) 2/49 (4%) 1/49 (2%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 26.6% 10.8% 27.3% 39.8% |7.4% 4.8% 2.5% 13.2% | |TERMINAL (d) | 2/7 (29%) 0/2 (0%) 3/8 (38%) 0/0 (0%) |1/26 (4%) 2/26 (8%) 1/22 (5%) 1/16 (6%) | |FIRST INCIDENCE | 591 644 621 610 |616 735 (T) 735 (T) 638 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.294N P=0.583N P=0.009 ** |P=0.057 P=0.490N P=0.344N P=0.238 | |POLY 3 | P=0.099 P=0.188N P=0.614 P=0.286 |P=0.118 P=0.493N P=0.313N P=0.315 | |POLY 1.5 | P=0.133 P=0.185N P=0.613 P=0.349 |P=0.128 P=0.496N P=0.309N P=0.336 | |POLY 6 | P=0.060 P=0.207N P=0.610 P=0.186 |P=0.105 P=0.489N P=0.326N P=0.289 | |LOGISTIC REGRESSION| P=0.032 * P=0.187N P=0.626N P=0.189 |P=0.102 P=0.488N P=0.309N P=0.319 | |COCH-ARM / FISHERS | P=0.183 P=0.193N P=0.601 P=0.414 |P=0.144 P=0.510N P=0.316N P=0.357 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 3/26 (12%) |0/15 (0%) 0/8 (0%) 0/11 (0%) 0/7 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 17.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/1 (0%) 0/2 (0%) 0/3 (0%) 0/0 (0%) |0/10 (0%) 0/4 (0%) 0/7 (0%) 0/2 (0%) | |FIRST INCIDENCE | --- --- --- 637 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) (e) P=0.035 * |(e) (e) (e) (e) | |POLY 3 | P=0.051 (e) (e) P=0.253 |(e) (e) (e) (e) | |POLY 1.5 | P=0.059 (e) (e) P=0.278 |(e) (e) (e) (e) | |POLY 6 | P=0.038 * (e) (e) P=0.208 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.081 (e) (e) P=0.291 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.068 (e) (e) P=0.335 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Artery | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/11 (0%) 2/13 (15%) 0/9 (0%) 22/26 (85%) |0/15 (0%) 0/8 (0%) 0/11 (0%) 0/7 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 20.8% 0.0% 91.2% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/1 (0%) 0/2 (0%) 0/3 (0%) 0/0 (0%) |0/10 (0%) 0/4 (0%) 0/7 (0%) 0/2 (0%) | |FIRST INCIDENCE | --- 637 --- 555 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.207 (e) P<0.001 ** |(e) (e) (e) (e) | |POLY 3 | P<0.001 ** P=0.252 (e) P<0.001 ** |(e) (e) (e) (e) | |POLY 1.5 | P<0.001 ** P=0.259 (e) P<0.001 ** |(e) (e) (e) (e) | |POLY 6 | P<0.001 ** P=0.247 (e) P<0.001 ** |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** P=0.239 (e) P<0.001 ** |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.283 (e) P<0.001 ** |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/11 (0%) 2/13 (15%) 1/9 (11%) 2/26 (8%) |1/15 (7%) 0/8 (0%) 0/11 (0%) 0/7 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 20.8% 12.8% 11.7% |7.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/1 (0%) 1/2 (50%) 0/3 (0%) 0/0 (0%) |1/10 (10%) 0/4 (0%) 0/7 (0%) 0/2 (0%) | |FIRST INCIDENCE | --- 616 688 581 |735 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.121 P=0.319 P=0.523 P=0.226 |P=0.767N P=0.682N P=0.571N P=0.814N | |POLY 3 | P=0.611 P=0.253 P=0.484 P=0.397 |P=0.619N P=0.641N P=0.561N P=0.682N | |POLY 1.5 | P=0.646 P=0.260 P=0.472 P=0.419 |P=0.627N P=0.634N P=0.562N P=0.669N | |POLY 6 | P=0.539 P=0.247 P=0.508 P=0.355 |P=0.603N P=0.651N P=0.559N P=0.698N | |LOGISTIC REGRESSION| P=0.595N P=0.244 P=0.475 P=0.671 |P=0.767N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.616N P=0.283 P=0.450 P=0.488 |P=0.639N P=0.652N P=0.577N P=0.682N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 28 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/11 (91%) 6/13 (46%) 7/9 (78%) 4/26 (15%) |13/15 (87%) 7/8 (88%) 11/11 (100%) 6/7 (86%) | |POLY-3 ADJUSTED (b)| 92.5% 52.6% 79.4% 22.1% |88.3% 90.0% 100.0% 96.8% | |TERMINAL (d) | 1/1 (100%) 0/2 (0%) 2/3 (67%) 0/0 (0%) |9/10 (90%) 4/4 (100%) 7/7 (100%) 2/2 (100%) | |FIRST INCIDENCE | 578 578 616 580 |581 506 518 632 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.511 P=0.284N P=0.167N P=0.497 |P=0.371 P=0.535N P=0.487 P=0.514 | |POLY 3 | P<0.001N** P=0.030N* P=0.424N P<0.001N** |P=0.465 P=0.725 P=0.345 P=0.587 | |POLY 1.5 | P<0.001N** P=0.024N* P=0.426N P<0.001N** |P=0.562 P=0.721 P=0.324 P=0.651 | |POLY 6 | P<0.001N** P=0.045N* P=0.422N P<0.001N** |P=0.424 P=0.728 P=0.387 P=0.559 | |LOGISTIC REGRESSION| P<0.001N** P=0.019N* P=0.544N P<0.001N** |P=0.563 P=0.717 P=0.301 P=0.510 | |COCH-ARM / FISHERS | P<0.001N** P=0.027N* P=0.421N P<0.001N** |P=0.679N P=0.743N P=0.323 P=0.705N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 6/50 (12%) 17/50 (34%) 44/50 (88%) |4/49 (8%) 1/50 (2%) 5/48 (10%) 23/49 (47%) | |POLY-3 ADJUSTED (b)| 9.0% 18.4% 45.5% 95.6% |9.9% 2.4% 12.6% 53.5% | |TERMINAL (d) | 1/8 (13%) 2/5 (40%) 2/9 (22%) 0/0 (0%) |2/26 (8%) 0/26 (0%) 2/22 (9%) 6/16 (38%) | |FIRST INCIDENCE | 333 609 572 469 |456 707 679 302 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.158 P=0.002 ** P<0.001 ** |P<0.001 ** P=0.183N P=0.445 P<0.001 ** | |POLY 3 | P<0.001 ** P=0.221 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.167N P=0.489 P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.234 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.168N P=0.495 P<0.001 ** | |POLY 6 | P<0.001 ** P=0.195 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.165N P=0.476 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.228 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.186N P=0.490 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.243 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.175N P=0.487 P<0.001 ** | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 29 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 15/50 (30%) 11/50 (22%) 2/50 (4%) |7/49 (14%) 3/50 (6%) 6/48 (13%) 5/49 (10%) | |POLY-3 ADJUSTED (b)| 26.8% 41.0% 28.7% 7.0% |16.9% 7.1% 14.4% 13.0% | |TERMINAL (d) | 0/8 (0%) 1/5 (20%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 302 490 428 469 |456 651 518 597 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.040N* P=0.162 P=0.505 P=0.063N |P=0.503 P=0.150N P=0.542N P=0.482N | |POLY 3 | P=0.008N** P=0.139 P=0.532 P=0.037N* |P=0.566 P=0.148N P=0.497N P=0.433N | |POLY 1.5 | P=0.003N** P=0.158 P=0.523 P=0.021N* |P=0.581N P=0.146N P=0.497N P=0.407N | |POLY 6 | P=0.039N* P=0.116 P=0.540 P=0.105N |P=0.535 P=0.149N P=0.503N P=0.465N | |LOGISTIC REGRESSION| P<0.001N** P=0.176 P=0.422 P=0.011N* |P=0.495N P=0.168N P=0.605N P=0.368N | |COCH-ARM / FISHERS | P=0.002N** P=0.178 P=0.500 P=0.014N* |P=0.544N P=0.151N P=0.516N P=0.380N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose: Glands | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 22/50 (44%) 49/50 (98%) |0/49 (0%) 0/50 (0%) 24/48 (50%) 46/49 (94%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 54.1% 99.4% |0.0% 0.0% 54.0% 97.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 3/9 (33%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 11/22 (50%) 15/16 (94%) | |FIRST INCIDENCE | --- --- 473 347 |--- --- 518 429 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** (e) P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** (e) P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 30 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose: Lateral Wall | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 49/50 (98%) 50/50 (100%) 50/50 (100%)|0/49 (0%) 39/50 (78%) 48/48 (100%) 49/49 (100%) | |POLY-3 ADJUSTED (b)| 3.1% 99.7% 100.0% 100.0% |0.0% 79.5% 100.0% 100.0% | |TERMINAL (d) | 0/8 (0%) 5/5 (100%) 9/9 (100%) 0/0 (0%) |0/26 (0%) 17/26 (65%) 22/22 (100%) 16/16 (100%) | |FIRST INCIDENCE | 727 462 428 347 |--- 428 518 302 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose: Lateral Wall | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 8/50 (16%) 33/50 (66%) |0/49 (0%) 1/50 (2%) 0/48 (0%) 24/49 (49%) | |POLY-3 ADJUSTED (b)| 3.1% 3.1% 22.2% 79.2% |0.0% 2.4% 0.0% 55.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 1/26 (4%) 0/22 (0%) 7/16 (44%) | |FIRST INCIDENCE | 715 726 478 472 |--- 735 (T) --- 438 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.709 P=0.027 * P<0.001 ** |P<0.001 ** P=0.500 (e) P<0.001 ** | |POLY 3 | P<0.001 ** P=0.758 P=0.021 * P<0.001 ** |P<0.001 ** P=0.512 (e) P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.761 P=0.019 * P<0.001 ** |P<0.001 ** P=0.510 (e) P<0.001 ** | |POLY 6 | P<0.001 ** P=0.748 P=0.024 * P<0.001 ** |P<0.001 ** P=0.515 (e) P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.718 P=0.019 * P<0.001 ** |P<0.001 ** P=0.500 (e) P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.753N P=0.015 * P<0.001 ** |P<0.001 ** P=0.505 (e) P<0.001 ** | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 31 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 12/50 (24%) 47/50 (94%) 50/50 (100%)|0/49 (0%) 6/50 (12%) 44/48 (92%) 49/49 (100%) | |POLY-3 ADJUSTED (b)| 3.1% 33.2% 96.7% 100.0% |0.0% 14.2% 91.7% 100.0% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 9/9 (100%) 0/0 (0%) |0/26 (0%) 4/26 (15%) 18/22 (82%) 16/16 (100%) | |FIRST INCIDENCE | 735 (T) 490 428 347 |--- 603 518 302 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.020 * P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.019 * P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.018 * P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.020 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.021 * P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 42/50 (84%) 48/50 (96%) 50/50 (100%) 47/50 (94%) |43/49 (88%) 50/50 (100%) 47/48 (98%) 48/49 (98%) | |POLY-3 ADJUSTED (b)| 88.2% 97.0% 100.0% 95.9% |91.6% 100.0% 97.9% 98.9% | |TERMINAL (d) | 7/8 (88%) 5/5 (100%) 9/9 (100%) 0/0 (0%) |24/26 (92%) 26/26 (100%) 21/22 (96%) 16/16 (100%) | |FIRST INCIDENCE | 302 399 428 347 |456 428 518 302 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.124 P=0.284 P<0.001 ** |P=0.007 ** P=0.231 P=0.137 P=0.010 * | |POLY 3 | P=0.315 P=0.072 P=0.008 ** P=0.120 |P=0.231 P=0.040 * P=0.160 P=0.089 | |POLY 1.5 | P=0.306 P=0.058 P=0.005 ** P=0.110 |P=0.237 P=0.031 * P=0.125 P=0.087 | |POLY 6 | P=0.316 P=0.102 P=0.019 * P=0.134 |P=0.225 P=0.061 P=0.226 P=0.097 | |LOGISTIC REGRESSION| P=0.370 P=0.049 * P=0.004 ** P=0.168 |P=0.162 P=0.024 * P=0.088 P=0.053 | |COCH-ARM / FISHERS | P=0.291 P=0.046 * P=0.003 ** P=0.100 |P=0.185 P=0.012 * P=0.059 P=0.056 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 32 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 26/50 (52%) 40/50 (80%) |0/49 (0%) 0/50 (0%) 16/48 (33%) 31/49 (63%) | |POLY-3 ADJUSTED (b)| 0.0% 3.1% 63.4% 87.4% |0.0% 0.0% 39.2% 71.9% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 5/9 (56%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 9/22 (41%) 11/16 (69%) | |FIRST INCIDENCE | --- 490 473 347 |--- --- 547 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.504 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.501 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.502 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.494 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.420 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 42/50 (84%) 40/50 (80%) |0/49 (0%) 0/50 (0%) 31/48 (65%) 41/49 (84%) | |POLY-3 ADJUSTED (b)| 0.0% 3.1% 90.5% 86.9% |0.0% 0.0% 71.7% 90.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 9/9 (100%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 17/22 (77%) 14/16 (88%) | |FIRST INCIDENCE | --- 490 428 347 |--- --- 518 478 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.504 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.501 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.502 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.494 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.420 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 33 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 8/50 (16%) 37/50 (74%) 49/50 (98%) |0/49 (0%) 5/50 (10%) 37/48 (77%) 48/49 (98%) | |POLY-3 ADJUSTED (b)| 3.1% 22.9% 84.0% 99.8% |0.0% 11.9% 81.3% 99.6% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 9/9 (100%) 0/0 (0%) |0/26 (0%) 4/26 (15%) 17/22 (77%) 16/16 (100%) | |FIRST INCIDENCE | 735 (T) 543 428 421 |--- 603 518 302 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.034 * P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.018 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.036 * P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.017 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.035 * P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.018 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.038 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.018 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.039 * P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.015 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.030 * P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 14/50 (28%) 45/50 (90%) 3/50 (6%) |23/49 (47%) 39/50 (78%) 45/48 (94%) 6/49 (12%) | |POLY-3 ADJUSTED (b)| 31.7% 37.1% 92.9% 10.2% |51.5% 82.1% 95.0% 15.4% | |TERMINAL (d) | 1/8 (13%) 2/5 (40%) 9/9 (100%) 0/0 (0%) |10/26 (39%) 20/26 (77%) 21/22 (96%) 1/16 (6%) | |FIRST INCIDENCE | 302 462 428 347 |456 428 518 478 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.207N P=0.333 P<0.001 ** P=0.116N |P<0.001N** P=0.017 * P<0.001 ** P=0.007N** | |POLY 3 | P=0.005N** P=0.397 P<0.001 ** P=0.031N* |P<0.001N** P<0.001 ** P<0.001 ** P<0.001N** | |POLY 1.5 | P<0.001N** P=0.408 P<0.001 ** P=0.017N* |P<0.001N** P<0.001 ** P<0.001 ** P<0.001N** | |POLY 6 | P=0.367N P=0.371 P<0.001 ** P=0.099N |P<0.001N** P<0.001 ** P<0.001 ** P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.388 P<0.001 ** P=0.008N** |P<0.001N** P<0.001 ** P<0.001 ** P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.410 P<0.001 ** P=0.011N* |P<0.001N** P<0.001 ** P<0.001 ** P<0.001N** | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 34 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 26/50 (52%) 50/50 (100%) 50/50 (100%)|0/49 (0%) 18/50 (36%) 40/48 (83%) 49/49 (100%) | |POLY-3 ADJUSTED (b)| 0.0% 63.6% 100.0% 100.0% |0.0% 41.2% 83.9% 100.0% | |TERMINAL (d) | 0/8 (0%) 2/5 (40%) 9/9 (100%) 0/0 (0%) |0/26 (0%) 10/26 (39%) 16/22 (73%) 16/16 (100%) | |FIRST INCIDENCE | --- 462 428 347 |--- 547 518 302 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 26/50 (52%) |0/49 (0%) 0/50 (0%) 2/48 (4%) 10/49 (20%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 8.7% 67.6% |0.0% 0.0% 5.0% 26.3% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 3/16 (19%) | |FIRST INCIDENCE | --- --- 571 472 |--- --- 609 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.132 P<0.001 ** |P<0.001 ** (e) P=0.236 P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.127 P<0.001 ** |P<0.001 ** (e) P=0.241 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.125 P<0.001 ** |P<0.001 ** (e) P=0.240 P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.130 P<0.001 ** |P<0.001 ** (e) P=0.240 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.120 P<0.001 ** |P<0.001 ** (e) P=0.207 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.121 P<0.001 ** |P<0.001 ** (e) P=0.242 P<0.001 ** | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 35 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |3/50 (6%) 5/50 (10%) 6/49 (12%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| |7.5% 11.8% 14.5% 17.9% | |TERMINAL (d) | |2/26 (8%) 4/26 (15%) 2/22 (9%) 2/16 (13%) | |FIRST INCIDENCE | |707 428 518 581 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.069 P=0.360 P=0.203 P=0.082 | |POLY 3 | |P=0.154 P=0.386 P=0.253 P=0.141 | |POLY 1.5 | |P=0.168 P=0.378 P=0.250 P=0.150 | |POLY 6 | |P=0.140 P=0.395 P=0.251 P=0.132 | |LOGISTIC REGRESSION| |P=0.190 P=0.370 P=0.232 P=0.145 | |COCH-ARM / FISHERS | |P=0.187 P=0.357 P=0.233 P=0.159 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/50 (44%) 22/50 (44%) 23/50 (46%) 17/49 (35%) |10/49 (20%) 11/49 (22%) 11/48 (23%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 56.8% 55.2% 57.5% 49.8% |24.6% 25.8% 27.2% 27.5% | |TERMINAL (d) | 6/8 (75%) 2/5 (40%) 5/9 (56%) 0/0 (0%) |5/26 (19%) 7/26 (27%) 6/22 (27%) 3/16 (19%) | |FIRST INCIDENCE | 469 477 478 497 |581 497 623 438 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.048 * P=0.377 P=0.556 P=0.031 * |P=0.194 P=0.522 P=0.388 P=0.266 | |POLY 3 | P=0.308N P=0.535N P=0.569 P=0.347N |P=0.463 P=0.549 P=0.494 P=0.482 | |POLY 1.5 | P=0.214N P=0.541N P=0.552 P=0.266N |P=0.497 P=0.536 P=0.499 P=0.505 | |POLY 6 | P=0.547N P=0.545N P=0.587 P=0.571N |P=0.418 P=0.563 P=0.476 P=0.449 | |LOGISTIC REGRESSION| P=0.227N P=0.578N P=0.541 P=0.335N |P=0.478 P=0.536 P=0.497 P=0.500 | |COCH-ARM / FISHERS | P=0.157N P=0.580N P=0.500 P=0.229N |P=0.536 P=0.500 P=0.479 P=0.521 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 36 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 1/49 (2%) |4/49 (8%) 1/49 (2%) 1/48 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 9.1% 3.1% 5.9% 3.6% |10.1% 2.4% 2.6% 2.7% | |TERMINAL (d) | 2/8 (25%) 1/5 (20%) 1/9 (11%) 0/0 (0%) |2/26 (8%) 0/26 (0%) 1/22 (5%) 0/16 (0%) | |FIRST INCIDENCE | 606 735 (T) 505 583 |599 497 735 (T) 706 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.636 P=0.426N P=0.465N P=0.753 |P=0.384N P=0.179N P=0.229N P=0.292N | |POLY 3 | P=0.423N P=0.314N P=0.484N P=0.368N |P=0.308N P=0.162N P=0.182N P=0.197N | |POLY 1.5 | P=0.396N P=0.306N P=0.487N P=0.334N |P=0.293N P=0.167N P=0.180N P=0.185N | |POLY 6 | P=0.484N P=0.336N P=0.485N P=0.459N |P=0.328N P=0.156N P=0.189N P=0.217N | |LOGISTIC REGRESSION| P=0.488N P=0.355N P=0.488N P=0.494N |P=0.273N P=0.190N P=0.181N P=0.196N | |COCH-ARM / FISHERS | P=0.372N P=0.309N P=0.500N P=0.316N |P=0.271N P=0.181N P=0.187N P=0.175N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/50 (4%) 0/50 (0%) 2/49 (4%) |1/49 (2%) 1/49 (2%) 0/48 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 14.8% 6.2% 0.0% 7.2% |2.6% 2.4% 0.0% 0.0% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |1/26 (4%) 1/26 (4%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 572 616 --- 532 |735 (T) 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.583 P=0.278N P=0.038N* P=0.623 |P=0.440N P=0.762 P=0.533N P=0.597N | |POLY 3 | P=0.394N P=0.227N P=0.029N* P=0.295N |P=0.355N P=0.750N P=0.500N P=0.511N | |POLY 1.5 | P=0.375N P=0.218N P=0.029N* P=0.251N |P=0.351N P=0.753N P=0.500N P=0.503N | |POLY 6 | P=0.429N P=0.253N P=0.031N* P=0.418N |P=0.360N P=0.745N P=0.504N P=0.522N | |LOGISTIC REGRESSION| P=0.406N P=0.222N P=0.031N* P=0.286N |P=0.440N P=0.762 (e) (e) | |COCH-ARM / FISHERS | P=0.358N P=0.218N P=0.028N* P=0.226N |P=0.344N P=0.753N P=0.505N P=0.495N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 37 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Artery | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 5/49 (10%) |0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 3.1% 0.0% 17.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- 560 --- 606 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.500 (e) P=0.009 ** |(e) (e) (e) (e) | |POLY 3 | P<0.001 ** P=0.500 (e) P=0.019 * |(e) (e) (e) (e) | |POLY 1.5 | P<0.001 ** P=0.502 (e) P=0.025 * |(e) (e) (e) (e) | |POLY 6 | P<0.001 ** P=0.493 (e) P=0.011 * |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.002 ** P=0.482 (e) P=0.023 * |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.002 ** P=0.500 (e) P=0.027 * |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Artery | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/49 (6%) |0/49 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 3.0% 10.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- 730 638 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.545 P=0.003 ** |(e) (e) (e) (e) | |POLY 3 | P=0.015 * (e) P=0.506 P=0.090 |(e) (e) (e) (e) | |POLY 1.5 | P=0.019 * (e) P=0.505 P=0.105 |(e) (e) (e) (e) | |POLY 6 | P=0.010 * (e) P=0.505 P=0.064 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.002 ** (e) P=0.521 P=0.036 * |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.022 * (e) P=0.500 P=0.117 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 38 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Parathyroid Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/49 (18%) 5/45 (11%) 12/50 (24%) 39/49 (80%) |1/46 (2%) 1/43 (2%) 1/44 (2%) 1/46 (2%) | |POLY-3 ADJUSTED (b)| 26.8% 17.2% 34.1% 92.2% |2.7% 2.8% 2.8% 2.9% | |TERMINAL (d) | 2/8 (25%) 1/5 (20%) 4/9 (44%) 0/0 (0%) |0/24 (0%) 0/22 (0%) 0/19 (0%) 0/16 (0%) | |FIRST INCIDENCE | 522 716 546 532 |707 679 670 715 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.381N P=0.390 P<0.001 ** |P=0.610 P=0.750N P=0.733 P=0.686 | |POLY 3 | P<0.001 ** P=0.267N P=0.341 P<0.001 ** |P=0.663 P=0.755 P=0.753 P=0.747 | |POLY 1.5 | P<0.001 ** P=0.248N P=0.344 P<0.001 ** |P=0.675 P=0.753 P=0.755 P=0.754 | |POLY 6 | P<0.001 ** P=0.315N P=0.333 P<0.001 ** |P=0.647 P=0.758 P=0.748 P=0.737 | |LOGISTIC REGRESSION| P<0.001 ** P=0.294N P=0.325 P<0.001 ** |P=0.677 P=0.754 P=0.755 P=0.740 | |COCH-ARM / FISHERS | P<0.001 ** P=0.244N P=0.331 P<0.001 ** |P=0.672N P=0.736 P=0.742 P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/48 (0%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 3/48 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 3.6% |0.0% 0.0% 7.7% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 2/22 (9%) 0/16 (0%) | |FIRST INCIDENCE | --- --- --- 599 |--- --- 693 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.221 (e) (e) P=0.494 |P=0.696N (e) P=0.098 (e) | |POLY 3 | P=0.207 (e) (e) P=0.469 |P=0.623N (e) P=0.113 (e) | |POLY 1.5 | P=0.220 (e) (e) P=0.488 |P=0.602N (e) P=0.114 (e) | |POLY 6 | P=0.180 (e) (e) P=0.426 |P=0.652N (e) P=0.109 (e) | |LOGISTIC REGRESSION| P=0.236 (e) (e) P=0.503 |P=0.644N (e) P=0.106 (e) | |COCH-ARM / FISHERS | P=0.229 (e) (e) P=0.500 |P=0.577N (e) P=0.114 (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 39 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 8/50 (16%) 3/48 (6%) 11/50 (22%) |8/50 (16%) 10/49 (20%) 7/48 (15%) 9/50 (18%) | |POLY-3 ADJUSTED (b)| 11.8% 23.2% 9.0% 34.1% |18.9% 23.5% 17.3% 22.5% | |TERMINAL (d) | 1/8 (13%) 1/5 (20%) 0/9 (0%) 0/0 (0%) |3/26 (12%) 6/26 (23%) 4/22 (18%) 3/16 (19%) | |FIRST INCIDENCE | 469 490 473 347 |470 547 518 518 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.002 ** P=0.147 P=0.490N P=0.002 ** |P=0.261 P=0.424 P=0.569N P=0.315 | |POLY 3 | P=0.022 * P=0.173 P=0.508N P=0.025 * |P=0.473 P=0.403 P=0.537N P=0.448 | |POLY 1.5 | P=0.031 * P=0.179 P=0.510N P=0.036 * |P=0.503 P=0.397 P=0.527N P=0.473 | |POLY 6 | P=0.010 * P=0.159 P=0.510N P=0.009 ** |P=0.435 P=0.412 P=0.560N P=0.416 | |LOGISTIC REGRESSION| P=0.049 * P=0.178 P=0.555N P=0.051 |P=0.567 P=0.373 P=0.558N P=0.517 | |COCH-ARM / FISHERS | P=0.040 * P=0.178 P=0.523N P=0.045 * |P=0.543 P=0.379 P=0.535N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/50 (0%) 2/49 (4%) 4/50 (8%) | | |POLY-3 ADJUSTED (b)| 3.2% 0.0% 6.1% 13.8% | | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) | | |FIRST INCIDENCE | 717 --- 708 568 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.545N P=0.541 P=0.019 * | | |POLY 3 | P=0.028 * P=0.500N P=0.509 P=0.146 | | |POLY 1.5 | P=0.034 * P=0.496N P=0.508 P=0.169 | | |POLY 6 | P=0.018 * P=0.511N P=0.508 P=0.100 | | |LOGISTIC REGRESSION| P=0.012 * P=0.539N P=0.517 P=0.136 | | |COCH-ARM / FISHERS | P=0.040 * P=0.495N P=0.500 P=0.187 | | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 40 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 3/50 (6%) 5/50 (10%) 0/50 (0%) | | |POLY-3 ADJUSTED (b)| 20.9% 9.3% 14.8% 0.0% | | |TERMINAL (d) | 3/8 (38%) 1/5 (20%) 3/9 (33%) 0/0 (0%) | | |FIRST INCIDENCE | 599 678 639 --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.279N P=0.275N P=0.325N P=0.251N | | |POLY 3 | P=0.029N* P=0.164N P=0.368N P=0.014N* | | |POLY 1.5 | P=0.022N* P=0.156N P=0.366N P=0.009N** | | |POLY 6 | P=0.057N P=0.186N P=0.381N P=0.033N* | | |LOGISTIC REGRESSION| P=0.104N P=0.195N P=0.353N P=0.064N | | |COCH-ARM / FISHERS | P=0.018N* P=0.159N P=0.380N P=0.006N** | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 8/50 (16%) 3/50 (6%) 5/50 (10%) | | |POLY-3 ADJUSTED (b)| 25.8% 23.0% 8.9% 17.2% | | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) | | |FIRST INCIDENCE | 525 477 679 580 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.337 P=0.578N P=0.063N P=0.271 | | |POLY 3 | P=0.286N P=0.504N P=0.059N P=0.297N | | |POLY 1.5 | P=0.235N P=0.492N P=0.057N P=0.232N | | |POLY 6 | P=0.404N P=0.543N P=0.068N P=0.479N | | |LOGISTIC REGRESSION| P=0.290N P=0.502N P=0.054N P=0.350N | | |COCH-ARM / FISHERS | P=0.199N P=0.500N P=0.061N P=0.194N | | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 41 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Seminal Vesicle | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 1/46 (2%) 3/47 (6%) | | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 3.2% 11.2% | | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) | | |FIRST INCIDENCE | --- --- 692 610 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.525 P=0.009 ** | | |POLY 3 | P=0.015 * (e) P=0.497 P=0.089 | | |POLY 1.5 | P=0.018 * (e) P=0.494 P=0.102 | | |POLY 6 | P=0.010 * (e) P=0.499 P=0.063 | | |LOGISTIC REGRESSION| P=0.007 ** (e) P=0.498 P=0.060 | | |COCH-ARM / FISHERS | P=0.022 * (e) P=0.484 P=0.113 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Cyst Epithelial Inclusion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 6.2% 0.0% 0.0% |2.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |1/26 (4%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- 678 --- --- |735 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.843N P=0.207 (e) (e) |P=0.629N P=0.500N P=0.533N P=0.597N | |POLY 3 | P=0.415N P=0.233 (e) (e) |P=0.553N P=0.492N P=0.504N P=0.516N | |POLY 1.5 | P=0.400N P=0.237 (e) (e) |P=0.552N P=0.494N P=0.503N P=0.508N | |POLY 6 | P=0.438N P=0.223 (e) (e) |P=0.554N P=0.490N P=0.508N P=0.527N | |LOGISTIC REGRESSION| P=0.583N P=0.207 (e) (e) |P=0.629N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.390N P=0.247 (e) (e) |P=0.546N P=0.500N P=0.510N P=0.500N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 42 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Inflammation Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 6.1% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- 490 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.389N P=0.242 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.411N P=0.239 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.398N P=0.241 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.431N P=0.234 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.385N P=0.195 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.390N P=0.247 (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 0/48 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 3.1% 6.1% 6.0% 7.0% |0.0% 4.8% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 1/26 (4%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 696 477 692 497 |--- 679 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.135 P=0.457 P=0.536 P=0.235 |P=0.460N P=0.250 (e) (e) | |POLY 3 | P=0.451 P=0.500 P=0.510 P=0.453 |P=0.395N P=0.247 (e) (e) | |POLY 1.5 | P=0.490 P=0.504 P=0.509 P=0.482 |P=0.392N P=0.244 (e) (e) | |POLY 6 | P=0.364 P=0.487 P=0.509 P=0.383 |P=0.399N P=0.251 (e) (e) | |LOGISTIC REGRESSION| P=0.488 P=0.500 P=0.513 P=0.505 |P=0.417N P=0.246 (e) (e) | |COCH-ARM / FISHERS | P=0.518 P=0.500 P=0.500 P=0.500 |P=0.390N P=0.247 (e) (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 43 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Skin: Tail | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 6/50 (12%) 18/50 (36%) |0/50 (0%) 0/50 (0%) 0/48 (0%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 3.1% 6.1% 17.9% 51.8% |0.0% 0.0% 0.0% 13.2% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 4/9 (44%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 2/16 (13%) | |FIRST INCIDENCE | 727 578 671 476 |--- --- --- 560 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.471 P=0.069 P<0.001 ** |P<0.001 ** (e) (e) P=0.013 * | |POLY 3 | P<0.001 ** P=0.503 P=0.056 P<0.001 ** |P<0.001 ** (e) (e) P=0.025 * | |POLY 1.5 | P<0.001 ** P=0.505 P=0.058 P<0.001 ** |P<0.001 ** (e) (e) P=0.028 * | |POLY 6 | P<0.001 ** P=0.496 P=0.053 P<0.001 ** |P<0.001 ** (e) (e) P=0.021 * | |LOGISTIC REGRESSION| P<0.001 ** P=0.499 P=0.054 P<0.001 ** |P<0.001 ** (e) (e) P=0.026 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.056 P<0.001 ** |P<0.001 ** (e) (e) P=0.028 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Accessory Spleen | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/49 (0%) 0/49 (0%) 2/49 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 8.9% 0.0% 0.0% 3.6% |0.0% 0.0% 5.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 1/22 (5%) 0/16 (0%) | |FIRST INCIDENCE | 536 --- --- 693 |--- --- 623 632 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.677 P=0.131N P=0.121N P=0.689N |P=0.359 (e) P=0.224 P=0.500 | |POLY 3 | P=0.549N P=0.126N P=0.118N P=0.379N |P=0.386 (e) P=0.242 P=0.491 | |POLY 1.5 | P=0.543N P=0.121N P=0.116N P=0.335N |P=0.404 (e) P=0.242 P=0.498 | |POLY 6 | P=0.548N P=0.141N P=0.123N P=0.486N |P=0.361 (e) P=0.238 P=0.482 | |LOGISTIC REGRESSION| P=0.552N P=0.121N P=0.124N P=0.340N |P=0.430 (e) P=0.239 P=0.508 | |COCH-ARM / FISHERS | P=0.532N P=0.121N P=0.121N P=0.309N |P=0.425 (e) P=0.247 P=0.505 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 44 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 13/50 (26%) 10/50 (20%) 12/50 (24%) |5/49 (10%) 3/49 (6%) 3/49 (6%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 39.7% 35.9% 27.8% 36.7% |12.8% 7.2% 7.4% 13.3% | |TERMINAL (d) | 3/8 (38%) 0/5 (0%) 2/9 (22%) 0/0 (0%) |5/26 (19%) 0/26 (0%) 1/22 (5%) 2/16 (13%) | |FIRST INCIDENCE | 522 462 492 472 |735 (T) 693 609 670 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.016 * P=0.497 P=0.236N P=0.004 ** |P=0.211 P=0.347N P=0.429N P=0.377 | |POLY 3 | P=0.552N P=0.464N P=0.197N P=0.498N |P=0.373 P=0.323N P=0.338N P=0.608 | |POLY 1.5 | P=0.483N P=0.470N P=0.210N P=0.435N |P=0.399 P=0.334N P=0.340N P=0.626 | |POLY 6 | P=0.430 P=0.467N P=0.187N P=0.565 |P=0.340 P=0.306N P=0.340N P=0.585 | |LOGISTIC REGRESSION| P=0.546 P=0.521N P=0.212N P=0.592 |P=0.340 P=0.308N P=0.358N P=0.529 | |COCH-ARM / FISHERS | P=0.436N P=0.500N P=0.241N P=0.410N |P=0.433 P=0.357N P=0.357N P=0.617N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 4/50 (8%) |2/49 (4%) 4/49 (8%) 2/49 (4%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 3.1% 6.1% 5.8% 13.8% |5.0% 9.3% 5.0% 12.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |1/26 (4%) 0/26 (0%) 1/22 (5%) 0/16 (0%) | |FIRST INCIDENCE | 679 399 546 522 |604 497 522 429 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.023 * P=0.480 P=0.489 P=0.014 * |P=0.144 P=0.362 P=0.669 P=0.162 | |POLY 3 | P=0.097 P=0.502 P=0.519 P=0.139 |P=0.197 P=0.376 P=0.688N P=0.211 | |POLY 1.5 | P=0.117 P=0.505 P=0.513 P=0.162 |P=0.210 P=0.363 P=0.686N P=0.219 | |POLY 6 | P=0.064 P=0.490 P=0.525 P=0.093 |P=0.181 P=0.393 P=0.694 P=0.198 | |LOGISTIC REGRESSION| P=0.152 P=0.490 P=0.488 P=0.149 |P=0.281 P=0.269 P=0.681 P=0.232 | |COCH-ARM / FISHERS | P=0.134 P=0.500 P=0.500 P=0.181 |P=0.223 P=0.339 P=0.691N P=0.226 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 45 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |1/49 (2%) 0/49 (0%) 1/49 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 10.3% |2.5% 0.0% 2.5% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | --- --- --- 421 |707 --- 589 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.004 ** (e) (e) P=0.089 |P=0.521N P=0.494N P=0.739 P=0.560N | |POLY 3 | P=0.006 ** (e) (e) P=0.098 |P=0.499N P=0.490N P=0.756N P=0.511N | |POLY 1.5 | P=0.007 ** (e) (e) P=0.111 |P=0.489N P=0.493N P=0.755N P=0.503N | |POLY 6 | P=0.004 ** (e) (e) P=0.071 |P=0.514N P=0.487N P=0.760N P=0.523N | |LOGISTIC REGRESSION| P=0.009 ** (e) (e) P=0.098 |P=0.462N P=0.489N P=0.755 P=0.521N | |COCH-ARM / FISHERS | P=0.008 ** (e) (e) P=0.121 |P=0.473N P=0.500N P=0.753N P=0.495N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |1/49 (2%) 1/49 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 6.0% 6.1% 8.7% 7.1% |2.5% 2.4% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 532 490 580 610 |477 677 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.503 P=0.691N P=0.497 P=0.654 |P=0.370N P=0.745N P=0.492N P=0.500N | |POLY 3 | P=0.563 P=0.690 P=0.512 P=0.633 |P=0.356N P=0.753N P=0.501N P=0.514N | |POLY 1.5 | P=0.612 P=0.695N P=0.510 P=0.669 |P=0.352N P=0.755N P=0.498N P=0.505N | |POLY 6 | P=0.453 P=0.675 P=0.513 P=0.543 |P=0.361N P=0.749N P=0.507N P=0.527N | |LOGISTIC REGRESSION| P=0.578N P=0.670 P=0.491 P=0.684N |P=0.332N P=0.716 P=0.641N P=0.537N | |COCH-ARM / FISHERS | P=0.600N P=0.691N P=0.500 P=0.691N |P=0.344N P=0.753N P=0.500N P=0.495N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 46 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 12/50 (24%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 3.1% 6.2% 6.0% 38.3% |2.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 727 637 692 581 |616 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.411 P=0.552 P<0.001 ** |P=0.558N P=0.485N P=0.495N P=0.505N | |POLY 3 | P<0.001 ** P=0.497 P=0.512 P<0.001 ** |P=0.552N P=0.494N P=0.504N P=0.518N | |POLY 1.5 | P<0.001 ** P=0.502 P=0.509 P<0.001 ** |P=0.551N P=0.495N P=0.502N P=0.509N | |POLY 6 | P<0.001 ** P=0.484 P=0.513 P<0.001 ** |P=0.551N P=0.493N P=0.510N P=0.530N | |LOGISTIC REGRESSION| P<0.001 ** P=0.456 P=0.518 P<0.001 ** |P=0.533N P=0.526N P=0.532N P=0.496N | |COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 P<0.001 ** |P=0.546N P=0.500N P=0.505N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 6/50 (12%) 10/50 (20%) 6/50 (12%) |5/50 (10%) 6/50 (12%) 5/49 (10%) 12/50 (24%) | |POLY-3 ADJUSTED (b)| 25.5% 18.1% 27.7% 20.0% |11.9% 13.9% 12.2% 30.3% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 1/16 (6%) | |FIRST INCIDENCE | 490 571 571 421 |456 535 623 597 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.189 P=0.401N P=0.540 P=0.334 |P=0.007 ** P=0.533 P=0.584 P=0.032 * | |POLY 3 | P=0.455N P=0.325N P=0.522 P=0.409N |P=0.011 * P=0.519 P=0.612 P=0.034 * | |POLY 1.5 | P=0.379N P=0.298N P=0.520 P=0.333N |P=0.013 * P=0.514 P=0.621 P=0.042 * | |POLY 6 | P=0.525 P=0.389N P=0.519 P=0.597N |P=0.008 ** P=0.527 P=0.597 P=0.028 * | |LOGISTIC REGRESSION| P=0.420N P=0.294N P=0.518 P=0.319N |P=0.022 * P=0.448 P=0.578 P=0.055 | |COCH-ARM / FISHERS | P=0.326N P=0.288N P=0.500 P=0.288N |P=0.019 * P=0.500 P=0.617 P=0.054 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 47 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 32/49 (65%) |2/50 (4%) 2/49 (4%) 1/49 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 6.1% 6.2% 8.9% 82.3% |4.9% 4.8% 2.5% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 1/22 (5%) 1/16 (6%) | |FIRST INCIDENCE | 686 637 688 555 |599 679 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.621 P=0.556 P<0.001 ** |P=0.522N P=0.670N P=0.519N P=0.570N | |POLY 3 | P<0.001 ** P=0.692 P=0.515 P<0.001 ** |P=0.443N P=0.690N P=0.511N P=0.535N | |POLY 1.5 | P<0.001 ** P=0.694N P=0.512 P<0.001 ** |P=0.427N P=0.692N P=0.505N P=0.517N | |POLY 6 | P<0.001 ** P=0.678 P=0.517 P<0.001 ** |P=0.465N P=0.688N P=0.525N P=0.560N | |LOGISTIC REGRESSION| P<0.001 ** P=0.656 P=0.515 P<0.001 ** |P=0.419N P=0.675 P=0.522N P=0.496N | |COCH-ARM / FISHERS | P<0.001 ** P=0.691N P=0.500 P<0.001 ** |P=0.406N P=0.684 P=0.508N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 3/50 (6%) 4/50 (8%) 4/49 (8%) |1/50 (2%) 2/49 (4%) 3/49 (6%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 20.0% 9.3% 11.6% 13.8% |2.5% 4.8% 7.5% 18.4% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 382 678 554 472 |661 651 679 642 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.241 P=0.236N P=0.253N P=0.589 |P=0.003 ** P=0.527 P=0.285 P=0.018 * | |POLY 3 | P=0.505N P=0.185N P=0.263N P=0.372N |P=0.007 ** P=0.510 P=0.302 P=0.023 * | |POLY 1.5 | P=0.463N P=0.168N P=0.258N P=0.312N |P=0.008 ** P=0.505 P=0.304 P=0.026 * | |POLY 6 | P=0.580 P=0.229N P=0.280N P=0.529N |P=0.005 ** P=0.517 P=0.294 P=0.019 * | |LOGISTIC REGRESSION| P=0.457N P=0.159N P=0.260N P=0.261N |P=0.006 ** P=0.496 P=0.301 P=0.024 * | |COCH-ARM / FISHERS | P=0.430N P=0.159N P=0.262N P=0.274N |P=0.011 * P=0.492 P=0.301 P=0.030 * | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 48 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Testes | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 5/50 (10%) | | |POLY-3 ADJUSTED (b)| 3.0% 3.1% 8.6% 17.3% | | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) | | |FIRST INCIDENCE | 591 644 505 610 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.004 ** P=0.737 P=0.307 P=0.016 * | | |POLY 3 | P=0.024 * P=0.757 P=0.325 P=0.069 | | |POLY 1.5 | P=0.031 * P=0.761 P=0.319 P=0.087 | | |POLY 6 | P=0.013 * P=0.747 P=0.331 P=0.039 * | | |LOGISTIC REGRESSION| P=0.039 * P=0.762 P=0.265 P=0.065 | | |COCH-ARM / FISHERS | P=0.040 * P=0.753N P=0.309 P=0.102 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Testes: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 4/50 (8%) 8/50 (16%) | | |POLY-3 ADJUSTED (b)| 9.1% 3.1% 11.7% 26.1% | | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 0/9 (0%) 0/0 (0%) | | |FIRST INCIDENCE | 581 726 646 555 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.400N P=0.534 P=0.010 * | | |POLY 3 | P=0.007 ** P=0.318N P=0.518 P=0.065 | | |POLY 1.5 | P=0.009 ** P=0.308N P=0.514 P=0.084 | | |POLY 6 | P=0.003 ** P=0.343N P=0.522 P=0.033 * | | |LOGISTIC REGRESSION| P=0.004 ** P=0.327N P=0.514 P=0.073 | | |COCH-ARM / FISHERS | P=0.012 * P=0.309N P=0.500 P=0.100 | | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 49 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Testes: Interstitial Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 6/50 (12%) 4/50 (8%) 7/50 (14%) | | |POLY-3 ADJUSTED (b)| 11.4% 16.9% 11.1% 22.3% | | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) | | |FIRST INCIDENCE | 351 490 428 421 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.273 P=0.378 P=0.632N P=0.273 | | |POLY 3 | P=0.183 P=0.371 P=0.633N P=0.189 | | |POLY 1.5 | P=0.224 P=0.375 P=0.633N P=0.230 | | |POLY 6 | P=0.115 P=0.358 P=0.637N P=0.115 | | |LOGISTIC REGRESSION| P=0.292 P=0.244 P=0.426 P=0.239 | | |COCH-ARM / FISHERS | P=0.260 P=0.370 P=0.643N P=0.262 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/49 (55%) 33/49 (67%) 30/49 (61%) 21/47 (45%) |40/49 (82%) 41/49 (84%) 35/47 (74%) 39/48 (81%) | |POLY-3 ADJUSTED (b)| 68.7% 76.2% 71.4% 58.9% |86.7% 86.3% 78.7% 86.9% | |TERMINAL (d) | 6/8 (75%) 2/5 (40%) 7/9 (78%) 0/0 (0%) |22/26 (85%) 24/26 (92%) 17/22 (77%) 13/16 (81%) | |FIRST INCIDENCE | 302 399 483 472 |456 428 518 302 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.117 P=0.128 P=0.446 P=0.044 * |P=0.036 * P=0.551 P=0.499N P=0.090 | |POLY 3 | P=0.077N P=0.285 P=0.492 P=0.235N |P=0.503 P=0.603N P=0.222N P=0.617 | |POLY 1.5 | P=0.050N P=0.228 P=0.432 P=0.203N |P=0.549 P=0.615N P=0.216N P=0.595N | |POLY 6 | P=0.196N P=0.351 P=0.562 P=0.380N |P=0.468 P=0.604N P=0.244N P=0.591 | |LOGISTIC REGRESSION| P=0.059N P=0.155 P=0.389 P=0.265N |P=0.521 P=0.572 P=0.215N P=0.592 | |COCH-ARM / FISHERS | P=0.042N* P=0.150 P=0.341 P=0.207N |P=0.544N P=0.500 P=0.274N P=0.584N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 05 Page 50 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - FURFURYL ALCOHOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/49 (2%) 2/49 (4%) 2/47 (4%) |0/49 (0%) 0/49 (0%) 0/47 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 3.2% 3.2% 6.1% 7.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/8 (13%) 0/5 (0%) 1/9 (11%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 0/22 (0%) 0/16 (0%) | |FIRST INCIDENCE | 735 (T) 525 708 585 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.083 P=0.709 P=0.556 P=0.163 |(e) (e) (e) (e) | |POLY 3 | P=0.334 P=0.760N P=0.513 P=0.441 |(e) (e) (e) (e) | |POLY 1.5 | P=0.367 P=0.758N P=0.510 P=0.469 |(e) (e) (e) (e) | |POLY 6 | P=0.263 P=0.761 P=0.516 P=0.375 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.298 P=0.762N P=0.543 P=0.365 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.392 P=0.753N P=0.500 P=0.484 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Urinary Bladder: Transitional Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/49 (0%) 2/49 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 3.1% 0.0% 0.0% |0.0% 0.0% 5.0% 2.7% | |TERMINAL (d) | 0/8 (0%) 0/5 (0%) 0/9 (0%) 0/0 (0%) |0/26 (0%) 0/26 (0%) 1/22 (5%) 1/16 (6%) | |FIRST INCIDENCE | --- 689 --- --- |--- --- 518 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.970N P=0.487 (e) (e) |P=0.327 (e) P=0.230 P=0.403 | |POLY 3 | P=0.620N P=0.497 (e) (e) |P=0.384 (e) P=0.243 P=0.489 | |POLY 1.5 | P=0.614N P=0.501 (e) (e) |P=0.403 (e) P=0.243 P=0.497 | |POLY 6 | P=0.623N P=0.489 (e) (e) |P=0.356 (e) P=0.240 P=0.478 | |LOGISTIC REGRESSION| P=0.759N P=0.480 (e) (e) |P=0.430 (e) P=0.209 P=0.403 | |COCH-ARM / FISHERS | P=0.608N P=0.500 (e) (e) |P=0.425 (e) P=0.247 P=0.505 | |=================================================================================================================================| (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).