TDMS Study 05201-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 04/25/97 EXPERIMENT: 05201 TEST: 06 TIME: 18:44:56 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: MILLER, RODNEY CAS: 0098-00-0000 Mice(B6C3F1) ----------------------------- 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: 06 TIME: 18:44:56 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: MILLER, RODNEY CAS: 0098-00-0000 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF FURFURYL ALCOHOL =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex Hypertrophy Kidney: Renal Tubule Degeneration Liver Angiectasis Basophilic Focus Degeneration Fatty Vacuolization Cytoplasmic Nose Inflammation Nose: Glands Hyperplasia Metaplasia Nose: Lateral Wall Metaplasia Nose: Olfactory Epithelium Atrophy Degeneration Hyaline Metaplasia Nose: Respiratory Epithelium Degeneration Hyaline Metaplasia Regeneration =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Epididymis Hyperplasia Eye: Cornea Degeneration Hyperplasia Heart Cardiomyopathy Liver Basophilic Focus Clear Cell Focus Eosinophilic Focus Hematopoietic Cell Proliferation Lymph Node Angiectasis Nose Inflammation Nose: Glands Hyperplasia Metaplasia Nose: Lateral Wall Metaplasia Nose: Olfactory Epithelium Atrophy Degeneration Hyaline Metaplasia Nose: Respiratory Epithelium Degeneration Hyaline Metaplasia Necrosis Regeneration Spleen Hematopoietic Cell Proliferation Stomach, Forestomach: Epithelium Hyperplasia NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 04/25/97 EXPERIMENT: 05201 TEST: 06 TIME: 18:44:56 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C PATHOLOGIST: MILLER, RODNEY CAS: 0098-00-0000 Thyroid Gland: Follicular Cell Hyperplasia Uterus Hyperplasia Cystic =============================================================== Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | 1/50 (2%) 1/49 (2%) 5/49 (10%) 2/48 (4%) |0/50 (0%) 2/49 (4%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.3% 2.3% 12.8% 4.6% |0.0% 4.7% 0.0% 0.0% | |TERMINAL (d) | 1/34 (3%) 1/36 (3%) 4/30 (13%) 2/37 (5%) |0/34 (0%) 1/33 (3%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) 665 733 (T) |--- 497 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.546 P=0.749N P=0.079 P=0.530 |P=0.365N P=0.229 (e) (e) | |POLY 3 | P=0.522 P=0.759 P=0.080 P=0.506 |P=0.375N P=0.235 (e) (e) | |POLY 1.5 | P=0.509 P=0.758 P=0.086 P=0.497 |P=0.383N P=0.233 (e) (e) | |POLY 6 | P=0.537 P=0.761N P=0.075 P=0.515 |P=0.365N P=0.239 (e) (e) | |LOGISTIC REGRESSION| P=0.540 P=0.749N P=0.074 P=0.530 |P=0.472N P=0.251 (e) (e) | |COCH-ARM / FISHERS | P=0.490 P=0.747 P=0.098 P=0.485 |P=0.393N P=0.242 (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 | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 35/50 (70%) 37/49 (76%) 31/49 (63%) 28/48 (58%) |4/50 (8%) 1/49 (2%) 3/50 (6%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 78.4% 80.6% 75.4% 62.6% |9.3% 2.4% 7.0% 6.5% | |TERMINAL (d) | 30/34 (88%) 31/36 (86%) 26/30 (87%) 25/37 (68%) |4/34 (12%) 1/33 (3%) 3/32 (9%) 3/40 (8%) | |FIRST INCIDENCE | 547 433 471 590 |734 (T) 734 (T) 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.007N** P=0.573 P=0.584 P=0.027N* |P=0.567N P=0.187N P=0.534N P=0.411N | |POLY 3 | P=0.017N* P=0.501 P=0.465N P=0.069N |P=0.599 P=0.185N P=0.502N P=0.464N | |POLY 1.5 | P=0.031N* P=0.428 P=0.401N P=0.100N |P=0.580 P=0.187N P=0.500N P=0.482N | |POLY 6 | P=0.008N** P=0.584 P=0.533N P=0.043N* |P=0.616 P=0.181N P=0.507N P=0.444N | |LOGISTIC REGRESSION| P=0.011N* P=0.380 P=0.593N P=0.048N* |P=0.567N P=0.187N P=0.534N P=0.411N | |COCH-ARM / FISHERS | P=0.069N P=0.349 P=0.310N P=0.160N |P=0.546 P=0.187N P=0.500N P=0.511N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | 0/50 (0%) 0/49 (0%) 0/48 (0%) 1/48 (2%) |4/48 (8%) 1/48 (2%) 2/49 (4%) 4/49 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.3% |9.7% 2.4% 4.7% 8.6% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 1/37 (3%) |4/33 (12%) 0/32 (0%) 1/31 (3%) 3/40 (8%) | |FIRST INCIDENCE | --- --- --- 733 (T) |734 (T) 601 666 713 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.245 (e) (e) P=0.517 |P=0.438 P=0.188N P=0.364N P=0.535N | |POLY 3 | P=0.232 (e) (e) P=0.503 |P=0.382 P=0.175N P=0.325N P=0.580N | |POLY 1.5 | P=0.229 (e) (e) P=0.499 |P=0.366 P=0.178N P=0.326N P=0.600N | |POLY 6 | P=0.235 (e) (e) P=0.509 |P=0.397 P=0.169N P=0.327N P=0.557N | |LOGISTIC REGRESSION| (e) (e) (e) P=0.517 |P=0.385 P=0.180N P=0.336N P=0.540N | |COCH-ARM / FISHERS | P=0.223 (e) (e) P=0.490 |P=0.336 P=0.181N P=0.329N P=0.631N | |=================================================================================================================================| | | | | | | 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) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |16/50 (32%) 19/49 (39%) 15/50 (30%) 22/50 (44%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 5.0% 0.0% |36.0% 44.7% 34.3% 46.7% | |TERMINAL (d) | 0/34 (0%) 1/36 (3%) 0/30 (0%) 0/38 (0%) |12/34 (35%) 18/33 (55%) 12/32 (38%) 21/40 (53%) | |FIRST INCIDENCE | --- 733 (T) 576 --- |547 649 632 609 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.442N P=0.511 P=0.216 (e) |P=0.394 P=0.296 P=0.568N P=0.334 | |POLY 3 | P=0.450N P=0.499 P=0.219 (e) |P=0.217 P=0.268 P=0.524N P=0.200 | |POLY 1.5 | P=0.459N P=0.498 P=0.225 (e) |P=0.190 P=0.279 P=0.512N P=0.182 | |POLY 6 | P=0.440N P=0.500 P=0.214 (e) |P=0.243 P=0.263 P=0.546N P=0.217 | |LOGISTIC REGRESSION| P=0.478N P=0.511 P=0.252 (e) |P=0.284 P=0.310 P=0.508N P=0.245 | |COCH-ARM / FISHERS | P=0.473N P=0.500 P=0.247 (e) |P=0.147 P=0.310 P=0.500N P=0.151 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | 2/50 (4%) 2/49 (4%) 0/49 (0%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 1/49 (2%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 4.6% 4.6% 0.0% 2.2% |0.0% 0.0% 2.4% 2.2% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 1/40 (3%) | |FIRST INCIDENCE | 537 287 --- 716 |--- --- 693 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.402N P=0.690 P=0.281N P=0.469N |P=0.392 (e) P=0.489 P=0.532 | |POLY 3 | P=0.412N P=0.694N P=0.264N P=0.485N |P=0.376 (e) P=0.496 P=0.513 | |POLY 1.5 | P=0.421N P=0.692 P=0.256N P=0.491N |P=0.365 (e) P=0.496 P=0.507 | |POLY 6 | P=0.402N P=0.693N P=0.274N P=0.478N |P=0.385 (e) P=0.496 P=0.520 | |LOGISTIC REGRESSION| P=0.501N P=0.694N P=0.200N P=0.537N |P=0.365 (e) P=0.496 P=0.532 | |COCH-ARM / FISHERS | P=0.433N P=0.684 P=0.253N P=0.500N |P=0.346 (e) P=0.495 P=0.495 | |=================================================================================================================================| | | | | | | 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%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 2/49 (4%) 1/49 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.7% 2.4% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 1/32 (3%) 0/40 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 525 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.335N P=0.227 P=0.488 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.343N P=0.236 P=0.496 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.354N P=0.233 P=0.496 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.331N P=0.241 P=0.494 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.422N P=0.254 P=0.488 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.369N P=0.242 P=0.495 (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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: Meninges | | Infiltration Cellular Mononuclear Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |4/50 (8%) 4/49 (8%) 2/49 (4%) 4/49 (8%) | |POLY-3 ADJUSTED (b)| 2.3% 0.0% 0.0% 0.0% |9.2% 9.5% 4.7% 8.5% | |TERMINAL (d) | 1/34 (3%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |3/34 (9%) 4/33 (12%) 2/32 (6%) 2/40 (5%) | |FIRST INCIDENCE | 733 (T) --- --- --- |693 734 (T) 734 (T) 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.528N P=0.489N P=0.525N P=0.478N |P=0.530N P=0.627 P=0.365N P=0.558N | |POLY 3 | P=0.536N P=0.501N P=0.520N P=0.488N |P=0.592N P=0.629 P=0.349N P=0.600N | |POLY 1.5 | P=0.539N P=0.502N P=0.514N P=0.493N |P=0.593 P=0.627 P=0.347N P=0.621N | |POLY 6 | P=0.532N P=0.500N P=0.526N P=0.482N |P=0.566N P=0.634 P=0.353N P=0.575N | |LOGISTIC REGRESSION| P=0.528N (e) (e) (e) |P=0.591N P=0.644N P=0.357N P=0.635 | |COCH-ARM / FISHERS | P=0.546N P=0.500N P=0.505N P=0.500N |P=0.554 P=0.631 P=0.349N P=0.631 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) | | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.1% 0.0% | | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 1/30 (3%) 0/38 (0%) | | |FIRST INCIDENCE | --- --- 576 --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.622N (e) P=0.218 (e) | | |POLY 3 | P=0.634N (e) P=0.218 (e) | | |POLY 1.5 | P=0.640N (e) P=0.223 (e) | | |POLY 6 | P=0.627N (e) P=0.213 (e) | | |LOGISTIC REGRESSION| P=0.670N (e) P=0.242 (e) | | |COCH-ARM / FISHERS | P=0.651N (e) P=0.242 (e) | | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/49 (0%) 2/50 (4%) | | |POLY-3 ADJUSTED (b)| 4.6% 2.3% 0.0% 4.4% | | |TERMINAL (d) | 1/34 (3%) 1/36 (3%) 0/30 (0%) 2/38 (5%) | | |FIRST INCIDENCE | 721 733 (T) --- 733 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.520 P=0.484N P=0.271N P=0.653N | | |POLY 3 | P=0.507 P=0.502N P=0.260N P=0.673N | | |POLY 1.5 | P=0.497 P=0.503N P=0.253N P=0.681N | | |POLY 6 | P=0.518 P=0.500N P=0.267N P=0.663N | | |LOGISTIC REGRESSION| P=0.528 P=0.496N P=0.270N P=0.654N | | |COCH-ARM / FISHERS | P=0.480 P=0.500N P=0.253N P=0.691N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Spermatocele | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | | |POLY-3 ADJUSTED (b)| 4.6% 0.0% 0.0% 0.0% | | |TERMINAL (d) | 2/34 (6%) 0/36 (0%) 0/30 (0%) 0/38 (0%) | | |FIRST INCIDENCE | 733 (T) --- --- --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.293N P=0.226N P=0.266N P=0.214N | | |POLY 3 | P=0.293N P=0.238N P=0.260N P=0.224N | | |POLY 1.5 | P=0.298N P=0.239N P=0.253N P=0.229N | | |POLY 6 | P=0.288N P=0.236N P=0.267N P=0.218N | | |LOGISTIC REGRESSION| P=0.293N (e) (e) (e) | | |COCH-ARM / FISHERS | P=0.308N P=0.247N P=0.253N P=0.247N | | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Eye | | Cataract | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/48 (2%) 3/49 (6%) 0/49 (0%) |2/49 (4%) 1/49 (2%) 0/49 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.6% 2.4% 7.5% 0.0% |4.7% 2.3% 0.0% 2.1% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 1/30 (3%) 0/38 (0%) |2/34 (6%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 567 598 400 --- |734 (T) 448 --- 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.191N P=0.492N P=0.441 P=0.217N |P=0.518N P=0.509N P=0.252N P=0.449N | |POLY 3 | P=0.194N P=0.512N P=0.459 P=0.232N |P=0.537N P=0.500N P=0.241N P=0.468N | |POLY 1.5 | P=0.200N P=0.513N P=0.471 P=0.236N |P=0.544N P=0.502N P=0.239N P=0.478N | |POLY 6 | P=0.189N P=0.510N P=0.446 P=0.228N |P=0.529N P=0.495N P=0.243N P=0.457N | |LOGISTIC REGRESSION| P=0.238N P=0.507N P=0.569 P=0.267N |P=0.659N P=0.467N (e) P=0.521N | |COCH-ARM / FISHERS | P=0.209N P=0.515N P=0.490 P=0.253N |P=0.556N P=0.500N P=0.247N P=0.492N | |=================================================================================================================================| | | | | | | 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) | 2/50 (4%) 0/48 (0%) 0/49 (0%) 1/49 (2%) |0/49 (0%) 1/49 (2%) 2/49 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.6% 0.0% 0.0% 2.2% |0.0% 2.4% 4.7% 0.0% | |TERMINAL (d) | 2/34 (6%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 1/32 (3%) 0/40 (0%) | |FIRST INCIDENCE | 733 (T) --- --- 707 |--- 721 604 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.673N P=0.226N P=0.266N P=0.454N |P=0.433N P=0.511 P=0.243 (e) | |POLY 3 | P=0.702N P=0.243N P=0.260N P=0.486N |P=0.442N P=0.497 P=0.235 (e) | |POLY 1.5 | P=0.708N P=0.245N P=0.253N P=0.495N |P=0.451N P=0.497 P=0.236 (e) | |POLY 6 | P=0.696N P=0.241N P=0.267N P=0.475N |P=0.433N P=0.499 P=0.234 (e) | |LOGISTIC REGRESSION| P=0.685N (e) (e) P=0.476N |P=0.478N P=0.498 P=0.241 (e) | |COCH-ARM / FISHERS | P=0.699 P=0.258N P=0.253N P=0.508N |P=0.467N P=0.500 P=0.247 (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Eye: Cornea | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) |3/49 (6%) 1/49 (2%) 4/49 (8%) 26/50 (52%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |7.0% 2.4% 9.5% 54.6% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |3/34 (9%) 1/33 (3%) 4/32 (13%) 22/40 (55%) | |FIRST INCIDENCE | --- --- --- --- |734 (T) 734 (T) 734 (T) 609 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P<0.001 ** P=0.315N P=0.466 P<0.001 ** | |POLY 3 | (e) (e) (e) (e) |P<0.001 ** P=0.312N P=0.491 P<0.001 ** | |POLY 1.5 | (e) (e) (e) (e) |P<0.001 ** P=0.311N P=0.495 P<0.001 ** | |POLY 6 | (e) (e) (e) (e) |P<0.001 ** P=0.308N P=0.484 P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P<0.001 ** P=0.315N P=0.466 P<0.001 ** | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P<0.001 ** P=0.309N P=0.500 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 | | | | | |=================================================================================================================================| | | |Eye: Cornea | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/48 (0%) 2/49 (4%) 1/49 (2%) |2/49 (4%) 0/49 (0%) 4/49 (8%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 2.3% 0.0% 5.1% 2.2% |4.7% 0.0% 9.5% 14.9% | |TERMINAL (d) | 1/34 (3%) 0/36 (0%) 2/30 (7%) 1/38 (3%) |2/34 (6%) 0/33 (0%) 4/32 (13%) 6/40 (15%) | |FIRST INCIDENCE | 733 (T) --- 733 (T) 733 (T) |734 (T) --- 734 (T) 609 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.625 P=0.489N P=0.456 P=0.737N |P=0.020 * P=0.245N P=0.308 P=0.125 | |POLY 3 | P=0.613 P=0.506N P=0.465 P=0.752N |P=0.012 * P=0.241N P=0.329 P=0.102 | |POLY 1.5 | P=0.605 P=0.507N P=0.475 P=0.757N |P=0.010 * P=0.241N P=0.333 P=0.095 | |POLY 6 | P=0.621 P=0.504N P=0.455 P=0.746N |P=0.013 * P=0.239N P=0.323 P=0.112 | |LOGISTIC REGRESSION| P=0.625 (e) P=0.456 P=0.737N |P=0.015 * (e) P=0.308 P=0.103 | |COCH-ARM / FISHERS | P=0.593 P=0.510N P=0.492 P=0.747 |P=0.009 ** P=0.247N P=0.339 P=0.085 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 8 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Eye: Cornea | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/48 (2%) 0/49 (0%) 0/49 (0%) |1/49 (2%) 0/49 (0%) 1/49 (2%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 2.4% 0.0% 0.0% |2.3% 0.0% 2.4% 6.4% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 1/32 (3%) 3/40 (8%) | |FIRST INCIDENCE | --- 632 --- --- |712 --- 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.585N P=0.495 (e) (e) |P=0.121 P=0.500N P=0.740 P=0.363 | |POLY 3 | P=0.594N P=0.496 (e) (e) |P=0.096 P=0.504N P=0.757 P=0.335 | |POLY 1.5 | P=0.600N P=0.494 (e) (e) |P=0.092 P=0.504N P=0.758 P=0.326 | |POLY 6 | P=0.586N P=0.499 (e) (e) |P=0.100 P=0.503N P=0.754 P=0.344 | |LOGISTIC REGRESSION| P=0.631N P=0.495 (e) (e) |P=0.110 P=0.503N P=0.755 P=0.350 | |COCH-ARM / FISHERS | P=0.609N P=0.490 (e) (e) |P=0.084 P=0.500N P=0.753N P=0.316 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Gallbladder | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/45 (0%) 0/42 (0%) 0/42 (0%) 0/43 (0%) |0/43 (0%) 2/45 (4%) 0/47 (0%) 0/41 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 5.1% 0.0% 0.0% | |TERMINAL (d) | 0/32 (0%) 0/33 (0%) 0/28 (0%) 0/36 (0%) |0/31 (0%) 1/31 (3%) 0/32 (0%) 0/34 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 687 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.367N P=0.237 (e) (e) | |POLY 3 | (e) (e) (e) (e) |P=0.396N P=0.244 (e) (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.401N P=0.244 (e) (e) | |POLY 6 | (e) (e) (e) (e) |P=0.389N P=0.245 (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.395N P=0.244 (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.405N P=0.259 (e) (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 9 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | 46/50 (92%) 47/50 (94%) 43/50 (86%) 45/50 (90%) |36/50 (72%) 40/49 (82%) 46/49 (94%) 42/50 (84%) | |POLY-3 ADJUSTED (b)| 92.0% 97.7% 93.6% 91.5% |77.5% 85.3% 94.7% 86.2% | |TERMINAL (d) | 30/34 (88%) 35/36 (97%) 28/30 (93%) 34/38 (90%) |27/34 (79%) 29/33 (88%) 30/32 (94%) 35/40 (88%) | |FIRST INCIDENCE | 385 433 455 382 |547 441 411 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.144N P=0.501N P=0.405 P=0.210N |P=0.250N P=0.226 P=0.032 * P=0.573 | |POLY 3 | P=0.333N P=0.206 P=0.540 P=0.608N |P=0.355 P=0.231 P=0.010 * P=0.190 | |POLY 1.5 | P=0.342N P=0.256 P=0.606N P=0.576N |P=0.318 P=0.198 P=0.006 ** P=0.159 | |POLY 6 | P=0.336N P=0.193 P=0.428 P=0.627N |P=0.376 P=0.284 P=0.018 * P=0.224 | |LOGISTIC REGRESSION| P=0.248N P=0.442 P=0.432N P=0.502N |P=0.375 P=0.153 P=0.004 ** P=0.253 | |COCH-ARM / FISHERS | P=0.421N P=0.500 P=0.262N P=0.500N |P=0.236 P=0.185 P=0.004 ** P=0.114 | |=================================================================================================================================| | | | | | | 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) | 9/50 (18%) 7/49 (14%) 10/48 (21%) 5/48 (10%) |2/49 (4%) 1/48 (2%) 2/49 (4%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 20.1% 16.3% 24.5% 11.1% |4.7% 2.4% 4.7% 0.0% | |TERMINAL (d) | 6/34 (18%) 7/36 (19%) 7/30 (23%) 3/38 (8%) |1/33 (3%) 0/33 (0%) 1/32 (3%) 0/40 (0%) | |FIRST INCIDENCE | 547 733 (T) 455 413 |715 601 621 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.137N P=0.352N P=0.397 P=0.153N |P=0.184N P=0.497N P=0.687 P=0.205N | |POLY 3 | P=0.152N P=0.428N P=0.411 P=0.187N |P=0.191N P=0.499N P=0.691N P=0.218N | |POLY 1.5 | P=0.170N P=0.421N P=0.430 P=0.198N |P=0.197N P=0.504N P=0.692N P=0.225N | |POLY 6 | P=0.134N P=0.438N P=0.389 P=0.176N |P=0.184N P=0.491N P=0.692N P=0.211N | |LOGISTIC REGRESSION| P=0.208N P=0.404N P=0.486 P=0.248N |P=0.222N P=0.507N P=0.695N P=0.209N | |COCH-ARM / FISHERS | P=0.199N P=0.410N P=0.460 P=0.217N |P=0.210N P=0.508N P=0.691N P=0.247N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 10 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/49 (6%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.3% 7.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/34 (3%) 3/36 (8%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.157N P=0.325 P=0.525N P=0.478N |(e) (e) (e) (e) | |POLY 3 | P=0.152N P=0.303 P=0.520N P=0.488N |(e) (e) (e) (e) | |POLY 1.5 | P=0.159N P=0.300 P=0.514N P=0.493N |(e) (e) (e) (e) | |POLY 6 | P=0.144N P=0.305 P=0.526N P=0.482N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.157N P=0.325 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.170N P=0.301 P=0.505N P=0.500N |(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 | | | | | |=================================================================================================================================| | | |Kidney | | Hydronephrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/49 (4%) 1/49 (2%) 2/50 (4%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 4.6% 4.5% 2.5% 4.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/34 (3%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 721 287 582 582 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.621N P=0.684N P=0.544N P=0.652N |(e) (e) (e) (e) | |POLY 3 | P=0.633N P=0.685N P=0.531N P=0.665N |(e) (e) (e) (e) | |POLY 1.5 | P=0.634 P=0.691N P=0.523N P=0.677N |(e) (e) (e) (e) | |POLY 6 | P=0.618N P=0.679N P=0.539N P=0.650N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.540 P=0.696N P=0.510N P=0.665 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.617 P=0.684 P=0.508N P=0.691N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 11 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 1/49 (2%) 0/50 (0%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 4.5% 0.0% 2.5% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 537 --- 630 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.285N P=0.245N P=0.543N P=0.230N |(e) (e) (e) (e) | |POLY 3 | P=0.284N P=0.243N P=0.539N P=0.228N |(e) (e) (e) (e) | |POLY 1.5 | P=0.289N P=0.243N P=0.527N P=0.232N |(e) (e) (e) (e) | |POLY 6 | P=0.278N P=0.244N P=0.551N P=0.225N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.325N P=0.228N P=0.440N P=0.271N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.298N P=0.253N P=0.508N P=0.247N |(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 | | | | | |=================================================================================================================================| | | |Kidney | | Metaplasia Osseous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/49 (8%) 0/49 (0%) 4/50 (8%) |1/50 (2%) 3/48 (6%) 2/49 (4%) 4/49 (8%) | |POLY-3 ADJUSTED (b)| 7.0% 9.3% 0.0% 8.7% |2.3% 7.2% 4.7% 8.7% | |TERMINAL (d) | 3/34 (9%) 4/36 (11%) 0/30 (0%) 4/38 (11%) |1/34 (3%) 3/33 (9%) 1/32 (3%) 4/40 (10%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- 733 (T) |734 (T) 734 (T) 632 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.479 P=0.532 P=0.143N P=0.561 |P=0.285 P=0.294 P=0.494 P=0.231 | |POLY 3 | P=0.463 P=0.496 P=0.137N P=0.533 |P=0.236 P=0.294 P=0.495 P=0.199 | |POLY 1.5 | P=0.447 P=0.493 P=0.132N P=0.519 |P=0.222 P=0.291 P=0.495 P=0.189 | |POLY 6 | P=0.481 P=0.501 P=0.143N P=0.548 |P=0.250 P=0.300 P=0.495 P=0.211 | |LOGISTIC REGRESSION| P=0.479 P=0.532 (e) P=0.561 |P=0.253 P=0.294 P=0.493 P=0.231 | |COCH-ARM / FISHERS | P=0.424 P=0.489 P=0.125N P=0.500 |P=0.200 P=0.293 P=0.492 P=0.175 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 12 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 49/50 (98%) 48/49 (98%) 43/49 (88%) 47/50 (94%) |41/50 (82%) 35/48 (73%) 40/49 (82%) 39/49 (80%) | |POLY-3 ADJUSTED (b)| 98.5% 99.9% 95.2% 96.3% |88.3% 81.0% 83.8% 81.3% | |TERMINAL (d) | 34/34 (100%) 36/36 (100%) 30/30 (100%) 38/38 (100%)|31/34 (91%) 29/33 (88%) 26/32 (81%) 34/40 (85%) | |FIRST INCIDENCE | 385 433 455 413 |547 601 411 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.112N P=0.340N P=0.547N P=0.109N |P=0.097N P=0.197N P=0.529 P=0.069N | |POLY 3 | P=0.282N P=0.677 P=0.327N P=0.477N |P=0.341N P=0.235N P=0.365N P=0.246N | |POLY 1.5 | P=0.287N P=0.675 P=0.160N P=0.412N |P=0.441N P=0.223N P=0.449N P=0.325N | |POLY 6 | P=0.283N P=0.810 P=0.618N P=0.533N |P=0.269N P=0.249N P=0.286N P=0.188N | |LOGISTIC REGRESSION| P=0.147N P=0.737 P=0.121N P=0.239N |P=0.334N P=0.128N P=0.581N P=0.187N | |COCH-ARM / FISHERS | P=0.332N P=0.747N P=0.053N P=0.309N |P=0.500 P=0.202N P=0.584N P=0.480N | |=================================================================================================================================| | | | | | | 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 | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/49 (2%) 48/50 (96%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 97.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 38/38 (100%)|0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- --- 471 413 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.492 P<0.001 ** |(e) (e) (e) (e) | |POLY 3 | P<0.001 ** (e) P=0.484 P<0.001 ** |(e) (e) (e) (e) | |POLY 1.5 | P<0.001 ** (e) P=0.488 P<0.001 ** |(e) (e) (e) (e) | |POLY 6 | P<0.001 ** (e) P=0.479 P<0.001 ** |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.637 P<0.001 ** |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.495 P<0.001 ** |(e) (e) (e) (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 13 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | 1/50 (2%) 3/49 (6%) 0/49 (0%) 3/50 (6%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.3% 7.0% 0.0% 6.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/34 (3%) 3/36 (8%) 0/30 (0%) 2/38 (5%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- 646 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.358 P=0.325 P=0.525N P=0.343 |(e) (e) (e) (e) | |POLY 3 | P=0.346 P=0.303 P=0.520N P=0.330 |(e) (e) (e) (e) | |POLY 1.5 | P=0.332 P=0.300 P=0.514N P=0.319 |(e) (e) (e) (e) | |POLY 6 | P=0.363 P=0.305 P=0.526N P=0.342 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.355 P=0.325 (e) P=0.320 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.314 P=0.301 P=0.505N P=0.309 |(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 | | | | | |=================================================================================================================================| | | |Larynx | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/49 (2%) 2/49 (4%) 1/48 (2%) |5/49 (10%) 9/49 (18%) 3/50 (6%) 5/49 (10%) | |POLY-3 ADJUSTED (b)| 4.6% 2.3% 5.0% 2.3% |11.6% 21.2% 6.9% 10.7% | |TERMINAL (d) | 1/34 (3%) 0/36 (0%) 0/30 (0%) 0/37 (0%) |4/33 (12%) 6/33 (18%) 2/32 (6%) 3/40 (8%) | |FIRST INCIDENCE | 484 582 471 582 |352 684 693 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.459N P=0.490N P=0.658 P=0.475N |P=0.261N P=0.200 P=0.374N P=0.525N | |POLY 3 | P=0.477N P=0.504N P=0.664 P=0.496N |P=0.315N P=0.181 P=0.354N P=0.575N | |POLY 1.5 | P=0.486N P=0.506N P=0.672 P=0.504N |P=0.342N P=0.181 P=0.351N P=0.598N | |POLY 6 | P=0.466N P=0.501N P=0.657 P=0.486N |P=0.283N P=0.189 P=0.358N P=0.547N | |LOGISTIC REGRESSION| P=0.588N P=0.496N P=0.581N P=0.569N |P=0.362N P=0.191 P=0.346N P=0.506 | |COCH-ARM / FISHERS | P=0.500N P=0.508N P=0.684 P=0.515N |P=0.383N P=0.194 P=0.346N P=0.630N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 14 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Larynx | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 1/49 (2%) 0/48 (0%) |0/49 (0%) 3/49 (6%) 0/50 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 2.3% 0.0% 2.5% 0.0% |0.0% 7.1% 0.0% 2.2% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/37 (0%) |0/33 (0%) 1/33 (3%) 0/32 (0%) 1/40 (3%) | |FIRST INCIDENCE | 484 --- 532 --- |--- 721 --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.469N P=0.504N P=0.738 P=0.500N |P=0.560N P=0.127 (e) P=0.538 | |POLY 3 | P=0.473N P=0.505N P=0.738 P=0.500N |P=0.603N P=0.118 (e) P=0.518 | |POLY 1.5 | P=0.478N P=0.505N P=0.744 P=0.504N |P=0.613N P=0.118 (e) P=0.511 | |POLY 6 | P=0.468N P=0.504N P=0.732 P=0.496N |P=0.588N P=0.121 (e) P=0.525 | |LOGISTIC REGRESSION| P=0.553N P=0.445N P=0.661N P=0.534N |P=0.571N P=0.124 (e) P=0.538 | |COCH-ARM / FISHERS | P=0.485N P=0.505N P=0.747 P=0.510N |P=0.625N P=0.121 (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 | | | | | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 2/38 (5%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- --- --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.054 (e) (e) P=0.263 |(e) (e) (e) (e) | |POLY 3 | P=0.046 * (e) (e) P=0.251 |(e) (e) (e) (e) | |POLY 1.5 | P=0.044 * (e) (e) P=0.245 |(e) (e) (e) (e) | |POLY 6 | P=0.048 * (e) (e) P=0.257 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) P=0.263 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 15 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | 0/50 (0%) 5/50 (10%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 11.6% 0.0% 0.0% |0.0% 0.0% 0.0% 4.3% | |TERMINAL (d) | 0/34 (0%) 4/36 (11%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 1/40 (3%) | |FIRST INCIDENCE | --- 715 --- --- |--- --- --- 663 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.126N P=0.039 * (e) (e) |P=0.060 (e) (e) P=0.277 | |POLY 3 | P=0.117N P=0.030 * (e) (e) |P=0.046 * (e) (e) P=0.254 | |POLY 1.5 | P=0.124N P=0.030 * (e) (e) |P=0.044 * (e) (e) P=0.245 | |POLY 6 | P=0.109N P=0.030 * (e) (e) |P=0.049 * (e) (e) P=0.263 | |LOGISTIC REGRESSION| P=0.122N P=0.033 * (e) (e) |P=0.041 * (e) (e) P=0.220 | |COCH-ARM / FISHERS | P=0.140N P=0.028 * (e) (e) |P=0.041 * (e) (e) P=0.242 | |=================================================================================================================================| | | | | | | 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) | 0/50 (0%) 3/50 (6%) 3/49 (6%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 7.0% 7.7% 2.2% |0.0% 0.0% 0.0% 4.3% | |TERMINAL (d) | 0/34 (0%) 3/36 (8%) 3/30 (10%) 1/38 (3%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 2/40 (5%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) 733 (T) |--- --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.459N P=0.131 P=0.099 P=0.522 |P=0.062 (e) (e) P=0.275 | |POLY 3 | P=0.470N P=0.117 P=0.101 P=0.512 |P=0.046 * (e) (e) P=0.252 | |POLY 1.5 | P=0.484N P=0.117 P=0.106 P=0.507 |P=0.044 * (e) (e) P=0.245 | |POLY 6 | P=0.455N P=0.118 P=0.096 P=0.518 |P=0.048 * (e) (e) P=0.261 | |LOGISTIC REGRESSION| (e) P=0.131 P=0.099 P=0.522 |(e) (e) (e) P=0.275 | |COCH-ARM / FISHERS | P=0.505N P=0.121 P=0.117 P=0.500 |P=0.041 * (e) (e) P=0.242 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 16 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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%) 1/50 (2%) 0/49 (0%) 1/50 (2%) |1/50 (2%) 1/49 (2%) 1/49 (2%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 11.6% 2.3% 0.0% 2.2% |2.3% 2.3% 2.3% 2.2% | |TERMINAL (d) | 5/34 (15%) 1/36 (3%) 0/30 (0%) 1/38 (3%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 1/40 (3%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- 733 (T) |596 441 604 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.178N P=0.089N P=0.044N* P=0.079N |P=0.648N P=0.758 P=0.743N P=0.732N | |POLY 3 | P=0.178N P=0.102N P=0.039N* P=0.088N |P=0.663N P=0.757 P=0.756 P=0.748N | |POLY 1.5 | P=0.186N P=0.103N P=0.037N* P=0.093N |P=0.671N P=0.756 P=0.756 P=0.754N | |POLY 6 | P=0.170N P=0.100N P=0.042N* P=0.082N |P=0.655N P=0.760 P=0.754 P=0.741N | |LOGISTIC REGRESSION| P=0.178N P=0.089N (e) P=0.079N |P=0.541 P=0.711N P=0.755 P=0.715 | |COCH-ARM / FISHERS | P=0.203N P=0.102N P=0.030N* P=0.102N |P=0.680 P=0.747 P=0.747 P=0.747 | |=================================================================================================================================| | | | | | | 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) | 13/50 (26%) 18/50 (36%) 12/49 (24%) 14/50 (28%) |14/50 (28%) 19/49 (39%) 20/49 (41%) 8/49 (16%) | |POLY-3 ADJUSTED (b)| 30.2% 41.5% 30.4% 30.2% |31.3% 44.2% 45.5% 17.1% | |TERMINAL (d) | 13/34 (38%) 17/36 (47%) 11/30 (37%) 12/38 (32%) |9/34 (27%) 13/33 (39%) 14/32 (44%) 7/40 (18%) | |FIRST INCIDENCE | 733 (T) 574 576 582 |547 649 632 582 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.310N P=0.235 P=0.546 P=0.542N |P=0.006N** P=0.197 P=0.131 P=0.063N | |POLY 3 | P=0.340N P=0.188 P=0.586 P=0.590 |P=0.006N** P=0.150 P=0.120 P=0.088N | |POLY 1.5 | P=0.390N P=0.184 P=0.576N P=0.552 |P=0.009N** P=0.155 P=0.123 P=0.100N | |POLY 6 | P=0.286N P=0.197 P=0.563 P=0.548N |P=0.005N** P=0.152 P=0.118 P=0.079N | |LOGISTIC REGRESSION| P=0.305N P=0.184 P=0.517 P=0.563N |P=0.008N** P=0.170 P=0.126 P=0.110N | |COCH-ARM / FISHERS | P=0.465N P=0.194 P=0.523N P=0.500 |P=0.019N* P=0.178 P=0.129 P=0.124N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 17 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/49 (2%) 1/50 (2%) |1/50 (2%) 0/49 (0%) 5/49 (10%) 5/49 (10%) | |POLY-3 ADJUSTED (b)| 4.6% 2.3% 2.6% 2.2% |2.3% 0.0% 11.2% 10.8% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 1/38 (3%) |0/34 (0%) 0/33 (0%) 1/32 (3%) 4/40 (10%) | |FIRST INCIDENCE | 687 693 712 733 (T) |604 --- 411 689 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.473N P=0.497N P=0.561N P=0.464N |P=0.067 P=0.505N P=0.115 P=0.143 | |POLY 3 | P=0.494N P=0.503N P=0.537N P=0.481N |P=0.050 P=0.507N P=0.107 P=0.116 | |POLY 1.5 | P=0.504N P=0.503N P=0.526N P=0.489N |P=0.045 * P=0.507N P=0.104 P=0.109 | |POLY 6 | P=0.485N P=0.501N P=0.548N P=0.473N |P=0.056 P=0.506N P=0.108 P=0.124 | |LOGISTIC REGRESSION| P=0.498N P=0.502N P=0.532N P=0.485N |P=0.009 ** P=0.480N P=0.073 P=0.096 | |COCH-ARM / FISHERS | P=0.520N P=0.500N P=0.508N P=0.500N |P=0.038 * P=0.505N P=0.098 P=0.098 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) 2/50 (4%) |0/50 (0%) 4/49 (8%) 4/49 (8%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 2.3% 0.0% 2.6% 4.3% |0.0% 9.2% 9.2% 2.2% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 1/30 (3%) 0/38 (0%) |0/34 (0%) 2/33 (6%) 1/32 (3%) 1/40 (3%) | |FIRST INCIDENCE | 687 --- 733 (T) 637 |--- 457 411 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.288 P=0.505N P=0.721 P=0.542 |P=0.333N P=0.064 P=0.064 P=0.532 | |POLY 3 | P=0.263 P=0.502N P=0.737 P=0.523 |P=0.345N P=0.060 P=0.061 P=0.513 | |POLY 1.5 | P=0.254 P=0.502N P=0.744 P=0.513 |P=0.363N P=0.059 P=0.060 P=0.507 | |POLY 6 | P=0.273 P=0.501N P=0.729 P=0.534 |P=0.325N P=0.063 P=0.062 P=0.520 | |LOGISTIC REGRESSION| P=0.244 P=0.500N P=0.740 P=0.484 |P=0.530N P=0.066 P=0.055 P=0.532 | |COCH-ARM / FISHERS | P=0.239 P=0.500N P=0.747 P=0.500 |P=0.394N P=0.056 P=0.056 P=0.495 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 18 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Inflammation Focal Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |1/50 (2%) 2/49 (4%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.3% 4.7% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |1/34 (3%) 2/33 (6%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- --- --- --- |734 (T) 734 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.209N P=0.490 P=0.512N P=0.468N | |POLY 3 | (e) (e) (e) (e) |P=0.228N P=0.492 P=0.504N P=0.487N | |POLY 1.5 | (e) (e) (e) (e) |P=0.234N P=0.490 P=0.504N P=0.493N | |POLY 6 | (e) (e) (e) (e) |P=0.221N P=0.496 P=0.506N P=0.480N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.209N P=0.490 (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.242N P=0.492 P=0.505N P=0.505N | |=================================================================================================================================| | | | | | | 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) | 2/50 (4%) 4/50 (8%) 6/49 (12%) 2/50 (4%) |2/50 (4%) 1/49 (2%) 4/49 (8%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 4.6% 9.2% 14.5% 4.3% |4.5% 2.3% 9.3% 4.3% | |TERMINAL (d) | 0/34 (0%) 1/36 (3%) 1/30 (3%) 1/38 (3%) |0/34 (0%) 0/33 (0%) 1/32 (3%) 2/40 (5%) | |FIRST INCIDENCE | 687 598 471 637 |352 601 617 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.317N P=0.352 P=0.106 P=0.651N |P=0.592N P=0.511N P=0.335 P=0.652N | |POLY 3 | P=0.327N P=0.338 P=0.117 P=0.672N |P=0.627N P=0.513N P=0.325 P=0.679N | |POLY 1.5 | P=0.344N P=0.335 P=0.120 P=0.681N |P=0.613 P=0.513N P=0.326 P=0.688N | |POLY 6 | P=0.311N P=0.343 P=0.116 P=0.662N |P=0.614N P=0.509N P=0.325 P=0.668N | |LOGISTIC REGRESSION| P=0.418N P=0.336 P=0.168 P=0.689 |P=0.463 P=0.425N P=0.316 P=0.503 | |COCH-ARM / FISHERS | P=0.371N P=0.339 P=0.128 P=0.691N |P=0.585 P=0.508N P=0.329 P=0.684 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 19 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 3/50 (6%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 0.0% 6.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 1/36 (3%) 0/30 (0%) 3/38 (8%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- 733 (T) --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.055 P=0.511 (e) P=0.141 |(e) (e) (e) (e) | |POLY 3 | P=0.046 * P=0.499 (e) P=0.130 |(e) (e) (e) (e) | |POLY 1.5 | P=0.044 * P=0.498 (e) P=0.125 |(e) (e) (e) (e) | |POLY 6 | P=0.049 * P=0.500 (e) P=0.135 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.511 (e) P=0.141 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.041 * P=0.500 (e) P=0.121 |(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 | | | | | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/49 (2%) 2/50 (4%) |0/50 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 2.6% 4.4% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/34 (0%) 1/36 (3%) 1/30 (3%) 1/38 (3%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) 707 |--- --- 639 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.257 P=0.511 P=0.475 P=0.272 |P=0.752N (e) P=0.500 (e) | |POLY 3 | P=0.236 P=0.499 P=0.480 P=0.251 |P=0.757N (e) P=0.497 (e) | |POLY 1.5 | P=0.228 P=0.498 P=0.486 P=0.245 |P=0.761N (e) P=0.497 (e) | |POLY 6 | P=0.245 P=0.500 P=0.474 P=0.258 |P=0.752N (e) P=0.497 (e) | |LOGISTIC REGRESSION| P=0.253 P=0.511 P=0.475 P=0.253 |P=0.820N (e) P=0.493 (e) | |COCH-ARM / FISHERS | P=0.215 P=0.500 P=0.495 P=0.247 |P=0.770N (e) P=0.495 (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 20 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | 4/50 (8%) 4/50 (8%) 5/49 (10%) 7/50 (14%) |3/50 (6%) 5/49 (10%) 2/49 (4%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 9.2% 9.2% 12.6% 15.2% |6.7% 11.5% 4.7% 6.4% | |TERMINAL (d) | 3/34 (9%) 3/36 (8%) 3/30 (10%) 5/38 (13%) |1/34 (3%) 3/33 (9%) 1/32 (3%) 2/40 (5%) | |FIRST INCIDENCE | 687 497 548 707 |448 448 639 579 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.254 P=0.620N P=0.417 P=0.338 |P=0.397N P=0.334 P=0.515N P=0.609N | |POLY 3 | P=0.216 P=0.640N P=0.445 P=0.296 |P=0.435N P=0.344 P=0.521N P=0.636N | |POLY 1.5 | P=0.202 P=0.643 P=0.460 P=0.282 |P=0.449N P=0.342 P=0.516N P=0.646N | |POLY 6 | P=0.233 P=0.635N P=0.430 P=0.314 |P=0.420N P=0.350 P=0.527N P=0.624N | |LOGISTIC REGRESSION| P=0.212 P=0.641 P=0.441 P=0.312 |P=0.608 P=0.389 P=0.517N P=0.453 | |COCH-ARM / FISHERS | P=0.180 P=0.643N P=0.487 P=0.262 |P=0.471N P=0.346 P=0.510N P=0.661N | |=================================================================================================================================| | | | | | | 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) | 5/50 (10%) 2/50 (4%) 2/49 (4%) 2/50 (4%) |2/50 (4%) 0/49 (0%) 1/49 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 11.4% 4.6% 5.0% 4.4% |4.6% 0.0% 2.4% 4.3% | |TERMINAL (d) | 4/34 (12%) 1/36 (3%) 1/30 (3%) 2/38 (5%) |2/34 (6%) 0/33 (0%) 0/32 (0%) 2/40 (5%) | |FIRST INCIDENCE | 484 632 471 733 (T) |734 (T) --- 665 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.280N P=0.206N P=0.265N P=0.181N |P=0.464 P=0.245N P=0.511N P=0.635N | |POLY 3 | P=0.286N P=0.221N P=0.257N P=0.198N |P=0.430 P=0.242N P=0.506N P=0.666N | |POLY 1.5 | P=0.297N P=0.222N P=0.245N P=0.206N |P=0.420 P=0.243N P=0.506N P=0.676N | |POLY 6 | P=0.275N P=0.217N P=0.269N P=0.189N |P=0.438 P=0.239N P=0.506N P=0.655N | |LOGISTIC REGRESSION| P=0.324N P=0.216N P=0.206N P=0.214N |P=0.437 (e) P=0.508N P=0.635N | |COCH-ARM / FISHERS | P=0.317N P=0.218N P=0.226N P=0.218N |P=0.399 P=0.253N P=0.508N P=0.691N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 21 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/2 (0%) 0/2 (0%) 0/1 (0%) 0/1 (0%) |4/6 (67%) 3/4 (75%) 2/5 (40%) 0/4 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |74.2% 75.3% 47.9% 0.0% | |TERMINAL (d) | 0/1 (0%) 0/2 (0%) 0/0 (0%) 0/0 (0%) |3/3 (100%) 2/2 (100%) 1/3 (33%) 0/2 (0%) | |FIRST INCIDENCE | --- --- --- --- |596 600 637 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.033N* P=0.755N P=0.298N P=0.059N | |POLY 3 | (e) (e) (e) (e) |P=0.014N* P=0.755 P=0.437N P=0.022N* | |POLY 1.5 | (e) (e) (e) (e) |P=0.016N* P=0.708 P=0.433N P=0.029N* | |POLY 6 | (e) (e) (e) (e) |P=0.014N* P=0.745N P=0.412N P=0.015N* | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.026N* P=0.696 P=0.439N P=0.057N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.031N* P=0.667 P=0.392N P=0.071N | |=================================================================================================================================| | | | | | | 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, Bronchial | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/27 (0%) 0/22 (0%) 2/27 (7%) 0/28 (0%) |1/33 (3%) 1/27 (4%) 1/30 (3%) 2/37 (5%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 8.9% 0.0% |3.2% 4.4% 3.9% 5.8% | |TERMINAL (d) | 0/19 (0%) 0/16 (0%) 1/16 (6%) 0/19 (0%) |1/26 (4%) 1/18 (6%) 1/19 (5%) 1/29 (3%) | |FIRST INCIDENCE | --- --- 548 --- |734 (T) 734 (T) 734 (T) 713 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.628N (e) P=0.211 (e) |P=0.472 P=0.678 P=0.691 P=0.544 | |POLY 3 | P=0.611N (e) P=0.227 (e) |P=0.464 P=0.691 P=0.719 P=0.539 | |POLY 1.5 | P=0.615N (e) P=0.231 (e) |P=0.460 P=0.698 P=0.728 P=0.540 | |POLY 6 | P=0.610N (e) P=0.220 (e) |P=0.467 P=0.685 P=0.708 P=0.538 | |LOGISTIC REGRESSION| P=0.656N (e) P=0.243 (e) |P=0.471 P=0.678 P=0.691 P=0.536 | |COCH-ARM / FISHERS | P=0.624N (e) P=0.245 (e) |P=0.448 P=0.702 P=0.730 P=0.543 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 22 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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, Mandibular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/28 (0%) 0/33 (0%) 0/23 (0%) 1/28 (4%) |1/36 (3%) 2/40 (5%) 0/43 (0%) 2/40 (5%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 3.7% |3.1% 5.7% 0.0% 5.4% | |TERMINAL (d) | 0/22 (0%) 0/23 (0%) 0/14 (0%) 0/25 (0%) |1/26 (4%) 1/28 (4%) 0/27 (0%) 2/31 (7%) | |FIRST INCIDENCE | --- --- --- 707 |734 (T) 600 --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.256 (e) (e) P=0.526 |P=0.502 P=0.520 P=0.492N P=0.562 | |POLY 3 | P=0.237 (e) (e) P=0.510 |P=0.479 P=0.524 P=0.476N P=0.543 | |POLY 1.5 | P=0.231 (e) (e) P=0.506 |P=0.474 P=0.525 P=0.472N P=0.540 | |POLY 6 | P=0.243 (e) (e) P=0.515 |P=0.485 P=0.530 P=0.481N P=0.548 | |LOGISTIC REGRESSION| P=0.232 (e) (e) P=0.493 |P=0.476 P=0.543 (e) P=0.562 | |COCH-ARM / FISHERS | P=0.223 (e) (e) P=0.500 |P=0.466 P=0.540 P=0.456N P=0.540 | |=================================================================================================================================| | | | | | | 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 | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/40 (5%) 0/39 (0%) 1/38 (3%) 1/31 (3%) |4/41 (10%) 1/34 (3%) 3/40 (8%) 2/40 (5%) | |POLY-3 ADJUSTED (b)| 5.8% 0.0% 3.1% 3.3% |10.7% 3.4% 8.2% 5.2% | |TERMINAL (d) | 1/27 (4%) 0/30 (0%) 1/27 (4%) 0/26 (0%) |3/30 (10%) 0/23 (0%) 0/27 (0%) 2/35 (6%) | |FIRST INCIDENCE | 692 --- 733 (T) 637 |547 646 411 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.643N P=0.228N P=0.524N P=0.482N |P=0.381N P=0.239N P=0.522N P=0.277N | |POLY 3 | P=0.676 P=0.233N P=0.521N P=0.547N |P=0.397N P=0.256N P=0.514N P=0.321N | |POLY 1.5 | P=0.665 P=0.236N P=0.521N P=0.563N |P=0.416N P=0.251N P=0.514N P=0.333N | |POLY 6 | P=0.688 P=0.229N P=0.523N P=0.529N |P=0.377N P=0.260N P=0.514N P=0.306N | |LOGISTIC REGRESSION| P=0.652 P=0.233N P=0.520N P=0.634N |P=0.608 P=0.213N P=0.315N P=0.398N | |COCH-ARM / FISHERS | P=0.649 P=0.253N P=0.519N P=0.596N |P=0.443N P=0.243N P=0.514N P=0.350N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 23 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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, Mesenteric | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/46 (2%) 2/46 (4%) 0/47 (0%) |0/48 (0%) 1/47 (2%) 0/47 (0%) 2/46 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 2.5% 5.4% 0.0% |0.0% 2.4% 0.0% 4.6% | |TERMINAL (d) | 0/34 (0%) 1/34 (3%) 1/29 (3%) 0/36 (0%) |0/33 (0%) 1/32 (3%) 0/31 (0%) 2/37 (5%) | |FIRST INCIDENCE | --- 733 (T) 630 --- |--- 734 (T) --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.448N P=0.500 P=0.211 (e) |P=0.186 P=0.494 (e) P=0.264 | |POLY 3 | P=0.453N P=0.487 P=0.206 (e) |P=0.160 P=0.498 (e) P=0.247 | |POLY 1.5 | P=0.463N P=0.485 P=0.210 (e) |P=0.155 P=0.496 (e) P=0.240 | |POLY 6 | P=0.442N P=0.489 P=0.202 (e) |P=0.167 P=0.502 (e) P=0.255 | |LOGISTIC REGRESSION| P=0.470N P=0.500 P=0.216 (e) |(e) P=0.494 (e) P=0.264 | |COCH-ARM / FISHERS | P=0.479N P=0.479 P=0.227 (e) |P=0.145 P=0.495 (e) P=0.237 | |=================================================================================================================================| | | | | | | 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, Mesenteric | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/46 (4%) 0/46 (0%) 3/47 (6%) |0/48 (0%) 2/47 (4%) 1/47 (2%) 1/46 (2%) | |POLY-3 ADJUSTED (b)| 2.3% 5.0% 0.0% 6.9% |0.0% 4.9% 2.4% 2.3% | |TERMINAL (d) | 1/34 (3%) 2/34 (6%) 0/29 (0%) 3/36 (8%) |0/33 (0%) 2/32 (6%) 0/31 (0%) 1/37 (3%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- 733 (T) |--- 734 (T) 637 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.238 P=0.500 P=0.532N P=0.325 |P=0.666N P=0.231 P=0.510 P=0.523 | |POLY 3 | P=0.226 P=0.477 P=0.531N P=0.309 |P=0.676 P=0.235 P=0.499 P=0.509 | |POLY 1.5 | P=0.217 P=0.474 P=0.526N P=0.299 |P=0.664 P=0.233 P=0.498 P=0.502 | |POLY 6 | P=0.237 P=0.480 P=0.535N P=0.320 |P=0.685N P=0.239 P=0.499 P=0.516 | |LOGISTIC REGRESSION| P=0.238 P=0.500 (e) P=0.325 |P=0.662 P=0.231 P=0.491 P=0.523 | |COCH-ARM / FISHERS | P=0.202 P=0.468 P=0.521N P=0.285 |P=0.645 P=0.242 P=0.495 P=0.489 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 24 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 0/2 (0%) 0/2 (0%) 0/0 (0%) |0/50 (0%) 2/49 (4%) 1/49 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.7% 2.4% 4.3% | |TERMINAL (d) | 0/1 (0%) 0/2 (0%) 0/0 (0%) 0/0 (0%) |0/34 (0%) 1/33 (3%) 1/32 (3%) 1/40 (3%) | |FIRST INCIDENCE | --- --- --- --- |--- 721 734 (T) 713 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.410 P=0.243 P=0.488 P=0.276 | |POLY 3 | (e) (e) (e) (e) |P=0.378 P=0.232 P=0.496 P=0.255 | |POLY 1.5 | (e) (e) (e) (e) |P=0.366 P=0.231 P=0.496 P=0.248 | |POLY 6 | (e) (e) (e) (e) |P=0.391 P=0.235 P=0.494 P=0.263 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.393 P=0.237 P=0.488 P=0.260 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.346 P=0.242 P=0.495 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 | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/7 (100%) 4/4 (100%) 6/7 (86%) 3/3 (100%) |13/15 (87%) 6/6 (100%) 8/11 (73%) 7/10 (70%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 85.7% 100.0% |87.2% 100.0% 75.0% 74.4% | |TERMINAL (d) | 5/5 (100%) 2/2 (100%) 4/5 (80%) 3/3 (100%) |12/13 (92%) 5/5 (100%) 6/8 (75%) 4/5 (80%) | |FIRST INCIDENCE | 385 665 630 733 (T) |566 497 621 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.166N (e) P=0.544N (e) |P=0.448 P=0.594 P=0.550N P=0.527 | |POLY 3 | P=0.859N (e) P=0.500N (e) |P=0.262N P=0.468 P=0.395N P=0.396N | |POLY 1.5 | P=0.859N (e) P=0.500N (e) |P=0.229N P=0.461 P=0.376N P=0.354N | |POLY 6 | P=0.859N (e) P=0.500N (e) |P=0.321N P=0.481 P=0.426N P=0.467N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.215N P=0.469 P=0.363N P=0.363N | |COCH-ARM / FISHERS | P=0.871N (e) P=0.500N (e) |P=0.193N P=0.500 P=0.346N P=0.301N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 25 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 11/49 (22%) 27/49 (55%) 28/50 (56%) |5/50 (10%) 12/48 (25%) 25/49 (51%) 42/50 (84%) | |POLY-3 ADJUSTED (b)| 16.0% 25.0% 64.9% 59.0% |11.1% 28.0% 56.9% 85.3% | |TERMINAL (d) | 5/34 (15%) 8/36 (22%) 21/30 (70%) 23/38 (61%) |2/34 (6%) 9/33 (27%) 22/32 (69%) 35/40 (88%) | |FIRST INCIDENCE | 547 574 287 413 |448 497 411 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.265 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.055 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.216 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.040 * P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.210 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.040 * P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.226 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.041 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.207 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.045 * P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.204 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.044 * 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: Glands | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 10/49 (20%) 48/49 (98%) 46/50 (92%) |0/50 (0%) 33/48 (69%) 46/49 (94%) 47/50 (94%) | |POLY-3 ADJUSTED (b)| 0.0% 22.9% 99.4% 92.9% |0.0% 75.3% 96.3% 95.0% | |TERMINAL (d) | 0/34 (0%) 7/36 (19%) 30/30 (100%) 35/38 (92%) |0/34 (0%) 29/33 (88%) 31/32 (97%) 38/40 (95%) | |FIRST INCIDENCE | --- 574 287 382 |--- 457 413 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 26 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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: Glands | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 6/49 (12%) 35/49 (71%) 47/50 (94%) |1/50 (2%) 1/48 (2%) 34/49 (69%) 46/50 (92%) | |POLY-3 ADJUSTED (b)| 0.0% 13.6% 79.5% 94.1% |2.3% 2.4% 70.6% 93.1% | |TERMINAL (d) | 0/34 (0%) 4/36 (11%) 25/30 (83%) 36/38 (95%) |1/34 (3%) 1/33 (3%) 20/32 (63%) 38/40 (95%) | |FIRST INCIDENCE | --- 287 287 382 |734 (T) 734 (T) 411 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.755 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.754 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.752 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.017 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.758 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.015 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.755 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.742 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) | 0/50 (0%) 9/49 (18%) 10/49 (20%) 20/50 (40%) |3/50 (6%) 14/48 (29%) 16/49 (33%) 36/50 (72%) | |POLY-3 ADJUSTED (b)| 0.0% 19.6% 24.2% 42.4% |6.8% 30.9% 34.0% 72.9% | |TERMINAL (d) | 0/34 (0%) 4/36 (11%) 5/30 (17%) 16/38 (42%) |1/34 (3%) 5/33 (15%) 6/32 (19%) 28/40 (70%) | |FIRST INCIDENCE | --- 287 471 582 |448 457 411 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.006 ** P=0.002 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.003 ** 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=0.002 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 27 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 3/49 (6%) 0/50 (0%) |0/50 (0%) 0/48 (0%) 4/49 (8%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 7.6% 0.0% |0.0% 0.0% 9.2% 2.1% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 2/30 (7%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 2/32 (6%) 1/40 (3%) | |FIRST INCIDENCE | --- --- 548 --- |--- --- 469 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.551N (e) P=0.103 (e) |P=0.563 (e) P=0.063 P=0.532 | |POLY 3 | P=0.559N (e) P=0.103 (e) |P=0.559 (e) P=0.060 P=0.515 | |POLY 1.5 | P=0.567N (e) P=0.107 (e) |P=0.544 (e) P=0.059 P=0.510 | |POLY 6 | P=0.550N (e) P=0.100 (e) |P=0.573 (e) P=0.060 P=0.521 | |LOGISTIC REGRESSION| P=0.589N (e) P=0.117 (e) |P=0.468 (e) P=0.058 P=0.532 | |COCH-ARM / FISHERS | P=0.578N (e) P=0.117 (e) |P=0.514 (e) P=0.056 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 | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 15/49 (31%) 49/49 (100%) 50/50 (100%)|2/50 (4%) 35/48 (73%) 49/49 (100%) 50/50 (100%) | |POLY-3 ADJUSTED (b)| 6.8% 33.6% 100.0% 100.0% |4.6% 78.1% 100.0% 100.0% | |TERMINAL (d) | 1/34 (3%) 10/36 (28%) 30/30 (100%) 38/38 (100%)|1/34 (3%) 28/33 (85%) 32/32 (100%) 40/40 (100%) | |FIRST INCIDENCE | 547 574 287 382 |547 441 411 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.005 ** 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=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 28 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/49 (6%) 21/49 (43%) 39/50 (78%) |7/50 (14%) 14/48 (29%) 28/49 (57%) 45/50 (90%) | |POLY-3 ADJUSTED (b)| 4.5% 6.9% 50.4% 81.7% |16.2% 32.1% 59.0% 90.2% | |TERMINAL (d) | 0/34 (0%) 2/36 (6%) 15/30 (50%) 32/38 (84%) |7/34 (21%) 10/33 (30%) 15/32 (47%) 36/40 (90%) | |FIRST INCIDENCE | 567 632 471 413 |734 (T) 457 413 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.512 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.063 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.490 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.067 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.490 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.060 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.491 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.080 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.490 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.058 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.490 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.056 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 | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 12/49 (24%) 49/49 (100%) 50/50 (100%)|0/50 (0%) 31/48 (65%) 49/49 (100%) 49/50 (98%) | |POLY-3 ADJUSTED (b)| 0.0% 27.2% 100.0% 100.0% |0.0% 71.0% 100.0% 98.0% | |TERMINAL (d) | 0/34 (0%) 8/36 (22%) 30/30 (100%) 38/38 (100%)|0/34 (0%) 27/33 (82%) 32/32 (100%) 39/40 (98%) | |FIRST INCIDENCE | --- 574 287 382 |--- 457 411 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 29 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 18/49 (37%) 42/49 (86%) 45/50 (90%) |19/50 (38%) 44/48 (92%) 49/49 (100%) 48/50 (96%) | |POLY-3 ADJUSTED (b)| 11.5% 41.2% 89.7% 92.5% |42.3% 94.5% 100.0% 96.0% | |TERMINAL (d) | 4/34 (12%) 15/36 (42%) 27/30 (90%) 35/38 (92%) |14/34 (41%) 31/33 (94%) 32/32 (100%) 38/40 (95%) | |FIRST INCIDENCE | 651 582 287 413 |547 261 411 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P=0.046 * 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=0.002 ** 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=0.002 ** 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%) 2/49 (4%) 10/49 (20%) 20/50 (40%) |1/50 (2%) 9/48 (19%) 21/49 (43%) 39/50 (78%) | |POLY-3 ADJUSTED (b)| 0.0% 4.6% 24.6% 42.3% |2.3% 20.7% 45.5% 79.7% | |TERMINAL (d) | 0/34 (0%) 1/36 (3%) 6/30 (20%) 17/38 (45%) |0/34 (0%) 4/33 (12%) 12/32 (38%) 32/40 (80%) | |FIRST INCIDENCE | --- 433 471 582 |651 600 411 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.244 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.240 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.237 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.242 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.241 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.242 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 30 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/49 (0%) 1/50 (2%) |0/50 (0%) 0/48 (0%) 2/49 (4%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 2.3% 0.0% 0.0% 2.2% |0.0% 0.0% 4.7% 6.4% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 1/38 (3%) |0/34 (0%) 0/33 (0%) 1/32 (3%) 3/40 (8%) | |FIRST INCIDENCE | 721 --- --- 733 (T) |--- --- 665 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.547 P=0.494N P=0.531N P=0.736N |P=0.074 (e) P=0.236 P=0.151 | |POLY 3 | P=0.538 P=0.502N P=0.520N P=0.747N |P=0.057 (e) P=0.233 P=0.133 | |POLY 1.5 | P=0.533 P=0.503N P=0.514N P=0.753N |P=0.054 (e) P=0.233 P=0.128 | |POLY 6 | P=0.544 P=0.500N P=0.526N P=0.741N |P=0.060 (e) P=0.233 P=0.139 | |LOGISTIC REGRESSION| P=0.549 P=0.500N P=0.526N P=0.741N |P=0.061 (e) P=0.233 P=0.151 | |COCH-ARM / FISHERS | P=0.525 P=0.505N P=0.505N P=0.753N |P=0.048 * (e) P=0.242 P=0.121 | |=================================================================================================================================| | | | | | | 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 | | Regeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/49 (2%) 13/49 (27%) 21/50 (42%) |0/50 (0%) 0/48 (0%) 9/49 (18%) 13/50 (26%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 32.7% 43.4% |0.0% 0.0% 20.9% 27.1% | |TERMINAL (d) | 0/34 (0%) 1/36 (3%) 10/30 (33%) 14/38 (37%) |0/34 (0%) 0/33 (0%) 6/32 (19%) 9/40 (23%) | |FIRST INCIDENCE | --- 733 (T) 651 382 |--- --- 637 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.511 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.003 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.499 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.002 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.497 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.002 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.511 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.002 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.495 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 31 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 2/49 (4%) 1/48 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| |0.0% 4.7% 2.4% 0.0% | |TERMINAL (d) | |0/34 (0%) 1/33 (3%) 0/31 (0%) 0/40 (0%) | |FIRST INCIDENCE | |--- 649 698 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.331N P=0.236 P=0.483 (e) | |POLY 3 | |P=0.344N P=0.233 P=0.491 (e) | |POLY 1.5 | |P=0.354N P=0.232 P=0.492 (e) | |POLY 6 | |P=0.332N P=0.237 P=0.490 (e) | |LOGISTIC REGRESSION| |P=0.369N P=0.233 P=0.492 (e) | |COCH-ARM / FISHERS | |P=0.368N P=0.242 P=0.490 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |4/50 (8%) 3/49 (6%) 1/48 (2%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| |9.3% 7.1% 2.4% 4.3% | |TERMINAL (d) | |4/34 (12%) 3/33 (9%) 0/31 (0%) 2/40 (5%) | |FIRST INCIDENCE | |734 (T) 734 (T) 639 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.271N P=0.517N P=0.204N P=0.264N | |POLY 3 | |P=0.319N P=0.513N P=0.190N P=0.307N | |POLY 1.5 | |P=0.332N P=0.515N P=0.190N P=0.322N | |POLY 6 | |P=0.305N P=0.506N P=0.190N P=0.291N | |LOGISTIC REGRESSION| |P=0.296N P=0.517N P=0.194N P=0.264N | |COCH-ARM / FISHERS | |P=0.355N P=0.511N P=0.194N P=0.349N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 32 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | |14/50 (28%) 14/49 (29%) 18/48 (38%) 15/49 (31%) | |POLY-3 ADJUSTED (b)| |31.3% 32.4% 41.9% 31.9% | |TERMINAL (d) | |10/34 (29%) 11/33 (33%) 15/31 (48%) 11/40 (28%) | |FIRST INCIDENCE | |448 457 413 609 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.351N P=0.557 P=0.193 P=0.486N | |POLY 3 | |P=0.496N P=0.545 P=0.204 P=0.565 | |POLY 1.5 | |P=0.544N P=0.546 P=0.211 P=0.530 | |POLY 6 | |P=0.440N P=0.550 P=0.189 P=0.573N | |LOGISTIC REGRESSION| |P=0.547N P=0.557 P=0.213 P=0.505 | |COCH-ARM / FISHERS | |P=0.490 P=0.563 P=0.216 P=0.474 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Ovary: Interstitial Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/50 (2%) 2/49 (4%) 1/48 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| |2.3% 4.7% 2.4% 0.0% | |TERMINAL (d) | |1/34 (3%) 1/33 (3%) 1/31 (3%) 0/40 (0%) | |FIRST INCIDENCE | |734 (T) 649 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.205N P=0.493 P=0.741 P=0.468N | |POLY 3 | |P=0.220N P=0.494 P=0.751 P=0.487N | |POLY 1.5 | |P=0.228N P=0.492 P=0.751 P=0.493N | |POLY 6 | |P=0.211N P=0.501 P=0.749 P=0.480N | |LOGISTIC REGRESSION| |P=0.223N P=0.491 P=0.741 (e) | |COCH-ARM / FISHERS | |P=0.240N P=0.492 P=0.742 P=0.505N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 33 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 3/49 (6%) 4/48 (8%) 10/49 (20%) |7/50 (14%) 3/48 (6%) 5/49 (10%) 9/49 (18%) | |POLY-3 ADJUSTED (b)| 16.2% 7.0% 10.2% 21.9% |16.2% 7.1% 11.7% 19.3% | |TERMINAL (d) | 6/34 (18%) 3/36 (8%) 3/30 (10%) 8/38 (21%) |7/34 (21%) 2/33 (6%) 4/32 (13%) 8/40 (20%) | |FIRST INCIDENCE | 721 733 (T) 471 413 |734 (T) 601 621 609 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.091 P=0.137N P=0.335N P=0.387 |P=0.220 P=0.168N P=0.412N P=0.530 | |POLY 3 | P=0.070 P=0.159N P=0.315N P=0.343 |P=0.152 P=0.163N P=0.387N P=0.457 | |POLY 1.5 | P=0.062 P=0.163N P=0.305N P=0.318 |P=0.138 P=0.170N P=0.389N P=0.425 | |POLY 6 | P=0.080 P=0.155N P=0.325N P=0.371 |P=0.167 P=0.152N P=0.387N P=0.493 | |LOGISTIC REGRESSION| P=0.066 P=0.143N P=0.325N P=0.315 |P=0.164 P=0.163N P=0.405N P=0.487 | |COCH-ARM / FISHERS | P=0.053 P=0.167N P=0.286N P=0.282 |P=0.115 P=0.176N P=0.394N P=0.376 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 2/48 (4%) 0/49 (0%) |1/50 (2%) 0/48 (0%) 2/49 (4%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 2.3% 0.0% 5.2% 0.0% |2.3% 0.0% 4.7% 2.2% | |TERMINAL (d) | 1/34 (3%) 0/36 (0%) 2/30 (7%) 0/38 (0%) |1/34 (3%) 0/33 (0%) 0/32 (0%) 1/40 (3%) | |FIRST INCIDENCE | 733 (T) --- 733 (T) --- |734 (T) --- 632 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.409N P=0.489N P=0.456 P=0.478N |P=0.637 P=0.506N P=0.498 P=0.725N | |POLY 3 | P=0.422N P=0.501N P=0.461 P=0.492N |P=0.627 P=0.506N P=0.497 P=0.746N | |POLY 1.5 | P=0.429N P=0.503N P=0.470 P=0.497N |P=0.615 P=0.508N P=0.496 P=0.753N | |POLY 6 | P=0.414N P=0.500N P=0.453 P=0.487N |P=0.638 P=0.502N P=0.499 P=0.737N | |LOGISTIC REGRESSION| P=0.409N (e) P=0.456 (e) |P=0.587 (e) P=0.492 P=0.725N | |COCH-ARM / FISHERS | P=0.439N P=0.505N P=0.485 P=0.505N |P=0.593 P=0.510N P=0.492 P=0.747 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 34 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | 3/50 (6%) 4/48 (8%) 1/48 (2%) 2/49 (4%) |15/48 (31%) 17/48 (35%) 15/48 (31%) 17/49 (35%) | |POLY-3 ADJUSTED (b)| 7.0% 9.6% 2.6% 4.5% |35.7% 40.8% 35.2% 36.4% | |TERMINAL (d) | 3/34 (9%) 4/35 (11%) 1/29 (3%) 2/37 (5%) |14/33 (42%) 14/33 (42%) 12/32 (38%) 14/40 (35%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |651 684 637 665 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.327N P=0.516 P=0.363N P=0.461N |P=0.367N P=0.413 P=0.557 P=0.504N | |POLY 3 | P=0.336N P=0.484 P=0.352N P=0.483N |P=0.505N P=0.396 P=0.572N P=0.559 | |POLY 1.5 | P=0.350N P=0.480 P=0.340N P=0.494N |P=0.557N P=0.396 P=0.578N P=0.514 | |POLY 6 | P=0.320N P=0.487 P=0.364N P=0.470N |P=0.449N P=0.411 P=0.567N P=0.567N | |LOGISTIC REGRESSION| P=0.327N P=0.516 P=0.363N P=0.461N |P=0.442N P=0.435 P=0.581 P=0.561N | |COCH-ARM / FISHERS | P=0.371N P=0.477 P=0.324N P=0.510N |P=0.467 P=0.414 P=0.587N P=0.443 | |=================================================================================================================================| | | | | | | 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 | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/49 (6%) 2/49 (4%) 6/50 (12%) | | |POLY-3 ADJUSTED (b)| 7.0% 7.0% 5.1% 12.9% | | |TERMINAL (d) | 3/34 (9%) 3/36 (8%) 1/30 (3%) 2/38 (5%) | | |FIRST INCIDENCE | 733 (T) 733 (T) 665 637 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.174 P=0.637N P=0.555N P=0.313 | | |POLY 3 | P=0.147 P=0.660 P=0.543N P=0.279 | | |POLY 1.5 | P=0.136 P=0.656 P=0.531N P=0.263 | | |POLY 6 | P=0.163 P=0.662N P=0.554N P=0.301 | | |LOGISTIC REGRESSION| P=0.152 P=0.637N P=0.559N P=0.268 | | |COCH-ARM / FISHERS | P=0.120 P=0.651 P=0.510N P=0.243 | | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 35 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | 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 | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/49 (0%) 1/49 (2%) 2/50 (4%) | | |POLY-3 ADJUSTED (b)| 7.0% 0.0% 2.6% 4.4% | | |TERMINAL (d) | 2/34 (6%) 0/36 (0%) 0/30 (0%) 1/38 (3%) | | |FIRST INCIDENCE | 721 --- 665 707 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.586 P=0.115N P=0.354N P=0.444N | | |POLY 3 | P=0.567 P=0.120N P=0.340N P=0.472N | | |POLY 1.5 | P=0.558 P=0.121N P=0.330N P=0.484N | | |POLY 6 | P=0.578 P=0.118N P=0.349N P=0.459N | | |LOGISTIC REGRESSION| P=0.572 P=0.118N P=0.345N P=0.457N | | |COCH-ARM / FISHERS | P=0.543 P=0.125N P=0.316N 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 | | | | | |=================================================================================================================================| | | |Skin | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/48 (0%) 0/49 (0%) |1/50 (2%) 0/49 (0%) 1/49 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.6% 2.3% 0.0% 0.0% |2.3% 0.0% 2.4% 2.1% | |TERMINAL (d) | 1/34 (3%) 1/36 (3%) 0/29 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 721 733 (T) --- --- |693 --- 665 574 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.199N P=0.484N P=0.275N P=0.216N |P=0.600 P=0.505N P=0.757 P=0.732N | |POLY 3 | P=0.200N P=0.502N P=0.266N P=0.227N |P=0.596 P=0.505N P=0.756 P=0.742N | |POLY 1.5 | P=0.206N P=0.503N P=0.259N P=0.233N |P=0.586 P=0.506N P=0.756 P=0.749N | |POLY 6 | P=0.193N P=0.500N P=0.274N P=0.220N |P=0.605 P=0.504N P=0.755 P=0.734N | |LOGISTIC REGRESSION| P=0.195N P=0.496N P=0.277N P=0.216N |P=0.504 P=0.505N P=0.758 P=0.684 | |COCH-ARM / FISHERS | P=0.216N P=0.500N P=0.258N P=0.253N |P=0.566 P=0.505N P=0.747 P=0.753N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 36 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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: Prepuce | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/48 (6%) 2/49 (4%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.5% 4.6% 7.7% 4.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 1/36 (3%) 1/29 (3%) 1/38 (3%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 537 287 582 716 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.551N P=0.690 P=0.441 P=0.662N |(e) (e) (e) (e) | |POLY 3 | P=0.576N P=0.692 P=0.442 P=0.683N |(e) (e) (e) (e) | |POLY 1.5 | P=0.589N P=0.692 P=0.456 P=0.690N |(e) (e) (e) (e) | |POLY 6 | P=0.562N P=0.692 P=0.429 P=0.675N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.579 P=0.620N P=0.537 P=0.655 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.608N P=0.691N P=0.480 P=0.684 |(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: Subcutaneous Tissue | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/48 (2%) 0/49 (0%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.6% 2.6% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 1/29 (3%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- 590 733 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.343N P=0.242 P=0.468 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.346N P=0.240 P=0.475 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.357N P=0.237 P=0.481 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.334N P=0.244 P=0.468 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.383N P=0.251 P=0.468 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.371N P=0.247 P=0.490 (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 37 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 12/49 (24%) 11/49 (22%) 9/50 (18%) |11/50 (22%) 11/48 (23%) 12/49 (24%) 17/49 (35%) | |POLY-3 ADJUSTED (b)| 15.2% 26.0% 26.5% 18.9% |24.7% 24.8% 26.0% 35.9% | |TERMINAL (d) | 1/34 (3%) 5/36 (14%) 3/30 (10%) 4/38 (11%) |6/34 (18%) 6/33 (18%) 3/32 (9%) 13/40 (33%) | |FIRST INCIDENCE | 465 287 497 413 |566 457 411 582 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.407N P=0.188 P=0.161 P=0.471 |P=0.208 P=0.566 P=0.473 P=0.271 | |POLY 3 | P=0.456N P=0.154 P=0.150 P=0.423 |P=0.102 P=0.590 P=0.537 P=0.172 | |POLY 1.5 | P=0.474N P=0.149 P=0.166 P=0.411 |P=0.090 P=0.572 P=0.516 P=0.151 | |POLY 6 | P=0.437N P=0.161 P=0.142 P=0.439 |P=0.113 P=0.583N P=0.554 P=0.196 | |LOGISTIC REGRESSION| P=0.529 P=0.110 P=0.264 P=0.266 |P=0.037 * P=0.554 P=0.474 P=0.131 | |COCH-ARM / FISHERS | P=0.502N P=0.142 P=0.204 P=0.393 |P=0.071 P=0.553 P=0.478 P=0.119 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/49 (0%) 0/50 (0%) |8/50 (16%) 8/48 (17%) 4/49 (8%) 5/49 (10%) | |POLY-3 ADJUSTED (b)| 0.0% 4.7% 0.0% 0.0% |18.5% 18.9% 9.5% 10.8% | |TERMINAL (d) | 0/34 (0%) 2/36 (6%) 0/30 (0%) 0/38 (0%) |7/34 (21%) 7/33 (21%) 4/32 (13%) 5/40 (13%) | |FIRST INCIDENCE | --- 733 (T) --- --- |715 600 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.371N P=0.251 (e) (e) |P=0.137N P=0.589 P=0.207N P=0.181N | |POLY 3 | P=0.368N P=0.235 (e) (e) |P=0.189N P=0.592 P=0.186N P=0.234N | |POLY 1.5 | P=0.376N P=0.234 (e) (e) |P=0.207N P=0.580 P=0.186N P=0.255N | |POLY 6 | P=0.358N P=0.237 (e) (e) |P=0.171N P=0.608N P=0.189N P=0.213N | |LOGISTIC REGRESSION| (e) P=0.251 (e) (e) |P=0.159N P=0.602 P=0.207N P=0.186N | |COCH-ARM / FISHERS | P=0.388N P=0.242 (e) (e) |P=0.239N P=0.572 P=0.188N P=0.290N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 38 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 2/48 (4%) 1/49 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 0.0% 2.2% |0.0% 4.8% 2.3% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 1/38 (3%) |0/34 (0%) 1/33 (3%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | --- 497 --- 733 (T) |--- 721 632 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.494 P=0.500 (e) P=0.522 |P=0.332N P=0.243 P=0.514 (e) | |POLY 3 | P=0.498 P=0.502 (e) P=0.512 |P=0.342N P=0.231 P=0.497 (e) | |POLY 1.5 | P=0.491 P=0.499 (e) P=0.507 |P=0.352N P=0.229 P=0.497 (e) | |POLY 6 | P=0.507 P=0.505 (e) P=0.518 |P=0.330N P=0.235 P=0.497 (e) | |LOGISTIC REGRESSION| P=0.446 P=0.547 (e) P=0.522 |P=0.367N P=0.236 P=0.493 (e) | |COCH-ARM / FISHERS | P=0.480 P=0.495 (e) P=0.500 |P=0.367N P=0.237 P=0.495 (e) | |=================================================================================================================================| | | | | | | 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 | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 3/48 (6%) 0/49 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 0.0% |0.0% 7.0% 0.0% 2.2% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 1/33 (3%) 0/32 (0%) 1/40 (3%) | |FIRST INCIDENCE | --- --- 502 --- |--- 441 --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.760N (e) P=0.482 (e) |P=0.573N P=0.121 (e) P=0.532 | |POLY 3 | P=0.762N (e) P=0.484 (e) |P=0.598N P=0.116 (e) P=0.513 | |POLY 1.5 | P=0.766N (e) P=0.489 (e) |P=0.610N P=0.114 (e) P=0.507 | |POLY 6 | P=0.758N (e) P=0.479 (e) |P=0.583N P=0.120 (e) P=0.520 | |LOGISTIC REGRESSION| P=0.849N (e) P=0.631 (e) |P=0.687N P=0.118 (e) P=0.532 | |COCH-ARM / FISHERS | P=0.771N (e) P=0.500 (e) |P=0.625N P=0.114 (e) P=0.495 | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 39 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/49 (10%) 2/50 (4%) 5/50 (10%) |2/50 (4%) 8/48 (17%) 6/49 (12%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 4.6% 11.4% 5.0% 10.9% |4.5% 18.6% 13.6% 6.5% | |TERMINAL (d) | 1/34 (3%) 3/36 (8%) 1/30 (3%) 5/38 (13%) |0/34 (0%) 5/33 (15%) 2/32 (6%) 2/40 (5%) | |FIRST INCIDENCE | 484 497 502 733 (T) |352 441 413 689 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.338 P=0.238 P=0.654 P=0.258 |P=0.230N P=0.049 * P=0.143 P=0.544 | |POLY 3 | P=0.313 P=0.217 P=0.658 P=0.234 |P=0.261N P=0.038 * P=0.128 P=0.517 | |POLY 1.5 | P=0.301 P=0.213 P=0.670 P=0.227 |P=0.277N P=0.038 * P=0.128 P=0.506 | |POLY 6 | P=0.327 P=0.223 P=0.648 P=0.243 |P=0.242N P=0.040 * P=0.129 P=0.530 | |LOGISTIC REGRESSION| P=0.264 P=0.206 P=0.632N P=0.216 |P=0.446N P=0.042 * P=0.102 P=0.211 | |COCH-ARM / FISHERS | P=0.283 P=0.210 P=0.691N P=0.218 |P=0.303N P=0.039 * P=0.128 P=0.490 | |=================================================================================================================================| | | | | | | 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 | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/48 (0%) 2/47 (4%) 2/48 (4%) |0/50 (0%) 2/46 (4%) 2/49 (4%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 2.3% 0.0% 5.2% 4.5% |0.0% 5.0% 4.7% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 2/30 (7%) 2/38 (5%) |0/34 (0%) 2/33 (6%) 2/32 (6%) 0/40 (0%) | |FIRST INCIDENCE | 567 --- 733 (T) 733 (T) |--- 734 (T) 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.331 P=0.491N P=0.457 P=0.536 |P=0.296N P=0.232 P=0.225 (e) | |POLY 3 | P=0.306 P=0.508N P=0.456 P=0.504 |P=0.313N P=0.221 P=0.232 (e) | |POLY 1.5 | P=0.298 P=0.508N P=0.464 P=0.496 |P=0.326N P=0.219 P=0.233 (e) | |POLY 6 | P=0.316 P=0.508N P=0.446 P=0.513 |P=0.298N P=0.225 P=0.230 (e) | |LOGISTIC REGRESSION| P=0.295 P=0.488N P=0.479 P=0.469 |(e) P=0.232 P=0.225 (e) | |COCH-ARM / FISHERS | P=0.285 P=0.510N P=0.477 P=0.485 |P=0.348N P=0.227 P=0.242 (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 40 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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 | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/48 (0%) 1/47 (2%) 0/48 (0%) |1/50 (2%) 0/46 (0%) 0/49 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 4.6% 0.0% 2.6% 0.0% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 661 --- 471 --- |715 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.283N P=0.243N P=0.541N P=0.216N |P=0.523N P=0.494N P=0.518N P=0.473N | |POLY 3 | P=0.291N P=0.245N P=0.537N P=0.234N |P=0.544N P=0.515N P=0.505N P=0.489N | |POLY 1.5 | P=0.297N P=0.246N P=0.531N P=0.239N |P=0.546N P=0.517N P=0.504N P=0.497N | |POLY 6 | P=0.285N P=0.245N P=0.544N P=0.228N |P=0.543N P=0.512N P=0.507N P=0.482N | |LOGISTIC REGRESSION| P=0.332N P=0.247N P=0.471N P=0.255N |P=0.533N P=0.514N P=0.505N P=0.494N | |COCH-ARM / FISHERS | P=0.305N P=0.258N P=0.523N P=0.258N |P=0.548N P=0.521N P=0.505N P=0.510N | |=================================================================================================================================| | | | | | | 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) | 4/50 (8%) 3/50 (6%) 5/49 (10%) 2/50 (4%) | | |POLY-3 ADJUSTED (b)| 9.1% 6.9% 12.6% 4.4% | | |TERMINAL (d) | 1/34 (3%) 1/36 (3%) 3/30 (10%) 2/38 (5%) | | |FIRST INCIDENCE | 567 598 582 733 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.247N P=0.484N P=0.420 P=0.291N | | |POLY 3 | P=0.262N P=0.501N P=0.436 P=0.317N | | |POLY 1.5 | P=0.273N P=0.503N P=0.454 P=0.325N | | |POLY 6 | P=0.253N P=0.496N P=0.417 P=0.309N | | |LOGISTIC REGRESSION| P=0.289N P=0.490N P=0.464 P=0.335N | | |COCH-ARM / FISHERS | P=0.293N P=0.500N P=0.487 P=0.339N | | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 41 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 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) | 8/50 (16%) 9/49 (18%) 6/49 (12%) 13/48 (27%) |17/50 (34%) 21/49 (43%) 17/49 (35%) 30/49 (61%) | |POLY-3 ADJUSTED (b)| 18.1% 21.0% 15.4% 29.6% |39.1% 49.3% 39.8% 64.6% | |TERMINAL (d) | 5/34 (15%) 9/36 (25%) 6/30 (20%) 12/37 (32%) |15/34 (44%) 18/33 (55%) 15/32 (47%) 28/40 (70%) | |FIRST INCIDENCE | 484 733 (T) 733 (T) 707 |693 681 637 689 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.140 P=0.538 P=0.488N P=0.226 |P=0.045 * P=0.231 P=0.500 P=0.040 * | |POLY 3 | P=0.095 P=0.470 P=0.488N P=0.152 |P=0.007 ** P=0.229 P=0.564 P=0.010 * | |POLY 1.5 | P=0.087 P=0.474 P=0.455N P=0.146 |P=0.005 ** P=0.226 P=0.562 P=0.008 ** | |POLY 6 | P=0.105 P=0.463 P=0.523N P=0.160 |P=0.010 * P=0.246 P=0.561 P=0.014 * | |LOGISTIC REGRESSION| P=0.122 P=0.493 P=0.462N P=0.166 |P=0.020 * P=0.255 P=0.515 P=0.024 * | |COCH-ARM / FISHERS | P=0.077 P=0.482 P=0.403N P=0.138 |P=0.004 ** P=0.242 P=0.555 P=0.006 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Trachea | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/48 (0%) 0/48 (0%) 0/49 (0%) |0/50 (0%) 0/48 (0%) 1/49 (2%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 4.6% 0.0% 0.0% 0.0% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 1/34 (3%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 597 --- --- --- |--- --- 411 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.295N P=0.233N P=0.268N P=0.220N |P=0.768N (e) P=0.504 (e) | |POLY 3 | P=0.296N P=0.246N P=0.265N P=0.231N |P=0.761N (e) P=0.499 (e) | |POLY 1.5 | P=0.301N P=0.246N P=0.258N P=0.235N |P=0.766N (e) P=0.499 (e) | |POLY 6 | P=0.292N P=0.245N P=0.272N P=0.226N |P=0.755N (e) P=0.499 (e) | |LOGISTIC REGRESSION| P=0.314N P=0.247N P=0.239N P=0.256N |P=0.910 (e) P=0.432 (e) | |COCH-ARM / FISHERS | P=0.308N P=0.258N P=0.258N P=0.253N |P=0.776N (e) P=0.495 (e) | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 42 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | 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 | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/47 (2%) 0/47 (0%) 0/50 (0%) |0/49 (0%) 0/45 (0%) 0/49 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 4.5% 2.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/35 (0%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/31 (0%) 0/32 (0%) 0/40 (0%) | |FIRST INCIDENCE | 537 693 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.201N P=0.503N P=0.270N P=0.230N |(e) (e) (e) (e) | |POLY 3 | P=0.196N P=0.524N P=0.271N P=0.228N |(e) (e) (e) (e) | |POLY 1.5 | P=0.201N P=0.524N P=0.263N P=0.232N |(e) (e) (e) (e) | |POLY 6 | P=0.191N P=0.525N P=0.279N P=0.225N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.223N P=0.514N P=0.202N P=0.271N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.208N P=0.523N P=0.263N P=0.247N |(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 | | | | | |=================================================================================================================================| | | |Uterus | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |3/50 (6%) 0/49 (0%) 4/49 (8%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| |6.8% 0.0% 9.5% 4.4% | |TERMINAL (d) | |1/34 (3%) 0/33 (0%) 4/32 (13%) 1/39 (3%) | |FIRST INCIDENCE | |547 --- 734 (T) 689 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.564N P=0.132N P=0.482 P=0.451N | |POLY 3 | |P=0.605N P=0.127N P=0.475 P=0.484N | |POLY 1.5 | |P=0.619N P=0.126N P=0.482 P=0.493N | |POLY 6 | |P=0.594N P=0.127N P=0.464 P=0.475N | |LOGISTIC REGRESSION| |P=0.606 P=0.109N P=0.489 P=0.613N | |COCH-ARM / FISHERS | |P=0.606 P=0.125N P=0.489 P=0.510N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 43 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |5/50 (10%) 5/49 (10%) 4/49 (8%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| |11.4% 11.8% 9.4% 6.5% | |TERMINAL (d) | |3/34 (9%) 4/33 (12%) 3/32 (9%) 2/39 (5%) | |FIRST INCIDENCE | |651 730 637 579 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.210N P=0.612 P=0.525N P=0.292N | |POLY 3 | |P=0.244N P=0.607 P=0.517N P=0.328N | |POLY 1.5 | |P=0.261N P=0.608 P=0.514N P=0.342N | |POLY 6 | |P=0.229N P=0.609 P=0.526N P=0.314N | |LOGISTIC REGRESSION| |P=0.259N P=0.620 P=0.513N P=0.389N | |COCH-ARM / FISHERS | |P=0.291N P=0.617 P=0.513N P=0.369N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |4/50 (8%) 3/49 (6%) 2/49 (4%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| |9.2% 7.1% 4.7% 0.0% | |TERMINAL (d) | |3/34 (9%) 3/33 (9%) 2/32 (6%) 0/39 (0%) | |FIRST INCIDENCE | |689 734 (T) 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.039N* P=0.518N P=0.367N P=0.049N* | |POLY 3 | |P=0.044N* P=0.515N P=0.349N P=0.054N | |POLY 1.5 | |P=0.047N* P=0.516N P=0.347N P=0.057N | |POLY 6 | |P=0.041N* P=0.510N P=0.354N P=0.051N | |LOGISTIC REGRESSION| |P=0.042N* P=0.501N P=0.356N P=0.052N | |COCH-ARM / FISHERS | |P=0.054N P=0.511N P=0.349N P=0.061N | |=================================================================================================================================| Date: 04/25/97 EXPERIMENT: 05201 TEST: 06 Page 44 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - FURFURYL ALCOHOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/50 (2%) 2/49 (4%) 1/49 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| |2.3% 4.7% 2.4% 0.0% | |TERMINAL (d) | |0/34 (0%) 1/33 (3%) 1/32 (3%) 0/39 (0%) | |FIRST INCIDENCE | |693 600 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.211N P=0.496 P=0.747 P=0.475N | |POLY 3 | |P=0.224N P=0.494 P=0.755 P=0.490N | |POLY 1.5 | |P=0.230N P=0.492 P=0.756 P=0.495N | |POLY 6 | |P=0.217N P=0.500 P=0.753 P=0.484N | |LOGISTIC REGRESSION| |P=0.242N P=0.496 P=0.757 P=0.514N | |COCH-ARM / FISHERS | |P=0.240N P=0.492 P=0.747 P=0.505N | |=================================================================================================================================| (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).