TDMS Study 88050-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus METHACRYLONITRILE DATE: 02/24/00 EXPERIMENT: 88050 TEST: 05 TIME: 14:19:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: 88050B PATHOLOGIST: YARRINGTON, JOHN CAS: 126-98-7 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#1 2 YEAR CHRONIC RATS REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus METHACRYLONITRILE DATE: 02/24/00 EXPERIMENT: 88050 TEST: 05 TIME: 14:19:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: 88050B PATHOLOGIST: YARRINGTON, JOHN CAS: 126-98-7 Rats(FISCHER 344) ----------------------------- 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 THE NUMBER OF ANIMALS NECROPSIED. --------------- Adrenal Cortex Adrenal Medulla Brain Clitoral/Preputial Gland Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Prostate Salivary Glands Spleen Testes Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus METHACRYLONITRILE DATE: 02/24/00 EXPERIMENT: 88050 TEST: 05 TIME: 14:19:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: 88050B PATHOLOGIST: YARRINGTON, JOHN CAS: 126-98-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF METHACRYLONITRILE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Testes Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Malignant and Benign Tumors =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Skin Fibroma Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma =============================================================== Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 4.4% 0.0% 0.0% |2.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/25 (4%) 1/34 (3%) 0/35 (0%) 0/31 (0%) |1/38 (3%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) 592 --- --- |731 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.197N P=0.584 P=0.433N P=0.457N |P=0.474N P=0.528N P=0.522N P=0.511N | |POLY 3 | P=0.203N P=0.537 P=0.483N P=0.490N |P=0.463N P=0.513N P=0.516N P=0.511N | |POLY 1.5 | P=0.205N P=0.524 P=0.490N P=0.493N |P=0.467N P=0.508N P=0.511N P=0.507N | |POLY 6 | P=0.200N P=0.555 P=0.473N P=0.484N |P=0.459N P=0.519N P=0.520N P=0.515N | |LOGISTIC REGRESSION| P=0.209N P=0.502 (e) (e) |P=0.474N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.209N P=0.500 P=0.500N P=0.500N |P=0.474N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 7/50 (14%) 6/50 (12%) 2/50 (4%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 7.3% 15.5% 13.5% 4.6% |2.1% 6.8% 4.7% 2.3% | |TERMINAL (d) | 2/25 (8%) 6/34 (18%) 6/35 (17%) 1/31 (3%) |0/38 (0%) 2/33 (6%) 2/34 (6%) 1/36 (3%) | |FIRST INCIDENCE | 716 697 729 (T) 680 |718 441 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.152N P=0.299 P=0.425 P=0.415N |P=0.421N P=0.270 P=0.456 P=0.743 | |POLY 3 | P=0.167N P=0.199 P=0.283 P=0.475N |P=0.440N P=0.288 P=0.471 P=0.748 | |POLY 1.5 | P=0.172N P=0.185 P=0.266 P=0.483N |P=0.433N P=0.295 P=0.480 P=0.752 | |POLY 6 | P=0.158N P=0.221 P=0.310 P=0.461N |P=0.447N P=0.279 P=0.464 P=0.743 | |LOGISTIC REGRESSION| P=0.164N P=0.249 P=0.387 P=0.458N |P=0.416N P=0.363 P=0.461 P=0.746 | |COCH-ARM / FISHERS | P=0.185N P=0.159 P=0.243 P=0.500N |P=0.419N P=0.309 P=0.500 P=0.753N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 2.2% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/25 (4%) 0/34 (0%) 2/35 (6%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) 536 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.320N P=0.719N P=0.617 P=0.457N |(e) (e) (e) (e) | |POLY 3 | P=0.333N P=0.736N P=0.529 P=0.490N |(e) (e) (e) (e) | |POLY 1.5 | P=0.332N P=0.744N P=0.517 P=0.493N |(e) (e) (e) (e) | |POLY 6 | P=0.332N P=0.724N P=0.547 P=0.484N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.334N P=0.735 P=0.617 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.333N P=0.753N P=0.500 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 8/50 (16%) 8/50 (16%) 2/50 (4%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 9.8% 17.5% 18.0% 4.6% |2.1% 6.8% 4.7% 2.3% | |TERMINAL (d) | 3/25 (12%) 6/34 (18%) 8/35 (23%) 1/31 (3%) |0/38 (0%) 2/33 (6%) 2/34 (6%) 1/36 (3%) | |FIRST INCIDENCE | 716 536 729 (T) 680 |718 441 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.089N P=0.335 P=0.372 P=0.254N |P=0.421N P=0.270 P=0.456 P=0.743 | |POLY 3 | P=0.101N P=0.235 P=0.217 P=0.311N |P=0.440N P=0.288 P=0.471 P=0.748 | |POLY 1.5 | P=0.104N P=0.213 P=0.201 P=0.320N |P=0.433N P=0.295 P=0.480 P=0.752 | |POLY 6 | P=0.095N P=0.264 P=0.245 P=0.297N |P=0.447N P=0.279 P=0.464 P=0.743 | |LOGISTIC REGRESSION| P=0.104N P=0.232 P=0.333 P=0.290N |P=0.416N P=0.363 P=0.461 P=0.746 | |COCH-ARM / FISHERS | P=0.114N P=0.178 P=0.178 P=0.339N |P=0.419N P=0.309 P=0.500 P=0.753N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Bone | | Osteosarcoma or Osteoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 4.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 1/34 (3%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 474 716 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.201N P=0.566 P=0.500N P=0.500N |(e) (e) (e) (e) | |POLY 3 | P=0.205N P=0.528 P=0.487N P=0.493N |(e) (e) (e) (e) | |POLY 1.5 | P=0.206N P=0.519 P=0.492N P=0.495N |(e) (e) (e) (e) | |POLY 6 | P=0.202N P=0.541 P=0.478N P=0.489N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.218N P=0.451 P=0.591N P=0.605N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.209N P=0.500 P=0.500N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 4/49 (8%) |2/49 (4%) 0/48 (0%) 0/50 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 4.9% 2.2% 9.0% 9.5% |4.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/25 (8%) 1/34 (3%) 4/35 (11%) 3/30 (10%) |2/37 (5%) 0/31 (0%) 0/34 (0%) 0/34 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 681 |731 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.181 P=0.393N P=0.500 P=0.418 |P=0.246N P=0.278N P=0.257N P=0.257N | |POLY 3 | P=0.169 P=0.466N P=0.376 P=0.352 |P=0.231N P=0.258N P=0.251N P=0.255N | |POLY 1.5 | P=0.170 P=0.478N P=0.360 P=0.344 |P=0.235N P=0.252N P=0.245N P=0.251N | |POLY 6 | P=0.170 P=0.451N P=0.401 P=0.365 |P=0.227N P=0.265N P=0.255N P=0.260N | |LOGISTIC REGRESSION| P=0.173 P=0.393N P=0.500 P=0.375 |P=0.246N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.170 P=0.500N P=0.339 P=0.329 |P=0.243N P=0.253N P=0.242N P=0.253N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 2/49 (4%) |1/49 (2%) 2/48 (4%) 1/50 (2%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 2.2% 6.6% 4.6% |2.2% 4.8% 2.3% 0.0% | |TERMINAL (d) | 0/25 (0%) 1/34 (3%) 1/35 (3%) 0/30 (0%) |0/37 (0%) 2/31 (7%) 1/34 (3%) 0/34 (0%) | |FIRST INCIDENCE | 579 729 (T) 464 466 |438 731 (T) 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.403 P=0.716N P=0.366 P=0.514 |P=0.237N P=0.457 P=0.744 P=0.504N | |POLY 3 | P=0.402 P=0.741N P=0.338 P=0.514 |P=0.249N P=0.462 P=0.743 P=0.519N | |POLY 1.5 | P=0.399 P=0.748N P=0.325 P=0.507 |P=0.244N P=0.474 P=0.750 P=0.514N | |POLY 6 | P=0.408 P=0.733N P=0.358 P=0.524 |P=0.255N P=0.450 P=0.738 P=0.524N | |LOGISTIC REGRESSION| P=0.360 P=0.748 P=0.258 P=0.415 |P=0.219N P=0.586 P=0.664N P=0.260N | |COCH-ARM / FISHERS | P=0.390 P=0.753N P=0.309 P=0.492 |P=0.233N P=0.492 P=0.747N P=0.505N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 7/50 (14%) 6/49 (12%) |3/49 (6%) 2/48 (4%) 1/50 (2%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 7.2% 4.4% 15.4% 13.9% |6.5% 4.8% 2.3% 0.0% | |TERMINAL (d) | 2/25 (8%) 2/34 (6%) 5/35 (14%) 3/30 (10%) |2/37 (5%) 2/31 (7%) 1/34 (3%) 0/34 (0%) | |FIRST INCIDENCE | 579 729 (T) 464 466 |438 731 (T) 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.141 P=0.381N P=0.289 P=0.313 |P=0.090N P=0.566N P=0.335N P=0.134N | |POLY 3 | P=0.132 P=0.461N P=0.196 P=0.263 |P=0.090N P=0.549N P=0.333N P=0.137N | |POLY 1.5 | P=0.129 P=0.474N P=0.181 P=0.253 |P=0.089N P=0.534N P=0.322N P=0.132N | |POLY 6 | P=0.137 P=0.445N P=0.221 P=0.279 |P=0.091N P=0.565N P=0.342N P=0.142N | |LOGISTIC REGRESSION| P=0.125 P=0.470N P=0.163 P=0.229 |P=0.084N P=0.461N P=0.240N P=0.076N | |COCH-ARM / FISHERS | P=0.125 P=0.500N P=0.159 P=0.233 |P=0.087N P=0.510N P=0.301N P=0.125N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.4% 2.3% 2.3% |0.0% 2.3% 2.3% 0.0% | |TERMINAL (d) | 0/25 (0%) 2/34 (6%) 1/35 (3%) 0/31 (0%) |0/38 (0%) 1/33 (3%) 1/34 (3%) 0/36 (0%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 680 |--- 731 (T) 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.638 P=0.308 P=0.567 P=0.528 |P=0.535N P=0.472 P=0.478 (e) | |POLY 3 | P=0.638 P=0.259 P=0.516 P=0.511 |P=0.550N P=0.487 P=0.484 (e) | |POLY 1.5 | P=0.631 P=0.252 P=0.510 P=0.507 |P=0.546N P=0.492 P=0.489 (e) | |POLY 6 | P=0.648 P=0.270 P=0.527 P=0.517 |P=0.555N P=0.481 P=0.480 (e) | |LOGISTIC REGRESSION| P=0.625 P=0.308 P=0.567 P=0.502 |(e) P=0.472 P=0.478 (e) | |COCH-ARM / FISHERS | P=0.619 P=0.247 P=0.500 P=0.500 |P=0.536N P=0.500 P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 2/34 (6%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- 729 (T) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.353N P=0.308 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.348N P=0.259 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.355N P=0.252 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.340N P=0.270 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.308 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.369N P=0.247 (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 4/50 (8%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 8.9% 2.3% 2.3% |0.0% 2.3% 2.3% 0.0% | |TERMINAL (d) | 0/25 (0%) 4/34 (12%) 1/35 (3%) 0/31 (0%) |0/38 (0%) 1/33 (3%) 1/34 (3%) 0/36 (0%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 680 |--- 731 (T) 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.440N P=0.107 P=0.567 P=0.528 |P=0.535N P=0.472 P=0.478 (e) | |POLY 3 | P=0.436N P=0.073 P=0.516 P=0.511 |P=0.550N P=0.487 P=0.484 (e) | |POLY 1.5 | P=0.445N P=0.069 P=0.510 P=0.507 |P=0.546N P=0.492 P=0.489 (e) | |POLY 6 | P=0.422N P=0.080 P=0.527 P=0.517 |P=0.555N P=0.481 P=0.480 (e) | |LOGISTIC REGRESSION| P=0.455N P=0.107 P=0.567 P=0.502 |(e) P=0.472 P=0.478 (e) | |COCH-ARM / FISHERS | P=0.465N P=0.059 P=0.500 P=0.500 |P=0.536N P=0.500 P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |1/50 (2%) 0/49 (0%) 0/48 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 4.4% 0.0% 0.0% |2.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/25 (4%) 2/34 (6%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- |589 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.192N P=0.607 P=0.433N P=0.457N |P=0.482N P=0.517N P=0.522N P=0.517N | |POLY 3 | P=0.206N P=0.534 P=0.483N P=0.493N |P=0.463N P=0.516N P=0.521N P=0.513N | |POLY 1.5 | P=0.208N P=0.522 P=0.490N P=0.497N |P=0.467N P=0.511N P=0.517N P=0.509N | |POLY 6 | P=0.203N P=0.549 P=0.473N P=0.488N |P=0.458N P=0.522N P=0.524N P=0.518N | |LOGISTIC REGRESSION| P=0.192N P=0.607 (e) (e) |P=0.437N P=0.424N P=0.417N P=0.414N | |COCH-ARM / FISHERS | P=0.213N P=0.500 P=0.500N P=0.505N |P=0.473N P=0.505N P=0.510N P=0.500N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 6.6% 2.3% 2.3% |0.0% 0.0% 0.0% 4.5% | |TERMINAL (d) | 0/25 (0%) 2/34 (6%) 1/35 (3%) 1/31 (3%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 1/36 (3%) | |FIRST INCIDENCE | --- 674 729 (T) 729 (T) |--- --- --- 549 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.564N P=0.175 P=0.567 P=0.543 |P=0.044 * (e) (e) P=0.229 | |POLY 3 | P=0.559N P=0.138 P=0.516 P=0.510 |P=0.040 * (e) (e) P=0.228 | |POLY 1.5 | P=0.566N P=0.131 P=0.510 P=0.507 |P=0.040 * (e) (e) P=0.231 | |POLY 6 | P=0.549N P=0.148 P=0.527 P=0.516 |P=0.040 * (e) (e) P=0.225 | |LOGISTIC REGRESSION| P=0.575N P=0.140 P=0.567 P=0.543 |P=0.044 * (e) (e) P=0.277 | |COCH-ARM / FISHERS | P=0.581N P=0.121 P=0.500 P=0.500 |P=0.042 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 6.6% 2.3% 2.3% |0.0% 0.0% 0.0% 4.5% | |TERMINAL (d) | 0/25 (0%) 2/34 (6%) 1/35 (3%) 1/31 (3%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 1/36 (3%) | |FIRST INCIDENCE | --- 674 729 (T) 729 (T) |--- --- --- 549 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.564N P=0.175 P=0.567 P=0.543 |P=0.044 * (e) (e) P=0.229 | |POLY 3 | P=0.559N P=0.138 P=0.516 P=0.510 |P=0.040 * (e) (e) P=0.228 | |POLY 1.5 | P=0.566N P=0.131 P=0.510 P=0.507 |P=0.040 * (e) (e) P=0.231 | |POLY 6 | P=0.549N P=0.148 P=0.527 P=0.516 |P=0.040 * (e) (e) P=0.225 | |LOGISTIC REGRESSION| P=0.575N P=0.140 P=0.567 P=0.543 |P=0.044 * (e) (e) P=0.277 | |COCH-ARM / FISHERS | P=0.581N P=0.121 P=0.500 P=0.500 |P=0.042 * (e) (e) P=0.247 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.4% 2.3% 2.3% 2.3% | |TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |3/38 (8%) 0/33 (0%) 1/34 (3%) 1/36 (3%) | |FIRST INCIDENCE | --- --- --- --- |731 (T) 609 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.347N P=0.353N P=0.345N P=0.324N | |POLY 3 | (e) (e) (e) (e) |P=0.344N P=0.326N P=0.335N P=0.326N | |POLY 1.5 | (e) (e) (e) (e) |P=0.344N P=0.318N P=0.326N P=0.319N | |POLY 6 | (e) (e) (e) (e) |P=0.344N P=0.334N P=0.342N P=0.332N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.350N P=0.305N P=0.345N P=0.324N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.342N P=0.309N P=0.309N P=0.309N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.4% 2.3% 2.3% 2.3% | |TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |3/38 (8%) 0/33 (0%) 1/34 (3%) 1/36 (3%) | |FIRST INCIDENCE | --- --- --- --- |731 (T) 609 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.347N P=0.353N P=0.345N P=0.324N | |POLY 3 | (e) (e) (e) (e) |P=0.344N P=0.326N P=0.335N P=0.326N | |POLY 1.5 | (e) (e) (e) (e) |P=0.344N P=0.318N P=0.326N P=0.319N | |POLY 6 | (e) (e) (e) (e) |P=0.344N P=0.334N P=0.342N P=0.332N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.350N P=0.305N P=0.345N P=0.324N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.342N P=0.309N P=0.309N P=0.309N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 7/50 (14%) 2/50 (4%) 8/50 (16%) |21/50 (42%) 26/50 (52%) 19/50 (38%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 4.9% 15.4% 4.5% 18.5% |44.9% 57.0% 43.5% 39.5% | |TERMINAL (d) | 0/25 (0%) 5/34 (15%) 2/35 (6%) 7/31 (23%) |19/38 (50%) 20/33 (61%) 15/34 (44%) 13/36 (36%) | |FIRST INCIDENCE | 724 696 729 (T) 680 |679 527 651 499 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.100 P=0.168 P=0.583N P=0.092 |P=0.161N P=0.080 P=0.566 P=0.424N | |POLY 3 | P=0.089 P=0.105 P=0.664N P=0.053 |P=0.155N P=0.165 P=0.531N P=0.378N | |POLY 1.5 | P=0.087 P=0.095 P=0.676N P=0.051 |P=0.154N P=0.179 P=0.500N P=0.369N | |POLY 6 | P=0.092 P=0.119 P=0.645N P=0.058 |P=0.153N P=0.155 P=0.547N P=0.381N | |LOGISTIC REGRESSION| P=0.086 P=0.127 P=0.603N P=0.067 |P=0.177N P=0.121 P=0.579 P=0.427N | |COCH-ARM / FISHERS | P=0.084 P=0.080 P=0.691N P=0.046 * |P=0.149N P=0.212 P=0.419N P=0.341N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 7/50 (14%) 2/50 (4%) 8/50 (16%) |21/50 (42%) 26/50 (52%) 19/50 (38%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 4.9% 15.4% 4.5% 18.5% |44.9% 57.0% 43.5% 39.5% | |TERMINAL (d) | 0/25 (0%) 5/34 (15%) 2/35 (6%) 7/31 (23%) |19/38 (50%) 20/33 (61%) 15/34 (44%) 13/36 (36%) | |FIRST INCIDENCE | 724 696 729 (T) 680 |679 527 651 499 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.100 P=0.168 P=0.583N P=0.092 |P=0.161N P=0.080 P=0.566 P=0.424N | |POLY 3 | P=0.089 P=0.105 P=0.664N P=0.053 |P=0.155N P=0.165 P=0.531N P=0.378N | |POLY 1.5 | P=0.087 P=0.095 P=0.676N P=0.051 |P=0.154N P=0.179 P=0.500N P=0.369N | |POLY 6 | P=0.092 P=0.119 P=0.645N P=0.058 |P=0.153N P=0.155 P=0.547N P=0.381N | |LOGISTIC REGRESSION| P=0.086 P=0.127 P=0.603N P=0.067 |P=0.177N P=0.121 P=0.579 P=0.427N | |COCH-ARM / FISHERS | P=0.084 P=0.080 P=0.691N P=0.046 * |P=0.149N P=0.212 P=0.419N P=0.341N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 7/50 (14%) 2/50 (4%) 8/50 (16%) |23/50 (46%) 26/50 (52%) 20/50 (40%) 19/50 (38%) | |POLY-3 ADJUSTED (b)| 4.9% 15.4% 4.5% 18.5% |49.1% 57.0% 45.7% 41.7% | |TERMINAL (d) | 0/25 (0%) 5/34 (15%) 2/35 (6%) 7/31 (23%) |21/38 (55%) 20/33 (61%) 16/34 (47%) 14/36 (39%) | |FIRST INCIDENCE | 724 696 729 (T) 680 |679 527 651 499 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.100 P=0.168 P=0.583N P=0.092 |P=0.153N P=0.149 P=0.529N P=0.355N | |POLY 3 | P=0.089 P=0.105 P=0.664N P=0.053 |P=0.147N P=0.289 P=0.455N P=0.304N | |POLY 1.5 | P=0.087 P=0.095 P=0.676N P=0.051 |P=0.147N P=0.306 P=0.424N P=0.297N | |POLY 6 | P=0.092 P=0.119 P=0.645N P=0.058 |P=0.144N P=0.278 P=0.471N P=0.306N | |LOGISTIC REGRESSION| P=0.086 P=0.127 P=0.603N P=0.067 |P=0.171N P=0.217 P=0.521N P=0.359N | |COCH-ARM / FISHERS | P=0.084 P=0.080 P=0.691N P=0.046 * |P=0.142N P=0.345 P=0.343N P=0.272N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.9% 0.0% 2.3% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/25 (8%) 0/34 (0%) 1/35 (3%) 2/31 (7%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.426 P=0.173N P=0.383N P=0.616N |(e) (e) (e) (e) | |POLY 3 | P=0.391 P=0.217N P=0.471N P=0.676N |(e) (e) (e) (e) | |POLY 1.5 | P=0.398 P=0.225N P=0.483N P=0.681N |(e) (e) (e) (e) | |POLY 6 | P=0.385 P=0.207N P=0.453N P=0.666N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.426 (e) P=0.383N P=0.616N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.407 P=0.253N P=0.500N P=0.691N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/50 (34%) 18/50 (36%) 11/50 (22%) 20/50 (40%) |12/50 (24%) 14/50 (28%) 19/50 (38%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 38.0% 39.1% 23.6% 45.4% |25.7% 31.6% 43.9% 31.3% | |TERMINAL (d) | 8/25 (32%) 13/34 (38%) 7/35 (20%) 14/31 (45%) |10/38 (26%) 10/33 (30%) 16/34 (47%) 13/36 (36%) | |FIRST INCIDENCE | 453 592 464 624 |718 609 690 527 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.359 P=0.337N P=0.050N P=0.574N |P=0.458 P=0.269 P=0.048 * P=0.347 | |POLY 3 | P=0.242 P=0.547 P=0.100N P=0.312 |P=0.418 P=0.347 P=0.052 P=0.358 | |POLY 1.5 | P=0.260 P=0.537 P=0.111N P=0.330 |P=0.431 P=0.369 P=0.064 P=0.375 | |POLY 6 | P=0.229 P=0.565 P=0.085N P=0.305 |P=0.405 P=0.326 P=0.045 * P=0.341 | |LOGISTIC REGRESSION| P=0.288 P=0.527 P=0.155N P=0.374 |P=0.405 P=0.298 P=0.039 * P=0.328 | |COCH-ARM / FISHERS | P=0.284 P=0.500 P=0.133N P=0.339 |P=0.459 P=0.410 P=0.097 P=0.410 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/50 (34%) 18/50 (36%) 11/50 (22%) 20/50 (40%) |13/50 (26%) 14/50 (28%) 19/50 (38%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 38.0% 39.1% 23.6% 45.4% |27.8% 31.6% 43.9% 31.3% | |TERMINAL (d) | 8/25 (32%) 13/34 (38%) 7/35 (20%) 14/31 (45%) |11/38 (29%) 10/33 (30%) 16/34 (47%) 13/36 (36%) | |FIRST INCIDENCE | 453 592 464 624 |718 609 690 527 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.359 P=0.337N P=0.050N P=0.574N |P=0.514 P=0.342 P=0.073 P=0.432 | |POLY 3 | P=0.242 P=0.547 P=0.100N P=0.312 |P=0.478 P=0.434 P=0.082 P=0.446 | |POLY 1.5 | P=0.260 P=0.537 P=0.111N P=0.330 |P=0.490 P=0.458 P=0.098 P=0.463 | |POLY 6 | P=0.229 P=0.565 P=0.085N P=0.305 |P=0.465 P=0.412 P=0.071 P=0.428 | |LOGISTIC REGRESSION| P=0.288 P=0.527 P=0.155N P=0.374 |P=0.462 P=0.379 P=0.061 P=0.412 | |COCH-ARM / FISHERS | P=0.284 P=0.500 P=0.133N P=0.339 |P=0.516 P=0.500 P=0.142 P=0.500 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Salivary Glands | | Schwannoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.8% 0.0% 2.3% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/34 (0%) 1/35 (3%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 563 --- 729 (T) 618 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.614N P=0.214N P=0.442N P=0.480N |(e) (e) (e) (e) | |POLY 3 | P=0.629N P=0.220N P=0.478N P=0.486N |(e) (e) (e) (e) | |POLY 1.5 | P=0.625N P=0.226N P=0.487N P=0.490N |(e) (e) (e) (e) | |POLY 6 | P=0.634N P=0.214N P=0.465N P=0.479N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.634N P=0.285N P=0.524N P=0.549N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.619N P=0.247N P=0.500N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous | | Tumor (benign, malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.5% 0.0% |2.1% 2.3% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/34 (0%) 1/35 (3%) 0/31 (0%) |1/38 (3%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- --- 722 --- |731 (T) 609 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.684N (e) P=0.314 (e) |P=0.311N P=0.735 P=0.522N P=0.511N | |POLY 3 | P=0.696N (e) P=0.256 (e) |P=0.306N P=0.748 P=0.516N P=0.511N | |POLY 1.5 | P=0.696N (e) P=0.248 (e) |P=0.305N P=0.752 P=0.511N P=0.507N | |POLY 6 | P=0.694N (e) P=0.269 (e) |P=0.307N P=0.743 P=0.520N P=0.515N | |LOGISTIC REGRESSION| P=0.692N (e) P=0.289 (e) |P=0.295N P=0.742N (e) (e) | |COCH-ARM / FISHERS | P=0.697N (e) P=0.247 (e) |P=0.303N P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor | | (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 5/50 (10%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.8% 11.0% 11.2% 4.6% |4.3% 2.3% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 3/34 (9%) 4/35 (11%) 2/31 (7%) |2/38 (5%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 579 674 722 729 (T) |731 (T) 609 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.330N P=0.326 P=0.340 P=0.644N |P=0.176N P=0.543N P=0.263N P=0.250N | |POLY 3 | P=0.349N P=0.253 P=0.243 P=0.682N |P=0.168N P=0.520N P=0.256N P=0.250N | |POLY 1.5 | P=0.349N P=0.241 P=0.233 P=0.685N |P=0.168N P=0.513N P=0.250N P=0.246N | |POLY 6 | P=0.347N P=0.270 P=0.261 P=0.677N |P=0.168N P=0.527N P=0.260N P=0.254N | |LOGISTIC REGRESSION| P=0.351N P=0.218 P=0.237 P=0.694N |P=0.168N P=0.487N (e) (e) | |COCH-ARM / FISHERS | P=0.357N P=0.218 P=0.218 P=0.691N |P=0.169N P=0.500N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/50 (8%) 2/50 (4%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 7.3% 8.8% 4.5% 11.6% |0.0% 0.0% 0.0% 4.5% | |TERMINAL (d) | 2/25 (8%) 2/34 (6%) 2/35 (6%) 5/31 (16%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 2/36 (6%) | |FIRST INCIDENCE | 701 641 729 (T) 729 (T) |--- --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.334 P=0.637 P=0.361N P=0.472 |P=0.044 * (e) (e) P=0.226 | |POLY 3 | P=0.308 P=0.557 P=0.464N P=0.383 |P=0.039 * (e) (e) P=0.225 | |POLY 1.5 | P=0.309 P=0.537 P=0.478N P=0.375 |P=0.040 * (e) (e) P=0.229 | |POLY 6 | P=0.307 P=0.585 P=0.441N P=0.396 |P=0.039 * (e) (e) P=0.221 | |LOGISTIC REGRESSION| P=0.311 P=0.552 P=0.405N P=0.435 |(e) (e) (e) P=0.226 | |COCH-ARM / FISHERS | P=0.305 P=0.500 P=0.500N P=0.357 |P=0.042 * (e) (e) P=0.247 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 3/50 (6%) 8/50 (16%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 7.3% 11.0% 6.8% 18.2% |0.0% 0.0% 0.0% 4.5% | |TERMINAL (d) | 2/25 (8%) 3/34 (9%) 3/35 (9%) 5/31 (16%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 2/36 (6%) | |FIRST INCIDENCE | 701 641 729 (T) 603 |--- --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.085 P=0.508 P=0.511N P=0.168 |P=0.044 * (e) (e) P=0.226 | |POLY 3 | P=0.078 P=0.416 P=0.625N P=0.121 |P=0.039 * (e) (e) P=0.225 | |POLY 1.5 | P=0.076 P=0.394 P=0.640N P=0.113 |P=0.040 * (e) (e) P=0.229 | |POLY 6 | P=0.082 P=0.445 P=0.601N P=0.135 |P=0.039 * (e) (e) P=0.221 | |LOGISTIC REGRESSION| P=0.073 P=0.416 P=0.560N P=0.115 |(e) (e) (e) P=0.226 | |COCH-ARM / FISHERS | P=0.072 P=0.357 P=0.661N P=0.100 |P=0.042 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.3% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/34 (0%) 1/35 (3%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- --- 729 (T) 603 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.085 (e) P=0.567 P=0.260 |(e) (e) (e) (e) | |POLY 3 | P=0.086 (e) P=0.516 P=0.252 |(e) (e) (e) (e) | |POLY 1.5 | P=0.085 (e) P=0.510 P=0.247 |(e) (e) (e) (e) | |POLY 6 | P=0.089 (e) P=0.527 P=0.261 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.083 (e) P=0.567 P=0.221 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.084 (e) P=0.500 P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.2% 2.3% 6.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 1/34 (3%) 1/35 (3%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 603 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.067 P=0.561 P=0.567 P=0.140 |(e) (e) (e) (e) | |POLY 3 | P=0.070 P=0.519 P=0.516 P=0.132 |(e) (e) (e) (e) | |POLY 1.5 | P=0.068 P=0.513 P=0.510 P=0.127 |(e) (e) (e) (e) | |POLY 6 | P=0.073 P=0.528 P=0.527 P=0.141 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.063 P=0.561 P=0.567 P=0.105 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.064 P=0.500 P=0.500 P=0.121 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 5/50 (10%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 11.0% 6.8% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 3/34 (9%) 3/35 (9%) 2/31 (7%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 579 674 729 (T) 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.441N P=0.172 P=0.404 P=0.552 |(e) (e) (e) (e) | |POLY 3 | P=0.450N P=0.124 P=0.331 P=0.514 |(e) (e) (e) (e) | |POLY 1.5 | P=0.453N P=0.116 P=0.321 P=0.510 |(e) (e) (e) (e) | |POLY 6 | P=0.443N P=0.136 P=0.347 P=0.521 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.461N P=0.105 P=0.316 P=0.503 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.466N P=0.102 P=0.309 P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.8% 11.0% 6.8% 4.6% |2.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 3/34 (9%) 3/35 (9%) 2/31 (7%) |1/38 (3%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 579 674 729 (T) 729 (T) |731 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.338N P=0.326 P=0.610 P=0.644N |P=0.474N P=0.528N P=0.522N P=0.511N | |POLY 3 | P=0.352N P=0.253 P=0.530 P=0.682N |P=0.463N P=0.513N P=0.516N P=0.511N | |POLY 1.5 | P=0.353N P=0.241 P=0.518 P=0.685N |P=0.467N P=0.508N P=0.511N P=0.507N | |POLY 6 | P=0.350N P=0.270 P=0.548 P=0.677N |P=0.459N P=0.519N P=0.520N P=0.515N | |LOGISTIC REGRESSION| P=0.356N P=0.218 P=0.511 P=0.694N |P=0.474N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.361N P=0.218 P=0.500 P=0.691N |P=0.474N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 5/50 (10%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 11.0% 6.8% 4.6% |2.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 3/34 (9%) 3/35 (9%) 2/31 (7%) |1/38 (3%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 579 674 729 (T) 729 (T) |731 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.441N P=0.172 P=0.404 P=0.552 |P=0.474N P=0.528N P=0.522N P=0.511N | |POLY 3 | P=0.450N P=0.124 P=0.331 P=0.514 |P=0.463N P=0.513N P=0.516N P=0.511N | |POLY 1.5 | P=0.453N P=0.116 P=0.321 P=0.510 |P=0.467N P=0.508N P=0.511N P=0.507N | |POLY 6 | P=0.443N P=0.136 P=0.347 P=0.521 |P=0.459N P=0.519N P=0.520N P=0.515N | |LOGISTIC REGRESSION| P=0.461N P=0.105 P=0.316 P=0.503 |P=0.474N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.466N P=0.102 P=0.309 P=0.500 |P=0.474N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 17 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 40/50 (80%) 45/50 (90%) 47/50 (94%) 46/50 (92%) | | |POLY-3 ADJUSTED (b)| 89.1% 92.6% 98.7% 95.8% | | |TERMINAL (d) | 25/25 (100%) 32/34 (94%) 35/35 (100%) 30/31 (97%) | | |FIRST INCIDENCE | 439 474 464 456 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.418 P=0.179N P=0.202N P=0.468N | | |POLY 3 | P=0.152 P=0.394 P=0.024 * P=0.155 | | |POLY 1.5 | P=0.132 P=0.271 P=0.026 * P=0.113 | | |POLY 6 | P=0.230 P=0.623 P=0.046 * P=0.304 | | |LOGISTIC REGRESSION| P=0.086 P=0.359 P=0.039 * P=0.094 | | |COCH-ARM / FISHERS | P=0.117 P=0.131 P=0.036 * P=0.074 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 12/50 (24%) 8/50 (16%) 6/50 (12%) |3/50 (6%) 8/50 (16%) 5/50 (10%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 21.6% 26.4% 17.6% 13.6% |6.4% 18.1% 11.6% 17.7% | |TERMINAL (d) | 6/25 (24%) 9/34 (27%) 5/35 (14%) 4/31 (13%) |3/38 (8%) 7/33 (21%) 5/34 (15%) 5/36 (14%) | |FIRST INCIDENCE | 579 674 464 456 |731 (T) 505 731 (T) 527 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.109N P=0.577 P=0.278N P=0.185N |P=0.199 P=0.065 P=0.295 P=0.088 | |POLY 3 | P=0.116N P=0.391 P=0.420N P=0.247N |P=0.184 P=0.083 P=0.313 P=0.089 | |POLY 1.5 | P=0.120N P=0.364 P=0.451N P=0.259N |P=0.187 P=0.089 P=0.326 P=0.092 | |POLY 6 | P=0.112N P=0.428 P=0.375N P=0.230N |P=0.184 P=0.076 P=0.302 P=0.088 | |LOGISTIC REGRESSION| P=0.127N P=0.432 P=0.467N P=0.267N |P=0.186 P=0.086 P=0.295 P=0.101 | |COCH-ARM / FISHERS | P=0.132N P=0.312 P=0.500N P=0.288N |P=0.196 P=0.100 P=0.357 P=0.100 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 18 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 2.2% 2.3% 0.0% |4.3% 2.3% 2.3% 0.0% | |TERMINAL (d) | 0/25 (0%) 1/34 (3%) 1/35 (3%) 0/31 (0%) |2/38 (5%) 1/33 (3%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 697 729 (T) 729 (T) --- |731 (T) 731 (T) 724 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.308N P=0.703N P=0.703N P=0.477N |P=0.196N P=0.549N P=0.538N P=0.250N | |POLY 3 | P=0.323N P=0.739N P=0.743N P=0.490N |P=0.196N P=0.523N P=0.528N P=0.250N | |POLY 1.5 | P=0.322N P=0.747N P=0.750N P=0.493N |P=0.196N P=0.514N P=0.520N P=0.246N | |POLY 6 | P=0.322N P=0.730N P=0.731N P=0.485N |P=0.197N P=0.533N P=0.534N P=0.254N | |LOGISTIC REGRESSION| P=0.316N P=0.735N P=0.738N P=0.492N |P=0.200N P=0.549N P=0.542N (e) | |COCH-ARM / FISHERS | P=0.323N P=0.753N P=0.753N P=0.500N |P=0.194N P=0.500N P=0.500N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 13/50 (26%) 9/50 (18%) 6/50 (12%) |5/50 (10%) 9/50 (18%) 6/50 (12%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 23.9% 28.6% 19.8% 13.6% |10.7% 20.3% 13.9% 17.7% | |TERMINAL (d) | 6/25 (24%) 10/34 (29%) 6/35 (17%) 4/31 (13%) |5/38 (13%) 8/33 (24%) 5/34 (15%) 5/36 (14%) | |FIRST INCIDENCE | 579 674 464 456 |731 (T) 505 724 527 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.068N P=0.587N P=0.267N P=0.126N |P=0.392 P=0.126 P=0.422 P=0.244 | |POLY 3 | P=0.072N P=0.399 P=0.417N P=0.171N |P=0.377 P=0.164 P=0.444 P=0.257 | |POLY 1.5 | P=0.075N P=0.372 P=0.449N P=0.182N |P=0.379 P=0.175 P=0.461 P=0.262 | |POLY 6 | P=0.069N P=0.435 P=0.372N P=0.158N |P=0.379 P=0.152 P=0.431 P=0.254 | |LOGISTIC REGRESSION| P=0.080N P=0.447 P=0.459N P=0.188N |P=0.372 P=0.159 P=0.407 P=0.270 | |COCH-ARM / FISHERS | P=0.084N P=0.318 P=0.500N P=0.207N |P=0.390 P=0.194 P=0.500 P=0.277 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 19 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/34 (0%) 2/35 (6%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 629 --- 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.444N P=0.471N P=0.591 P=0.490N |(e) (e) (e) (e) | |POLY 3 | P=0.462N P=0.482N P=0.526 P=0.491N |(e) (e) (e) (e) | |POLY 1.5 | P=0.459N P=0.488N P=0.516 P=0.494N |(e) (e) (e) (e) | |POLY 6 | P=0.465N P=0.475N P=0.542 P=0.487N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.454N P=0.535N P=0.516 P=0.518N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.455N P=0.500N P=0.500 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.2% 2.2% 4.6% |2.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/34 (0%) 0/35 (0%) 2/31 (7%) |1/38 (3%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- 696 642 729 (T) |731 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.201 P=0.545 P=0.535 P=0.286 |P=0.474N P=0.528N P=0.522N P=0.511N | |POLY 3 | P=0.201 P=0.520 P=0.518 P=0.249 |P=0.463N P=0.513N P=0.516N P=0.511N | |POLY 1.5 | P=0.199 P=0.513 P=0.511 P=0.245 |P=0.467N P=0.508N P=0.511N P=0.507N | |POLY 6 | P=0.204 P=0.529 P=0.529 P=0.255 |P=0.459N P=0.519N P=0.520N P=0.515N | |LOGISTIC REGRESSION| P=0.194 P=0.511 P=0.486 P=0.286 |P=0.474N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.194 P=0.500 P=0.500 P=0.247 |P=0.474N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 20 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 2.2% 6.7% 4.6% |2.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/34 (0%) 2/35 (6%) 2/31 (7%) |1/38 (3%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 629 696 642 729 (T) |731 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.416 P=0.719N P=0.396 P=0.555 |P=0.474N P=0.528N P=0.522N P=0.511N | |POLY 3 | P=0.401 P=0.740N P=0.335 P=0.515 |P=0.463N P=0.513N P=0.516N P=0.511N | |POLY 1.5 | P=0.402 P=0.747N P=0.323 P=0.511 |P=0.467N P=0.508N P=0.511N P=0.507N | |POLY 6 | P=0.401 P=0.731N P=0.354 P=0.522 |P=0.459N P=0.519N P=0.520N P=0.515N | |LOGISTIC REGRESSION| P=0.401 P=0.753 P=0.308 P=0.513 |P=0.474N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.399 P=0.753N P=0.309 P=0.500 |P=0.474N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |7/50 (14%) 8/50 (16%) 9/50 (18%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| |14.9% 18.3% 20.6% 24.8% | |TERMINAL (d) | |5/38 (13%) 8/33 (24%) 8/34 (24%) 8/36 (22%) | |FIRST INCIDENCE | |616 731 (T) 470 693 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.185 P=0.384 P=0.307 P=0.188 | |POLY 3 | |P=0.155 P=0.437 P=0.332 P=0.176 | |POLY 1.5 | |P=0.163 P=0.461 P=0.350 P=0.190 | |POLY 6 | |P=0.149 P=0.409 P=0.316 P=0.164 | |LOGISTIC REGRESSION| |P=0.157 P=0.417 P=0.353 P=0.172 | |COCH-ARM / FISHERS | |P=0.179 P=0.500 P=0.393 P=0.218 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 21 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |0.0% 2.3% 2.3% 4.4% | |TERMINAL (d) | |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | |--- 441 711 549 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.190 P=0.500 P=0.469 P=0.225 | |POLY 3 | |P=0.188 P=0.490 P=0.484 P=0.229 | |POLY 1.5 | |P=0.190 P=0.494 P=0.489 P=0.232 | |POLY 6 | |P=0.188 P=0.486 P=0.481 P=0.228 | |LOGISTIC REGRESSION| |P=0.225 P=0.758 P=0.488 P=0.313 | |COCH-ARM / FISHERS | |P=0.194 P=0.500 P=0.500 P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |7/50 (14%) 9/50 (18%) 10/50 (20%) 13/50 (26%) | |POLY-3 ADJUSTED (b)| |14.9% 20.3% 22.8% 28.7% | |TERMINAL (d) | |5/38 (13%) 8/33 (24%) 8/34 (24%) 8/36 (22%) | |FIRST INCIDENCE | |616 441 470 549 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.098 P=0.289 P=0.222 P=0.093 | |POLY 3 | |P=0.079 P=0.345 P=0.242 P=0.085 | |POLY 1.5 | |P=0.082 P=0.364 P=0.258 P=0.091 | |POLY 6 | |P=0.079 P=0.321 P=0.229 P=0.081 | |LOGISTIC REGRESSION| |P=0.083 P=0.372 P=0.260 P=0.092 | |COCH-ARM / FISHERS | |P=0.090 P=0.393 P=0.298 P=0.105 | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 22 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.4% 0.0% 2.3% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/25 (0%) 1/34 (3%) 0/35 (0%) 1/31 (3%) |0/38 (0%) 0/33 (0%) 1/34 (3%) 0/36 (0%) | |FIRST INCIDENCE | --- 697 --- 729 (T) |--- --- 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.638 P=0.297 (e) P=0.543 |P=0.782N (e) P=0.478 (e) | |POLY 3 | P=0.641 P=0.260 (e) P=0.510 |P=0.790N (e) P=0.484 (e) | |POLY 1.5 | P=0.635 P=0.252 (e) P=0.507 |P=0.789N (e) P=0.489 (e) | |POLY 6 | P=0.649 P=0.271 (e) P=0.516 |P=0.791N (e) P=0.480 (e) | |LOGISTIC REGRESSION| P=0.628 P=0.265 (e) P=0.543 |(e) (e) P=0.478 (e) | |COCH-ARM / FISHERS | P=0.622 P=0.247 (e) P=0.500 |P=0.786N (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.4% 2.3% 2.3% |2.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 2/34 (6%) 1/35 (3%) 1/31 (3%) |1/38 (3%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |731 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.642 P=0.308 P=0.567 P=0.543 |P=0.474N P=0.528N P=0.522N P=0.511N | |POLY 3 | P=0.636 P=0.259 P=0.516 P=0.510 |P=0.463N P=0.513N P=0.516N P=0.511N | |POLY 1.5 | P=0.631 P=0.252 P=0.510 P=0.507 |P=0.467N P=0.508N P=0.511N P=0.507N | |POLY 6 | P=0.645 P=0.270 P=0.527 P=0.516 |P=0.459N P=0.519N P=0.520N P=0.515N | |LOGISTIC REGRESSION| (e) P=0.308 P=0.567 P=0.543 |P=0.474N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.619 P=0.247 P=0.500 P=0.500 |P=0.474N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 23 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 20/50 (40%) 20/50 (40%) 14/50 (28%) 12/50 (24%) |21/50 (42%) 19/50 (38%) 16/50 (32%) 19/50 (38%) | |POLY-3 ADJUSTED (b)| 46.4% 42.9% 30.9% 26.9% |42.2% 40.3% 35.5% 41.2% | |TERMINAL (d) | 9/25 (36%) 13/34 (38%) 7/35 (20%) 7/31 (23%) |12/38 (32%) 9/33 (27%) 8/34 (24%) 12/36 (33%) | |FIRST INCIDENCE | 584 589 642 351 |438 527 562 500 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.036N* P=0.238N P=0.039N* P=0.033N* |P=0.481N P=0.545 P=0.361N P=0.516N | |POLY 3 | P=0.030N* P=0.450N P=0.096N P=0.043N* |P=0.539N P=0.505N P=0.323N P=0.540N | |POLY 1.5 | P=0.030N* P=0.492N P=0.112N P=0.047N* |P=0.508N P=0.477N P=0.285N P=0.499N | |POLY 6 | P=0.033N* P=0.401N P=0.077N P=0.040N* |P=0.526 P=0.529N P=0.348N P=0.582N | |LOGISTIC REGRESSION| P=0.033N* P=0.448N P=0.090N P=0.052N |P=0.442N P=0.298N P=0.173N P=0.366N | |COCH-ARM / FISHERS | P=0.036N* P=0.581N P=0.146N P=0.066N |P=0.454N P=0.419N P=0.204N P=0.419N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.5% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/34 (0%) 2/35 (6%) 2/31 (7%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.128 (e) P=0.315 P=0.286 |(e) (e) (e) (e) | |POLY 3 | P=0.123 (e) P=0.256 P=0.249 |(e) (e) (e) (e) | |POLY 1.5 | P=0.123 (e) P=0.248 P=0.245 |(e) (e) (e) (e) | |POLY 6 | P=0.124 (e) P=0.268 P=0.255 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.315 P=0.286 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.122 (e) P=0.247 P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 24 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.5% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/34 (0%) 2/35 (6%) 2/31 (7%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.128 (e) P=0.315 P=0.286 |(e) (e) (e) (e) | |POLY 3 | P=0.123 (e) P=0.256 P=0.249 |(e) (e) (e) (e) | |POLY 1.5 | P=0.123 (e) P=0.248 P=0.245 |(e) (e) (e) (e) | |POLY 6 | P=0.124 (e) P=0.268 P=0.255 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.315 P=0.286 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.122 (e) P=0.247 P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 4.4% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 1/34 (3%) 0/35 (0%) 0/31 (0%) |0/38 (0%) 0/33 (0%) 0/34 (0%) 0/36 (0%) | |FIRST INCIDENCE | 474 716 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.201N P=0.566 P=0.500N P=0.500N |(e) (e) (e) (e) | |POLY 3 | P=0.205N P=0.528 P=0.487N P=0.493N |(e) (e) (e) (e) | |POLY 1.5 | P=0.206N P=0.519 P=0.492N P=0.495N |(e) (e) (e) (e) | |POLY 6 | P=0.202N P=0.541 P=0.478N P=0.489N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.218N P=0.451 P=0.591N P=0.605N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.209N P=0.500 P=0.500N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 25 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 47/50 (94%) 49/50 (98%) 49/50 (98%) 47/50 (94%) |35/50 (70%) 38/50 (76%) 34/50 (68%) 37/50 (74%) | |POLY-3 ADJUSTED (b)| 97.8% 99.7% 99.9% 97.2% |73.2% 80.4% 76.3% 78.0% | |TERMINAL (d) | 25/25 (100%) 34/34 (100%) 35/35 (100%) 30/31 (97%) |29/38 (76%) 28/33 (85%) 28/34 (82%) 28/36 (78%) | |FIRST INCIDENCE | 439 474 464 456 |589 441 470 499 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.298N P=0.072N P=0.053N P=0.146N |P=0.467 P=0.098 P=0.355 P=0.285 | |POLY 3 | P=0.405N P=0.540 P=0.489 P=0.700N |P=0.461 P=0.271 P=0.457 P=0.378 | |POLY 1.5 | P=0.357N P=0.487 P=0.423 P=0.648N |P=0.452 P=0.289 P=0.525 P=0.380 | |POLY 6 | P=0.409N P=0.692 P=0.679 P=0.701N |P=0.481 P=0.251 P=0.403 P=0.384 | |LOGISTIC REGRESSION| P=0.352N P=0.627 P=0.373 P=0.530N |P=0.383 P=0.203 P=0.403 P=0.292 | |COCH-ARM / FISHERS | P=0.414N P=0.309 P=0.309 P=0.661N |P=0.468 P=0.326 P=0.500N P=0.412 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 29/50 (58%) 30/50 (60%) 24/50 (48%) 26/50 (52%) |26/50 (52%) 21/50 (42%) 21/50 (42%) 24/50 (48%) | |POLY-3 ADJUSTED (b)| 62.4% 62.0% 51.9% 54.7% |52.3% 43.8% 45.7% 49.3% | |TERMINAL (d) | 11/25 (44%) 18/34 (53%) 15/35 (43%) 14/31 (45%) |17/38 (45%) 10/33 (30%) 10/34 (29%) 13/36 (36%) | |FIRST INCIDENCE | 474 400 464 351 |438 441 434 246 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.239N P=0.235N P=0.050N P=0.182N |P=0.503 P=0.420N P=0.405N P=0.530N | |POLY 3 | P=0.243N P=0.569N P=0.206N P=0.291N |P=0.526 P=0.263N P=0.330N P=0.462N | |POLY 1.5 | P=0.239N P=0.582 P=0.200N P=0.292N |P=0.531 P=0.246N P=0.294N P=0.446N | |POLY 6 | P=0.254N P=0.558N P=0.208N P=0.298N |P=0.517 P=0.279N P=0.350N P=0.479N | |LOGISTIC REGRESSION| P=0.263N P=0.516 P=0.177N P=0.352N |P=0.530N P=0.120N P=0.185N P=0.280N | |COCH-ARM / FISHERS | P=0.265N P=0.500 P=0.212N P=0.344N |P=0.529 P=0.212N P=0.212N P=0.421N | |=================================================================================================================================| Date: 02/24/00 EXPERIMENT: 88050 TEST: 05 Page 26 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG |0 MG/KG 3 MG/KG 10 MG/KG 30 MG/KG | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 49/50 (98%) 50/50 (100%) 49/50 (98%) 49/50 (98%) |45/50 (90%) 45/50 (90%) 42/50 (84%) 46/50 (92%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 99.9% 98.0% |90.0% 92.0% 89.9% 92.0% | |TERMINAL (d) | 25/25 (100%) 34/34 (100%) 35/35 (100%) 30/31 (97%) |33/38 (87%) 30/33 (91%) 30/34 (88%) 32/36 (89%) | |FIRST INCIDENCE | 439 400 464 351 |438 441 434 246 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.338N P=0.056N P=0.028N* P=0.156N |P=0.434 P=0.211 P=0.448 P=0.328 | |POLY 3 | P=0.218N P=1.000 P=1.000N P=0.504N |P=0.487 P=0.499 P=0.626N P=0.500 | |POLY 1.5 | P=0.231N P=1.000 P=1.000N P=0.509N |P=0.464 P=0.537 P=0.519N P=0.500 | |POLY 6 | P=0.216N P=1.000 P=1.000N P=0.504N |P=0.505 P=0.467 P=0.576 P=0.500 | |LOGISTIC REGRESSION| P=0.373N (e) (e) P=0.612N |P=0.363 P=0.598 P=0.472N (e) | |COCH-ARM / FISHERS | P=0.545N P=0.500 P=0.753N P=0.753N |P=0.412 P=0.630N P=0.277N P=0.500 | |=================================================================================================================================| (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).