TDMS Study 88050-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus METHACRYLONITRILE DATE: 10/19/99 EXPERIMENT: 88050 TEST: 06 TIME: 12:44:54 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: 88050B PATHOLOGIST: TOFT, JOHN CAS: 126-98-7 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY MICE FINAL#1 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: 10/19/99 EXPERIMENT: 88050 TEST: 06 TIME: 12:44:54 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: 88050B PATHOLOGIST: TOFT, JOHN CAS: 126-98-7 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 THE NUMBER OF ANIMALS NECROPSIED. --------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Islets, Pancreatic Kidney Liver Lung Ovary Pancreas Pituitary Gland Prostate Spleen Testes Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus METHACRYLONITRILE DATE: 10/19/99 EXPERIMENT: 88050 TEST: 06 TIME: 12:44:54 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: 88050B PATHOLOGIST: TOFT, JOHN CAS: 126-98-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF METHACRYLONITRILE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex Adenoma Liver Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Adenoma All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Intestine Large: Cecum Leiomyoma Lung Alveolar/Bronchiolar Adenoma Mammary Gland Carcinoma All Organs Hemangiosarcoma or Hemangioma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant and Benign Tumors =============================================================== Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 1 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 4/50 (8%) 4/50 (8%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 11.1% 8.4% 8.5% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 5/35 (14%) 3/43 (7%) 4/43 (9%) 0/22 (0%) |0/34 (0%) 0/35 (0%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | 729 (T) 644 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.069N P=0.386N P=0.372N P=0.086N |(e) (e) (e) (e) | |POLY 3 | P=0.083N P=0.460N P=0.474N P=0.078N |(e) (e) (e) (e) | |POLY 1.5 | P=0.058N P=0.472N P=0.482N P=0.054N |(e) (e) (e) (e) | |POLY 6 | P=0.111N P=0.442N P=0.456N P=0.105N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.078N P=0.455N P=0.372N (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.028N* P=0.487N P=0.487N P=0.027N* |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 5/50 (10%) 1/50 (2%) |2/50 (4%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 6.7% 4.2% 10.7% 3.2% |4.4% 4.6% 4.2% 5.7% | |TERMINAL (d) | 3/35 (9%) 2/43 (5%) 5/43 (12%) 1/22 (5%) |2/35 (6%) 1/35 (3%) 1/43 (2%) 2/25 (8%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |730 (T) 638 589 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.530N P=0.406N P=0.473 P=0.482N |P=0.473 P=0.689 P=0.635N P=0.569 | |POLY 3 | P=0.534N P=0.474N P=0.380 P=0.446N |P=0.493 P=0.679 P=0.671N P=0.596 | |POLY 1.5 | P=0.454N P=0.481N P=0.372 P=0.388N |P=0.527 P=0.682 P=0.680N P=0.632 | |POLY 6 | P=0.512 P=0.463N P=0.396 P=0.499N |P=0.468 P=0.684 P=0.658N P=0.567 | |LOGISTIC REGRESSION| P=0.530N P=0.406N P=0.473 P=0.482N |P=0.532 P=0.682 P=0.676 P=0.569 | |COCH-ARM / FISHERS | P=0.319N P=0.500N P=0.357 P=0.309N |P=0.596 P=0.691N P=0.691N P=0.691N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 2 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.2% 0.0% |4.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/43 (0%) 1/43 (2%) 0/22 (0%) |2/35 (6%) 0/35 (0%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | --- --- 502 --- |730 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.490 (e) P=0.262 (e) |P=0.124N P=0.238N P=0.194N P=0.315N | |POLY 3 | P=0.350 (e) P=0.250 (e) |P=0.094N P=0.248N P=0.226N P=0.299N | |POLY 1.5 | P=0.448 (e) P=0.246 (e) |P=0.102N P=0.246N P=0.230N P=0.276N | |POLY 6 | P=0.285 (e) P=0.258 (e) |P=0.086N P=0.247N P=0.219N P=0.319N | |LOGISTIC REGRESSION| P=0.679 (e) P=0.187 (e) |P=0.124N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.115N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 7/50 (14%) 1/50 (2%) |4/50 (8%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 6.7% 4.2% 14.7% 3.2% |8.9% 4.6% 4.2% 5.7% | |TERMINAL (d) | 3/35 (9%) 2/43 (5%) 6/43 (14%) 1/22 (5%) |4/35 (11%) 1/35 (3%) 1/43 (2%) 2/25 (8%) | |FIRST INCIDENCE | 729 (T) 729 (T) 502 729 (T) |730 (T) 638 589 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.558 P=0.406N P=0.244 P=0.482N |P=0.411N P=0.341N P=0.262N P=0.500N | |POLY 3 | P=0.464 P=0.474N P=0.181 P=0.446N |P=0.344N P=0.356N P=0.309N P=0.462N | |POLY 1.5 | P=0.543N P=0.481N P=0.173 P=0.388N |P=0.329N P=0.353N P=0.321N P=0.417N | |POLY 6 | P=0.368 P=0.463N P=0.196 P=0.499N |P=0.349N P=0.350N P=0.293N P=0.500N | |LOGISTIC REGRESSION| P=0.575N P=0.406N P=0.164 P=0.482N |P=0.370N P=0.357N P=0.338N P=0.500N | |COCH-ARM / FISHERS | P=0.367N P=0.500N P=0.159 P=0.309N |P=0.292N P=0.339N P=0.339N P=0.339N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 3 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Intestine Large: Cecum | | Leiomyoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.6% 2.3% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/43 (0%) 0/43 (0%) 0/22 (0%) |3/35 (9%) 1/35 (3%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | --- --- --- --- |730 (T) 730 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.050N P=0.305N P=0.087N P=0.186N | |POLY 3 | (e) (e) (e) (e) |P=0.040N* P=0.323N P=0.110N P=0.172N | |POLY 1.5 | (e) (e) (e) (e) |P=0.042N* P=0.319N P=0.113N P=0.152N | |POLY 6 | (e) (e) (e) (e) |P=0.038N* P=0.320N P=0.105N P=0.191N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.050N P=0.305N (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.044N* P=0.309N P=0.121N P=0.121N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Intestine Small: Duodenum | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.5% 0.0% 4.3% 3.2% |2.2% 2.3% 0.0% 0.0% | |TERMINAL (d) | 2/35 (6%) 0/43 (0%) 2/43 (5%) 1/22 (5%) |1/35 (3%) 1/35 (3%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |730 (T) 730 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.582 P=0.194N P=0.619N P=0.660N |P=0.264N P=0.762 P=0.459N P=0.567N | |POLY 3 | P=0.560 P=0.225N P=0.679N P=0.623N |P=0.231N P=0.750 P=0.490N P=0.551N | |POLY 1.5 | P=0.591N P=0.228N P=0.684N P=0.576N |P=0.236N P=0.752 P=0.494N P=0.533N | |POLY 6 | P=0.529 P=0.219N P=0.668N P=0.664N |P=0.223N P=0.751 P=0.484N P=0.565N | |LOGISTIC REGRESSION| P=0.582 (e) P=0.619N P=0.660N |P=0.264N P=0.762 (e) (e) | |COCH-ARM / FISHERS | P=0.531N P=0.247N P=0.691N P=0.500N |P=0.236N P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 4 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 2.1% 4.3% 6.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/35 (3%) 1/43 (2%) 2/43 (5%) 0/22 (0%) |0/35 (0%) 0/35 (0%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 481 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.204 P=0.715N P=0.572 P=0.396 |(e) (e) (e) (e) | |POLY 3 | P=0.214 P=0.748N P=0.515 P=0.384 |(e) (e) (e) (e) | |POLY 1.5 | P=0.255 P=0.751N P=0.510 P=0.428 |(e) (e) (e) (e) | |POLY 6 | P=0.192 P=0.742N P=0.525 P=0.347 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.296 P=0.715N P=0.572 P=0.503 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.337 P=0.753N P=0.500 P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.5% 0.0% 4.3% 3.2% |2.2% 2.3% 0.0% 0.0% | |TERMINAL (d) | 2/35 (6%) 0/43 (0%) 2/43 (5%) 1/22 (5%) |1/35 (3%) 1/35 (3%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |730 (T) 730 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.582 P=0.194N P=0.619N P=0.660N |P=0.264N P=0.762 P=0.459N P=0.567N | |POLY 3 | P=0.560 P=0.225N P=0.679N P=0.623N |P=0.231N P=0.750 P=0.490N P=0.551N | |POLY 1.5 | P=0.591N P=0.228N P=0.684N P=0.576N |P=0.236N P=0.752 P=0.494N P=0.533N | |POLY 6 | P=0.529 P=0.219N P=0.668N P=0.664N |P=0.223N P=0.751 P=0.484N P=0.565N | |LOGISTIC REGRESSION| P=0.582 (e) P=0.619N P=0.660N |P=0.264N P=0.762 (e) (e) | |COCH-ARM / FISHERS | P=0.531N P=0.247N P=0.691N P=0.500N |P=0.236N P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 5 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 4.2% 6.4% 6.3% |0.0% 0.0% 2.1% 0.0% | |TERMINAL (d) | 1/35 (3%) 2/43 (5%) 2/43 (5%) 0/22 (0%) |0/35 (0%) 0/35 (0%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 612 481 |--- --- 589 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.234 P=0.572 P=0.367 P=0.396 |P=0.656 (e) P=0.504 (e) | |POLY 3 | P=0.233 P=0.520 P=0.324 P=0.384 |P=0.562 (e) P=0.512 (e) | |POLY 1.5 | P=0.290 P=0.514 P=0.317 P=0.428 |P=0.614 (e) P=0.507 (e) | |POLY 6 | P=0.198 P=0.528 P=0.336 P=0.347 |P=0.513 (e) P=0.519 (e) | |LOGISTIC REGRESSION| P=0.376 P=0.572 P=0.304 P=0.503 |P=0.734N (e) P=0.365 (e) | |COCH-ARM / FISHERS | P=0.404 P=0.500 P=0.309 P=0.500 |P=0.694 (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 5/50 (10%) 3/50 (6%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 6.7% 4.2% 10.6% 9.4% |2.2% 2.3% 2.1% 0.0% | |TERMINAL (d) | 3/35 (9%) 2/43 (5%) 4/43 (9%) 1/22 (5%) |1/35 (3%) 1/35 (3%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 612 481 |730 (T) 730 (T) 589 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.251 P=0.406N P=0.462 P=0.478 |P=0.374N P=0.762 P=0.735N P=0.567N | |POLY 3 | P=0.269 P=0.474N P=0.385 P=0.497 |P=0.354N P=0.750 P=0.746N P=0.551N | |POLY 1.5 | P=0.339 P=0.481N P=0.375 P=0.563 |P=0.341N P=0.752 P=0.752N P=0.533N | |POLY 6 | P=0.225 P=0.463N P=0.404 P=0.438 |P=0.361N P=0.751 P=0.738N P=0.565N | |LOGISTIC REGRESSION| P=0.339 P=0.406N P=0.375 P=0.529 |P=0.312N P=0.762 P=0.719 (e) | |COCH-ARM / FISHERS | P=0.481 P=0.500N P=0.357 P=0.661N |P=0.311N P=0.753N P=0.753N P=0.500N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 6 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 4.4% 0.0% 2.1% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/43 (0%) 1/43 (2%) 0/22 (0%) |0/35 (0%) 0/35 (0%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | 677 --- 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.255N P=0.222N P=0.452N P=0.371N |(e) (e) (e) (e) | |POLY 3 | P=0.212N P=0.226N P=0.488N P=0.330N |(e) (e) (e) (e) | |POLY 1.5 | P=0.206N P=0.229N P=0.491N P=0.291N |(e) (e) (e) (e) | |POLY 6 | P=0.226N P=0.222N P=0.480N P=0.367N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.205N P=0.257N P=0.494N P=0.289N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.185N P=0.242N P=0.492N P=0.242N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/49 (35%) 27/50 (54%) 24/50 (48%) 12/50 (24%) |9/50 (18%) 9/50 (18%) 12/49 (24%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 36.3% 54.7% 49.2% 34.7% |19.8% 20.8% 25.5% 14.1% | |TERMINAL (d) | 12/35 (34%) 22/43 (51%) 21/43 (49%) 7/22 (32%) |7/35 (20%) 8/35 (23%) 12/43 (28%) 4/25 (16%) | |FIRST INCIDENCE | 501 605 429 481 |653 638 730 (T) 480 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.512 P=0.168 P=0.318 P=0.518 |P=0.384N P=0.599 P=0.507 P=0.411N | |POLY 3 | P=0.442N P=0.053 P=0.143 P=0.531N |P=0.380N P=0.559 P=0.341 P=0.355N | |POLY 1.5 | P=0.253N P=0.046 * P=0.135 P=0.380N |P=0.305N P=0.569 P=0.322 P=0.292N | |POLY 6 | P=0.448 P=0.064 P=0.159 P=0.517 |P=0.440N P=0.563 P=0.367 P=0.411N | |LOGISTIC REGRESSION| P=0.123N P=0.030 * P=0.119 P=0.296N |P=0.386N P=0.564 P=0.408 P=0.370N | |COCH-ARM / FISHERS | P=0.051N P=0.041 * P=0.127 P=0.172N |P=0.183N P=0.602N P=0.294 P=0.194N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 7 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/49 (27%) 7/50 (14%) 7/50 (14%) 4/50 (8%) |2/50 (4%) 2/50 (4%) 4/49 (8%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 27.5% 14.4% 14.9% 12.4% |4.4% 4.7% 8.5% 2.9% | |TERMINAL (d) | 6/35 (17%) 3/43 (7%) 6/43 (14%) 1/22 (5%) |0/35 (0%) 2/35 (6%) 3/43 (7%) 1/25 (4%) | |FIRST INCIDENCE | 501 625 694 481 |662 730 (T) 653 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.112N P=0.074N P=0.064N P=0.161N |P=0.565N P=0.692N P=0.412 P=0.621N | |POLY 3 | P=0.063N P=0.091N P=0.106N P=0.097N |P=0.565N P=0.674 P=0.356 P=0.591N | |POLY 1.5 | P=0.040N* P=0.093N P=0.103N P=0.049N* |P=0.520N P=0.679 P=0.345 P=0.559N | |POLY 6 | P=0.087N P=0.087N P=0.105N P=0.165N |P=0.534 P=0.674 P=0.371 P=0.618N | |LOGISTIC REGRESSION| P=0.010N* P=0.155N P=0.097N P=0.019N* |P=0.537N P=0.682 P=0.309 P=0.587N | |COCH-ARM / FISHERS | P=0.014N* P=0.096N P=0.096N P=0.014N* |P=0.433N P=0.691N P=0.329 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/49 (29%) 7/50 (14%) 7/50 (14%) 4/50 (8%) |2/50 (4%) 2/50 (4%) 4/49 (8%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 29.6% 14.4% 14.9% 12.4% |4.4% 4.7% 8.5% 2.9% | |TERMINAL (d) | 7/35 (20%) 3/43 (7%) 6/43 (14%) 1/22 (5%) |0/35 (0%) 2/35 (6%) 3/43 (7%) 1/25 (4%) | |FIRST INCIDENCE | 501 625 694 481 |662 730 (T) 653 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.079N P=0.047N* P=0.040N* P=0.123N |P=0.565N P=0.692N P=0.412 P=0.621N | |POLY 3 | P=0.040N* P=0.058N P=0.069N P=0.067N |P=0.565N P=0.674 P=0.356 P=0.591N | |POLY 1.5 | P=0.025N* P=0.060N P=0.067N P=0.031N* |P=0.520N P=0.679 P=0.345 P=0.559N | |POLY 6 | P=0.056N P=0.055N P=0.069N P=0.124N |P=0.534 P=0.674 P=0.371 P=0.618N | |LOGISTIC REGRESSION| P=0.006N** P=0.104N P=0.064N P=0.013N* |P=0.537N P=0.682 P=0.309 P=0.587N | |COCH-ARM / FISHERS | P=0.008N** P=0.063N P=0.063N P=0.008N** |P=0.433N P=0.691N P=0.329 P=0.500N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 8 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/49 (49%) 29/50 (58%) 28/50 (56%) 15/50 (30%) |10/50 (20%) 11/50 (22%) 14/49 (29%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 50.7% 58.6% 57.2% 41.9% |21.9% 25.4% 29.6% 16.9% | |TERMINAL (d) | 16/35 (46%) 23/43 (54%) 24/43 (56%) 7/22 (32%) |7/35 (20%) 10/35 (29%) 13/43 (30%) 5/25 (20%) | |FIRST INCIDENCE | 501 605 429 481 |653 638 653 480 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.477N P=0.539 P=0.538N P=0.503N |P=0.414N P=0.494 P=0.431 P=0.454N | |POLY 3 | P=0.256N P=0.281 P=0.331 P=0.283N |P=0.410N P=0.444 P=0.269 P=0.392N | |POLY 1.5 | P=0.117N P=0.264 P=0.321 P=0.156N |P=0.322N P=0.458 P=0.251 P=0.319N | |POLY 6 | P=0.410N P=0.311 P=0.352 P=0.429N |P=0.483N P=0.443 P=0.294 P=0.458N | |LOGISTIC REGRESSION| P=0.050N P=0.205 P=0.298 P=0.118N |P=0.400N P=0.453 P=0.284 P=0.401N | |COCH-ARM / FISHERS | P=0.014N* P=0.243 P=0.309 P=0.042N* |P=0.181N P=0.500 P=0.224 P=0.207N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/49 (49%) 29/50 (58%) 28/50 (56%) 15/50 (30%) |10/50 (20%) 11/50 (22%) 14/49 (29%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 50.7% 58.6% 57.2% 41.9% |21.9% 25.4% 29.6% 16.9% | |TERMINAL (d) | 16/35 (46%) 23/43 (54%) 24/43 (56%) 7/22 (32%) |7/35 (20%) 10/35 (29%) 13/43 (30%) 5/25 (20%) | |FIRST INCIDENCE | 501 605 429 481 |653 638 653 480 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.477N P=0.539 P=0.538N P=0.503N |P=0.414N P=0.494 P=0.431 P=0.454N | |POLY 3 | P=0.256N P=0.281 P=0.331 P=0.283N |P=0.410N P=0.444 P=0.269 P=0.392N | |POLY 1.5 | P=0.117N P=0.264 P=0.321 P=0.156N |P=0.322N P=0.458 P=0.251 P=0.319N | |POLY 6 | P=0.410N P=0.311 P=0.352 P=0.429N |P=0.483N P=0.443 P=0.294 P=0.458N | |LOGISTIC REGRESSION| P=0.050N P=0.205 P=0.298 P=0.118N |P=0.400N P=0.453 P=0.284 P=0.401N | |COCH-ARM / FISHERS | P=0.014N* P=0.243 P=0.309 P=0.042N* |P=0.181N P=0.500 P=0.224 P=0.207N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 9 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocholangiocarcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 4.2% 2.1% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 1/43 (2%) 0/43 (0%) 0/22 (0%) |0/35 (0%) 0/35 (0%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | 513 625 694 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.368N P=0.536 P=0.750N P=0.630N |(e) (e) (e) (e) | |POLY 3 | P=0.330N P=0.518 P=0.754N P=0.574N |(e) (e) (e) (e) | |POLY 1.5 | P=0.301N P=0.513 P=0.756N P=0.545N |(e) (e) (e) (e) | |POLY 6 | P=0.366N P=0.526 P=0.748N P=0.598N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.130N P=0.315 P=0.716N P=0.316N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.243N P=0.508 P=0.747N P=0.495N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 11/50 (22%) 8/50 (16%) 5/50 (10%) |6/50 (12%) 3/50 (6%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 4.5% 22.9% 16.9% 15.7% |13.3% 7.0% 2.1% 5.7% | |TERMINAL (d) | 2/35 (6%) 9/43 (21%) 7/43 (16%) 4/22 (18%) |5/35 (14%) 3/35 (9%) 1/43 (2%) 1/25 (4%) | |FIRST INCIDENCE | 729 (T) 629 612 481 |709 730 (T) 730 (T) 673 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.149 P=0.023 * P=0.088 P=0.088 |P=0.127N P=0.239N P=0.033N* P=0.267N | |POLY 3 | P=0.165 P=0.010 * P=0.054 P=0.104 |P=0.092N P=0.267N P=0.048N* P=0.231N | |POLY 1.5 | P=0.258 P=0.009 ** P=0.051 P=0.141 |P=0.089N P=0.261N P=0.051N P=0.193N | |POLY 6 | P=0.114 P=0.012 * P=0.060 P=0.078 |P=0.091N P=0.264N P=0.044N* P=0.264N | |LOGISTIC REGRESSION| P=0.185 P=0.012 * P=0.055 P=0.088 |P=0.134N P=0.240N P=0.038N* P=0.267N | |COCH-ARM / FISHERS | P=0.485 P=0.008 ** P=0.049 * P=0.226 |P=0.079N P=0.243N P=0.056N P=0.134N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 10 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 8.9% 6.2% 2.1% 3.2% |2.2% 0.0% 2.1% 8.5% | |TERMINAL (d) | 4/35 (11%) 2/43 (5%) 1/43 (2%) 1/22 (5%) |1/35 (3%) 0/35 (0%) 1/43 (2%) 1/25 (4%) | |FIRST INCIDENCE | 729 (T) 563 729 (T) 729 (T) |730 (T) --- 730 (T) 641 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.172N P=0.400N P=0.123N P=0.341N |P=0.050 P=0.500N P=0.715N P=0.199 | |POLY 3 | P=0.128N P=0.462N P=0.166N P=0.311N |P=0.077 P=0.510N P=0.749N P=0.224 | |POLY 1.5 | P=0.118N P=0.474N P=0.170N P=0.253N |P=0.082 P=0.507N P=0.753N P=0.250 | |POLY 6 | P=0.136N P=0.447N P=0.158N P=0.367N |P=0.074 P=0.509N P=0.742N P=0.206 | |LOGISTIC REGRESSION| P=0.150N P=0.501N P=0.123N P=0.341N |P=0.062 (e) P=0.715N P=0.219 | |COCH-ARM / FISHERS | P=0.089N P=0.489N P=0.175N P=0.175N |P=0.097 P=0.500N P=0.753N P=0.309 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/49 (12%) 13/50 (26%) 9/50 (18%) 5/50 (10%) |6/50 (12%) 3/50 (6%) 2/50 (4%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 13.4% 26.8% 19.1% 15.7% |13.3% 7.0% 4.2% 14.1% | |TERMINAL (d) | 6/35 (17%) 10/43 (23%) 8/43 (19%) 4/22 (18%) |5/35 (14%) 3/35 (9%) 2/43 (5%) 2/25 (8%) | |FIRST INCIDENCE | 729 (T) 563 612 481 |709 730 (T) 730 (T) 641 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.506 P=0.145 P=0.439 P=0.463 |P=0.470 P=0.239N P=0.081N P=0.524 | |POLY 3 | P=0.534 P=0.087 P=0.325 P=0.515 |P=0.547N P=0.267N P=0.117N P=0.586 | |POLY 1.5 | P=0.424N P=0.078 P=0.312 P=0.608 |P=0.537N P=0.261N P=0.124N P=0.610N | |POLY 6 | P=0.442 P=0.100 P=0.350 P=0.431 |P=0.547N P=0.264N P=0.109N P=0.546 | |LOGISTIC REGRESSION| P=0.528N P=0.075 P=0.334 P=0.442 |P=0.476 P=0.240N P=0.093N P=0.543 | |COCH-ARM / FISHERS | P=0.218N P=0.068 P=0.303 P=0.486N |P=0.500N P=0.243N P=0.134N P=0.500N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 11 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 5.7% | |TERMINAL (d) | 0/35 (0%) 0/43 (0%) 0/43 (0%) 0/22 (0%) |0/35 (0%) 0/35 (0%) 0/43 (0%) 1/25 (4%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 581 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.024 * (e) (e) P=0.163 | |POLY 3 | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.187 | |POLY 1.5 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.203 | |POLY 6 | (e) (e) (e) (e) |P=0.039 * (e) (e) P=0.176 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.051 (e) (e) P=0.228 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 2.3% 0.0% 5.7% | |TERMINAL (d) | 0/35 (0%) 0/43 (0%) 0/43 (0%) 0/22 (0%) |0/35 (0%) 1/35 (3%) 0/43 (0%) 1/25 (4%) | |FIRST INCIDENCE | --- --- --- --- |--- 730 (T) --- 581 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.086 P=0.500 (e) P=0.163 | |POLY 3 | (e) (e) (e) (e) |P=0.116 P=0.490 (e) P=0.187 | |POLY 1.5 | (e) (e) (e) (e) |P=0.122 P=0.493 (e) P=0.203 | |POLY 6 | (e) (e) (e) (e) |P=0.114 P=0.491 (e) P=0.176 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.129 P=0.500 (e) P=0.228 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.140 P=0.500 (e) P=0.247 | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 12 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 2.3% 0.0% 5.7% | |TERMINAL (d) | 0/35 (0%) 0/43 (0%) 0/43 (0%) 0/22 (0%) |0/35 (0%) 1/35 (3%) 0/43 (0%) 1/25 (4%) | |FIRST INCIDENCE | --- --- --- --- |--- 730 (T) --- 581 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.086 P=0.500 (e) P=0.163 | |POLY 3 | (e) (e) (e) (e) |P=0.116 P=0.490 (e) P=0.187 | |POLY 1.5 | (e) (e) (e) (e) |P=0.122 P=0.493 (e) P=0.203 | |POLY 6 | (e) (e) (e) (e) |P=0.114 P=0.491 (e) P=0.176 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.129 P=0.500 (e) P=0.228 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.140 P=0.500 (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 1/50 (2%) 1/50 (2%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| |4.4% 2.3% 2.1% 2.9% | |TERMINAL (d) | |2/35 (6%) 1/35 (3%) 1/43 (2%) 1/25 (4%) | |FIRST INCIDENCE | |730 (T) 730 (T) 730 (T) 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.499N P=0.500N P=0.428N P=0.617N | |POLY 3 | |P=0.444N P=0.517N P=0.482N P=0.595N | |POLY 1.5 | |P=0.438N P=0.513N P=0.489N P=0.565N | |POLY 6 | |P=0.444N P=0.515N P=0.471N P=0.618N | |LOGISTIC REGRESSION| |P=0.499N P=0.500N P=0.428N P=0.617N | |COCH-ARM / FISHERS | |P=0.416N P=0.500N P=0.500N P=0.508N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 13 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Ovary | | Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| |4.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | |2/35 (6%) 0/35 (0%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | |730 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.124N P=0.238N P=0.194N P=0.315N | |POLY 3 | |P=0.095N P=0.248N P=0.226N P=0.304N | |POLY 1.5 | |P=0.103N P=0.246N P=0.230N P=0.281N | |POLY 6 | |P=0.087N P=0.247N P=0.219N P=0.322N | |LOGISTIC REGRESSION| |P=0.124N (e) (e) (e) | |COCH-ARM / FISHERS | |P=0.116N P=0.247N P=0.247N P=0.253N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/46 (0%) |2/49 (4%) 1/49 (2%) 2/49 (4%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 2.3% 4.3% 5.8% | |TERMINAL (d) | 0/35 (0%) 0/42 (0%) 0/42 (0%) 0/22 (0%) |2/35 (6%) 1/35 (3%) 2/43 (5%) 1/25 (4%) | |FIRST INCIDENCE | --- --- --- --- |730 (T) 730 (T) 730 (T) 641 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.410 P=0.500N P=0.619N P=0.567 | |POLY 3 | (e) (e) (e) (e) |P=0.434 P=0.515N P=0.674N P=0.599 | |POLY 1.5 | (e) (e) (e) (e) |P=0.464 P=0.512N P=0.682N P=0.633 | |POLY 6 | (e) (e) (e) (e) |P=0.414 P=0.513N P=0.664N P=0.574 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.418 P=0.500N P=0.619N P=0.592 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.526 P=0.500N P=0.691N P=0.691N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 14 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/46 (0%) |2/49 (4%) 0/49 (0%) 0/49 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/35 (0%) 0/42 (0%) 0/42 (0%) 0/22 (0%) |2/35 (6%) 0/35 (0%) 0/43 (0%) 1/25 (4%) | |FIRST INCIDENCE | --- --- --- --- |730 (T) --- --- 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.533N P=0.238N P=0.194N P=0.617N | |POLY 3 | (e) (e) (e) (e) |P=0.421N P=0.247N P=0.225N P=0.589N | |POLY 1.5 | (e) (e) (e) (e) |P=0.439N P=0.245N P=0.230N P=0.558N | |POLY 6 | (e) (e) (e) (e) |P=0.401N P=0.246N P=0.219N P=0.613N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.533N (e) (e) P=0.617N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.461N P=0.247N P=0.247N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 5/50 (10%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.4% 4.6% 10.2% 2.9% | |TERMINAL (d) | 0/35 (0%) 0/43 (0%) 0/43 (0%) 0/22 (0%) |1/35 (3%) 0/35 (0%) 1/43 (2%) 1/25 (4%) | |FIRST INCIDENCE | --- --- --- --- |671 521 589 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.571 P=0.677 P=0.268 P=0.614N | |POLY 3 | (e) (e) (e) (e) |P=0.528 P=0.683 P=0.250 P=0.590N | |POLY 1.5 | (e) (e) (e) (e) |P=0.559N P=0.684 P=0.236 P=0.559N | |POLY 6 | (e) (e) (e) (e) |P=0.472 P=0.688 P=0.269 P=0.616N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.365N P=0.648N P=0.125 P=0.606N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.456N P=0.691N P=0.218 P=0.500N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 15 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 5/50 (10%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.4% 2.3% 10.2% 2.9% | |TERMINAL (d) | 0/35 (0%) 0/43 (0%) 0/43 (0%) 0/22 (0%) |1/35 (3%) 0/35 (0%) 1/43 (2%) 1/25 (4%) | |FIRST INCIDENCE | --- --- --- --- |671 521 589 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.521 P=0.510N P=0.268 P=0.614N | |POLY 3 | (e) (e) (e) (e) |P=0.477 P=0.513N P=0.250 P=0.590N | |POLY 1.5 | (e) (e) (e) (e) |P=0.543 P=0.511N P=0.236 P=0.559N | |POLY 6 | (e) (e) (e) (e) |P=0.421 P=0.511N P=0.269 P=0.616N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.438N P=0.449N P=0.125 P=0.606N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.523N P=0.500N P=0.218 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 5/50 (10%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.4% 4.6% 10.2% 2.9% | |TERMINAL (d) | 0/35 (0%) 0/43 (0%) 0/43 (0%) 0/22 (0%) |1/35 (3%) 0/35 (0%) 1/43 (2%) 1/25 (4%) | |FIRST INCIDENCE | --- --- --- --- |671 521 589 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.571 P=0.677 P=0.268 P=0.614N | |POLY 3 | (e) (e) (e) (e) |P=0.528 P=0.683 P=0.250 P=0.590N | |POLY 1.5 | (e) (e) (e) (e) |P=0.559N P=0.684 P=0.236 P=0.559N | |POLY 6 | (e) (e) (e) (e) |P=0.472 P=0.688 P=0.269 P=0.616N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.365N P=0.648N P=0.125 P=0.606N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.456N P=0.691N P=0.218 P=0.500N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 16 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Skin | | Schwannoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/43 (0%) 0/43 (0%) 0/22 (0%) |1/35 (3%) 0/35 (0%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | --- --- --- --- |607 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.133N P=0.252N P=0.219N P=0.326N | |POLY 3 | (e) (e) (e) (e) |P=0.093N P=0.250N P=0.228N P=0.302N | |POLY 1.5 | (e) (e) (e) (e) |P=0.101N P=0.247N P=0.232N P=0.278N | |POLY 6 | (e) (e) (e) (e) |P=0.085N P=0.250N P=0.223N P=0.323N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.101N P=0.222N P=0.272N P=0.238N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 4.2% 2.1% 0.0% |0.0% 0.0% 2.1% 0.0% | |TERMINAL (d) | 0/35 (0%) 2/43 (5%) 1/43 (2%) 0/22 (0%) |0/35 (0%) 0/35 (0%) 1/43 (2%) 0/25 (0%) | |FIRST INCIDENCE | 513 729 (T) 729 (T) --- |--- --- 730 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.350N P=0.552 P=0.740N P=0.630N |P=0.672 (e) P=0.541 (e) | |POLY 3 | P=0.329N P=0.515 P=0.754N P=0.574N |P=0.563 (e) P=0.510 (e) | |POLY 1.5 | P=0.300N P=0.511 P=0.756N P=0.545N |P=0.615 (e) P=0.506 (e) | |POLY 6 | P=0.364N P=0.521 P=0.749N P=0.599N |P=0.515 (e) P=0.516 (e) | |LOGISTIC REGRESSION| P=0.229N P=0.440 P=0.729 P=0.410N |(e) (e) P=0.541 (e) | |COCH-ARM / FISHERS | P=0.247N P=0.500 P=0.753N P=0.500N |P=0.694 (e) P=0.500 (e) | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 17 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 0.0% |0.0% 4.6% 0.0% 0.0% | |TERMINAL (d) | 1/35 (3%) 0/43 (0%) 0/43 (0%) 0/22 (0%) |0/35 (0%) 1/35 (3%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- |--- 644 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.344N P=0.459N P=0.459N P=0.593N |P=0.465N P=0.235 (e) (e) | |POLY 3 | P=0.242N P=0.488N P=0.492N P=0.571N |P=0.431N P=0.231 (e) (e) | |POLY 1.5 | P=0.271N P=0.492N P=0.494N P=0.543N |P=0.425N P=0.234 (e) (e) | |POLY 6 | P=0.234N P=0.484N P=0.486N P=0.595N |P=0.430N P=0.233 (e) (e) | |LOGISTIC REGRESSION| P=0.344N (e) (e) (e) |P=0.410N P=0.242 (e) (e) | |COCH-ARM / FISHERS | P=0.303N P=0.495N P=0.495N P=0.495N |P=0.402N P=0.253 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/49 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 2.1% 3.1% |0.0% 4.6% 2.1% 0.0% | |TERMINAL (d) | 1/35 (3%) 0/43 (0%) 1/43 (2%) 0/22 (0%) |0/35 (0%) 1/35 (3%) 1/43 (2%) 0/25 (0%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) 481 |--- 644 730 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.463 P=0.459N P=0.715N P=0.710 |P=0.539N P=0.235 P=0.541 (e) | |POLY 3 | P=0.431 P=0.488N P=0.751N P=0.677 |P=0.535N P=0.231 P=0.514 (e) | |POLY 1.5 | P=0.469 P=0.492N P=0.754N P=0.712 |P=0.510N P=0.234 P=0.510 (e) | |POLY 6 | P=0.412 P=0.484N P=0.745N P=0.645 |P=0.552N P=0.233 P=0.519 (e) | |LOGISTIC REGRESSION| P=0.648 (e) P=0.715N P=0.719N |P=0.498N P=0.242 P=0.541 (e) | |COCH-ARM / FISHERS | P=0.543 P=0.495N P=0.747N P=0.747N |P=0.457N P=0.253 P=0.505 (e) | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 18 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |Uterus | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| |0.0% 4.6% 0.0% 0.0% | |TERMINAL (d) | |0/35 (0%) 1/35 (3%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | |--- 711 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.459N P=0.246 (e) (e) | |POLY 3 | |P=0.434N P=0.227 (e) (e) | |POLY 1.5 | |P=0.428N P=0.229 (e) (e) | |POLY 6 | |P=0.432N P=0.228 (e) (e) | |LOGISTIC REGRESSION| |P=0.460N P=0.229 (e) (e) | |COCH-ARM / FISHERS | |P=0.405N P=0.247 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 0.0% |4.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 1/43 (2%) 0/43 (0%) 0/22 (0%) |2/35 (6%) 0/35 (0%) 0/43 (0%) 0/25 (0%) | |FIRST INCIDENCE | --- 729 (T) --- --- |730 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.646N P=0.541 (e) (e) |P=0.124N P=0.238N P=0.194N P=0.315N | |POLY 3 | P=0.550N P=0.512 (e) (e) |P=0.094N P=0.248N P=0.226N P=0.299N | |POLY 1.5 | P=0.561N P=0.508 (e) (e) |P=0.102N P=0.246N P=0.230N P=0.276N | |POLY 6 | P=0.562N P=0.516 (e) (e) |P=0.086N P=0.247N P=0.219N P=0.319N | |LOGISTIC REGRESSION| (e) P=0.541 (e) (e) |P=0.124N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.115N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 19 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 3/50 (6%) 0/50 (0%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 6.6% 2.1% 2.1% 3.1% |4.4% 6.8% 0.0% 8.6% | |TERMINAL (d) | 2/35 (6%) 1/43 (2%) 0/43 (0%) 0/22 (0%) |1/35 (3%) 1/35 (3%) 0/43 (0%) 3/25 (12%) | |FIRST INCIDENCE | 650 729 (T) 655 481 |704 405 --- 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.354N P=0.254N P=0.263N P=0.453N |P=0.388 P=0.505 P=0.202N P=0.346 | |POLY 3 | P=0.280N P=0.287N P=0.291N P=0.439N |P=0.444 P=0.487 P=0.226N P=0.383 | |POLY 1.5 | P=0.272N P=0.292N P=0.296N P=0.385N |P=0.459 P=0.489 P=0.231N P=0.424 | |POLY 6 | P=0.284N P=0.281N P=0.281N P=0.490N |P=0.440 P=0.491 P=0.220N P=0.351 | |LOGISTIC REGRESSION| P=0.196N P=0.295N P=0.311N P=0.304N |P=0.484 P=0.544 P=0.225N P=0.341 | |COCH-ARM / FISHERS | P=0.242N P=0.309N P=0.309N P=0.309N |P=0.500 P=0.500 P=0.247N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |4/50 (8%) 3/50 (6%) 0/50 (0%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 6.6% 4.2% 2.1% 3.1% |8.8% 6.8% 0.0% 8.6% | |TERMINAL (d) | 2/35 (6%) 2/43 (5%) 0/43 (0%) 0/22 (0%) |3/35 (9%) 1/35 (3%) 0/43 (0%) 3/25 (12%) | |FIRST INCIDENCE | 650 729 (T) 655 481 |704 405 --- 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.309N P=0.426N P=0.263N P=0.453N |P=0.490N P=0.495N P=0.043N* P=0.627 | |POLY 3 | P=0.247N P=0.477N P=0.291N P=0.439N |P=0.385N P=0.516N P=0.054N P=0.639N | |POLY 1.5 | P=0.235N P=0.483N P=0.296N P=0.385N |P=0.387N P=0.514N P=0.057N P=0.591N | |POLY 6 | P=0.255N P=0.468N P=0.281N P=0.490N |P=0.374N P=0.511N P=0.051N P=0.625 | |LOGISTIC REGRESSION| P=0.171N P=0.482N P=0.311N P=0.304N |P=0.414N P=0.482N P=0.050N P=0.624 | |COCH-ARM / FISHERS | P=0.199N P=0.500N P=0.309N P=0.309N |P=0.371N P=0.500N P=0.059N P=0.500N | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 20 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 1/50 (2%) |9/50 (18%) 7/50 (14%) 7/50 (14%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 4.5% 6.3% 6.4% 3.2% |19.5% 15.9% 14.7% 5.7% | |TERMINAL (d) | 2/35 (6%) 3/43 (7%) 3/43 (7%) 1/22 (5%) |5/35 (14%) 5/35 (14%) 7/43 (16%) 2/25 (8%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |623 289 730 (T) 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.536N P=0.594 P=0.594 P=0.660N |P=0.060N P=0.404N P=0.263N P=0.098N | |POLY 3 | P=0.509N P=0.526 P=0.519 P=0.623N |P=0.065N P=0.432N P=0.367N P=0.073N | |POLY 1.5 | P=0.449N P=0.519 P=0.513 P=0.576N |P=0.047N* P=0.419N P=0.376N P=0.051N | |POLY 6 | P=0.562N P=0.537 P=0.532 P=0.664N |P=0.084N P=0.438N P=0.356N P=0.100N | |LOGISTIC REGRESSION| P=0.536N P=0.594 P=0.594 P=0.660N |P=0.038N* P=0.380N P=0.369N P=0.068N | |COCH-ARM / FISHERS | P=0.343N P=0.500 P=0.500 P=0.500N |P=0.023N* P=0.393N P=0.393N P=0.026N* | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 29/50 (58%) 35/50 (70%) 33/50 (66%) 19/50 (38%) |24/50 (48%) 15/50 (30%) 20/50 (40%) 13/50 (26%) | |POLY-3 ADJUSTED (b)| 60.7% 70.8% 67.6% 52.7% |51.5% 34.6% 41.6% 36.1% | |TERMINAL (d) | 21/35 (60%) 29/43 (67%) 30/43 (70%) 12/22 (55%) |20/35 (57%) 14/35 (40%) 19/43 (44%) 10/25 (40%) | |FIRST INCIDENCE | 501 605 429 481 |362 638 589 480 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.531N P=0.547 P=0.464N P=0.565N |P=0.204N P=0.048N* P=0.074N P=0.190N | |POLY 3 | P=0.247N P=0.201 P=0.309 P=0.303N |P=0.143N P=0.076N P=0.223N P=0.116N | |POLY 1.5 | P=0.088N P=0.188 P=0.306 P=0.145N |P=0.095N P=0.069N P=0.245N P=0.064N | |POLY 6 | P=0.454N P=0.227 P=0.321 P=0.502N |P=0.183N P=0.075N P=0.192N P=0.174N | |LOGISTIC REGRESSION| P=0.083N P=0.167 P=0.284 P=0.176N |P=0.186N P=0.069N P=0.220N P=0.134N | |COCH-ARM / FISHERS | P=0.008N** P=0.149 P=0.268 P=0.036N* |P=0.036N* P=0.050N P=0.273N P=0.019N* | |=================================================================================================================================| Date: 10/19/99 EXPERIMENT: 88050 TEST: 06 Page 21 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHACRYLONITRILE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 24/50 (48%) 17/50 (34%) 16/50 (32%) 8/50 (16%) |19/50 (38%) 17/50 (34%) 17/50 (34%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 49.5% 34.3% 33.1% 23.8% |40.3% 36.4% 34.4% 38.7% | |TERMINAL (d) | 14/35 (40%) 11/43 (26%) 12/43 (28%) 3/22 (14%) |11/35 (31%) 9/35 (26%) 11/43 (26%) 8/25 (32%) | |FIRST INCIDENCE | 501 563 502 481 |607 289 589 581 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.047N* P=0.058N P=0.037N* P=0.065N |P=0.534N P=0.442N P=0.242N P=0.528 | |POLY 3 | P=0.015N* P=0.092N P=0.075N P=0.016N* |P=0.452N P=0.428N P=0.349N P=0.531N | |POLY 1.5 | P=0.005N** P=0.094N P=0.072N P=0.004N** |P=0.354N P=0.424N P=0.374N P=0.397N | |POLY 6 | P=0.033N* P=0.088N P=0.073N P=0.050N |P=0.519N P=0.431N P=0.320N P=0.539 | |LOGISTIC REGRESSION| P<0.001N** P=0.158N P=0.086N P=0.002N** |P=0.230N P=0.365N P=0.469N P=0.522N | |COCH-ARM / FISHERS | P<0.001N** P=0.111N P=0.076N P<0.001N** |P=0.174N P=0.418N P=0.418N P=0.198N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 1.5 3 MG/KG 6 MG/KG |0 MG/KG 1.5 3 MG/KG 6 MG/KG | | | MG/KG | MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 40/50 (80%) 41/50 (82%) 39/50 (78%) 24/50 (48%) |33/50 (66%) 28/50 (56%) 29/50 (58%) 21/50 (42%) | |POLY-3 ADJUSTED (b)| 81.9% 82.0% 78.2% 62.1% |68.8% 59.5% 58.7% 57.0% | |TERMINAL (d) | 27/35 (77%) 34/43 (79%) 33/43 (77%) 12/22 (55%) |24/35 (69%) 19/35 (54%) 23/43 (54%) 14/25 (56%) | |FIRST INCIDENCE | 501 563 429 481 |362 289 589 480 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.360N P=0.195N P=0.121N P=0.378N |P=0.268N P=0.261N P=0.074N P=0.346N | |POLY 3 | P=0.017N* P=0.595 P=0.418N P=0.027N* |P=0.164N P=0.230N P=0.204N P=0.180N | |POLY 1.5 | P=0.002N** P=0.587 P=0.422N P=0.005N** |P=0.082N P=0.225N P=0.231N P=0.077N | |POLY 6 | P=0.071N P=0.600N P=0.415N P=0.098N |P=0.244N P=0.225N P=0.170N P=0.310N | |LOGISTIC REGRESSION| P<0.001N** P=0.539 P=0.490N P=0.010N* |P=0.063N P=0.208N P=0.274N P=0.179N | |COCH-ARM / FISHERS | P<0.001N** P=0.500 P=0.500N P<0.001N** |P=0.013N* P=0.206N P=0.268N P=0.013N* | |=================================================================================================================================| (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).