TDMS Study 88004-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest DIVINYLBENZENE DATE: 08/14/03 EXPERIMENT: 88004 TEST: 06 TIME: 13:01:16 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88004B PATHOLOGIST: GRUMBEIN, SONDR CAS: 1321-74-0 ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 MICE REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest DIVINYLBENZENE DATE: 08/14/03 EXPERIMENT: 88004 TEST: 06 TIME: 13:01:16 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88004B PATHOLOGIST: GRUMBEIN, SONDR CAS: 1321-74-0 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 Epididymis Gallbladder Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Pituitary Gland Spleen Testes Thyroid Gland NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest DIVINYLBENZENE DATE: 08/14/03 EXPERIMENT: 88004 TEST: 06 TIME: 13:01:16 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88004B PATHOLOGIST: GRUMBEIN, SONDR CAS: 1321-74-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF DIVINYLBENZENE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex Adenoma Adrenal Medulla Pheochromocytoma Benign Heart Hemangiosarcoma Liver Hemangiosarcoma Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Skin Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma All Organs Hemangiosarcoma Hemangiosarcoma or Hemangioma Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma Malignant Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Ovary Cystadenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 1 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/45.45 1/45.52 0/46.42 0/47.18 |0/42.71 0/44.99 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 6.6% 2.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/41 (7%) 1/38 (3%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.101N P=0.333N P=0.117N P=0.113N |(e) (e) (e) (e) | |POLY 3 | P=0.104N P=0.305N P=0.115N P=0.112N |(e) (e) (e) (e) | |POLY 1.5 | P=0.105N P=0.306N P=0.115N P=0.114N |(e) (e) (e) (e) | |POLY 6 | P=0.103N P=0.304N P=0.114N P=0.110N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.101N P=0.333N (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.107N P=0.309N P=0.117N P=0.117N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.018N* (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 2/45.45 0/45.52 0/46.42 0/47.18 |0/41.71 0/44.99 1/43.89 0/46.93 | |POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 2/41 (5%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |0/32 (0%) 0/35 (0%) 1/38 (3%) 0/42 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- |--- --- 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.251N P=0.255N P=0.233N P=0.228N |P=0.744N (e) P=0.534 (e) | |POLY 3 | P=0.257N P=0.237N P=0.232N P=0.229N |P=0.765N (e) P=0.510 (e) | |POLY 1.5 | P=0.257N P=0.237N P=0.233N P=0.231N |P=0.771N (e) P=0.507 (e) | |POLY 6 | P=0.257N P=0.236N P=0.232N P=0.226N |P=0.756N (e) P=0.515 (e) | |LOGISTIC REGRESSION| P=0.251N (e) (e) (e) |(e) (e) P=0.534 (e) | |COCH-ARM / FISHERS | P=0.259N P=0.247N P=0.242N P=0.242N |P=0.777N (e) P=0.500 (e) | |ORDER RESTRICTED | P=0.027N* (e) (e) (e) |P=0.391 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 2 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/45.45 0/45.52 1/46.42 0/47.18 |0/41.71 0/44.99 0/43.89 2/46.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |0.0% 0.0% 0.0% 4.3% | |TERMINAL (d) | 0/41 (0%) 0/38 (0%) 1/42 (2%) 0/43 (0%) |0/32 (0%) 0/35 (0%) 0/38 (0%) 2/42 (5%) | |FIRST INCIDENCE | --- --- 729 (T) --- |--- --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.767N (e) P=0.505 (e) |P=0.061 (e) (e) P=0.300 | |POLY 3 | P=0.773N (e) P=0.504 (e) |P=0.046 * (e) (e) P=0.264 | |POLY 1.5 | P=0.775N (e) P=0.504 (e) |P=0.044 * (e) (e) P=0.254 | |POLY 6 | P=0.771N (e) P=0.505 (e) |P=0.049 * (e) (e) P=0.278 | |LOGISTIC REGRESSION| (e) (e) P=0.505 (e) |(e) (e) (e) P=0.300 | |COCH-ARM / FISHERS | P=0.777N (e) P=0.505 (e) |P=0.043 * (e) (e) P=0.253 | |ORDER RESTRICTED | P=0.385 (e) (e) (e) |P=0.040 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 1/49 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 2/45.45 0/45.52 1/46.42 0/47.18 |0/41.71 0/44.99 1/43.89 2/46.93 | |POLY-3 PERCENT (g) | 4.4% 0.0% 2.2% 0.0% |0.0% 0.0% 2.3% 4.3% | |TERMINAL (d) | 2/41 (5%) 0/38 (0%) 1/42 (2%) 0/43 (0%) |0/32 (0%) 0/35 (0%) 1/38 (3%) 2/42 (5%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- --- 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.261N P=0.255N P=0.492N P=0.228N |P=0.127 (e) P=0.534 P=0.300 | |POLY 3 | P=0.269N P=0.237N P=0.493N P=0.229N |P=0.104 (e) P=0.510 P=0.264 | |POLY 1.5 | P=0.270N P=0.237N P=0.493N P=0.231N |P=0.098 (e) P=0.507 P=0.254 | |POLY 6 | P=0.266N P=0.236N P=0.492N P=0.226N |P=0.113 (e) P=0.515 P=0.278 | |LOGISTIC REGRESSION| P=0.261N (e) P=0.492N (e) |(e) (e) P=0.534 P=0.300 | |COCH-ARM / FISHERS | P=0.272N P=0.247N P=0.492N P=0.242N |P=0.092 (e) P=0.500 P=0.253 | |ORDER RESTRICTED | P=0.069N (e) (e) (e) |P=0.093 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 3 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/48 (2%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/46.11 1/45.48 0/46.42 0/47.18 |0/41.88 2/44.33 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 4.3% 2.2% 0.0% 0.0% |0.0% 4.5% 0.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 1/35 (3%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 609 716 --- --- |--- 656 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.179N P=0.512N P=0.237N P=0.232N |P=0.359N P=0.249 (e) (e) | |POLY 3 | P=0.183N P=0.505N P=0.236N P=0.232N |P=0.365N P=0.250 (e) (e) | |POLY 1.5 | P=0.184N P=0.508N P=0.236N P=0.234N |P=0.374N P=0.246 (e) (e) | |POLY 6 | P=0.182N P=0.504N P=0.235N P=0.230N |P=0.355N P=0.253 (e) (e) | |LOGISTIC REGRESSION| P=0.186N P=0.557N P=0.247N P=0.254N |P=0.388N P=0.238 (e) (e) | |COCH-ARM / FISHERS | P=0.183N P=0.515N P=0.247N P=0.247N |P=0.388N P=0.247 (e) (e) | |ORDER RESTRICTED | P=0.072N (e) (e) (e) |P=0.237N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 6/50 (12%) 7/50 (14%) |4/50 (8%) 1/50 (2%) 4/50 (8%) 5/50 (10%) | |POLY-3 RATE (b) | 5/45.69 3/46.01 6/46.42 7/47.18 |4/43.26 1/44.99 4/43.99 5/46.96 | |POLY-3 PERCENT (g) | 10.9% 6.5% 12.9% 14.8% |9.3% 2.2% 9.1% 10.7% | |TERMINAL (d) | 5/41 (12%) 2/38 (5%) 6/42 (14%) 7/43 (16%) |2/33 (6%) 1/35 (3%) 4/38 (11%) 4/42 (10%) | |FIRST INCIDENCE | 729 (T) 711 729 (T) 729 (T) |596 731 (T) 731 (T) 725 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.252 P=0.396N P=0.517 P=0.412 |P=0.343 P=0.167N P=0.576N P=0.633N | |POLY 3 | P=0.221 P=0.353N P=0.511 P=0.402 |P=0.258 P=0.167N P=0.634N P=0.551 | |POLY 1.5 | P=0.214 P=0.355N P=0.507 P=0.393 |P=0.241 P=0.170N P=0.638N P=0.528 | |POLY 6 | P=0.231 P=0.351N P=0.516 P=0.414 |P=0.283 P=0.166N P=0.629N P=0.579 | |LOGISTIC REGRESSION| P=0.249 P=0.362N P=0.517 P=0.412 |P=0.277 P=0.171N P=0.629N P=0.543 | |COCH-ARM / FISHERS | P=0.204 P=0.357N P=0.500 P=0.380 |P=0.228 P=0.181N P=0.643N P=0.500 | |ORDER RESTRICTED | P=0.281 (e) (e) (e) |P=0.299 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 4 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 4/50 (8%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 1/45.69 1/45.94 0/46.42 0/47.18 |2/42.88 4/44.99 1/43.99 2/46.93 | |POLY-3 PERCENT (g) | 2.2% 2.2% 0.0% 0.0% |4.7% 8.9% 2.3% 4.3% | |TERMINAL (d) | 1/41 (2%) 1/38 (3%) 0/42 (0%) 0/43 (0%) |1/33 (3%) 4/35 (11%) 1/38 (3%) 2/42 (5%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- |687 731 (T) 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.311N P=0.745 P=0.495N P=0.490N |P=0.365N P=0.368 P=0.456N P=0.605N | |POLY 3 | P=0.323N P=0.759N P=0.497N P=0.494N |P=0.430N P=0.359 P=0.491N P=0.661N | |POLY 1.5 | P=0.324N P=0.760N P=0.498N P=0.496N |P=0.447N P=0.354 P=0.495N P=0.676N | |POLY 6 | P=0.322N P=0.759N P=0.495N P=0.490N |P=0.410N P=0.362 P=0.486N P=0.642N | |LOGISTIC REGRESSION| P=0.311N P=0.745 (e) (e) |P=0.392N P=0.367 P=0.487N P=0.657N | |COCH-ARM / FISHERS | P=0.325N P=0.753N P=0.500N P=0.500N |P=0.465N P=0.339 P=0.500N P=0.691N | |ORDER RESTRICTED | P=0.245N (e) (e) (e) |P=0.355N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 4/50 (8%) 6/50 (12%) 7/50 (14%) |6/50 (12%) 5/50 (10%) 5/50 (10%) 7/50 (14%) | |POLY-3 RATE (b) | 6/45.69 4/46.01 6/46.42 7/47.18 |6/43.43 5/44.99 5/43.99 7/46.96 | |POLY-3 PERCENT (g) | 13.1% 8.7% 12.9% 14.8% |13.8% 11.1% 11.4% 14.9% | |TERMINAL (d) | 6/41 (15%) 3/38 (8%) 6/42 (14%) 7/43 (16%) |3/33 (9%) 5/35 (14%) 5/38 (13%) 6/42 (14%) | |FIRST INCIDENCE | 729 (T) 711 729 (T) 729 (T) |596 731 (T) 731 (T) 725 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.385 P=0.415N P=0.605N P=0.537 |P=0.536 P=0.458N P=0.417N P=0.559N | |POLY 3 | P=0.347 P=0.365N P=0.610N P=0.525 |P=0.417 P=0.475N P=0.491N P=0.560 | |POLY 1.5 | P=0.338 P=0.368N P=0.614N P=0.514 |P=0.391 P=0.480N P=0.494N P=0.533 | |POLY 6 | P=0.359 P=0.364N P=0.605N P=0.538 |P=0.453 P=0.477N P=0.486N P=0.591 | |LOGISTIC REGRESSION| P=0.383 P=0.378N P=0.605N P=0.537 |P=0.458 P=0.465N P=0.479N P=0.561 | |COCH-ARM / FISHERS | P=0.325 P=0.370N P=0.620N P=0.500 |P=0.367 P=0.500N P=0.500N P=0.500 | |ORDER RESTRICTED | P=0.448 (e) (e) (e) |P=0.540 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 5 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Heart | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/45.95 0/45.52 0/46.42 0/47.18 |0/42.71 0/44.99 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 662 --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.252N P=0.248N P=0.235N P=0.227N |(e) (e) (e) (e) | |POLY 3 | P=0.261N P=0.239N P=0.235N P=0.231N |(e) (e) (e) (e) | |POLY 1.5 | P=0.260N P=0.240N P=0.236N P=0.234N |(e) (e) (e) (e) | |POLY 6 | P=0.260N P=0.239N P=0.234N P=0.229N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.264N P=0.243N P=0.240N P=0.243N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.261N P=0.253N P=0.247N P=0.247N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.027N* (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 4/50 (8%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/46.11 0/45.94 0/46.42 4/47.74 |0/42.71 2/44.99 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 6.5% 0.0% 0.0% 8.4% |0.0% 4.5% 0.0% 0.0% | |TERMINAL (d) | 2/41 (5%) 0/38 (0%) 0/42 (0%) 3/43 (7%) |0/33 (0%) 2/35 (6%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 609 --- --- 558 |--- 731 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.136 P=0.131N P=0.120N P=0.522 |P=0.350N P=0.251 (e) (e) | |POLY 3 | P=0.122 P=0.119N P=0.118N P=0.519 |P=0.370N P=0.249 (e) (e) | |POLY 1.5 | P=0.120 P=0.119N P=0.118N P=0.511 |P=0.378N P=0.246 (e) (e) | |POLY 6 | P=0.126 P=0.120N P=0.117N P=0.528 |P=0.360N P=0.251 (e) (e) | |LOGISTIC REGRESSION| P=0.108 P=0.120N P=0.124N P=0.476 |(e) P=0.251 (e) (e) | |COCH-ARM / FISHERS | P=0.119 P=0.121N P=0.121N P=0.500 |P=0.392N P=0.247 (e) (e) | |ORDER RESTRICTED | P=0.082 (e) (e) (e) |P=0.240N (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 6 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 5/50 (10%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 3/46.11 1/46.26 0/46.42 5/47.74 |0/42.71 2/44.99 1/43.99 0/46.93 | |POLY-3 PERCENT (g) | 6.5% 2.2% 0.0% 10.5% |0.0% 4.5% 2.3% 0.0% | |TERMINAL (d) | 2/41 (5%) 0/38 (0%) 0/42 (0%) 4/43 (9%) |0/33 (0%) 2/35 (6%) 1/38 (3%) 0/42 (0%) | |FIRST INCIDENCE | 609 641 --- 558 |--- 731 (T) 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.098 P=0.317N P=0.120N P=0.381 |P=0.330N P=0.251 P=0.528 (e) | |POLY 3 | P=0.084 P=0.304N P=0.118N P=0.376 |P=0.353N P=0.249 P=0.506 (e) | |POLY 1.5 | P=0.082 P=0.305N P=0.118N P=0.368 |P=0.366N P=0.246 P=0.503 (e) | |POLY 6 | P=0.086 P=0.304N P=0.117N P=0.385 |P=0.338N P=0.251 P=0.510 (e) | |LOGISTIC REGRESSION| P=0.072 P=0.302N P=0.124N P=0.337 |(e) P=0.251 P=0.528 (e) | |COCH-ARM / FISHERS | P=0.081 P=0.309N P=0.121N P=0.357 |P=0.383N P=0.247 P=0.500 (e) | |ORDER RESTRICTED | P=0.060 (e) (e) (e) |P=0.318N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/46.36 1/45.99 0/46.42 0/47.18 |0/41.88 0/44.99 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 6.5% 2.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 609 716 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.105N P=0.318N P=0.121N P=0.116N |(e) (e) (e) (e) | |POLY 3 | P=0.106N P=0.308N P=0.119N P=0.116N |(e) (e) (e) (e) | |POLY 1.5 | P=0.107N P=0.307N P=0.119N P=0.117N |(e) (e) (e) (e) | |POLY 6 | P=0.105N P=0.311N P=0.119N P=0.114N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.115N P=0.303N P=0.128N P=0.133N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.110N P=0.309N P=0.121N P=0.121N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.019N* (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 7 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/45.69 0/45.94 2/47.35 0/47.18 |0/41.88 0/44.99 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.2% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/41 (0%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | --- --- 479 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.668N (e) P=0.247 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.666N (e) P=0.245 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.670N (e) P=0.242 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.660N (e) P=0.249 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.747N (e) P=0.179 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.675N (e) P=0.247 (e) |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.254 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/50 (44%) 17/50 (34%) 12/50 (24%) 12/50 (24%) |17/49 (35%) 7/50 (14%) 6/50 (12%) 5/50 (10%) | |POLY-3 RATE (b) | 22/46.70 17/47.51 12/47.55 12/47.18 |17/42.80 7/45.62 6/44.08 5/46.93 | |POLY-3 PERCENT (g) | 47.1% 35.8% 25.2% 25.4% |39.7% 15.4% 13.6% 10.7% | |TERMINAL (d) | 20/41 (49%) 13/38 (34%) 9/42 (21%) 12/43 (28%) |13/33 (39%) 5/35 (14%) 5/38 (13%) 5/42 (12%) | |FIRST INCIDENCE | 456 543 526 729 (T) |625 537 709 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.028N* P=0.290N P=0.028N* P=0.019N* |P=0.006N** P=0.014N* P=0.004N** P<0.001N** | |POLY 3 | P=0.039N* P=0.181N P=0.020N* P=0.022N* |P=0.010N* P=0.008N** P=0.004N** P<0.001N** | |POLY 1.5 | P=0.040N* P=0.193N P=0.023N* P=0.024N* |P=0.012N* P=0.009N** P=0.005N** P<0.001N** | |POLY 6 | P=0.037N* P=0.167N P=0.018N* P=0.019N* |P=0.008N** P=0.008N** P=0.004N** P<0.001N** | |LOGISTIC REGRESSION| P=0.039N* P=0.204N P=0.027N* P=0.020N* |P=0.010N* P=0.010N* P=0.005N** P<0.001N** | |COCH-ARM / FISHERS | P=0.043N* P=0.206N P=0.028N* P=0.028N* |P=0.017N* P=0.015N* P=0.007N** P=0.003N** | |ORDER RESTRICTED | P=0.015N* (e) (e) (e) |P<0.001N** (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 8 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 11/50 (22%) 9/50 (18%) 10/50 (20%) |5/49 (10%) 4/50 (8%) 3/50 (6%) 2/50 (4%) | |POLY-3 RATE (b) | 13/47.80 11/47.65 9/48.87 10/47.79 |5/42.74 4/45.04 3/44.67 2/46.93 | |POLY-3 PERCENT (g) | 27.2% 23.1% 18.4% 20.9% |11.7% 8.9% 6.7% 4.3% | |TERMINAL (d) | 8/41 (20%) 5/38 (13%) 4/42 (10%) 9/43 (21%) |3/33 (9%) 3/35 (9%) 2/38 (5%) 2/42 (5%) | |FIRST INCIDENCE | 565 600 479 533 |586 719 501 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.298N P=0.447N P=0.236N P=0.287N |P=0.129N P=0.465N P=0.313N P=0.149N | |POLY 3 | P=0.347N P=0.411N P=0.216N P=0.317N |P=0.162N P=0.467N P=0.332N P=0.180N | |POLY 1.5 | P=0.345N P=0.411N P=0.223N P=0.316N |P=0.173N P=0.471N P=0.337N P=0.192N | |POLY 6 | P=0.352N P=0.411N P=0.212N P=0.321N |P=0.147N P=0.470N P=0.327N P=0.166N | |LOGISTIC REGRESSION| P=0.403N P=0.411N P=0.264N P=0.347N |P=0.181N P=0.470N P=0.351N P=0.204N | |COCH-ARM / FISHERS | P=0.346N P=0.408N P=0.235N P=0.318N |P=0.183N P=0.487N P=0.346N P=0.210N | |ORDER RESTRICTED | P=0.300N (e) (e) (e) |P=0.148N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 11/50 (22%) 9/50 (18%) 10/50 (20%) |5/49 (10%) 4/50 (8%) 3/50 (6%) 2/50 (4%) | |POLY-3 RATE (b) | 13/47.80 11/47.65 9/48.87 10/47.79 |5/42.74 4/45.04 3/44.67 2/46.93 | |POLY-3 PERCENT (g) | 27.2% 23.1% 18.4% 20.9% |11.7% 8.9% 6.7% 4.3% | |TERMINAL (d) | 8/41 (20%) 5/38 (13%) 4/42 (10%) 9/43 (21%) |3/33 (9%) 3/35 (9%) 2/38 (5%) 2/42 (5%) | |FIRST INCIDENCE | 565 600 479 533 |586 719 501 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.298N P=0.447N P=0.236N P=0.287N |P=0.129N P=0.465N P=0.313N P=0.149N | |POLY 3 | P=0.347N P=0.411N P=0.216N P=0.317N |P=0.162N P=0.467N P=0.332N P=0.180N | |POLY 1.5 | P=0.345N P=0.411N P=0.223N P=0.316N |P=0.173N P=0.471N P=0.337N P=0.192N | |POLY 6 | P=0.352N P=0.411N P=0.212N P=0.321N |P=0.147N P=0.470N P=0.327N P=0.166N | |LOGISTIC REGRESSION| P=0.403N P=0.411N P=0.264N P=0.347N |P=0.181N P=0.470N P=0.351N P=0.204N | |COCH-ARM / FISHERS | P=0.346N P=0.408N P=0.235N P=0.318N |P=0.183N P=0.487N P=0.346N P=0.210N | |ORDER RESTRICTED | P=0.300N (e) (e) (e) |P=0.148N (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 9 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/50 (60%) 26/50 (52%) 20/50 (40%) 22/50 (44%) |19/49 (39%) 10/50 (20%) 8/50 (16%) 7/50 (14%) | |POLY-3 RATE (b) | 30/48.55 26/48.90 20/50.00 22/47.79 |19/43.29 10/45.66 8/44.75 7/46.93 | |POLY-3 PERCENT (g) | 61.8% 53.2% 40.0% 46.0% |43.9% 21.9% 17.9% 14.9% | |TERMINAL (d) | 24/41 (59%) 17/38 (45%) 12/42 (29%) 21/43 (49%) |14/33 (42%) 7/35 (20%) 6/38 (16%) 7/42 (17%) | |FIRST INCIDENCE | 456 543 479 533 |586 537 501 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.084N P=0.394N P=0.051N P=0.062N |P=0.006N** P=0.031N* P=0.006N** P<0.001N** | |POLY 3 | P=0.131N P=0.256N P=0.023N* P=0.086N |P=0.012N* P=0.021N* P=0.006N** P=0.002N** | |POLY 1.5 | P=0.122N P=0.267N P=0.027N* P=0.083N |P=0.014N* P=0.023N* P=0.007N** P=0.002N** | |POLY 6 | P=0.145N P=0.241N P=0.019N* P=0.092N |P=0.009N** P=0.021N* P=0.006N** P<0.001N** | |LOGISTIC REGRESSION| P=0.131N P=0.275N P=0.039N* P=0.077N |P=0.013N* P=0.023N* P=0.008N** P=0.002N** | |COCH-ARM / FISHERS | P=0.112N P=0.273N P=0.036N* P=0.080N |P=0.019N* P=0.033N* P=0.010N* P=0.005N** | |ORDER RESTRICTED | P=0.045N* (e) (e) (e) |P<0.001N** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/50 (60%) 26/50 (52%) 20/50 (40%) 22/50 (44%) |19/49 (39%) 10/50 (20%) 8/50 (16%) 7/50 (14%) | |POLY-3 RATE (b) | 30/48.55 26/48.90 20/50.00 22/47.79 |19/43.29 10/45.66 8/44.75 7/46.93 | |POLY-3 PERCENT (g) | 61.8% 53.2% 40.0% 46.0% |43.9% 21.9% 17.9% 14.9% | |TERMINAL (d) | 24/41 (59%) 17/38 (45%) 12/42 (29%) 21/43 (49%) |14/33 (42%) 7/35 (20%) 6/38 (16%) 7/42 (17%) | |FIRST INCIDENCE | 456 543 479 533 |586 537 501 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.084N P=0.394N P=0.051N P=0.062N |P=0.006N** P=0.031N* P=0.006N** P<0.001N** | |POLY 3 | P=0.131N P=0.256N P=0.023N* P=0.086N |P=0.012N* P=0.021N* P=0.006N** P=0.002N** | |POLY 1.5 | P=0.122N P=0.267N P=0.027N* P=0.083N |P=0.014N* P=0.023N* P=0.007N** P=0.002N** | |POLY 6 | P=0.145N P=0.241N P=0.019N* P=0.092N |P=0.009N** P=0.021N* P=0.006N** P<0.001N** | |LOGISTIC REGRESSION| P=0.131N P=0.275N P=0.039N* P=0.077N |P=0.013N* P=0.023N* P=0.008N** P=0.002N** | |COCH-ARM / FISHERS | P=0.112N P=0.273N P=0.036N* P=0.080N |P=0.019N* P=0.033N* P=0.010N* P=0.005N** | |ORDER RESTRICTED | P=0.045N* (e) (e) (e) |P<0.001N** (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 10 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/49 (24%) 6/49 (12%) 6/49 (12%) 15/49 (31%) |4/50 (8%) 9/50 (18%) 4/50 (8%) 8/49 (16%) | |POLY-3 RATE (b) | 12/46.05 6/45.52 6/46.05 15/47.42 |4/42.71 9/44.99 4/44.08 8/46.89 | |POLY-3 PERCENT (g) | 26.1% 13.2% 13.0% 31.6% |9.4% 20.0% 9.1% 17.1% | |TERMINAL (d) | 11/41 (27%) 6/38 (16%) 6/42 (14%) 13/43 (30%) |4/33 (12%) 9/35 (26%) 3/38 (8%) 7/42 (17%) | |FIRST INCIDENCE | 536 729 (T) 729 (T) 598 |731 (T) 731 (T) 709 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.091 P=0.126N P=0.087N P=0.381 |P=0.469 P=0.134 P=0.565N P=0.315 | |POLY 3 | P=0.067 P=0.097N P=0.093N P=0.358 |P=0.352 P=0.134 P=0.626N P=0.225 | |POLY 1.5 | P=0.063 P=0.097N P=0.094N P=0.343 |P=0.316 P=0.129 P=0.633N P=0.199 | |POLY 6 | P=0.075 P=0.098N P=0.091N P=0.381 |P=0.399 P=0.137 P=0.615N P=0.259 | |LOGISTIC REGRESSION| P=0.070 P=0.094N P=0.090N P=0.340 |P=0.446 P=0.134 P=0.592N P=0.289 | |COCH-ARM / FISHERS | P=0.060 P=0.096N P=0.096N P=0.326 |P=0.276 P=0.117 P=0.643N P=0.168 | |ORDER RESTRICTED | P=0.063 (e) (e) (e) |P=0.233 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 4/49 (8%) 3/49 (6%) 9/49 (18%) |2/50 (4%) 5/50 (10%) 4/50 (8%) 5/49 (10%) | |POLY-3 RATE (b) | 5/45.45 4/45.59 3/46.05 9/47.20 |2/42.71 5/45.04 4/44.59 5/46.77 | |POLY-3 PERCENT (g) | 11.0% 8.8% 6.5% 19.1% |4.7% 11.1% 9.0% 10.7% | |TERMINAL (d) | 5/41 (12%) 3/38 (8%) 3/42 (7%) 7/43 (16%) |2/33 (6%) 4/35 (11%) 3/38 (8%) 4/42 (10%) | |FIRST INCIDENCE | 729 (T) 711 729 (T) 669 |731 (T) 719 536 729 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.088 P=0.544N P=0.343N P=0.228 |P=0.443 P=0.245 P=0.395 P=0.326 | |POLY 3 | P=0.069 P=0.498N P=0.349N P=0.214 |P=0.360 P=0.238 P=0.357 P=0.255 | |POLY 1.5 | P=0.066 P=0.500N P=0.353N P=0.205 |P=0.330 P=0.232 P=0.349 P=0.234 | |POLY 6 | P=0.075 P=0.496N P=0.345N P=0.229 |P=0.397 P=0.242 P=0.369 P=0.280 | |LOGISTIC REGRESSION| P=0.074 P=0.509N P=0.343N P=0.213 |P=0.358 P=0.251 P=0.343 P=0.333 | |COCH-ARM / FISHERS | P=0.062 P=0.500N P=0.357N P=0.194 |P=0.295 P=0.218 P=0.339 P=0.210 | |ORDER RESTRICTED | P=0.088 (e) (e) (e) |P=0.256 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 11 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/49 (33%) 10/49 (20%) 8/49 (16%) 20/49 (41%) |6/50 (12%) 12/50 (24%) 8/50 (16%) 13/49 (27%) | |POLY-3 RATE (b) | 16/46.05 10/45.59 8/46.05 20/47.65 |6/42.71 12/45.04 8/44.68 13/46.90 | |POLY-3 PERCENT (g) | 34.7% 21.9% 17.4% 42.0% |14.1% 26.7% 17.9% 27.7% | |TERMINAL (d) | 15/41 (37%) 9/38 (24%) 8/42 (19%) 17/43 (40%) |6/33 (18%) 11/35 (31%) 6/38 (16%) 11/42 (26%) | |FIRST INCIDENCE | 536 711 729 (T) 598 |731 (T) 719 536 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.079 P=0.174N P=0.042N* P=0.332 |P=0.284 P=0.117 P=0.491 P=0.171 | |POLY 3 | P=0.053 P=0.128N P=0.046N* P=0.306 |P=0.161 P=0.114 P=0.421 P=0.092 | |POLY 1.5 | P=0.048 * P=0.128N P=0.047N* P=0.286 |P=0.133 P=0.109 P=0.407 P=0.074 | |POLY 6 | P=0.062 P=0.128N P=0.044N* P=0.339 |P=0.204 P=0.117 P=0.443 P=0.118 | |LOGISTIC REGRESSION| P=0.056 P=0.121N P=0.044N* P=0.287 |P=0.205 P=0.127 P=0.413 P=0.155 | |COCH-ARM / FISHERS | P=0.045 * P=0.126N P=0.049N* P=0.265 |P=0.105 P=0.096 P=0.387 P=0.056 | |ORDER RESTRICTED | P=0.041 * (e) (e) (e) |P=0.088 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/45.69 0/45.94 0/46.42 0/47.18 |0/42.71 2/45.40 0/43.99 1/46.94 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 0.0% 2.1% | |TERMINAL (d) | 0/41 (0%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 1/35 (3%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 613 --- 729 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.661 P=0.251 (e) P=0.553 | |POLY 3 | (e) (e) (e) (e) |P=0.647 P=0.251 (e) P=0.519 | |POLY 1.5 | (e) (e) (e) (e) |P=0.634 P=0.247 (e) P=0.510 | |POLY 6 | (e) (e) (e) (e) |P=0.663 P=0.254 (e) P=0.529 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.616 P=0.221 (e) P=0.546 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.617 P=0.247 (e) P=0.500 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.331 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 12 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |3/48 (6%) 0/50 (0%) 0/49 (0%) 1/49 (2%) | |POLY-3 RATE (b) | |3/40.96 0/44.99 0/42.99 1/45.93 | |POLY-3 PERCENT (g) | |7.3% 0.0% 0.0% 2.2% | |TERMINAL (d) | |3/33 (9%) 0/35 (0%) 0/37 (0%) 1/41 (2%) | |FIRST INCIDENCE | |731 (T) --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.414N P=0.110N P=0.101N P=0.231N | |POLY 3 | |P=0.475N P=0.102N P=0.110N P=0.265N | |POLY 1.5 | |P=0.477N P=0.105N P=0.112N P=0.280N | |POLY 6 | |P=0.469N P=0.101N P=0.107N P=0.249N | |LOGISTIC REGRESSION| |P=0.414N (e) (e) P=0.231N | |COCH-ARM / FISHERS | |P=0.473N P=0.114N P=0.117N P=0.301N | |ORDER RESTRICTED | |P=0.027N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/47 (0%) 0/46 (0%) |8/47 (17%) 8/50 (16%) 1/49 (2%) 1/45 (2%) | |POLY-3 RATE (b) | 0/43.90 0/44.39 0/44.18 0/44.12 |8/40.43 8/45.23 1/42.99 1/42.76 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |19.8% 17.7% 2.3% 2.3% | |TERMINAL (d) | 0/40 (0%) 0/38 (0%) 0/41 (0%) 0/41 (0%) |6/31 (19%) 6/35 (17%) 1/37 (3%) 1/38 (3%) | |FIRST INCIDENCE | --- --- --- --- |596 693 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.004N** P=0.511N P=0.010N* P=0.009N** | |POLY 3 | (e) (e) (e) (e) |P=0.005N** P=0.511N P=0.011N* P=0.012N* | |POLY 1.5 | (e) (e) (e) (e) |P=0.006N** P=0.523N P=0.012N* P=0.014N* | |POLY 6 | (e) (e) (e) (e) |P=0.004N** P=0.506N P=0.011N* P=0.009N** | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.006N** P=0.499N P=0.013N* P=0.014N* | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.009N** P=0.554N P=0.013N* P=0.018N* | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.006N** (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 13 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 3/46.30 1/46.06 1/46.42 0/47.18 |1/43.48 2/45.99 3/44.61 1/47.06 | |POLY-3 PERCENT (g) | 6.5% 2.2% 2.2% 0.0% |2.3% 4.4% 6.7% 2.1% | |TERMINAL (d) | 2/41 (5%) 0/38 (0%) 1/42 (2%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 1/38 (3%) 0/42 (0%) | |FIRST INCIDENCE | 536 697 729 (T) --- |450 506 564 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.117N P=0.317N P=0.301N P=0.118N |P=0.453N P=0.525 P=0.335 P=0.731N | |POLY 3 | P=0.120N P=0.307N P=0.304N P=0.115N |P=0.469N P=0.520 P=0.314 P=0.743N | |POLY 1.5 | P=0.121N P=0.307N P=0.305N P=0.117N |P=0.485N P=0.514 P=0.310 P=0.751N | |POLY 6 | P=0.118N P=0.308N P=0.304N P=0.113N |P=0.446N P=0.525 P=0.322 P=0.731N | |LOGISTIC REGRESSION| P=0.129N P=0.301N P=0.316N P=0.134N |P=0.503N P=0.230 P=0.284 P=0.750 | |COCH-ARM / FISHERS | P=0.123N P=0.309N P=0.309N P=0.121N |P=0.500N P=0.500 P=0.309 P=0.753N | |ORDER RESTRICTED | P=0.035N* (e) (e) (e) |P=0.446N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 3/46.30 1/46.06 1/46.42 0/47.18 |1/43.48 2/45.99 3/44.61 1/47.06 | |POLY-3 PERCENT (g) | 6.5% 2.2% 2.2% 0.0% |2.3% 4.4% 6.7% 2.1% | |TERMINAL (d) | 2/41 (5%) 0/38 (0%) 1/42 (2%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 1/38 (3%) 0/42 (0%) | |FIRST INCIDENCE | 536 697 729 (T) --- |450 506 564 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.117N P=0.317N P=0.301N P=0.118N |P=0.453N P=0.525 P=0.335 P=0.731N | |POLY 3 | P=0.120N P=0.307N P=0.304N P=0.115N |P=0.469N P=0.520 P=0.314 P=0.743N | |POLY 1.5 | P=0.121N P=0.307N P=0.305N P=0.117N |P=0.485N P=0.514 P=0.310 P=0.751N | |POLY 6 | P=0.118N P=0.308N P=0.304N P=0.113N |P=0.446N P=0.525 P=0.322 P=0.731N | |LOGISTIC REGRESSION| P=0.129N P=0.301N P=0.316N P=0.134N |P=0.503N P=0.230 P=0.284 P=0.750 | |COCH-ARM / FISHERS | P=0.123N P=0.309N P=0.309N P=0.121N |P=0.500N P=0.500 P=0.309 P=0.753N | |ORDER RESTRICTED | P=0.035N* (e) (e) (e) |P=0.446N (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 14 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/45.69 0/45.94 1/46.42 0/47.18 |0/42.71 0/44.99 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 4.4% 0.0% 2.2% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/41 (5%) 0/38 (0%) 1/42 (2%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.261N P=0.255N P=0.492N P=0.228N |(e) (e) (e) (e) | |POLY 3 | P=0.271N P=0.236N P=0.495N P=0.230N |(e) (e) (e) (e) | |POLY 1.5 | P=0.273N P=0.237N P=0.497N P=0.233N |(e) (e) (e) (e) | |POLY 6 | P=0.268N P=0.236N P=0.492N P=0.226N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.261N (e) P=0.492N (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.276N P=0.247N P=0.500N P=0.247N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.070N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Skin | | Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 1/46.30 1/46.06 0/46.42 0/47.18 |1/43.48 2/45.99 3/44.61 1/47.06 | |POLY-3 PERCENT (g) | 2.2% 2.2% 0.0% 0.0% |2.3% 4.4% 6.7% 2.1% | |TERMINAL (d) | 0/41 (0%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 1/38 (3%) 0/42 (0%) | |FIRST INCIDENCE | 536 697 --- --- |450 506 564 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.321N P=0.755N P=0.500N P=0.500N |P=0.453N P=0.525 P=0.335 P=0.731N | |POLY 3 | P=0.323N P=0.759 P=0.499N P=0.496N |P=0.469N P=0.520 P=0.314 P=0.743N | |POLY 1.5 | P=0.324N P=0.760 P=0.500N P=0.498N |P=0.485N P=0.514 P=0.310 P=0.751N | |POLY 6 | P=0.322N P=0.759 P=0.499N P=0.494N |P=0.446N P=0.525 P=0.322 P=0.731N | |LOGISTIC REGRESSION| P=0.358N P=0.749N P=0.566N P=0.543N |P=0.503N P=0.230 P=0.284 P=0.750 | |COCH-ARM / FISHERS | P=0.325N P=0.753N P=0.500N P=0.500N |P=0.500N P=0.500 P=0.309 P=0.753N | |ORDER RESTRICTED | P=0.247N (e) (e) (e) |P=0.446N (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 15 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/48 (4%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 3/50 (6%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 1/45.70 2/45.48 0/46.42 0/47.18 |0/41.88 3/45.27 0/43.50 0/46.76 | |POLY-3 PERCENT (g) | 2.2% 4.4% 0.0% 0.0% |0.0% 6.6% 0.0% 0.0% | |TERMINAL (d) | 0/41 (0%) 1/38 (3%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 2/35 (6%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 662 716 --- --- |--- 656 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.217N P=0.485 P=0.495N P=0.487N |P=0.240N P=0.131 (e) (e) | |POLY 3 | P=0.221N P=0.498 P=0.497N P=0.494N |P=0.246N P=0.133 (e) (e) | |POLY 1.5 | P=0.222N P=0.497 P=0.497N P=0.495N |P=0.257N P=0.130 (e) (e) | |POLY 6 | P=0.219N P=0.498 P=0.497N P=0.492N |P=0.236N P=0.135 (e) (e) | |LOGISTIC REGRESSION| P=0.223N P=0.482 P=0.490N P=0.496N |P=0.269N P=0.130 (e) (e) | |COCH-ARM / FISHERS | P=0.223N P=0.492 P=0.495N P=0.495N |P=0.277N P=0.125 (e) (e) | |ORDER RESTRICTED | P=0.161N (e) (e) (e) |P=0.158N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/45.69 1/45.94 1/46.42 2/47.63 |0/42.71 0/44.99 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 2.2% 2.2% 2.2% 4.2% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 1/38 (3%) 1/42 (2%) 1/43 (2%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 598 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.389 P=0.745 P=0.756N P=0.516 |(e) (e) (e) (e) | |POLY 3 | P=0.379 P=0.759N P=0.757N P=0.514 |(e) (e) (e) (e) | |POLY 1.5 | P=0.373 P=0.760N P=0.758N P=0.508 |(e) (e) (e) (e) | |POLY 6 | P=0.388 P=0.759N P=0.756N P=0.522 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.361 P=0.745 P=0.756N P=0.483 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.364 P=0.753N P=0.753N P=0.500 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.434 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 16 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | | |POLY-3 RATE (b) | 1/45.69 2/45.94 0/46.42 1/47.18 | | |POLY-3 PERCENT (g) | 2.2% 4.4% 0.0% 2.1% | | |TERMINAL (d) | 1/41 (2%) 2/38 (5%) 0/42 (0%) 1/43 (2%) | | |FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.551N P=0.473 P=0.495N P=0.751N | | |POLY 3 | P=0.571N P=0.502 P=0.497N P=0.753N | | |POLY 1.5 | P=0.573N P=0.501 P=0.498N P=0.756N | | |POLY 6 | P=0.567N P=0.502 P=0.495N P=0.750N | | |LOGISTIC REGRESSION| P=0.551N P=0.473 (e) P=0.751N | | |COCH-ARM / FISHERS | P=0.577N P=0.500 P=0.500N P=0.753N | | |ORDER RESTRICTED | P=0.370N (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |1/50 (2%) 3/50 (6%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | |1/42.71 3/44.99 0/43.99 2/46.93 | |POLY-3 PERCENT (g) | |2.3% 6.7% 0.0% 4.3% | |TERMINAL (d) | |1/33 (3%) 3/35 (9%) 0/38 (0%) 2/42 (5%) | |FIRST INCIDENCE | |731 (T) 731 (T) --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.639N P=0.326 P=0.472N P=0.584 | |POLY 3 | |P=0.596 P=0.324 P=0.494N P=0.533 | |POLY 1.5 | |P=0.581 P=0.319 P=0.497N P=0.518 | |POLY 6 | |P=0.615 P=0.327 P=0.490N P=0.551 | |LOGISTIC REGRESSION| |P=0.639N P=0.326 (e) P=0.584 | |COCH-ARM / FISHERS | |P=0.563 P=0.309 P=0.500N P=0.500 | |ORDER RESTRICTED | |P=0.424N (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 17 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/45.69 2/45.94 0/46.42 1/47.18 |1/42.80 0/44.99 0/43.99 1/46.93 | |POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 2.1% |2.3% 0.0% 0.0% 2.1% | |TERMINAL (d) | 0/41 (0%) 2/38 (5%) 0/42 (0%) 1/43 (2%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 1/42 (2%) | |FIRST INCIDENCE | --- 729 (T) --- 729 (T) |709 --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.636 P=0.222 (e) P=0.510 |P=0.578 P=0.484N P=0.474N P=0.711N | |POLY 3 | P=0.626 P=0.238 (e) P=0.506 |P=0.546 P=0.490N P=0.495N P=0.740N | |POLY 1.5 | P=0.622 P=0.238 (e) P=0.504 |P=0.540 P=0.493N P=0.497N P=0.749N | |POLY 6 | P=0.631 P=0.238 (e) P=0.510 |P=0.555 P=0.489N P=0.491N P=0.728N | |LOGISTIC REGRESSION| (e) P=0.222 (e) P=0.510 |P=0.558 P=0.491N P=0.495N P=0.741N | |COCH-ARM / FISHERS | P=0.617 P=0.247 (e) P=0.500 |P=0.536 P=0.500N P=0.500N P=0.753N | |ORDER RESTRICTED | P=0.326 (e) (e) (e) |P=0.376N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 6/46.36 2/45.99 0/46.42 0/47.18 |1/42.79 3/45.27 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 12.9% 4.4% 0.0% 0.0% |2.3% 6.6% 0.0% 0.0% | |TERMINAL (d) | 4/41 (10%) 1/38 (3%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 2/35 (6%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 609 716 --- --- |711 656 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.017N* P=0.157N P=0.018N* P=0.017N* |P=0.138N P=0.330 P=0.468N P=0.449N | |POLY 3 | P=0.016N* P=0.136N P=0.015N* P=0.014N* |P=0.149N P=0.326 P=0.495N P=0.482N | |POLY 1.5 | P=0.016N* P=0.135N P=0.015N* P=0.015N* |P=0.155N P=0.320 P=0.497N P=0.490N | |POLY 6 | P=0.015N* P=0.138N P=0.015N* P=0.014N* |P=0.141N P=0.330 P=0.491N P=0.471N | |LOGISTIC REGRESSION| P=0.019N* P=0.134N P=0.018N* P=0.018N* |P=0.159N P=0.319 P=0.494N P=0.488N | |COCH-ARM / FISHERS | P=0.019N* P=0.134N P=0.013N* P=0.013N* |P=0.166N P=0.309 P=0.500N P=0.500N | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.108N (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 18 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 4/50 (8%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 3/50 (6%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 6/46.36 4/45.99 0/46.42 1/47.18 |2/42.88 3/45.27 0/43.99 1/46.93 | |POLY-3 PERCENT (g) | 12.9% 8.7% 0.0% 2.1% |4.7% 6.6% 0.0% 2.1% | |TERMINAL (d) | 4/41 (10%) 3/38 (8%) 0/42 (0%) 1/43 (2%) |0/33 (0%) 2/35 (6%) 0/38 (0%) 1/42 (2%) | |FIRST INCIDENCE | 609 716 --- 729 (T) |709 656 --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.042N* P=0.407N P=0.018N* P=0.055N |P=0.259N P=0.530 P=0.208N P=0.420N | |POLY 3 | P=0.043N* P=0.375N P=0.015N* P=0.053N |P=0.296N P=0.525 P=0.231N P=0.469N | |POLY 1.5 | P=0.044N* P=0.373N P=0.015N* P=0.055N |P=0.306N P=0.518 P=0.234N P=0.483N | |POLY 6 | P=0.042N* P=0.380N P=0.015N* P=0.052N |P=0.284N P=0.530 P=0.228N P=0.452N | |LOGISTIC REGRESSION| P=0.046N* P=0.368N P=0.018N* P=0.060N |P=0.298N P=0.519 P=0.231N P=0.468N | |COCH-ARM / FISHERS | P=0.048N* P=0.370N P=0.013N* P=0.056N |P=0.316N P=0.500 P=0.247N P=0.500N | |ORDER RESTRICTED | P=0.009N** (e) (e) (e) |P=0.178N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 1/45.69 0/45.94 0/46.42 1/47.63 |1/43.43 0/44.99 2/43.99 0/46.93 | |POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 2.1% |2.3% 0.0% 4.6% 0.0% | |TERMINAL (d) | 1/41 (2%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 2/38 (5%) 0/42 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 598 |479 --- 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.548 P=0.515N P=0.495N P=0.750N |P=0.404N P=0.483N P=0.538 P=0.496N | |POLY 3 | P=0.544 P=0.499N P=0.497N P=0.751N |P=0.422N P=0.493N P=0.504 P=0.485N | |POLY 1.5 | P=0.540 P=0.500N P=0.498N P=0.755N |P=0.433N P=0.495N P=0.502 P=0.492N | |POLY 6 | P=0.548 P=0.499N P=0.495N P=0.746N |P=0.407N P=0.492N P=0.509 P=0.475N | |LOGISTIC REGRESSION| P=0.516 (e) (e) P=0.745 |P=0.447N P=0.767N P=0.490 P=0.489N | |COCH-ARM / FISHERS | P=0.536 P=0.500N P=0.500N P=0.753N |P=0.441N P=0.500N P=0.500 P=0.500N | |ORDER RESTRICTED | P=0.391N (e) (e) (e) |P=0.311N (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 19 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |11/50 (22%) 10/50 (20%) 5/50 (10%) 1/50 (2%) | |POLY-3 RATE (b) | 1/45.69 0/45.94 1/46.42 1/47.18 |11/44.81 10/46.74 5/44.70 1/46.93 | |POLY-3 PERCENT (g) | 2.2% 0.0% 2.2% 2.1% |24.6% 21.4% 11.2% 2.1% | |TERMINAL (d) | 1/41 (2%) 0/38 (0%) 1/42 (2%) 1/43 (2%) |5/33 (15%) 5/35 (14%) 2/38 (5%) 1/42 (2%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |386 550 550 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.580 P=0.515N P=0.756N P=0.751N |P<0.001N** P=0.448N P=0.071N P<0.001N** | |POLY 3 | P=0.569 P=0.499N P=0.757N P=0.753N |P<0.001N** P=0.456N P=0.083N P<0.001N** | |POLY 1.5 | P=0.565 P=0.500N P=0.758N P=0.756N |P<0.001N** P=0.468N P=0.084N P=0.002N** | |POLY 6 | P=0.574 P=0.499N P=0.756N P=0.750N |P<0.001N** P=0.450N P=0.081N P<0.001N** | |LOGISTIC REGRESSION| P=0.580 (e) P=0.756N P=0.751N |P=0.002N** P=0.554N P=0.089N P=0.003N** | |COCH-ARM / FISHERS | P=0.559 P=0.500N P=0.753N P=0.753N |P=0.002N** P=0.500N P=0.086N P=0.002N** | |ORDER RESTRICTED | P=0.542 (e) (e) (e) |P<0.001N** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 35/50 (70%) 24/50 (48%) 21/50 (42%) 27/50 (54%) |28/50 (56%) 21/50 (42%) 14/50 (28%) 19/50 (38%) | |POLY-3 RATE (b) | 35/47.30 24/47.58 21/47.55 27/47.81 |28/44.18 21/45.86 14/44.08 19/47.09 | |POLY-3 PERCENT (g) | 74.0% 50.4% 44.2% 56.5% |63.4% 45.8% 31.8% 40.4% | |TERMINAL (d) | 32/41 (78%) 19/38 (50%) 18/42 (43%) 25/43 (58%) |22/33 (67%) 17/35 (49%) 13/38 (34%) 17/42 (41%) | |FIRST INCIDENCE | 456 543 526 598 |596 537 709 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.182N P=0.057N P=0.004N** P=0.041N* |P=0.021N* P=0.074N P<0.001N** P=0.005N** | |POLY 3 | P=0.279N P=0.012N* P=0.002N** P=0.052N |P=0.077N P=0.066N P=0.002N** P=0.020N* | |POLY 1.5 | P=0.290N P=0.015N* P=0.002N** P=0.061N |P=0.100N P=0.076N P=0.002N** P=0.031N* | |POLY 6 | P=0.261N P=0.010N* P<0.001N** P=0.041N* |P=0.054N P=0.063N P=0.002N** P=0.013N* | |LOGISTIC REGRESSION| P=0.260N P=0.019N* P=0.003N** P=0.047N* |P=0.044N* P=0.060N P<0.001N** P=0.012N* | |COCH-ARM / FISHERS | P=0.306N P=0.021N* P=0.004N** P=0.074N |P=0.131N P=0.115N P=0.004N** P=0.054N | |ORDER RESTRICTED | P=0.011N* (e) (e) (e) |P=0.004N** (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 20 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 26/50 (52%) 21/50 (42%) 14/50 (28%) 23/50 (46%) |22/50 (44%) 29/50 (58%) 19/50 (38%) 13/50 (26%) | |POLY-3 RATE (b) | 26/48.60 21/48.86 14/48.87 23/49.20 |22/47.00 29/49.13 19/46.60 13/47.07 | |POLY-3 PERCENT (g) | 53.5% 43.0% 28.7% 46.8% |46.8% 59.0% 40.8% 27.6% | |TERMINAL (d) | 19/41 (46%) 11/38 (29%) 9/42 (21%) 18/43 (42%) |10/33 (30%) 18/35 (51%) 12/38 (32%) 11/42 (26%) | |FIRST INCIDENCE | 536 338 479 533 |386 506 501 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.424N P=0.309N P=0.019N* P=0.293N |P=0.002N** P=0.240 P=0.240N P=0.016N* | |POLY 3 | P=0.520N P=0.202N P=0.009N** P=0.322N |P=0.004N** P=0.158 P=0.352N P=0.041N* | |POLY 1.5 | P=0.528N P=0.204N P=0.010N* P=0.330N |P=0.004N** P=0.144 P=0.349N P=0.044N* | |POLY 6 | P=0.511N P=0.203N P=0.010N* P=0.314N |P=0.003N** P=0.169 P=0.352N P=0.038N* | |LOGISTIC REGRESSION| P=0.500 P=0.215N P=0.013N* P=0.379N |P=0.005N** P=0.084 P=0.353N P=0.048N* | |COCH-ARM / FISHERS | P=0.537N P=0.212N P=0.012N* P=0.345N |P=0.005N** P=0.115 P=0.342N P=0.046N* | |ORDER RESTRICTED | P=0.084N (e) (e) (e) |P=0.007N** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 43/50 (86%) 38/50 (76%) 29/50 (58%) 41/50 (82%) |40/50 (80%) 40/50 (80%) 26/50 (52%) 26/50 (52%) | |POLY-3 RATE (b) | 43/49.36 38/50.00 29/50.00 41/49.20 |40/47.46 40/50.00 26/46.60 26/47.10 | |POLY-3 PERCENT (g) | 87.1% 76.0% 58.0% 83.3% |84.3% 80.0% 55.8% 55.2% | |TERMINAL (d) | 35/41 (85%) 26/38 (68%) 21/42 (50%) 36/43 (84%) |27/33 (82%) 25/35 (71%) 19/38 (50%) 23/42 (55%) | |FIRST INCIDENCE | 456 338 479 533 |386 506 501 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.423N P=0.377N P=0.009N** P=0.276N |P<0.001N** P=0.409N P=0.003N** P<0.001N** | |POLY 3 | P=0.409 P=0.120N P<0.001N** P=0.403N |P<0.001N** P=0.387N P=0.002N** P<0.001N** | |POLY 1.5 | P=0.421 P=0.132N P<0.001N** P=0.401N |P<0.001N** P=0.455N P=0.002N** P=0.002N** | |POLY 6 | P=0.400 P=0.110N P<0.001N** P=0.401N |P<0.001N** P=0.330N P=0.002N** P<0.001N** | |LOGISTIC REGRESSION| P=0.407 P=0.156N P=0.002N** P=0.374N |P<0.001N** P=0.577N P=0.002N** P<0.001N** | |COCH-ARM / FISHERS | P=0.450 P=0.154N P=0.002N** P=0.393N |P<0.001N** P=0.598N P=0.003N** P=0.003N** | |ORDER RESTRICTED | P=0.033N* (e) (e) (e) |P<0.001N** (e) (e) (e) | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Number of tumor-bearing animals / Poly-3 number (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. (g) Poly-3 adjusted lifetime tumor incidence. (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).