TDMS Study 88120-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus P,P'-DICHLORODIPHENYL SULFONE DATE: 09/24/99 EXPERIMENT: 88120 TEST: 04 TIME: 08:28:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-55388 ROUTE: DOSED FEED NTP C#: 88120B PATHOLOGIST: RYAN, MICHAEL CAS: 80-07-9 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus P,P'-DICHLORODIPHENYL SULFONE DATE: 09/24/99 EXPERIMENT: 88120 TEST: 04 TIME: 08:28:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55388 ROUTE: DOSED FEED NTP C#: 88120B PATHOLOGIST: RYAN, MICHAEL CAS: 80-07-9 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 Pituitary Gland Spleen Testes Thyroid Gland NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus P,P'-DICHLORODIPHENYL SULFONE DATE: 09/24/99 EXPERIMENT: 88120 TEST: 04 TIME: 08:28:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55388 ROUTE: DOSED FEED NTP C#: 88120B PATHOLOGIST: RYAN, MICHAEL CAS: 80-07-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF P,P'-DICHLORODIPHENYL SULFONE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Liver Hepatocellular Carcinoma Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Malignant Tumors Malignant and Benign Tumors =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Skin Sarcoma NOS =============================================================== Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 1 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |3/50 (6%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 10.8% 2.1% 4.3% 2.2% |6.4% 4.3% 4.1% 2.0% | |TERMINAL (d) | 5/40 (13%) 1/45 (2%) 2/44 (5%) 1/42 (2%) |3/42 (7%) 2/40 (5%) 2/43 (5%) 1/45 (2%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |734 (T) 734 (T) 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.161N P=0.079N P=0.180N P=0.092N |P=0.238N P=0.522N P=0.489N P=0.281N | |POLY 3 | P=0.176N P=0.094N P=0.218N P=0.109N |P=0.253N P=0.509N P=0.485N P=0.291N | |POLY 1.5 | P=0.172N P=0.098N P=0.220N P=0.108N |P=0.260N P=0.506N P=0.491N P=0.297N | |POLY 6 | P=0.179N P=0.089N P=0.211N P=0.105N |P=0.244N P=0.513N P=0.479N P=0.283N | |LOGISTIC REGRESSION| P=0.161N P=0.079N P=0.180N P=0.092N |P=0.238N P=0.522N P=0.489N P=0.281N | |COCH-ARM / FISHERS | P=0.162N P=0.102N P=0.218N P=0.102N |P=0.269N P=0.500N P=0.500N P=0.309N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |3/50 (6%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 10.8% 4.1% 4.3% 2.2% |6.4% 4.3% 4.1% 4.1% | |TERMINAL (d) | 5/40 (13%) 1/45 (2%) 2/44 (5%) 1/42 (2%) |3/42 (7%) 2/40 (5%) 2/43 (5%) 2/45 (4%) | |FIRST INCIDENCE | 733 (T) 652 733 (T) 733 (T) |734 (T) 734 (T) 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.126N P=0.177N P=0.180N P=0.092N |P=0.447N P=0.522N P=0.489N P=0.469N | |POLY 3 | P=0.138N P=0.201N P=0.218N P=0.109N |P=0.470N P=0.509N P=0.485N P=0.481N | |POLY 1.5 | P=0.134N P=0.208N P=0.220N P=0.108N |P=0.479N P=0.506N P=0.491N P=0.489N | |POLY 6 | P=0.140N P=0.191N P=0.211N P=0.105N |P=0.459N P=0.513N P=0.479N P=0.472N | |LOGISTIC REGRESSION| P=0.133N P=0.209N P=0.180N P=0.092N |P=0.447N P=0.522N P=0.489N P=0.469N | |COCH-ARM / FISHERS | P=0.125N P=0.218N P=0.218N P=0.102N |P=0.491N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 2 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Intestine Small: Duodenum | | Polyp Adenomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 4.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 2/42 (5%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | --- 712 --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.149 P=0.527 (e) P=0.249 |(e) (e) (e) (e) | |POLY 3 | P=0.145 P=0.507 (e) P=0.231 |(e) (e) (e) (e) | |POLY 1.5 | P=0.146 P=0.504 (e) P=0.231 |(e) (e) (e) (e) | |POLY 6 | P=0.147 P=0.512 (e) P=0.233 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.142 P=0.501 (e) P=0.249 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.151 P=0.500 (e) P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Polyp Adenomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 4.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 2/42 (5%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | --- 712 --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.149 P=0.527 (e) P=0.249 |(e) (e) (e) (e) | |POLY 3 | P=0.145 P=0.507 (e) P=0.231 |(e) (e) (e) (e) | |POLY 1.5 | P=0.146 P=0.504 (e) P=0.231 |(e) (e) (e) (e) | |POLY 6 | P=0.147 P=0.512 (e) P=0.233 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.142 P=0.501 (e) P=0.249 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.151 P=0.500 (e) P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 3 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.3% 0.0% 0.0% 2.2% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 0/45 (0%) 0/44 (0%) 1/42 (2%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | 603 --- --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.657N P=0.227N P=0.234N P=0.496N |(e) (e) (e) (e) | |POLY 3 | P=0.658N P=0.232N P=0.240N P=0.514N |(e) (e) (e) (e) | |POLY 1.5 | P=0.655N P=0.234N P=0.240N P=0.511N |(e) (e) (e) (e) | |POLY 6 | P=0.661N P=0.228N P=0.238N P=0.512N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.646N P=0.242N P=0.234N P=0.497N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.650N P=0.247N P=0.247N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 9/50 (18%) 5/50 (10%) 9/50 (18%) |4/50 (8%) 4/50 (8%) 6/50 (12%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 12.9% 18.5% 10.8% 19.6% |8.5% 8.7% 12.3% 16.3% | |TERMINAL (d) | 6/40 (15%) 8/45 (18%) 5/44 (11%) 8/42 (19%) |4/42 (10%) 4/40 (10%) 5/43 (12%) 8/45 (18%) | |FIRST INCIDENCE | 733 (T) 565 733 (T) 369 |734 (T) 734 (T) 702 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.326 P=0.372 P=0.433N P=0.321 |P=0.142 P=0.617 P=0.388 P=0.212 | |POLY 3 | P=0.312 P=0.320 P=0.503N P=0.279 |P=0.123 P=0.632 P=0.392 P=0.198 | |POLY 1.5 | P=0.316 P=0.306 P=0.506N P=0.278 |P=0.115 P=0.636 P=0.383 P=0.190 | |POLY 6 | P=0.315 P=0.341 P=0.491N P=0.290 |P=0.134 P=0.627 P=0.403 P=0.209 | |LOGISTIC REGRESSION| P=0.314 P=0.300 P=0.433N P=0.278 |P=0.146 P=0.617 P=0.403 P=0.212 | |COCH-ARM / FISHERS | P=0.332 P=0.288 P=0.500N P=0.288 |P=0.103 P=0.643N P=0.370 P=0.178 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 4 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 3/50 (6%) 4/50 (8%) 5/50 (10%) |3/50 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 19.0% 6.2% 8.5% 10.9% |6.3% 2.2% 4.1% 2.0% | |TERMINAL (d) | 5/40 (13%) 3/45 (7%) 3/44 (7%) 3/42 (7%) |1/42 (2%) 0/40 (0%) 2/43 (5%) 1/45 (2%) | |FIRST INCIDENCE | 631 733 (T) 513 407 |631 690 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.384N P=0.048N* P=0.105N P=0.191N |P=0.312N P=0.327N P=0.486N P=0.287N | |POLY 3 | P=0.394N P=0.057N P=0.120N P=0.210N |P=0.327N P=0.315N P=0.490N P=0.295N | |POLY 1.5 | P=0.388N P=0.058N P=0.120N P=0.207N |P=0.334N P=0.311N P=0.494N P=0.299N | |POLY 6 | P=0.396N P=0.056N P=0.117N P=0.209N |P=0.319N P=0.320N P=0.487N P=0.290N | |LOGISTIC REGRESSION| P=0.361N P=0.061N P=0.116N P=0.188N |P=0.380N P=0.284N P=0.548N P=0.366N | |COCH-ARM / FISHERS | P=0.371N P=0.061N P=0.117N P=0.194N |P=0.343N P=0.309N P=0.500N P=0.309N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 11/50 (22%) 9/50 (18%) 13/50 (26%) |6/50 (12%) 5/50 (10%) 6/50 (12%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 31.6% 22.7% 19.2% 27.7% |12.6% 10.8% 12.3% 16.3% | |TERMINAL (d) | 11/40 (28%) 10/45 (22%) 8/44 (18%) 10/42 (24%) |4/42 (10%) 4/40 (10%) 5/43 (12%) 8/45 (18%) | |FIRST INCIDENCE | 631 565 513 369 |631 690 702 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.551N P=0.169N P=0.092N P=0.376N |P=0.325 P=0.534N P=0.597N P=0.440 | |POLY 3 | P=0.547 P=0.225N P=0.124N P=0.425N |P=0.285 P=0.519N P=0.603N P=0.411 | |POLY 1.5 | P=0.554 P=0.234N P=0.125N P=0.424N |P=0.273 P=0.511N P=0.609N P=0.402 | |POLY 6 | P=0.546 P=0.214N P=0.120N P=0.419N |P=0.299 P=0.528N P=0.596N P=0.422 | |LOGISTIC REGRESSION| P=0.545N P=0.240N P=0.123N P=0.413N |P=0.283 P=0.507N P=0.615 P=0.397 | |COCH-ARM / FISHERS | P=0.539N P=0.247N P=0.121N P=0.412N |P=0.254 P=0.500N P=0.620N P=0.387 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 5 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 11/50 (22%) 9/50 (18%) 13/50 (26%) |6/50 (12%) 5/50 (10%) 6/50 (12%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 31.6% 22.7% 19.2% 27.7% |12.6% 10.8% 12.3% 16.3% | |TERMINAL (d) | 11/40 (28%) 10/45 (22%) 8/44 (18%) 10/42 (24%) |4/42 (10%) 4/40 (10%) 5/43 (12%) 8/45 (18%) | |FIRST INCIDENCE | 631 565 513 369 |631 690 702 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.551N P=0.169N P=0.092N P=0.376N |P=0.325 P=0.534N P=0.597N P=0.440 | |POLY 3 | P=0.547 P=0.225N P=0.124N P=0.425N |P=0.285 P=0.519N P=0.603N P=0.411 | |POLY 1.5 | P=0.554 P=0.234N P=0.125N P=0.424N |P=0.273 P=0.511N P=0.609N P=0.402 | |POLY 6 | P=0.546 P=0.214N P=0.120N P=0.419N |P=0.299 P=0.528N P=0.596N P=0.422 | |LOGISTIC REGRESSION| P=0.545N P=0.240N P=0.123N P=0.413N |P=0.283 P=0.507N P=0.615 P=0.397 | |COCH-ARM / FISHERS | P=0.539N P=0.247N P=0.121N P=0.412N |P=0.254 P=0.500N P=0.620N P=0.387 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 6/50 (12%) 4/50 (8%) 2/50 (4%) |0/50 (0%) 4/50 (8%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 12.8% 12.4% 8.6% 4.4% |0.0% 8.5% 4.1% 4.1% | |TERMINAL (d) | 5/40 (13%) 5/45 (11%) 4/44 (9%) 1/42 (2%) |0/42 (0%) 2/40 (5%) 2/43 (5%) 2/45 (4%) | |FIRST INCIDENCE | 631 565 733 (T) 609 |--- 592 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.087N P=0.547N P=0.319N P=0.131N |P=0.587 P=0.062 P=0.244 P=0.254 | |POLY 3 | P=0.095N P=0.595N P=0.377N P=0.142N |P=0.571 P=0.060 P=0.245 P=0.247 | |POLY 1.5 | P=0.092N P=0.606N P=0.378N P=0.142N |P=0.562 P=0.060 P=0.242 P=0.243 | |POLY 6 | P=0.094N P=0.579N P=0.370N P=0.138N |P=0.583 P=0.060 P=0.248 P=0.252 | |LOGISTIC REGRESSION| P=0.086N P=0.620N P=0.371N P=0.137N |P=0.511 P=0.069 P=0.244 P=0.254 | |COCH-ARM / FISHERS | P=0.083N P=0.620N P=0.370N P=0.134N |P=0.549 P=0.059 P=0.247 P=0.247 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 6 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 6/50 (12%) 4/50 (8%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 15.0% 12.5% 8.6% 4.4% |0.0% 4.3% 2.1% 4.1% | |TERMINAL (d) | 6/40 (15%) 5/45 (11%) 4/44 (9%) 1/42 (2%) |0/42 (0%) 2/40 (5%) 1/43 (2%) 2/45 (4%) | |FIRST INCIDENCE | 661 718 733 (T) 712 |--- 734 (T) 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.060N P=0.416N P=0.216N P=0.075N |P=0.350 P=0.228 P=0.505 P=0.254 | |POLY 3 | P=0.067N P=0.478N P=0.267N P=0.087N |P=0.334 P=0.233 P=0.506 P=0.247 | |POLY 1.5 | P=0.065N P=0.488N P=0.268N P=0.086N |P=0.328 P=0.235 P=0.504 P=0.243 | |POLY 6 | P=0.067N P=0.464N P=0.260N P=0.084N |P=0.343 P=0.231 P=0.509 P=0.252 | |LOGISTIC REGRESSION| P=0.065N P=0.473N P=0.258N P=0.087N |(e) P=0.228 P=0.505 P=0.254 | |COCH-ARM / FISHERS | P=0.058N P=0.500N P=0.262N P=0.080N |P=0.318 P=0.247 P=0.500 P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 11/50 (22%) 8/50 (16%) 4/50 (8%) |0/50 (0%) 6/50 (12%) 3/50 (6%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 27.6% 22.6% 17.3% 8.8% |0.0% 12.8% 6.2% 6.1% | |TERMINAL (d) | 11/40 (28%) 9/45 (20%) 8/44 (18%) 2/42 (5%) |0/42 (0%) 4/40 (10%) 3/43 (7%) 3/45 (7%) | |FIRST INCIDENCE | 631 565 733 (T) 609 |--- 592 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.014N* P=0.303N P=0.117N P=0.017N* |P=0.559 P=0.017 * P=0.125 P=0.134 | |POLY 3 | P=0.015N* P=0.373N P=0.172N P=0.017N* |P=0.537 P=0.015 * P=0.125 P=0.127 | |POLY 1.5 | P=0.014N* P=0.388N P=0.171N P=0.017N* |P=0.526 P=0.015 * P=0.123 P=0.123 | |POLY 6 | P=0.014N* P=0.353N P=0.167N P=0.016N* |P=0.552 P=0.015 * P=0.128 P=0.131 | |LOGISTIC REGRESSION| P=0.014N* P=0.396N P=0.163N P=0.018N* |P=0.499 P=0.019 * P=0.125 P=0.134 | |COCH-ARM / FISHERS | P=0.012N* P=0.408N P=0.163N P=0.016N* |P=0.510 P=0.013 * P=0.121 P=0.121 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 7 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 4/48 (8%) 1/49 (2%) 2/48 (4%) | |POLY-3 ADJUSTED (b)| |4.2% 9.0% 2.1% 4.2% | |TERMINAL (d) | |2/42 (5%) 3/39 (8%) 1/42 (2%) 2/44 (5%) | |FIRST INCIDENCE | |734 (T) 694 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.408N P=0.307 P=0.500N P=0.678N | |POLY 3 | |P=0.440N P=0.312 P=0.496N P=0.693N | |POLY 1.5 | |P=0.447N P=0.314 P=0.500N P=0.688 | |POLY 6 | |P=0.431N P=0.311 P=0.491N P=0.684N | |LOGISTIC REGRESSION| |P=0.420N P=0.308 P=0.500N P=0.678N | |COCH-ARM / FISHERS | |P=0.457N P=0.319 P=0.508N P=0.676 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |3/48 (6%) 2/46 (4%) 6/48 (13%) 6/48 (13%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.5% 4.6% 12.7% 12.6% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/43 (0%) 0/42 (0%) |2/41 (5%) 1/38 (3%) 6/43 (14%) 6/44 (14%) | |FIRST INCIDENCE | --- --- --- --- |657 550 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.166 P=0.524N P=0.269 P=0.281 | |POLY 3 | (e) (e) (e) (e) |P=0.150 P=0.526N P=0.258 P=0.261 | |POLY 1.5 | (e) (e) (e) (e) |P=0.142 P=0.523N P=0.252 P=0.253 | |POLY 6 | (e) (e) (e) (e) |P=0.159 P=0.528N P=0.265 P=0.270 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.105 P=0.475N P=0.241 P=0.236 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.130 P=0.520N P=0.243 P=0.243 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 8 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Skin | | Sarcoma NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 6.1% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 2/45 (4%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 701 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.012 * (e) (e) P=0.137 | |POLY 3 | (e) (e) (e) (e) |P=0.009 ** (e) (e) P=0.127 | |POLY 1.5 | (e) (e) (e) (e) |P=0.008 ** (e) (e) P=0.124 | |POLY 6 | (e) (e) (e) (e) |P=0.009 ** (e) (e) P=0.132 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.009 ** (e) (e) P=0.118 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.009 ** (e) (e) P=0.121 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |2/50 (4%) 1/49 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 2.2% 0.0% |4.2% 2.2% 0.0% 2.0% | |TERMINAL (d) | 1/40 (3%) 0/45 (0%) 1/44 (2%) 0/42 (0%) |2/42 (5%) 1/40 (3%) 0/43 (0%) 1/45 (2%) | |FIRST INCIDENCE | 733 (T) --- 733 (T) --- |734 (T) 734 (T) --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.464N P=0.477N P=0.740N P=0.490N |P=0.471N P=0.517N P=0.233N P=0.476N | |POLY 3 | P=0.477N P=0.493N P=0.760 P=0.507N |P=0.489N P=0.514N P=0.230N P=0.486N | |POLY 1.5 | P=0.475N P=0.496N P=0.759 P=0.507N |P=0.493N P=0.511N P=0.233N P=0.492N | |POLY 6 | P=0.479N P=0.489N P=0.758N P=0.504N |P=0.486N P=0.516N P=0.227N P=0.478N | |LOGISTIC REGRESSION| P=0.464N (e) P=0.740N (e) |P=0.471N P=0.517N (e) P=0.476N | |COCH-ARM / FISHERS | P=0.468N P=0.500N P=0.753N P=0.505N |P=0.497N P=0.508N P=0.247N P=0.500N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 9 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 6.4% 2.1% 2.2% 2.2% |0.0% 4.3% 0.0% 0.0% | |TERMINAL (d) | 2/40 (5%) 1/45 (2%) 1/44 (2%) 1/42 (2%) |0/42 (0%) 2/40 (5%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | 603 733 (T) 733 (T) 733 (T) |--- 734 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.346N P=0.276N P=0.286N P=0.300N |P=0.352N P=0.228 (e) (e) | |POLY 3 | P=0.358N P=0.297N P=0.310N P=0.320N |P=0.367N P=0.233 (e) (e) | |POLY 1.5 | P=0.354N P=0.301N P=0.310N P=0.317N |P=0.368N P=0.235 (e) (e) | |POLY 6 | P=0.360N P=0.291N P=0.306N P=0.317N |P=0.367N P=0.231 (e) (e) | |LOGISTIC REGRESSION| P=0.347N P=0.307N P=0.305N P=0.306N |(e) P=0.228 (e) (e) | |COCH-ARM / FISHERS | P=0.342N P=0.309N P=0.309N P=0.309N |P=0.369N P=0.247 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 6.4% 4.2% 2.2% 2.2% |0.0% 4.3% 2.1% 0.0% | |TERMINAL (d) | 2/40 (5%) 2/45 (4%) 1/44 (2%) 1/42 (2%) |0/42 (0%) 2/40 (5%) 1/43 (2%) 0/45 (0%) | |FIRST INCIDENCE | 603 733 (T) 733 (T) 733 (T) |--- 734 (T) 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.267N P=0.457N P=0.286N P=0.300N |P=0.356N P=0.228 P=0.505 (e) | |POLY 3 | P=0.278N P=0.489N P=0.310N P=0.320N |P=0.368N P=0.233 P=0.506 (e) | |POLY 1.5 | P=0.275N P=0.494N P=0.310N P=0.317N |P=0.372N P=0.235 P=0.504 (e) | |POLY 6 | P=0.279N P=0.482N P=0.306N P=0.317N |P=0.363N P=0.231 P=0.509 (e) | |LOGISTIC REGRESSION| P=0.269N P=0.501N P=0.305N P=0.306N |(e) P=0.228 P=0.505 (e) | |COCH-ARM / FISHERS | P=0.263N P=0.500N P=0.309N P=0.309N |P=0.378N P=0.247 P=0.500 (e) | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 10 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.1% 0.0% |0.0% 4.2% 2.1% 4.1% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 1/45 (2%) | |FIRST INCIDENCE | --- --- 649 --- |--- 512 732 723 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.796N (e) P=0.500 (e) |P=0.342 P=0.243 P=0.509 P=0.260 | |POLY 3 | P=0.793N (e) P=0.500 (e) |P=0.334 P=0.239 P=0.507 P=0.247 | |POLY 1.5 | P=0.791N (e) P=0.499 (e) |P=0.327 P=0.238 P=0.504 P=0.243 | |POLY 6 | P=0.792N (e) P=0.505 (e) |P=0.342 P=0.240 P=0.509 P=0.252 | |LOGISTIC REGRESSION| P=0.777N (e) P=0.505 (e) |P=0.100 P=0.244 P=0.511 P=0.247 | |COCH-ARM / FISHERS | P=0.786N (e) P=0.500 (e) |P=0.318 P=0.247 P=0.500 P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |6/50 (12%) 10/50 (20%) 5/50 (10%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 6.3% 6.2% 4.3% 2.2% |12.4% 21.6% 10.1% 6.1% | |TERMINAL (d) | 1/40 (3%) 3/45 (7%) 1/44 (2%) 1/42 (2%) |3/42 (7%) 9/40 (23%) 3/43 (7%) 3/45 (7%) | |FIRST INCIDENCE | 550 733 (T) 705 733 (T) |491 694 586 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.217N P=0.621N P=0.480N P=0.311N |P=0.058N P=0.187 P=0.478N P=0.219N | |POLY 3 | P=0.228N P=0.656N P=0.509N P=0.323N |P=0.065N P=0.181 P=0.485N P=0.234N | |POLY 1.5 | P=0.223N P=0.658N P=0.508N P=0.319N |P=0.068N P=0.191 P=0.491N P=0.238N | |POLY 6 | P=0.229N P=0.650N P=0.506N P=0.322N |P=0.062N P=0.171 P=0.477N P=0.229N | |LOGISTIC REGRESSION| P=0.208N P=0.657 P=0.494N P=0.293N |P=0.096N P=0.212 P=0.580 P=0.358N | |COCH-ARM / FISHERS | P=0.209N P=0.661N P=0.500N P=0.309N |P=0.073N P=0.207 P=0.500N P=0.243N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 11 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 16/50 (32%) 18/50 (36%) 11/50 (22%) 12/50 (24%) |15/50 (30%) 15/50 (30%) 15/50 (30%) 16/50 (32%) | |POLY-3 ADJUSTED (b)| 34.2% 37.0% 23.8% 25.9% |31.4% 31.5% 30.5% 32.6% | |TERMINAL (d) | 15/40 (38%) 15/45 (33%) 11/44 (25%) 10/42 (24%) |13/42 (31%) 11/40 (28%) 13/43 (30%) 16/45 (36%) | |FIRST INCIDENCE | 631 565 733 (T) 369 |636 550 652 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.153N P=0.574 P=0.116N P=0.217N |P=0.518N P=0.527 P=0.547N P=0.579N | |POLY 3 | P=0.162N P=0.472 P=0.190N P=0.259N |P=0.495 P=0.581 P=0.551N P=0.537 | |POLY 1.5 | P=0.159N P=0.448 P=0.192N P=0.262N |P=0.478 P=0.583 P=0.565N P=0.522 | |POLY 6 | P=0.157N P=0.508 P=0.179N P=0.242N |P=0.513 P=0.581 P=0.535N P=0.553 | |LOGISTIC REGRESSION| P=0.168N P=0.447 P=0.164N P=0.268N |P=0.474 P=0.584 P=0.564N P=0.564 | |COCH-ARM / FISHERS | P=0.146N P=0.417 P=0.184N P=0.252N |P=0.452 P=0.586N P=0.586N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 21/50 (42%) 16/50 (32%) 12/50 (24%) 11/50 (22%) |12/50 (24%) 18/50 (36%) 9/50 (18%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 43.1% 33.0% 24.9% 23.8% |24.3% 37.3% 18.2% 22.2% | |TERMINAL (d) | 14/40 (35%) 13/45 (29%) 8/44 (18%) 8/42 (19%) |6/42 (14%) 13/40 (33%) 6/43 (14%) 8/45 (18%) | |FIRST INCIDENCE | 550 652 413 407 |491 512 586 690 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.051N P=0.135N P=0.042N* P=0.032N* |P=0.174N P=0.134 P=0.298N P=0.433N | |POLY 3 | P=0.049N* P=0.209N P=0.046N* P=0.037N* |P=0.219N P=0.120 P=0.314N P=0.499N | |POLY 1.5 | P=0.044N* P=0.207N P=0.045N* P=0.033N* |P=0.223N P=0.128 P=0.313N P=0.499N | |POLY 6 | P=0.053N P=0.210N P=0.045N* P=0.040N* |P=0.214N P=0.111 P=0.318N P=0.498N | |LOGISTIC REGRESSION| P=0.036N* P=0.200N P=0.043N* P=0.027N* |P=0.411N P=0.170 P=0.510N P=0.476 | |COCH-ARM / FISHERS | P=0.035N* P=0.204N P=0.044N* P=0.026N* |P=0.227N P=0.138 P=0.312N P=0.500N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 12 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 32/50 (64%) 28/50 (56%) 22/50 (44%) 21/50 (42%) |23/50 (46%) 28/50 (56%) 20/50 (40%) 23/50 (46%) | |POLY-3 ADJUSTED (b)| 65.6% 57.1% 45.7% 44.3% |46.6% 57.3% 40.3% 46.5% | |TERMINAL (d) | 25/40 (63%) 24/45 (53%) 18/44 (41%) 16/42 (38%) |17/42 (41%) 22/40 (55%) 16/43 (37%) 20/45 (44%) | |FIRST INCIDENCE | 550 565 413 369 |491 512 586 690 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.043N* P=0.136N P=0.026N* P=0.028N* |P=0.242N P=0.186 P=0.317N P=0.459N | |POLY 3 | P=0.032N* P=0.257N P=0.036N* P=0.027N* |P=0.364N P=0.194 P=0.337N P=0.577N | |POLY 1.5 | P=0.028N* P=0.262N P=0.035N* P=0.024N* |P=0.369N P=0.203 P=0.339N P=0.578N | |POLY 6 | P=0.033N* P=0.249N P=0.035N* P=0.027N* |P=0.357N P=0.182 P=0.336N P=0.576N | |LOGISTIC REGRESSION| P=0.027N* P=0.254N P=0.036N* P=0.024N* |P=0.497N P=0.241 P=0.449N P=0.490 | |COCH-ARM / FISHERS | P=0.024N* P=0.270N P=0.035N* P=0.022N* |P=0.374N P=0.212 P=0.343N P=0.579N | |=================================================================================================================================| (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). --multipart-boundary Content-type: text/plain Range: bytes 95669-95669/95669 --multipart-boundary--