TDMS Study 88120-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus P,P'-DICHLORODIPHENYL SULFONE DATE: 10/27/99 EXPERIMENT: 88120 TEST: 03 TIME: 12:53:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-55388 ROUTE: DOSED FEED NTP C#: 88120B PATHOLOGIST: SINGER, ALLEN CAS: 80-07-9 ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 CORE STUDY RATS 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: 10/27/99 EXPERIMENT: 88120 TEST: 03 TIME: 12:53:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55388 ROUTE: DOSED FEED NTP C#: 88120B PATHOLOGIST: SINGER, ALLEN CAS: 80-07-9 Rats(FISCHER 344) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED. --------------- Adrenal Cortex Adrenal Medulla Brain Clitoral/Preputial Gland Heart Islets, Pancreatic Kidney Liver Lung Ovary Pancreas Pituitary Gland Salivary Glands Spleen Testes Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus P,P'-DICHLORODIPHENYL SULFONE DATE: 10/27/99 EXPERIMENT: 88120 TEST: 03 TIME: 12:53:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55388 ROUTE: DOSED FEED NTP C#: 88120B PATHOLOGIST: SINGER, ALLEN CAS: 80-07-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF P,P'-DICHLORODIPHENYL SULFONE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Liver Hepatocellular Adenoma Testes Adenoma All Organs Benign Tumors =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Ovary Granulosa Cell Tumor: Benign, Malignant, NOS Pituitary Gland: Pars Distalis or Unspecified Site Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors =============================================================== Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 4.4% 2.2% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |2/36 (6%) 1/38 (3%) 1/35 (3%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |730 (T) 666 730 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.151N P=0.672N P=0.510N P=0.244N | |POLY 3 | (e) (e) (e) (e) |P=0.150N P=0.689N P=0.489N P=0.247N | |POLY 1.5 | (e) (e) (e) (e) |P=0.148N P=0.691N P=0.493N P=0.244N | |POLY 6 | (e) (e) (e) (e) |P=0.152N P=0.684N P=0.486N P=0.248N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.148N P=0.692N P=0.510N (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.141N P=0.691N P=0.500N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 7/50 (14%) 1/50 (2%) |2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 9.9% 6.8% 17.1% 2.4% |4.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 2/30 (7%) 3/20 (15%) 1/28 (4%) |2/36 (6%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 640 603 614 729 (T) |730 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.147N P=0.406N P=0.231 P=0.151N |P=0.250N P=0.226N P=0.244N P=0.244N | |POLY 3 | P=0.143N P=0.453N P=0.266 P=0.162N |P=0.244N P=0.238N P=0.230N P=0.247N | |POLY 1.5 | P=0.142N P=0.469N P=0.269 P=0.166N |P=0.242N P=0.240N P=0.233N P=0.244N | |POLY 6 | P=0.149N P=0.437N P=0.258 P=0.162N |P=0.246N P=0.235N P=0.228N P=0.248N | |LOGISTIC REGRESSION| P=0.142N P=0.468N P=0.261 P=0.160N |P=0.250N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.151N P=0.500N P=0.262 P=0.181N |P=0.241N P=0.253N P=0.247N P=0.247N | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 2.3% 4.9% 2.4% |0.0% 2.3% 0.0% 0.0% | |TERMINAL (d) | 2/24 (8%) 1/30 (3%) 0/20 (0%) 1/28 (4%) |0/36 (0%) 1/38 (3%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 549 729 (T) |--- 730 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.452N P=0.422N P=0.663 P=0.446N |P=0.585N P=0.511 (e) (e) | |POLY 3 | P=0.475N P=0.469N P=0.684N P=0.478N |P=0.575N P=0.499 (e) (e) | |POLY 1.5 | P=0.474N P=0.480N P=0.685N P=0.483N |P=0.576N P=0.497 (e) (e) | |POLY 6 | P=0.479N P=0.457N P=0.686N P=0.475N |P=0.574N P=0.501 (e) (e) | |LOGISTIC REGRESSION| P=0.471N P=0.422N P=0.693N P=0.446N |(e) P=0.511 (e) (e) | |COCH-ARM / FISHERS | P=0.479N P=0.500N P=0.691N P=0.500N |P=0.575N P=0.495 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 4/50 (8%) 9/50 (18%) 2/50 (4%) |2/50 (4%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 14.9% 9.1% 21.6% 4.7% |4.5% 2.3% 0.0% 0.0% | |TERMINAL (d) | 3/24 (13%) 3/30 (10%) 3/20 (15%) 2/28 (7%) |2/36 (6%) 1/38 (3%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 640 603 549 729 (T) |730 (T) 730 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.123N P=0.261N P=0.248 P=0.100N |P=0.177N P=0.481N P=0.244N P=0.244N | |POLY 3 | P=0.122N P=0.315N P=0.308 P=0.115N |P=0.172N P=0.502N P=0.230N P=0.247N | |POLY 1.5 | P=0.121N P=0.333N P=0.305 P=0.119N |P=0.171N P=0.504N P=0.233N P=0.244N | |POLY 6 | P=0.129N P=0.297N P=0.308 P=0.114N |P=0.174N P=0.498N P=0.228N P=0.248N | |LOGISTIC REGRESSION| P=0.121N P=0.312N P=0.292 P=0.110N |P=0.177N P=0.481N (e) (e) | |COCH-ARM / FISHERS | P=0.131N P=0.370N P=0.288 P=0.134N |P=0.168N P=0.508N P=0.247N P=0.247N | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Brain | | Oligodendroglioma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.9% 0.0% |0.0% 0.0% 0.0% 2.3% | |TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- 549 --- |--- --- --- 347 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.671N (e) P=0.234 (e) |P=0.211 (e) (e) P=0.496 | |POLY 3 | P=0.669N (e) P=0.244 (e) |P=0.210 (e) (e) P=0.496 | |POLY 1.5 | P=0.669N (e) P=0.243 (e) |P=0.212 (e) (e) P=0.497 | |POLY 6 | P=0.672N (e) P=0.244 (e) |P=0.209 (e) (e) P=0.495 | |LOGISTIC REGRESSION| P=0.756 (e) P=0.192 (e) |P=0.752 (e) (e) P=0.931 | |COCH-ARM / FISHERS | P=0.675N (e) P=0.247 (e) |P=0.214 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.5% 0.0% 4.9% 0.0% |2.2% 2.2% 0.0% 4.6% | |TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 1/38 (3%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 312 --- 549 --- |414 730 (T) --- 347 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.439N P=0.500N P=0.494 P=0.500N |P=0.322 P=0.757N P=0.500N P=0.490 | |POLY 3 | P=0.443N P=0.487N P=0.504 P=0.492N |P=0.326 P=0.759 P=0.497N P=0.489 | |POLY 1.5 | P=0.440N P=0.492N P=0.504 P=0.494N |P=0.328 P=0.759 P=0.498N P=0.492 | |POLY 6 | P=0.448N P=0.481N P=0.503 P=0.491N |P=0.325 P=0.760 P=0.496N P=0.489 | |LOGISTIC REGRESSION| P=0.704N (e) P=0.315 (e) |P=0.552 P=0.763N (e) P=0.763 | |COCH-ARM / FISHERS | P=0.441N P=0.500N P=0.500 P=0.500N |P=0.333 P=0.753N P=0.500N P=0.500 | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 3/50 (6%) |1/47 (2%) 3/50 (6%) 1/50 (2%) 3/48 (6%) | |POLY-3 ADJUSTED (b)| 7.5% 6.9% 2.5% 7.1% |2.3% 6.7% 2.2% 7.3% | |TERMINAL (d) | 2/24 (8%) 2/30 (7%) 0/20 (0%) 2/28 (7%) |1/36 (3%) 3/38 (8%) 1/35 (3%) 2/34 (6%) | |FIRST INCIDENCE | 611 709 725 699 |730 (T) 730 (T) 730 (T) 633 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.606 P=0.577N P=0.363N P=0.607N |P=0.308 P=0.324 P=0.756 P=0.285 | |POLY 3 | P=0.594 P=0.625N P=0.305N P=0.637N |P=0.317 P=0.321 P=0.746N P=0.291 | |POLY 1.5 | P=0.592 P=0.637N P=0.302N P=0.642N |P=0.324 P=0.323 P=0.746N P=0.298 | |POLY 6 | P=0.592 P=0.612N P=0.312N P=0.636N |P=0.313 P=0.319 P=0.747N P=0.287 | |LOGISTIC REGRESSION| P=0.594 P=0.617N P=0.303N P=0.633N |P=0.309 P=0.324 P=0.756 P=0.295 | |COCH-ARM / FISHERS | P=0.582 P=0.661N P=0.309N P=0.661N |P=0.340 P=0.332 P=0.737N P=0.316 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/47 (0%) 0/50 (0%) 1/50 (2%) 1/48 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 4.5% 0.0% 2.3% |0.0% 0.0% 2.2% 2.4% | |TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/34 (0%) | |FIRST INCIDENCE | --- 603 --- 562 |--- --- 714 701 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.619 P=0.261 (e) P=0.513 |P=0.291 (e) P=0.505 P=0.495 | |POLY 3 | P=0.644 P=0.261 (e) P=0.515 |P=0.282 (e) P=0.513 P=0.491 | |POLY 1.5 | P=0.636 P=0.252 (e) P=0.511 |P=0.288 (e) P=0.513 P=0.495 | |POLY 6 | P=0.651 P=0.271 (e) P=0.518 |P=0.278 (e) P=0.513 P=0.488 | |LOGISTIC REGRESSION| P=0.571 P=0.207 (e) P=0.397 |P=0.290 (e) P=0.513 P=0.498 | |COCH-ARM / FISHERS | P=0.617 P=0.247 (e) P=0.500 |P=0.300 (e) P=0.515 P=0.505 | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 1/50 (2%) 4/50 (8%) |1/47 (2%) 3/50 (6%) 2/50 (4%) 4/48 (8%) | |POLY-3 ADJUSTED (b)| 7.5% 11.3% 2.5% 9.3% |2.3% 6.7% 4.4% 9.7% | |TERMINAL (d) | 2/24 (8%) 2/30 (7%) 0/20 (0%) 2/28 (7%) |1/36 (3%) 3/38 (8%) 1/35 (3%) 2/34 (6%) | |FIRST INCIDENCE | 611 603 725 562 |730 (T) 730 (T) 714 633 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.553 P=0.447 P=0.363N P=0.559 |P=0.165 P=0.324 P=0.497 P=0.168 | |POLY 3 | P=0.555 P=0.410 P=0.305N P=0.537 |P=0.168 P=0.321 P=0.523 P=0.167 | |POLY 1.5 | P=0.549 P=0.391 P=0.302N P=0.528 |P=0.174 P=0.323 P=0.523 P=0.172 | |POLY 6 | P=0.557 P=0.432 P=0.312N P=0.544 |P=0.166 P=0.319 P=0.523 P=0.165 | |LOGISTIC REGRESSION| P=0.541 P=0.381 P=0.303N P=0.518 |P=0.161 P=0.324 P=0.520 P=0.171 | |COCH-ARM / FISHERS | P=0.529 P=0.357 P=0.309N P=0.500 |P=0.187 P=0.332 P=0.523 P=0.187 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Heart | | Schwannoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% 0.0% |0.0% 2.2% 4.4% 4.7% | |TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 1/38 (3%) 2/35 (6%) 2/35 (6%) | |FIRST INCIDENCE | --- --- 400 --- |--- 730 (T) 730 (T) 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.772N (e) P=0.517 (e) |P=0.212 P=0.511 P=0.232 P=0.232 | |POLY 3 | P=0.776N (e) P=0.506 (e) |P=0.212 P=0.502 P=0.244 P=0.228 | |POLY 1.5 | P=0.776N (e) P=0.505 (e) |P=0.217 P=0.501 P=0.242 P=0.230 | |POLY 6 | P=0.777N (e) P=0.504 (e) |P=0.208 P=0.503 P=0.246 P=0.226 | |LOGISTIC REGRESSION| P=0.804 (e) P=0.239 (e) |(e) P=0.511 P=0.232 P=0.232 | |COCH-ARM / FISHERS | P=0.779N (e) P=0.500 (e) |P=0.228 P=0.500 P=0.247 P=0.247 | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.0% 0.0% |0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/30 (0%) 2/20 (10%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 1/34 (3%) 0/35 (0%) | |FIRST INCIDENCE | --- --- 729 (T) --- |--- --- 730 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.653N (e) P=0.198 (e) |P=0.792N (e) P=0.489 (e) | |POLY 3 | P=0.670N (e) P=0.239 (e) |P=0.792N (e) P=0.502 (e) | |POLY 1.5 | P=0.670N (e) P=0.240 (e) |P=0.790N (e) P=0.500 (e) | |POLY 6 | P=0.673N (e) P=0.235 (e) |P=0.794N (e) P=0.503 (e) | |LOGISTIC REGRESSION| (e) (e) P=0.198 (e) |(e) (e) P=0.489 (e) | |COCH-ARM / FISHERS | P=0.675N (e) P=0.247 (e) |P=0.785N (e) P=0.495 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.5% 0.0% 5.0% 0.0% |0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/30 (0%) 2/20 (10%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 1/34 (3%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- --- 730 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.421N P=0.455N P=0.436 P=0.469N |P=0.792N (e) P=0.489 (e) | |POLY 3 | P=0.440N P=0.482N P=0.503 P=0.487N |P=0.792N (e) P=0.502 (e) | |POLY 1.5 | P=0.438N P=0.488N P=0.505 P=0.491N |P=0.790N (e) P=0.500 (e) | |POLY 6 | P=0.446N P=0.476N P=0.498 P=0.486N |P=0.794N (e) P=0.503 (e) | |LOGISTIC REGRESSION| P=0.421N (e) P=0.436 (e) |(e) (e) P=0.489 (e) | |COCH-ARM / FISHERS | P=0.441N P=0.500N P=0.500 P=0.500N |P=0.785N (e) P=0.495 (e) | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 1/28 (4%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- 677 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.049 * (e) (e) P=0.267 |(e) (e) (e) (e) | |POLY 3 | P=0.042 * (e) (e) P=0.252 |(e) (e) (e) (e) | |POLY 1.5 | P=0.042 * (e) (e) P=0.248 |(e) (e) (e) (e) | |POLY 6 | P=0.042 * (e) (e) P=0.255 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.044 * (e) (e) P=0.251 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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)| 5.0% 0.0% 0.0% 2.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 633 --- --- 701 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.663N P=0.205N P=0.263N P=0.468N |(e) (e) (e) (e) | |POLY 3 | P=0.682N P=0.219N P=0.236N P=0.480N |(e) (e) (e) (e) | |POLY 1.5 | P=0.678N P=0.225N P=0.235N P=0.485N |(e) (e) (e) (e) | |POLY 6 | P=0.685N P=0.214N P=0.241N P=0.479N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.668N P=0.230N P=0.235N P=0.486N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.673N P=0.247N P=0.247N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 0.0% 0.0% 7.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/30 (0%) 0/20 (0%) 1/28 (4%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 633 --- --- 677 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.163 P=0.205N P=0.263N P=0.547 |(e) (e) (e) (e) | |POLY 3 | P=0.145 P=0.219N P=0.236N P=0.528 |(e) (e) (e) (e) | |POLY 1.5 | P=0.146 P=0.225N P=0.235N P=0.521 |(e) (e) (e) (e) | |POLY 6 | P=0.142 P=0.214N P=0.241N P=0.532 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.154 P=0.230N P=0.235N P=0.524 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.148 P=0.247N P=0.247N P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 0.0% 0.0% 7.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/30 (0%) 0/20 (0%) 1/28 (4%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 633 --- --- 677 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.163 P=0.205N P=0.263N P=0.547 |(e) (e) (e) (e) | |POLY 3 | P=0.145 P=0.219N P=0.236N P=0.528 |(e) (e) (e) (e) | |POLY 1.5 | P=0.146 P=0.225N P=0.235N P=0.521 |(e) (e) (e) (e) | |POLY 6 | P=0.142 P=0.214N P=0.241N P=0.532 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.154 P=0.230N P=0.235N P=0.524 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.148 P=0.247N P=0.247N P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 0.0% 5.0% 2.4% |0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/30 (0%) 1/20 (5%) 1/28 (4%) |0/36 (0%) 0/38 (0%) 1/35 (3%) 0/35 (0%) | |FIRST INCIDENCE | 613 --- 725 729 (T) |--- --- 730 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.571N P=0.210N P=0.639 P=0.467N |P=0.793N (e) P=0.494 (e) | |POLY 3 | P=0.595N P=0.220N P=0.695 P=0.482N |P=0.793N (e) P=0.506 (e) | |POLY 1.5 | P=0.592N P=0.225N P=0.691N P=0.485N |P=0.791N (e) P=0.504 (e) | |POLY 6 | P=0.602N P=0.214N P=0.687 P=0.481N |P=0.794N (e) P=0.508 (e) | |LOGISTIC REGRESSION| P=0.582N P=0.236N P=0.695N P=0.484N |(e) (e) P=0.494 (e) | |COCH-ARM / FISHERS | P=0.592N P=0.247N P=0.691N P=0.500N |P=0.786N (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 0.0% 5.0% 4.7% |0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/30 (0%) 1/20 (5%) 2/28 (7%) |0/36 (0%) 0/38 (0%) 1/35 (3%) 0/35 (0%) | |FIRST INCIDENCE | 613 --- 725 729 (T) |--- --- 730 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.460 P=0.210N P=0.639 P=0.655N |P=0.793N (e) P=0.494 (e) | |POLY 3 | P=0.435 P=0.220N P=0.695 P=0.675N |P=0.793N (e) P=0.506 (e) | |POLY 1.5 | P=0.439 P=0.225N P=0.691N P=0.679N |P=0.791N (e) P=0.504 (e) | |POLY 6 | P=0.427 P=0.214N P=0.687 P=0.676N |P=0.794N (e) P=0.508 (e) | |LOGISTIC REGRESSION| P=0.447 P=0.236N P=0.695N P=0.674N |(e) (e) P=0.494 (e) | |COCH-ARM / FISHERS | P=0.437 P=0.247N P=0.691N P=0.691N |P=0.786N (e) P=0.500 (e) | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 2.2% 4.3% 2.3% | |TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 1/38 (3%) 1/35 (3%) 1/35 (3%) | |FIRST INCIDENCE | --- --- --- --- |613 730 (T) 667 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.644 P=0.752N P=0.513 P=0.752 | |POLY 3 | (e) (e) (e) (e) |P=0.638 P=0.761N P=0.509 P=0.749 | |POLY 1.5 | (e) (e) (e) (e) |P=0.645 P=0.760 P=0.506 P=0.753 | |POLY 6 | (e) (e) (e) (e) |P=0.631 P=0.760N P=0.512 P=0.746 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.641N P=0.762 P=0.473 P=0.757N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.640N P=0.753N P=0.500 P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.4% |4.5% 2.2% 4.3% 2.3% | |TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 1/28 (4%) |1/36 (3%) 1/38 (3%) 1/35 (3%) 1/35 (3%) | |FIRST INCIDENCE | --- --- --- 729 (T) |613 730 (T) 667 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.239 (e) (e) P=0.531 |P=0.500N P=0.485N P=0.685N P=0.512N | |POLY 3 | P=0.224 (e) (e) P=0.513 |P=0.499N P=0.500N P=0.684N P=0.518N | |POLY 1.5 | P=0.224 (e) (e) P=0.509 |P=0.493N P=0.500N P=0.687N P=0.512N | |POLY 6 | P=0.223 (e) (e) P=0.514 |P=0.504N P=0.499N P=0.682N P=0.523N | |LOGISTIC REGRESSION| (e) (e) (e) P=0.531 |P=0.485N P=0.500N P=0.683 P=0.503N | |COCH-ARM / FISHERS | P=0.221 (e) (e) P=0.500 |P=0.479N P=0.500N P=0.691N P=0.500N | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 6/50 (12%) 3/50 (6%) 2/50 (4%) |15/50 (30%) 20/50 (40%) 20/50 (40%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 7.5% 13.8% 7.4% 4.7% |33.0% 43.7% 42.8% 18.6% | |TERMINAL (d) | 2/24 (8%) 5/30 (17%) 1/20 (5%) 2/28 (7%) |11/36 (31%) 17/38 (45%) 15/35 (43%) 7/35 (20%) | |FIRST INCIDENCE | 640 723 621 729 (T) |613 633 536 633 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.207N P=0.352 P=0.606 P=0.444N |P=0.027N* P=0.265 P=0.204 P=0.099N | |POLY 3 | P=0.208N P=0.282 P=0.658N P=0.475N |P=0.022N* P=0.199 P=0.224 P=0.095N | |POLY 1.5 | P=0.212N P=0.269 P=0.656N P=0.480N |P=0.019N* P=0.198 P=0.217 P=0.088N | |POLY 6 | P=0.209N P=0.296 P=0.664 P=0.474N |P=0.025N* P=0.202 P=0.227 P=0.102N | |LOGISTIC REGRESSION| P=0.217N P=0.316 P=0.661N P=0.467N |P=0.020N* P=0.208 P=0.231 P=0.092N | |COCH-ARM / FISHERS | P=0.228N P=0.243 P=0.661N P=0.500N |P=0.015N* P=0.201 P=0.201 P=0.077N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 6/50 (12%) 3/50 (6%) 3/50 (6%) |16/50 (32%) 20/50 (40%) 20/50 (40%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 7.5% 13.8% 7.4% 7.1% |35.2% 43.7% 42.8% 18.6% | |TERMINAL (d) | 2/24 (8%) 5/30 (17%) 1/20 (5%) 3/28 (11%) |12/36 (33%) 17/38 (45%) 15/35 (43%) 7/35 (20%) | |FIRST INCIDENCE | 640 723 621 729 (T) |613 633 536 633 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.357N P=0.352 P=0.606 P=0.603N |P=0.020N* P=0.338 P=0.264 P=0.067N | |POLY 3 | P=0.368N P=0.282 P=0.658N P=0.637N |P=0.015N* P=0.267 P=0.296 P=0.062N | |POLY 1.5 | P=0.372N P=0.269 P=0.656N P=0.642N |P=0.013N* P=0.265 P=0.287 P=0.058N | |POLY 6 | P=0.370N P=0.296 P=0.664 P=0.637N |P=0.018N* P=0.271 P=0.300 P=0.068N | |LOGISTIC REGRESSION| P=0.377N P=0.316 P=0.661N P=0.629N |P=0.015N* P=0.276 P=0.304 P=0.062N | |COCH-ARM / FISHERS | P=0.392N P=0.243 P=0.661N P=0.661N |P=0.011N* P=0.266 P=0.266 P=0.050N | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 6/50 (12%) 3/50 (6%) 3/50 (6%) |16/50 (32%) 21/50 (42%) 22/50 (44%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 7.5% 13.8% 7.4% 7.1% |35.2% 45.9% 46.8% 18.6% | |TERMINAL (d) | 2/24 (8%) 5/30 (17%) 1/20 (5%) 3/28 (11%) |12/36 (33%) 18/38 (47%) 16/35 (46%) 7/35 (20%) | |FIRST INCIDENCE | 640 723 621 729 (T) |613 633 536 633 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.357N P=0.352 P=0.606 P=0.603N |P=0.017N* P=0.271 P=0.161 P=0.067N | |POLY 3 | P=0.368N P=0.282 P=0.658N P=0.637N |P=0.012N* P=0.201 P=0.175 P=0.062N | |POLY 1.5 | P=0.372N P=0.269 P=0.656N P=0.642N |P=0.010N* P=0.201 P=0.167 P=0.058N | |POLY 6 | P=0.370N P=0.296 P=0.664 P=0.637N |P=0.014N* P=0.204 P=0.182 P=0.068N | |LOGISTIC REGRESSION| P=0.377N P=0.316 P=0.661N P=0.629N |P=0.012N* P=0.212 P=0.177 P=0.062N | |COCH-ARM / FISHERS | P=0.392N P=0.243 P=0.661N P=0.661N |P=0.008N** P=0.204 P=0.151 P=0.050N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 0.0% 2.3% | |TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 1/38 (3%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 680 --- 511 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.610 P=0.249 (e) P=0.496 | |POLY 3 | (e) (e) (e) (e) |P=0.615 P=0.240 (e) P=0.495 | |POLY 1.5 | (e) (e) (e) (e) |P=0.616 P=0.239 (e) P=0.496 | |POLY 6 | (e) (e) (e) (e) |P=0.615 P=0.243 (e) P=0.494 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.666 P=0.238 (e) P=0.614 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.622 P=0.247 (e) P=0.500 | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |0.0% 0.0% 0.0% 4.7% | |TERMINAL (d) | |0/36 (0%) 0/38 (0%) 0/35 (0%) 2/35 (6%) | |FIRST INCIDENCE | |--- --- --- 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.038 * (e) (e) P=0.232 | |POLY 3 | |P=0.038 * (e) (e) P=0.228 | |POLY 1.5 | |P=0.039 * (e) (e) P=0.230 | |POLY 6 | |P=0.038 * (e) (e) P=0.226 | |LOGISTIC REGRESSION| |(e) (e) (e) P=0.232 | |COCH-ARM / FISHERS | |P=0.042 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 13/50 (26%) 7/50 (14%) 11/50 (22%) |23/50 (46%) 13/49 (27%) 17/50 (34%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 26.9% 29.5% 16.4% 25.4% |49.6% 29.0% 35.4% 18.6% | |TERMINAL (d) | 7/24 (29%) 8/30 (27%) 1/20 (5%) 8/28 (29%) |16/36 (44%) 11/37 (30%) 10/35 (29%) 7/35 (20%) | |FIRST INCIDENCE | 614 663 482 633 |575 540 468 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.449N P=0.549N P=0.281N P=0.466N |P=0.011N* P=0.032N* P=0.182N P=0.003N** | |POLY 3 | P=0.482N P=0.491 P=0.182N P=0.539N |P=0.007N** P=0.033N* P=0.115N P<0.001N** | |POLY 1.5 | P=0.484N P=0.464 P=0.190N P=0.551N |P=0.006N** P=0.032N* P=0.127N P<0.001N** | |POLY 6 | P=0.489N P=0.520 P=0.178N P=0.536N |P=0.008N** P=0.034N* P=0.110N P=0.002N** | |LOGISTIC REGRESSION| P=0.482N P=0.529 P=0.215N P=0.528N |P=0.005N** P=0.034N* P=0.152N P=0.002N** | |COCH-ARM / FISHERS | P=0.509N P=0.408 P=0.218N P=0.595N |P=0.004N** P=0.035N* P=0.154N P<0.001N** | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Salivary Glands | | Schwannoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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 ADJUSTED (b)| 5.0% 0.0% 2.5% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 687 --- 549 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.267N P=0.190N P=0.513N P=0.206N |(e) (e) (e) (e) | |POLY 3 | P=0.283N P=0.218N P=0.493N P=0.224N |(e) (e) (e) (e) | |POLY 1.5 | P=0.280N P=0.225N P=0.493N P=0.227N |(e) (e) (e) (e) | |POLY 6 | P=0.288N P=0.212N P=0.497N P=0.223N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.283N P=0.213N P=0.503N P=0.222N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.276N P=0.247N P=0.500N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma, Basosquamous Tumor Benign, or | | Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 2.3% 2.5% 2.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 1/30 (3%) 0/20 (0%) 1/28 (4%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 642 729 (T) 708 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.486N P=0.436N P=0.513N P=0.463N |(e) (e) (e) (e) | |POLY 3 | P=0.498N P=0.472N P=0.499N P=0.481N |(e) (e) (e) (e) | |POLY 1.5 | P=0.497N P=0.481N P=0.496N P=0.485N |(e) (e) (e) (e) | |POLY 6 | P=0.502N P=0.463N P=0.506N P=0.481N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.491N P=0.473N P=0.497N P=0.480N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.500N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous | | Tumor (benign, malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 2.3% 2.5% 2.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 1/30 (3%) 0/20 (0%) 1/28 (4%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 642 729 (T) 708 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.486N P=0.436N P=0.513N P=0.463N |(e) (e) (e) (e) | |POLY 3 | P=0.498N P=0.472N P=0.499N P=0.481N |(e) (e) (e) (e) | |POLY 1.5 | P=0.497N P=0.481N P=0.496N P=0.485N |(e) (e) (e) (e) | |POLY 6 | P=0.502N P=0.463N P=0.506N P=0.481N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.491N P=0.473N P=0.497N P=0.480N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.500N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor | | (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 6/50 (12%) 3/50 (6%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 14.9% 13.8% 7.4% 9.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/24 (13%) 5/30 (17%) 1/20 (5%) 3/28 (11%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 642 718 708 676 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.282N P=0.476N P=0.295N P=0.297N |(e) (e) (e) (e) | |POLY 3 | P=0.294N P=0.566N P=0.239N P=0.334N |(e) (e) (e) (e) | |POLY 1.5 | P=0.297N P=0.584N P=0.236N P=0.342N |(e) (e) (e) (e) | |POLY 6 | P=0.296N P=0.551N P=0.249N P=0.332N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.294N P=0.522N P=0.243N P=0.324N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.311N P=0.620N P=0.243N P=0.370N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 4.6% 2.5% 2.4% |0.0% 4.4% 0.0% 0.0% | |TERMINAL (d) | 2/24 (8%) 2/30 (7%) 0/20 (0%) 1/28 (4%) |0/36 (0%) 1/38 (3%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 691 729 (T) |--- 429 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.370N P=0.613N P=0.530N P=0.446N |P=0.379N P=0.246 (e) (e) | |POLY 3 | P=0.387N P=0.662N P=0.495N P=0.478N |P=0.370N P=0.243 (e) (e) | |POLY 1.5 | P=0.388N P=0.673N P=0.494N P=0.483N |P=0.370N P=0.241 (e) (e) | |POLY 6 | P=0.388N P=0.650N P=0.499N P=0.475N |P=0.369N P=0.246 (e) (e) | |LOGISTIC REGRESSION| P=0.385N P=0.613N P=0.507N P=0.446N |P=0.283N P=0.237 (e) (e) | |COCH-ARM / FISHERS | P=0.395N P=0.691N P=0.500N P=0.500N |P=0.369N P=0.247 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.5% 4.6% 4.9% 4.7% |2.2% 4.4% 2.2% 0.0% | |TERMINAL (d) | 2/24 (8%) 2/30 (7%) 0/20 (0%) 1/28 (4%) |0/36 (0%) 1/38 (3%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 728 729 (T) 557 537 |665 429 703 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.467N P=0.403N P=0.545N P=0.440N |P=0.245N P=0.512 P=0.741N P=0.516N | |POLY 3 | P=0.487N P=0.459N P=0.488N P=0.465N |P=0.244N P=0.508 P=0.754N P=0.509N | |POLY 1.5 | P=0.489N P=0.473N P=0.489N P=0.475N |P=0.240N P=0.505 P=0.756N P=0.507N | |POLY 6 | P=0.488N P=0.444N P=0.489N P=0.457N |P=0.247N P=0.510 P=0.753N P=0.512N | |LOGISTIC REGRESSION| P=0.493N P=0.416N P=0.496N P=0.479N |P=0.187N P=0.503 P=0.755 P=0.491N | |COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.500N P=0.500N |P=0.231N P=0.500 P=0.753N P=0.500N | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 17 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.5% 11.5% 5.0% 9.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/24 (13%) 4/30 (13%) 1/20 (5%) 3/28 (11%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 729 (T) 718 708 676 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.583 P=0.477 P=0.567N P=0.582 |(e) (e) (e) (e) | |POLY 3 | P=0.569 P=0.406 P=0.495N P=0.537 |(e) (e) (e) (e) | |POLY 1.5 | P=0.563 P=0.389 P=0.493N P=0.527 |(e) (e) (e) (e) | |POLY 6 | P=0.572 P=0.426 P=0.501N P=0.545 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.560 P=0.457 P=0.528N P=0.549 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.542 P=0.357 P=0.500N P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 5/50 (10%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 10.0% 11.5% 5.0% 9.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/24 (13%) 4/30 (13%) 1/20 (5%) 3/28 (11%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 682 718 708 676 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.512N P=0.626 P=0.395N P=0.566N |(e) (e) (e) (e) | |POLY 3 | P=0.535N P=0.554 P=0.333N P=0.609N |(e) (e) (e) (e) | |POLY 1.5 | P=0.538N P=0.536 P=0.331N P=0.617N |(e) (e) (e) (e) | |POLY 6 | P=0.534N P=0.573 P=0.340N P=0.605N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.539N P=0.604 P=0.346N P=0.601N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.555N P=0.500 P=0.339N P=0.643N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 18 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 5/50 (10%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 10.0% 11.5% 5.0% 9.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/24 (13%) 4/30 (13%) 1/20 (5%) 3/28 (11%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 682 718 708 676 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.512N P=0.626 P=0.395N P=0.566N |(e) (e) (e) (e) | |POLY 3 | P=0.535N P=0.554 P=0.333N P=0.609N |(e) (e) (e) (e) | |POLY 1.5 | P=0.538N P=0.536 P=0.331N P=0.617N |(e) (e) (e) (e) | |POLY 6 | P=0.534N P=0.573 P=0.340N P=0.605N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.539N P=0.604 P=0.346N P=0.601N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.555N P=0.500 P=0.339N P=0.643N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 41/50 (82%) 46/50 (92%) 45/50 (90%) 49/50 (98%) | | |POLY-3 ADJUSTED (b)| 91.5% 95.5% 94.7% 98.0% | | |TERMINAL (d) | 22/24 (92%) 29/30 (97%) 19/20 (95%) 27/28 (96%) | | |FIRST INCIDENCE | 569 512 444 490 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.301 P=0.372N P=0.146 P=0.384 | | |POLY 3 | P=0.148 P=0.345 P=0.415 P=0.143 | | |POLY 1.5 | P=0.066 P=0.234 P=0.339 P=0.050 | | |POLY 6 | P=0.265 P=0.441 P=0.432 P=0.273 | | |LOGISTIC REGRESSION| P=0.045 * P=0.333 P=0.251 P=0.043 * | | |COCH-ARM / FISHERS | P=0.018 * P=0.117 P=0.194 P=0.008 ** | | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 19 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 7/50 (14%) 5/50 (10%) 8/50 (16%) |5/50 (10%) 8/50 (16%) 6/50 (12%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 20.0% 15.8% 12.3% 18.3% |11.2% 17.8% 13.1% 4.7% | |TERMINAL (d) | 7/24 (29%) 6/30 (20%) 4/20 (20%) 5/28 (18%) |4/36 (11%) 8/38 (21%) 6/35 (17%) 2/35 (6%) | |FIRST INCIDENCE | 682 386 549 569 |701 730 (T) 730 (T) 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.550 P=0.326N P=0.378N P=0.501N |P=0.089N P=0.308 P=0.487 P=0.229N | |POLY 3 | P=0.526 P=0.412N P=0.259N P=0.532N |P=0.091N P=0.279 P=0.520 P=0.234N | |POLY 1.5 | P=0.516 P=0.442N P=0.261N P=0.556N |P=0.087N P=0.278 P=0.513 P=0.229N | |POLY 6 | P=0.536 P=0.384N P=0.264N P=0.510N |P=0.094N P=0.282 P=0.525 P=0.238N | |LOGISTIC REGRESSION| P=0.512 P=0.424N P=0.279N P=0.554N |P=0.089N P=0.289 P=0.528 P=0.235N | |COCH-ARM / FISHERS | P=0.490 P=0.500N P=0.277N P=0.607N |P=0.078N P=0.277 P=0.500 P=0.218N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 2.5% 4.7% |4.5% 0.0% 0.0% 2.3% | |TERMINAL (d) | 0/24 (0%) 1/30 (3%) 0/20 (0%) 1/28 (4%) |2/36 (6%) 0/38 (0%) 0/35 (0%) 1/35 (3%) | |FIRST INCIDENCE | --- 729 (T) 708 634 |730 (T) --- --- 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.213 P=0.545 P=0.500 P=0.260 |P=0.664N P=0.226N P=0.244N P=0.510N | |POLY 3 | P=0.214 P=0.518 P=0.502 P=0.253 |P=0.656N P=0.235N P=0.230N P=0.515N | |POLY 1.5 | P=0.211 P=0.512 P=0.503 P=0.249 |P=0.654N P=0.236N P=0.233N P=0.511N | |POLY 6 | P=0.216 P=0.524 P=0.500 P=0.256 |P=0.658N P=0.233N P=0.228N P=0.517N | |LOGISTIC REGRESSION| P=0.207 P=0.545 P=0.499 P=0.242 |P=0.664N (e) (e) P=0.510N | |COCH-ARM / FISHERS | P=0.200 P=0.500 P=0.500 P=0.247 |P=0.650N P=0.247N P=0.247N P=0.500N | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 20 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 8/50 (16%) 6/50 (12%) 10/50 (20%) |7/50 (14%) 8/50 (16%) 6/50 (12%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 20.0% 18.1% 14.7% 22.7% |15.7% 17.8% 13.1% 7.0% | |TERMINAL (d) | 7/24 (29%) 7/30 (23%) 4/20 (20%) 6/28 (21%) |6/36 (17%) 8/38 (21%) 6/35 (17%) 3/35 (9%) | |FIRST INCIDENCE | 682 386 549 569 |701 730 (T) 730 (T) 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.361 P=0.425N P=0.500N P=0.508 |P=0.096N P=0.543 P=0.516N P=0.170N | |POLY 3 | P=0.345 P=0.519N P=0.368N P=0.486 |P=0.099N P=0.506 P=0.478N P=0.175N | |POLY 1.5 | P=0.332 P=0.549N P=0.369N P=0.457 |P=0.094N P=0.503 P=0.485N P=0.170N | |POLY 6 | P=0.360 P=0.489N P=0.373N P=0.516 |P=0.102N P=0.510 P=0.472N P=0.179N | |LOGISTIC REGRESSION| P=0.323 P=0.526N P=0.392N P=0.453 |P=0.097N P=0.522 P=0.471N P=0.176N | |COCH-ARM / FISHERS | P=0.302 P=0.607N P=0.387N P=0.398 |P=0.084N P=0.500 P=0.500N P=0.159N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.6% 0.0% 0.0% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- 617 --- --- |723 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.390N P=0.270 (e) (e) |P=0.485N P=0.495N P=0.500N P=0.511N | |POLY 3 | P=0.366N P=0.260 (e) (e) |P=0.475N P=0.498N P=0.494N P=0.509N | |POLY 1.5 | P=0.375N P=0.252 (e) (e) |P=0.475N P=0.499N P=0.496N P=0.506N | |POLY 6 | P=0.358N P=0.269 (e) (e) |P=0.475N P=0.497N P=0.492N P=0.510N | |LOGISTIC REGRESSION| P=0.394N P=0.233 (e) (e) |P=0.484N P=0.496N P=0.492N P=0.510N | |COCH-ARM / FISHERS | P=0.392N P=0.247 (e) (e) |P=0.474N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 21 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Tongue | | Squamous Cell Carcinoma or Papilloma Squamous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 0.0% 2.3% | |TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/20 (0%) 0/28 (0%) |0/36 (0%) 1/38 (3%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 680 --- 511 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.610 P=0.249 (e) P=0.496 | |POLY 3 | (e) (e) (e) (e) |P=0.615 P=0.240 (e) P=0.495 | |POLY 1.5 | (e) (e) (e) (e) |P=0.616 P=0.239 (e) P=0.496 | |POLY 6 | (e) (e) (e) (e) |P=0.615 P=0.243 (e) P=0.494 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.666 P=0.238 (e) P=0.614 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.622 P=0.247 (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |10/50 (20%) 8/50 (16%) 5/50 (10%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| |22.1% 17.3% 10.9% 11.6% | |TERMINAL (d) | |8/36 (22%) 5/38 (13%) 5/35 (14%) 4/35 (11%) | |FIRST INCIDENCE | |543 429 730 (T) 637 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.149N P=0.361N P=0.140N P=0.150N | |POLY 3 | |P=0.145N P=0.377N P=0.121N P=0.151N | |POLY 1.5 | |P=0.138N P=0.386N P=0.124N P=0.145N | |POLY 6 | |P=0.152N P=0.365N P=0.120N P=0.155N | |LOGISTIC REGRESSION| |P=0.131N P=0.398N P=0.116N P=0.148N | |COCH-ARM / FISHERS | |P=0.121N P=0.398N P=0.131N P=0.131N | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 22 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |2.2% 0.0% 0.0% 4.7% | |TERMINAL (d) | |0/36 (0%) 0/38 (0%) 0/35 (0%) 1/35 (3%) | |FIRST INCIDENCE | |645 --- --- 639 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.167 P=0.495N P=0.491N P=0.471 | |POLY 3 | |P=0.181 P=0.499N P=0.495N P=0.486 | |POLY 1.5 | |P=0.184 P=0.500N P=0.497N P=0.490 | |POLY 6 | |P=0.180 P=0.499N P=0.494N P=0.483 | |LOGISTIC REGRESSION| |P=0.203 P=0.500N P=0.532N P=0.511 | |COCH-ARM / FISHERS | |P=0.189 P=0.500N P=0.500N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |11/50 (22%) 8/50 (16%) 5/50 (10%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| |24.2% 17.3% 10.9% 13.9% | |TERMINAL (d) | |8/36 (22%) 5/38 (13%) 5/35 (14%) 4/35 (11%) | |FIRST INCIDENCE | |543 429 730 (T) 637 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.200N P=0.277N P=0.094N P=0.175N | |POLY 3 | |P=0.188N P=0.291N P=0.080N P=0.166N | |POLY 1.5 | |P=0.180N P=0.297N P=0.081N P=0.159N | |POLY 6 | |P=0.194N P=0.284N P=0.080N P=0.171N | |LOGISTIC REGRESSION| |P=0.168N P=0.306N P=0.077N P=0.156N | |COCH-ARM / FISHERS | |P=0.161N P=0.306N P=0.086N P=0.143N | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 23 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 27/50 (54%) 22/50 (44%) 25/50 (50%) 27/50 (54%) |8/50 (16%) 7/50 (14%) 14/50 (28%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 57.2% 47.8% 55.7% 57.1% |17.5% 15.4% 29.4% 30.7% | |TERMINAL (d) | 8/24 (33%) 11/30 (37%) 6/20 (30%) 11/28 (39%) |5/36 (14%) 4/38 (11%) 7/35 (20%) 7/35 (20%) | |FIRST INCIDENCE | 313 585 444 529 |501 659 575 309 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.458 P=0.108N P=0.535N P=0.413N |P=0.049 * P=0.470N P=0.138 P=0.115 | |POLY 3 | P=0.389 P=0.239N P=0.524N P=0.579N |P=0.050 P=0.505N P=0.131 P=0.107 | |POLY 1.5 | P=0.385 P=0.223N P=0.474N P=0.569N |P=0.051 P=0.505N P=0.123 P=0.107 | |POLY 6 | P=0.385 P=0.260N P=0.583N P=0.569 |P=0.053 P=0.501N P=0.143 P=0.111 | |LOGISTIC REGRESSION| P=0.342 P=0.248N P=0.434N P=0.503 |P=0.067 P=0.502N P=0.098 P=0.136 | |COCH-ARM / FISHERS | P=0.359 P=0.212N P=0.421N P=0.579N |P=0.055 P=0.500N P=0.114 P=0.114 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 5/50 (10%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 4.5% 12.3% 13.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/30 (0%) 3/20 (15%) 2/28 (7%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 687 585 537 569 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.095 P=0.637N P=0.176 P=0.177 |(e) (e) (e) (e) | |POLY 3 | P=0.086 P=0.655N P=0.222 P=0.165 |(e) (e) (e) (e) | |POLY 1.5 | P=0.083 P=0.669N P=0.224 P=0.155 |(e) (e) (e) (e) | |POLY 6 | P=0.087 P=0.639N P=0.217 P=0.175 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.068 P=0.670 P=0.218 P=0.125 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.074 P=0.691N P=0.218 P=0.134 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 24 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 5/50 (10%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 4.5% 12.3% 13.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/24 (4%) 0/30 (0%) 3/20 (15%) 2/28 (7%) |0/36 (0%) 0/38 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE | 687 585 537 569 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.095 P=0.637N P=0.176 P=0.177 |(e) (e) (e) (e) | |POLY 3 | P=0.086 P=0.655N P=0.222 P=0.165 |(e) (e) (e) (e) | |POLY 1.5 | P=0.083 P=0.669N P=0.224 P=0.155 |(e) (e) (e) (e) | |POLY 6 | P=0.087 P=0.639N P=0.217 P=0.175 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.068 P=0.670 P=0.218 P=0.125 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.074 P=0.691N P=0.218 P=0.134 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 42/50 (84%) 48/50 (96%) 47/50 (94%) 50/50 (100%)|37/50 (74%) 35/50 (70%) 35/50 (70%) 20/50 (40%) | |POLY-3 ADJUSTED (b)| 93.8% 97.6% 97.5% 100.0% |77.1% 73.3% 71.8% 45.8% | |TERMINAL (d) | 23/24 (96%) 29/30 (97%) 20/20 (100%) 28/28 (100%)|27/36 (75%) 28/38 (74%) 25/35 (71%) 17/35 (49%) | |FIRST INCIDENCE | 569 386 444 490 |429 429 468 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.337 P=0.418N P=0.109 P=0.391 |P=0.002N** P=0.314N P=0.447N P=0.003N** | |POLY 3 | P=0.081 P=0.319 P=0.315 P=0.073 |P<0.001N** P=0.421N P=0.357N P<0.001N** | |POLY 1.5 | P=0.033 * P=0.152 P=0.212 P=0.017 * |P<0.001N** P=0.418N P=0.371N P<0.001N** | |POLY 6 | P=0.168 P=0.506 P=0.377 P=0.205 |P<0.001N** P=0.426N P=0.359N P=0.002N** | |LOGISTIC REGRESSION| P=0.036 * P=0.147 P=0.130 P=0.026 * |P<0.001N** P=0.405N P=0.391N P<0.001N** | |COCH-ARM / FISHERS | P=0.011 * P=0.046 * P=0.100 P=0.003 ** |P<0.001N** P=0.412N P=0.412N P<0.001N** | |=================================================================================================================================| Date: 10/27/99 EXPERIMENT: 88120 TEST: 03 Page 25 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 34/50 (68%) 33/50 (66%) 37/50 (74%) 36/50 (72%) |15/50 (30%) 14/50 (28%) 20/50 (40%) 25/50 (50%) | |POLY-3 ADJUSTED (b)| 69.1% 66.2% 75.5% 73.0% |31.5% 29.9% 41.8% 52.4% | |TERMINAL (d) | 10/24 (42%) 15/30 (50%) 11/20 (55%) 15/28 (54%) |8/36 (22%) 8/38 (21%) 11/35 (31%) 14/35 (40%) | |FIRST INCIDENCE | 312 386 400 529 |414 429 575 309 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.489 P=0.238N P=0.291 P=0.481N |P=0.012 * P=0.456N P=0.242 P=0.046 * | |POLY 3 | P=0.326 P=0.461N P=0.315 P=0.419 |P=0.009 ** P=0.523N P=0.201 P=0.029 * | |POLY 1.5 | P=0.328 P=0.478N P=0.320 P=0.413 |P=0.009 ** P=0.516N P=0.200 P=0.029 * | |POLY 6 | P=0.333 P=0.439N P=0.312 P=0.435 |P=0.010 * P=0.525N P=0.207 P=0.030 * | |LOGISTIC REGRESSION| P=0.301 P=0.442 P=0.330 P=0.315 |P=0.015 * P=0.508N P=0.165 P=0.045 * | |COCH-ARM / FISHERS | P=0.339 P=0.500N P=0.330 P=0.414 |P=0.010 * P=0.500N P=0.201 P=0.033 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 10 PPM 30 PPM 100 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 49/50 (98%) 50/50 (100%) 50/50 (100%) 50/50 (100%)|42/50 (84%) 40/50 (80%) 42/50 (84%) 36/50 (72%) | |POLY-3 ADJUSTED (b)| 98.0% 100.0% 100.0% 100.0% |84.9% 83.1% 84.0% 75.5% | |TERMINAL (d) | 23/24 (96%) 30/30 (100%) 20/20 (100%) 28/28 (100%)|30/36 (83%) 31/38 (82%) 27/35 (77%) 25/35 (71%) | |FIRST INCIDENCE | 312 386 400 490 |414 429 468 309 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.408N P=0.166N P=0.284 P=0.313N |P=0.304N P=0.306N P=0.554 P=0.271N | |POLY 3 | P=0.500 P=0.500 P=0.500 P=0.500 |P=0.129N P=0.517N P=0.562N P=0.177N | |POLY 1.5 | P=0.500 P=0.500 P=0.500 P=0.500 |P=0.111N P=0.480N P=0.583N P=0.152N | |POLY 6 | P=0.500 P=0.500 P=0.500 P=0.500 |P=0.147N P=0.535N P=0.530N P=0.198N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.092N P=0.394N P=0.574 P=0.112N | |COCH-ARM / FISHERS | P=0.500 P=0.500 P=0.500 P=0.500 |P=0.087N P=0.398N P=0.607N P=0.114N | |=================================================================================================================================| (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 198562-198562/198562 --multipart-boundary--