TDMS Study 89002-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus PENTACHLOROPHENOL DATE: 09/15/97 EXPERIMENT: 89002 TEST: 02 TIME: 16:13:34 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15322 ROUTE: DOSED FEED NTP C#: C89002 PATHOLOGIST: TOFT, J. CAS: 87-86-5 Rats(FISCHER344) ----------------------------- 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 NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus PENTACHLOROPHENOL DATE: 09/15/97 EXPERIMENT: 89002 TEST: 02 TIME: 16:13:34 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15322 ROUTE: DOSED FEED NTP C#: C89002 PATHOLOGIST: TOFT, J. CAS: 87-86-5 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF PENTACHLOROPHENOL =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma Benign Clitoral/Preputial Gland Carcinoma Carcinoma or Adenoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Testes Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) Papilloma Squamous or Papilloma Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma All Organs Benign Tumors =============================================================== Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 21/50 (42%) 20/50 (40%) 23/50 (46%) |0/50 (0%) 3/50 (6%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 35.0% 53.7% 50.0% 52.3% |0.0% 7.0% 2.3% 2.5% | |TERMINAL (d) | 5/12 (42%) 11/16 (69%) 13/21 (62%) 19/31 (61%) |0/28 (0%) 3/33 (9%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE | 579 507 583 702 |--- 738 (T) 690 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.105N P=0.214 P=0.507 P=0.252N |P=0.496 P=0.151 P=0.511 P=0.500 | |POLY 3 | P=0.087 P=0.064 P=0.120 P=0.078 |P=0.508 P=0.126 P=0.510 P=0.498 | |POLY 1.5 | P=0.067 P=0.080 P=0.131 P=0.061 |P=0.505 P=0.121 P=0.505 P=0.499 | |POLY 6 | P=0.128 P=0.049 * P=0.107 P=0.108 |P=0.513 P=0.134 P=0.517 P=0.495 | |LOGISTIC REGRESSION| P=0.252 P=0.070 P=0.154 P=0.220 |P=0.488 P=0.151 P=0.501 P=0.500 | |COCH-ARM / FISHERS | P=0.053 P=0.104 P=0.146 P=0.048 * |P=0.500 P=0.121 P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 2.8% 7.9% 2.3% |0.0% 2.3% 0.0% 0.0% | |TERMINAL (d) | 1/12 (8%) 1/16 (6%) 3/21 (14%) 1/31 (3%) |0/28 (0%) 1/33 (3%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 736 (T) 736 (T) 736 (T) 736 (T) |--- 738 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.374N P=0.698N P=0.520 P=0.537N |P=0.498N P=0.533 (e) (e) | |POLY 3 | P=0.522 P=0.754 P=0.311 P=0.726N |P=0.502N P=0.508 (e) (e) | |POLY 1.5 | P=0.477 P=0.756 P=0.309 P=0.742N |P=0.501N P=0.503 (e) (e) | |POLY 6 | P=0.588 P=0.753 P=0.318 P=0.699N |P=0.506N P=0.517 (e) (e) | |LOGISTIC REGRESSION| P=0.374N P=0.698N P=0.520 P=0.537N |(e) P=0.533 (e) (e) | |COCH-ARM / FISHERS | P=0.426 P=0.753N P=0.309 P=0.753N |P=0.500N P=0.500 (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 22/50 (44%) 21/50 (42%) 24/50 (48%) |0/50 (0%) 4/50 (8%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 39.9% 55.1% 52.5% 54.5% |0.0% 9.3% 2.3% 2.5% | |TERMINAL (d) | 6/12 (50%) 11/16 (69%) 14/21 (67%) 20/31 (65%) |0/28 (0%) 4/33 (12%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE | 579 450 583 702 |--- 738 (T) 690 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.054N P=0.294 P=0.522N P=0.132N |P=0.573 P=0.085 P=0.511 P=0.500 | |POLY 3 | P=0.125 P=0.115 P=0.173 P=0.122 |P=0.571N P=0.065 P=0.510 P=0.498 | |POLY 1.5 | P=0.099 P=0.131 P=0.187 P=0.097 |P=0.572N P=0.062 P=0.505 P=0.499 | |POLY 6 | P=0.177 P=0.098 P=0.155 P=0.167 |P=0.572N P=0.071 P=0.517 P=0.495 | |LOGISTIC REGRESSION| P=0.321 P=0.110 P=0.217 P=0.339 |P=0.562 P=0.085 P=0.501 P=0.500 | |COCH-ARM / FISHERS | P=0.079 P=0.151 P=0.204 P=0.076 |P=0.574N P=0.059 P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |4/50 (8%) 1/50 (2%) 1/48 (2%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 10.5% 2.7% 7.7% 2.3% |9.7% 2.3% 2.4% 7.1% | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 2/21 (10%) 0/31 (0%) |3/28 (11%) 0/33 (0%) 1/34 (3%) 1/28 (4%) | |FIRST INCIDENCE | 647 450 521 544 |645 701 738 (T) 417 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.081N P=0.177N P=0.372N P=0.085N |P=0.384N P=0.143N P=0.136N P=0.507N | |POLY 3 | P=0.136N P=0.186N P=0.490N P=0.136N |P=0.385N P=0.167N P=0.178N P=0.493N | |POLY 1.5 | P=0.156N P=0.183N P=0.494N P=0.155N |P=0.383N P=0.175N P=0.184N P=0.494N | |POLY 6 | P=0.109N P=0.189N P=0.483N P=0.113N |P=0.391N P=0.155N P=0.169N P=0.497N | |LOGISTIC REGRESSION| P=0.204N P=0.176N P=0.493N P=0.193N |P=0.387N P=0.166N P=0.169N P=0.501N | |COCH-ARM / FISHERS | P=0.180N P=0.181N P=0.500N P=0.181N |P=0.386N P=0.181N P=0.194N P=0.500N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 7/50 (14%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 2/48 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 18.8% 2.6% 0.0% |4.9% 2.3% 4.8% 0.0% | |TERMINAL (d) | 0/12 (0%) 3/16 (19%) 0/21 (0%) 0/31 (0%) |1/28 (4%) 0/33 (0%) 1/34 (3%) 0/28 (0%) | |FIRST INCIDENCE | 396 544 360 --- |715 700 670 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.038N* P=0.054 P=0.758 P=0.504N |P=0.211N P=0.434N P=0.633N P=0.243N | |POLY 3 | P=0.074N P=0.025 * P=0.757N P=0.474N |P=0.223N P=0.486N P=0.691N P=0.239N | |POLY 1.5 | P=0.088N P=0.027 * P=0.758N P=0.487N |P=0.217N P=0.495N P=0.689 P=0.238N | |POLY 6 | P=0.054N P=0.024 * P=0.753N P=0.455N |P=0.236N P=0.470N P=0.677N P=0.243N | |LOGISTIC REGRESSION| P=0.137N P=0.033 * (e) P=0.435N |P=0.212N P=0.480N P=0.690N P=0.245N | |COCH-ARM / FISHERS | P=0.111N P=0.030 * P=0.753N P=0.500N |P=0.213N P=0.500N P=0.676 P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 8/50 (16%) 4/50 (8%) 1/50 (2%) |6/50 (12%) 2/50 (4%) 3/48 (6%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 12.8% 21.0% 10.1% 2.3% |14.4% 4.6% 7.2% 7.1% | |TERMINAL (d) | 1/12 (8%) 3/16 (19%) 2/21 (10%) 0/31 (0%) |4/28 (14%) 0/33 (0%) 2/34 (6%) 1/28 (4%) | |FIRST INCIDENCE | 396 450 360 544 |645 700 670 417 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.009N** P=0.346 P=0.389N P=0.048N* |P=0.199N P=0.095N P=0.174N P=0.255N | |POLY 3 | P=0.026N* P=0.254 P=0.488N P=0.074N |P=0.196N P=0.120N P=0.239N P=0.234N | |POLY 1.5 | P=0.034N* P=0.263 P=0.492N P=0.086N |P=0.195N P=0.128N P=0.250N P=0.236N | |POLY 6 | P=0.016N* P=0.248 P=0.481N P=0.059N |P=0.204N P=0.107N P=0.223N P=0.238N | |LOGISTIC REGRESSION| P=0.067N P=0.279 P=0.518N P=0.137N |P=0.198N P=0.118N P=0.229N P=0.242N | |COCH-ARM / FISHERS | P=0.049N* P=0.277 P=0.500N P=0.102N |P=0.199N P=0.134N P=0.264N P=0.243N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/48 (4%) |1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.8% |2.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 2/30 (7%) |1/28 (4%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- 736 (T) |738 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.125 (e) (e) P=0.455 |P=0.176N P=0.467N P=0.461N P=0.500N | |POLY 3 | P=0.058 (e) (e) P=0.262 |P=0.192N P=0.496N P=0.491N P=0.502N | |POLY 1.5 | P=0.055 (e) (e) P=0.246 |P=0.188N P=0.501N P=0.495N P=0.501N | |POLY 6 | P=0.064 (e) (e) P=0.288 |P=0.200N P=0.487N P=0.485N P=0.505N | |LOGISTIC REGRESSION| (e) (e) (e) P=0.455 |P=0.176N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.053 (e) (e) P=0.237 |P=0.185N P=0.505N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 2/31 (7%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- 736 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.129 (e) (e) P=0.463 |(e) (e) (e) (e) | |POLY 3 | P=0.062 (e) (e) P=0.272 |(e) (e) (e) (e) | |POLY 1.5 | P=0.058 (e) (e) P=0.256 |(e) (e) (e) (e) | |POLY 6 | P=0.069 (e) (e) P=0.299 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) P=0.463 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.056 (e) (e) P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 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)| 2.7% 2.8% 0.0% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 0/21 (0%) 2/31 (7%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 695 736 (T) --- 736 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.526N P=0.729N P=0.484N P=0.713N |(e) (e) (e) (e) | |POLY 3 | P=0.446 P=0.753 P=0.497N P=0.551 |(e) (e) (e) (e) | |POLY 1.5 | P=0.429 P=0.756 P=0.498N P=0.528 |(e) (e) (e) (e) | |POLY 6 | P=0.473 P=0.751 P=0.493N P=0.586 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.553 P=0.760 P=0.494N P=0.638 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.411 P=0.753N P=0.500N P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 5.5% 0.0% 0.0% |4.8% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 2/16 (13%) 0/21 (0%) 0/31 (0%) |1/28 (4%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 736 (T) --- --- |645 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.201N P=0.302 (e) (e) |P=0.055N P=0.216N P=0.216N P=0.255N | |POLY 3 | P=0.355N P=0.228 (e) (e) |P=0.057N P=0.230N P=0.229N P=0.241N | |POLY 1.5 | P=0.364N P=0.232 (e) (e) |P=0.056N P=0.235N P=0.233N P=0.238N | |POLY 6 | P=0.338N P=0.226 (e) (e) |P=0.060N P=0.222N P=0.223N P=0.245N | |LOGISTIC REGRESSION| (e) P=0.302 (e) (e) |P=0.056N P=0.236N P=0.235N P=0.238N | |COCH-ARM / FISHERS | P=0.375N P=0.247 (e) (e) |P=0.056N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 5.5% 2.6% 0.0% |7.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 2/16 (13%) 0/21 (0%) 0/31 (0%) |2/28 (7%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 736 (T) 688 --- |645 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.308N P=0.302 P=0.515 (e) |P=0.017N* P=0.101N P=0.099N P=0.131N | |POLY 3 | P=0.451N P=0.228 P=0.505 (e) |P=0.018N* P=0.113N P=0.112N P=0.121N | |POLY 1.5 | P=0.474N P=0.232 P=0.503 (e) |P=0.018N* P=0.117N P=0.115N P=0.120N | |POLY 6 | P=0.415N P=0.226 P=0.511 (e) |P=0.019N* P=0.106N P=0.107N P=0.125N | |LOGISTIC REGRESSION| P=0.400N P=0.302 P=0.504 (e) |P=0.018N* P=0.115N P=0.114N P=0.122N | |COCH-ARM / FISHERS | P=0.500N P=0.247 P=0.500 (e) |P=0.019N* P=0.121N P=0.121N P=0.121N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.8% 0.0% 0.0% |2.4% 6.9% 4.7% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 0/21 (0%) 0/31 (0%) |1/28 (4%) 2/33 (6%) 2/34 (6%) 0/28 (0%) | |FIRST INCIDENCE | --- 736 (T) --- --- |738 (T) 430 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.360N P=0.557 (e) (e) |P=0.281N P=0.347 P=0.568 P=0.500N | |POLY 3 | P=0.498N P=0.493 (e) (e) |P=0.295N P=0.326 P=0.516 P=0.502N | |POLY 1.5 | P=0.500N P=0.496 (e) (e) |P=0.291N P=0.315 P=0.508 P=0.501N | |POLY 6 | P=0.492N P=0.491 (e) (e) |P=0.303N P=0.344 P=0.526 P=0.505N | |LOGISTIC REGRESSION| (e) P=0.557 (e) (e) |P=0.289N P=0.304 P=0.568 (e) | |COCH-ARM / FISHERS | P=0.500N P=0.500 (e) (e) |P=0.289N P=0.309 P=0.500 P=0.500N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 3/50 (6%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.8% 0.0% 0.0% |2.4% 6.9% 7.0% 2.5% | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 0/21 (0%) 0/31 (0%) |1/28 (4%) 2/33 (6%) 3/34 (9%) 1/28 (4%) | |FIRST INCIDENCE | --- 736 (T) --- --- |738 (T) 430 738 (T) 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.360N P=0.557 (e) (e) |P=0.562N P=0.347 P=0.376 P=0.762 | |POLY 3 | P=0.498N P=0.493 (e) (e) |P=0.561 P=0.326 P=0.321 P=0.759 | |POLY 1.5 | P=0.500N P=0.496 (e) (e) |P=0.564 P=0.315 P=0.314 P=0.760 | |POLY 6 | P=0.492N P=0.491 (e) (e) |P=0.554 P=0.344 P=0.332 P=0.756 | |LOGISTIC REGRESSION| (e) P=0.557 (e) (e) |P=0.564 P=0.304 P=0.376 P=0.762 | |COCH-ARM / FISHERS | P=0.500N P=0.500 (e) (e) |P=0.564N P=0.309 P=0.309 P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 5/50 (10%) 4/50 (8%) 2/50 (4%) |25/50 (50%) 20/50 (40%) 19/50 (38%) 12/50 (24%) | |POLY-3 ADJUSTED (b)| 13.0% 13.8% 10.4% 4.6% |56.7% 45.7% 41.9% 28.6% | |TERMINAL (d) | 1/12 (8%) 3/16 (19%) 3/21 (14%) 2/31 (7%) |16/28 (57%) 16/33 (49%) 14/34 (41%) 7/28 (25%) | |FIRST INCIDENCE | 619 698 698 736 (T) |507 620 417 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.015N* P=0.544N P=0.329N P=0.052N |P=0.007N** P=0.087N P=0.063N P=0.013N* | |POLY 3 | P=0.099N P=0.598 P=0.501N P=0.166N |P=0.005N** P=0.202N P=0.111N P=0.005N** | |POLY 1.5 | P=0.120N P=0.612 P=0.500N P=0.188N |P=0.004N** P=0.215N P=0.128N P=0.005N** | |POLY 6 | P=0.074N P=0.582 P=0.500N P=0.138N |P=0.006N** P=0.178N P=0.095N P=0.007N** | |LOGISTIC REGRESSION| P=0.060N P=0.608 P=0.474N P=0.159N |P=0.005N** P=0.160N P=0.134N P=0.006N** | |COCH-ARM / FISHERS | P=0.147N P=0.630N P=0.500N P=0.218N |P=0.006N** P=0.211N P=0.157N P=0.006N** | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 5/50 (10%) 4/50 (8%) 2/50 (4%) |25/50 (50%) 20/50 (40%) 19/50 (38%) 13/50 (26%) | |POLY-3 ADJUSTED (b)| 13.0% 13.8% 10.4% 4.6% |56.7% 45.7% 41.9% 31.0% | |TERMINAL (d) | 1/12 (8%) 3/16 (19%) 3/21 (14%) 2/31 (7%) |16/28 (57%) 16/33 (49%) 14/34 (41%) 8/28 (29%) | |FIRST INCIDENCE | 619 698 698 736 (T) |507 620 417 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.015N* P=0.544N P=0.329N P=0.052N |P=0.012N* P=0.087N P=0.063N P=0.022N* | |POLY 3 | P=0.099N P=0.598 P=0.501N P=0.166N |P=0.009N** P=0.202N P=0.111N P=0.011N* | |POLY 1.5 | P=0.120N P=0.612 P=0.500N P=0.188N |P=0.008N** P=0.215N P=0.128N P=0.010N* | |POLY 6 | P=0.074N P=0.582 P=0.500N P=0.138N |P=0.011N* P=0.178N P=0.095N P=0.013N* | |LOGISTIC REGRESSION| P=0.060N P=0.608 P=0.474N P=0.159N |P=0.009N** P=0.160N P=0.134N P=0.011N* | |COCH-ARM / FISHERS | P=0.147N P=0.630N P=0.500N P=0.218N |P=0.010N* P=0.211N P=0.157N P=0.011N* | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 5/50 (10%) 4/50 (8%) 2/50 (4%) |25/50 (50%) 22/50 (44%) 21/50 (42%) 13/50 (26%) | |POLY-3 ADJUSTED (b)| 13.0% 13.8% 10.4% 4.6% |56.7% 49.4% 46.3% 31.0% | |TERMINAL (d) | 1/12 (8%) 3/16 (19%) 3/21 (14%) 2/31 (7%) |16/28 (57%) 17/33 (52%) 16/34 (47%) 8/28 (29%) | |FIRST INCIDENCE | 619 698 698 736 (T) |507 430 417 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.015N* P=0.544N P=0.329N P=0.052N |P=0.013N* P=0.164N P=0.115N P=0.022N* | |POLY 3 | P=0.099N P=0.598 P=0.501N P=0.166N |P=0.010N* P=0.314N P=0.215N P=0.011N* | |POLY 1.5 | P=0.120N P=0.612 P=0.500N P=0.188N |P=0.009N** P=0.337N P=0.238N P=0.010N* | |POLY 6 | P=0.074N P=0.582 P=0.500N P=0.138N |P=0.013N* P=0.276N P=0.191N P=0.013N* | |LOGISTIC REGRESSION| P=0.060N P=0.608 P=0.474N P=0.159N |P=0.009N** P=0.303N P=0.237N P=0.011N* | |COCH-ARM / FISHERS | P=0.147N P=0.630N P=0.500N P=0.218N |P=0.010N* P=0.344N P=0.274N P=0.011N* | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Nose | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 8.1% 2.6% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 643 505 593 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.167N P=0.301 P=0.744 P=0.473N |(e) (e) (e) (e) | |POLY 3 | P=0.171N P=0.299 P=0.756N P=0.471N |(e) (e) (e) (e) | |POLY 1.5 | P=0.188N P=0.301 P=0.758N P=0.485N |(e) (e) (e) (e) | |POLY 6 | P=0.147N P=0.300 P=0.752N P=0.452N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.237N P=0.314 P=0.758 P=0.520N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.209N P=0.309 P=0.753N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 2.6% 0.0% |4.9% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 0/21 (0%) 0/31 (0%) |2/28 (7%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 702 --- 640 --- |738 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.083N P=0.204N P=0.423N P=0.094N |P=0.049N* P=0.202N P=0.196N P=0.238N | |POLY 3 | P=0.131N P=0.245N P=0.491N P=0.205N |P=0.057N P=0.228N P=0.227N P=0.239N | |POLY 1.5 | P=0.140N P=0.242N P=0.495N P=0.220N |P=0.056N P=0.234N P=0.232N P=0.238N | |POLY 6 | P=0.120N P=0.247N P=0.482N P=0.185N |P=0.060N P=0.219N P=0.220N P=0.242N | |LOGISTIC REGRESSION| P=0.127N P=0.237N P=0.490N P=0.159N |P=0.049N* (e) (e) (e) | |COCH-ARM / FISHERS | P=0.149N P=0.247N P=0.500N P=0.247N |P=0.056N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 2.6% 2.3% |4.9% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 0/21 (0%) 0/31 (0%) |2/28 (7%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 702 --- 640 605 |738 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.283N P=0.204N P=0.423N P=0.305N |P=0.049N* P=0.202N P=0.196N P=0.238N | |POLY 3 | P=0.381N P=0.245N P=0.491N P=0.445N |P=0.057N P=0.228N P=0.227N P=0.239N | |POLY 1.5 | P=0.396N P=0.242N P=0.495N P=0.470N |P=0.056N P=0.234N P=0.232N P=0.238N | |POLY 6 | P=0.358N P=0.247N P=0.482N P=0.407N |P=0.060N P=0.219N P=0.220N P=0.242N | |LOGISTIC REGRESSION| P=0.401N P=0.237N P=0.490N P=0.490N |P=0.049N* (e) (e) (e) | |COCH-ARM / FISHERS | P=0.411N P=0.247N P=0.500N P=0.500N |P=0.056N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/48 (0%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 2.6% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 1/21 (5%) 0/30 (0%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 660 --- 736 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.068N P=0.219N P=0.380N P=0.123N |(e) (e) (e) (e) | |POLY 3 | P=0.137N P=0.246N P=0.495N P=0.215N |(e) (e) (e) (e) | |POLY 1.5 | P=0.145N P=0.242N P=0.497N P=0.229N |(e) (e) (e) (e) | |POLY 6 | P=0.125N P=0.249N P=0.490N P=0.195N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.115N P=0.245N P=0.477N P=0.211N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.154N P=0.247N P=0.500N P=0.258N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 16/50 (32%) 14/49 (29%) 13/50 (26%) |22/50 (44%) 20/50 (40%) 14/50 (28%) 16/50 (32%) | |POLY-3 ADJUSTED (b)| 41.5% 40.1% 34.4% 29.5% |49.1% 44.9% 31.5% 38.1% | |TERMINAL (d) | 4/12 (33%) 6/16 (38%) 5/21 (24%) 11/31 (36%) |11/28 (39%) 15/33 (46%) 10/34 (29%) 11/28 (39%) | |FIRST INCIDENCE | 396 524 443 620 |507 522 544 592 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.004N** P=0.372N P=0.142N P=0.006N** |P=0.078N P=0.247N P=0.039N* P=0.197N | |POLY 3 | P=0.108N P=0.540N P=0.327N P=0.168N |P=0.083N P=0.425N P=0.066N P=0.201N | |POLY 1.5 | P=0.124N P=0.490N P=0.309N P=0.183N |P=0.071N P=0.433N P=0.067N P=0.174N | |POLY 6 | P=0.086N P=0.587N P=0.343N P=0.144N |P=0.107N P=0.409N P=0.065N P=0.256N | |LOGISTIC REGRESSION| P=0.128N P=0.406N P=0.294N P=0.215N |P=0.063N P=0.401N P=0.065N P=0.152N | |COCH-ARM / FISHERS | P=0.141N P=0.417N P=0.283N P=0.194N |P=0.065N P=0.420N P=0.072N P=0.151N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 16/50 (32%) 14/49 (29%) 14/50 (28%) |22/50 (44%) 20/50 (40%) 14/50 (28%) 16/50 (32%) | |POLY-3 ADJUSTED (b)| 41.5% 40.1% 34.4% 31.8% |49.1% 44.9% 31.5% 38.1% | |TERMINAL (d) | 4/12 (33%) 6/16 (38%) 5/21 (24%) 12/31 (39%) |11/28 (39%) 15/33 (46%) 10/34 (29%) 11/28 (39%) | |FIRST INCIDENCE | 396 524 443 620 |507 522 544 592 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.006N** P=0.372N P=0.142N P=0.008N** |P=0.078N P=0.247N P=0.039N* P=0.197N | |POLY 3 | P=0.156N P=0.540N P=0.327N P=0.232N |P=0.083N P=0.425N P=0.066N P=0.201N | |POLY 1.5 | P=0.175N P=0.490N P=0.309N P=0.249N |P=0.071N P=0.433N P=0.067N P=0.174N | |POLY 6 | P=0.129N P=0.587N P=0.343N P=0.204N |P=0.107N P=0.409N P=0.065N P=0.256N | |LOGISTIC REGRESSION| P=0.173N P=0.406N P=0.294N P=0.277N |P=0.063N P=0.401N P=0.065N P=0.152N | |COCH-ARM / FISHERS | P=0.193N P=0.417N P=0.283N P=0.260N |P=0.065N P=0.420N P=0.072N P=0.151N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 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) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 8.0% 8.3% 5.2% 11.3% |0.0% 0.0% 2.3% 2.5% | |TERMINAL (d) | 2/12 (17%) 1/16 (6%) 2/21 (10%) 4/31 (13%) |0/28 (0%) 0/33 (0%) 1/34 (3%) 1/28 (4%) | |FIRST INCIDENCE | 684 722 736 (T) 518 |--- --- 738 (T) 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.374N P=0.574N P=0.301N P=0.522N |P=0.163 (e) P=0.539 P=0.500 | |POLY 3 | P=0.378 P=0.647 P=0.493N P=0.448 |P=0.171 (e) P=0.509 P=0.498 | |POLY 1.5 | P=0.342 P=0.653 P=0.496N P=0.406 |P=0.172 (e) P=0.505 P=0.499 | |POLY 6 | P=0.438 P=0.644 P=0.486N P=0.511 |P=0.170 (e) P=0.515 P=0.495 | |LOGISTIC REGRESSION| P=0.469 P=0.665N P=0.428N P=0.447 |(e) (e) P=0.539 P=0.500 | |COCH-ARM / FISHERS | P=0.304 P=0.661N P=0.500N P=0.357 |P=0.170 (e) P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.2% 5.4% 5.2% 4.5% |4.8% 2.3% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 1/21 (5%) 1/31 (3%) |1/28 (4%) 1/33 (3%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 603 505 666 614 |523 738 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.365N P=0.680N P=0.649N P=0.551N |P=0.055N P=0.465N P=0.216N P=0.237N | |POLY 3 | P=0.508N P=0.683 P=0.692N P=0.642N |P=0.061N P=0.491N P=0.230N P=0.242N | |POLY 1.5 | P=0.535N P=0.687 P=0.693N P=0.666N |P=0.060N P=0.498N P=0.234N P=0.240N | |POLY 6 | P=0.466N P=0.678 P=0.689N P=0.604N |P=0.063N P=0.479N P=0.225N P=0.247N | |LOGISTIC REGRESSION| P=0.552 P=0.686N P=0.694N P=0.670 |P=0.060N P=0.501N P=0.248N P=0.239N | |COCH-ARM / FISHERS | P=0.564N P=0.691N P=0.691N P=0.691N |P=0.059N P=0.500N P=0.247N P=0.247N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 2/50 (4%) 4/50 (8%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 13.1% 8.0% 5.2% 9.1% |7.2% 2.3% 2.3% 2.4% | |TERMINAL (d) | 2/12 (17%) 1/16 (6%) 1/21 (5%) 3/31 (10%) |2/28 (7%) 1/33 (3%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 603 505 666 614 |523 738 (T) 733 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.117N P=0.315N P=0.136N P=0.159N |P=0.174N P=0.265N P=0.254N P=0.316N | |POLY 3 | P=0.304N P=0.366N P=0.211N P=0.413N |P=0.181N P=0.296N P=0.294N P=0.311N | |POLY 1.5 | P=0.329N P=0.362N P=0.214N P=0.453N |P=0.179N P=0.303N P=0.300N P=0.308N | |POLY 6 | P=0.265N P=0.369N P=0.206N P=0.357N |P=0.187N P=0.283N P=0.286N P=0.316N | |LOGISTIC REGRESSION| P=0.336N P=0.354N P=0.206N P=0.431N |P=0.177N P=0.305N P=0.306N P=0.305N | |COCH-ARM / FISHERS | P=0.355N P=0.357N P=0.218N P=0.500N |P=0.177N P=0.309N P=0.309N P=0.309N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 0.0% 4.6% |2.4% 0.0% 2.3% 2.4% | |TERMINAL (d) | 2/12 (17%) 0/16 (0%) 0/21 (0%) 2/31 (7%) |1/28 (4%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 736 (T) --- --- 736 (T) |738 (T) --- 733 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.311N P=0.175N P=0.124N P=0.329N |P=0.494 P=0.467N P=0.713N P=0.748 | |POLY 3 | P=0.586N P=0.244N P=0.232N P=0.638N |P=0.500 P=0.492N P=0.751N P=0.761 | |POLY 1.5 | P=0.589N P=0.241N P=0.234N P=0.664N |P=0.501 P=0.497N P=0.755N P=0.760N | |POLY 6 | P=0.578N P=0.245N P=0.226N P=0.596N |P=0.498 P=0.483N P=0.744N P=0.759 | |LOGISTIC REGRESSION| P=0.311N (e) (e) P=0.329N |P=0.499 (e) P=0.731N P=0.762 | |COCH-ARM / FISHERS | P=0.589N P=0.247N P=0.247N P=0.691N |P=0.500 P=0.500N P=0.753N P=0.753N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 8.0% 2.7% 0.0% 4.6% |2.4% 0.0% 2.3% 2.4% | |TERMINAL (d) | 2/12 (17%) 0/16 (0%) 0/21 (0%) 2/31 (7%) |1/28 (4%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 695 507 --- 736 (T) |738 (T) --- 733 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.110N P=0.259N P=0.061N P=0.158N |P=0.494 P=0.467N P=0.713N P=0.748 | |POLY 3 | P=0.275N P=0.311N P=0.114N P=0.433N |P=0.500 P=0.492N P=0.751N P=0.761 | |POLY 1.5 | P=0.283N P=0.309N P=0.116N P=0.464N |P=0.501 P=0.497N P=0.755N P=0.760N | |POLY 6 | P=0.262N P=0.310N P=0.110N P=0.387N |P=0.498 P=0.483N P=0.744N P=0.759 | |LOGISTIC REGRESSION| P=0.246N P=0.311N P=0.095N P=0.279N |P=0.499 (e) P=0.731N P=0.762 | |COCH-ARM / FISHERS | P=0.289N P=0.309N P=0.121N P=0.500N |P=0.500 P=0.500N P=0.753N P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 5.5% 2.6% 6.8% |0.0% 0.0% 0.0% 2.5% | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 1/21 (5%) 2/31 (7%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE | --- 722 736 (T) 518 |--- --- --- 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.266 P=0.290 P=0.612 P=0.249 |P=0.178 (e) (e) P=0.500 | |POLY 3 | P=0.128 P=0.229 P=0.504 P=0.151 |P=0.193 (e) (e) P=0.498 | |POLY 1.5 | P=0.113 P=0.232 P=0.502 P=0.136 |P=0.189 (e) (e) P=0.499 | |POLY 6 | P=0.157 P=0.227 P=0.509 P=0.177 |P=0.199 (e) (e) P=0.495 | |LOGISTIC REGRESSION| P=0.130 P=0.246 P=0.612 P=0.109 |(e) (e) (e) P=0.500 | |COCH-ARM / FISHERS | P=0.097 P=0.247 P=0.500 P=0.121 |P=0.185 (e) (e) P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 2.8% 0.0% 6.9% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 2/12 (17%) 0/16 (0%) 0/21 (0%) 3/31 (10%) |0/28 (0%) 0/33 (0%) 1/34 (3%) 0/28 (0%) | |FIRST INCIDENCE | 736 (T) 723 --- 736 (T) |--- --- 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.391N P=0.413N P=0.124N P=0.456N |P=0.502 (e) P=0.539 (e) | |POLY 3 | P=0.462 P=0.512N P=0.232N P=0.569 |P=0.498 (e) P=0.509 (e) | |POLY 1.5 | P=0.444 P=0.507N P=0.234N P=0.537 |P=0.499 (e) P=0.505 (e) | |POLY 6 | P=0.492 P=0.514N P=0.226N P=0.617 |P=0.494 (e) P=0.515 (e) | |LOGISTIC REGRESSION| P=0.465N P=0.468N (e) P=0.456N |(e) (e) P=0.539 (e) | |COCH-ARM / FISHERS | P=0.426 P=0.500N P=0.247N P=0.500 |P=0.500 (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 8.3% 2.6% 11.3% |0.0% 0.0% 2.3% 2.5% | |TERMINAL (d) | 2/12 (17%) 1/16 (6%) 1/21 (5%) 4/31 (13%) |0/28 (0%) 0/33 (0%) 1/34 (3%) 1/28 (4%) | |FIRST INCIDENCE | 736 (T) 722 736 (T) 518 |--- --- 738 (T) 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.536N P=0.608 P=0.306N P=0.617 |P=0.163 (e) P=0.539 P=0.500 | |POLY 3 | P=0.253 P=0.485 P=0.493N P=0.289 |P=0.171 (e) P=0.509 P=0.498 | |POLY 1.5 | P=0.228 P=0.491 P=0.496N P=0.254 |P=0.172 (e) P=0.505 P=0.499 | |POLY 6 | P=0.298 P=0.483 P=0.485N P=0.344 |P=0.170 (e) P=0.515 P=0.495 | |LOGISTIC REGRESSION| P=0.335 P=0.535 P=0.306N P=0.291 |(e) (e) P=0.539 P=0.500 | |COCH-ARM / FISHERS | P=0.203 P=0.500 P=0.500N P=0.218 |P=0.170 (e) P=0.500 P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 8.3% 2.6% 11.3% |0.0% 0.0% 2.3% 2.5% | |TERMINAL (d) | 2/12 (17%) 1/16 (6%) 1/21 (5%) 4/31 (13%) |0/28 (0%) 0/33 (0%) 1/34 (3%) 1/28 (4%) | |FIRST INCIDENCE | 736 (T) 722 736 (T) 518 |--- --- 738 (T) 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.536N P=0.608 P=0.306N P=0.617 |P=0.163 (e) P=0.539 P=0.500 | |POLY 3 | P=0.253 P=0.485 P=0.493N P=0.289 |P=0.171 (e) P=0.509 P=0.498 | |POLY 1.5 | P=0.228 P=0.491 P=0.496N P=0.254 |P=0.172 (e) P=0.505 P=0.499 | |POLY 6 | P=0.298 P=0.483 P=0.485N P=0.344 |P=0.170 (e) P=0.515 P=0.495 | |LOGISTIC REGRESSION| P=0.335 P=0.535 P=0.306N P=0.291 |(e) (e) P=0.539 P=0.500 | |COCH-ARM / FISHERS | P=0.203 P=0.500 P=0.500N P=0.218 |P=0.170 (e) P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 42/50 (84%) 47/50 (94%) 45/50 (90%) 46/50 (92%) | | |POLY-3 ADJUSTED (b)| 93.8% 97.5% 95.8% 95.6% | | |TERMINAL (d) | 12/12 (100%) 16/16 (100%) 21/21 (100%) 31/31 (100%)| | |FIRST INCIDENCE | 561 410 521 518 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.465 P=0.181N P<0.001N** | | |POLY 3 | P=0.458 P=0.293 P=0.514 P=0.535 | | |POLY 1.5 | P=0.271 P=0.180 P=0.375 P=0.313 | | |POLY 6 | P=0.489N P=0.589 P=0.784 P=0.782N | | |LOGISTIC REGRESSION| P=0.468 P=0.031 * P=0.242 P=0.621 | | |COCH-ARM / FISHERS | P=0.171 P=0.100 P=0.277 P=0.178 | | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 17 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 8/50 (16%) 7/50 (14%) 6/50 (12%) |3/50 (6%) 3/50 (6%) 1/50 (2%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 12.9% 21.5% 17.7% 13.6% |7.2% 7.0% 2.3% 9.7% | |TERMINAL (d) | 1/12 (8%) 5/16 (31%) 3/21 (14%) 5/31 (16%) |1/28 (4%) 3/33 (9%) 1/34 (3%) 2/28 (7%) | |FIRST INCIDENCE | 535 450 593 544 |585 738 (T) 738 (T) 586 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.165N P=0.354 P=0.528 P=0.348N |P=0.506 P=0.593N P=0.263N P=0.507 | |POLY 3 | P=0.494N P=0.243 P=0.390 P=0.591 |P=0.503 P=0.652N P=0.295N P=0.494 | |POLY 1.5 | P=0.531 P=0.258 P=0.385 P=0.549 |P=0.503 P=0.660N P=0.300N P=0.498 | |POLY 6 | P=0.411N P=0.226 P=0.403 P=0.606N |P=0.501 P=0.637N P=0.287N P=0.485 | |LOGISTIC REGRESSION| P=0.537 P=0.259 P=0.383 P=0.520 |P=0.498 P=0.652N P=0.303N P=0.499 | |COCH-ARM / FISHERS | P=0.463 P=0.277 P=0.380 P=0.500 |P=0.500 P=0.661N P=0.309N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 5.5% 5.2% 4.6% |4.9% 2.3% 4.7% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 2/21 (10%) 2/31 (7%) |2/28 (7%) 1/33 (3%) 2/34 (6%) 0/28 (0%) | |FIRST INCIDENCE | --- 663 736 (T) 736 (T) |738 (T) 738 (T) 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.433 P=0.259 P=0.367 P=0.463 |P=0.197N P=0.442N P=0.624N P=0.238N | |POLY 3 | P=0.234 P=0.230 P=0.241 P=0.272 |P=0.218N P=0.486N P=0.678N P=0.239N | |POLY 1.5 | P=0.207 P=0.233 P=0.239 P=0.256 |P=0.212N P=0.495N P=0.685N P=0.238N | |POLY 6 | P=0.282 P=0.229 P=0.245 P=0.299 |P=0.229N P=0.471N P=0.667N P=0.242N | |LOGISTIC REGRESSION| P=0.304 P=0.229 P=0.367 P=0.463 |P=0.197N P=0.442N P=0.624N (e) | |COCH-ARM / FISHERS | P=0.177 P=0.247 P=0.247 P=0.247 |P=0.209N P=0.500N P=0.691N P=0.247N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 18 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 10/50 (20%) 9/50 (18%) 8/50 (16%) |5/50 (10%) 4/50 (8%) 3/50 (6%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 12.9% 26.7% 22.8% 18.1% |12.0% 9.3% 7.0% 9.7% | |TERMINAL (d) | 1/12 (8%) 6/16 (38%) 5/21 (24%) 7/31 (23%) |3/28 (11%) 4/33 (12%) 3/34 (9%) 2/28 (7%) | |FIRST INCIDENCE | 535 450 593 544 |585 738 (T) 738 (T) 586 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.230N P=0.191 P=0.366 P=0.492N |P=0.353N P=0.407N P=0.273N P=0.494N | |POLY 3 | P=0.400 P=0.106 P=0.196 P=0.363 |P=0.367N P=0.485N P=0.340N P=0.507N | |POLY 1.5 | P=0.338 P=0.116 P=0.195 P=0.322 |P=0.363N P=0.496N P=0.348N P=0.502N | |POLY 6 | P=0.499 P=0.095 P=0.203 P=0.426 |P=0.377N P=0.465N P=0.329N P=0.518N | |LOGISTIC REGRESSION| P=0.385 P=0.117 P=0.200 P=0.320 |P=0.369N P=0.466N P=0.328N P=0.503N | |COCH-ARM / FISHERS | P=0.273 P=0.131 P=0.194 P=0.277 |P=0.363N P=0.500N P=0.357N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.8% 2.6% 2.3% |4.9% 2.3% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 0/21 (0%) 1/31 (3%) |2/28 (7%) 1/33 (3%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 736 (T) 688 736 (T) |738 (T) 738 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.491 P=0.557 P=0.515 P=0.689 |P=0.052N P=0.442N P=0.196N P=0.238N | |POLY 3 | P=0.360 P=0.493 P=0.505 P=0.530 |P=0.060N P=0.486N P=0.227N P=0.239N | |POLY 1.5 | P=0.333 P=0.496 P=0.503 P=0.516 |P=0.059N P=0.495N P=0.232N P=0.238N | |POLY 6 | P=0.404 P=0.491 P=0.511 P=0.551 |P=0.062N P=0.471N P=0.220N P=0.242N | |LOGISTIC REGRESSION| P=0.396 P=0.557 P=0.504 P=0.689 |P=0.052N P=0.442N (e) (e) | |COCH-ARM / FISHERS | P=0.301 P=0.500 P=0.500 P=0.500 |P=0.059N P=0.500N P=0.247N P=0.247N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 19 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |6/50 (12%) 6/50 (12%) 3/50 (6%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| |14.6% 14.0% 7.0% 9.7% | |TERMINAL (d) | |6/28 (21%) 4/33 (12%) 3/34 (9%) 3/28 (11%) | |FIRST INCIDENCE | |738 (T) 715 738 (T) 592 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.181N P=0.498N P=0.151N P=0.364N | |POLY 3 | |P=0.189N P=0.591N P=0.219N P=0.366N | |POLY 1.5 | |P=0.190N P=0.610N P=0.230N P=0.367N | |POLY 6 | |P=0.191N P=0.557N P=0.203N P=0.370N | |LOGISTIC REGRESSION| |P=0.202N P=0.508N P=0.151N P=0.388N | |COCH-ARM / FISHERS | |P=0.194N P=0.620N P=0.243N P=0.370N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |6/50 (12%) 6/50 (12%) 4/50 (8%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| |14.6% 14.0% 9.3% 12.1% | |TERMINAL (d) | |6/28 (21%) 4/33 (12%) 4/34 (12%) 4/28 (14%) | |FIRST INCIDENCE | |738 (T) 715 738 (T) 592 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.328N P=0.498N P=0.249N P=0.497N | |POLY 3 | |P=0.336N P=0.591N P=0.340N P=0.498N | |POLY 1.5 | |P=0.335N P=0.610N P=0.354N P=0.497N | |POLY 6 | |P=0.341N P=0.557N P=0.321N P=0.503N | |LOGISTIC REGRESSION| |P=0.359N P=0.508N P=0.249N P=0.525N | |COCH-ARM / FISHERS | |P=0.340N P=0.620N P=0.370N P=0.500N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 20 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 1/31 (3%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- 698 708 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.136 (e) P=0.524 P=0.424 |(e) (e) (e) (e) | |POLY 3 | P=0.076 (e) P=0.505 P=0.273 |(e) (e) (e) (e) | |POLY 1.5 | P=0.068 (e) P=0.503 P=0.256 |(e) (e) (e) (e) | |POLY 6 | P=0.091 (e) P=0.510 P=0.301 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.090 (e) P=0.507 P=0.320 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.059 (e) P=0.500 P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 25/50 (50%) 26/50 (52%) 26/50 (52%) 23/50 (46%) |15/50 (30%) 15/50 (30%) 15/50 (30%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 58.8% 61.5% 57.8% 48.9% |33.9% 32.6% 32.0% 39.7% | |TERMINAL (d) | 5/12 (42%) 8/16 (50%) 8/21 (38%) 11/31 (36%) |5/28 (18%) 6/33 (18%) 7/34 (21%) 8/28 (29%) | |FIRST INCIDENCE | 561 507 482 518 |475 392 451 459 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.011N* P=0.544N P=0.351N P=0.013N* |P=0.311 P=0.436N P=0.442N P=0.345 | |POLY 3 | P=0.158N P=0.485 P=0.552N P=0.231N |P=0.323 P=0.537N P=0.511N P=0.361 | |POLY 1.5 | P=0.242N P=0.490 P=0.572 P=0.308N |P=0.314 P=0.564N P=0.543N P=0.353 | |POLY 6 | P=0.086N P=0.495 P=0.488N P=0.153N |P=0.325 P=0.501N P=0.476N P=0.364 | |LOGISTIC REGRESSION| P=0.306N P=0.454 P=0.510 P=0.338N |P=0.286 P=0.581 P=0.550 P=0.335 | |COCH-ARM / FISHERS | P=0.376N P=0.500 P=0.500 P=0.421N |P=0.293 P=0.586N P=0.586N P=0.335 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 21 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.9% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 613 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.052 (e) (e) P=0.237 | |POLY 3 | (e) (e) (e) (e) |P=0.057 (e) (e) P=0.237 | |POLY 1.5 | (e) (e) (e) (e) |P=0.056 (e) (e) P=0.238 | |POLY 6 | (e) (e) (e) (e) |P=0.059 (e) (e) P=0.235 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.056 (e) (e) P=0.238 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.056 (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 0.0% 5.1% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 617 --- 593 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.461N P=0.517N P=0.490 P=0.470N |(e) (e) (e) (e) | |POLY 3 | P=0.447N P=0.509N P=0.511 P=0.472N |(e) (e) (e) (e) | |POLY 1.5 | P=0.472N P=0.505N P=0.506 P=0.485N |(e) (e) (e) (e) | |POLY 6 | P=0.410N P=0.513N P=0.521 P=0.453N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.535N P=0.493N P=0.491 P=0.527N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.500 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 22 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 48/50 (96%) 50/50 (100%) 48/50 (96%) 48/50 (96%) |37/50 (74%) 37/50 (74%) 27/50 (54%) 30/50 (60%) | |POLY-3 ADJUSTED (b)| 99.3% 100.0% 99.2% 98.7% |80.3% 81.7% 58.0% 67.5% | |TERMINAL (d) | 12/12 (100%) 16/16 (100%) 21/21 (100%) 31/31 (100%)|23/28 (82%) 28/33 (85%) 19/34 (56%) 20/28 (71%) | |FIRST INCIDENCE | 396 410 443 518 |507 522 417 417 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.499N P=0.113N P<0.001N** |P=0.045N* P=0.224N P=0.011N* P=0.168N | |POLY 3 | P=0.453N P=0.992 P=0.991N P=0.868N |P=0.015N* P=0.536 P=0.014N* P=0.111N | |POLY 1.5 | P=0.480N P=0.593 P=0.866N P=0.821N |P=0.015N* P=0.537 P=0.018N* P=0.098N | |POLY 6 | P=0.515N P=1.000 P=1.000N P=0.973N |P=0.021N* P=0.557 P=0.011N* P=0.153N | |LOGISTIC REGRESSION| P=0.189N P=0.313 P=0.553N P=0.481N |P=0.019N* P=0.555N P=0.023N* P=0.092N | |COCH-ARM / FISHERS | P=0.426N P=0.247 P=0.691N P=0.691N |P=0.023N* P=0.590N P=0.030N* P=0.101N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 32/50 (64%) 37/50 (74%) 36/50 (72%) 32/50 (64%) |20/50 (40%) 18/50 (36%) 23/50 (46%) 24/50 (48%) | |POLY-3 ADJUSTED (b)| 71.3% 81.3% 75.3% 67.3% |45.2% 39.1% 48.6% 51.4% | |TERMINAL (d) | 7/12 (58%) 11/16 (69%) 12/21 (57%) 18/31 (58%) |10/28 (36%) 9/33 (27%) 12/34 (35%) 10/28 (36%) | |FIRST INCIDENCE | 396 450 360 518 |475 392 451 459 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.005N** P=0.392 P=0.429N P=0.007N** |P=0.188 P=0.268N P=0.562 P=0.296 | |POLY 3 | P=0.274N P=0.174 P=0.416 P=0.424N |P=0.210 P=0.355N P=0.455 P=0.352 | |POLY 1.5 | P=0.374N P=0.173 P=0.343 P=0.503N |P=0.186 P=0.388N P=0.405 P=0.318 | |POLY 6 | P=0.170N P=0.206 P=0.526 P=0.322N |P=0.236 P=0.312N P=0.517 P=0.392 | |LOGISTIC REGRESSION| P=0.456N P=0.171 P=0.259 P=0.506N |P=0.151 P=0.418N P=0.337 P=0.273 | |COCH-ARM / FISHERS | P=0.500N P=0.194 P=0.260 P=0.582N |P=0.153 P=0.418N P=0.343 P=0.273 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 23 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) 48/50 (96%) |45/50 (90%) 43/50 (86%) 42/50 (84%) 43/50 (86%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 100.0% 98.7% |94.2% 89.9% 85.4% 87.4% | |TERMINAL (d) | 12/12 (100%) 16/16 (100%) 21/21 (100%) 31/31 (100%)|26/28 (93%) 29/33 (88%) 27/34 (79%) 22/28 (79%) | |FIRST INCIDENCE | 396 410 360 518 |475 392 417 417 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** (e) (e) P<0.001N** |P=0.389N P=0.131N P=0.100N P=0.469N | |POLY 3 | P=0.262N (e) (e) P=0.728N |P=0.124N P=0.340N P=0.132N P=0.203N | |POLY 1.5 | P=0.157N (e) (e) P=0.530N |P=0.167N P=0.372N P=0.176N P=0.259N | |POLY 6 | P=0.467N (e) (e) P=0.959N |P=0.096N P=0.308N P=0.103N P=0.164N | |LOGISTIC REGRESSION| P=0.051N (e) (e) P=0.192N |P=0.278N P=0.401N P=0.246N P=0.375N | |COCH-ARM / FISHERS | P=0.056N (e) (e) P=0.247N |P=0.289N P=0.380N P=0.277N P=0.380N | |=================================================================================================================================| (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).