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 ----- ---------- Skin Keratoacanthoma Testes Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Mesothelioma: Benign, Malignant, NOS Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma =============================================================== 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 16/50 (32%) | 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 35.0% 37.8% | 0.0% 2.4% | |TERMINAL (d) | 5/12 (42%) 10/27 (37%) | 0/28 (0%) 1/28 (4%) | |FIRST INCIDENCE | 579 684 | --- 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.142N | P=0.500 | |POLY 3 | P=0.484 | P=0.500 | |POLY 1.5 | P=0.446 | P=0.500 | |POLY 6 | P=0.548 | P=0.501 | |LOGISTIC REGRESSION| P=0.566N | P=0.500 | |COCH-ARM / FISHERS | P=0.414 | P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 7.2% | 0.0% 0.0% | |TERMINAL (d) | 1/12 (8%) 2/27 (7%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 736 (T) 680 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.563 | (e) | |POLY 3 | P=0.337 | (e) | |POLY 1.5 | P=0.320 | (e) | |POLY 6 | P=0.366 | (e) | |LOGISTIC REGRESSION| P=0.424 | (e) | |COCH-ARM / FISHERS | P=0.309 | (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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 18/50 (36%) | 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 39.9% 42.3% | 0.0% 2.4% | |TERMINAL (d) | 6/12 (50%) 11/27 (41%) | 0/28 (0%) 1/28 (4%) | |FIRST INCIDENCE | 579 680 | --- 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.106N | P=0.500 | |POLY 3 | P=0.499 | P=0.500 | |POLY 1.5 | P=0.455 | P=0.500 | |POLY 6 | P=0.575 | P=0.501 | |LOGISTIC REGRESSION| P=0.527N | P=0.500 | |COCH-ARM / FISHERS | P=0.417 | P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.6% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 265 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.242 | (e) | |POLY 3 | P=0.256 | (e) | |POLY 1.5 | P=0.247 | (e) | |POLY 6 | P=0.272 | (e) | |LOGISTIC REGRESSION| P=0.286 | (e) | |COCH-ARM / FISHERS | P=0.247 | (e) | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/49 (8%) | 4/50 (8%) 5/49 (10%) | |POLY-3 ADJUSTED (b)| 10.5% 9.6% | 9.7% 11.7% | |TERMINAL (d) | 1/12 (8%) 2/27 (7%) | 3/28 (11%) 1/27 (4%) | |FIRST INCIDENCE | 647 550 | 645 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.408N | P=0.510 | |POLY 3 | P=0.585N | P=0.519 | |POLY 1.5 | P=0.620N | P=0.503 | |POLY 6 | P=0.530N | P=0.534 | |LOGISTIC REGRESSION| P=0.634 | P=0.488 | |COCH-ARM / FISHERS | P=0.631 | P=0.487 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/49 (4%) | 2/50 (4%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 2.6% 4.8% | 4.9% 2.4% | |TERMINAL (d) | 0/12 (0%) 1/27 (4%) | 1/28 (4%) 0/27 (0%) | |FIRST INCIDENCE | 396 536 | 715 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.588 | P=0.489N | |POLY 3 | P=0.519 | P=0.491N | |POLY 1.5 | P=0.506 | P=0.502N | |POLY 6 | P=0.542 | P=0.480N | |LOGISTIC REGRESSION| P=0.481 | P=0.507N | |COCH-ARM / FISHERS | P=0.492 | P=0.508N | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 5/49 (10%) | 6/50 (12%) 6/49 (12%) | |POLY-3 ADJUSTED (b)| 12.8% 11.8% | 14.4% 13.9% | |TERMINAL (d) | 1/12 (8%) 2/27 (7%) | 4/28 (14%) 1/27 (4%) | |FIRST INCIDENCE | 396 536 | 645 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.420N | P=0.602N | |POLY 3 | P=0.570N | P=0.590N | |POLY 1.5 | P=0.608N | P=0.613N | |POLY 6 | P=0.509N | P=0.566N | |LOGISTIC REGRESSION| P=0.580 | P=0.607 | |COCH-ARM / FISHERS | P=0.617 | P=0.606 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.8% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/27 (4%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 614 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.339 | (e) | |POLY 3 | P=0.252 | (e) | |POLY 1.5 | P=0.244 | (e) | |POLY 6 | P=0.267 | (e) | |LOGISTIC REGRESSION| P=0.240 | (e) | |COCH-ARM / FISHERS | P=0.247 | (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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 4.8% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 2/27 (7%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 695 736 (T) | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.722 | (e) | |POLY 3 | P=0.525 | (e) | |POLY 1.5 | P=0.512 | (e) | |POLY 6 | P=0.548 | (e) | |LOGISTIC REGRESSION| P=0.617 | (e) | |COCH-ARM / FISHERS | P=0.500 | (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 4.8% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 2/27 (7%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 695 736 (T) | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.722 | (e) | |POLY 3 | P=0.525 | (e) | |POLY 1.5 | P=0.512 | (e) | |POLY 6 | P=0.548 | (e) | |LOGISTIC REGRESSION| P=0.617 | (e) | |COCH-ARM / FISHERS | P=0.500 | (e) | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% | 4.8% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 1/28 (4%) 0/28 (0%) | |FIRST INCIDENCE | --- --- | 645 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) | P=0.232N | |POLY 3 | (e) | P=0.228N | |POLY 1.5 | (e) | P=0.234N | |POLY 6 | (e) | P=0.223N | |LOGISTIC REGRESSION| (e) | P=0.236N | |COCH-ARM / FISHERS | (e) | P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) | 3/50 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% | 7.2% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 2/28 (7%) 0/28 (0%) | |FIRST INCIDENCE | --- --- | 645 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) | P=0.118N | |POLY 3 | (e) | P=0.112N | |POLY 1.5 | (e) | P=0.117N | |POLY 6 | (e) | P=0.108N | |LOGISTIC REGRESSION| (e) | P=0.115N | |COCH-ARM / FISHERS | (e) | P=0.121N | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/50 (4%) | 25/50 (50%) 15/50 (30%) | |POLY-3 ADJUSTED (b)| 13.0% 4.8% | 56.7% 34.6% | |TERMINAL (d) | 1/12 (8%) 1/27 (4%) | 16/28 (57%) 11/28 (39%) | |FIRST INCIDENCE | 619 715 | 507 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.081N | P=0.036N* | |POLY 3 | P=0.177N | P=0.027N* | |POLY 1.5 | P=0.196N | P=0.030N* | |POLY 6 | P=0.149N | P=0.025N* | |LOGISTIC REGRESSION| P=0.175N | P=0.022N* | |COCH-ARM / FISHERS | P=0.218N | P=0.033N* | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/50 (4%) | 25/50 (50%) 15/50 (30%) | |POLY-3 ADJUSTED (b)| 13.0% 4.8% | 56.7% 34.6% | |TERMINAL (d) | 1/12 (8%) 1/27 (4%) | 16/28 (57%) 11/28 (39%) | |FIRST INCIDENCE | 619 715 | 507 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.081N | P=0.036N* | |POLY 3 | P=0.177N | P=0.027N* | |POLY 1.5 | P=0.196N | P=0.030N* | |POLY 6 | P=0.149N | P=0.025N* | |LOGISTIC REGRESSION| P=0.175N | P=0.022N* | |COCH-ARM / FISHERS | P=0.218N | P=0.033N* | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/50 (4%) | 25/50 (50%) 15/50 (30%) | |POLY-3 ADJUSTED (b)| 13.0% 4.8% | 56.7% 34.6% | |TERMINAL (d) | 1/12 (8%) 1/27 (4%) | 16/28 (57%) 11/28 (39%) | |FIRST INCIDENCE | 619 715 | 507 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.081N | P=0.036N* | |POLY 3 | P=0.177N | P=0.027N* | |POLY 1.5 | P=0.196N | P=0.030N* | |POLY 6 | P=0.149N | P=0.025N* | |LOGISTIC REGRESSION| P=0.175N | P=0.022N* | |COCH-ARM / FISHERS | P=0.218N | P=0.033N* | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose | | Squamous Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 5/50 (10%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 11.6% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 2/27 (7%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 643 460 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.210 | (e) | |POLY 3 | P=0.128 | (e) | |POLY 1.5 | P=0.115 | (e) | |POLY 6 | P=0.153 | (e) | |LOGISTIC REGRESSION| P=0.093 | (e) | |COCH-ARM / FISHERS | P=0.102 | (e) | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) | 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 4.8% | 4.9% 2.3% | |TERMINAL (d) | 1/12 (8%) 2/27 (7%) | 2/28 (7%) 0/28 (0%) | |FIRST INCIDENCE | 702 736 (T) | 738 (T) 724 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.419N | P=0.500N | |POLY 3 | P=0.648N | P=0.484N | |POLY 1.5 | P=0.671N | P=0.494N | |POLY 6 | P=0.609N | P=0.473N | |LOGISTIC REGRESSION| P=0.541N | P=0.482N | |COCH-ARM / FISHERS | P=0.691N | P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) | 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 5.3% 4.8% | 4.9% 4.7% | |TERMINAL (d) | 1/12 (8%) 2/27 (7%) | 2/28 (7%) 0/28 (0%) | |FIRST INCIDENCE | 702 736 (T) | 738 (T) 701 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.419N | P=0.679N | |POLY 3 | P=0.648N | P=0.677N | |POLY 1.5 | P=0.671N | P=0.687N | |POLY 6 | P=0.609N | P=0.666N | |LOGISTIC REGRESSION| P=0.541N | P=0.675N | |COCH-ARM / FISHERS | P=0.691N | P=0.691N | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% | 0.0% 2.4% | |TERMINAL (d) | 1/12 (8%) 0/27 (0%) | 0/28 (0%) 1/28 (4%) | |FIRST INCIDENCE | 660 --- | --- 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.132N | P=0.500 | |POLY 3 | P=0.206N | P=0.500 | |POLY 1.5 | P=0.221N | P=0.500 | |POLY 6 | P=0.183N | P=0.501 | |LOGISTIC REGRESSION| P=0.209N | P=0.500 | |COCH-ARM / FISHERS | P=0.247N | P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 16/50 (32%) | 22/50 (44%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 41.5% 36.6% | 49.1% 41.5% | |TERMINAL (d) | 4/12 (33%) 7/27 (26%) | 11/28 (39%) 13/28 (46%) | |FIRST INCIDENCE | 396 565 | 507 652 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.082N | P=0.262N | |POLY 3 | P=0.400N | P=0.307N | |POLY 1.5 | P=0.420N | P=0.299N | |POLY 6 | P=0.347N | P=0.332N | |LOGISTIC REGRESSION| P=0.438N | P=0.239N | |COCH-ARM / FISHERS | P=0.417N | P=0.270N | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 16/50 (32%) | 22/50 (44%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 41.5% 36.6% | 49.1% 41.5% | |TERMINAL (d) | 4/12 (33%) 7/27 (26%) | 11/28 (39%) 13/28 (46%) | |FIRST INCIDENCE | 396 565 | 507 652 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.082N | P=0.262N | |POLY 3 | P=0.400N | P=0.307N | |POLY 1.5 | P=0.420N | P=0.299N | |POLY 6 | P=0.347N | P=0.332N | |LOGISTIC REGRESSION| P=0.438N | P=0.239N | |COCH-ARM / FISHERS | P=0.417N | P=0.270N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 4.7% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/27 (4%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 684 592 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.628 | (e) | |POLY 3 | P=0.528 | (e) | |POLY 1.5 | P=0.514 | (e) | |POLY 6 | P=0.552 | (e) | |LOGISTIC REGRESSION| P=0.503 | (e) | |COCH-ARM / FISHERS | P=0.500 | (e) | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma, Basosquamous Tumor Benign, or | | Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 9.4% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/27 (4%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 684 592 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.312 | (e) | |POLY 3 | P=0.210 | (e) | |POLY 1.5 | P=0.194 | (e) | |POLY 6 | P=0.240 | (e) | |LOGISTIC REGRESSION| P=0.184 | (e) | |COCH-ARM / FISHERS | P=0.181 | (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous | | Tumor (benign, malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 9.4% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/27 (4%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 684 592 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.312 | (e) | |POLY 3 | P=0.210 | (e) | |POLY 1.5 | P=0.194 | (e) | |POLY 6 | P=0.240 | (e) | |LOGISTIC REGRESSION| P=0.184 | (e) | |COCH-ARM / FISHERS | P=0.181 | (e) | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 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%) 9/50 (18%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.0% 21.1% | 0.0% 0.0% | |TERMINAL (d) | 2/12 (17%) 4/27 (15%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 684 592 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.297 | (e) | |POLY 3 | P=0.087 | (e) | |POLY 1.5 | P=0.072 | (e) | |POLY 6 | P=0.119 | (e) | |LOGISTIC REGRESSION| P=0.102 | (e) | |COCH-ARM / FISHERS | P=0.061 | (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.2% 2.4% | 4.8% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 1/28 (4%) 0/28 (0%) | |FIRST INCIDENCE | 603 614 | 523 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.447N | P=0.240N | |POLY 3 | P=0.455N | P=0.231N | |POLY 1.5 | P=0.478N | P=0.236N | |POLY 6 | P=0.421N | P=0.226N | |LOGISTIC REGRESSION| P=0.520N | P=0.226N | |COCH-ARM / FISHERS | P=0.500N | P=0.247N | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/50 (4%) | 3/50 (6%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 13.1% 4.7% | 7.2% 2.3% | |TERMINAL (d) | 2/12 (17%) 0/27 (0%) | 2/28 (7%) 0/28 (0%) | |FIRST INCIDENCE | 603 614 | 523 516 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.098N | P=0.306N | |POLY 3 | P=0.171N | P=0.290N | |POLY 1.5 | P=0.193N | P=0.300N | |POLY 6 | P=0.140N | P=0.280N | |LOGISTIC REGRESSION| P=0.207N | P=0.289N | |COCH-ARM / FISHERS | P=0.218N | P=0.309N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 2.4% | 2.4% 2.3% | |TERMINAL (d) | 2/12 (17%) 0/27 (0%) | 1/28 (4%) 0/28 (0%) | |FIRST INCIDENCE | 736 (T) 680 | 738 (T) 516 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.288N | P=0.758N | |POLY 3 | P=0.449N | P=0.744N | |POLY 1.5 | P=0.474N | P=0.754N | |POLY 6 | P=0.408N | P=0.735N | |LOGISTIC REGRESSION| P=0.405N | P=0.755N | |COCH-ARM / FISHERS | P=0.500N | P=0.753N | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 8.0% 2.4% | 2.4% 2.3% | |TERMINAL (d) | 2/12 (17%) 0/27 (0%) | 1/28 (4%) 0/28 (0%) | |FIRST INCIDENCE | 695 680 | 738 (T) 516 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.135N | P=0.758N | |POLY 3 | P=0.259N | P=0.744N | |POLY 1.5 | P=0.281N | P=0.754N | |POLY 6 | P=0.224N | P=0.735N | |LOGISTIC REGRESSION| P=0.228N | P=0.755N | |COCH-ARM / FISHERS | P=0.309N | P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 7/50 (14%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 16.7% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 4/27 (15%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 708 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.061 | (e) | |POLY 3 | P=0.011 * | (e) | |POLY 1.5 | P=0.009 ** | (e) | |POLY 6 | P=0.015 * | (e) | |LOGISTIC REGRESSION| P=0.025 * | (e) | |COCH-ARM / FISHERS | P=0.006 ** | (e) | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% | 0.0% 0.0% | |TERMINAL (d) | 2/12 (17%) 0/27 (0%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 736 (T) --- | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.085N | (e) | |POLY 3 | P=0.204N | (e) | |POLY 1.5 | P=0.220N | (e) | |POLY 6 | P=0.179N | (e) | |LOGISTIC REGRESSION| (e) | (e) | |COCH-ARM / FISHERS | P=0.247N | (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 7/50 (14%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 16.7% | 0.0% 0.0% | |TERMINAL (d) | 2/12 (17%) 4/27 (15%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 736 (T) 708 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.353 | (e) | |POLY 3 | P=0.103 | (e) | |POLY 1.5 | P=0.090 | (e) | |POLY 6 | P=0.130 | (e) | |LOGISTIC REGRESSION| P=0.208 | (e) | |COCH-ARM / FISHERS | P=0.080 | (e) | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 7/50 (14%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 16.7% | 0.0% 0.0% | |TERMINAL (d) | 2/12 (17%) 4/27 (15%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 736 (T) 708 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.353 | (e) | |POLY 3 | P=0.103 | (e) | |POLY 1.5 | P=0.090 | (e) | |POLY 6 | P=0.130 | (e) | |LOGISTIC REGRESSION| P=0.208 | (e) | |COCH-ARM / FISHERS | P=0.080 | (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Trichoepithelioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.8% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 661 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.328 | (e) | |POLY 3 | P=0.252 | (e) | |POLY 1.5 | P=0.244 | (e) | |POLY 6 | P=0.267 | (e) | |LOGISTIC REGRESSION| P=0.246 | (e) | |COCH-ARM / FISHERS | P=0.247 | (e) | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 42/50 (84%) 45/50 (90%) | | |POLY-3 ADJUSTED (b)| 93.8% 96.3% | | |TERMINAL (d) | 12/12 (100%) 27/27 (100%) | | |FIRST INCIDENCE | 561 502 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.004N** | | |POLY 3 | P=0.448 | | |POLY 1.5 | P=0.320 | | |POLY 6 | P=0.744 | | |LOGISTIC REGRESSION| P=0.410 | | |COCH-ARM / FISHERS | P=0.277 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 4/50 (8%) | 3/50 (6%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 12.9% 9.6% | 7.2% 16.3% | |TERMINAL (d) | 1/12 (8%) 3/27 (11%) | 1/28 (4%) 4/28 (14%) | |FIRST INCIDENCE | 535 675 | 585 668 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.235N | P=0.186 | |POLY 3 | P=0.447N | P=0.167 | |POLY 1.5 | P=0.474N | P=0.160 | |POLY 6 | P=0.402N | P=0.174 | |LOGISTIC REGRESSION| P=0.471N | P=0.166 | |COCH-ARM / FISHERS | P=0.500N | P=0.159 | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% | 4.9% 2.4% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 2/28 (7%) 1/28 (4%) | |FIRST INCIDENCE | --- --- | 738 (T) 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) | P=0.500N | |POLY 3 | (e) | P=0.484N | |POLY 1.5 | (e) | P=0.494N | |POLY 6 | (e) | P=0.474N | |LOGISTIC REGRESSION| (e) | P=0.500N | |COCH-ARM / FISHERS | (e) | P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 4/50 (8%) | 5/50 (10%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 12.9% 9.6% | 12.0% 18.6% | |TERMINAL (d) | 1/12 (8%) 3/27 (11%) | 3/28 (11%) 5/28 (18%) | |FIRST INCIDENCE | 535 675 | 585 668 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.235N | P=0.304 | |POLY 3 | P=0.447N | P=0.292 | |POLY 1.5 | P=0.474N | P=0.281 | |POLY 6 | P=0.402N | P=0.304 | |LOGISTIC REGRESSION| P=0.471N | P=0.298 | |COCH-ARM / FISHERS | P=0.500N | P=0.277 | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.8% | 2.4% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/27 (4%) | 1/28 (4%) 0/28 (0%) | |FIRST INCIDENCE | --- 711 | 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.385 | P=0.500N | |POLY 3 | P=0.251 | P=0.487N | |POLY 1.5 | P=0.243 | P=0.495N | |POLY 6 | P=0.265 | P=0.478N | |LOGISTIC REGRESSION| P=0.312 | (e) | |COCH-ARM / FISHERS | P=0.247 | P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) | 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 7.2% | 4.9% 0.0% | |TERMINAL (d) | 0/12 (0%) 2/27 (7%) | 2/28 (7%) 0/28 (0%) | |FIRST INCIDENCE | --- 711 | 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.267 | P=0.238N | |POLY 3 | P=0.132 | P=0.226N | |POLY 1.5 | P=0.125 | P=0.233N | |POLY 6 | P=0.147 | P=0.219N | |LOGISTIC REGRESSION| P=0.197 | (e) | |COCH-ARM / FISHERS | P=0.121 | P=0.247N | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | | 6/50 (12%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| | 14.6% 13.9% | |TERMINAL (d) | | 6/28 (21%) 4/28 (14%) | |FIRST INCIDENCE | | 738 (T) 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.611N | |POLY 3 | | P=0.585N | |POLY 1.5 | | P=0.606N | |POLY 6 | | P=0.561N | |LOGISTIC REGRESSION| | P=0.581N | |COCH-ARM / FISHERS | | P=0.620N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | | 6/50 (12%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| | 14.6% 16.2% | |TERMINAL (d) | | 6/28 (21%) 4/28 (14%) | |FIRST INCIDENCE | | 738 (T) 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.518 | |POLY 3 | | P=0.538 | |POLY 1.5 | | P=0.516 | |POLY 6 | | P=0.564 | |LOGISTIC REGRESSION| | P=0.541 | |COCH-ARM / FISHERS | | P=0.500 | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 25/50 (50%) 15/50 (30%) | 15/50 (30%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 58.8% 34.5% | 33.9% 24.4% | |TERMINAL (d) | 5/12 (42%) 8/27 (30%) | 5/28 (18%) 2/28 (7%) | |FIRST INCIDENCE | 561 536 | 475 472 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** | P=0.231N | |POLY 3 | P=0.016N* | P=0.221N | |POLY 1.5 | P=0.022N* | P=0.238N | |POLY 6 | P=0.011N* | P=0.208N | |LOGISTIC REGRESSION| P=0.018N* | P=0.247N | |COCH-ARM / FISHERS | P=0.033N* | P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 9/50 (18%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 20.6% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 4/27 (15%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 617 502 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.049 * | (e) | |POLY 3 | P=0.014 * | (e) | |POLY 1.5 | P=0.011 * | (e) | |POLY 6 | P=0.021 * | (e) | |LOGISTIC REGRESSION| P=0.009 ** | (e) | |COCH-ARM / FISHERS | P=0.008 ** | (e) | |=================================================================================================================================| 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 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 48/50 (96%) 47/50 (94%) | 37/50 (74%) 35/50 (70%) | |POLY-3 ADJUSTED (b)| 99.3% 99.1% | 80.3% 76.9% | |TERMINAL (d) | 12/12 (100%) 27/27 (100%) | 23/28 (82%) 22/28 (79%) | |FIRST INCIDENCE | 396 502 | 507 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** | P=0.379N | |POLY 3 | P=0.993N | P=0.443N | |POLY 1.5 | P=0.812N | P=0.445N | |POLY 6 | P=1.000N | P=0.466N | |LOGISTIC REGRESSION| P=0.401N | P=0.352N | |COCH-ARM / FISHERS | P=0.500N | P=0.412N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 32/50 (64%) 29/50 (58%) | 20/50 (40%) 16/50 (32%) | |POLY-3 ADJUSTED (b)| 71.3% 61.8% | 45.2% 34.3% | |TERMINAL (d) | 7/12 (58%) 14/27 (52%) | 10/28 (36%) 3/28 (11%) | |FIRST INCIDENCE | 396 265 | 475 472 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.013N* | P=0.251N | |POLY 3 | P=0.219N | P=0.195N | |POLY 1.5 | P=0.268N | P=0.232N | |POLY 6 | P=0.163N | P=0.160N | |LOGISTIC REGRESSION| P=0.337N | P=0.267N | |COCH-ARM / FISHERS | P=0.341N | P=0.266N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 24 Statistical Analysis of Primary Tumors in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # | # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 49/50 (98%) | 45/50 (90%) 42/50 (84%) | |POLY-3 ADJUSTED (b)| 100.0% 99.8% | 94.2% 86.6% | |TERMINAL (d) | 12/12 (100%) 27/27 (100%) | 26/28 (93%) 22/28 (79%) | |FIRST INCIDENCE | 396 265 | 475 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.002N** | P=0.315N | |POLY 3 | P=1.000N | P=0.170N | |POLY 1.5 | P=0.973N | P=0.226N | |POLY 6 | P=1.000N | P=0.140N | |LOGISTIC REGRESSION| P=0.680N | P=0.284N | |COCH-ARM / FISHERS | P=0.500N | P=0.277N | |=================================================================================================================================| (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).