TDMS Study 54591-09 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: BIORELIANCE TRANS-1,2-DICHLOROETHYLENE DATE: 10/25/04 EXPERIMENT: 54591 TEST: 09 TIME: 11:05:04 TEST TYPE: SUBCHRON 90-DAY PAGE: 1 CONT: NO1-ES-15319 ROUTE: DOSED FEED NTP C#: 54591D PATHOLOGIST: MISSING CAS: 156-60-5 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: BIORELIANCE TRANS-1,2-DICHLOROETHYLENE DATE: 10/25/04 EXPERIMENT: 54591 TEST: 09 TIME: 11:05:04 TEST TYPE: SUBCHRON 90-DAY CONT: NO1-ES-15319 ROUTE: DOSED FEED NTP C#: 54591D PATHOLOGIST: MISSING CAS: 156-60-5 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF TRANS-1,2-DICHLOROETHYLENE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Kidney: Bilateral Nephropathy Chronic Liver Hepatodiaphragmatic Nodule Lymph Node, Mandibular Hemorrhage Preputial Gland Inflammation Chronic =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Lung: Interstitium Inflammation Chronic Ovary Cyst Uterus Hydrometra =============================================================== Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Bone Marrow | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 0/20.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Bone Marrow | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/20 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |POLY-3 RATE (b) | 6/20.00 0/0.00 0/0.00 0/0.00 0/0.00 2/10.00 | |POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 0.0% 20.0% | |TERMINAL (d) | 6/20 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.360N P=1.000N P=1.000N P=1.000N P=1.000N P=0.443N | |POLY 3 | (e) (e) (e) (e) (e) P=0.444N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.444N | |POLY 6 | (e) (e) (e) (e) (e) P=0.444N | |LOGISTIC REGRESSION| P=0.360N (e) (e) (e) (e) P=0.443N | |COCH-ARM / FISHERS | P=0.358N P=1.000 P=1.000 P=1.000 P=1.000 P=0.452N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Bone Marrow | | Myelofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 0/20.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Bone Marrow | | Myelofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/20 (5%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |POLY-3 RATE (b) | 1/20.00 0/0.00 0/0.00 0/0.00 0/0.00 3/10.00 | |POLY-3 PERCENT (g) | 5.0% 0.0% 0.0% 0.0% 0.0% 30.0% | |TERMINAL (d) | 1/20 (5%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.056 P=1.000N P=1.000N P=1.000N P=1.000N P=0.096 | |POLY 3 | (e) (e) (e) (e) (e) P=0.085 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.085 | |POLY 6 | (e) (e) (e) (e) (e) P=0.085 | |LOGISTIC REGRESSION| P=0.056 (e) (e) (e) (e) P=0.096 | |COCH-ARM / FISHERS | P=0.053 P=1.000 P=1.000 P=1.000 P=1.000 P=0.095 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | | |POLY-3 RATE (b) | | |POLY-3 PERCENT (g) | | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |ORDER RESTRICTED | | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 9/20 (45%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |POLY-3 RATE (b) | 9/20.00 0/0.00 0/0.00 0/0.00 0/0.00 3/10.00 | |POLY-3 PERCENT (g) | 45.0% 0.0% 0.0% 0.0% 0.0% 30.0% | |TERMINAL (d) | 9/20 (45%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.280N P=1.000N P=1.000N P=1.000N P=1.000N P=0.349N | |POLY 3 | (e) (e) (e) (e) (e) P=0.350N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.350N | |POLY 6 | (e) (e) (e) (e) (e) P=0.350N | |LOGISTIC REGRESSION| P=0.280N (e) (e) (e) (e) P=0.349N | |COCH-ARM / FISHERS | P=0.277N P=1.000 P=1.000 P=1.000 P=1.000 P=0.350N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Clitoral Gland: Bilateral | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | | |POLY-3 RATE (b) | | |POLY-3 PERCENT (g) | | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |ORDER RESTRICTED | | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Clitoral Gland: Bilateral | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/20 (25%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |POLY-3 RATE (b) | 5/20.00 0/0.00 0/0.00 0/0.00 0/0.00 2/10.00 | |POLY-3 PERCENT (g) | 25.0% 0.0% 0.0% 0.0% 0.0% 20.0% | |TERMINAL (d) | 5/20 (25%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.470N P=1.000N P=1.000N P=1.000N P=1.000N P=0.560N | |POLY 3 | (e) (e) (e) (e) (e) P=0.559N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.559N | |POLY 6 | (e) (e) (e) (e) (e) P=0.559N | |LOGISTIC REGRESSION| P=0.470N (e) (e) (e) (e) P=0.560N | |COCH-ARM / FISHERS | P=0.470N P=1.000 P=1.000 P=1.000 P=1.000 P=0.571N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 15/20 (75%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 7/10 (70%) | |POLY-3 RATE (b) | 15/20.00 0/0.00 0/0.00 0/0.00 0/0.00 7/10.00 | |POLY-3 PERCENT (g) | 75.0% 0.0% 0.0% 0.0% 0.0% 70.0% | |TERMINAL (d) | 15/20 (75%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 7/10 (70%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.471N P=1.000N P=1.000N P=1.000N P=1.000N P=0.557N | |POLY 3 | (e) (e) (e) (e) (e) P=0.556N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.556N | |POLY 6 | (e) (e) (e) (e) (e) P=0.556N | |LOGISTIC REGRESSION| P=0.471N (e) (e) (e) (e) P=0.557N | |COCH-ARM / FISHERS | P=0.471N P=1.000 P=1.000 P=1.000 P=1.000 P=0.548N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/20 (15%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |POLY-3 RATE (b) | 3/20.00 0/0.00 0/0.00 0/0.00 0/0.00 2/10.00 | |POLY-3 PERCENT (g) | 15.0% 0.0% 0.0% 0.0% 0.0% 20.0% | |TERMINAL (d) | 3/20 (15%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.466 P=1.000N P=1.000N P=1.000N P=1.000N P=0.568 | |POLY 3 | (e) (e) (e) (e) (e) P=0.567 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.567 | |POLY 6 | (e) (e) (e) (e) (e) P=0.567 | |LOGISTIC REGRESSION| P=0.466 (e) (e) (e) (e) P=0.568 | |COCH-ARM / FISHERS | P=0.465 P=1.000 P=1.000 P=1.000 P=1.000 P=0.551 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Kidney | | Mineralization Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 0/20.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Kidney | | Mineralization Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 20/20 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |POLY-3 RATE (b) | 20/20.00 0/0.00 0/0.00 0/0.00 0/0.00 10/10.00 | |POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 0.0% 100.0% | |TERMINAL (d) | 20/20 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Kidney | | Nephropathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 19/20 (95%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/10 (80%) | |POLY-3 RATE (b) | 19/20.00 0/0.00 0/0.00 0/0.00 0/0.00 8/10.00 | |POLY-3 PERCENT (g) | 95.0% 0.0% 0.0% 0.0% 0.0% 80.0% | |TERMINAL (d) | 19/20 (95%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/10 (80%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.171N P=1.000N P=1.000N P=1.000N P=1.000N P=0.263N | |POLY 3 | (e) (e) (e) (e) (e) P=0.261N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.261N | |POLY 6 | (e) (e) (e) (e) (e) P=0.261N | |LOGISTIC REGRESSION| P=0.171N (e) (e) (e) (e) P=0.263N | |COCH-ARM / FISHERS | P=0.166N P=1.000 P=1.000 P=1.000 P=1.000 P=0.251N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Kidney | | Nephropathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/20 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 2/20.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 | |POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/20 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.262N P=1.000N P=1.000N P=1.000N P=1.000N P=0.400N | |POLY 3 | (e) (e) (e) (e) (e) P=0.400N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.400N | |POLY 6 | (e) (e) (e) (e) (e) P=0.400N | |LOGISTIC REGRESSION| P=0.262N (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.259N P=1.000 P=1.000 P=1.000 P=1.000 P=0.437N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Kidney: Bilateral | | Mineralization Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 0/20.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Kidney: Bilateral | | Mineralization Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 20/20 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |POLY-3 RATE (b) | 20/20.00 0/0.00 0/0.00 0/0.00 0/0.00 10/10.00 | |POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 0.0% 100.0% | |TERMINAL (d) | 20/20 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Kidney: Bilateral | | Nephropathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 16/20 (80%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) | |POLY-3 RATE (b) | 16/20.00 0/0.00 0/0.00 0/0.00 0/0.00 4/10.00 | |POLY-3 PERCENT (g) | 80.0% 0.0% 0.0% 0.0% 0.0% 40.0% | |TERMINAL (d) | 16/20 (80%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.025N* P=1.000N P=1.000N P=1.000N P=1.000N P=0.040N* | |POLY 3 | (e) (e) (e) (e) (e) P=0.030N* | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.030N* | |POLY 6 | (e) (e) (e) (e) (e) P=0.030N* | |LOGISTIC REGRESSION| P=0.025N* (e) (e) (e) (e) P=0.040N* | |COCH-ARM / FISHERS | P=0.024N* P=1.000 P=1.000 P=1.000 P=1.000 P=0.039N* | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Kidney: Bilateral | | Nephropathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 0/20.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/20 (0%) 1/1 (100%) 0/0 (0%) 1/2 (50%) 0/0 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 0/20.00 1/1.00 0/0.00 1/2.00 0/0.00 0/10.00 | |POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 50.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 1/1 (100%) 0/0 (0%) 1/2 (50%) 0/0 (0%) 0/10 (0%) | |FIRST INCIDENCE | --- 92 (T) --- 92 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.451N P=0.017 * (e) P=0.077 (e) (e) | |POLY 3 | (e) P=0.048 * (e) P=0.028 * (e) (e) | |POLY 1.5 | (e) P=0.048 * (e) P=0.028 * (e) (e) | |POLY 6 | (e) P=0.048 * (e) P=0.028 * (e) (e) | |LOGISTIC REGRESSION| (e) P=0.017 * (e) P=0.077 (e) (e) | |COCH-ARM / FISHERS | P=0.450N P=0.048 * (e) P=0.091 (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/20 (15%) 1/2 (50%) 0/0 (0%) 1/1 (100%) 0/1 (0%) 2/10 (20%) | |POLY-3 RATE (b) | 3/20.00 1/2.00 0/0.00 1/1.00 0/1.00 2/10.00 | |POLY-3 PERCENT (g) | 15.0% 50.0% 0.0% 100.0% 0.0% 20.0% | |TERMINAL (d) | 3/20 (15%) 1/2 (50%) 0/0 (0%) 1/1 (100%) 0/1 (0%) 2/10 (20%) | |FIRST INCIDENCE | 92 (T) 92 (T) --- 92 (T) --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.565 P=0.399 P=1.000N P=0.215 P=0.846N P=0.568 | |POLY 3 | (e) P=0.398 (e) P=0.193 P=0.841N P=0.567 | |POLY 1.5 | (e) P=0.398 (e) P=0.193 P=0.841N P=0.567 | |POLY 6 | (e) P=0.398 (e) P=0.193 P=0.841N P=0.567 | |LOGISTIC REGRESSION| P=0.565 P=0.399 (e) P=0.215 (e) P=0.568 | |COCH-ARM / FISHERS | P=0.566 P=0.338 P=1.000 P=0.190 P=0.857N P=0.551 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/20 (15%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |POLY-3 RATE (b) | 3/20.00 0/0.00 0/0.00 0/0.00 0/0.00 3/10.00 | |POLY-3 PERCENT (g) | 15.0% 0.0% 0.0% 0.0% 0.0% 30.0% | |TERMINAL (d) | 3/20 (15%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.238 P=1.000N P=1.000N P=1.000N P=1.000N P=0.317 | |POLY 3 | (e) (e) (e) (e) (e) P=0.317 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.317 | |POLY 6 | (e) (e) (e) (e) (e) P=0.317 | |LOGISTIC REGRESSION| P=0.238 (e) (e) (e) (e) P=0.317 | |COCH-ARM / FISHERS | P=0.234 P=1.000 P=1.000 P=1.000 P=1.000 P=0.306 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |POLY-3 RATE (b) | 0/20.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% | |TERMINAL (d) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |FIRST INCIDENCE | --- --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.188 (e) (e) (e) (e) P=0.362 | |POLY 3 | (e) (e) (e) (e) (e) P=0.359 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.359 | |POLY 6 | (e) (e) (e) (e) (e) P=0.359 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.362 | |COCH-ARM / FISHERS | P=0.184 (e) (e) (e) (e) P=0.333 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Lung: Interstitium | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/20 (15%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |POLY-3 RATE (b) | 3/20.00 0/0.00 0/0.00 0/0.00 0/0.00 3/10.00 | |POLY-3 PERCENT (g) | 15.0% 0.0% 0.0% 0.0% 0.0% 30.0% | |TERMINAL (d) | 3/20 (15%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.238 P=1.000N P=1.000N P=1.000N P=1.000N P=0.317 | |POLY 3 | (e) (e) (e) (e) (e) P=0.317 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.317 | |POLY 6 | (e) (e) (e) (e) (e) P=0.317 | |LOGISTIC REGRESSION| P=0.238 (e) (e) (e) (e) P=0.317 | |COCH-ARM / FISHERS | P=0.234 P=1.000 P=1.000 P=1.000 P=1.000 P=0.306 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Lung: Interstitium | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/20 (5%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) | |POLY-3 RATE (b) | 1/20.00 0/0.00 0/0.00 0/0.00 0/0.00 4/10.00 | |POLY-3 PERCENT (g) | 5.0% 0.0% 0.0% 0.0% 0.0% 40.0% | |TERMINAL (d) | 1/20 (5%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.017 * P=1.000N P=1.000N P=1.000N P=1.000N P=0.031 * | |POLY 3 | (e) (e) (e) (e) (e) P=0.020 * | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.020 * | |POLY 6 | (e) (e) (e) (e) (e) P=0.020 * | |LOGISTIC REGRESSION| P=0.017 * (e) (e) (e) (e) P=0.031 * | |COCH-ARM / FISHERS | P=0.015 * P=1.000 P=1.000 P=1.000 P=1.000 P=0.031 * | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |POLY-3 RATE (b) | 0/20.00 0/0.00 0/0.00 0/0.00 0/0.00 2/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 20.0% | |TERMINAL (d) | 0/20 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |FIRST INCIDENCE | --- --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.049 * (e) (e) (e) (e) P=0.102 | |POLY 3 | (e) (e) (e) (e) (e) P=0.088 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.088 | |POLY 6 | (e) (e) (e) (e) (e) P=0.088 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.102 | |COCH-ARM / FISHERS | P=0.046 * (e) (e) (e) (e) P=0.103 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/20 (5%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 1/20.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 | |POLY-3 PERCENT (g) | 5.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/20 (5%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.430N P=1.000N P=1.000N P=1.000N P=1.000 P=0.638N | |POLY 3 | (e) (e) (e) (e) (e) P=0.637N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.637N | |POLY 6 | (e) (e) (e) (e) (e) P=0.637N | |LOGISTIC REGRESSION| P=0.430N (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.429N P=1.000 P=1.000 P=1.000 P=1.000 P=0.667N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/20 (5%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |POLY-3 RATE (b) | 1/20.00 0/0.00 0/0.00 0/0.00 0/0.00 3/10.00 | |POLY-3 PERCENT (g) | 5.0% 0.0% 0.0% 0.0% 0.0% 30.0% | |TERMINAL (d) | 1/20 (5%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.056 P=1.000N P=1.000N P=1.000N P=1.000N P=0.096 | |POLY 3 | (e) (e) (e) (e) (e) P=0.085 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.085 | |POLY 6 | (e) (e) (e) (e) (e) P=0.085 | |LOGISTIC REGRESSION| P=0.056 (e) (e) (e) (e) P=0.096 | |COCH-ARM / FISHERS | P=0.053 P=1.000 P=1.000 P=1.000 P=1.000 P=0.095 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/20 (35%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |POLY-3 RATE (b) | 7/20.00 0/0.00 0/0.00 0/0.00 0/0.00 3/10.00 | |POLY-3 PERCENT (g) | 35.0% 0.0% 0.0% 0.0% 0.0% 30.0% | |TERMINAL (d) | 7/20 (35%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.473N P=1.000N P=1.000N P=1.000N P=1.000 P=0.554N | |POLY 3 | (e) (e) (e) (e) (e) P=0.553N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.553N | |POLY 6 | (e) (e) (e) (e) (e) P=0.553N | |LOGISTIC REGRESSION| P=0.473N (e) (e) (e) (e) P=0.554N | |COCH-ARM / FISHERS | P=0.473N P=1.000 P=1.000 P=1.000 P=1.000 P=0.560N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | | |POLY-3 RATE (b) | | |POLY-3 PERCENT (g) | | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |ORDER RESTRICTED | | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/20 (0%) 2/2 (100%) 1/1 (100%) 1/1 (100%) 0/0 (0%) 1/10 (10%) | |POLY-3 RATE (b) | 0/20.00 2/2.00 1/1.00 1/1.00 0/0.00 1/10.00 | |POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 100.0% 0.0% 10.0% | |TERMINAL (d) | 0/20 (0%) 2/2 (100%) 1/1 (100%) 1/1 (100%) 0/0 (0%) 1/10 (10%) | |FIRST INCIDENCE | --- 92 (T) 92 (T) 92 (T) --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.587N P<0.001 ** P=0.017 * P=0.017 * (e) P=0.362 | |POLY 3 | (e) P=0.004 ** P=0.048 * P=0.048 * (e) P=0.359 | |POLY 1.5 | (e) P=0.004 ** P=0.048 * P=0.048 * (e) P=0.359 | |POLY 6 | (e) P=0.004 ** P=0.048 * P=0.048 * (e) P=0.359 | |LOGISTIC REGRESSION| (e) P<0.001 ** P=0.017 * P=0.017 * (e) P=0.362 | |COCH-ARM / FISHERS | P=0.588N P=0.004 ** P=0.048 * P=0.048 * (e) P=0.333 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/20 (25%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 5/20.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 | |POLY-3 PERCENT (g) | 25.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 5/20 (25%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.074N P=1.000N P=1.000N P=1.000N P=1.000N P=0.117N | |POLY 3 | (e) (e) (e) (e) (e) P=0.108N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.108N | |POLY 6 | (e) (e) (e) (e) (e) P=0.108N | |LOGISTIC REGRESSION| P=0.074N (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.070N P=1.000 P=1.000 P=1.000 P=1.000 P=0.109N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/20 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 2/20.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 | |POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/20 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.262N P=1.000N P=1.000N P=1.000N P=1.000N P=0.400N | |POLY 3 | (e) (e) (e) (e) (e) P=0.400N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.400N | |POLY 6 | (e) (e) (e) (e) (e) P=0.400N | |LOGISTIC REGRESSION| P=0.262N (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.259N P=1.000 P=1.000 P=1.000 P=1.000 P=0.437N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 14/20 (70%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/9 (33%) | |POLY-3 RATE (b) | 14/20.00 0/0.00 0/0.00 0/0.00 0/0.00 3/9.00 | |POLY-3 PERCENT (g) | 70.0% 0.0% 0.0% 0.0% 0.0% 33.3% | |TERMINAL (d) | 14/20 (70%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/9 (33%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.052N P=1.000N P=1.000N P=1.000N P=1.000N P=0.077N | |POLY 3 | (e) (e) (e) (e) (e) P=0.068N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.068N | |POLY 6 | (e) (e) (e) (e) (e) P=0.068N | |LOGISTIC REGRESSION| P=0.052N (e) (e) (e) (e) P=0.077N | |COCH-ARM / FISHERS | P=0.049N* P=1.000 P=1.000 P=1.000 P=1.000 P=0.074N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | | |POLY-3 RATE (b) | | |POLY-3 PERCENT (g) | | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |ORDER RESTRICTED | | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Preputial Gland: Bilateral | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/20 (25%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/9 (22%) | |POLY-3 RATE (b) | 5/20.00 0/0.00 0/0.00 0/0.00 0/0.00 2/9.00 | |POLY-3 PERCENT (g) | 25.0% 0.0% 0.0% 0.0% 0.0% 22.2% | |TERMINAL (d) | 5/20 (25%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/9 (22%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.529N P=1.000N P=1.000N P=1.000N P=1.000N P=0.619N | |POLY 3 | (e) (e) (e) (e) (e) P=0.617N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.617N | |POLY 6 | (e) (e) (e) (e) (e) P=0.617N | |LOGISTIC REGRESSION| P=0.529N (e) (e) (e) (e) P=0.619N | |COCH-ARM / FISHERS | P=0.529N P=1.000 P=1.000 P=1.000 P=1.000 P=0.631N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Preputial Gland: Bilateral | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | | |POLY-3 RATE (b) | | |POLY-3 PERCENT (g) | | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |ORDER RESTRICTED | | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Thymus | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/20 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) | |POLY-3 RATE (b) | 4/20.00 0/0.00 0/0.00 0/0.00 0/0.00 1/9.00 | |POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% 11.1% | |TERMINAL (d) | 4/20 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.376N P=1.000N P=1.000N P=1.000N P=1.000N P=0.478N | |POLY 3 | (e) (e) (e) (e) (e) P=0.479N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.479N | |POLY 6 | (e) (e) (e) (e) (e) P=0.479N | |LOGISTIC REGRESSION| P=0.376N (e) (e) (e) (e) P=0.478N | |COCH-ARM / FISHERS | P=0.374N P=1.000 P=1.000 P=1.000 P=1.000 P=0.498N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Thymus | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/20 (5%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |POLY-3 RATE (b) | 1/20.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00 | |POLY-3 PERCENT (g) | 5.0% 0.0% 0.0% 0.0% 0.0% 10.0% | |TERMINAL (d) | 1/20 (5%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.449 P=1.000N P=1.000N P=1.000N P=1.000N P=0.600 | |POLY 3 | (e) (e) (e) (e) (e) P=0.599 | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.599 | |POLY 6 | (e) (e) (e) (e) (e) P=0.599 | |LOGISTIC REGRESSION| P=0.449 (e) (e) (e) (e) P=0.600 | |COCH-ARM / FISHERS | P=0.449 P=1.000 P=1.000 P=1.000 P=1.000 P=0.563 | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Thyroid Gland | | Ultimobranchial Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 4/20 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 4/20.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 | |POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/20 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.112N P=1.000N P=1.000N P=1.000N P=1.000N P=0.175N | |POLY 3 | (e) (e) (e) (e) (e) P=0.170N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.170N | |POLY 6 | (e) (e) (e) (e) (e) P=0.170N | |LOGISTIC REGRESSION| P=0.112N (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.109N P=1.000 P=1.000 P=1.000 P=1.000 P=0.177N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Thyroid Gland | | Ultimobranchial Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/20 (5%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |POLY-3 RATE (b) | 1/20.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 | |POLY-3 PERCENT (g) | 5.0% 0.0% 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/20 (5%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |FIRST INCIDENCE | 92 (T) --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.430N P=1.000N P=1.000N P=1.000N P=1.000N P=0.638N | |POLY 3 | (e) (e) (e) (e) (e) P=0.637N | |POLY 1.5 | (e) (e) (e) (e) (e) P=0.637N | |POLY 6 | (e) (e) (e) (e) (e) P=0.637N | |LOGISTIC REGRESSION| P=0.430N (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.429N P=1.000 P=1.000 P=1.000 P=1.000 P=0.667N | |ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 54591 TEST: 09 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-1,2-DICHLOROETHYLENE Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | | |POLY-3 RATE (b) | | |POLY-3 PERCENT (g) | | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |ORDER RESTRICTED | | |=================================================================================================================================| | | | | | Females | |Dose | UNTREAT 3125 PPM 6250 PPM 12500 25000 50000 | | | CONTROL PPM PPM PPM | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 5/20 (25%) 1/1 (100%) 4/4 (100%) 2/2 (100%) 1/1 (100%) 4/10 (40%) | |POLY-3 RATE (b) | 5/20.00 1/1.00 4/4.00 2/2.00 1/1.00 4/10.00 | |POLY-3 PERCENT (g) | 25.0% 100.0% 100.0% 100.0% 100.0% 40.0% | |TERMINAL (d) | 5/20 (25%) 1/1 (100%) 4/4 (100%) 2/2 (100%) 1/1 (100%) 4/10 (40%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.458 P=0.318 P=0.013 * P=0.090 P=0.318 P=0.339 | |POLY 3 | P=0.452 P=0.311 P=0.004 ** P=0.070 P=0.311 P=0.340 | |POLY 1.5 | P=0.452 P=0.311 P=0.004 ** P=0.070 P=0.311 P=0.340 | |POLY 6 | P=0.452 P=0.311 P=0.004 ** P=0.070 P=0.311 P=0.340 | |LOGISTIC REGRESSION| P=0.458 P=0.318 P=0.013 * P=0.090 P=0.318 P=0.339 | |COCH-ARM / FISHERS | P=0.457 P=0.286 P=0.012 * P=0.091 P=0.286 P=0.331 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Number of tumor-bearing animals / Poly-3 number (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (g) Poly-3 adjusted lifetime tumor incidence. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).