TDMS Study 88120-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus P,P'-DICHLORODIPHENYL SULFONE DATE: 09/24/99 EXPERIMENT: 88120 TEST: 04 TIME: 08:34:25 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-55388 ROUTE: DOSED FEED NTP C#: 88120B PATHOLOGIST: RYAN, MICHAEL CAS: 80-07-9 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus P,P'-DICHLORODIPHENYL SULFONE DATE: 09/24/99 EXPERIMENT: 88120 TEST: 04 TIME: 08:34:25 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-55388 ROUTE: DOSED FEED NTP C#: 88120B PATHOLOGIST: RYAN, MICHAEL CAS: 80-07-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF P,P'-DICHLORODIPHENYL SULFONE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Heart: Artery Inflammation Chronic Kidney Nephropathy Kidney: Renal Tubule Necrosis Acute Liver Basophilic Focus Fatty Change Diffuse Inflammation Focal Liver: Centrilobular Hypertrophy Preputial Gland Cyst Inflammation Inflammation Chronic Spleen Hematopoietic Cell Proliferation Spleen: Lymphoid Follicle Atrophy Hyperplasia Thymus Atrophy =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Bone Fibrosis Liver Eosinophilic Focus Liver: Centrilobular Hypertrophy Lung Inflammation Chronic Focal Ovary Hemorrhage Spleen Hematopoietic Cell Proliferation Stomach, Glandular: Epithelium Cyst Thymus Hyperplasia Lymphoid Uterus Inflammation Inflammation Granulomatous Uterus: Endometrium Hyperplasia Cystic =============================================================== Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Cytoplasmic Alteration Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 10/49 (20%) 13/50 (26%) 11/50 (22%) 7/50 (14%) |1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 21.9% 27.1% 23.8% 15.5% |2.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 10/40 (25%) 13/45 (29%) 11/44 (25%) 7/42 (17%) |1/42 (2%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |734 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.137N P=0.437 P=0.599 P=0.257N |P=0.461N P=0.510N P=0.495N P=0.486N | |POLY 3 | P=0.161N P=0.368 P=0.515 P=0.305N |P=0.473N P=0.506N P=0.494N P=0.492N | |POLY 1.5 | P=0.155N P=0.355 P=0.512 P=0.302N |P=0.473N P=0.505N P=0.496N P=0.495N | |POLY 6 | P=0.159N P=0.388 P=0.530 P=0.297N |P=0.474N P=0.507N P=0.491N P=0.487N | |LOGISTIC REGRESSION| P=0.137N P=0.437 P=0.599 P=0.257N |P=0.461N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.134N P=0.337 P=0.521 P=0.282N |P=0.473N P=0.505N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 4/50 (8%) 1/50 (2%) 3/50 (6%) |1/50 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 6.6% 8.3% 2.2% 6.7% |2.1% 2.2% 0.0% 0.0% | |TERMINAL (d) | 3/40 (8%) 3/45 (7%) 1/44 (2%) 3/42 (7%) |1/42 (2%) 1/40 (3%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | 733 (T) 718 733 (T) 733 (T) |734 (T) 734 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.543N P=0.563 P=0.272N P=0.641N |P=0.288N P=0.751 P=0.495N P=0.486N | |POLY 3 | P=0.551N P=0.528 P=0.300N P=0.657 |P=0.300N P=0.753 P=0.494N P=0.492N | |POLY 1.5 | P=0.547N P=0.521 P=0.301N P=0.659 |P=0.301N P=0.754 P=0.496N P=0.495N | |POLY 6 | P=0.550N P=0.540 P=0.295N P=0.662 |P=0.298N P=0.753 P=0.491N P=0.487N | |LOGISTIC REGRESSION| P=0.552N P=0.550 P=0.272N P=0.641N |P=0.288N P=0.751 (e) (e) | |COCH-ARM / FISHERS | P=0.533N P=0.511 P=0.301N P=0.651N |P=0.301N P=0.747 P=0.500N P=0.500N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 14/49 (29%) 16/50 (32%) 21/50 (42%) 15/50 (30%) |2/50 (4%) 0/49 (0%) 0/50 (0%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 30.7% 33.3% 45.4% 33.3% |4.2% 0.0% 0.0% 6.1% | |TERMINAL (d) | 14/40 (35%) 16/45 (36%) 21/44 (48%) 15/42 (36%) |2/42 (5%) 0/40 (0%) 0/43 (0%) 3/45 (7%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |734 (T) --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.553N P=0.569 P=0.170 P=0.565 |P=0.179 P=0.249N P=0.233N P=0.531 | |POLY 3 | P=0.499 P=0.479 P=0.106 P=0.485 |P=0.164 P=0.244N P=0.230N P=0.519 | |POLY 1.5 | P=0.517 P=0.462 P=0.106 P=0.491 |P=0.161 P=0.243N P=0.233N P=0.511 | |POLY 6 | P=0.501 P=0.506 P=0.115 P=0.498 |P=0.168 P=0.245N P=0.227N P=0.528 | |LOGISTIC REGRESSION| P=0.553N P=0.569 P=0.170 P=0.565 |P=0.179 (e) (e) P=0.531 | |COCH-ARM / FISHERS | P=0.525N P=0.440 P=0.117 P=0.526 |P=0.157 P=0.253N P=0.247N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex: Subcapsular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 40/49 (82%) 42/50 (84%) 41/50 (82%) 44/50 (88%) |47/50 (94%) 47/49 (96%) 50/50 (100%) 47/50 (94%) | |POLY-3 ADJUSTED (b)| 85.3% 85.7% 83.9% 94.4% |95.9% 96.4% 100.0% 94.3% | |TERMINAL (d) | 36/40 (90%) 38/45 (84%) 37/44 (84%) 40/42 (95%) |41/42 (98%) 40/40 (100%) 43/43 (100%) 44/45 (98%) | |FIRST INCIDENCE | 550 565 406 379 |580 512 586 578 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.199 P=0.352N P=0.366N P=0.374 |P=0.111N P=0.375 P=0.428 P=0.255N | |POLY 3 | P=0.088 P=0.592 P=0.537N P=0.115 |P=0.376N P=0.661 P=0.204 P=0.545N | |POLY 1.5 | P=0.118 P=0.542 P=0.579N P=0.145 |P=0.427N P=0.601 P=0.157 P=0.593N | |POLY 6 | P=0.081 P=0.563N P=0.468N P=0.122 |P=0.324N P=0.722 P=0.288 P=0.495N | |LOGISTIC REGRESSION| P=0.117 P=0.551 P=0.551 P=0.092 |P=0.338N P=0.459 P=0.252 P=0.465N | |COCH-ARM / FISHERS | P=0.246 P=0.482 P=0.584 P=0.274 |P=0.504N P=0.510 P=0.121 P=0.661N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Bone | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |10/50 (20%) 4/50 (8%) 12/50 (24%) 15/50 (30%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 4.4% |21.2% 8.7% 24.6% 30.5% | |TERMINAL (d) | 0/40 (0%) 1/45 (2%) 0/44 (0%) 2/42 (5%) |10/42 (24%) 4/40 (10%) 12/43 (28%) 15/45 (33%) | |FIRST INCIDENCE | --- 733 (T) --- 733 (T) |734 (T) 734 (T) 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.148 P=0.523 (e) P=0.249 |P=0.043 * P=0.087N P=0.428 P=0.230 | |POLY 3 | P=0.145 P=0.507 (e) P=0.231 |P=0.033 * P=0.078N P=0.438 P=0.209 | |POLY 1.5 | P=0.146 P=0.504 (e) P=0.231 |P=0.029 * P=0.076N P=0.425 P=0.196 | |POLY 6 | P=0.147 P=0.511 (e) P=0.233 |P=0.039 * P=0.080N P=0.454 P=0.227 | |LOGISTIC REGRESSION| (e) P=0.523 (e) P=0.249 |P=0.043 * P=0.087N P=0.428 P=0.230 | |COCH-ARM / FISHERS | P=0.151 P=0.500 (e) P=0.247 |P=0.025 * P=0.074N P=0.405 P=0.178 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 1/50 (2%) 3/50 (6%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| |0.0% 2.2% 6.1% 2.1% | |TERMINAL (d) | |0/42 (0%) 1/40 (3%) 2/43 (5%) 1/45 (2%) | |FIRST INCIDENCE | |--- 734 (T) 702 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.544 P=0.490 P=0.130 P=0.514 | |POLY 3 | |P=0.534 P=0.496 P=0.125 P=0.505 | |POLY 1.5 | |P=0.521 P=0.498 P=0.123 P=0.501 | |POLY 6 | |P=0.550 P=0.494 P=0.129 P=0.509 | |LOGISTIC REGRESSION| |P=0.526 P=0.490 P=0.121 P=0.514 | |COCH-ARM / FISHERS | |P=0.504 P=0.500 P=0.121 P=0.495 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Granuloma Sperm | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) | | |POLY-3 ADJUSTED (b)| 4.3% 0.0% 4.3% 4.4% | | |TERMINAL (d) | 2/40 (5%) 0/45 (0%) 2/44 (5%) 2/42 (5%) | | |FIRST INCIDENCE | 733 (T) --- 733 (T) 733 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.420 P=0.213N P=0.660N P=0.677N | | |POLY 3 | P=0.399 P=0.230N P=0.692 P=0.683 | | |POLY 1.5 | P=0.405 P=0.233N P=0.691 P=0.684 | | |POLY 6 | P=0.398 P=0.225N P=0.689N P=0.687 | | |LOGISTIC REGRESSION| P=0.420 (e) P=0.660N P=0.677N | | |COCH-ARM / FISHERS | P=0.423 P=0.247N P=0.691N P=0.691N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Eye | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |0/1 (0%) 2/3 (67%) 1/3 (33%) 0/1 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 66.7% 33.3% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 2/3 (67%) 1/3 (33%) 0/1 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 734 (T) 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.388N P=1.000 P=1.000 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.484N P=0.535 P=0.707 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.493N P=0.518 P=0.699 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.467N P=0.567 P=0.720 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=1.000 P=1.000 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.504N P=0.500 P=0.750 (e) | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Eye | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) |0/1 (0%) 1/3 (33%) 2/3 (67%) 1/1 (100%) | |POLY-3 ADJUSTED (b)| 0.0% 100.0% 0.0% 0.0% |0.0% 33.3% 66.7% 100.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 1/3 (33%) 2/3 (67%) 1/1 (100%) | |FIRST INCIDENCE | --- 652 --- --- |--- 734 (T) 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.388 P=1.000 P=1.000 P=1.000N | |POLY 3 | (e) (e) (e) (e) |P=0.299 P=0.707 P=0.535 P=1.000N | |POLY 1.5 | (e) (e) (e) (e) |P=0.289 P=0.699 P=0.518 P=1.000N | |POLY 6 | (e) (e) (e) (e) |P=0.317 P=0.720 P=0.567 P=1.000N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=1.000 P=1.000 P=1.000N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.249 P=0.750 P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Heart: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 4/50 (8%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 2.2% 8.9% |2.1% 0.0% 0.0% 4.1% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 1/44 (2%) 4/42 (10%) |1/42 (2%) 0/40 (0%) 0/43 (0%) 2/45 (4%) | |FIRST INCIDENCE | --- 565 733 (T) 733 (T) |734 (T) --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.018 * P=0.504 P=0.519 P=0.070 |P=0.210 P=0.510N P=0.495N P=0.524 | |POLY 3 | P=0.016 * P=0.509 P=0.499 P=0.057 |P=0.198 P=0.504N P=0.494N P=0.514 | |POLY 1.5 | P=0.017 * P=0.505 P=0.498 P=0.057 |P=0.194 P=0.502N P=0.496N P=0.508 | |POLY 6 | P=0.016 * P=0.514 P=0.503 P=0.058 |P=0.202 P=0.506N P=0.491N P=0.522 | |LOGISTIC REGRESSION| P=0.019 * P=0.488 P=0.519 P=0.070 |P=0.210 (e) (e) P=0.524 | |COCH-ARM / FISHERS | P=0.019 * P=0.500 P=0.500 P=0.059 |P=0.189 P=0.500N P=0.500N P=0.500 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Heart: Myocardium | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 6.2% 2.1% 2.2% |2.1% 0.0% 2.1% 4.1% | |TERMINAL (d) | 0/40 (0%) 2/45 (4%) 0/44 (0%) 0/42 (0%) |1/42 (2%) 0/40 (0%) 1/43 (2%) 1/45 (2%) | |FIRST INCIDENCE | --- 565 649 712 |734 (T) --- 734 (T) 726 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.592N P=0.139 P=0.500 P=0.510 |P=0.259 P=0.510N P=0.756N P=0.526 | |POLY 3 | P=0.588N P=0.127 P=0.500 P=0.494 |P=0.248 P=0.504N P=0.753N P=0.515 | |POLY 1.5 | P=0.588N P=0.124 P=0.499 P=0.495 |P=0.241 P=0.502N P=0.756N P=0.508 | |POLY 6 | P=0.582N P=0.132 P=0.505 P=0.497 |P=0.256 P=0.506N P=0.750N P=0.522 | |LOGISTIC REGRESSION| P=0.570N P=0.116 P=0.505 P=0.497 |P=0.258 (e) P=0.756N P=0.526 | |COCH-ARM / FISHERS | P=0.581N P=0.121 P=0.500 P=0.500 |P=0.231 P=0.500N P=0.753N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Heart: Myocardium | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 6.3% 0.0% 0.0% 0.0% |0.0% 2.1% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | 550 --- --- --- |--- 512 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.142N P=0.119N P=0.126N P=0.132N |P=0.574N P=0.504 (e) (e) | |POLY 3 | P=0.134N P=0.117N P=0.124N P=0.128N |P=0.576N P=0.499 (e) (e) | |POLY 1.5 | P=0.133N P=0.118N P=0.123N P=0.126N |P=0.576N P=0.499 (e) (e) | |POLY 6 | P=0.136N P=0.115N P=0.123N P=0.128N |P=0.576N P=0.498 (e) (e) | |LOGISTIC REGRESSION| P=0.123N P=0.125N P=0.113N P=0.108N |P=0.996 P=0.553 (e) (e) | |COCH-ARM / FISHERS | P=0.134N P=0.121N P=0.121N P=0.121N |P=0.576N P=0.500 (e) (e) | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Intestine Small, Jejunum: Peyer's Patch | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.2% |4.2% 0.0% 0.0% 8.1% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 1/42 (2%) |2/42 (5%) 0/40 (0%) 0/43 (0%) 4/45 (9%) | |FIRST INCIDENCE | --- --- --- 733 (T) |734 (T) --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.212 (e) (e) P=0.510 |P=0.067 P=0.249N P=0.233N P=0.369 | |POLY 3 | P=0.207 (e) (e) P=0.494 |P=0.056 P=0.242N P=0.230N P=0.357 | |POLY 1.5 | P=0.209 (e) (e) P=0.495 |P=0.054 P=0.240N P=0.233N P=0.349 | |POLY 6 | P=0.208 (e) (e) P=0.496 |P=0.059 P=0.244N P=0.227N P=0.367 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.510 |P=0.067 (e) (e) P=0.369 | |COCH-ARM / FISHERS | P=0.214 (e) (e) P=0.500 |P=0.053 P=0.247N P=0.247N P=0.339 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 13/49 (27%) 7/49 (14%) 9/49 (18%) |4/50 (8%) 2/50 (4%) 3/50 (6%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 27.6% 26.8% 14.9% 19.4% |8.5% 4.3% 6.1% 4.1% | |TERMINAL (d) | 11/40 (28%) 12/45 (27%) 6/44 (14%) 7/42 (17%) |4/42 (10%) 1/40 (3%) 2/43 (5%) 2/45 (4%) | |FIRST INCIDENCE | 631 565 406 407 |734 (T) 512 586 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.188N P=0.464N P=0.077N P=0.216N |P=0.336N P=0.356N P=0.486N P=0.306N | |POLY 3 | P=0.194N P=0.554N P=0.103N P=0.243N |P=0.353N P=0.340N P=0.477N P=0.319N | |POLY 1.5 | P=0.195N P=0.570N P=0.105N P=0.249N |P=0.361N P=0.339N P=0.486N P=0.327N | |POLY 6 | P=0.189N P=0.533N P=0.097N P=0.231N |P=0.342N P=0.341N P=0.466N P=0.309N | |LOGISTIC REGRESSION| P=0.173N P=0.588 P=0.115N P=0.250N |P=0.461N P=0.318N P=0.535N P=0.306N | |COCH-ARM / FISHERS | P=0.185N P=0.567 P=0.115N P=0.251N |P=0.373N P=0.339N P=0.500N P=0.339N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 8 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |3/50 (6%) 2/50 (4%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 4.3% 2.2% |6.4% 4.3% 4.1% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 2/44 (5%) 1/42 (2%) |3/42 (7%) 2/40 (5%) 2/43 (5%) 0/45 (0%) | |FIRST INCIDENCE | --- 652 733 (T) 733 (T) |734 (T) 734 (T) 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.495 P=0.513 P=0.260 P=0.510 |P=0.085N P=0.522N P=0.489N P=0.109N | |POLY 3 | P=0.480 P=0.508 P=0.236 P=0.494 |P=0.090N P=0.509N P=0.485N P=0.112N | |POLY 1.5 | P=0.484 P=0.504 P=0.235 P=0.495 |P=0.094N P=0.506N P=0.491N P=0.115N | |POLY 6 | P=0.482 P=0.513 P=0.240 P=0.496 |P=0.086N P=0.513N P=0.479N P=0.108N | |LOGISTIC REGRESSION| P=0.494 P=0.494 P=0.260 P=0.510 |P=0.085N P=0.522N P=0.489N (e) | |COCH-ARM / FISHERS | P=0.500 P=0.500 P=0.247 P=0.500 |P=0.098N P=0.500N P=0.500N P=0.121N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 36/50 (72%) 44/50 (88%) 42/50 (84%) 36/50 (72%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 77.2% 91.5% 87.4% 79.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 35/40 (88%) 43/45 (96%) 39/44 (89%) 36/42 (86%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | 691 712 406 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.160N P=0.215 P=0.347 P=0.410N |(e) (e) (e) (e) | |POLY 3 | P=0.350N P=0.040 * P=0.138 P=0.478 |(e) (e) (e) (e) | |POLY 1.5 | P=0.308N P=0.035 * P=0.118 P=0.497 |(e) (e) (e) (e) | |POLY 6 | P=0.339N P=0.053 P=0.187 P=0.513 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.387N P=0.174 P=0.070 P=0.466N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.201N P=0.039 * P=0.114 P=0.588N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 9 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Casts Protein | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |32/50 (64%) 30/50 (60%) 31/50 (62%) 38/50 (76%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |64.6% 61.4% 63.1% 76.3% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |25/42 (60%) 23/40 (58%) 28/43 (65%) 36/45 (80%) | |FIRST INCIDENCE | --- --- --- --- |491 512 652 578 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.225 P=0.525N P=0.438N P=0.306 | |POLY 3 | (e) (e) (e) (e) |P=0.068 P=0.453N P=0.522N P=0.143 | |POLY 1.5 | (e) (e) (e) (e) |P=0.065 P=0.437N P=0.512N P=0.141 | |POLY 6 | (e) (e) (e) (e) |P=0.072 P=0.475N P=0.541N P=0.144 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.050 P=0.390N P=0.520N P=0.106 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.061 P=0.418N P=0.500N P=0.138 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 6.2% 0.0% 2.2% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 3/45 (7%) 0/44 (0%) 1/42 (2%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.428N P=0.348 P=0.481N P=0.751N |(e) (e) (e) (e) | |POLY 3 | P=0.433N P=0.317 P=0.501N P=0.754 |(e) (e) (e) (e) | |POLY 1.5 | P=0.432N P=0.312 P=0.502N P=0.755 |(e) (e) (e) (e) | |POLY 6 | P=0.429N P=0.325 P=0.497N P=0.757 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.428N P=0.348 (e) P=0.751N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.427N P=0.309 P=0.500N P=0.753N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 10 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |2/42 (5%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | --- --- --- --- |734 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.230N P=0.249N P=0.233N P=0.223N | |POLY 3 | (e) (e) (e) (e) |P=0.237N P=0.242N P=0.230N P=0.228N | |POLY 1.5 | (e) (e) (e) (e) |P=0.239N P=0.240N P=0.233N P=0.232N | |POLY 6 | (e) (e) (e) (e) |P=0.235N P=0.244N P=0.227N P=0.224N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.230N (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.242N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Necrosis Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 6.4% |2.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | --- --- --- 379 |580 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.008 ** (e) (e) P=0.118 |P=0.472N P=0.508N P=0.496N P=0.500N | |POLY 3 | P=0.008 ** (e) (e) P=0.122 |P=0.471N P=0.506N P=0.496N P=0.494N | |POLY 1.5 | P=0.008 ** (e) (e) P=0.120 |P=0.473N P=0.504N P=0.497N P=0.496N | |POLY 6 | P=0.008 ** (e) (e) P=0.126 |P=0.470N P=0.509N P=0.494N P=0.491N | |LOGISTIC REGRESSION| P=0.011 * (e) (e) P=0.134 |P=0.731N P=0.441N P=0.789N P=0.784N | |COCH-ARM / FISHERS | P=0.009 ** (e) (e) P=0.121 |P=0.474N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 11 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/50 (8%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 6.5% 8.2% 2.2% 0.0% |0.0% 2.2% 0.0% 4.1% | |TERMINAL (d) | 3/40 (8%) 3/45 (7%) 1/44 (2%) 0/42 (0%) |0/42 (0%) 1/40 (3%) 0/43 (0%) 2/45 (4%) | |FIRST INCIDENCE | 733 (T) 565 733 (T) --- |--- 734 (T) --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.048N* P=0.556 P=0.272N P=0.113N |P=0.170 P=0.490 (e) P=0.254 | |POLY 3 | P=0.051N P=0.524 P=0.307N P=0.124N |P=0.158 P=0.496 (e) P=0.247 | |POLY 1.5 | P=0.050N P=0.514 P=0.308N P=0.124N |P=0.155 P=0.498 (e) P=0.243 | |POLY 6 | P=0.050N P=0.539 P=0.301N P=0.122N |P=0.162 P=0.494 (e) P=0.252 | |LOGISTIC REGRESSION| P=0.049N* P=0.500 P=0.272N (e) |(e) P=0.490 (e) P=0.254 | |COCH-ARM / FISHERS | P=0.048N* P=0.500 P=0.309N P=0.121N |P=0.151 P=0.500 (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 6/50 (12%) 3/50 (6%) 4/50 (8%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 10.8% 12.5% 6.4% 8.9% |4.2% 2.2% 0.0% 2.0% | |TERMINAL (d) | 5/40 (13%) 6/45 (13%) 2/44 (5%) 4/42 (10%) |2/42 (5%) 1/40 (3%) 0/43 (0%) 1/45 (2%) | |FIRST INCIDENCE | 733 (T) 733 (T) 406 733 (T) |734 (T) 734 (T) --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.375N P=0.582 P=0.313N P=0.469N |P=0.471N P=0.517N P=0.233N P=0.476N | |POLY 3 | P=0.397N P=0.523 P=0.349N P=0.519N |P=0.492N P=0.507N P=0.230N P=0.486N | |POLY 1.5 | P=0.392N P=0.513 P=0.355N P=0.517N |P=0.495N P=0.504N P=0.233N P=0.492N | |POLY 6 | P=0.395N P=0.538 P=0.338N P=0.511N |P=0.488N P=0.510N P=0.227N P=0.478N | |LOGISTIC REGRESSION| P=0.385N P=0.582 P=0.354N P=0.469N |P=0.471N P=0.517N (e) P=0.476N | |COCH-ARM / FISHERS | P=0.372N P=0.500 P=0.357N P=0.500N |P=0.500N P=0.500N P=0.247N P=0.500N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 12 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 9/50 (18%) 7/50 (14%) 8/50 (16%) |2/50 (4%) 1/50 (2%) 4/50 (8%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 10.8% 18.7% 15.1% 17.6% |4.2% 2.2% 8.2% 28.5% | |TERMINAL (d) | 5/40 (13%) 9/45 (20%) 7/44 (16%) 7/42 (17%) |2/42 (5%) 1/40 (3%) 4/43 (9%) 14/45 (31%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 609 |734 (T) 734 (T) 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.390 P=0.263 P=0.447 P=0.304 |P<0.001 ** P=0.517N P=0.348 P=0.002 ** | |POLY 3 | P=0.368 P=0.212 P=0.376 P=0.262 |P<0.001 ** P=0.507N P=0.353 P<0.001 ** | |POLY 1.5 | P=0.372 P=0.204 P=0.374 P=0.262 |P<0.001 ** P=0.504N P=0.347 P<0.001 ** | |POLY 6 | P=0.378 P=0.225 P=0.388 P=0.273 |P<0.001 ** P=0.510N P=0.359 P<0.001 ** | |LOGISTIC REGRESSION| P=0.358 P=0.263 P=0.447 P=0.259 |P<0.001 ** P=0.517N P=0.348 P=0.002 ** | |COCH-ARM / FISHERS | P=0.397 P=0.194 P=0.380 P=0.277 |P<0.001 ** P=0.500N P=0.339 P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Fatty Change Diffuse | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 3/50 (6%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.4% |0.0% 6.3% 0.0% 2.0% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 1/42 (2%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 1/45 (2%) | |FIRST INCIDENCE | --- --- --- 609 |--- 512 --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.040 * (e) (e) P=0.240 |P=0.582N P=0.124 (e) P=0.514 | |POLY 3 | P=0.039 * (e) (e) P=0.233 |P=0.593N P=0.121 (e) P=0.508 | |POLY 1.5 | P=0.039 * (e) (e) P=0.233 |P=0.597N P=0.120 (e) P=0.505 | |POLY 6 | P=0.039 * (e) (e) P=0.237 |P=0.588N P=0.122 (e) P=0.513 | |LOGISTIC REGRESSION| P=0.044 * (e) (e) P=0.243 |P=0.489 P=0.150 (e) P=0.514 | |COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |P=0.602N P=0.121 (e) P=0.500 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 13 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Infiltration Cellular Mononuclear Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |8/50 (16%) 9/50 (18%) 12/50 (24%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |17.0% 19.5% 24.6% 20.4% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |8/42 (19%) 9/40 (23%) 11/43 (26%) 10/45 (22%) | |FIRST INCIDENCE | --- --- --- --- |734 (T) 734 (T) 709 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.494 P=0.455 P=0.246 P=0.460 | |POLY 3 | (e) (e) (e) (e) |P=0.452 P=0.482 P=0.253 P=0.435 | |POLY 1.5 | (e) (e) (e) (e) |P=0.427 P=0.489 P=0.242 P=0.419 | |POLY 6 | (e) (e) (e) (e) |P=0.482 P=0.474 P=0.266 P=0.455 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.510 P=0.455 P=0.269 P=0.460 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.393 P=0.500 P=0.227 P=0.398 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |4/50 (8%) 6/50 (12%) 3/50 (6%) 9/50 (18%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |8.5% 13.0% 6.1% 18.3% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |4/42 (10%) 6/40 (15%) 2/43 (5%) 9/45 (20%) | |FIRST INCIDENCE | --- --- --- --- |734 (T) 734 (T) 711 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.118 P=0.338 P=0.486N P=0.144 | |POLY 3 | (e) (e) (e) (e) |P=0.096 P=0.357 P=0.481N P=0.132 | |POLY 1.5 | (e) (e) (e) (e) |P=0.091 P=0.362 P=0.489N P=0.126 | |POLY 6 | (e) (e) (e) (e) |P=0.103 P=0.351 P=0.472N P=0.141 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.122 P=0.338 P=0.471N P=0.144 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.083 P=0.370 P=0.500N P=0.117 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 14 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Inflammation Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.6% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/40 (10%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | 733 (T) --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.076N P=0.049N* P=0.052N P=0.057N |(e) (e) (e) (e) | |POLY 3 | P=0.077N P=0.056N P=0.061N P=0.064N |(e) (e) (e) (e) | |POLY 1.5 | P=0.076N P=0.058N P=0.062N P=0.064N |(e) (e) (e) (e) | |POLY 6 | P=0.080N P=0.054N P=0.059N P=0.062N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.076N (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.077N P=0.059N P=0.059N P=0.059N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 0/50 (0%) 3/50 (6%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.2% 8.3% 0.0% 6.6% |2.1% 2.2% 2.1% 4.1% | |TERMINAL (d) | 1/40 (3%) 4/45 (9%) 0/44 (0%) 2/42 (5%) |1/42 (2%) 1/40 (3%) 1/43 (2%) 2/45 (4%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- 609 |734 (T) 734 (T) 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.422 P=0.217 P=0.481N P=0.316 |P=0.393 P=0.751 P=0.756N P=0.524 | |POLY 3 | P=0.418 P=0.189 P=0.501N P=0.298 |P=0.379 P=0.756 P=0.753N P=0.514 | |POLY 1.5 | P=0.418 P=0.185 P=0.502N P=0.298 |P=0.372 P=0.758 P=0.756N P=0.508 | |POLY 6 | P=0.425 P=0.196 P=0.497N P=0.304 |P=0.388 P=0.754 P=0.750N P=0.522 | |LOGISTIC REGRESSION| P=0.414 P=0.217 (e) P=0.303 |P=0.393 P=0.751 P=0.756N P=0.524 | |COCH-ARM / FISHERS | P=0.427 P=0.181 P=0.500N P=0.309 |P=0.360 P=0.753N P=0.753N P=0.500 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 15 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Necrosis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.2% 2.1% 4.3% 8.5% |4.2% 2.2% 2.1% 2.0% | |TERMINAL (d) | 1/40 (3%) 1/45 (2%) 2/44 (5%) 1/42 (2%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 1/45 (2%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 379 |580 667 732 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.071 P=0.735N P=0.533 P=0.183 |P=0.462N P=0.512N P=0.488N P=0.487N | |POLY 3 | P=0.073 P=0.753N P=0.499 P=0.183 |P=0.476N P=0.512N P=0.495N P=0.492N | |POLY 1.5 | P=0.072 P=0.756N P=0.497 P=0.180 |P=0.481N P=0.507N P=0.497N P=0.495N | |POLY 6 | P=0.076 P=0.748N P=0.504 P=0.191 |P=0.471N P=0.517N P=0.494N P=0.488N | |LOGISTIC REGRESSION| P=0.086 P=0.735N P=0.533 P=0.203 |P=0.658N P=0.423N P=0.716N P=0.726N | |COCH-ARM / FISHERS | P=0.073 P=0.753N P=0.500 P=0.181 |P=0.488N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Tension Lipidosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |4/50 (8%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.6% 2.1% 6.3% 2.2% |8.5% 2.2% 0.0% 0.0% | |TERMINAL (d) | 4/40 (10%) 1/45 (2%) 1/44 (2%) 1/42 (2%) |4/42 (10%) 1/40 (3%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) 406 733 (T) |734 (T) 734 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.250N P=0.146N P=0.465N P=0.165N |P=0.051N P=0.194N P=0.060N P=0.055N | |POLY 3 | P=0.265N P=0.169N P=0.483N P=0.188N |P=0.052N P=0.185N P=0.056N P=0.055N | |POLY 1.5 | P=0.260N P=0.174N P=0.491N P=0.187N |P=0.053N P=0.183N P=0.058N P=0.058N | |POLY 6 | P=0.267N P=0.163N P=0.470N P=0.184N |P=0.050N P=0.187N P=0.055N P=0.053N | |LOGISTIC REGRESSION| P=0.225N P=0.146N P=0.484N P=0.165N |P=0.051N P=0.194N (e) (e) | |COCH-ARM / FISHERS | P=0.244N P=0.181N P=0.500N P=0.181N |P=0.057N P=0.181N P=0.059N P=0.059N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 16 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver | | Vacuolization Cytoplasmic Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 0.0% |2.1% 2.2% 4.1% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |1/42 (2%) 1/40 (3%) 2/43 (5%) 0/45 (0%) | |FIRST INCIDENCE | --- 565 --- --- |734 (T) 734 (T) 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.589N P=0.504 (e) (e) |P=0.309N P=0.751 P=0.508 P=0.486N | |POLY 3 | P=0.572N P=0.509 (e) (e) |P=0.317N P=0.756 P=0.511 P=0.492N | |POLY 1.5 | P=0.574N P=0.505 (e) (e) |P=0.324N P=0.758 P=0.507 P=0.495N | |POLY 6 | P=0.568N P=0.514 (e) (e) |P=0.309N P=0.754 P=0.516 P=0.487N | |LOGISTIC REGRESSION| P=0.555N P=0.488 (e) (e) |P=0.309N P=0.751 P=0.508 (e) | |COCH-ARM / FISHERS | P=0.576N P=0.500 (e) (e) |P=0.333N P=0.753N P=0.500 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 24/50 (48%) 43/50 (86%) 45/50 (90%) |0/50 (0%) 0/50 (0%) 9/50 (18%) 29/50 (58%) | |POLY-3 ADJUSTED (b)| 2.2% 50.0% 89.7% 94.9% |0.0% 0.0% 18.5% 58.4% | |TERMINAL (d) | 1/40 (3%) 24/45 (53%) 41/44 (93%) 40/42 (95%) |0/42 (0%) 0/40 (0%) 9/43 (21%) 28/45 (62%) | |FIRST INCIDENCE | 733 (T) 733 (T) 406 379 |--- --- 734 (T) 578 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.003 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.002 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.002 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.003 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 17 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | 603 --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.249N P=0.230N P=0.237N P=0.244N |(e) (e) (e) (e) | |POLY 3 | P=0.246N P=0.232N P=0.240N P=0.246N |(e) (e) (e) (e) | |POLY 1.5 | P=0.244N P=0.235N P=0.240N P=0.245N |(e) (e) (e) (e) | |POLY 6 | P=0.249N P=0.229N P=0.238N P=0.245N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.235N P=0.242N P=0.234N P=0.230N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.242N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.2% 0.0% 2.1% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |2/42 (5%) 0/40 (0%) 1/43 (2%) 0/45 (0%) | |FIRST INCIDENCE | --- --- --- --- |734 (T) --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.254N P=0.249N P=0.492N P=0.223N | |POLY 3 | (e) (e) (e) (e) |P=0.260N P=0.242N P=0.489N P=0.228N | |POLY 1.5 | (e) (e) (e) (e) |P=0.265N P=0.240N P=0.493N P=0.232N | |POLY 6 | (e) (e) (e) (e) |P=0.255N P=0.244N P=0.484N P=0.224N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.254N (e) P=0.492N (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.271N P=0.247N P=0.500N P=0.247N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 18 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lung | | Inflammation Chronic Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 2.2% 0.0% |0.0% 0.0% 0.0% 4.1% | |TERMINAL (d) | 1/40 (3%) 0/45 (0%) 1/44 (2%) 0/42 (0%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 2/45 (4%) | |FIRST INCIDENCE | 733 (T) --- 733 (T) --- |--- --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.464N P=0.477N P=0.740N P=0.490N |P=0.049 * (e) (e) P=0.254 | |POLY 3 | P=0.476N P=0.493N P=0.760 P=0.506N |P=0.043 * (e) (e) P=0.247 | |POLY 1.5 | P=0.473N P=0.496N P=0.759 P=0.505N |P=0.042 * (e) (e) P=0.243 | |POLY 6 | P=0.478N P=0.489N P=0.758N P=0.504N |P=0.045 * (e) (e) P=0.252 | |LOGISTIC REGRESSION| P=0.464N (e) P=0.740N (e) |(e) (e) (e) P=0.254 | |COCH-ARM / FISHERS | P=0.464N P=0.500N P=0.753N P=0.500N |P=0.042 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lung | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.2% 0.0% 2.2% |0.0% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 2/45 (4%) 0/44 (0%) 0/42 (0%) |0/42 (0%) 1/40 (3%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | --- 733 (T) --- 407 |--- 734 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.618 P=0.265 (e) P=0.492 |P=0.561N P=0.490 (e) (e) | |POLY 3 | P=0.621 P=0.245 (e) P=0.498 |P=0.578N P=0.496 (e) (e) | |POLY 1.5 | P=0.619 P=0.241 (e) P=0.497 |P=0.577N P=0.498 (e) (e) | |POLY 6 | P=0.626 P=0.250 (e) P=0.501 |P=0.579N P=0.494 (e) (e) | |LOGISTIC REGRESSION| P=0.644 P=0.265 (e) P=0.537 |(e) P=0.490 (e) (e) | |COCH-ARM / FISHERS | P=0.622 P=0.247 (e) P=0.500 |P=0.576N P=0.500 (e) (e) | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 19 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 4/50 (8%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 4.2% 4.3% 8.9% |2.1% 2.2% 0.0% 4.1% | |TERMINAL (d) | 0/40 (0%) 2/45 (4%) 2/44 (5%) 4/42 (10%) |1/42 (2%) 1/40 (3%) 0/43 (0%) 2/45 (4%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) 733 (T) |734 (T) 734 (T) --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.059 P=0.265 P=0.260 P=0.070 |P=0.362 P=0.751 P=0.495N P=0.524 | |POLY 3 | P=0.055 P=0.245 P=0.236 P=0.057 |P=0.346 P=0.756 P=0.494N P=0.514 | |POLY 1.5 | P=0.056 P=0.241 P=0.235 P=0.057 |P=0.341 P=0.758 P=0.496N P=0.508 | |POLY 6 | P=0.056 P=0.250 P=0.240 P=0.058 |P=0.352 P=0.754 P=0.491N P=0.522 | |LOGISTIC REGRESSION| (e) P=0.265 P=0.260 P=0.070 |P=0.362 P=0.751 (e) P=0.524 | |COCH-ARM / FISHERS | P=0.061 P=0.247 P=0.247 P=0.059 |P=0.333 P=0.753N P=0.500N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/46 (2%) 6/49 (12%) 4/48 (8%) 0/50 (0%) |0/47 (0%) 1/47 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.3% 12.7% 9.0% 0.0% |0.0% 2.3% 0.0% 0.0% | |TERMINAL (d) | 0/38 (0%) 6/45 (13%) 4/42 (10%) 0/42 (0%) |0/40 (0%) 1/40 (3%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | 691 733 (T) 733 (T) --- |--- 734 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.086N P=0.090 P=0.210 P=0.495N |P=0.557N P=0.500 (e) (e) | |POLY 3 | P=0.092N P=0.069 P=0.181 P=0.495N |P=0.569N P=0.495 (e) (e) | |POLY 1.5 | P=0.090N P=0.066 P=0.181 P=0.493N |P=0.568N P=0.497 (e) (e) | |POLY 6 | P=0.091N P=0.073 P=0.184 P=0.493N |P=0.570N P=0.494 (e) (e) | |LOGISTIC REGRESSION| P=0.091N P=0.070 P=0.184 P=0.475N |(e) P=0.500 (e) (e) | |COCH-ARM / FISHERS | P=0.080N P=0.066 P=0.194 P=0.479N |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 20 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Erythrophagocytosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 0/45 (0%) 0/47 (0%) 2/46 (4%) |1/50 (2%) 0/46 (0%) 0/49 (0%) 1/46 (2%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 4.6% |2.1% 0.0% 0.0% 2.2% | |TERMINAL (d) | 1/39 (3%) 0/42 (0%) 0/43 (0%) 1/40 (3%) |1/42 (2%) 0/39 (0%) 0/43 (0%) 1/42 (2%) | |FIRST INCIDENCE | 733 (T) --- --- 485 |734 (T) --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.182 P=0.485N P=0.481N P=0.499 |P=0.543 P=0.515N P=0.495N P=0.762 | |POLY 3 | P=0.181 P=0.506N P=0.502N P=0.486 |P=0.537 P=0.519N P=0.496N P=0.753 | |POLY 1.5 | P=0.182 P=0.509N P=0.503N P=0.484 |P=0.532 P=0.518N P=0.499N P=0.749 | |POLY 6 | P=0.181 P=0.502N P=0.498N P=0.493 |P=0.543 P=0.520N P=0.492N P=0.759 | |LOGISTIC REGRESSION| P=0.278 (e) (e) P=0.588 |P=0.543 (e) (e) P=0.762 | |COCH-ARM / FISHERS | P=0.185 P=0.516N P=0.505N P=0.484 |P=0.525 P=0.521N P=0.505N P=0.731 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 1/45 (2%) 4/47 (9%) 0/46 (0%) |4/50 (8%) 1/46 (2%) 3/49 (6%) 1/46 (2%) | |POLY-3 ADJUSTED (b)| 2.2% 2.3% 8.9% 0.0% |8.5% 2.3% 6.2% 2.2% | |TERMINAL (d) | 1/39 (3%) 1/42 (2%) 4/43 (9%) 0/40 (0%) |4/42 (10%) 1/39 (3%) 3/43 (7%) 1/42 (2%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) --- |734 (T) 734 (T) 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.343N P=0.745N P=0.210 P=0.495N |P=0.233N P=0.202N P=0.487N P=0.180N | |POLY 3 | P=0.361N P=0.754 P=0.176 P=0.511N |P=0.240N P=0.209N P=0.488N P=0.189N | |POLY 1.5 | P=0.358N P=0.750 P=0.174 P=0.511N |P=0.249N P=0.208N P=0.497N P=0.196N | |POLY 6 | P=0.358N P=0.759 P=0.182 P=0.508N |P=0.230N P=0.209N P=0.477N P=0.181N | |LOGISTIC REGRESSION| P=0.343N P=0.745N P=0.210 (e) |P=0.233N P=0.202N P=0.487N P=0.180N | |COCH-ARM / FISHERS | P=0.347N P=0.736 P=0.174 P=0.511N |P=0.262N P=0.208N P=0.511N P=0.208N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 21 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Lumbar | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/2 (0%) 0/1 (0%) 0/1 (0%) 0/1 (0%) |0/3 (0%) 1/6 (17%) 2/4 (50%) 1/4 (25%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 18.7% 51.6% 25.2% | |TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/1 (0%) 0/1 (0%) |0/1 (0%) 1/5 (20%) 2/3 (67%) 1/3 (33%) | |FIRST INCIDENCE | --- --- --- --- |--- 734 (T) 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.541 P=0.814 P=0.500 P=0.718 | |POLY 3 | (e) (e) (e) (e) |P=0.581 P=0.662 P=0.341 P=0.605 | |POLY 1.5 | (e) (e) (e) (e) |P=0.536 P=0.648 P=0.307 P=0.583 | |POLY 6 | (e) (e) (e) (e) |P=0.637 P=0.688 P=0.399 P=0.639 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.814 P=0.500 P=0.718 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.478 P=0.667 P=0.286 P=0.571 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Renal | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/2 (0%) 0/1 (0%) 0/1 (0%) 0/1 (0%) |0/3 (0%) 1/6 (17%) 1/4 (25%) 2/4 (50%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 18.7% 25.8% 50.0% | |TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/1 (0%) 0/1 (0%) |0/1 (0%) 1/5 (20%) 1/3 (33%) 1/3 (33%) | |FIRST INCIDENCE | --- --- --- --- |--- 734 (T) 734 (T) 726 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.200 P=0.814 P=0.718 P=0.365 | |POLY 3 | (e) (e) (e) (e) |P=0.209 P=0.662 P=0.602 P=0.354 | |POLY 1.5 | (e) (e) (e) (e) |P=0.184 P=0.648 P=0.581 P=0.314 | |POLY 6 | (e) (e) (e) (e) |P=0.247 P=0.688 P=0.633 P=0.420 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.240 P=0.814 P=0.718 P=0.534 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.144 P=0.667 P=0.571 P=0.286 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 22 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 2.0% 4.1% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 2/45 (4%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 652 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.098 (e) P=0.517 P=0.254 | |POLY 3 | (e) (e) (e) (e) |P=0.091 (e) P=0.508 P=0.247 | |POLY 1.5 | (e) (e) (e) (e) |P=0.088 (e) P=0.505 P=0.243 | |POLY 6 | (e) (e) (e) (e) |P=0.095 (e) P=0.512 P=0.252 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.064 (e) P=0.379 P=0.254 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.084 (e) P=0.500 P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/3 (67%) 2/2 (100%) 1/1 (100%) 0/0 (0%) |4/5 (80%) 1/2 (50%) 3/5 (60%) 4/5 (80%) | |POLY-3 ADJUSTED (b)| 66.7% 100.0% 100.0% 0.0% |84.8% 50.0% 60.0% 80.0% | |TERMINAL (d) | 1/2 (50%) 2/2 (100%) 1/1 (100%) 0/0 (0%) |4/4 (100%) 1/2 (50%) 1/3 (33%) 4/5 (80%) | |FIRST INCIDENCE | 603 733 (T) 733 (T) --- |734 (T) 734 (T) 586 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.583N P=0.750N P=0.677N P=0.495N |P=0.609N P=0.362N P=0.633N P=0.545N | |POLY 3 | (e) P=0.577 P=0.691 (e) |P=0.574 P=0.508N P=0.445N P=0.729N | |POLY 1.5 | (e) P=0.577 P=0.691 (e) |P=0.557 P=0.528N P=0.471N P=0.745N | |POLY 6 | (e) P=0.577 P=0.691 (e) |P=0.600 P=0.471N P=0.398N P=0.694N | |LOGISTIC REGRESSION| (e) P=0.750N P=0.677N (e) |P=0.546 P=0.362N P=0.502N P=0.545N | |COCH-ARM / FISHERS | P=0.988 P=0.600 P=0.750 P=1.000 |P=0.542 P=0.524N P=0.500N P=0.778N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 23 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Nose | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | --- --- --- --- |580 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.235N P=0.247N P=0.230N P=0.230N | |POLY 3 | (e) (e) (e) (e) |P=0.234N P=0.246N P=0.234N P=0.232N | |POLY 1.5 | (e) (e) (e) (e) |P=0.237N P=0.242N P=0.235N P=0.234N | |POLY 6 | (e) (e) (e) (e) |P=0.231N P=0.250N P=0.233N P=0.229N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.387N P=0.180N P=0.428N P=0.434N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.242N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Nose: Sinus | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | 691 --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.243N P=0.217N P=0.224N P=0.232N |(e) (e) (e) (e) | |POLY 3 | P=0.247N P=0.231N P=0.239N P=0.245N |(e) (e) (e) (e) | |POLY 1.5 | P=0.245N P=0.234N P=0.240N P=0.244N |(e) (e) (e) (e) | |POLY 6 | P=0.250N P=0.227N P=0.236N P=0.243N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.244N P=0.237N P=0.238N P=0.241N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.242N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 24 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Nose: Turbinate | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 6.4% 4.2% 2.2% 0.0% |2.1% 0.0% 2.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 1/45 (2%) 1/44 (2%) 0/42 (0%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | 661 718 733 (T) --- |580 --- 586 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.090N P=0.459N P=0.289N P=0.123N |P=0.459N P=0.508N P=0.754N P=0.500N | |POLY 3 | P=0.093N P=0.490N P=0.311N P=0.126N |P=0.452N P=0.506N P=0.753N P=0.494N | |POLY 1.5 | P=0.091N P=0.494N P=0.311N P=0.125N |P=0.457N P=0.504N P=0.756N P=0.496N | |POLY 6 | P=0.093N P=0.483N P=0.308N P=0.126N |P=0.446N P=0.509N P=0.750N P=0.491N | |LOGISTIC REGRESSION| P=0.087N P=0.503N P=0.304N P=0.118N |P=0.798N P=0.441N P=0.474 P=0.784N | |COCH-ARM / FISHERS | P=0.086N P=0.500N P=0.309N P=0.121N |P=0.464N P=0.500N P=0.753N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Oral Mucosa | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 23/50 (46%) 27/50 (54%) 25/50 (50%) 18/50 (36%) |14/31 (45%) 7/21 (33%) 17/37 (46%) 18/37 (49%) | |POLY-3 ADJUSTED (b)| 48.6% 55.8% 53.7% 39.9% |45.6% 33.3% 46.2% 48.7% | |TERMINAL (d) | 18/40 (45%) 25/45 (56%) 24/44 (55%) 18/42 (43%) |14/30 (47%) 7/21 (33%) 15/34 (44%) 18/36 (50%) | |FIRST INCIDENCE | 649 652 649 733 (T) |734 (T) 734 (T) 702 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.080N P=0.487 P=0.568N P=0.165N |P=0.297 P=0.256N P=0.489 P=0.491 | |POLY 3 | P=0.121N P=0.308 P=0.387 P=0.265N |P=0.308 P=0.279N P=0.576 P=0.495 | |POLY 1.5 | P=0.106N P=0.293 P=0.391 P=0.249N |P=0.305 P=0.283N P=0.574 P=0.490 | |POLY 6 | P=0.129N P=0.331 P=0.398 P=0.267N |P=0.312 P=0.272N P=0.580 P=0.504 | |LOGISTIC REGRESSION| P=0.106N P=0.325 P=0.414 P=0.231N |P=0.315 P=0.256N P=0.566 P=0.491 | |COCH-ARM / FISHERS | P=0.075N P=0.274 P=0.421 P=0.208N |P=0.300 P=0.287N P=0.571 P=0.483 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 25 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Oral Mucosa: Gingival | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 36/50 (72%) 36/50 (72%) 34/50 (68%) 33/50 (66%) |31/31 (100%) 21/21 (100%) 37/37 (100%) 36/37 (97%) | |POLY-3 ADJUSTED (b)| 75.5% 74.4% 71.8% 71.7% |100.0% 100.0% 100.0% 97.3% | |TERMINAL (d) | 30/40 (75%) 34/45 (76%) 31/44 (71%) 31/42 (74%) |30/30 (100%) 21/21 (100%) 34/34 (100%) 35/36 (97%) | |FIRST INCIDENCE | 631 652 513 369 |657 734 (T) 683 723 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.298N P=0.265N P=0.214N P=0.236N |P=0.445N (e) (e) P=0.501N | |POLY 3 | P=0.392N P=0.546N P=0.432N P=0.427N |P=0.260N (e) (e) P=0.535N | |POLY 1.5 | P=0.353N P=0.564N P=0.437N P=0.399N |P=0.260N (e) (e) P=0.535N | |POLY 6 | P=0.416N P=0.518N P=0.404N P=0.437N |P=0.260N (e) (e) P=0.535N | |LOGISTIC REGRESSION| P=0.408N P=0.479N P=0.450N P=0.433N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.272N P=0.588N P=0.414N P=0.333N |P=0.259N (e) (e) P=0.544N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 7/48 (15%) 2/49 (4%) 1/48 (2%) | |POLY-3 ADJUSTED (b)| |4.2% 15.8% 4.1% 2.1% | |TERMINAL (d) | |1/42 (2%) 7/39 (18%) 0/42 (0%) 1/44 (2%) | |FIRST INCIDENCE | |636 734 (T) 586 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.097N P=0.067 P=0.676N P=0.482N | |POLY 3 | |P=0.105N P=0.064 P=0.688N P=0.502N | |POLY 1.5 | |P=0.109N P=0.066 P=0.693N P=0.507N | |POLY 6 | |P=0.101N P=0.061 P=0.682N P=0.495N | |LOGISTIC REGRESSION| |P=0.134N P=0.068 P=0.533 P=0.579N | |COCH-ARM / FISHERS | |P=0.117N P=0.070 P=0.684 P=0.515N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 26 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |15/50 (30%) 11/48 (23%) 16/49 (33%) 9/48 (19%) | |POLY-3 ADJUSTED (b)| |31.5% 24.8% 33.4% 19.1% | |TERMINAL (d) | |14/42 (33%) 11/39 (28%) 15/42 (36%) 9/44 (21%) | |FIRST INCIDENCE | |600 734 (T) 683 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.096N P=0.316N P=0.505 P=0.096N | |POLY 3 | |P=0.127N P=0.313N P=0.508 P=0.122N | |POLY 1.5 | |P=0.142N P=0.302N P=0.494 P=0.131N | |POLY 6 | |P=0.109N P=0.324N P=0.525 P=0.111N | |LOGISTIC REGRESSION| |P=0.105N P=0.309N P=0.527 P=0.113N | |COCH-ARM / FISHERS | |P=0.166N P=0.286N P=0.473 P=0.145N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |7/50 (14%) 0/48 (0%) 4/49 (8%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| |14.7% 0.0% 8.4% 0.0% | |TERMINAL (d) | |6/42 (14%) 0/39 (0%) 3/42 (7%) 0/44 (0%) | |FIRST INCIDENCE | |600 --- 683 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.030N* P=0.013N* P=0.259N P=0.009N** | |POLY 3 | |P=0.028N* P=0.010N* P=0.258N P=0.008N** | |POLY 1.5 | |P=0.030N* P=0.010N* P=0.264N P=0.008N** | |POLY 6 | |P=0.025N* P=0.010N* P=0.251N P=0.007N** | |LOGISTIC REGRESSION| |P=0.038N* P=0.011N* P=0.288N P=0.012N* | |COCH-ARM / FISHERS | |P=0.037N* P=0.007N** P=0.274N P=0.007N** | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 27 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 0/48 (0%) 1/49 (2%) 2/48 (4%) | |POLY-3 ADJUSTED (b)| |0.0% 0.0% 2.1% 4.2% | |TERMINAL (d) | |0/42 (0%) 0/39 (0%) 1/42 (2%) 2/44 (5%) | |FIRST INCIDENCE | |--- --- 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.096 (e) P=0.500 P=0.249 | |POLY 3 | |P=0.088 (e) P=0.502 P=0.238 | |POLY 1.5 | |P=0.085 (e) P=0.500 P=0.234 | |POLY 6 | |P=0.092 (e) P=0.505 P=0.243 | |LOGISTIC REGRESSION| |(e) (e) P=0.500 P=0.249 | |COCH-ARM / FISHERS | |P=0.080 (e) P=0.495 P=0.237 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |1/50 (2%) 4/48 (8%) 0/49 (0%) 1/48 (2%) | |POLY-3 ADJUSTED (b)| |2.1% 8.9% 0.0% 2.1% | |TERMINAL (d) | |1/42 (2%) 3/39 (8%) 0/42 (0%) 0/44 (0%) | |FIRST INCIDENCE | |734 (T) 616 --- 578 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.308N P=0.162 P=0.500N P=0.753N | |POLY 3 | |P=0.324N P=0.164 P=0.498N P=0.757N | |POLY 1.5 | |P=0.329N P=0.165 P=0.500N P=0.758 | |POLY 6 | |P=0.317N P=0.164 P=0.495N P=0.751N | |LOGISTIC REGRESSION| |P=0.434N P=0.169 (e) P=0.638 | |COCH-ARM / FISHERS | |P=0.337N P=0.168 P=0.505N P=0.742 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 28 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/49 (6%) 1/50 (2%) 1/49 (2%) |2/50 (4%) 0/49 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 6.2% 2.2% 2.2% |4.2% 0.0% 2.1% 0.0% | |TERMINAL (d) | 0/40 (0%) 3/45 (7%) 1/44 (2%) 0/42 (0%) |2/42 (5%) 0/40 (0%) 1/43 (2%) 0/45 (0%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) 702 |734 (T) --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.581N P=0.143 P=0.519 P=0.514 |P=0.254N P=0.249N P=0.492N P=0.223N | |POLY 3 | P=0.585N P=0.125 P=0.499 P=0.494 |P=0.259N P=0.246N P=0.489N P=0.228N | |POLY 1.5 | P=0.587N P=0.122 P=0.498 P=0.493 |P=0.263N P=0.244N P=0.493N P=0.232N | |POLY 6 | P=0.579N P=0.129 P=0.503 P=0.497 |P=0.254N P=0.247N P=0.484N P=0.224N | |LOGISTIC REGRESSION| P=0.597N P=0.143 P=0.519 P=0.496 |P=0.254N (e) P=0.492N (e) | |COCH-ARM / FISHERS | P=0.585N P=0.117 P=0.500 P=0.495 |P=0.269N P=0.253N P=0.500N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/50 (4%) 1/49 (2%) 0/50 (0%) |0/48 (0%) 0/46 (0%) 0/48 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.2% 2.2% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 2/45 (4%) 1/43 (2%) 0/42 (0%) |0/41 (0%) 0/38 (0%) 0/43 (0%) 0/44 (0%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.378N P=0.265 P=0.514 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.384N P=0.247 P=0.497 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.383N P=0.245 P=0.497 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.382N P=0.251 P=0.499 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.265 P=0.514 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.375N P=0.253 P=0.500 (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 29 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) |5/48 (10%) 6/46 (13%) 7/48 (15%) 11/48 (23%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 2.2% 0.0% |11.0% 14.0% 14.7% 23.1% | |TERMINAL (d) | 0/40 (0%) 1/45 (2%) 1/43 (2%) 0/42 (0%) |5/41 (12%) 5/38 (13%) 6/43 (14%) 11/44 (25%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) --- |734 (T) 731 702 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.537N P=0.523 P=0.514 (e) |P=0.081 P=0.450 P=0.415 P=0.110 | |POLY 3 | P=0.543N P=0.509 P=0.497 (e) |P=0.067 P=0.455 P=0.408 P=0.099 | |POLY 1.5 | P=0.541N P=0.507 P=0.497 (e) |P=0.061 P=0.461 P=0.396 P=0.093 | |POLY 6 | P=0.541N P=0.512 P=0.499 (e) |P=0.074 P=0.451 P=0.423 P=0.108 | |LOGISTIC REGRESSION| (e) P=0.523 P=0.514 (e) |P=0.085 P=0.455 P=0.425 P=0.110 | |COCH-ARM / FISHERS | P=0.533N P=0.505 P=0.500 (e) |P=0.053 P=0.470 P=0.379 P=0.085 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 26/50 (52%) 23/50 (46%) 25/50 (50%) 11/50 (22%) | | |POLY-3 ADJUSTED (b)| 55.2% 47.1% 53.9% 23.6% | | |TERMINAL (d) | 23/40 (58%) 21/45 (47%) 24/44 (55%) 9/42 (21%) | | |FIRST INCIDENCE | 649 565 705 407 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.177N P=0.319N P=0.002N** | | |POLY 3 | P<0.001N** P=0.277N P=0.532N P<0.001N** | | |POLY 1.5 | P<0.001N** P=0.305N P=0.529N P<0.001N** | | |POLY 6 | P<0.001N** P=0.241N P=0.515N P<0.001N** | | |LOGISTIC REGRESSION| P<0.001N** P=0.302N P=0.467N P=0.002N** | | |COCH-ARM / FISHERS | P<0.001N** P=0.345N P=0.500N P=0.002N** | | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 30 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 3/50 (6%) 0/50 (0%) 2/50 (4%) | | |POLY-3 ADJUSTED (b)| 14.9% 6.2% 0.0% 4.4% | | |TERMINAL (d) | 6/40 (15%) 3/45 (7%) 0/44 (0%) 1/42 (2%) | | |FIRST INCIDENCE | 631 733 (T) --- 609 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.105N P=0.120N P=0.007N** P=0.079N | | |POLY 3 | P=0.105N P=0.148N P=0.008N** P=0.086N | | |POLY 1.5 | P=0.103N P=0.153N P=0.008N** P=0.085N | | |POLY 6 | P=0.106N P=0.141N P=0.008N** P=0.082N | | |LOGISTIC REGRESSION| P=0.105N P=0.150N P=0.009N** P=0.084N | | |COCH-ARM / FISHERS | P=0.101N P=0.159N P=0.006N** P=0.080N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 30/50 (60%) 29/50 (58%) 23/50 (46%) 14/50 (28%) | | |POLY-3 ADJUSTED (b)| 63.0% 58.1% 48.9% 29.9% | | |TERMINAL (d) | 26/40 (65%) 25/45 (56%) 21/44 (48%) 12/42 (29%) | | |FIRST INCIDENCE | 603 61 513 369 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.273N P=0.055N P<0.001N** | | |POLY 3 | P<0.001N** P=0.385N P=0.117N P<0.001N** | | |POLY 1.5 | P<0.001N** P=0.414N P=0.119N P<0.001N** | | |POLY 6 | P<0.001N** P=0.345N P=0.107N P<0.001N** | | |LOGISTIC REGRESSION| P<0.001N** P=0.494N P=0.119N P<0.001N** | | |COCH-ARM / FISHERS | P<0.001N** P=0.500N P=0.115N P<0.001N** | | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 31 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 17/50 (34%) 12/50 (24%) 9/50 (18%) 13/49 (27%) |11/49 (22%) 15/49 (31%) 11/50 (22%) 21/50 (42%) | |POLY-3 ADJUSTED (b)| 35.4% 24.6% 18.8% 27.9% |23.1% 31.5% 22.5% 42.7% | |TERMINAL (d) | 12/40 (30%) 10/45 (22%) 7/44 (16%) 10/42 (24%) |8/42 (19%) 11/40 (28%) 10/43 (23%) 20/45 (44%) | |FIRST INCIDENCE | 550 565 406 407 |580 512 702 726 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.402N P=0.131N P=0.046N* P=0.244N |P=0.052 P=0.225 P=0.564N P=0.049 * | |POLY 3 | P=0.425N P=0.173N P=0.054N P=0.288N |P=0.027 * P=0.247 P=0.568N P=0.032 * | |POLY 1.5 | P=0.420N P=0.180N P=0.055N P=0.287N |P=0.026 * P=0.248 P=0.569N P=0.031 * | |POLY 6 | P=0.427N P=0.162N P=0.052N P=0.281N |P=0.027 * P=0.246 P=0.569N P=0.032 * | |LOGISTIC REGRESSION| P=0.396N P=0.189N P=0.054N P=0.276N |P=0.016 * P=0.270 P=0.569 P=0.027 * | |COCH-ARM / FISHERS | P=0.405N P=0.189N P=0.055N P=0.278N |P=0.026 * P=0.246 P=0.574N P=0.031 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 2/50 (4%) 3/50 (6%) 8/49 (16%) |5/49 (10%) 7/49 (14%) 4/50 (8%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 16.5% 4.1% 6.3% 16.4% |10.4% 14.4% 8.1% 4.1% | |TERMINAL (d) | 2/40 (5%) 0/45 (0%) 2/44 (5%) 2/42 (5%) |0/42 (0%) 1/40 (3%) 0/43 (0%) 1/45 (2%) | |FIRST INCIDENCE | 30 652 15 16 |580 512 652 726 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.211 P=0.045N* P=0.100N P=0.599N |P=0.085N P=0.368 P=0.467N P=0.204N | |POLY 3 | P=0.214 P=0.046N* P=0.108N P=0.602N |P=0.088N P=0.389 P=0.483N P=0.208N | |POLY 1.5 | P=0.211 P=0.048N* P=0.106N P=0.602 |P=0.088N P=0.386 P=0.484N P=0.208N | |POLY 6 | P=0.218 P=0.045N* P=0.108N P=0.590N |P=0.089N P=0.391 P=0.483N P=0.209N | |LOGISTIC REGRESSION| P=0.285 P=0.048N* P=0.059N P=0.564N |P=0.380N P=0.445 P=0.507 P=0.444N | |COCH-ARM / FISHERS | P=0.201 P=0.046N* P=0.100N P=0.590 |P=0.088N P=0.380 P=0.487N P=0.210N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 32 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 5/50 (10%) 7/50 (14%) 2/49 (4%) |10/49 (20%) 9/49 (18%) 11/50 (22%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 2.2% 10.3% 15.1% 4.4% |21.6% 19.7% 22.6% 16.2% | |TERMINAL (d) | 1/40 (3%) 4/45 (9%) 7/44 (16%) 2/42 (5%) |10/42 (24%) 9/40 (23%) 11/43 (26%) 7/45 (16%) | |FIRST INCIDENCE | 733 (T) 565 733 (T) 733 (T) |734 (T) 734 (T) 734 (T) 690 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.448N P=0.130 P=0.044 * P=0.517 |P=0.281N P=0.548N P=0.525 P=0.335N | |POLY 3 | P=0.475N P=0.112 P=0.030 * P=0.489 |P=0.301N P=0.512N P=0.553 P=0.341N | |POLY 1.5 | P=0.472N P=0.108 P=0.029 * P=0.488 |P=0.321N P=0.508N P=0.540 P=0.357N | |POLY 6 | P=0.468N P=0.119 P=0.031 * P=0.494 |P=0.276N P=0.517N P=0.566 P=0.321N | |LOGISTIC REGRESSION| P=0.469N P=0.102 P=0.044 * P=0.517 |P=0.263N P=0.548N P=0.525 P=0.316N | |COCH-ARM / FISHERS | P=0.456N P=0.102 P=0.030 * P=0.492 |P=0.350N P=0.500N P=0.521 P=0.379N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.3% 0.0% |4.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 2/44 (5%) 0/42 (0%) |1/42 (2%) 0/40 (0%) 0/43 (0%) 0/45 (0%) | |FIRST INCIDENCE | --- --- 733 (T) --- |711 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.700N (e) P=0.260 (e) |P=0.229N P=0.250N P=0.232N P=0.223N | |POLY 3 | P=0.713N (e) P=0.236 (e) |P=0.237N P=0.242N P=0.231N P=0.229N | |POLY 1.5 | P=0.710N (e) P=0.235 (e) |P=0.238N P=0.240N P=0.233N P=0.232N | |POLY 6 | P=0.712N (e) P=0.240 (e) |P=0.235N P=0.245N P=0.228N P=0.224N | |LOGISTIC REGRESSION| (e) (e) P=0.260 (e) |P=0.238N P=0.241N P=0.235N P=0.235N | |COCH-ARM / FISHERS | P=0.697N (e) P=0.247 (e) |P=0.242N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 33 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular: Epithelium | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.1% | |TERMINAL (d) | 0/40 (0%) 0/45 (0%) 0/44 (0%) 0/42 (0%) |0/42 (0%) 0/40 (0%) 0/43 (0%) 2/45 (4%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.049 * (e) (e) P=0.254 | |POLY 3 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.247 | |POLY 1.5 | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.243 | |POLY 6 | (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.252 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.254 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Testes: Germinal Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 4/50 (8%) | | |POLY-3 ADJUSTED (b)| 2.2% 2.1% 6.5% 8.6% | | |TERMINAL (d) | 1/40 (3%) 1/45 (2%) 3/44 (7%) 1/42 (2%) | | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 485 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.087 P=0.735N P=0.340 P=0.189 | | |POLY 3 | P=0.085 P=0.753N P=0.304 P=0.178 | | |POLY 1.5 | P=0.084 P=0.756N P=0.303 P=0.176 | | |POLY 6 | P=0.088 P=0.748N P=0.310 P=0.186 | | |LOGISTIC REGRESSION| P=0.092 P=0.735N P=0.340 P=0.191 | | |COCH-ARM / FISHERS | P=0.089 P=0.753N P=0.309 P=0.181 | | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 34 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 25/45 (56%) 35/47 (74%) 25/39 (64%) 20/44 (45%) |28/49 (57%) 25/48 (52%) 26/50 (52%) 33/50 (66%) | |POLY-3 ADJUSTED (b)| 55.9% 74.5% 67.1% 46.4% |58.5% 53.2% 52.5% 66.7% | |TERMINAL (d) | 20/39 (51%) 30/42 (71%) 23/34 (68%) 16/39 (41%) |24/42 (57%) 19/39 (49%) 20/43 (47%) 29/45 (64%) | |FIRST INCIDENCE | 30 61 15 16 |600 512 652 690 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.041N* P=0.105 P=0.350 P=0.229N |P=0.262 P=0.479N P=0.374N P=0.364 | |POLY 3 | P=0.032N* P=0.048 * P=0.210 P=0.248N |P=0.132 P=0.380N P=0.350N P=0.264 | |POLY 1.5 | P=0.031N* P=0.046 * P=0.230 P=0.246N |P=0.126 P=0.380N P=0.361N P=0.256 | |POLY 6 | P=0.031N* P=0.051 P=0.200 P=0.245N |P=0.140 P=0.385N P=0.338N P=0.275 | |LOGISTIC REGRESSION| P=0.022N* P=0.040 * P=0.298 P=0.186N |P=0.108 P=0.359N P=0.375N P=0.274 | |COCH-ARM / FISHERS | P=0.028N* P=0.046 * P=0.284 P=0.229N |P=0.119 P=0.384N P=0.378N P=0.242 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/45 (9%) 6/47 (13%) 6/39 (15%) 5/44 (11%) |4/49 (8%) 4/48 (8%) 4/50 (8%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 9.3% 13.3% 16.9% 12.4% |8.6% 9.0% 8.2% 14.1% | |TERMINAL (d) | 4/39 (10%) 6/42 (14%) 6/34 (18%) 5/39 (13%) |3/42 (7%) 4/39 (10%) 4/43 (9%) 6/45 (13%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |711 734 (T) 734 (T) 578 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.540 P=0.416 P=0.284 P=0.500 |P=0.216 P=0.603 P=0.628N P=0.305 | |POLY 3 | P=0.498 P=0.402 P=0.258 P=0.463 |P=0.203 P=0.614 P=0.620N P=0.297 | |POLY 1.5 | P=0.504 P=0.400 P=0.264 P=0.467 |P=0.192 P=0.621 P=0.624N P=0.288 | |POLY 6 | P=0.502 P=0.404 P=0.258 P=0.467 |P=0.216 P=0.606 P=0.616N P=0.309 | |LOGISTIC REGRESSION| P=0.540 P=0.416 P=0.284 P=0.500 |P=0.187 P=0.607 P=0.613N P=0.241 | |COCH-ARM / FISHERS | P=0.532 P=0.398 P=0.281 P=0.486 |P=0.176 P=0.631 P=0.631N P=0.274 | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 35 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/45 (0%) 0/47 (0%) 0/39 (0%) 0/44 (0%) |0/49 (0%) 0/48 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.1% | |TERMINAL (d) | 0/39 (0%) 0/42 (0%) 0/34 (0%) 0/39 (0%) |0/42 (0%) 0/39 (0%) 0/43 (0%) 2/45 (4%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.050 (e) (e) P=0.254 | |POLY 3 | (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.249 | |POLY 1.5 | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.246 | |POLY 6 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.253 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.254 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.253 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |3/50 (6%) 2/50 (4%) 7/50 (14%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| |6.4% 4.3% 14.4% 22.4% | |TERMINAL (d) | |3/42 (7%) 1/40 (3%) 7/43 (16%) 10/45 (22%) | |FIRST INCIDENCE | |734 (T) 512 734 (T) 723 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.005 ** P=0.516N P=0.167 P=0.031 * | |POLY 3 | |P=0.003 ** P=0.503N P=0.172 P=0.024 * | |POLY 1.5 | |P=0.002 ** P=0.502N P=0.166 P=0.022 * | |POLY 6 | |P=0.003 ** P=0.504N P=0.178 P=0.027 * | |LOGISTIC REGRESSION| |P=0.003 ** P=0.474N P=0.167 P=0.032 * | |COCH-ARM / FISHERS | |P=0.002 ** P=0.500N P=0.159 P=0.020 * | |=================================================================================================================================| Date: 09/24/99 EXPERIMENT: 88120 TEST: 04 Page 36 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - P,P'-DICHLORODIPHENYL SULFONE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |0.0% 0.0% 0.0% 4.1% | |TERMINAL (d) | |0/42 (0%) 0/40 (0%) 0/43 (0%) 2/45 (4%) | |FIRST INCIDENCE | |--- --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.049 * (e) (e) P=0.254 | |POLY 3 | |P=0.043 * (e) (e) P=0.247 | |POLY 1.5 | |P=0.042 * (e) (e) P=0.243 | |POLY 6 | |P=0.045 * (e) (e) P=0.252 | |LOGISTIC REGRESSION| |(e) (e) (e) P=0.254 | |COCH-ARM / FISHERS | |P=0.042 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 30 PPM 100 PPM 300 PPM |0 PPM 30 PPM 100 PPM 300 PPM | | | | | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |41/50 (82%) 44/50 (88%) 48/50 (96%) 47/50 (94%) | |POLY-3 ADJUSTED (b)| |84.5% 90.6% 96.8% 94.1% | |TERMINAL (d) | |37/42 (88%) 38/40 (95%) 43/43 (100%) 43/45 (96%) | |FIRST INCIDENCE | |580 512 586 578 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.489 P=0.165 P=0.096 P=0.299 | |POLY 3 | |P=0.112 P=0.258 P=0.029 * P=0.103 | |POLY 1.5 | |P=0.084 P=0.273 P=0.028 * P=0.082 | |POLY 6 | |P=0.166 P=0.237 P=0.031 * P=0.138 | |LOGISTIC REGRESSION| |P=0.143 P=0.213 P=0.060 P=0.116 | |COCH-ARM / FISHERS | |P=0.060 P=0.288 P=0.026 * P=0.061 | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Poly-3 adjusted lifetime tumor incidence. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01). --multipart-boundary Content-type: text/plain Range: bytes 280076-280076/280076 --multipart-boundary--