TDMS Study 88124-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest INDIUM PHOSPHIDE DATE: 10/28/99 EXPERIMENT: 88124 TEST: 03 TIME: 14:14:47 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88124 PATHOLOGIST: GRUMBEIN, S. CAS: 22398-80-7 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#1 CORE STUDY RATS REASONS FOR REMOVAL: 25022 Accidently Killed 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 CONTROL INCLUDE 002 CONTROL INCLUDE 005 0.1MG/M3 STOP INCLUDE 006 0.1MG/M3 STOP INCLUDE 007 0.3MG/M3 STOP INCLUDE 008 0.3MG/M3 STOP NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest INDIUM PHOSPHIDE DATE: 10/28/99 EXPERIMENT: 88124 TEST: 03 TIME: 14:14:47 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88124 PATHOLOGIST: GRUMBEIN, S. CAS: 22398-80-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF INDIUM PHOSPHIDE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Liver Hepatodiaphragmatic Nodule Lung Foreign Body Hyperplasia Atypical Inflammation Chronic Lung: Alveolar Epithelium Hyperplasia Metaplasia Lung: Alveolus Infiltration Cellular Histiocyte Proteinosis Lung: Interstitium Fibrosis Lymph Node, Bronchial Foreign Body Lymph Node, Mediastinal Foreign Body Pituitary Gland: Pars Distalis Hyperplasia Skin Hyperkeratosis =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Cortex Hypertrophy Necrosis Adrenal Medulla Hyperplasia Heart Cardiomyopathy Liver Clear Cell Focus Necrosis Liver: Bile Duct Hyperplasia Liver: Centrilobular Necrosis Lung Cyst Foreign Body Hyperplasia Atypical Inflammation Chronic Metaplasia Lung: Alveolar Epithelium Hyperplasia Metaplasia Lung: Alveolus Infiltration Cellular Histiocyte Proteinosis Lung: Interstitium Fibrosis Lymph Node, Bronchial Foreign Body Lymph Node, Mediastinal Foreign Body Nose Thrombosis Nose: Respiratory Epithelium Hyperplasia Ovary Cyst Spleen Fibrosis Hematopoietic Cell Proliferation =============================================================== Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Adrenal Cortex | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 0/49 (0%) 0/50 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% | 0.0% 0.0% 4.6% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | --- --- 695 | --- --- 588 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.291 (e) P=0.494 | P=0.091 (e) P=0.245 | |POLY 3 | P=0.306 (e) P=0.510 | P=0.092 (e) P=0.245 | |POLY 1.5 | P=0.304 (e) P=0.508 | P=0.092 (e) P=0.243 | |POLY 6 | P=0.307 (e) P=0.512 | P=0.092 (e) P=0.246 | |LOGISTIC REGRESSION| P=0.301 (e) P=0.507 | P=0.069 (e) P=0.194 | |COCH-ARM / FISHERS | P=0.296 (e) P=0.500 | P=0.090 (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) | 3/49 (6%) 2/50 (4%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 2.5% 2.4% 2.4% | 7.1% 4.5% 4.7% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 1/26 (4%) | 3/34 (9%) 2/36 (6%) 2/34 (6%) | |FIRST INCIDENCE | 733 (T) 656 733 (T) | 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.676N P=0.746N P=0.754 | P=0.464N P=0.474N P=0.500N | |POLY 3 | P=0.670N P=0.754N P=0.750N | P=0.459N P=0.476N P=0.493N | |POLY 1.5 | P=0.671N P=0.756N P=0.752N | P=0.457N P=0.481N P=0.492N | |POLY 6 | P=0.670N P=0.751N P=0.749N | P=0.464N P=0.470N P=0.497N | |LOGISTIC REGRESSION| P=0.668N P=0.758N P=0.754 | P=0.464N P=0.474N P=0.500N | |COCH-ARM / FISHERS | P=0.680N P=0.753N P=0.753N | P=0.461N P=0.490N P=0.500N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 32/50 (64%) 33/50 (66%) 33/50 (66%) | 21/49 (43%) 27/50 (54%) 25/49 (51%) | |POLY-3 ADJUSTED (b)| 73.1% 72.1% 70.6% | 47.4% 58.3% 57.8% | |TERMINAL (d) | 22/27 (82%) 21/29 (72%) 20/26 (77%) | 18/34 (53%) 20/36 (56%) 24/34 (71%) | |FIRST INCIDENCE | 408 460 525 | 124 436 610 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.462 P=0.512N P=0.500 | P=0.288 P=0.248 P=0.251 | |POLY 3 | P=0.453N P=0.554N P=0.486N | P=0.237 P=0.198 P=0.217 | |POLY 1.5 | P=0.510N P=0.589 P=0.547N | P=0.269 P=0.183 P=0.241 | |POLY 6 | P=0.391N P=0.480N P=0.412N | P=0.197 P=0.226 P=0.186 | |LOGISTIC REGRESSION| P=0.517N P=0.560 P=0.551N | P=0.322 P=0.198 P=0.292 | |COCH-ARM / FISHERS | P=0.482 P=0.500 P=0.500 | P=0.306 P=0.182 P=0.272 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 3/50 (6%) 9/50 (18%) | 11/49 (22%) 3/50 (6%) 6/49 (12%) | |POLY-3 ADJUSTED (b)| 17.3% 7.1% 21.0% | 25.1% 6.7% 14.0% | |TERMINAL (d) | 5/27 (19%) 2/29 (7%) 6/26 (23%) | 7/34 (21%) 1/36 (3%) 5/34 (15%) | |FIRST INCIDENCE | 700 552 658 | 476 672 727 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.222 P=0.140N P=0.385 | P=0.199N P=0.020N* P=0.152N | |POLY 3 | P=0.255 P=0.141N P=0.438 | P=0.191N P=0.016N* P=0.151N | |POLY 1.5 | P=0.250 P=0.146N P=0.427 | P=0.184N P=0.017N* P=0.142N | |POLY 6 | P=0.256 P=0.135N P=0.446 | P=0.203N P=0.016N* P=0.166N | |LOGISTIC REGRESSION| P=0.263 P=0.144N P=0.434 | P=0.181N P=0.020N* P=0.136N | |COCH-ARM / FISHERS | P=0.235 P=0.159N P=0.393 | P=0.186N P=0.018N* P=0.143N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Adrenal Cortex | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 4/50 (8%) | 0/49 (0%) 0/50 (0%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 4.9% 4.7% 9.3% | 0.0% 0.0% 6.9% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 1/26 (4%) | 0/34 (0%) 0/36 (0%) 2/34 (6%) | |FIRST INCIDENCE | 569 602 603 | --- --- 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.263 P=0.668N P=0.353 | P=0.031 * (e) P=0.125 | |POLY 3 | P=0.265 P=0.683N P=0.359 | P=0.029 * (e) P=0.124 | |POLY 1.5 | P=0.262 P=0.686N P=0.354 | P=0.029 * (e) P=0.123 | |POLY 6 | P=0.265 P=0.678N P=0.361 | P=0.029 * (e) P=0.123 | |LOGISTIC REGRESSION| P=0.235 P=0.676 P=0.342 | P=0.028 * (e) P=0.112 | |COCH-ARM / FISHERS | P=0.248 P=0.691N P=0.339 | P=0.030 * (e) P=0.121 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 1/49 (2%) 1/50 (2%) 4/49 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 2.4% 0.0% | 2.4% 2.2% 9.2% | |TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/26 (0%) | 1/34 (3%) 1/36 (3%) 3/34 (9%) | |FIRST INCIDENCE | --- 733 (T) --- | 735 (T) 735 (T) 411 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.715N P=0.514 (e) | P=0.089 P=0.749N P=0.182 | |POLY 3 | P=0.695N P=0.505 (e) | P=0.093 P=0.749N P=0.188 | |POLY 1.5 | P=0.697N P=0.504 (e) | P=0.093 P=0.751N P=0.188 | |POLY 6 | P=0.694N P=0.507 (e) | P=0.091 P=0.746N P=0.187 | |LOGISTIC REGRESSION| (e) P=0.514 (e) | P=0.086 P=0.749N P=0.168 | |COCH-ARM / FISHERS | P=0.704N P=0.500 (e) | P=0.089 P=0.747N P=0.181 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 26/50 (52%) 24/49 (49%) 32/50 (64%) | 6/50 (12%) 9/50 (18%) 15/49 (31%) | |POLY-3 ADJUSTED (b)| 60.8% 55.0% 69.8% | 14.1% 20.2% 33.8% | |TERMINAL (d) | 17/27 (63%) 15/28 (54%) 20/26 (77%) | 6/34 (18%) 9/36 (25%) 11/34 (32%) | |FIRST INCIDENCE | 495 460 525 | 735 (T) 735 (T) 585 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.127 P=0.371N P=0.186 | P=0.014 * P=0.325 P=0.026 * | |POLY 3 | P=0.154 P=0.369N P=0.240 | P=0.017 * P=0.318 P=0.026 * | |POLY 1.5 | P=0.140 P=0.398N P=0.214 | P=0.016 * P=0.307 P=0.024 * | |POLY 6 | P=0.164 P=0.330N P=0.264 | P=0.019 * P=0.330 P=0.029 * | |LOGISTIC REGRESSION| P=0.152 P=0.418N P=0.225 | P=0.014 * P=0.325 P=0.024 * | |COCH-ARM / FISHERS | P=0.106 P=0.460N P=0.156 | P=0.014 * P=0.288 P=0.021 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Bone | | Osteopetrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 6/50 (12%) 6/50 (12%) 7/49 (14%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 14.0% 13.5% 16.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 5/34 (15%) 6/36 (17%) 5/34 (15%) | |FIRST INCIDENCE | --- --- --- | 669 735 (T) 588 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.439 P=0.577N P=0.502 | |POLY 3 | (e) (e) (e) | P=0.459 P=0.594N P=0.517 | |POLY 1.5 | (e) (e) (e) | P=0.454 P=0.603N P=0.510 | |POLY 6 | (e) (e) (e) | P=0.462 P=0.585N P=0.522 | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.442 P=0.572N P=0.500 | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.431 P=0.620N P=0.484 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Clitoral Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | | 5/49 (10%) 2/47 (4%) 4/49 (8%) | |POLY-3 ADJUSTED (b)| | 12.0% 4.7% 9.0% | |TERMINAL (d) | | 5/33 (15%) 2/35 (6%) 1/34 (3%) | |FIRST INCIDENCE | | 735 (T) 735 (T) 519 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.523N P=0.191N P=0.483N | |POLY 3 | | P=0.507N P=0.210N P=0.460N | |POLY 1.5 | | P=0.512N P=0.219N P=0.471N | |POLY 6 | | P=0.503N P=0.200N P=0.447N | |LOGISTIC REGRESSION| | P=0.529N P=0.191N P=0.508N | |COCH-ARM / FISHERS | | P=0.528N P=0.235N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Eye | | Cataract | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/1 (100%) 1/1 (100%) 1/1 (100%) | 1/1 (100%) 3/3 (100%) 3/3 (100%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 100.0% | 100.0% 100.0% 100.0% | |TERMINAL (d) | 0/0 (0%) 1/1 (100%) 0/0 (0%) | 1/1 (100%) 1/1 (100%) 2/2 (100%) | |FIRST INCIDENCE | 703 733 (T) 686 | 735 (T) 566 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | (e) (e) (e) | |POLY 3 | (e) (e) (e) | (e) (e) (e) | |POLY 1.5 | (e) (e) (e) | (e) (e) (e) | |POLY 6 | (e) (e) (e) | (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) | (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) | (e) (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Eye: Retina | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/1 (100%) 1/1 (100%) 1/1 (100%) | 1/1 (100%) 3/3 (100%) 3/3 (100%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 100.0% | 100.0% 100.0% 100.0% | |TERMINAL (d) | 0/0 (0%) 1/1 (100%) 0/0 (0%) | 1/1 (100%) 1/1 (100%) 2/2 (100%) | |FIRST INCIDENCE | 703 733 (T) 686 | 735 (T) 566 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | (e) (e) (e) | |POLY 3 | (e) (e) (e) | (e) (e) (e) | |POLY 1.5 | (e) (e) (e) | (e) (e) (e) | |POLY 6 | (e) (e) (e) | (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) | (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) | (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 44/50 (88%) 43/50 (86%) 46/50 (92%) | 37/50 (74%) 41/50 (82%) 30/50 (60%) | |POLY-3 ADJUSTED (b)| 91.4% 89.0% 96.5% | 83.7% 86.5% 67.1% | |TERMINAL (d) | 25/27 (93%) 26/29 (90%) 26/26 (100%) | 32/34 (94%) 32/36 (89%) 25/34 (74%) | |FIRST INCIDENCE | 408 403 525 | 551 436 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.380 P=0.355N P=0.451 | P=0.052N P=0.443 P=0.085N | |POLY 3 | P=0.170 P=0.481N P=0.239 | P=0.014N* P=0.467 P=0.043N* | |POLY 1.5 | P=0.243 P=0.459N P=0.333 | P=0.019N* P=0.355 P=0.059N | |POLY 6 | P=0.105 P=0.500N P=0.143 | P=0.010N* P=0.637 P=0.030N* | |LOGISTIC REGRESSION| P=0.426 P=0.452N P=0.575 | P=0.026N* P=0.361 P=0.063N | |COCH-ARM / FISHERS | P=0.291 P=0.500N P=0.370 | P=0.040N* P=0.235 P=0.101N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Heart: Atrium | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.9% 4.8% 2.3% | 0.0% 0.0% 2.3% | |TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 639 651 656 | --- --- 585 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.376N P=0.674N P=0.463N | P=0.304 (e) P=0.513 | |POLY 3 | P=0.390N P=0.688N P=0.485N | P=0.299 (e) P=0.503 | |POLY 1.5 | P=0.393N P=0.688N P=0.488N | P=0.298 (e) P=0.502 | |POLY 6 | P=0.391N P=0.687N P=0.486N | P=0.299 (e) P=0.504 | |LOGISTIC REGRESSION| P=0.410N P=0.695N P=0.521N | P=0.291 (e) P=0.489 | |COCH-ARM / FISHERS | P=0.404N P=0.691N P=0.500N | P=0.296 (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 9.8% 7.1% 2.4% | 0.0% 2.2% 0.0% | |TERMINAL (d) | 2/27 (7%) 1/29 (3%) 1/26 (4%) | 0/34 (0%) 1/36 (3%) 0/34 (0%) | |FIRST INCIDENCE | 647 644 733 (T) | --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.140N P=0.465N P=0.181N | P=0.707N P=0.511 (e) | |POLY 3 | P=0.133N P=0.483N P=0.166N | P=0.703N P=0.509 (e) | |POLY 1.5 | P=0.135N P=0.488N P=0.168N | P=0.703N P=0.506 (e) | |POLY 6 | P=0.134N P=0.477N P=0.166N | P=0.704N P=0.512 (e) | |LOGISTIC REGRESSION| P=0.132N P=0.489N P=0.163N | (e) P=0.511 (e) | |COCH-ARM / FISHERS | P=0.143N P=0.500N P=0.181N | P=0.708N P=0.500 (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Kidney | | Hydronephrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.7% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | --- 493 --- | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.565N P=0.247 (e) | (e) (e) (e) | |POLY 3 | P=0.558N P=0.247 (e) | (e) (e) (e) | |POLY 1.5 | P=0.562N P=0.244 (e) | (e) (e) (e) | |POLY 6 | P=0.556N P=0.251 (e) | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.643N P=0.206 (e) | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.575N P=0.247 (e) | (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/48 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 4.8% 2.3% | 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | --- 651 684 | --- --- 643 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.533 P=0.255 P=0.506 | P=0.291 (e) P=0.500 | |POLY 3 | P=0.526 P=0.246 P=0.511 | P=0.294 (e) P=0.498 | |POLY 1.5 | P=0.520 P=0.243 P=0.508 | P=0.294 (e) P=0.497 | |POLY 6 | P=0.531 P=0.250 P=0.513 | P=0.294 (e) P=0.499 | |LOGISTIC REGRESSION| P=0.490 P=0.231 P=0.503 | P=0.272 (e) P=0.472 | |COCH-ARM / FISHERS | P=0.500 P=0.247 P=0.500 | P=0.289 (e) P=0.490 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 47/50 (94%) 43/50 (86%) 46/50 (92%) | 41/50 (82%) 42/50 (84%) 38/48 (79%) | |POLY-3 ADJUSTED (b)| 97.7% 94.0% 94.8% | 91.2% 89.5% 85.9% | |TERMINAL (d) | 27/27 (100%) 29/29 (100%) 26/26 (100%) | 33/34 (97%) 34/36 (94%) 32/34 (94%) | |FIRST INCIDENCE | 135 460 525 | 476 436 411 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.536 P=0.171N P=0.483N | P=0.301N P=0.452N P=0.326N | |POLY 3 | P=0.367N P=0.295N P=0.390N | P=0.252N P=0.535N P=0.297N | |POLY 1.5 | P=0.449N P=0.205N P=0.426N | P=0.268N P=0.612N P=0.329N | |POLY 6 | P=0.289N P=0.576N P=0.390N | P=0.283N P=0.422N P=0.305N | |LOGISTIC REGRESSION| P=0.277N P=0.075N P=0.310N | P=0.280N P=0.518N P=0.318N | |COCH-ARM / FISHERS | P=0.560N P=0.159N P=0.500N | P=0.391N P=0.500 P=0.460N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Larynx | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.6% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | --- --- 560 | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.099 (e) P=0.251 | (e) (e) (e) | |POLY 3 | P=0.097 (e) P=0.252 | (e) (e) (e) | |POLY 1.5 | P=0.095 (e) P=0.248 | (e) (e) (e) | |POLY 6 | P=0.099 (e) P=0.256 | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.067 (e) P=0.192 | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.091 (e) P=0.247 | (e) (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Larynx | | Inflammation Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 4.9% 11.7% 7.0% | 0.0% 0.0% 2.3% | |TERMINAL (d) | 1/27 (4%) 1/29 (3%) 1/26 (4%) | 0/34 (0%) 0/36 (0%) 1/34 (3%) | |FIRST INCIDENCE | 703 403 560 | --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.544 P=0.238 P=0.502 | P=0.293 (e) P=0.500 | |POLY 3 | P=0.576 P=0.239 P=0.528 | P=0.297 (e) P=0.501 | |POLY 1.5 | P=0.565 P=0.232 P=0.521 | P=0.297 (e) P=0.501 | |POLY 6 | P=0.583 P=0.249 P=0.534 | P=0.296 (e) P=0.500 | |LOGISTIC REGRESSION| P=0.507 P=0.207 P=0.510 | (e) (e) P=0.500 | |COCH-ARM / FISHERS | P=0.535 P=0.218 P=0.500 | P=0.292 (e) P=0.495 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Larynx: Epiglottis | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 3/50 (6%) 1/50 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.4% 0.0% | 7.0% 2.2% 0.0% | |TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/26 (0%) | 2/34 (6%) 1/36 (3%) 0/34 (0%) | |FIRST INCIDENCE | --- 733 (T) --- | 669 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.715N P=0.514 (e) | P=0.090N P=0.281N P=0.126N | |POLY 3 | P=0.695N P=0.505 (e) | P=0.089N P=0.292N P=0.118N | |POLY 1.5 | P=0.697N P=0.504 (e) | P=0.088N P=0.296N P=0.119N | |POLY 6 | P=0.694N P=0.507 (e) | P=0.090N P=0.287N P=0.119N | |LOGISTIC REGRESSION| (e) P=0.514 (e) | P=0.087N P=0.287N P=0.120N | |COCH-ARM / FISHERS | P=0.704N P=0.500 (e) | P=0.090N P=0.309N P=0.125N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Larynx: Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 4/50 (8%) 4/50 (8%) 6/49 (12%) | |POLY-3 ADJUSTED (b)| 0.0% 2.4% 0.0% | 9.1% 9.0% 14.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 1/34 (3%) 4/36 (11%) 6/34 (18%) | |FIRST INCIDENCE | --- 651 --- | 550 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.680N P=0.516 (e) | P=0.294 P=0.613N P=0.373 | |POLY 3 | P=0.695N P=0.507 (e) | P=0.282 P=0.636N P=0.353 | |POLY 1.5 | P=0.697N P=0.505 (e) | P=0.289 P=0.637N P=0.360 | |POLY 6 | P=0.694N P=0.510 (e) | P=0.270 P=0.636N P=0.340 | |LOGISTIC REGRESSION| P=0.719N P=0.494 (e) | P=0.294 P=0.640 P=0.361 | |COCH-ARM / FISHERS | P=0.704N P=0.500 (e) | P=0.287 P=0.643N P=0.357 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.9% 0.0% 4.7% | 0.0% 2.2% 2.3% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 2/26 (8%) | 0/34 (0%) 1/36 (3%) 0/34 (0%) | |FIRST INCIDENCE | 649 --- 733 (T) | --- 735 (T) 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.551 P=0.223N P=0.693N | P=0.414 P=0.511 P=0.490 | |POLY 3 | P=0.563 P=0.233N P=0.679N | P=0.430 P=0.509 P=0.502 | |POLY 1.5 | P=0.562 P=0.233N P=0.682N | P=0.429 P=0.506 P=0.502 | |POLY 6 | P=0.563 P=0.232N P=0.681N | P=0.431 P=0.512 P=0.503 | |LOGISTIC REGRESSION| P=0.570 P=0.234N P=0.677N | P=0.424 P=0.511 P=0.498 | |COCH-ARM / FISHERS | P=0.554 P=0.247N P=0.691N | P=0.425 P=0.500 P=0.500 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 29/50 (58%) 31/50 (62%) 34/50 (68%) | 46/50 (92%) 47/50 (94%) 44/50 (88%) | |POLY-3 ADJUSTED (b)| 67.6% 72.4% 75.0% | 97.9% 98.4% 93.0% | |TERMINAL (d) | 20/27 (74%) 27/29 (93%) 23/26 (89%) | 34/34 (100%) 36/36 (100%) 33/34 (97%) | |FIRST INCIDENCE | 537 493 532 | 476 436 519 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.144 P=0.573 P=0.219 | P=0.412N P=0.431N P=0.428N | |POLY 3 | P=0.264 P=0.395 P=0.282 | P=0.097N P=0.815 P=0.223N | |POLY 1.5 | P=0.242 P=0.426 P=0.264 | P=0.145N P=0.670 P=0.266N | |POLY 6 | P=0.284 P=0.329 P=0.292 | P=0.064N P=0.993 P=0.191N | |LOGISTIC REGRESSION| P=0.268 P=0.506 P=0.303 | P=0.171N P=0.696 P=0.267N | |COCH-ARM / FISHERS | P=0.183 P=0.419 P=0.204 | P=0.267N P=0.500 P=0.370N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 22/50 (44%) 16/50 (32%) | 17/50 (34%) 17/50 (34%) 9/50 (18%) | |POLY-3 ADJUSTED (b)| 44.4% 53.0% 37.8% | 39.9% 38.0% 21.0% | |TERMINAL (d) | 16/27 (59%) 21/29 (72%) 16/26 (62%) | 17/34 (50%) 16/36 (44%) 9/34 (27%) | |FIRST INCIDENCE | 697 698 733 (T) | 735 (T) 686 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.358N P=0.339 P=0.462N | P=0.029N* P=0.500N P=0.041N* | |POLY 3 | P=0.229N P=0.280 P=0.345N | P=0.031N* P=0.517N P=0.044N* | |POLY 1.5 | P=0.249N P=0.283 P=0.362N | P=0.032N* P=0.542N P=0.047N* | |POLY 6 | P=0.219N P=0.276 P=0.340N | P=0.031N* P=0.483N P=0.042N* | |LOGISTIC REGRESSION| P=0.228N P=0.280 P=0.346N | P=0.027N* P=0.490N P=0.041N* | |COCH-ARM / FISHERS | P=0.310N P=0.270 P=0.417N | P=0.037N* P=0.583N P=0.055N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 5/50 (10%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.4% 12.0% 11.7% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/27 (11%) 4/29 (14%) 3/26 (12%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) 700 686 | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.324 P=0.390 P=0.346 | (e) (e) (e) | |POLY 3 | P=0.383 P=0.371 P=0.386 | (e) (e) (e) | |POLY 1.5 | P=0.375 P=0.368 P=0.379 | (e) (e) (e) | |POLY 6 | P=0.388 P=0.377 P=0.390 | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.369 P=0.377 P=0.378 | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.349 P=0.357 P=0.357 | (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/50 (8%) 3/50 (6%) | 2/50 (4%) 3/50 (6%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 7.3% 9.7% 7.0% | 4.7% 6.7% 11.7% | |TERMINAL (d) | 0/27 (0%) 4/29 (14%) 1/26 (4%) | 2/34 (6%) 3/36 (8%) 5/34 (15%) | |FIRST INCIDENCE | 600 733 (T) 686 | 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.572N P=0.526 P=0.646N | P=0.159 P=0.526 P=0.214 | |POLY 3 | P=0.548N P=0.504 P=0.646N | P=0.166 P=0.520 P=0.217 | |POLY 1.5 | P=0.552N P=0.506 P=0.648N | P=0.168 P=0.513 P=0.218 | |POLY 6 | P=0.550N P=0.500 P=0.648N | P=0.163 P=0.528 P=0.215 | |LOGISTIC REGRESSION| P=0.545N P=0.514 P=0.655N | P=0.159 P=0.526 P=0.214 | |COCH-ARM / FISHERS | P=0.569N P=0.500 P=0.661N | P=0.168 P=0.500 P=0.218 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Fatty Change | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 7/50 (14%) 3/50 (6%) | 4/50 (8%) 4/50 (8%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 12.0% 15.9% 6.9% | 9.2% 8.8% 6.9% | |TERMINAL (d) | 1/27 (4%) 1/29 (3%) 0/26 (0%) | 2/34 (6%) 1/36 (3%) 2/34 (6%) | |FIRST INCIDENCE | 569 403 525 | 615 595 585 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.233N P=0.421 P=0.327N | P=0.443N P=0.599N P=0.503N | |POLY 3 | P=0.231N P=0.416 P=0.331N | P=0.440N P=0.615N P=0.499N | |POLY 1.5 | P=0.236N P=0.405 P=0.336N | P=0.436N P=0.625N P=0.498N | |POLY 6 | P=0.233N P=0.428 P=0.332N | P=0.447N P=0.604N P=0.503N | |LOGISTIC REGRESSION| P=0.359N P=0.332 P=0.442N | P=0.434N P=0.634 P=0.499N | |COCH-ARM / FISHERS | P=0.256N P=0.380 P=0.357N | P=0.434N P=0.643N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 9/50 (18%) | 7/50 (14%) 2/50 (4%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 7.3% 4.8% 21.0% | 16.1% 4.5% 25.4% | |TERMINAL (d) | 2/27 (7%) 1/29 (3%) 7/26 (27%) | 4/34 (12%) 2/36 (6%) 9/34 (27%) | |FIRST INCIDENCE | 551 630 656 | 621 735 (T) 593 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.016 * P=0.472N P=0.059 | P=0.076 P=0.070N P=0.222 | |POLY 3 | P=0.018 * P=0.491N P=0.067 | P=0.070 P=0.072N P=0.211 | |POLY 1.5 | P=0.018 * P=0.492N P=0.066 | P=0.072 P=0.074N P=0.216 | |POLY 6 | P=0.018 * P=0.487N P=0.067 | P=0.066 P=0.071N P=0.202 | |LOGISTIC REGRESSION| P=0.021 * P=0.498N P=0.072 | P=0.075 P=0.073N P=0.218 | |COCH-ARM / FISHERS | P=0.018 * P=0.500N P=0.061 | P=0.079 P=0.080N P=0.218 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) | 6/50 (12%) 4/50 (8%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 2.5% 0.0% 4.7% | 13.9% 8.9% 9.3% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 1/26 (4%) | 4/34 (12%) 3/36 (8%) 3/34 (9%) | |FIRST INCIDENCE | 700 --- 671 | 667 686 726 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.325 P=0.500N P=0.505 | P=0.366N P=0.334N P=0.377N | |POLY 3 | P=0.331 P=0.495N P=0.518 | P=0.362N P=0.345N P=0.371N | |POLY 1.5 | P=0.328 P=0.496N P=0.514 | P=0.357N P=0.354N P=0.368N | |POLY 6 | P=0.332 P=0.495N P=0.520 | P=0.370N P=0.336N P=0.377N | |LOGISTIC REGRESSION| P=0.331 P=0.495N P=0.516 | P=0.358N P=0.337N P=0.367N | |COCH-ARM / FISHERS | P=0.320 P=0.500N P=0.500 | P=0.354N P=0.370N P=0.370N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 2.5% 2.4% 2.3% | 0.0% 0.0% 6.9% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 2/34 (6%) | |FIRST INCIDENCE | 624 644 684 | --- --- 588 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.665N P=0.741N P=0.751N | P=0.031 * (e) P=0.126 | |POLY 3 | P=0.670N P=0.756N P=0.751N | P=0.029 * (e) P=0.121 | |POLY 1.5 | P=0.672N P=0.756N P=0.753N | P=0.029 * (e) P=0.121 | |POLY 6 | P=0.671N P=0.754N P=0.751N | P=0.029 * (e) P=0.122 | |LOGISTIC REGRESSION| P=0.662 P=0.752 P=0.752 | P=0.031 * (e) P=0.121 | |COCH-ARM / FISHERS | P=0.680N P=0.753N P=0.753N | P=0.031 * (e) P=0.121 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Regeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 7.1% 0.0% | 2.3% 0.0% 9.3% | |TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 4/34 (12%) | |FIRST INCIDENCE | --- 552 --- | 615 --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.505N P=0.132 (e) | P=0.054 P=0.491N P=0.178 | |POLY 3 | P=0.475N P=0.126 (e) | P=0.053 P=0.493N P=0.177 | |POLY 1.5 | P=0.481N P=0.124 (e) | P=0.054 P=0.495N P=0.179 | |POLY 6 | P=0.472N P=0.129 (e) | P=0.052 P=0.491N P=0.173 | |LOGISTIC REGRESSION| P=0.513N P=0.117 (e) | P=0.056 P=0.519N P=0.180 | |COCH-ARM / FISHERS | P=0.500N P=0.121 (e) | P=0.057 P=0.500N P=0.181 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver | | Vacuolization Cytoplasmic Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 4/50 (8%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.4% 0.0% | 9.2% 0.0% 2.3% | |TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/26 (0%) | 2/34 (6%) 0/36 (0%) 1/34 (3%) | |FIRST INCIDENCE | --- 733 (T) --- | 566 --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.715N P=0.514 (e) | P=0.168N P=0.057N P=0.182N | |POLY 3 | P=0.695N P=0.505 (e) | P=0.167N P=0.057N P=0.182N | |POLY 1.5 | P=0.697N P=0.504 (e) | P=0.165N P=0.058N P=0.180N | |POLY 6 | P=0.694N P=0.507 (e) | P=0.169N P=0.056N P=0.186N | |LOGISTIC REGRESSION| (e) P=0.514 (e) | P=0.165N P=0.064N P=0.179N | |COCH-ARM / FISHERS | P=0.704N P=0.500 (e) | P=0.165N P=0.059N P=0.181N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 39/50 (78%) 40/50 (80%) 36/50 (72%) | 4/50 (8%) 4/50 (8%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 82.4% 86.1% 77.2% | 9.0% 9.0% 22.0% | |TERMINAL (d) | 20/27 (74%) 25/29 (86%) 20/26 (77%) | 1/34 (3%) 3/36 (8%) 3/34 (9%) | |FIRST INCIDENCE | 495 513 530 | 504 716 519 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.335N P=0.487N P=0.362N | P=0.040 * P=0.614N P=0.091 | |POLY 3 | P=0.251N P=0.417 P=0.347N | P=0.036 * P=0.640N P=0.078 | |POLY 1.5 | P=0.215N P=0.475 P=0.299N | P=0.035 * P=0.640N P=0.076 | |POLY 6 | P=0.347N P=0.355 P=0.450N | P=0.038 * P=0.640N P=0.082 | |LOGISTIC REGRESSION| P=0.151N P=0.565 P=0.232N | P=0.034 * P=0.628 P=0.068 | |COCH-ARM / FISHERS | P=0.251N P=0.500 P=0.322N | P=0.035 * P=0.643N P=0.074 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Liver: Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 6/50 (12%) 10/50 (20%) | 3/50 (6%) 3/50 (6%) 9/50 (18%) | |POLY-3 ADJUSTED (b)| 11.7% 14.0% 22.5% | 6.8% 6.7% 20.1% | |TERMINAL (d) | 0/27 (0%) 2/29 (7%) 1/26 (4%) | 1/34 (3%) 1/36 (3%) 3/34 (9%) | |FIRST INCIDENCE | 135 537 560 | 504 672 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.133 P=0.523 P=0.187 | P=0.028 * P=0.631N P=0.073 | |POLY 3 | P=0.104 P=0.498 P=0.144 | P=0.024 * P=0.653N P=0.063 | |POLY 1.5 | P=0.100 P=0.498 P=0.139 | P=0.024 * P=0.656N P=0.062 | |POLY 6 | P=0.109 P=0.501 P=0.150 | P=0.025 * P=0.648N P=0.066 | |LOGISTIC REGRESSION| P=0.051 P=0.428 P=0.064 | P=0.024 * P=0.643 P=0.058 | |COCH-ARM / FISHERS | P=0.093 P=0.500 P=0.131 | P=0.025 * P=0.661N P=0.061 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 0.0% 7.2% 4.7% | 0.0% 2.2% 23.3% | |TERMINAL (d) | 0/27 (0%) 3/29 (10%) 2/26 (8%) | 0/34 (0%) 1/36 (3%) 10/34 (29%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) | --- 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.291 P=0.133 P=0.229 | P<0.001 ** P=0.511 P<0.001 ** | |POLY 3 | P=0.338 P=0.123 P=0.248 | P<0.001 ** P=0.509 P<0.001 ** | |POLY 1.5 | P=0.332 P=0.122 P=0.246 | P<0.001 ** P=0.506 P<0.001 ** | |POLY 6 | P=0.340 P=0.124 P=0.249 | P<0.001 ** P=0.512 P<0.001 ** | |LOGISTIC REGRESSION| (e) P=0.133 P=0.229 | (e) P=0.511 P<0.001 ** | |COCH-ARM / FISHERS | P=0.313 P=0.121 P=0.247 | P<0.001 ** P=0.500 P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 50/50 (100%) 50/50 (100%) | 1/50 (2%) 50/50 (100%) 50/50 (100%) | |POLY-3 ADJUSTED (b)| 2.5% 100.0% 100.0% | 2.3% 100.0% 100.0% | |TERMINAL (d) | 0/27 (0%) 29/29 (100%) 26/26 (100%) | 1/34 (3%) 36/36 (100%) 34/34 (100%) | |FIRST INCIDENCE | 697 403 525 | 735 (T) 225 186 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung | | Hyperplasia Atypical | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 23/50 (46%) 39/50 (78%) | 0/50 (0%) 8/50 (16%) 39/50 (78%) | |POLY-3 ADJUSTED (b)| 0.0% 53.2% 83.8% | 0.0% 17.9% 83.4% | |TERMINAL (d) | 0/27 (0%) 18/29 (62%) 24/26 (92%) | 0/34 (0%) 7/36 (19%) 29/34 (85%) | |FIRST INCIDENCE | --- 435 525 | --- 684 519 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.007 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.004 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.004 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.005 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.006 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.003 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 50/50 (100%) 50/50 (100%) | 10/50 (20%) 50/50 (100%) 49/50 (98%) | |POLY-3 ADJUSTED (b)| 12.3% 100.0% 100.0% | 22.8% 100.0% 100.0% | |TERMINAL (d) | 3/27 (11%) 29/29 (100%) 26/26 (100%) | 7/34 (21%) 36/36 (100%) 34/34 (100%) | |FIRST INCIDENCE | 639 403 525 | 476 225 411 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 4/50 (8%) | 0/50 (0%) 1/50 (2%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 7.2% 9.4% | 0.0% 2.2% 9.3% | |TERMINAL (d) | 0/27 (0%) 3/29 (10%) 3/26 (12%) | 0/34 (0%) 1/36 (3%) 4/34 (12%) | |FIRST INCIDENCE | --- 733 (T) 706 | --- 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.064 P=0.133 P=0.061 | P=0.024 * P=0.511 P=0.062 | |POLY 3 | P=0.082 P=0.123 P=0.066 | P=0.024 * P=0.509 P=0.060 | |POLY 1.5 | P=0.080 P=0.122 P=0.065 | P=0.025 * P=0.506 P=0.061 | |POLY 6 | P=0.083 P=0.124 P=0.067 | P=0.024 * P=0.512 P=0.060 | |LOGISTIC REGRESSION| P=0.076 P=0.133 P=0.067 | (e) P=0.511 P=0.062 | |COCH-ARM / FISHERS | P=0.074 P=0.121 P=0.059 | P=0.026 * P=0.500 P=0.059 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% | 4.6% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/26 (0%) | 1/34 (3%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) --- --- | 566 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.402N P=0.486N P=0.508N | P=0.169N P=0.226N P=0.235N | |POLY 3 | P=0.397N P=0.495N P=0.490N | P=0.173N P=0.230N P=0.239N | |POLY 1.5 | P=0.396N P=0.496N P=0.492N | P=0.172N P=0.233N P=0.237N | |POLY 6 | P=0.398N P=0.493N P=0.489N | P=0.174N P=0.228N P=0.241N | |LOGISTIC REGRESSION| P=0.402N (e) (e) | P=0.173N P=0.247N P=0.240N | |COCH-ARM / FISHERS | P=0.394N P=0.500N P=0.500N | P=0.171N P=0.247N P=0.247N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 21/50 (42%) 31/50 (62%) | 8/50 (16%) 22/50 (44%) 16/50 (32%) | |POLY-3 ADJUSTED (b)| 26.9% 50.3% 70.0% | 18.3% 48.1% 37.0% | |TERMINAL (d) | 10/27 (37%) 19/29 (66%) 22/26 (85%) | 5/34 (15%) 20/36 (56%) 15/34 (44%) | |FIRST INCIDENCE | 551 656 603 | 590 436 613 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.028 * P<0.001 ** | P=0.122 P=0.004 ** P=0.050 | |POLY 3 | P<0.001 ** P=0.020 * P<0.001 ** | P=0.110 P=0.002 ** P=0.041 * | |POLY 1.5 | P<0.001 ** P=0.023 * P<0.001 ** | P=0.121 P=0.002 ** P=0.045 * | |POLY 6 | P<0.001 ** P=0.018 * P<0.001 ** | P=0.095 P=0.002 ** P=0.035 * | |LOGISTIC REGRESSION| P<0.001 ** P=0.024 * P<0.001 ** | P=0.129 P=0.003 ** P=0.049 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.026 * P<0.001 ** | P=0.138 P=0.002 ** P=0.050 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 45/50 (90%) 48/50 (96%) | 0/50 (0%) 47/50 (94%) 48/50 (96%) | |POLY-3 ADJUSTED (b)| 0.0% 93.3% 97.7% | 0.0% 96.3% 98.0% | |TERMINAL (d) | 0/27 (0%) 27/29 (93%) 26/26 (100%) | 0/34 (0%) 35/36 (97%) 34/34 (100%) | |FIRST INCIDENCE | --- 435 525 | --- 436 411 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung: Alveolus | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 0/50 (0%) 0/50 (0%) | 16/50 (32%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 19.3% 0.0% 0.0% | 37.2% 0.0% 0.0% | |TERMINAL (d) | 5/27 (19%) 0/29 (0%) 0/26 (0%) | 14/34 (41%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 525 --- --- | 667 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.003N** P=0.005N** P=0.005N** | P<0.001N** P<0.001N** P<0.001N** | |POLY 3 | P<0.001N** P=0.003N** P=0.003N** | P<0.001N** P<0.001N** P<0.001N** | |POLY 1.5 | P<0.001N** P=0.003N** P=0.003N** | P<0.001N** P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.003N** P=0.003N** | P<0.001N** P<0.001N** P<0.001N** | |LOGISTIC REGRESSION| P=0.002N** P=0.005N** P=0.004N** | P<0.001N** P<0.001N** P<0.001N** | |COCH-ARM / FISHERS | P=0.002N** P=0.003N** P=0.003N** | P<0.001N** P<0.001N** P<0.001N** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung: Alveolus | | Proteinosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 48/50 (96%) 47/50 (94%) | 0/50 (0%) 47/50 (94%) 50/50 (100%) | |POLY-3 ADJUSTED (b)| 0.0% 96.0% 94.4% | 0.0% 94.0% 100.0% | |TERMINAL (d) | 0/27 (0%) 27/29 (93%) 25/26 (96%) | 0/34 (0%) 33/36 (92%) 34/34 (100%) | |FIRST INCIDENCE | --- 403 525 | --- 225 186 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lung: Interstitium | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 50/50 (100%) 50/50 (100%) | 0/50 (0%) 50/50 (100%) 49/50 (98%) | |POLY-3 ADJUSTED (b)| 0.0% 100.0% 100.0% | 0.0% 100.0% 100.0% | |TERMINAL (d) | 0/27 (0%) 29/29 (100%) 26/26 (100%) | 0/34 (0%) 36/36 (100%) 34/34 (100%) | |FIRST INCIDENCE | --- 403 525 | --- 225 411 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lymph Node, Bronchial | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/26 (0%) 27/41 (66%) 36/44 (82%) | 0/25 (0%) 26/35 (74%) 20/30 (67%) | |POLY-3 ADJUSTED (b)| 0.0% 70.9% 83.7% | 0.0% 75.3% 72.6% | |TERMINAL (d) | 0/12 (0%) 19/27 (70%) 22/26 (85%) | 0/18 (0%) 19/26 (73%) 13/20 (65%) | |FIRST INCIDENCE | --- 493 525 | --- 225 588 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/25 (0%) 27/45 (60%) 15/40 (38%) | 0/28 (0%) 18/39 (46%) 13/26 (50%) | |POLY-3 ADJUSTED (b)| 0.0% 64.0% 41.2% | 0.0% 50.1% 59.6% | |TERMINAL (d) | 0/10 (0%) 16/27 (59%) 9/24 (38%) | 0/17 (0%) 13/29 (45%) 9/14 (64%) | |FIRST INCIDENCE | --- 435 530 | --- 566 588 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.149 P<0.001 ** P=0.002 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P=0.329 P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P=0.206 P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P=0.515 P<0.001 ** P=0.003 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.102 P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P=0.095 P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Mammary Gland | | Galactocele | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/24 (29%) 4/31 (13%) 5/24 (21%) | 2/50 (4%) 1/50 (2%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 32.0% 15.1% 22.7% | 4.6% 2.2% 11.4% | |TERMINAL (d) | 4/14 (29%) 1/18 (6%) 1/13 (8%) | 1/34 (3%) 1/36 (3%) 3/34 (9%) | |FIRST INCIDENCE | 525 435 530 | 551 735 (T) 610 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.393N P=0.202N P=0.374N | P=0.102 P=0.482N P=0.222 | |POLY 3 | P=0.399N P=0.142N P=0.363N | P=0.102 P=0.489N P=0.220 | |POLY 1.5 | P=0.407N P=0.137N P=0.367N | P=0.103 P=0.493N P=0.219 | |POLY 6 | P=0.393N P=0.142N P=0.357N | P=0.102 P=0.486N P=0.221 | |LOGISTIC REGRESSION| P=0.444N P=0.095N P=0.381N | P=0.103 P=0.507N P=0.215 | |COCH-ARM / FISHERS | P=0.420N P=0.124N P=0.370N | P=0.103 P=0.500N P=0.218 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/6 (100%) 6/6 (100%) 6/8 (75%) | 9/9 (100%) 15/15 (100%) 18/19 (95%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 80.6% | 100.0% 100.0% 98.1% | |TERMINAL (d) | 5/5 (100%) 4/4 (100%) 1/2 (50%) | 5/5 (100%) 9/9 (100%) 13/13 (100%) | |FIRST INCIDENCE | 714 658 560 | 476 436 411 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.206 (e) P=0.296 | P=0.495 (e) P=0.504 | |POLY 3 | P=0.183N (e) P=0.392N | P=0.879N (e) P=0.988N | |POLY 1.5 | P=0.148N (e) P=0.342N | P=0.607N (e) P=0.860N | |POLY 6 | P=0.248N (e) P=0.464N | P=1.000N (e) P=1.000N | |LOGISTIC REGRESSION| P=0.244N (e) P=0.505N | P=0.392N (e) P=0.634N | |COCH-ARM / FISHERS | P=0.123N (e) P=0.308N | P=0.395N (e) P=0.679N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 8/50 (16%) 8/50 (16%) | 6/50 (12%) 3/50 (6%) 9/49 (18%) | |POLY-3 ADJUSTED (b)| 21.7% 18.4% 18.8% | 13.7% 6.7% 20.5% | |TERMINAL (d) | 6/27 (22%) 2/29 (7%) 7/26 (27%) | 4/34 (12%) 2/36 (6%) 6/34 (18%) | |FIRST INCIDENCE | 551 493 672 | 124 714 610 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.481N P=0.449N P=0.518N | P=0.152 P=0.221N P=0.286 | |POLY 3 | P=0.462N P=0.458N P=0.476N | P=0.150 P=0.233N P=0.287 | |POLY 1.5 | P=0.459N P=0.472N P=0.477N | P=0.149 P=0.239N P=0.282 | |POLY 6 | P=0.475N P=0.436N P=0.483N | P=0.151 P=0.226N P=0.293 | |LOGISTIC REGRESSION| P=0.449N P=0.496N P=0.453N | P=0.137 P=0.261N P=0.245 | |COCH-ARM / FISHERS | P=0.477N P=0.500N P=0.500N | P=0.147 P=0.243N P=0.274 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Nose | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 6/50 (12%) 8/50 (16%) | 2/50 (4%) 1/50 (2%) 6/49 (12%) | |POLY-3 ADJUSTED (b)| 9.6% 13.5% 17.8% | 4.6% 2.2% 13.5% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 1/36 (3%) 1/34 (3%) | |FIRST INCIDENCE | 495 403 532 | 504 735 (T) 585 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.213 P=0.406 P=0.233 | P=0.053 P=0.488N P=0.150 | |POLY 3 | P=0.191 P=0.408 P=0.215 | P=0.047 * P=0.495N P=0.137 | |POLY 1.5 | P=0.180 P=0.396 P=0.203 | P=0.047 * P=0.496N P=0.135 | |POLY 6 | P=0.202 P=0.425 P=0.228 | P=0.048 * P=0.493N P=0.139 | |LOGISTIC REGRESSION| P=0.078 P=0.300 P=0.120 | P=0.031 * P=0.540N P=0.082 | |COCH-ARM / FISHERS | P=0.157 P=0.370 P=0.178 | P=0.046 * P=0.500N P=0.128 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 2/50 (4%) 7/50 (14%) | 1/50 (2%) 1/50 (2%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 14.7% 4.8% 16.5% | 2.3% 2.2% 2.3% | |TERMINAL (d) | 5/27 (19%) 2/29 (7%) 7/26 (27%) | 1/34 (3%) 1/36 (3%) 1/34 (3%) | |FIRST INCIDENCE | 600 733 (T) 733 (T) | 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.294 P=0.112N P=0.475 | P=0.678 P=0.749N P=0.762 | |POLY 3 | P=0.347 P=0.126N P=0.530 | P=0.680 P=0.751N P=0.760N | |POLY 1.5 | P=0.345 P=0.127N P=0.525 | P=0.680 P=0.754N P=0.760N | |POLY 6 | P=0.344 P=0.124N P=0.528 | P=0.679 P=0.747N P=0.760N | |LOGISTIC REGRESSION| P=0.355 P=0.121N P=0.539 | P=0.678 P=0.749N P=0.762 | |COCH-ARM / FISHERS | P=0.331 P=0.134N P=0.500 | P=0.675 P=0.753N P=0.747 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 4/50 (8%) 5/50 (10%) | 2/50 (4%) 1/50 (2%) 7/49 (14%) | |POLY-3 ADJUSTED (b)| 12.2% 9.5% 11.8% | 4.6% 2.2% 16.2% | |TERMINAL (d) | 2/27 (7%) 2/29 (7%) 5/26 (19%) | 1/34 (3%) 1/36 (3%) 6/34 (18%) | |FIRST INCIDENCE | 656 630 733 (T) | 124 735 (T) 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.559 P=0.468N P=0.628 | P=0.020 * P=0.487N P=0.082 | |POLY 3 | P=0.579 P=0.484N P=0.610N | P=0.018 * P=0.493N P=0.075 | |POLY 1.5 | P=0.577 P=0.487N P=0.611N | P=0.019 * P=0.497N P=0.075 | |POLY 6 | P=0.572 P=0.480N P=0.617N | P=0.018 * P=0.487N P=0.074 | |LOGISTIC REGRESSION| P=0.588N P=0.487N P=0.598N | P=0.017 * P=0.567N P=0.061 | |COCH-ARM / FISHERS | P=0.560 P=0.500N P=0.630N | P=0.020 * P=0.500N P=0.075 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 2.5% 2.4% 2.4% | 0.0% 0.0% 4.6% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 1/26 (4%) | 0/34 (0%) 0/36 (0%) 1/34 (3%) | |FIRST INCIDENCE | 733 (T) 651 733 (T) | --- --- 610 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.677N P=0.743N P=0.754 | P=0.090 (e) P=0.240 | |POLY 3 | P=0.670N P=0.754N P=0.750N | P=0.090 (e) P=0.240 | |POLY 1.5 | P=0.671N P=0.755N P=0.752N | P=0.090 (e) P=0.239 | |POLY 6 | P=0.670N P=0.751N P=0.749N | P=0.090 (e) P=0.241 | |LOGISTIC REGRESSION| P=0.668N P=0.759N P=0.754 | P=0.085 (e) P=0.225 | |COCH-ARM / FISHERS | P=0.680N P=0.753N P=0.753N | P=0.089 (e) P=0.242 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 28 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | | 9/50 (18%) 7/50 (14%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| | 21.0% 15.6% 6.9% | |TERMINAL (d) | | 8/34 (24%) 6/36 (17%) 2/34 (6%) | |FIRST INCIDENCE | | 667 679 588 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.053N P=0.341N P=0.064N | |POLY 3 | | P=0.047N* P=0.356N P=0.055N | |POLY 1.5 | | P=0.048N* P=0.369N P=0.057N | |POLY 6 | | P=0.047N* P=0.341N P=0.054N | |LOGISTIC REGRESSION| | P=0.049N* P=0.335N P=0.060N | |COCH-ARM / FISHERS | | P=0.054N P=0.393N P=0.065N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Ovary | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | | 2/50 (4%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| | 4.6% 0.0% 0.0% | |TERMINAL (d) | | 1/34 (3%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | | 621 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.174N P=0.226N P=0.242N | |POLY 3 | | P=0.175N P=0.229N P=0.238N | |POLY 1.5 | | P=0.173N P=0.232N P=0.238N | |POLY 6 | | P=0.176N P=0.227N P=0.240N | |LOGISTIC REGRESSION| | P=0.176N P=0.240N P=0.245N | |COCH-ARM / FISHERS | | P=0.173N P=0.247N P=0.253N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 29 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Pancreas | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 17/50 (34%) 19/50 (38%) | 5/50 (10%) 6/50 (12%) 8/49 (16%) | |POLY-3 ADJUSTED (b)| 33.7% 38.2% 43.7% | 11.7% 13.3% 18.3% | |TERMINAL (d) | 11/27 (41%) 10/29 (35%) 11/26 (42%) | 5/34 (15%) 4/36 (11%) 6/34 (18%) | |FIRST INCIDENCE | 552 403 658 | 735 (T) 566 585 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.188 P=0.417 P=0.204 | P=0.233 P=0.540 P=0.280 | |POLY 3 | P=0.212 P=0.416 P=0.230 | P=0.243 P=0.540 P=0.291 | |POLY 1.5 | P=0.211 P=0.388 P=0.225 | P=0.239 P=0.525 P=0.285 | |POLY 6 | P=0.208 P=0.452 P=0.233 | P=0.245 P=0.559 P=0.298 | |LOGISTIC REGRESSION| P=0.230 P=0.351 P=0.245 | P=0.230 P=0.533 P=0.277 | |COCH-ARM / FISHERS | P=0.190 P=0.333 P=0.198 | P=0.222 P=0.500 P=0.264 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Pancreas | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/50 (6%) 0/50 (0%) | 1/50 (2%) 3/50 (6%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 7.4% 7.2% 0.0% | 2.3% 6.7% 2.3% | |TERMINAL (d) | 3/27 (11%) 2/29 (7%) 0/26 (0%) | 1/34 (3%) 3/36 (8%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) 679 --- | 735 (T) 735 (T) 610 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.095N P=0.633N P=0.126N | P=0.553N P=0.325 P=0.760 | |POLY 3 | P=0.081N P=0.649N P=0.109N | P=0.542N P=0.321 P=0.757N | |POLY 1.5 | P=0.083N P=0.652N P=0.112N | P=0.544N P=0.315 P=0.759N | |POLY 6 | P=0.080N P=0.643N P=0.108N | P=0.541N P=0.327 P=0.757N | |LOGISTIC REGRESSION| P=0.082N P=0.646N (e) | P=0.551N P=0.325 P=0.753 | |COCH-ARM / FISHERS | P=0.091N P=0.661N P=0.121N | P=0.557N P=0.309 P=0.747 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 30 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Pancreas | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 9.7% 4.6% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/27 (7%) 4/29 (14%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) 545 | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.552N P=0.368 P=0.690N | (e) (e) (e) | |POLY 3 | P=0.502N P=0.348 P=0.670N | (e) (e) (e) | |POLY 1.5 | P=0.513N P=0.346 P=0.677N | (e) (e) (e) | |POLY 6 | P=0.493N P=0.351 P=0.664N | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.518N P=0.368 P=0.693 | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.539N P=0.339 P=0.691N | (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Pituitary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 0/48 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% | 2.3% 0.0% 4.6% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 1/26 (4%) | 1/34 (3%) 0/34 (0%) 0/34 (0%) | |FIRST INCIDENCE | --- --- 733 (T) | 735 (T) --- 588 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.285 (e) P=0.492 | P=0.317 P=0.500N P=0.499 | |POLY 3 | P=0.306 (e) P=0.512 | P=0.325 P=0.500N P=0.508 | |POLY 1.5 | P=0.305 (e) P=0.511 | P=0.323 P=0.503N P=0.504 | |POLY 6 | P=0.306 (e) P=0.512 | P=0.326 P=0.497N P=0.512 | |LOGISTIC REGRESSION| (e) (e) P=0.492 | P=0.301 (e) P=0.473 | |COCH-ARM / FISHERS | P=0.298 (e) P=0.505 | P=0.317 P=0.510N P=0.492 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 31 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 3/48 (6%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 2.3% 7.1% 2.3% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 3/34 (9%) 1/34 (3%) | |FIRST INCIDENCE | --- --- --- | 615 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.553N P=0.311 P=0.755 | |POLY 3 | (e) (e) (e) | P=0.547N P=0.301 P=0.760 | |POLY 1.5 | (e) (e) (e) | P=0.545N P=0.298 P=0.760 | |POLY 6 | (e) (e) (e) | P=0.552N P=0.303 P=0.758 | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.547N P=0.298 P=0.754 | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.553N P=0.293 P=0.747 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 12/50 (24%) 15/50 (30%) | 15/50 (30%) 13/48 (27%) 17/49 (35%) | |POLY-3 ADJUSTED (b)| 12.5% 27.9% 33.9% | 34.7% 29.4% 37.5% | |TERMINAL (d) | 4/27 (15%) 8/29 (28%) 9/26 (35%) | 13/34 (38%) 8/34 (24%) 11/34 (32%) | |FIRST INCIDENCE | 672 403 532 | 621 566 411 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.017 * P=0.075 P=0.014 * | P=0.334 P=0.388N P=0.415 | |POLY 3 | P=0.025 * P=0.067 P=0.017 * | P=0.385 P=0.384N P=0.479 | |POLY 1.5 | P=0.023 * P=0.065 P=0.016 * | P=0.370 P=0.414N P=0.454 | |POLY 6 | P=0.027 * P=0.070 P=0.018 * | P=0.394 P=0.347N P=0.500 | |LOGISTIC REGRESSION| P=0.022 * P=0.063 P=0.016 * | P=0.333 P=0.423N P=0.412 | |COCH-ARM / FISHERS | P=0.018 * P=0.059 P=0.013 * | P=0.318 P=0.462N P=0.388 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 32 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Preputial Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) | | |POLY-3 ADJUSTED (b)| 0.0% 4.8% 2.3% | | |TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/26 (0%) | | |FIRST INCIDENCE | --- 665 672 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.515 P=0.251 P=0.517 | | |POLY 3 | P=0.526 P=0.244 P=0.511 | | |POLY 1.5 | P=0.520 P=0.242 P=0.508 | | |POLY 6 | P=0.532 P=0.247 P=0.513 | | |LOGISTIC REGRESSION| P=0.508 P=0.242 P=0.497 | | |COCH-ARM / FISHERS | P=0.500 P=0.247 P=0.500 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) | | |POLY-3 ADJUSTED (b)| 7.3% 4.8% 9.3% | | |TERMINAL (d) | 1/27 (4%) 1/29 (3%) 2/26 (8%) | | |FIRST INCIDENCE | 617 665 530 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.392 P=0.480N P=0.499 | | |POLY 3 | P=0.415 P=0.491N P=0.528 | | |POLY 1.5 | P=0.410 P=0.493N P=0.522 | | |POLY 6 | P=0.415 P=0.490N P=0.529 | | |LOGISTIC REGRESSION| P=0.401 P=0.493N P=0.507 | | |COCH-ARM / FISHERS | P=0.391 P=0.500N P=0.500 | | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 33 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Prostate | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 13/50 (26%) 9/50 (18%) | | |POLY-3 ADJUSTED (b)| 34.5% 31.1% 21.1% | | |TERMINAL (d) | 12/27 (44%) 11/29 (38%) 7/26 (27%) | | |FIRST INCIDENCE | 697 665 676 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.155N P=0.417N P=0.180N | | |POLY 3 | P=0.103N P=0.463N P=0.127N | | |POLY 1.5 | P=0.113N P=0.473N P=0.139N | | |POLY 6 | P=0.096N P=0.448N P=0.118N | | |LOGISTIC REGRESSION| P=0.101N P=0.447N P=0.125N | | |COCH-ARM / FISHERS | P=0.142N P=0.500N P=0.171N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) | | |POLY-3 ADJUSTED (b)| 2.5% 7.2% 7.0% | | |TERMINAL (d) | 0/27 (0%) 2/29 (7%) 0/26 (0%) | | |FIRST INCIDENCE | 672 710 621 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.318 P=0.324 P=0.337 | | |POLY 3 | P=0.331 P=0.313 P=0.326 | | |POLY 1.5 | P=0.324 P=0.312 P=0.321 | | |POLY 6 | P=0.337 P=0.314 P=0.330 | | |LOGISTIC REGRESSION| P=0.317 P=0.316 P=0.301 | | |COCH-ARM / FISHERS | P=0.302 P=0.309 P=0.309 | | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 34 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Salivary Glands | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) | 3/50 (6%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 5.0% 0.0% 4.7% | 6.9% 2.2% 4.7% | |TERMINAL (d) | 2/27 (7%) 0/29 (0%) 2/26 (8%) | 0/34 (0%) 0/36 (0%) 2/34 (6%) | |FIRST INCIDENCE | 733 (T) --- 733 (T) | 566 600 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.536 P=0.222N P=0.683 | P=0.500N P=0.290N P=0.494N | |POLY 3 | P=0.565 P=0.231N P=0.677N | P=0.510N P=0.292N P=0.505N | |POLY 1.5 | P=0.562 P=0.233N P=0.680N | P=0.505N P=0.297N P=0.502N | |POLY 6 | P=0.565 P=0.229N P=0.675N | P=0.516N P=0.287N P=0.512N | |LOGISTIC REGRESSION| P=0.536 (e) P=0.683 | P=0.501N P=0.323N P=0.499N | |COCH-ARM / FISHERS | P=0.554 P=0.247N P=0.691N | P=0.500N P=0.309N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Salivary Glands | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 3/50 (6%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 5.0% 0.0% 2.4% | 6.9% 0.0% 4.7% | |TERMINAL (d) | 2/27 (7%) 0/29 (0%) 1/26 (4%) | 1/34 (3%) 0/36 (0%) 2/34 (6%) | |FIRST INCIDENCE | 733 (T) --- 733 (T) | 615 --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.516N P=0.222N P=0.513N | P=0.557N P=0.115N P=0.504N | |POLY 3 | P=0.496N P=0.231N P=0.483N | P=0.556N P=0.113N P=0.504N | |POLY 1.5 | P=0.497N P=0.233N P=0.487N | P=0.553N P=0.115N P=0.501N | |POLY 6 | P=0.497N P=0.229N P=0.481N | P=0.560N P=0.111N P=0.509N | |LOGISTIC REGRESSION| P=0.516N (e) P=0.513N | P=0.549N P=0.121N P=0.498N | |COCH-ARM / FISHERS | P=0.500N P=0.247N P=0.500N | P=0.548N P=0.121N P=0.500N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 35 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Skin | | Cyst Epithelial Inclusion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.8% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 2/29 (7%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | --- 733 (T) --- | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.590N P=0.254 (e) | (e) (e) (e) | |POLY 3 | P=0.563N P=0.243 (e) | (e) (e) (e) | |POLY 1.5 | P=0.567N P=0.242 (e) | (e) (e) (e) | |POLY 6 | P=0.560N P=0.244 (e) | (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.254 (e) | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.581N P=0.247 (e) | (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Skin | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/49 (6%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 7.2% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 3/26 (12%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | --- --- 733 (T) | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.026 * (e) P=0.113 | (e) (e) (e) | |POLY 3 | P=0.030 * (e) P=0.123 | (e) (e) (e) | |POLY 1.5 | P=0.029 * (e) P=0.122 | (e) (e) (e) | |POLY 6 | P=0.030 * (e) P=0.124 | (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.113 | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.029 * (e) P=0.117 | (e) (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 36 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Skin | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/50 (0%) 4/49 (8%) | 0/50 (0%) 1/50 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 9.9% 0.0% 9.5% | 0.0% 2.2% 0.0% | |TERMINAL (d) | 3/27 (11%) 0/29 (0%) 2/26 (8%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 709 --- 656 | --- 686 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.456 P=0.057N P=0.641N | P=0.710N P=0.521 (e) | |POLY 3 | P=0.467 P=0.056N P=0.624N | P=0.705N P=0.510 (e) | |POLY 1.5 | P=0.463 P=0.058N P=0.632N | P=0.706N P=0.506 (e) | |POLY 6 | P=0.471 P=0.055N P=0.617N | P=0.705N P=0.514 (e) | |LOGISTIC REGRESSION| P=0.476 P=0.056N P=0.625N | P=0.708N P=0.499 (e) | |COCH-ARM / FISHERS | P=0.451 P=0.059N P=0.631 | P=0.708N P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Spleen | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 9/49 (18%) 11/48 (23%) | 0/50 (0%) 1/50 (2%) 4/47 (9%) | |POLY-3 ADJUSTED (b)| 19.6% 21.4% 26.5% | 0.0% 2.2% 9.6% | |TERMINAL (d) | 5/27 (19%) 7/29 (24%) 9/26 (35%) | 0/34 (0%) 1/36 (3%) 3/34 (9%) | |FIRST INCIDENCE | 672 552 706 | --- 735 (T) 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.242 P=0.553 P=0.289 | P=0.024 * P=0.511 P=0.063 | |POLY 3 | P=0.274 P=0.528 P=0.315 | P=0.021 * P=0.509 P=0.056 | |POLY 1.5 | P=0.266 P=0.513 P=0.304 | P=0.021 * P=0.506 P=0.056 | |POLY 6 | P=0.274 P=0.544 P=0.319 | P=0.022 * P=0.512 P=0.057 | |LOGISTIC REGRESSION| P=0.295 P=0.525 P=0.334 | P=0.022 * P=0.511 P=0.058 | |COCH-ARM / FISHERS | P=0.237 P=0.482 P=0.271 | P=0.021 * P=0.500 P=0.051 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 37 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 1/48 (2%) | 1/50 (2%) 6/50 (12%) 2/47 (4%) | |POLY-3 ADJUSTED (b)| 2.5% 0.0% 2.4% | 2.3% 13.0% 4.8% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 1/34 (3%) 4/36 (11%) 1/34 (3%) | |FIRST INCIDENCE | 639 --- 545 | 735 (T) 225 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.659 P=0.485N P=0.747N | P=0.604 P=0.069 P=0.502 | |POLY 3 | P=0.652 P=0.498N P=0.754N | P=0.609 P=0.070 P=0.493 | |POLY 1.5 | P=0.648 P=0.499N P=0.758N | P=0.602 P=0.066 P=0.490 | |POLY 6 | P=0.655 P=0.497N P=0.751N | P=0.613N P=0.074 P=0.496 | |LOGISTIC REGRESSION| P=0.568 P=0.517N P=0.695 | P=0.508 P=0.043 * P=0.465 | |COCH-ARM / FISHERS | P=0.640 P=0.505N P=0.742 | P=0.577 P=0.056 P=0.477 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Spleen | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/49 (4%) 1/48 (2%) | 1/50 (2%) 1/50 (2%) 1/47 (2%) | |POLY-3 ADJUSTED (b)| 4.9% 4.7% 2.4% | 2.3% 2.2% 2.4% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 1/36 (3%) 0/34 (0%) | |FIRST INCIDENCE | 552 403 603 | 551 735 (T) 411 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.394N P=0.681N P=0.491N | P=0.677N P=0.749N P=0.756N | |POLY 3 | P=0.401N P=0.680N P=0.493N | P=0.672 P=0.754N P=0.755 | |POLY 1.5 | P=0.406N P=0.686N P=0.499N | P=0.671 P=0.756N P=0.753 | |POLY 6 | P=0.397N P=0.674N P=0.488N | P=0.672 P=0.752N P=0.755 | |LOGISTIC REGRESSION| P=0.600N P=0.596 P=0.574N | P=0.587 P=0.751 P=0.624 | |COCH-ARM / FISHERS | P=0.418N P=0.684 P=0.515N | P=0.664 P=0.753N P=0.737 | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 38 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Spleen | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/49 (2%) 1/48 (2%) | 0/50 (0%) 0/50 (0%) 0/47 (0%) | |POLY-3 ADJUSTED (b)| 4.8% 2.4% 2.4% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 552 700 658 | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.431N P=0.495N P=0.473N | (e) (e) (e) | |POLY 3 | P=0.448N P=0.502N P=0.499N | (e) (e) (e) | |POLY 1.5 | P=0.451N P=0.502N P=0.502N | (e) (e) (e) | |POLY 6 | P=0.447N P=0.502N P=0.497N | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.534N P=0.555N P=0.624N | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.459N P=0.508N P=0.515N | (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Stomach, Forestomach | | Diverticulum | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 4.9% 0.0% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 617 --- --- | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.171N P=0.227N P=0.238N | (e) (e) (e) | |POLY 3 | P=0.169N P=0.233N P=0.228N | (e) (e) (e) | |POLY 1.5 | P=0.169N P=0.234N P=0.230N | (e) (e) (e) | |POLY 6 | P=0.168N P=0.233N P=0.228N | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.170N P=0.237N P=0.237N | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.171N P=0.247N P=0.247N | (e) (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 39 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) | 2/50 (4%) 0/50 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 2.5% 7.0% 4.6% | 4.6% 0.0% 4.6% | |TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/26 (0%) | 1/34 (3%) 0/36 (0%) 1/34 (3%) | |FIRST INCIDENCE | 733 (T) 460 525 | 124 --- 411 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.522 P=0.331 P=0.509 | P=0.551 P=0.233N P=0.692N | |POLY 3 | P=0.536 P=0.326 P=0.524 | P=0.550 P=0.232N P=0.694N | |POLY 1.5 | P=0.526 P=0.319 P=0.517 | P=0.550 P=0.235N P=0.692 | |POLY 6 | P=0.545 P=0.336 P=0.530 | P=0.548 P=0.229N P=0.694N | |LOGISTIC REGRESSION| P=0.413 P=0.274 P=0.470 | P=0.370 P=0.288N P=0.505 | |COCH-ARM / FISHERS | P=0.500 P=0.309 P=0.500 | P=0.547 P=0.247N P=0.684 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.5% 7.1% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 1/29 (3%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) 460 --- | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.293N P=0.330 P=0.508N | (e) (e) (e) | |POLY 3 | P=0.274N P=0.323 P=0.490N | (e) (e) (e) | |POLY 1.5 | P=0.279N P=0.318 P=0.492N | (e) (e) (e) | |POLY 6 | P=0.273N P=0.331 P=0.489N | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.321N P=0.289 (e) | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.294N P=0.309 P=0.500N | (e) (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 40 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 2.4% 9.3% 2.3% | 2.3% 0.0% 2.3% | |TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 552 513 672 | 551 --- 643 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.479N P=0.198 P=0.746N | P=0.648 P=0.491N P=0.758N | |POLY 3 | P=0.479N P=0.193 P=0.752N | P=0.645 P=0.494N P=0.761 | |POLY 1.5 | P=0.482N P=0.189 P=0.753N | P=0.646 P=0.496N P=0.760 | |POLY 6 | P=0.478N P=0.199 P=0.752N | P=0.644 P=0.492N P=0.760 | |LOGISTIC REGRESSION| P=0.595N P=0.139 P=0.725 | P=0.598 P=0.536N P=0.716 | |COCH-ARM / FISHERS | P=0.500N P=0.181 P=0.753N | P=0.644 P=0.500N P=0.747 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/48 (4%) 3/49 (6%) | 0/49 (0%) 0/50 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 2.5% 4.9% 7.2% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/27 (4%) 1/29 (3%) 3/26 (12%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 733 (T) 710 733 (T) | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.235 P=0.525 P=0.290 | (e) (e) (e) | |POLY 3 | P=0.268 P=0.501 P=0.317 | (e) (e) (e) | |POLY 1.5 | P=0.264 P=0.496 P=0.313 | (e) (e) (e) | |POLY 6 | P=0.271 P=0.507 P=0.320 | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.260 P=0.511 P=0.290 | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.248 P=0.485 P=0.301 | (e) (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 41 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Stomach, Glandular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/48 (4%) 0/49 (0%) | 1/49 (2%) 1/50 (2%) 2/48 (4%) | |POLY-3 ADJUSTED (b)| 4.9% 4.8% 0.0% | 2.3% 2.2% 4.7% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | 624 403 --- | 551 600 585 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.165N P=0.678N P=0.217N | P=0.394 P=0.748N P=0.507 | |POLY 3 | P=0.168N P=0.692N P=0.233N | P=0.392 P=0.750N P=0.501 | |POLY 1.5 | P=0.169N P=0.692 P=0.234N | P=0.392 P=0.752N P=0.501 | |POLY 6 | P=0.169N P=0.688N P=0.233N | P=0.392 P=0.747N P=0.502 | |LOGISTIC REGRESSION| P=0.232N P=0.627 P=0.262N | P=0.309 P=0.743 P=0.410 | |COCH-ARM / FISHERS | P=0.175N P=0.676 P=0.253N | P=0.384 P=0.747N P=0.492 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Testes | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 5/50 (10%) 10/50 (20%) | | |POLY-3 ADJUSTED (b)| 19.4% 11.9% 23.4% | | |TERMINAL (d) | 6/27 (22%) 3/29 (10%) 8/26 (31%) | | |FIRST INCIDENCE | 495 651 676 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.253 P=0.246N P=0.380 | | |POLY 3 | P=0.290 P=0.263N P=0.428 | | |POLY 1.5 | P=0.288 P=0.266N P=0.423 | | |POLY 6 | P=0.287 P=0.258N P=0.427 | | |LOGISTIC REGRESSION| P=0.307 P=0.259N P=0.445 | | |COCH-ARM / FISHERS | P=0.272 P=0.277N P=0.398 | | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 42 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Testes: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) | | |POLY-3 ADJUSTED (b)| 5.0% 0.0% 4.7% | | |TERMINAL (d) | 2/27 (7%) 0/29 (0%) 2/26 (8%) | | |FIRST INCIDENCE | 733 (T) --- 733 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.536 P=0.222N P=0.683 | | |POLY 3 | P=0.565 P=0.231N P=0.677N | | |POLY 1.5 | P=0.562 P=0.233N P=0.680N | | |POLY 6 | P=0.565 P=0.229N P=0.675N | | |LOGISTIC REGRESSION| P=0.536 (e) P=0.683 | | |COCH-ARM / FISHERS | P=0.554 P=0.247N P=0.691N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Testes: Interstitial Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 6/50 (12%) 9/50 (18%) | | |POLY-3 ADJUSTED (b)| 14.4% 13.7% 20.2% | | |TERMINAL (d) | 2/27 (7%) 2/29 (7%) 3/26 (12%) | | |FIRST INCIDENCE | 551 460 545 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.255 P=0.584N P=0.325 | | |POLY 3 | P=0.259 P=0.587N P=0.333 | | |POLY 1.5 | P=0.250 P=0.596N P=0.321 | | |POLY 6 | P=0.265 P=0.580N P=0.342 | | |LOGISTIC REGRESSION| P=0.169 P=0.585 P=0.261 | | |COCH-ARM / FISHERS | P=0.225 P=0.620N P=0.288 | | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 43 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 41/49 (84%) 42/48 (88%) 37/48 (77%) | 41/47 (87%) 42/50 (84%) 39/47 (83%) | |POLY-3 ADJUSTED (b)| 89.1% 89.2% 82.2% | 90.1% 87.7% 84.1% | |TERMINAL (d) | 24/27 (89%) 25/29 (86%) 22/26 (85%) | 30/34 (88%) 32/36 (89%) 27/33 (82%) | |FIRST INCIDENCE | 476 403 530 | 476 436 411 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.283N P=0.482N P=0.315N | P=0.485N P=0.462N P=0.494N | |POLY 3 | P=0.179N P=0.632 P=0.242N | P=0.253N P=0.487N P=0.294N | |POLY 1.5 | P=0.156N P=0.573 P=0.226N | P=0.266N P=0.456N P=0.299N | |POLY 6 | P=0.240N P=0.599N P=0.298N | P=0.244N P=0.516N P=0.292N | |LOGISTIC REGRESSION| P=0.119N P=0.473 P=0.161N | P=0.332N P=0.403N P=0.363N | |COCH-ARM / FISHERS | P=0.194N P=0.403 P=0.287N | P=0.366N P=0.436N P=0.387N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/48 (4%) 1/48 (2%) | 1/47 (2%) 0/50 (0%) 0/47 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.9% 2.5% | 2.4% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 2/29 (7%) 0/26 (0%) | 1/34 (3%) 0/36 (0%) 0/33 (0%) | |FIRST INCIDENCE | --- 733 (T) 728 | 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.492 P=0.254 P=0.507 | P=0.400N P=0.489N P=0.506N | |POLY 3 | P=0.519 P=0.241 P=0.506 | P=0.398N P=0.484N P=0.500N | |POLY 1.5 | P=0.514 P=0.239 P=0.504 | P=0.397N P=0.486N P=0.499N | |POLY 6 | P=0.521 P=0.244 P=0.506 | P=0.399N P=0.483N P=0.502N | |LOGISTIC REGRESSION| P=0.498 P=0.254 P=0.503 | P=0.400N (e) (e) | |COCH-ARM / FISHERS | P=0.495 P=0.242 P=0.495 | P=0.395N P=0.485N P=0.500N | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 44 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Tongue | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/2 (100%) 0/0 (0%) 0/0 (0%) | 1/1 (100%) 0/1 (0%) 1/1 (100%) | |POLY-3 ADJUSTED (b)| 100.0% 0.0% 0.0% | 100.0% 0.0% 100.0% | |TERMINAL (d) | 2/2 (100%) 0/0 (0%) 0/0 (0%) | 1/1 (100%) 0/1 (0%) 1/1 (100%) | |FIRST INCIDENCE | 733 (T) --- --- | 735 (T) --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.704 P=0.500N (e) | |POLY 3 | (e) (e) (e) | P=1.000 P=1.000 (e) | |POLY 1.5 | (e) (e) (e) | P=1.000 P=1.000 (e) | |POLY 6 | (e) (e) (e) | P=1.000 P=1.000 (e) | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.704 P=0.250N (e) | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.744 P=0.500N (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Tooth | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/2 (100%) 2/3 (67%) 1/1 (100%) | 2/2 (100%) 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 100.0% 66.7% 100.0% | 100.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 2/3 (67%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 672 733 (T) 658 | 124 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.496N P=0.236N (e) | (e) (e) (e) | |POLY 3 | P=0.807 P=0.577N (e) | (e) (e) (e) | |POLY 1.5 | P=0.807 P=0.577N (e) | (e) (e) (e) | |POLY 6 | P=0.807 P=0.577N (e) | (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.236N (e) | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.863 P=0.600N (e) | (e) (e) (e) | |=================================================================================================================================| Date: 10/28/99 EXPERIMENT: 88124 TEST: 03 Page 45 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - INDIUM PHOSPHIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1MG/M3 0.3MG/M3 | CONTROL 0.1MG/M3 0.3MG/M3 | | | STOP STOP | STOP STOP | |=================================================================================================================================| | | |Urinary Bladder | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/50 (0%) | 0/49 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.8% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/26 (0%) | 0/34 (0%) 0/36 (0%) 0/34 (0%) | |FIRST INCIDENCE | --- 552 --- | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.567N P=0.250 (e) | (e) (e) (e) | |POLY 3 | P=0.556N P=0.243 (e) | (e) (e) (e) | |POLY 1.5 | P=0.560N P=0.239 (e) | (e) (e) (e) | |POLY 6 | P=0.554N P=0.248 (e) | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.612N P=0.217 (e) | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.574N P=0.242 (e) | (e) (e) (e) | |=================================================================================================================================| (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 346800-346800/346800 --multipart-boundary--