TDMS Study 05180-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest GALLIUM ARSENIDE DATE: 03/09/99 EXPERIMENT: 05180 TEST: 07 TIME: 14:29:27 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62033B PATHOLOGIST: MILLER, RODNEY CAS: 1303-00-0000 ------------------------------------------------------------------------------------------------------------------------------------ 2 YEAR CHRONIC MICE REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest GALLIUM ARSENIDE DATE: 03/09/99 EXPERIMENT: 05180 TEST: 07 TIME: 14:29:27 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62033B PATHOLOGIST: MILLER, RODNEY CAS: 1303-00-0000 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF GALLIUM ARSENIDE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex Hypertrophy Harderian Gland Hyperplasia Heart Cardiomyopathy Larynx: Squamous Epithelium Hyperplasia Liver Eosinophilic Focus Lung Infiltration Cellular Histiocyte Inflammation Chronic Focal Inflammation Focal Lung: Alveolar Epithelium Hyperplasia Lung: Alveolus Foreign Body Proteinosis Lymph Node, Bronchial Hyperplasia Mesentery: Fat Necrosis Preputial Gland Inflammation Testes Atrophy =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Kidney Nephropathy Liver Eosinophilic Focus Lung Infiltration Cellular Histiocyte Inflammation Chronic Focal Inflammation Focal Lung: Alveolar Epithelium Hyperplasia Lung: Alveolus Foreign Body Proteinosis Lymph Node, Bronchial Hyperplasia Mesentery: Fat Necrosis Nose: Olfactory Epithelium Degeneration Hyaline Pituitary Gland: Pars Distalis Hyperplasia Spleen Hematopoietic Cell Proliferation Hyperplasia Lymphoid =============================================================== Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 10/50 (20%) 7/50 (14%) 4/48 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 9.1% 21.6% 16.3% 9.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/35 (9%) 8/38 (21%) 7/34 (21%) 3/34 (9%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 647 609 733 (T) 723 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.293N P=0.105 P=0.240 P=0.634 |(e) (e) (e) (e) | |POLY 3 | P=0.251N P=0.086 P=0.243 P=0.642N |(e) (e) (e) (e) | |POLY 1.5 | P=0.254N P=0.083 P=0.253 P=0.640 |(e) (e) (e) (e) | |POLY 6 | P=0.253N P=0.090 P=0.232 P=0.641N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.261N P=0.087 P=0.237 P=0.638N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.274N P=0.074 P=0.262 P=0.619 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 38/50 (76%) 33/50 (66%) 38/50 (76%) 30/48 (63%) |5/50 (10%) 5/50 (10%) 7/50 (14%) 7/49 (14%) | |POLY-3 ADJUSTED (b)| 82.7% 71.1% 82.9% 65.0% |11.2% 11.0% 17.1% 16.8% | |TERMINAL (d) | 33/35 (94%) 29/38 (76%) 30/34 (88%) 25/34 (74%) |5/36 (14%) 5/34 (15%) 6/31 (19%) 5/29 (17%) | |FIRST INCIDENCE | 462 659 504 501 |735 (T) 735 (T) 629 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.255N P=0.053N P=0.490 P=0.077N |P=0.144 P=0.596 P=0.277 P=0.249 | |POLY 3 | P=0.079N P=0.128N P=0.606 P=0.037N* |P=0.202 P=0.624N P=0.316 P=0.328 | |POLY 1.5 | P=0.107N P=0.137N P=0.608 P=0.051N |P=0.221 P=0.629N P=0.336 P=0.343 | |POLY 6 | P=0.058N P=0.112N P=0.626 P=0.025N* |P=0.185 P=0.620N P=0.301 P=0.313 | |LOGISTIC REGRESSION| P=0.120N P=0.079N P=0.540 P=0.051N |P=0.171 P=0.596 P=0.286 P=0.297 | |COCH-ARM / FISHERS | P=0.190N P=0.189N P=0.592N P=0.109N |P=0.249 P=0.630N P=0.380 P=0.365 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/47 (2%) |1/50 (2%) 2/49 (4%) 1/50 (2%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.3% |2.2% 4.5% 2.4% 4.8% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 0/34 (0%) 1/34 (3%) |1/36 (3%) 2/34 (6%) 0/31 (0%) 2/29 (7%) | |FIRST INCIDENCE | --- --- --- 733 (T) |735 (T) 735 (T) 659 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.178 (e) (e) P=0.494 |P=0.403 P=0.480 P=0.726 P=0.424 | |POLY 3 | P=0.182 (e) (e) P=0.498 |P=0.444 P=0.496 P=0.740 P=0.471 | |POLY 1.5 | P=0.181 (e) (e) P=0.496 |P=0.457 P=0.494 P=0.746 P=0.480 | |POLY 6 | P=0.183 (e) (e) P=0.501 |P=0.431 P=0.499 P=0.734 P=0.462 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.494 |P=0.433 P=0.480 P=0.755 P=0.424 | |COCH-ARM / FISHERS | P=0.178 (e) (e) P=0.485 |P=0.475 P=0.492 P=0.753N P=0.492 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Bone | | Fibrous Osteodystrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |21/50 (42%) 24/50 (48%) 14/50 (28%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 2.3% 4.4% 4.7% 0.0% |44.8% 52.2% 34.0% 42.1% | |TERMINAL (d) | 1/34 (3%) 2/38 (5%) 2/34 (6%) 0/34 (0%) |16/36 (44%) 20/34 (59%) 11/31 (36%) 16/29 (55%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) --- |237 659 560 529 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.278N P=0.539 P=0.500 P=0.500N |P=0.374N P=0.285 P=0.235N P=0.513 | |POLY 3 | P=0.256N P=0.524 P=0.501 P=0.490N |P=0.220N P=0.307 P=0.204N P=0.481N | |POLY 1.5 | P=0.256N P=0.519 P=0.504 P=0.491N |P=0.174N P=0.307 P=0.167N P=0.425N | |POLY 6 | P=0.258N P=0.529 P=0.496 P=0.490N |P=0.279N P=0.308 P=0.241N P=0.544N | |LOGISTIC REGRESSION| P=0.278N P=0.539 P=0.500 (e) |P=0.207N P=0.346 P=0.152N P=0.401N | |COCH-ARM / FISHERS | P=0.260N P=0.508 P=0.508 P=0.495N |P=0.122N P=0.344 P=0.104N P=0.341N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 3/50 (6%) 2/50 (4%) 3/48 (6%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.5% 6.5% 4.6% 6.7% |4.4% 2.2% 4.8% 2.4% | |TERMINAL (d) | 0/34 (0%) 2/38 (5%) 1/34 (3%) 0/34 (0%) |0/36 (0%) 1/34 (3%) 1/31 (3%) 0/29 (0%) | |FIRST INCIDENCE | 462 729 639 555 |439 735 (T) 421 710 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.473 P=0.533 P=0.686 P=0.506 |P=0.531N P=0.518N P=0.649 P=0.542N | |POLY 3 | P=0.481 P=0.517 P=0.687 P=0.507 |P=0.512N P=0.503N P=0.658 P=0.527N | |POLY 1.5 | P=0.480 P=0.517 P=0.693 P=0.504 |P=0.498N P=0.503N P=0.670 P=0.516N | |POLY 6 | P=0.482 P=0.519 P=0.680 P=0.509 |P=0.526N P=0.502N P=0.648 P=0.539N | |LOGISTIC REGRESSION| P=0.432 P=0.447 P=0.690 P=0.355 |P=0.455N P=0.486N P=0.605N P=0.476N | |COCH-ARM / FISHERS | P=0.470 P=0.510 P=0.684N P=0.490 |P=0.479N P=0.500N P=0.691N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Brain: Meninges | | Infiltration Cellular Mononuclear Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |2/50 (4%) 5/50 (10%) 3/50 (6%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.3% 0.0% |4.5% 11.0% 7.3% 7.1% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 1/34 (3%) 0/34 (0%) |2/36 (6%) 4/34 (12%) 2/31 (7%) 2/29 (7%) | |FIRST INCIDENCE | --- --- 733 (T) --- |735 (T) 715 659 714 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.638 (e) P=0.494 (e) |P=0.516 P=0.200 P=0.432 P=0.409 | |POLY 3 | P=0.657 (e) P=0.496 (e) |P=0.560N P=0.221 P=0.458 P=0.472 | |POLY 1.5 | P=0.655 (e) P=0.498 (e) |P=0.541N P=0.218 P=0.471 P=0.484 | |POLY 6 | P=0.658 (e) P=0.493 (e) |P=0.561 P=0.224 P=0.447 P=0.459 | |LOGISTIC REGRESSION| (e) (e) P=0.494 (e) |P=0.556 P=0.213 P=0.448 P=0.440 | |COCH-ARM / FISHERS | P=0.646 (e) P=0.500 (e) |P=0.515N P=0.218 P=0.500 P=0.500 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Epididymis | | Granuloma Sperm | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/49 (2%) | | |POLY-3 ADJUSTED (b)| 0.0% 4.4% 0.0% 2.2% | | |TERMINAL (d) | 0/35 (0%) 2/38 (5%) 0/34 (0%) 1/34 (3%) | | |FIRST INCIDENCE | --- 733 (T) --- 733 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.626 P=0.257 (e) P=0.494 | | |POLY 3 | P=0.644N P=0.247 (e) P=0.504 | | |POLY 1.5 | P=0.644N P=0.245 (e) P=0.503 | | |POLY 6 | P=0.644N P=0.251 (e) P=0.505 | | |LOGISTIC REGRESSION| (e) P=0.257 (e) P=0.494 | | |COCH-ARM / FISHERS | P=0.640 P=0.247 (e) P=0.495 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Epididymis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | | |POLY-3 ADJUSTED (b)| 4.5% 2.2% 0.0% 0.0% | | |TERMINAL (d) | 1/35 (3%) 1/38 (3%) 0/34 (0%) 0/34 (0%) | | |FIRST INCIDENCE | 462 733 (T) --- --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.111N P=0.476N P=0.243N P=0.241N | | |POLY 3 | P=0.109N P=0.490N P=0.246N P=0.236N | | |POLY 1.5 | P=0.108N P=0.492N P=0.242N P=0.237N | | |POLY 6 | P=0.111N P=0.487N P=0.250N P=0.237N | | |LOGISTIC REGRESSION| P=0.113N P=0.548N P=0.245N P=0.298N | | |COCH-ARM / FISHERS | P=0.106N P=0.500N P=0.247N P=0.253N | | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Eye | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/2 (0%) 1/1 (100%) 0/0 (0%) 2/4 (50%) |0/1 (0%) 0/0 (0%) 1/2 (50%) 0/1 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 100.0% 0.0% 50.2% |0.0% 0.0% 50.0% 0.0% | |TERMINAL (d) | 0/2 (0%) 0/0 (0%) 0/0 (0%) 2/3 (67%) |0/0 (0%) 0/0 (0%) 1/2 (50%) 0/1 (0%) | |FIRST INCIDENCE | --- 609 --- 733 (T) |--- --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.360 P=0.527 (e) P=0.309 |P=0.638N (e) P=1.000 (e) | |POLY 3 | (e) P=1.000 (e) P=0.385 |(e) (e) P=0.677 (e) | |POLY 1.5 | (e) P=1.000 (e) P=0.386 |(e) (e) P=0.649 (e) | |POLY 6 | (e) P=1.000 (e) P=0.383 |(e) (e) P=0.714 (e) | |LOGISTIC REGRESSION| P=0.233 (e) (e) P=0.309 |(e) (e) P=1.000 (e) | |COCH-ARM / FISHERS | P=0.441 P=0.333 (e) P=0.400 |P=0.793 (e) P=0.667 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Harderian Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/47 (2%) 1/48 (2%) 10/49 (20%) 1/48 (2%) |0/5 (0%) 0/4 (0%) 0/3 (0%) 0/2 (0%) | |POLY-3 ADJUSTED (b)| 2.3% 2.3% 23.3% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 1/37 (3%) 9/34 (27%) 1/33 (3%) |0/3 (0%) 0/3 (0%) 0/2 (0%) 0/2 (0%) | |FIRST INCIDENCE | 699 733 (T) 729 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.276 P=0.746N P=0.005 ** P=0.754 |(e) (e) (e) (e) | |POLY 3 | P=0.312 P=0.755N P=0.004 ** P=0.758N |(e) (e) (e) (e) | |POLY 1.5 | P=0.317 P=0.756N P=0.004 ** P=0.757N |(e) (e) (e) (e) | |POLY 6 | P=0.302 P=0.754N P=0.003 ** P=0.760N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.297 P=0.757N P=0.004 ** P=0.759N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.326 P=0.747N P=0.005 ** P=0.747N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 48/50 (96%) 50/50 (100%) 49/50 (98%) 47/50 (94%) |49/50 (98%) 48/50 (96%) 47/50 (94%) 47/50 (94%) | |POLY-3 ADJUSTED (b)| 99.5% 100.0% 98.0% 95.2% |99.9% 97.9% 97.0% 97.6% | |TERMINAL (d) | 35/35 (100%) 38/38 (100%) 33/34 (97%) 33/34 (97%) |36/36 (100%) 33/34 (97%) 30/31 (97%) 29/29 (100%) | |FIRST INCIDENCE | 457 473 232 406 |439 302 281 412 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.464 P=0.424N P=0.402 P=0.548N |P=0.110 P=0.529 P=0.254 P=0.160 | |POLY 3 | P=0.044N* P=0.998 P=0.604N P=0.223N |P=0.327N P=0.511N P=0.339N P=0.430N | |POLY 1.5 | P=0.050N P=0.826 P=0.686N P=0.251N |P=0.214N P=0.544N P=0.290N P=0.301N | |POLY 6 | P=0.052N P=1.000 P=0.533N P=0.229N |P=0.488N P=0.500N P=0.420N P=0.666N | |LOGISTIC REGRESSION| P=0.109N (e) P=0.569 P=0.308N |P=0.228N P=0.641N P=0.528N P=0.357N | |COCH-ARM / FISHERS | P=0.185N P=0.247 P=0.500 P=0.500N |P=0.231N P=0.500N P=0.309N P=0.309N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Heart: Atrium | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.5% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 2.3% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 561 --- --- --- |--- --- --- 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.166N P=0.229N P=0.251N P=0.237N |P=0.182 (e) (e) P=0.492 | |POLY 3 | P=0.166N P=0.231N P=0.245N P=0.235N |P=0.180 (e) (e) P=0.491 | |POLY 1.5 | P=0.164N P=0.232N P=0.241N P=0.234N |P=0.183 (e) (e) P=0.495 | |POLY 6 | P=0.169N P=0.229N P=0.250N P=0.237N |P=0.176 (e) (e) P=0.486 | |LOGISTIC REGRESSION| P=0.167N P=0.266N P=0.240N P=0.261N |P=0.163 (e) (e) P=0.488 | |COCH-ARM / FISHERS | P=0.160N P=0.247N P=0.247N P=0.247N |P=0.186 (e) (e) P=0.500 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Intestine Small, Ileum: Peyer's Patch | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/44 (0%) 0/47 (0%) 1/45 (2%) 0/42 (0%) |1/48 (2%) 0/47 (0%) 2/49 (4%) 1/45 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 0.0% |2.3% 0.0% 5.0% 2.6% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 1/34 (3%) 0/34 (0%) |1/36 (3%) 0/34 (0%) 1/31 (3%) 1/29 (3%) | |FIRST INCIDENCE | --- --- 733 (T) --- |735 (T) --- 645 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.638 (e) P=0.494 (e) |P=0.368 P=0.511N P=0.448 P=0.713 | |POLY 3 | P=0.655 (e) P=0.501 (e) |P=0.368 P=0.499N P=0.468 P=0.729 | |POLY 1.5 | P=0.651 (e) P=0.504 (e) |P=0.382 P=0.501N P=0.479 P=0.735 | |POLY 6 | P=0.656 (e) P=0.498 (e) |P=0.357 P=0.498N P=0.460 P=0.723 | |LOGISTIC REGRESSION| (e) (e) P=0.494 (e) |P=0.382 (e) P=0.482 P=0.713 | |COCH-ARM / FISHERS | P=0.640 (e) P=0.506 (e) |P=0.408 P=0.505N P=0.508 P=0.736 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Intestine Small, Jejunum: Peyer's Patch | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/44 (2%) 0/48 (0%) 1/45 (2%) 1/43 (2%) |2/48 (4%) 1/47 (2%) 0/49 (0%) 0/43 (0%) | |POLY-3 ADJUSTED (b)| 2.5% 0.0% 2.5% 2.5% |4.5% 2.3% 0.0% 0.0% | |TERMINAL (d) | 1/35 (3%) 0/38 (0%) 1/34 (3%) 0/34 (0%) |2/36 (6%) 1/34 (3%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 733 (T) --- 733 (T) 723 |735 (T) 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.457 P=0.484N P=0.755 P=0.757N |P=0.128N P=0.520N P=0.272N P=0.287N | |POLY 3 | P=0.463 P=0.481N P=0.759N P=0.759N |P=0.123N P=0.498N P=0.260N P=0.274N | |POLY 1.5 | P=0.461 P=0.480N P=0.756N P=0.759N |P=0.119N P=0.501N P=0.252N P=0.270N | |POLY 6 | P=0.463 P=0.482N P=0.759 P=0.759N |P=0.126N P=0.496N P=0.267N P=0.277N | |LOGISTIC REGRESSION| P=0.457 (e) P=0.755 P=0.762N |P=0.128N P=0.520N (e) (e) | |COCH-ARM / FISHERS | P=0.453 P=0.478N P=0.747N P=0.747 |P=0.111N P=0.508N P=0.242N P=0.275N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 8 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/48 (6%) 2/49 (4%) 4/47 (9%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/48 (2%) | |POLY-3 ADJUSTED (b)| 4.6% 6.8% 4.7% 9.2% |2.2% 2.2% 2.5% 2.4% | |TERMINAL (d) | 2/35 (6%) 3/36 (8%) 2/34 (6%) 2/34 (6%) |0/36 (0%) 0/34 (0%) 1/31 (3%) 1/29 (3%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 665 |694 715 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.284 P=0.513 P=0.685 P=0.333 |P=0.569 P=0.755N P=0.725 P=0.724 | |POLY 3 | P=0.299 P=0.500 P=0.683 P=0.334 |P=0.591 P=0.759N P=0.737 P=0.740 | |POLY 1.5 | P=0.296 P=0.496 P=0.685 P=0.328 |P=0.601 P=0.760N P=0.745 P=0.745 | |POLY 6 | P=0.302 P=0.506 P=0.680 P=0.340 |P=0.580 P=0.758N P=0.730 P=0.734 | |LOGISTIC REGRESSION| P=0.295 P=0.513 P=0.685 P=0.332 |P=0.590 P=0.762N P=0.742 P=0.744 | |COCH-ARM / FISHERS | P=0.283 P=0.480 P=0.684 P=0.310 |P=0.615 P=0.753N P=0.753N P=0.742 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Kidney | | Glomerulosclerosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |1/36 (3%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- --- |237 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.173N P=0.248N P=0.256N P=0.263N | |POLY 3 | (e) (e) (e) (e) |P=0.165N P=0.240N P=0.265N P=0.256N | |POLY 1.5 | (e) (e) (e) (e) |P=0.162N P=0.241N P=0.256N P=0.249N | |POLY 6 | (e) (e) (e) (e) |P=0.168N P=0.238N P=0.272N P=0.264N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.145N P=0.171N P=0.132N P=0.221N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.160N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 9 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Kidney | | Hydronephrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/49 (4%) 3/48 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.5% 6.5% 4.6% 6.7% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 2/38 (5%) 1/34 (3%) 2/34 (6%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 561 617 504 659 |729 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.463 P=0.528 P=0.681 P=0.497 |P=0.381N P=0.516N P=0.534N P=0.547N | |POLY 3 | P=0.474 P=0.518 P=0.684 P=0.501 |P=0.358N P=0.498N P=0.520N P=0.513N | |POLY 1.5 | P=0.473 P=0.514 P=0.686 P=0.497 |P=0.356N P=0.500N P=0.513N P=0.507N | |POLY 6 | P=0.474 P=0.524 P=0.681 P=0.503 |P=0.360N P=0.497N P=0.526N P=0.519N | |LOGISTIC REGRESSION| P=0.438 P=0.475 P=0.680 P=0.460 |P=0.372N P=0.498N P=0.529N P=0.524N | |COCH-ARM / FISHERS | P=0.462 P=0.500 P=0.684 P=0.480 |P=0.351N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Kidney | | Metaplasia Osseous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/49 (8%) 0/48 (0%) |2/50 (4%) 3/50 (6%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.2% 9.4% 0.0% |4.5% 6.6% 2.5% 2.4% | |TERMINAL (d) | 0/35 (0%) 1/38 (3%) 3/34 (9%) 0/34 (0%) |2/36 (6%) 2/34 (6%) 1/31 (3%) 0/29 (0%) | |FIRST INCIDENCE | --- 733 (T) 692 --- |735 (T) 715 735 (T) 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.544 P=0.516 P=0.060 (e) |P=0.295N P=0.482 P=0.552N P=0.553N | |POLY 3 | P=0.584 P=0.509 P=0.056 (e) |P=0.256N P=0.505 P=0.535N P=0.519N | |POLY 1.5 | P=0.578 P=0.507 P=0.057 (e) |P=0.246N P=0.501 P=0.523N P=0.511N | |POLY 6 | P=0.587 P=0.512 P=0.056 (e) |P=0.266N P=0.509 P=0.545N P=0.528N | |LOGISTIC REGRESSION| P=0.561 P=0.516 P=0.057 (e) |P=0.263N P=0.502 P=0.552N P=0.512N | |COCH-ARM / FISHERS | P=0.554 P=0.500 P=0.056 (e) |P=0.232N P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 10 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 48/50 (96%) 49/50 (98%) 45/49 (92%) 47/48 (98%) |43/50 (86%) 44/50 (88%) 40/50 (80%) 36/50 (72%) | |POLY-3 ADJUSTED (b)| 99.5% 99.4% 97.0% 97.9% |88.7% 92.0% 84.8% 77.6% | |TERMINAL (d) | 35/35 (100%) 38/38 (100%) 34/34 (100%) 33/34 (97%) |32/36 (89%) 31/34 (91%) 26/31 (84%) 24/29 (83%) | |FIRST INCIDENCE | 457 473 393 501 |439 533 239 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.470 P=0.346N P=0.451N P=0.550N |P=0.496N P=0.393 P=0.384 P=0.559 | |POLY 3 | P=0.282N P=0.994N P=0.413N P=0.595N |P=0.024N* P=0.419 P=0.391N P=0.106N | |POLY 1.5 | P=0.379N P=0.912N P=0.289N P=0.676N |P=0.014N* P=0.418 P=0.337N P=0.078N | |POLY 6 | P=0.197N P=1.000N P=0.820N P=0.525N |P=0.051N P=0.438 P=0.456N P=0.163N | |LOGISTIC REGRESSION| P=0.357N P=0.804N P=0.305N P=0.674N |P=0.027N* P=0.488 P=0.389N P=0.093N | |COCH-ARM / FISHERS | P=0.574 P=0.500 P=0.329N P=0.515 |P=0.018N* P=0.500 P=0.298N P=0.070N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Kidney: Capsule | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/49 (4%) 0/48 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.2% 4.7% 0.0% |0.0% 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/35 (0%) 1/38 (3%) 2/34 (6%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) --- |--- --- --- 710 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.608N P=0.516 P=0.232 (e) |P=0.171 (e) (e) P=0.478 | |POLY 3 | P=0.584N P=0.509 P=0.230 (e) |P=0.178 (e) (e) P=0.488 | |POLY 1.5 | P=0.587N P=0.507 P=0.232 (e) |P=0.182 (e) (e) P=0.493 | |POLY 6 | P=0.582N P=0.512 P=0.228 (e) |P=0.174 (e) (e) P=0.482 | |LOGISTIC REGRESSION| (e) P=0.516 P=0.232 (e) |P=0.179 (e) (e) P=0.491 | |COCH-ARM / FISHERS | P=0.599N P=0.500 P=0.242 (e) |P=0.186 (e) (e) P=0.500 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 11 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Kidney: Cortex | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 0/49 (0%) 2/48 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.6% 8.7% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/35 (6%) 4/38 (11%) 0/34 (0%) 2/34 (6%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.335N P=0.375 P=0.245N P=0.685 |(e) (e) (e) (e) | |POLY 3 | P=0.316N P=0.358 P=0.244N P=0.691N |(e) (e) (e) (e) | |POLY 1.5 | P=0.317N P=0.353 P=0.242N P=0.693 |(e) (e) (e) (e) | |POLY 6 | P=0.316N P=0.365 P=0.246N P=0.688N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.335N P=0.375 (e) P=0.685 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.324N P=0.339 P=0.253N P=0.676 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/49 (6%) 1/48 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.6% 0.0% 7.1% 2.3% |0.0% 0.0% 0.0% 2.4% | |TERMINAL (d) | 2/35 (6%) 0/38 (0%) 3/34 (9%) 1/34 (3%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 733 (T) --- 733 (T) 733 (T) |--- --- --- 717 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.535 P=0.220N P=0.487 P=0.510N |P=0.170 (e) (e) P=0.466 | |POLY 3 | P=0.559 P=0.227N P=0.486 P=0.497N |P=0.178 (e) (e) P=0.488 | |POLY 1.5 | P=0.556 P=0.230N P=0.489 P=0.501N |P=0.182 (e) (e) P=0.493 | |POLY 6 | P=0.558 P=0.224N P=0.482 P=0.494N |P=0.173 (e) (e) P=0.482 | |LOGISTIC REGRESSION| P=0.535 (e) P=0.487 P=0.510N |P=0.176 (e) (e) P=0.486 | |COCH-ARM / FISHERS | P=0.546 P=0.247N P=0.490 P=0.515N |P=0.186 (e) (e) P=0.500 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 12 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Larynx | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/48 (2%) 0/48 (0%) |2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.2% 2.4% 0.0% |4.3% 4.3% 4.8% 2.3% | |TERMINAL (d) | 0/35 (0%) 1/38 (3%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- 733 (T) 504 --- |237 533 483 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.542N P=0.516 P=0.496 (e) |P=0.397N P=0.679N P=0.667 P=0.510N | |POLY 3 | P=0.534N P=0.509 P=0.493 (e) |P=0.403N P=0.693N P=0.659 P=0.526N | |POLY 1.5 | P=0.537N P=0.507 P=0.493 (e) |P=0.388N P=0.691 P=0.669 P=0.516N | |POLY 6 | P=0.532N P=0.512 P=0.492 (e) |P=0.418N P=0.689N P=0.651 P=0.537N | |LOGISTIC REGRESSION| P=0.590N P=0.516 P=0.453 (e) |P=0.331N P=0.652N P=0.511N P=0.470N | |COCH-ARM / FISHERS | P=0.546N P=0.500 P=0.490 (e) |P=0.366N P=0.691N P=0.691N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Larynx: Squamous Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 13/50 (26%) 11/48 (23%) 5/48 (10%) |11/50 (22%) 9/50 (18%) 7/50 (14%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 23.8% 28.2% 26.2% 10.9% |23.2% 19.4% 16.2% 16.4% | |TERMINAL (d) | 6/35 (17%) 10/38 (26%) 10/34 (29%) 1/34 (3%) |5/36 (14%) 6/34 (18%) 3/31 (10%) 5/29 (17%) | |FIRST INCIDENCE | 54 710 609 501 |237 533 365 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.059N P=0.500 P=0.564 P=0.102N |P=0.307N P=0.426N P=0.322N P=0.354N | |POLY 3 | P=0.039N* P=0.404 P=0.496 P=0.086N |P=0.243N P=0.423N P=0.286N P=0.292N | |POLY 1.5 | P=0.042N* P=0.405 P=0.514 P=0.091N |P=0.214N P=0.422N P=0.264N P=0.262N | |POLY 6 | P=0.037N* P=0.403 P=0.473 P=0.083N |P=0.278N P=0.427N P=0.307N P=0.330N | |LOGISTIC REGRESSION| P=0.052N P=0.380 P=0.553 P=0.177N |P=0.150N P=0.394N P=0.124N P=0.188N | |COCH-ARM / FISHERS | P=0.049N* P=0.408 P=0.553 P=0.100N |P=0.176N P=0.402N P=0.218N P=0.218N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 13 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.2% 4.7% 4.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 1/38 (3%) 2/34 (6%) 2/34 (6%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.146 P=0.516 P=0.232 P=0.232 |(e) (e) (e) (e) | |POLY 3 | P=0.168 P=0.509 P=0.232 P=0.243 |(e) (e) (e) (e) | |POLY 1.5 | P=0.169 P=0.507 P=0.235 P=0.242 |(e) (e) (e) (e) | |POLY 6 | P=0.166 P=0.512 P=0.229 P=0.242 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.516 P=0.232 P=0.232 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.164 P=0.500 P=0.247 P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.4% 4.7% 2.2% |2.2% 0.0% 2.5% 0.0% | |TERMINAL (d) | 0/35 (0%) 1/38 (3%) 2/34 (6%) 1/34 (3%) |1/36 (3%) 0/34 (0%) 1/31 (3%) 0/29 (0%) | |FIRST INCIDENCE | --- 715 733 (T) 733 (T) |735 (T) --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.501 P=0.263 P=0.232 P=0.494 |P=0.510N P=0.511N P=0.728 P=0.543N | |POLY 3 | P=0.533 P=0.248 P=0.232 P=0.505 |P=0.482N P=0.498N P=0.738 P=0.513N | |POLY 1.5 | P=0.532 P=0.245 P=0.235 P=0.505 |P=0.474N P=0.500N P=0.746 P=0.507N | |POLY 6 | P=0.531 P=0.251 P=0.229 P=0.505 |P=0.491N P=0.497N P=0.731 P=0.519N | |LOGISTIC REGRESSION| P=0.513 P=0.250 P=0.232 P=0.494 |P=0.510N (e) P=0.728 (e) | |COCH-ARM / FISHERS | P=0.523 P=0.247 P=0.247 P=0.500 |P=0.464N P=0.500N P=0.753N P=0.500N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 14 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 14/50 (28%) 14/50 (28%) 19/50 (38%) |5/50 (10%) 15/50 (30%) 11/50 (22%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 25.0% 30.4% 32.2% 41.7% |11.1% 32.4% 26.9% 32.2% | |TERMINAL (d) | 10/35 (29%) 11/38 (29%) 11/34 (32%) 15/34 (44%) |4/36 (11%) 11/34 (32%) 8/31 (26%) 10/29 (35%) | |FIRST INCIDENCE | 699 710 586 591 |639 533 659 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.039 * P=0.419 P=0.295 P=0.056 |P=0.042 * P=0.012 * P=0.049 * P=0.008 ** | |POLY 3 | P=0.058 P=0.369 P=0.306 P=0.071 |P=0.078 P=0.012 * P=0.052 P=0.013 * | |POLY 1.5 | P=0.060 P=0.357 P=0.315 P=0.070 |P=0.092 P=0.011 * P=0.062 P=0.015 * | |POLY 6 | P=0.055 P=0.388 P=0.296 P=0.071 |P=0.066 P=0.012 * P=0.045 * P=0.011 * | |LOGISTIC REGRESSION| P=0.049 * P=0.397 P=0.276 P=0.067 |P=0.077 P=0.012 * P=0.048 * P=0.016 * | |COCH-ARM / FISHERS | P=0.059 P=0.322 P=0.322 P=0.063 |P=0.118 P=0.011 * P=0.086 P=0.020 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |3/50 (6%) 4/50 (8%) 5/50 (10%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 6.7% 2.2% 4.5% 4.4% |6.6% 8.7% 11.7% 11.6% | |TERMINAL (d) | 1/35 (3%) 1/38 (3%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 1/34 (3%) 2/31 (7%) 1/29 (3%) | |FIRST INCIDENCE | 561 733 (T) 232 555 |639 644 365 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.565N P=0.289N P=0.516N P=0.503N |P=0.228 P=0.512 P=0.297 P=0.298 | |POLY 3 | P=0.557N P=0.295N P=0.504N P=0.491N |P=0.254 P=0.507 P=0.322 P=0.329 | |POLY 1.5 | P=0.554N P=0.297N P=0.499N P=0.491N |P=0.271 P=0.502 P=0.334 P=0.341 | |POLY 6 | P=0.561N P=0.293N P=0.511N P=0.492N |P=0.235 P=0.512 P=0.309 P=0.316 | |LOGISTIC REGRESSION| P=0.578 P=0.318N P=0.524N P=0.539N |P=0.321 P=0.502 P=0.448 P=0.373 | |COCH-ARM / FISHERS | P=0.555N P=0.309N P=0.500N P=0.500N |P=0.292 P=0.500 P=0.357 P=0.357 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 15 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 6.6% 2.5% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 2/34 (6%) 1/31 (3%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- --- |694 729 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.177N P=0.293 P=0.725 P=0.521N | |POLY 3 | (e) (e) (e) (e) |P=0.154N P=0.308 P=0.737 P=0.513N | |POLY 1.5 | (e) (e) (e) (e) |P=0.147N P=0.306 P=0.745 P=0.508N | |POLY 6 | (e) (e) (e) (e) |P=0.162N P=0.309 P=0.730 P=0.520N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.162N P=0.309 P=0.742 P=0.501N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.137N P=0.309 P=0.753N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.6% 6.5% 2.3% 0.0% |6.7% 2.2% 2.4% 0.0% | |TERMINAL (d) | 2/35 (6%) 2/38 (5%) 0/34 (0%) 0/34 (0%) |2/36 (6%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 733 (T) 715 502 --- |729 701 659 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.085N P=0.542 P=0.504N P=0.245N |P=0.122N P=0.321N P=0.365N P=0.165N | |POLY 3 | P=0.076N P=0.521 P=0.502N P=0.232N |P=0.105N P=0.301N P=0.339N P=0.130N | |POLY 1.5 | P=0.076N P=0.516 P=0.500N P=0.232N |P=0.099N P=0.304N P=0.328N P=0.125N | |POLY 6 | P=0.077N P=0.528 P=0.504N P=0.231N |P=0.110N P=0.297N P=0.348N P=0.136N | |LOGISTIC REGRESSION| P=0.078N P=0.534 P=0.501N (e) |P=0.102N P=0.299N P=0.339N P=0.148N | |COCH-ARM / FISHERS | P=0.078N P=0.500 P=0.500N P=0.247N |P=0.093N P=0.309N P=0.309N P=0.121N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 16 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 6/50 (12%) 5/50 (10%) 4/50 (8%) |3/50 (6%) 4/50 (8%) 7/50 (14%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 22.1% 12.8% 11.4% 8.7% |6.6% 8.8% 16.4% 11.6% | |TERMINAL (d) | 4/35 (11%) 4/38 (11%) 3/34 (9%) 1/34 (3%) |2/36 (6%) 1/34 (3%) 2/31 (7%) 2/29 (7%) | |FIRST INCIDENCE | 457 473 502 561 |533 688 483 464 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.100N P=0.177N P=0.164N P=0.089N |P=0.186 P=0.496 P=0.127 P=0.274 | |POLY 3 | P=0.076N P=0.182N P=0.142N P=0.066N |P=0.216 P=0.503 P=0.133 P=0.325 | |POLY 1.5 | P=0.075N P=0.187N P=0.136N P=0.067N |P=0.236 P=0.499 P=0.140 P=0.339 | |POLY 6 | P=0.079N P=0.177N P=0.151N P=0.065N |P=0.196 P=0.507 P=0.130 P=0.310 | |LOGISTIC REGRESSION| P=0.077N P=0.220N P=0.131N P=0.081N |P=0.278 P=0.501 P=0.197 P=0.373 | |COCH-ARM / FISHERS | P=0.075N P=0.207N P=0.131N P=0.074N |P=0.260 P=0.500 P=0.159 P=0.357 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 6/50 (12%) 6/50 (12%) 3/50 (6%) |9/50 (18%) 6/50 (12%) 5/50 (10%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 11.4% 13.1% 13.7% 6.7% |19.5% 13.2% 12.2% 11.4% | |TERMINAL (d) | 5/35 (14%) 6/38 (16%) 4/34 (12%) 3/34 (9%) |6/36 (17%) 5/34 (15%) 4/31 (13%) 1/29 (3%) | |FIRST INCIDENCE | 733 (T) 733 (T) 609 733 (T) |533 688 645 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.283N P=0.558 P=0.480 P=0.371N |P=0.298N P=0.319N P=0.283N P=0.297N | |POLY 3 | P=0.242N P=0.531 P=0.497 P=0.343N |P=0.221N P=0.297N P=0.265N P=0.223N | |POLY 1.5 | P=0.241N P=0.523 P=0.500 P=0.344N |P=0.205N P=0.297N P=0.239N P=0.210N | |POLY 6 | P=0.246N P=0.542 P=0.497 P=0.342N |P=0.238N P=0.300N P=0.289N P=0.239N | |LOGISTIC REGRESSION| P=0.251N P=0.558 P=0.485 P=0.371N |P=0.191N P=0.288N P=0.219N P=0.171N | |COCH-ARM / FISHERS | P=0.246N P=0.500 P=0.500 P=0.357N |P=0.185N P=0.288N P=0.194N P=0.194N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 17 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 10/50 (20%) 45/50 (90%) 48/50 (96%) |2/50 (4%) 13/50 (26%) 48/50 (96%) 49/50 (98%) | |POLY-3 ADJUSTED (b)| 6.7% 21.6% 94.5% 98.5% |4.5% 28.3% 99.5% 98.4% | |TERMINAL (d) | 1/35 (3%) 8/38 (21%) 33/34 (97%) 34/34 (100%)|2/36 (6%) 10/34 (29%) 31/31 (100%) 29/29 (100%) | |FIRST INCIDENCE | 561 617 393 501 |735 (T) 644 239 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.057 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.041 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.039 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.043 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.040 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.036 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Inflammation Chronic Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 12/50 (24%) |1/50 (2%) 2/50 (4%) 11/50 (22%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 2.3% 6.5% 6.7% 26.6% |2.2% 4.4% 26.2% 42.1% | |TERMINAL (d) | 0/35 (0%) 1/38 (3%) 1/34 (3%) 10/34 (29%) |1/36 (3%) 1/34 (3%) 6/31 (19%) 15/29 (52%) | |FIRST INCIDENCE | 561 617 393 699 |735 (T) 644 609 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.336 P=0.304 P=0.002 ** |P<0.001 ** P=0.497 P=0.002 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.321 P=0.305 P<0.001 ** |P<0.001 ** P=0.506 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.317 P=0.307 P<0.001 ** |P<0.001 ** P=0.502 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.327 P=0.302 P<0.001 ** |P<0.001 ** P=0.510 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.265 P=0.269 P=0.002 ** |P<0.001 ** P=0.500 P=0.002 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.309 P=0.309 P<0.001 ** |P<0.001 ** P=0.500 P=0.002 ** P<0.001 ** | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 18 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Inflammation Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 8/50 (16%) 23/50 (46%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 18.6% 48.9% |0.0% 0.0% 4.9% 32.9% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 8/34 (24%) 19/34 (56%) |0/36 (0%) 0/34 (0%) 2/31 (7%) 12/29 (41%) | |FIRST INCIDENCE | --- --- 733 (T) 406 |--- --- 735 (T) 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.004 ** P<0.001 ** |P<0.001 ** (e) P=0.206 P<0.001 ** | |POLY 3 | P<0.001 ** (e) P=0.003 ** P<0.001 ** |P<0.001 ** (e) P=0.216 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) P=0.003 ** P<0.001 ** |P<0.001 ** (e) P=0.223 P<0.001 ** | |POLY 6 | P<0.001 ** (e) P=0.003 ** P<0.001 ** |P<0.001 ** (e) P=0.209 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.004 ** P<0.001 ** |P<0.001 ** (e) P=0.206 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.003 ** P<0.001 ** |P<0.001 ** (e) P=0.247 P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 9/50 (18%) 39/50 (78%) 45/50 (90%) |2/50 (4%) 5/50 (10%) 27/50 (54%) 43/50 (86%) | |POLY-3 ADJUSTED (b)| 9.1% 19.6% 86.3% 92.5% |4.5% 11.0% 62.5% 92.2% | |TERMINAL (d) | 3/35 (9%) 9/38 (24%) 33/34 (97%) 33/34 (97%) |2/36 (6%) 5/34 (15%) 20/31 (65%) 27/29 (93%) | |FIRST INCIDENCE | 686 733 (T) 393 501 |735 (T) 735 (T) 365 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.148 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.192 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.130 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.220 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.127 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.217 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.134 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.222 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.144 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.192 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.117 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.218 P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 19 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung: Alveolus | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 4/50 (8%) 46/50 (92%) 50/50 (100%)|0/50 (0%) 8/50 (16%) 48/50 (96%) 49/50 (98%) | |POLY-3 ADJUSTED (b)| 0.0% 8.7% 95.6% 100.0% |0.0% 17.7% 99.5% 98.4% | |TERMINAL (d) | 0/35 (0%) 4/38 (11%) 33/34 (97%) 34/34 (100%)|0/36 (0%) 8/34 (24%) 31/31 (100%) 29/29 (100%) | |FIRST INCIDENCE | --- 733 (T) 393 406 |--- 735 (T) 239 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.074 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.066 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.065 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.068 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.074 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.059 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung: Alveolus | | Proteinosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 49/50 (98%) 50/50 (100%)|0/50 (0%) 4/50 (8%) 49/50 (98%) 50/50 (100%) | |POLY-3 ADJUSTED (b)| 2.3% 8.7% 99.9% 100.0% |0.0% 8.8% 99.9% 100.0% | |TERMINAL (d) | 0/35 (0%) 3/38 (8%) 34/34 (100%) 34/34 (100%)|0/36 (0%) 4/34 (12%) 31/31 (100%) 29/29 (100%) | |FIRST INCIDENCE | 561 710 393 406 |--- 735 (T) 281 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.208 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.056 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.189 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.061 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.187 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.061 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.192 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.062 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.176 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.056 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.181 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.059 P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 20 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung: Perivascular | | Infiltration Cellular Mononuclear Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 0.0% 4.9% 4.8% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |2/36 (6%) 0/34 (0%) 2/31 (7%) 2/29 (7%) | |FIRST INCIDENCE | --- --- --- --- |735 (T) --- 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.281 P=0.251N P=0.641 P=0.615 | |POLY 3 | (e) (e) (e) (e) |P=0.324 P=0.235N P=0.658 P=0.671 | |POLY 1.5 | (e) (e) (e) (e) |P=0.339 P=0.237N P=0.670 P=0.681 | |POLY 6 | (e) (e) (e) (e) |P=0.310 P=0.233N P=0.647 P=0.660 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.281 (e) P=0.641 P=0.615 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.356 P=0.247N P=0.691N P=0.691N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lymph Node | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/2 (0%) 0/0 (0%) 0/2 (0%) 0/1 (0%) |2/4 (50%) 1/8 (13%) 2/5 (40%) 0/6 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |65.8% 14.4% 56.3% 0.0% | |TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/2 (0%) 0/0 (0%) |2/2 (100%) 1/5 (20%) 2/3 (67%) 0/3 (0%) | |FIRST INCIDENCE | --- --- --- --- |735 (T) 735 (T) 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.204N P=0.157N P=0.581N P=0.122N | |POLY 3 | (e) (e) (e) (e) |P=0.160N P=0.183N P=0.706N P=0.057N | |POLY 1.5 | (e) (e) (e) (e) |P=0.170N P=0.208N P=0.694N P=0.074N | |POLY 6 | (e) (e) (e) (e) |P=0.151N P=0.151N P=0.687N P=0.038N* | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.204N P=0.157N P=0.581N (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.194N P=0.236N P=0.643N P=0.133N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 21 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lymph Node, Bronchial | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/38 (13%) 7/37 (19%) 17/40 (43%) 24/41 (59%) |10/39 (26%) 12/43 (28%) 13/42 (31%) 23/42 (55%) | |POLY-3 ADJUSTED (b)| 14.5% 20.3% 46.7% 60.9% |27.2% 29.9% 36.1% 61.9% | |TERMINAL (d) | 4/28 (14%) 6/28 (21%) 15/31 (48%) 22/32 (69%) |8/29 (28%) 10/31 (32%) 12/28 (43%) 19/26 (73%) | |FIRST INCIDENCE | 702 617 672 591 |533 659 711 628 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.388 P=0.006 ** P<0.001 ** |P<0.001 ** P=0.472 P=0.265 P<0.001 ** | |POLY 3 | P<0.001 ** P=0.374 P=0.002 ** P<0.001 ** |P<0.001 ** P=0.499 P=0.288 P=0.002 ** | |POLY 1.5 | P<0.001 ** P=0.367 P=0.002 ** P<0.001 ** |P<0.001 ** P=0.500 P=0.327 P=0.003 ** | |POLY 6 | P<0.001 ** P=0.385 P=0.002 ** P<0.001 ** |P<0.001 ** P=0.500 P=0.245 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.370 P=0.004 ** P<0.001 ** |P<0.001 ** P=0.508 P=0.290 P=0.003 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.358 P=0.004 ** P<0.001 ** |P=0.002 ** P=0.508 P=0.389 P=0.007 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/37 (5%) 3/40 (8%) 0/28 (0%) 0/32 (0%) |1/35 (3%) 0/37 (0%) 1/43 (2%) 2/43 (5%) | |POLY-3 ADJUSTED (b)| 6.3% 8.2% 0.0% 0.0% |3.3% 0.0% 2.9% 5.5% | |TERMINAL (d) | 1/26 (4%) 3/30 (10%) 0/18 (0%) 0/23 (0%) |1/25 (4%) 0/25 (0%) 1/27 (4%) 2/25 (8%) | |FIRST INCIDENCE | 686 733 (T) --- --- |735 (T) --- 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.071N P=0.556 P=0.292N P=0.256N |P=0.202 P=0.500N P=0.745N P=0.500 | |POLY 3 | P=0.067N P=0.563 P=0.307N P=0.251N |P=0.235 P=0.484N P=0.732N P=0.559 | |POLY 1.5 | P=0.067N P=0.556 P=0.304N P=0.255N |P=0.244 P=0.487N P=0.726N P=0.565 | |POLY 6 | P=0.067N P=0.571 P=0.309N P=0.248N |P=0.226 P=0.481N P=0.737N P=0.552 | |LOGISTIC REGRESSION| P=0.067N P=0.575 P=0.304N P=0.255N |P=0.202 (e) P=0.745N P=0.500 | |COCH-ARM / FISHERS | P=0.070N P=0.537 P=0.320N P=0.284N |P=0.251 P=0.486N P=0.699N P=0.578 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 22 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/38 (0%) 1/36 (3%) 0/38 (0%) 0/33 (0%) |0/40 (0%) 0/43 (0%) 2/49 (4%) 0/45 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.9% 0.0% 0.0% |0.0% 0.0% 5.0% 0.0% | |TERMINAL (d) | 0/29 (0%) 1/31 (3%) 0/28 (0%) 0/25 (0%) |0/29 (0%) 0/31 (0%) 1/30 (3%) 0/27 (0%) | |FIRST INCIDENCE | --- 733 (T) --- --- |--- --- 421 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.477N P=0.513 (e) (e) |P=0.525 (e) P=0.239 (e) | |POLY 3 | P=0.462N P=0.498 (e) (e) |P=0.516 (e) P=0.258 (e) | |POLY 1.5 | P=0.464N P=0.495 (e) (e) |P=0.532 (e) P=0.265 (e) | |POLY 6 | P=0.460N P=0.502 (e) (e) |P=0.503 (e) P=0.253 (e) | |LOGISTIC REGRESSION| (e) P=0.513 (e) (e) |P=0.676 (e) P=0.395 (e) | |COCH-ARM / FISHERS | P=0.465N P=0.486 (e) (e) |P=0.561 (e) P=0.300 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/38 (3%) 1/36 (3%) 4/38 (11%) 3/33 (9%) |5/40 (13%) 3/43 (7%) 6/49 (12%) 8/45 (18%) | |POLY-3 ADJUSTED (b)| 2.9% 2.9% 11.5% 9.4% |13.3% 7.4% 15.1% 20.9% | |TERMINAL (d) | 1/29 (3%) 1/31 (3%) 2/28 (7%) 0/25 (0%) |2/29 (7%) 2/31 (7%) 5/30 (17%) 7/27 (26%) | |FIRST INCIDENCE | 733 (T) 733 (T) 645 501 |533 715 659 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.119 P=0.747N P=0.168 P=0.301 |P=0.065 P=0.344N P=0.480 P=0.228 | |POLY 3 | P=0.117 P=0.758 P=0.176 P=0.274 |P=0.089 P=0.316N P=0.541 P=0.283 | |POLY 1.5 | P=0.113 P=0.754 P=0.175 P=0.267 |P=0.104 P=0.316N P=0.572 P=0.308 | |POLY 6 | P=0.121 P=0.758N P=0.179 P=0.281 |P=0.078 P=0.317N P=0.516 P=0.261 | |LOGISTIC REGRESSION| P=0.101 P=0.747N P=0.176 P=0.197 |P=0.096 P=0.350N P=0.591 P=0.320 | |COCH-ARM / FISHERS | P=0.106 P=0.740 P=0.179 P=0.255 |P=0.136 P=0.316N P=0.609N P=0.357 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 23 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/48 (6%) 5/49 (10%) 4/50 (8%) 4/46 (9%) |3/49 (6%) 3/49 (6%) 5/50 (10%) 6/47 (13%) | |POLY-3 ADJUSTED (b)| 6.9% 10.9% 9.3% 9.4% |6.7% 6.7% 12.1% 14.5% | |TERMINAL (d) | 2/35 (6%) 2/38 (5%) 3/34 (9%) 3/33 (9%) |3/36 (8%) 2/34 (6%) 3/31 (10%) 2/28 (7%) | |FIRST INCIDENCE | 686 609 729 723 |735 (T) 659 645 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.494 P=0.406 P=0.481 P=0.478 |P=0.080 P=0.647 P=0.280 P=0.180 | |POLY 3 | P=0.509 P=0.381 P=0.489 P=0.485 |P=0.098 P=0.661 P=0.311 P=0.205 | |POLY 1.5 | P=0.510 P=0.375 P=0.500 P=0.482 |P=0.106 P=0.657 P=0.326 P=0.211 | |POLY 6 | P=0.504 P=0.392 P=0.478 P=0.487 |P=0.092 P=0.659N P=0.301 P=0.199 | |LOGISTIC REGRESSION| P=0.512 P=0.367 P=0.478 P=0.490 |P=0.126 P=0.660 P=0.306 P=0.328 | |COCH-ARM / FISHERS | P=0.511 P=0.369 P=0.523 P=0.476 |P=0.115 P=0.661N P=0.369 P=0.223 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |4/50 (8%) 4/50 (8%) 2/50 (4%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |8.9% 8.8% 4.9% 7.3% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |4/36 (11%) 3/34 (9%) 2/31 (7%) 2/29 (7%) | |FIRST INCIDENCE | --- --- --- --- |735 (T) 701 735 (T) 717 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.453N P=0.619 P=0.407N P=0.613N | |POLY 3 | (e) (e) (e) (e) |P=0.399N P=0.636N P=0.384N P=0.546N | |POLY 1.5 | (e) (e) (e) (e) |P=0.380N P=0.641N P=0.368N P=0.531N | |POLY 6 | (e) (e) (e) (e) |P=0.418N P=0.631N P=0.398N P=0.563N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.443N P=0.641N P=0.407N P=0.595N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.354N P=0.643N P=0.339N P=0.511N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 24 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mesentery | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/4 (0%) 0/5 (0%) 0/4 (0%) 0/6 (0%) |0/8 (0%) 0/9 (0%) 2/16 (13%) 0/13 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 15.6% 0.0% | |TERMINAL (d) | 0/3 (0%) 0/4 (0%) 0/3 (0%) 0/5 (0%) |0/4 (0%) 0/4 (0%) 0/6 (0%) 0/7 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 421 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.511 (e) P=0.221 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.584 (e) P=0.376 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.610 (e) P=0.383 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.559 (e) P=0.367 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.665N (e) P=0.498 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.650 (e) P=0.435 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/4 (25%) 5/5 (100%) 3/4 (75%) 6/6 (100%) |4/8 (50%) 9/9 (100%) 13/16 (81%) 11/13 (85%) | |POLY-3 ADJUSTED (b)| 28.8% 100.0% 75.3% 100.0% |55.2% 100.0% 92.1% 94.8% | |TERMINAL (d) | 1/3 (33%) 4/4 (100%) 3/3 (100%) 5/5 (100%) |3/4 (75%) 4/4 (100%) 6/6 (100%) 7/7 (100%) | |FIRST INCIDENCE | 733 (T) 715 733 (T) 665 |645 533 421 505 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.111 P=0.086 P=0.215 P=0.064 |P=0.134 P=0.067 P=0.013 * P=0.077 | |POLY 3 | P=0.084 P=0.019 * P=0.299 P=0.009 ** |P=0.086 P=0.027 * P=0.045 * P=0.038 * | |POLY 1.5 | P=0.057 P=0.012 * P=0.272 P=0.005 ** |P=0.155 P=0.020 * P=0.064 P=0.057 | |POLY 6 | P=0.131 P=0.037 * P=0.335 P=0.021 * |P=0.046 * P=0.041 * P=0.033 * P=0.030 * | |LOGISTIC REGRESSION| P=0.103 P=0.088 P=0.215 P=0.048 * |P=0.115 P=0.033 * P=0.051 P=0.038 * | |COCH-ARM / FISHERS | P=0.079 P=0.048 * P=0.243 P=0.033 * |P=0.301 P=0.029 * P=0.134 P=0.115 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 25 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 3/49 (6%) 2/49 (4%) 1/48 (2%) |2/50 (4%) 0/49 (0%) 4/50 (8%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 6.6% 4.7% 2.3% |4.4% 0.0% 9.3% 9.3% | |TERMINAL (d) | 0/34 (0%) 3/38 (8%) 1/34 (3%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 1/31 (3%) 3/29 (10%) | |FIRST INCIDENCE | --- 733 (T) 608 699 |694 --- 239 490 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.580N P=0.141 P=0.242 P=0.500 |P=0.057 P=0.234N P=0.300 P=0.276 | |POLY 3 | P=0.548N P=0.128 P=0.235 P=0.507 |P=0.061 P=0.237N P=0.313 P=0.313 | |POLY 1.5 | P=0.553N P=0.126 P=0.237 P=0.504 |P=0.067 P=0.239N P=0.322 P=0.324 | |POLY 6 | P=0.543N P=0.132 P=0.234 P=0.509 |P=0.055 P=0.236N P=0.305 P=0.300 | |LOGISTIC REGRESSION| P=0.565N P=0.141 P=0.237 P=0.497 |P=0.091 P=0.242N P=0.473 P=0.343 | |COCH-ARM / FISHERS | P=0.571N P=0.121 P=0.247 P=0.495 |P=0.077 P=0.253N P=0.339 P=0.339 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/49 (14%) 2/49 (4%) 5/49 (10%) 8/48 (17%) |3/50 (6%) 1/49 (2%) 7/50 (14%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 16.3% 4.4% 11.9% 18.0% |6.7% 2.2% 16.9% 9.2% | |TERMINAL (d) | 7/34 (21%) 2/38 (5%) 5/34 (15%) 6/34 (18%) |3/36 (8%) 1/34 (3%) 5/31 (16%) 2/29 (7%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 699 |735 (T) 735 (T) 553 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.143 P=0.055N P=0.376N P=0.502 |P=0.115 P=0.325N P=0.110 P=0.409 | |POLY 3 | P=0.162 P=0.066N P=0.391N P=0.530 |P=0.151 P=0.302N P=0.127 P=0.480 | |POLY 1.5 | P=0.163 P=0.070N P=0.384N P=0.518 |P=0.164 P=0.307N P=0.136 P=0.489 | |POLY 6 | P=0.159 P=0.062N P=0.398N P=0.540 |P=0.140 P=0.299N P=0.121 P=0.471 | |LOGISTIC REGRESSION| P=0.161 P=0.055N P=0.376N P=0.536 |P=0.179 P=0.325N P=0.130 P=0.510 | |COCH-ARM / FISHERS | P=0.161 P=0.080N P=0.380N P=0.482 |P=0.183 P=0.316N P=0.159 P=0.500 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 26 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 4/49 (8%) 6/49 (12%) 1/48 (2%) |3/50 (6%) 1/49 (2%) 10/50 (20%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 2.3% 8.9% 14.2% 2.3% |6.7% 2.2% 23.6% 11.9% | |TERMINAL (d) | 1/34 (3%) 4/38 (11%) 5/34 (15%) 1/34 (3%) |3/36 (8%) 1/34 (3%) 6/31 (19%) 4/29 (14%) | |FIRST INCIDENCE | 733 (T) 733 (T) 715 733 (T) |735 (T) 735 (T) 239 714 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.484N P=0.214 P=0.059 P=0.762 |P=0.044 * P=0.325N P=0.023 * P=0.249 | |POLY 3 | P=0.434N P=0.195 P=0.052 P=0.754N |P=0.054 P=0.302N P=0.025 * P=0.323 | |POLY 1.5 | P=0.441N P=0.190 P=0.054 P=0.756N |P=0.065 P=0.307N P=0.028 * P=0.337 | |POLY 6 | P=0.431N P=0.201 P=0.051 P=0.752N |P=0.045 * P=0.299N P=0.023 * P=0.307 | |LOGISTIC REGRESSION| P=0.464N P=0.214 P=0.051 P=0.762 |P=0.080 P=0.325N P=0.036 * P=0.275 | |COCH-ARM / FISHERS | P=0.466N P=0.181 P=0.056 P=0.747 |P=0.087 P=0.316N P=0.036 * P=0.357 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/49 (4%) 2/49 (4%) 1/48 (2%) |15/50 (30%) 17/49 (35%) 21/50 (42%) 17/50 (34%) | |POLY-3 ADJUSTED (b)| 2.3% 4.4% 4.8% 2.3% |32.9% 37.0% 48.6% 38.4% | |TERMINAL (d) | 1/34 (3%) 2/38 (5%) 2/34 (6%) 1/34 (3%) |14/36 (39%) 14/34 (41%) 15/31 (48%) 13/29 (45%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |439 533 239 490 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.543N P=0.539 P=0.500 P=0.762 |P=0.132 P=0.349 P=0.061 P=0.187 | |POLY 3 | P=0.516N P=0.518 P=0.494 P=0.754N |P=0.287 P=0.425 P=0.094 P=0.371 | |POLY 1.5 | P=0.518N P=0.513 P=0.497 P=0.756N |P=0.324 P=0.407 P=0.109 P=0.390 | |POLY 6 | P=0.516N P=0.525 P=0.490 P=0.752N |P=0.253 P=0.441 P=0.087 P=0.350 | |LOGISTIC REGRESSION| P=0.543N P=0.539 P=0.500 P=0.762 |P=0.314 P=0.416 P=0.107 P=0.379 | |COCH-ARM / FISHERS | P=0.529N P=0.500 P=0.500 P=0.747 |P=0.375 P=0.388 P=0.149 P=0.415 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 27 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/48 (0%) |0/50 (0%) 0/49 (0%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.8% 4.7% | |TERMINAL (d) | 0/34 (0%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 1/31 (3%) 1/29 (3%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 239 682 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.057 (e) P=0.225 P=0.205 | |POLY 3 | (e) (e) (e) (e) |P=0.060 (e) P=0.220 P=0.224 | |POLY 1.5 | (e) (e) (e) (e) |P=0.065 (e) P=0.227 P=0.230 | |POLY 6 | (e) (e) (e) (e) |P=0.056 (e) P=0.215 P=0.219 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.077 (e) P=0.332 P=0.227 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.071 (e) P=0.247 P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Ovary | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/49 (4%) 0/50 (0%) 2/50 (4%) 0/46 (0%) | |POLY-3 ADJUSTED (b)| |4.5% 0.0% 4.9% 0.0% | |TERMINAL (d) | |2/36 (6%) 0/34 (0%) 2/31 (7%) 0/28 (0%) | |FIRST INCIDENCE | |735 (T) --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.394N P=0.251N P=0.641 P=0.295N | |POLY 3 | |P=0.373N P=0.235N P=0.658 P=0.272N | |POLY 1.5 | |P=0.360N P=0.236N P=0.671 P=0.265N | |POLY 6 | |P=0.385N P=0.233N P=0.647 P=0.280N | |LOGISTIC REGRESSION| |P=0.394N (e) P=0.641 (e) | |COCH-ARM / FISHERS | |P=0.344N P=0.242N P=0.684N P=0.263N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 28 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Ovary | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |3/49 (6%) 2/50 (4%) 2/50 (4%) 0/46 (0%) | |POLY-3 ADJUSTED (b)| |6.7% 4.4% 4.9% 0.0% | |TERMINAL (d) | |2/36 (6%) 0/34 (0%) 2/31 (7%) 0/28 (0%) | |FIRST INCIDENCE | |729 715 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.137N P=0.523N P=0.570N P=0.170N | |POLY 3 | |P=0.123N P=0.494N P=0.545N P=0.148N | |POLY 1.5 | |P=0.115N P=0.497N P=0.529N P=0.141N | |POLY 6 | |P=0.132N P=0.491N P=0.559N P=0.155N | |LOGISTIC REGRESSION| |P=0.134N P=0.494N P=0.570N P=0.162N | |COCH-ARM / FISHERS | |P=0.102N P=0.490N P=0.490N P=0.133N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |18/49 (37%) 17/50 (34%) 23/50 (46%) 15/46 (33%) | |POLY-3 ADJUSTED (b)| |38.9% 36.2% 51.2% 36.3% | |TERMINAL (d) | |15/36 (42%) 11/34 (32%) 13/31 (42%) 7/28 (25%) | |FIRST INCIDENCE | |439 302 239 464 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.379 P=0.546N P=0.107 P=0.561 | |POLY 3 | |P=0.480 P=0.477N P=0.164 P=0.486N | |POLY 1.5 | |P=0.514 P=0.484N P=0.178 P=0.466N | |POLY 6 | |P=0.460 P=0.466N P=0.164 P=0.497N | |LOGISTIC REGRESSION| |P=0.487N P=0.469N P=0.233 P=0.397N | |COCH-ARM / FISHERS | |P=0.500N P=0.470N P=0.232 P=0.419N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 29 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pancreas | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 7/50 (14%) 9/49 (18%) 6/47 (13%) |5/50 (10%) 10/50 (20%) 11/50 (22%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 28.2% 15.0% 20.6% 13.8% |11.1% 21.9% 26.4% 4.8% | |TERMINAL (d) | 8/35 (23%) 4/38 (11%) 6/34 (18%) 5/34 (15%) |4/36 (11%) 9/34 (27%) 8/31 (26%) 1/29 (3%) | |FIRST INCIDENCE | 457 473 608 645 |707 659 365 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.150N P=0.087N P=0.270N P=0.075N |P=0.194N P=0.113 P=0.051 P=0.295N | |POLY 3 | P=0.147N P=0.096N P=0.277N P=0.076N |P=0.135N P=0.134 P=0.058 P=0.244N | |POLY 1.5 | P=0.144N P=0.096N P=0.265N P=0.075N |P=0.121N P=0.131 P=0.067 P=0.236N | |POLY 6 | P=0.153N P=0.095N P=0.288N P=0.079N |P=0.152N P=0.137 P=0.052 P=0.254N | |LOGISTIC REGRESSION| P=0.150N P=0.119N P=0.251N P=0.088N |P=0.130N P=0.136 P=0.063 P=0.229N | |COCH-ARM / FISHERS | P=0.146N P=0.105N P=0.251N P=0.082N |P=0.110N P=0.131 P=0.086 P=0.226N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pancreas | | Cytoplasmic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 2.2% 4.9% 2.4% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 1/31 (3%) 1/29 (3%) | |FIRST INCIDENCE | --- --- --- --- |553 715 609 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.510 P=0.757N P=0.462 P=0.726 | |POLY 3 | (e) (e) (e) (e) |P=0.525 P=0.760 P=0.465 P=0.739 | |POLY 1.5 | (e) (e) (e) (e) |P=0.541 P=0.759 P=0.476 P=0.746 | |POLY 6 | (e) (e) (e) (e) |P=0.508 P=0.760N P=0.455 P=0.731 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.572 P=0.755N P=0.546 P=0.755N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.562 P=0.753N P=0.500 P=0.747 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 30 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pancreas: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 4.9% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 2/34 (6%) 1/31 (3%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 735 (T) 659 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.483N P=0.226 P=0.207 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.457N P=0.239 P=0.217 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.446N P=0.238 P=0.223 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.470N P=0.241 P=0.212 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.455N P=0.226 P=0.226 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.430N P=0.247 P=0.247 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 1/48 (2%) 1/47 (2%) 1/47 (2%) |16/46 (35%) 20/48 (42%) 20/50 (40%) 9/47 (19%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 2.5% 2.3% |37.5% 45.3% 46.6% 22.5% | |TERMINAL (d) | 0/34 (0%) 1/36 (3%) 1/33 (3%) 1/34 (3%) |12/33 (36%) 15/34 (44%) 13/31 (42%) 8/29 (28%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) 733 (T) |645 659 553 505 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.404 P=0.511 P=0.494 P=0.500 |P=0.109N P=0.312 P=0.192 P=0.150N | |POLY 3 | P=0.419 P=0.505 P=0.490 P=0.503 |P=0.055N P=0.301 P=0.260 P=0.105N | |POLY 1.5 | P=0.414 P=0.503 P=0.491 P=0.500 |P=0.040N* P=0.295 P=0.287 P=0.090N | |POLY 6 | P=0.423 P=0.507 P=0.488 P=0.506 |P=0.076N P=0.309 P=0.246 P=0.126N | |LOGISTIC REGRESSION| (e) P=0.511 P=0.494 P=0.500 |P=0.055N P=0.316 P=0.251 P=0.108N | |COCH-ARM / FISHERS | P=0.406 P=0.500 P=0.495 P=0.495 |P=0.028N* P=0.318 P=0.376 P=0.071N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 31 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Preputial Gland | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/49 (6%) 5/49 (10%) 5/48 (10%) | | |POLY-3 ADJUSTED (b)| 11.4% 6.7% 11.7% 11.2% | | |TERMINAL (d) | 5/35 (14%) 2/37 (5%) 4/34 (12%) 3/34 (9%) | | |FIRST INCIDENCE | 733 (T) 715 645 659 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.381 P=0.322N P=0.611 P=0.618 | | |POLY 3 | P=0.411 P=0.343N P=0.615 P=0.621N | | |POLY 1.5 | P=0.406 P=0.349N P=0.617 P=0.629N | | |POLY 6 | P=0.413 P=0.334N P=0.614 P=0.613N | | |LOGISTIC REGRESSION| P=0.407 P=0.324N P=0.605 P=0.621N | | |COCH-ARM / FISHERS | P=0.390 P=0.369N P=0.617 P=0.603 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Preputial Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/49 (6%) 4/49 (8%) 9/48 (19%) | | |POLY-3 ADJUSTED (b)| 6.8% 6.6% 9.2% 19.7% | | |TERMINAL (d) | 3/35 (9%) 2/37 (5%) 1/34 (3%) 3/34 (9%) | | |FIRST INCIDENCE | 733 (T) 617 609 555 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.018 * P=0.635N P=0.481 P=0.070 | | |POLY 3 | P=0.017 * P=0.648N P=0.494 P=0.069 | | |POLY 1.5 | P=0.016 * P=0.654N P=0.493 P=0.063 | | |POLY 6 | P=0.019 * P=0.639N P=0.498 P=0.076 | | |LOGISTIC REGRESSION| P=0.014 * P=0.657N P=0.488 P=0.051 | | |COCH-ARM / FISHERS | P=0.015 * P=0.651 P=0.489 P=0.052 | | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 32 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Prostate | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 1/49 (2%) 1/49 (2%) | | |POLY-3 ADJUSTED (b)| 4.4% 0.0% 2.4% 2.2% | | |TERMINAL (d) | 0/35 (0%) 0/37 (0%) 1/33 (3%) 0/34 (0%) | | |FIRST INCIDENCE | 462 --- 733 (T) 555 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.580N P=0.235N P=0.512N P=0.495N | | |POLY 3 | P=0.585N P=0.239N P=0.526N P=0.501N | | |POLY 1.5 | P=0.583N P=0.239N P=0.517N P=0.501N | | |POLY 6 | P=0.587N P=0.238N P=0.535N P=0.502N | | |LOGISTIC REGRESSION| P=0.616 P=0.345N P=0.524N P=0.665N | | |COCH-ARM / FISHERS | P=0.580N P=0.253N P=0.508N P=0.508N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin: Prepuce | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.5% 8.6% 6.8% 6.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/35 (3%) 2/38 (5%) 1/34 (3%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 561 617 548 555 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.527 P=0.373 P=0.487 P=0.499 |(e) (e) (e) (e) | |POLY 3 | P=0.553 P=0.356 P=0.494 P=0.513 |(e) (e) (e) (e) | |POLY 1.5 | P=0.553 P=0.352 P=0.498 P=0.511 |(e) (e) (e) (e) | |POLY 6 | P=0.551 P=0.363 P=0.491 P=0.514 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.531 P=0.322 P=0.496 P=0.464 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.545 P=0.339 P=0.500 P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 33 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.2% 4.8% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 124 483 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.434N P=0.240 P=0.220 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.453N P=0.249 P=0.221 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.440N P=0.246 P=0.226 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.466N P=0.251 P=0.218 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.467N P=0.304 P=0.302 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.424N P=0.247 P=0.247 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.7% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 2/34 (6%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- --- 733 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.520 (e) P=0.232 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.544 (e) P=0.232 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.544 (e) P=0.235 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.542 (e) P=0.229 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.232 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.536 (e) P=0.247 (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 34 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 17/50 (34%) 13/50 (26%) 19/49 (39%) 18/47 (38%) |23/50 (46%) 22/50 (44%) 22/50 (44%) 28/49 (57%) | |POLY-3 ADJUSTED (b)| 36.6% 27.2% 41.9% 39.3% |48.7% 46.5% 48.2% 62.4% | |TERMINAL (d) | 8/35 (23%) 8/38 (21%) 11/34 (32%) 8/34 (24%) |15/36 (42%) 14/34 (41%) 11/31 (36%) 16/29 (55%) | |FIRST INCIDENCE | 561 478 232 555 |533 533 281 412 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.231 P=0.213N P=0.383 P=0.498 |P=0.048 * P=0.538N P=0.432 P=0.081 | |POLY 3 | P=0.208 P=0.224N P=0.380 P=0.479 |P=0.077 P=0.496N P=0.564N P=0.129 | |POLY 1.5 | P=0.200 P=0.227N P=0.394 P=0.465 |P=0.096 P=0.505N P=0.539N P=0.151 | |POLY 6 | P=0.215 P=0.228N P=0.363 P=0.488 |P=0.059 P=0.490N P=0.575 P=0.107 | |LOGISTIC REGRESSION| P=0.158 P=0.280N P=0.388 P=0.380 |P=0.113 P=0.500N P=0.481N P=0.159 | |COCH-ARM / FISHERS | P=0.177 P=0.257N P=0.388 P=0.409 |P=0.121 P=0.500N P=0.500N P=0.182 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Spleen | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 5/50 (10%) 3/49 (6%) 2/47 (4%) |20/50 (40%) 12/50 (24%) 18/50 (36%) 7/49 (14%) | |POLY-3 ADJUSTED (b)| 2.3% 10.9% 7.1% 4.6% |43.6% 26.3% 43.0% 17.0% | |TERMINAL (d) | 1/35 (3%) 4/38 (11%) 3/34 (9%) 1/34 (3%) |17/36 (47%) 10/34 (29%) 14/31 (45%) 7/29 (24%) | |FIRST INCIDENCE | 733 (T) 715 733 (T) 723 |553 659 623 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.488N P=0.127 P=0.294 P=0.496 |P=0.067N P=0.087N P=0.517 P=0.015N* | |POLY 3 | P=0.463N P=0.112 P=0.294 P=0.496 |P=0.034N* P=0.061N P=0.561N P=0.005N** | |POLY 1.5 | P=0.468N P=0.110 P=0.297 P=0.492 |P=0.025N* P=0.064N P=0.516N P=0.004N** | |POLY 6 | P=0.460N P=0.116 P=0.291 P=0.499 |P=0.047N* P=0.060N P=0.583 P=0.007N** | |LOGISTIC REGRESSION| P=0.478N P=0.120 P=0.294 P=0.500 |P=0.040N* P=0.058N P=0.585N P=0.007N** | |COCH-ARM / FISHERS | P=0.486N P=0.102 P=0.301 P=0.477 |P=0.019N* P=0.066N P=0.418N P=0.004N** | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 35 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 1/49 (2%) |1/49 (2%) 1/50 (2%) 0/50 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 4.5% 0.0% 0.0% 2.3% |2.2% 2.2% 0.0% 4.7% | |TERMINAL (d) | 1/35 (3%) 0/38 (0%) 0/34 (0%) 1/34 (3%) |1/36 (3%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 462 --- --- 733 (T) |735 (T) 715 --- 497 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.543N P=0.226N P=0.243N P=0.504N |P=0.335 P=0.757 P=0.530N P=0.463 | |POLY 3 | P=0.546N P=0.231N P=0.248N P=0.502N |P=0.353 P=0.758N P=0.520N P=0.483 | |POLY 1.5 | P=0.543N P=0.232N P=0.245N P=0.501N |P=0.361 P=0.759N P=0.513N P=0.489 | |POLY 6 | P=0.550N P=0.229N P=0.251N P=0.502N |P=0.347 P=0.756N P=0.526N P=0.478 | |LOGISTIC REGRESSION| P=0.558N P=0.286N P=0.252N P=0.550N |P=0.406 P=0.759N (e) P=0.693 | |COCH-ARM / FISHERS | P=0.536N P=0.247N P=0.253N P=0.508N |P=0.372 P=0.747N P=0.495N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 2/50 (4%) 3/49 (6%) 3/49 (6%) |2/49 (4%) 6/50 (12%) 1/50 (2%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 13.5% 4.4% 7.0% 6.7% |4.4% 13.0% 2.5% 4.8% | |TERMINAL (d) | 4/35 (11%) 1/38 (3%) 2/34 (6%) 2/34 (6%) |1/36 (3%) 3/34 (9%) 1/31 (3%) 0/29 (0%) | |FIRST INCIDENCE | 647 710 645 656 |617 533 735 (T) 595 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.355N P=0.113N P=0.269N P=0.253N |P=0.276N P=0.137 P=0.551N P=0.639 | |POLY 3 | P=0.339N P=0.121N P=0.258N P=0.237N |P=0.242N P=0.139 P=0.537N P=0.666 | |POLY 1.5 | P=0.337N P=0.124N P=0.254N P=0.239N |P=0.229N P=0.137 P=0.524N P=0.676 | |POLY 6 | P=0.343N P=0.118N P=0.263N P=0.236N |P=0.256N P=0.142 P=0.550N P=0.656 | |LOGISTIC REGRESSION| P=0.332N P=0.122N P=0.255N P=0.239N |P=0.203N P=0.148 P=0.506N P=0.657N | |COCH-ARM / FISHERS | P=0.336N P=0.134N P=0.254N P=0.254N |P=0.206N P=0.141 P=0.492N P=0.691N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 36 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Stomach, Glandular | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/48 (0%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 1/34 (3%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 659 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.295N P=0.243 (e) (e) | |POLY 3 | (e) (e) (e) (e) |P=0.284N P=0.241 (e) (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.279N P=0.239 (e) (e) | |POLY 6 | (e) (e) (e) (e) |P=0.288N P=0.243 (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.271N P=0.243 (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.267N P=0.253 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Testes | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 9/50 (18%) 2/50 (4%) 2/50 (4%) | | |POLY-3 ADJUSTED (b)| 13.5% 19.2% 4.7% 4.4% | | |TERMINAL (d) | 4/35 (11%) 5/38 (13%) 2/34 (6%) 1/34 (3%) | | |FIRST INCIDENCE | 561 581 733 (T) 723 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.024N* P=0.356 P=0.151N P=0.145N | | |POLY 3 | P=0.017N* P=0.324 P=0.144N P=0.129N | | |POLY 1.5 | P=0.016N* P=0.314 P=0.139N P=0.128N | | |POLY 6 | P=0.018N* P=0.338 P=0.152N P=0.131N | | |LOGISTIC REGRESSION| P=0.017N* P=0.292 P=0.138N P=0.129N | | |COCH-ARM / FISHERS | P=0.017N* P=0.288 P=0.134N P=0.134N | | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 37 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 13/50 (26%) 7/50 (14%) 8/48 (17%) |10/50 (20%) 17/50 (34%) 14/50 (28%) 12/49 (24%) | |POLY-3 ADJUSTED (b)| 25.0% 28.0% 16.3% 18.1% |22.3% 37.1% 34.5% 28.8% | |TERMINAL (d) | 10/35 (29%) 11/38 (29%) 7/34 (21%) 7/34 (21%) |10/36 (28%) 13/34 (38%) 14/31 (45%) 9/28 (32%) | |FIRST INCIDENCE | 702 581 733 (T) 716 |735 (T) 672 735 (T) 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.161N P=0.502 P=0.234N P=0.323N |P=0.321 P=0.067 P=0.112 P=0.194 | |POLY 3 | P=0.132N P=0.466 P=0.230N P=0.296N |P=0.490 P=0.092 P=0.154 P=0.326 | |POLY 1.5 | P=0.134N P=0.449 P=0.222N P=0.306N |P=0.536 P=0.087 P=0.181 P=0.350 | |POLY 6 | P=0.134N P=0.486 P=0.240N P=0.289N |P=0.444 P=0.098 P=0.132 P=0.304 | |LOGISTIC REGRESSION| P=0.134N P=0.473 P=0.244N P=0.286N |P=0.384 P=0.087 P=0.112 P=0.261 | |COCH-ARM / FISHERS | P=0.145N P=0.408 P=0.218N P=0.341N |P=0.485N P=0.088 P=0.241 P=0.384 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Tooth | | Malformation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/1 (100%) 2/3 (67%) 1/1 (100%) 1/1 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 100.0% 80.1% 100.0% 100.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/1 (100%) 2/2 (100%) 1/1 (100%) 1/1 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=1.000N P=1.000N (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.719 P=0.895N (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.619 P=0.792N (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.934 P=0.997N (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=1.000N P=1.000N (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.562 P=0.750N (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 38 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Urinary Bladder | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/50 (0%) 0/46 (0%) 2/46 (4%) |0/48 (0%) 0/48 (0%) 0/50 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 2.3% 0.0% 0.0% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 0/33 (0%) 0/34 (0%) |0/36 (0%) 0/32 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 561 --- --- 555 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.208 P=0.500N P=0.509N P=0.502 |(e) (e) (e) (e) | |POLY 3 | P=0.194 P=0.492N P=0.517N P=0.495 |(e) (e) (e) (e) | |POLY 1.5 | P=0.194 P=0.493N P=0.514N P=0.491 |(e) (e) (e) (e) | |POLY 6 | P=0.194 P=0.492N P=0.520N P=0.498 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.126 P=0.571N P=0.567N P=0.377 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.191 P=0.495N P=0.516N P=0.476 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Uterus | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |1/49 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| |2.2% 2.2% 4.9% 0.0% | |TERMINAL (d) | |0/36 (0%) 1/34 (3%) 2/31 (7%) 0/29 (0%) | |FIRST INCIDENCE | |533 735 (T) 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.430N P=0.754 P=0.455 P=0.522N | |POLY 3 | |P=0.405N P=0.760 P=0.461 P=0.515N | |POLY 1.5 | |P=0.391N P=0.760 P=0.475 P=0.508N | |POLY 6 | |P=0.420N P=0.760 P=0.449 P=0.523N | |LOGISTIC REGRESSION| |P=0.366N P=0.729N P=0.537 P=0.329N | |COCH-ARM / FISHERS | |P=0.370N P=0.747N P=0.508 P=0.495N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 39 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/49 (4%) 4/50 (8%) 3/50 (6%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| |4.5% 8.8% 7.3% 9.4% | |TERMINAL (d) | |2/36 (6%) 4/34 (12%) 2/31 (7%) 2/29 (7%) | |FIRST INCIDENCE | |735 (T) 735 (T) 609 595 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.270 P=0.310 P=0.435 P=0.255 | |POLY 3 | |P=0.332 P=0.342 P=0.460 P=0.314 | |POLY 1.5 | |P=0.349 P=0.340 P=0.474 P=0.325 | |POLY 6 | |P=0.316 P=0.344 P=0.450 P=0.303 | |LOGISTIC REGRESSION| |P=0.330 P=0.310 P=0.466 P=0.317 | |COCH-ARM / FISHERS | |P=0.379 P=0.349 P=0.510 P=0.349 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Uterus | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/49 (4%) 2/50 (4%) 2/50 (4%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| |4.4% 4.4% 4.9% 7.1% | |TERMINAL (d) | |1/36 (3%) 1/34 (3%) 1/31 (3%) 3/29 (10%) | |FIRST INCIDENCE | |684 715 715 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.292 P=0.686 P=0.635 P=0.410 | |POLY 3 | |P=0.342 P=0.691N P=0.657 P=0.470 | |POLY 1.5 | |P=0.360 P=0.692N P=0.671 P=0.484 | |POLY 6 | |P=0.324 P=0.690N P=0.645 P=0.454 | |LOGISTIC REGRESSION| |P=0.324 P=0.691N P=0.659 P=0.455 | |COCH-ARM / FISHERS | |P=0.387 P=0.684N P=0.684N P=0.510 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 40 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Uterus: Myometrium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/49 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |4.5% 0.0% 4.9% 4.7% | |TERMINAL (d) | |2/36 (6%) 0/34 (0%) 2/31 (7%) 0/29 (0%) | |FIRST INCIDENCE | |735 (T) --- 735 (T) 628 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.292 P=0.251N P=0.641 P=0.631 | |POLY 3 | |P=0.331 P=0.235N P=0.658 P=0.675 | |POLY 1.5 | |P=0.344 P=0.236N P=0.671 P=0.684 | |POLY 6 | |P=0.320 P=0.233N P=0.647 P=0.667 | |LOGISTIC REGRESSION| |P=0.329 (e) P=0.641 P=0.692 | |COCH-ARM / FISHERS | |P=0.361 P=0.242N P=0.684N P=0.684N | |=================================================================================================================================| (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).