TDMS Study 05180-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest GALLIUM ARSENIDE DATE: 02/17/99 EXPERIMENT: 05180 TEST: 06 TIME: 08:20:28 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62033B PATHOLOGIST: GRUMBEIN, S. CAS: 1303-00-0000 ------------------------------------------------------------------------------------------------------------------------------------ 2 YEAR CHRONIC RATS 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: 02/17/99 EXPERIMENT: 05180 TEST: 06 TIME: 08:20:28 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62033B PATHOLOGIST: GRUMBEIN, S. CAS: 1303-00-0000 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF GALLIUM ARSENIDE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Hyperplasia Epididymis Granuloma Sperm Eye Degeneration Larynx Hyperplasia Inflammation Chronic Metaplasia Larynx: Epiglottis Hyperplasia Inflammation Chronic Metaplasia Liver Angiectasis Clear Cell Focus Lung Hyperplasia Atypical Inflammation Chronic Proteinosis Lung: Alveolar Epithelium Hyperplasia Metaplasia Nose: Olfactory Epithelium Degeneration Hyaline Spleen Necrosis Stomach, Glandular Necrosis =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Larynx Metaplasia Larynx: Epiglottis Hyperplasia Liver Mixed Cell Focus Liver: Bile Duct Hyperplasia Liver: Centrilobular Necrosis Lung Hyperplasia Atypical Inflammation Chronic Proteinosis Lung: Alveolar Epithelium Metaplasia Mesentery: Fat Necrosis Nose Inflammation Nose: Olfactory Epithelium Atrophy Pituitary Gland: Pars Distalis Angiectasis Hyperplasia Thyroid Gland: C-Cell Hyperplasia =============================================================== Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) |4/50 (8%) 2/50 (4%) 1/50 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.7% 0.0% |10.1% 5.2% 2.7% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |3/19 (16%) 1/17 (6%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | --- --- 722 --- |649 714 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.750N (e) P=0.513 (e) |P=0.184N P=0.382N P=0.163N P=0.134N | |POLY 3 | P=0.743N (e) P=0.506 (e) |P=0.122N P=0.352N P=0.198N P=0.081N | |POLY 1.5 | P=0.741N (e) P=0.503 (e) |P=0.116N P=0.346N P=0.192N P=0.074N | |POLY 6 | P=0.745N (e) P=0.510 (e) |P=0.131N P=0.359N P=0.201N P=0.091N | |LOGISTIC REGRESSION| P=0.752N (e) P=0.515 (e) |P=0.142N P=0.354N P=0.196N P=0.096N | |COCH-ARM / FISHERS | P=0.739N (e) P=0.500 (e) |P=0.107N P=0.339N P=0.181N P=0.061N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 24/49 (49%) 24/49 (49%) 23/49 (47%) 23/50 (46%) |27/50 (54%) 23/50 (46%) 25/50 (50%) 22/49 (45%) | |POLY-3 ADJUSTED (b)| 58.8% 62.5% 54.8% 56.0% |62.5% 54.8% 63.1% 59.2% | |TERMINAL (d) | 11/13 (85%) 10/13 (77%) 8/15 (53%) 6/13 (46%) |14/19 (74%) 11/17 (65%) 17/21 (81%) 7/11 (64%) | |FIRST INCIDENCE | 506 548 394 422 |506 559 604 556 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.514 P=0.498 P=0.351N P=0.562 |P=0.175 P=0.414N P=0.388N P=0.312 | |POLY 3 | P=0.430N P=0.453 P=0.437N P=0.484N |P=0.549N P=0.299N P=0.573 P=0.469N | |POLY 1.5 | P=0.438N P=0.496 P=0.467N P=0.483N |P=0.461N P=0.287N P=0.548N P=0.376N | |POLY 6 | P=0.396N P=0.416 P=0.381N P=0.453N |P=0.512 P=0.304N P=0.518 P=0.566N | |LOGISTIC REGRESSION| P=0.512N P=0.456 P=0.470N P=0.528N |P=0.544 P=0.319N P=0.567N P=0.510N | |COCH-ARM / FISHERS | P=0.441N P=0.580N P=0.500N P=0.462N |P=0.319N P=0.274N P=0.421N P=0.241N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 3/49 (6%) 3/49 (6%) 2/50 (4%) |10/50 (20%) 11/50 (22%) 9/50 (18%) 11/49 (22%) | |POLY-3 ADJUSTED (b)| 2.8% 8.8% 7.9% 5.7% |24.7% 27.0% 23.5% 31.2% | |TERMINAL (d) | 0/13 (0%) 2/13 (15%) 1/15 (7%) 1/13 (8%) |6/19 (32%) 2/17 (12%) 7/21 (33%) 5/11 (46%) | |FIRST INCIDENCE | 685 699 443 614 |582 548 534 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.608N P=0.312 P=0.331 P=0.488 |P=0.136 P=0.441 P=0.463N P=0.173 | |POLY 3 | P=0.606N P=0.282 P=0.323 P=0.490 |P=0.313 P=0.505 P=0.558N P=0.350 | |POLY 1.5 | P=0.595N P=0.290 P=0.315 P=0.496 |P=0.360 P=0.502 P=0.541N P=0.396 | |POLY 6 | P=0.617N P=0.273 P=0.334 P=0.485 |P=0.263 P=0.521 P=0.573N P=0.305 | |LOGISTIC REGRESSION| P=0.596N P=0.272 P=0.296 P=0.487 |P=0.308 P=0.478 P=0.562N P=0.290 | |COCH-ARM / FISHERS | P=0.580N P=0.309 P=0.309 P=0.508 |P=0.445 P=0.500 P=0.500N P=0.479 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Cortex | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/49 (0%) 4/49 (8%) 3/50 (6%) |0/50 (0%) 4/50 (8%) 2/50 (4%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 2.8% 0.0% 10.5% 8.3% |0.0% 10.3% 5.3% 5.8% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 1/15 (7%) 0/13 (0%) |0/19 (0%) 1/17 (6%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 645 --- 513 520 |--- 631 448 554 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.243 P=0.529N P=0.205 P=0.264 |P=0.527 P=0.056 P=0.240 P=0.208 | |POLY 3 | P=0.279 P=0.513N P=0.192 P=0.302 |P=0.589 P=0.057 P=0.228 P=0.209 | |POLY 1.5 | P=0.277 P=0.509N P=0.186 P=0.305 |P=0.605 P=0.058 P=0.230 P=0.217 | |POLY 6 | P=0.287 P=0.519N P=0.202 P=0.302 |P=0.571 P=0.056 P=0.228 P=0.201 | |LOGISTIC REGRESSION| P=0.285 P=0.501N P=0.175 P=0.341 |P=0.635 P=0.058 P=0.264 P=0.246 | |COCH-ARM / FISHERS | P=0.274 P=0.500N P=0.181 P=0.316 |P=0.636 P=0.059 P=0.247 P=0.242 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 5/49 (10%) 2/49 (4%) 1/50 (2%) |2/50 (4%) 4/50 (8%) 4/50 (8%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 5.5% 14.1% 5.3% 2.9% |5.1% 10.2% 10.7% 8.7% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 1/15 (7%) 1/13 (8%) |2/19 (11%) 2/17 (12%) 3/21 (14%) 1/11 (9%) | |FIRST INCIDENCE | 621 393 562 733 (T) |734 (T) 422 646 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.224N P=0.184 P=0.672N P=0.521N |P=0.452 P=0.305 P=0.370 P=0.330 | |POLY 3 | P=0.221N P=0.199 P=0.685N P=0.517N |P=0.589 P=0.333 P=0.312 P=0.439 | |POLY 1.5 | P=0.211N P=0.205 P=0.689N P=0.507N |P=0.611 P=0.336 P=0.319 P=0.457 | |POLY 6 | P=0.235N P=0.193 P=0.679N P=0.529N |P=0.565 P=0.332 P=0.311 P=0.420 | |LOGISTIC REGRESSION| P=0.199N P=0.213 P=0.695N P=0.518N |P=0.593 P=0.331 P=0.306 P=0.401 | |COCH-ARM / FISHERS | P=0.196N P=0.218 P=0.691N P=0.492N |P=0.590N P=0.339 P=0.339 P=0.490 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 22/50 (44%) 26/49 (53%) 23/49 (47%) 33/50 (66%) |16/50 (32%) 11/49 (22%) 16/50 (32%) 12/49 (24%) | |POLY-3 ADJUSTED (b)| 52.9% 63.2% 55.9% 75.2% |38.3% 28.0% 40.2% 32.4% | |TERMINAL (d) | 6/13 (46%) 7/13 (54%) 8/15 (53%) 9/13 (69%) |7/19 (37%) 3/16 (19%) 7/21 (33%) 3/11 (27%) | |FIRST INCIDENCE | 506 532 513 422 |581 613 448 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.030 * P=0.241 P=0.501N P=0.044 * |P=0.389 P=0.286N P=0.567 P=0.513 | |POLY 3 | P=0.019 * P=0.221 P=0.479 P=0.017 * |P=0.455N P=0.222N P=0.521 P=0.375N | |POLY 1.5 | P=0.018 * P=0.216 P=0.470 P=0.016 * |P=0.421N P=0.212N P=0.536 P=0.339N | |POLY 6 | P=0.026 * P=0.249 P=0.500 P=0.027 * |P=0.493N P=0.227N P=0.520 P=0.410N | |LOGISTIC REGRESSION| P=0.014 * P=0.194 P=0.505 P=0.015 * |P=0.466N P=0.224N P=0.514 P=0.371N | |COCH-ARM / FISHERS | P=0.021 * P=0.242 P=0.463 P=0.022 * |P=0.355N P=0.200N P=0.585N P=0.272N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Blood Vessel: Aorta | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/3 (100%) 4/4 (100%) 4/6 (67%) 6/6 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 75.3% 100.0% |0.0% 0.0% 0.0% 100.0% | |TERMINAL (d) | 0/0 (0%) 1/1 (100%) 1/1 (100%) 1/1 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 590 660 660 605 |--- --- --- 712 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.223 (e) P=0.624N (e) |(e) (e) (e) (e) | |POLY 3 | P=0.622 (e) P=0.523N (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.542 (e) P=0.453N (e) |(e) (e) (e) (e) | |POLY 6 | P=0.773 (e) P=0.680N (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.442 (e) P=0.265N (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.467 (e) P=0.417N (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Bone | | Fibrous Osteodystrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 9/50 (18%) 10/50 (20%) 11/50 (22%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 20.9% 24.7% 25.2% 29.8% |2.5% 0.0% 2.7% 5.8% | |TERMINAL (d) | 2/13 (15%) 2/13 (15%) 3/15 (20%) 4/13 (31%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 534 306 394 519 |703 --- 734 (T) 677 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.275 P=0.434 P=0.474 P=0.273 |P=0.164 P=0.508N P=0.759N P=0.399 | |POLY 3 | P=0.277 P=0.453 P=0.426 P=0.260 |P=0.228 P=0.507N P=0.747 P=0.454 | |POLY 1.5 | P=0.295 P=0.467 P=0.413 P=0.277 |P=0.238 P=0.504N P=0.751 P=0.471 | |POLY 6 | P=0.259 P=0.448 P=0.448 P=0.247 |P=0.216 P=0.510N P=0.745 P=0.435 | |LOGISTIC REGRESSION| P=0.298 P=0.469 P=0.406 P=0.261 |P=0.200 P=0.507N P=0.750 P=0.437 | |COCH-ARM / FISHERS | P=0.319 P=0.500 P=0.398 P=0.306 |P=0.258 P=0.500N P=0.753N P=0.500 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Bone | | Hyperostosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |7/50 (14%) 3/50 (6%) 7/50 (14%) 9/50 (18%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.9% |16.9% 7.6% 17.7% 24.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |1/19 (5%) 0/17 (0%) 1/21 (5%) 1/11 (9%) | |FIRST INCIDENCE | --- --- --- 700 |506 590 448 478 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.276 (e) (e) P=0.532 |P=0.064 P=0.192N P=0.566 P=0.206 | |POLY 3 | P=0.256 (e) (e) P=0.491 |P=0.094 P=0.177N P=0.580 P=0.277 | |POLY 1.5 | P=0.257 (e) (e) P=0.494 |P=0.112 P=0.168N P=0.587 P=0.319 | |POLY 6 | P=0.255 (e) (e) P=0.488 |P=0.076 P=0.187N P=0.580 P=0.233 | |LOGISTIC REGRESSION| P=0.247 (e) (e) P=0.487 |P=0.142 P=0.154N P=0.593N P=0.339 | |COCH-ARM / FISHERS | P=0.257 (e) (e) P=0.500 |P=0.150 P=0.159N P=0.613N P=0.393 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Clitoral Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 4/48 (8%) 3/47 (6%) 2/48 (4%) | |POLY-3 ADJUSTED (b)| |5.0% 10.5% 8.6% 6.1% | |TERMINAL (d) | |0/19 (0%) 1/16 (6%) 2/20 (10%) 0/10 (0%) | |FIRST INCIDENCE | |642 613 668 674 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.581N P=0.303 P=0.492 P=0.594 | |POLY 3 | |P=0.502N P=0.313 P=0.441 P=0.625 | |POLY 1.5 | |P=0.475N P=0.316 P=0.450 P=0.645 | |POLY 6 | |P=0.535N P=0.310 P=0.437 P=0.601 | |LOGISTIC REGRESSION| |P=0.500N P=0.314 P=0.443 P=0.635 | |COCH-ARM / FISHERS | |P=0.429N P=0.319 P=0.470 P=0.676 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 2/48 (4%) 1/47 (2%) 2/48 (4%) | |POLY-3 ADJUSTED (b)| |5.0% 5.3% 2.9% 6.0% | |TERMINAL (d) | |0/19 (0%) 1/16 (6%) 1/20 (5%) 0/10 (0%) | |FIRST INCIDENCE | |506 631 734 (T) 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.482 P=0.667 P=0.516N P=0.615 | |POLY 3 | |P=0.540 P=0.669 P=0.550N P=0.622 | |POLY 1.5 | |P=0.560 P=0.674 P=0.542N P=0.643 | |POLY 6 | |P=0.517 P=0.664 P=0.557N P=0.597 | |LOGISTIC REGRESSION| |P=0.575 P=0.682 P=0.517N P=0.693 | |COCH-ARM / FISHERS | |P=0.594 P=0.676 P=0.523N P=0.676 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Epididymis | | Granuloma Sperm | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 8.3% | | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) | | |FIRST INCIDENCE | --- --- --- 523 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.007 ** (e) (e) P=0.107 | | |POLY 3 | P=0.008 ** (e) (e) P=0.115 | | |POLY 1.5 | P=0.008 ** (e) (e) P=0.116 | | |POLY 6 | P=0.008 ** (e) (e) P=0.116 | | |LOGISTIC REGRESSION| P=0.009 ** (e) (e) P=0.138 | | |COCH-ARM / FISHERS | P=0.009 ** (e) (e) P=0.121 | | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Eye | | Cataract | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/4 (100%) 1/2 (50%) 0/1 (0%) 1/1 (100%) |1/1 (100%) 4/5 (80%) 1/6 (17%) 1/1 (100%) | |POLY-3 ADJUSTED (b)| 100.0% 93.2% 0.0% 100.0% |100.0% 80.0% 18.2% 100.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 1/1 (100%) |1/1 (100%) 1/2 (50%) 0/3 (0%) 0/0 (0%) | |FIRST INCIDENCE | 647 534 --- 733 (T) |734 (T) 422 674 674 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.350N P=0.232N P=0.067N (e) |P=0.707 P=0.240 P=0.641N (e) | |POLY 3 | P=1.000 P=1.000N P=1.000 (e) |P=0.707 P=0.793N P=0.301N (e) | |POLY 1.5 | P=0.998 P=0.990N P=1.000 (e) |P=0.701 P=0.793N P=0.293N (e) | |POLY 6 | P=1.000 P=1.000N P=1.000 (e) |P=0.716 P=0.793N P=0.316N (e) | |LOGISTIC REGRESSION| P=0.926 (e) (e) (e) |P=0.711 (e) P=0.273N (e) | |COCH-ARM / FISHERS | P=0.758 P=0.333N P=0.200N (e) |P=0.667 P=0.833N P=0.286N (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Eye | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/4 (0%) 0/2 (0%) 1/1 (100%) 0/1 (0%) |0/1 (0%) 1/5 (20%) 4/6 (67%) 0/1 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 100.0% 0.0% |0.0% 24.5% 72.1% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 1/1 (100%) 0/1 (0%) |0/1 (0%) 1/2 (50%) 3/3 (100%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 733 (T) --- |--- 734 (T) 660 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.500N (e) P=1.000 (e) |P=0.820N P=0.638 P=0.123 (e) | |POLY 3 | P=1.000N (e) P<0.001 ** (e) |P=0.744N P=0.778 P=0.394 (e) | |POLY 1.5 | P=1.000N (e) P<0.001 ** (e) |P=0.712N P=0.784 P=0.418 (e) | |POLY 6 | P=1.000N (e) P<0.001 ** (e) |P=0.819N P=0.772 P=0.341 (e) | |LOGISTIC REGRESSION| (e) (e) P=1.000 (e) |P=0.841N P=0.638 P=0.295 (e) | |COCH-ARM / FISHERS | P=0.910N (e) P=0.200 (e) |P=0.692N P=0.833 P=0.429 (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Eye: Retina | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/4 (100%) 1/2 (50%) 0/1 (0%) 1/1 (100%) |1/1 (100%) 4/5 (80%) 1/6 (17%) 1/1 (100%) | |POLY-3 ADJUSTED (b)| 100.0% 93.2% 0.0% 100.0% |100.0% 80.0% 18.2% 100.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 1/1 (100%) |1/1 (100%) 1/2 (50%) 0/3 (0%) 0/0 (0%) | |FIRST INCIDENCE | 647 534 --- 733 (T) |734 (T) 422 674 674 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.350N P=0.232N P=0.067N (e) |P=0.707 P=0.240 P=0.641N (e) | |POLY 3 | P=1.000 P=1.000N P=1.000N (e) |P=0.707 P=0.793N P=0.301N (e) | |POLY 1.5 | P=0.998 P=0.990N P=1.000N (e) |P=0.701 P=0.793N P=0.293N (e) | |POLY 6 | P=1.000 P=1.000N P=1.000N (e) |P=0.716 P=0.793N P=0.316N (e) | |LOGISTIC REGRESSION| P=0.926 (e) (e) (e) |P=0.711 (e) P=0.273N (e) | |COCH-ARM / FISHERS | P=0.758 P=0.333N P=0.200N (e) |P=0.667 P=0.833N P=0.286N (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 44/50 (88%) 37/50 (74%) 41/50 (82%) 40/50 (80%) |34/50 (68%) 37/50 (74%) 29/50 (58%) 31/50 (62%) | |POLY-3 ADJUSTED (b)| 93.0% 86.3% 88.1% 88.1% |76.2% 86.2% 70.5% 78.0% | |TERMINAL (d) | 12/13 (92%) 13/13 (100%) 13/15 (87%) 13/13 (100%)|16/19 (84%) 17/17 (100%) 18/21 (86%) 11/11 (100%) | |FIRST INCIDENCE | 506 548 450 422 |497 559 310 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.454 P=0.333N P=0.243N P=0.460N |P=0.069 P=0.233 P=0.221N P=0.103 | |POLY 3 | P=0.495N P=0.201N P=0.300N P=0.292N |P=0.548N P=0.147 P=0.351N P=0.528 | |POLY 1.5 | P=0.459N P=0.131N P=0.288N P=0.237N |P=0.433N P=0.222 P=0.285N P=0.548N | |POLY 6 | P=0.626N P=0.316N P=0.321N P=0.450N |P=0.501 P=0.086 P=0.440N P=0.364 | |LOGISTIC REGRESSION| P=0.573N P=0.151N P=0.257N P=0.291N |P=0.502 P=0.183 P=0.311N P=0.481 | |COCH-ARM / FISHERS | P=0.494N P=0.062N P=0.288N P=0.207N |P=0.281N P=0.330 P=0.204N P=0.338N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Heart: Artery | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 6/50 (12%) 5/50 (10%) 7/50 (14%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 13.3% 16.8% 13.1% 19.5% |0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 1/15 (7%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 590 306 660 605 |--- --- --- 712 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.317 P=0.438 P=0.585N P=0.347 |P=0.181 (e) (e) P=0.415 | |POLY 3 | P=0.318 P=0.462 P=0.626N P=0.341 |P=0.239 (e) (e) P=0.473 | |POLY 1.5 | P=0.332 P=0.474 P=0.628N P=0.355 |P=0.246 (e) (e) P=0.483 | |POLY 6 | P=0.305 P=0.452 P=0.622N P=0.329 |P=0.232 (e) (e) P=0.462 | |LOGISTIC REGRESSION| P=0.328 P=0.487 P=0.612N P=0.338 |P=0.218 (e) (e) P=0.450 | |COCH-ARM / FISHERS | P=0.350 P=0.500 P=0.630N P=0.380 |P=0.257 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Heart: Atrium | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 10.6% 2.9% 7.9% 5.6% |5.0% 7.7% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 599 600 566 604 |607 628 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.527N P=0.231N P=0.480N P=0.390N |P=0.201N P=0.473 P=0.263N P=0.279N | |POLY 3 | P=0.504N P=0.205N P=0.496N P=0.366N |P=0.182N P=0.488 P=0.253N P=0.272N | |POLY 1.5 | P=0.499N P=0.196N P=0.498N P=0.355N |P=0.174N P=0.493 P=0.248N P=0.258N | |POLY 6 | P=0.511N P=0.216N P=0.496N P=0.380N |P=0.195N P=0.484 P=0.258N P=0.290N | |LOGISTIC REGRESSION| P=0.497N P=0.175N P=0.499N P=0.336N |P=0.165N P=0.502 P=0.233N P=0.235N | |COCH-ARM / FISHERS | P=0.495N P=0.181N P=0.500N P=0.339N |P=0.163N P=0.500 P=0.247N P=0.247N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Intestine Large, Cecum | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/46 (0%) 3/43 (7%) 0/48 (0%) 0/49 (0%) |0/50 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 9.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- 655 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.337N P=0.101 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.307N P=0.107 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.301N P=0.107 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.314N P=0.109 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.308N P=0.108 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.295N P=0.109 (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Intestine Small, Duodenum | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 2/49 (4%) 0/50 (0%) |0/50 (0%) 1/48 (2%) 0/48 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.4% 0.0% |0.0% 2.7% 0.0% 5.8% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/16 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- --- 680 --- |--- 585 --- 554 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.587N (e) P=0.246 (e) |P=0.106 P=0.486 (e) P=0.166 | |POLY 3 | P=0.558N (e) P=0.249 (e) |P=0.140 P=0.489 (e) P=0.208 | |POLY 1.5 | P=0.556N (e) P=0.246 (e) |P=0.146 P=0.490 (e) P=0.216 | |POLY 6 | P=0.561N (e) P=0.256 (e) |P=0.133 P=0.489 (e) P=0.199 | |LOGISTIC REGRESSION| P=0.570N (e) P=0.252 (e) |P=0.171 P=0.495 (e) P=0.233 | |COCH-ARM / FISHERS | P=0.555N (e) P=0.253 (e) |P=0.158 P=0.490 (e) P=0.242 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 2/49 (4%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 2.8% 5.8% 5.3% 11.3% |0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 1/15 (7%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 1/11 (9%) | |FIRST INCIDENCE | 621 647 590 642 |--- --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.132 P=0.480 P=0.531 P=0.159 |P=0.159 (e) (e) P=0.391 | |POLY 3 | P=0.144 P=0.486 P=0.520 P=0.172 |P=0.236 (e) (e) P=0.470 | |POLY 1.5 | P=0.150 P=0.493 P=0.517 P=0.179 |P=0.242 (e) (e) P=0.480 | |POLY 6 | P=0.137 P=0.479 P=0.524 P=0.164 |P=0.229 (e) (e) P=0.459 | |LOGISTIC REGRESSION| P=0.144 P=0.498 P=0.513 P=0.172 |(e) (e) (e) P=0.391 | |COCH-ARM / FISHERS | P=0.158 P=0.508 P=0.515 P=0.194 |P=0.253 (e) (e) P=0.495 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 8.1% 8.6% 2.6% 2.9% |0.0% 2.6% 5.3% 0.0% | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 590 621 660 713 |--- 590 630 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.331N P=0.610 P=0.275N P=0.337N |P=0.469N P=0.490 P=0.251 (e) | |POLY 3 | P=0.310N P=0.642 P=0.295N P=0.323N |P=0.450N P=0.497 P=0.226 (e) | |POLY 1.5 | P=0.300N P=0.650 P=0.296N P=0.313N |P=0.436N P=0.498 P=0.228 (e) | |POLY 6 | P=0.323N P=0.638 P=0.292N P=0.336N |P=0.467N P=0.496 P=0.225 (e) | |LOGISTIC REGRESSION| P=0.293N P=0.663 P=0.297N P=0.314N |P=0.412N P=0.503 P=0.228 (e) | |COCH-ARM / FISHERS | P=0.288N P=0.651N P=0.301N P=0.301N |P=0.411N P=0.500 P=0.247 (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 3/50 (6%) 1/50 (2%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 5.8% 2.6% 5.6% |0.0% 7.6% 2.7% 2.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- 574 601 547 |--- 497 678 702 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.379 P=0.230 P=0.520 P=0.250 |P=0.667N P=0.111 P=0.465 P=0.445 | |POLY 3 | P=0.369 P=0.228 P=0.510 P=0.233 |P=0.628N P=0.117 P=0.489 P=0.471 | |POLY 1.5 | P=0.375 P=0.231 P=0.507 P=0.236 |P=0.614N P=0.118 P=0.492 P=0.480 | |POLY 6 | P=0.365 P=0.226 P=0.516 P=0.231 |P=0.645N P=0.118 P=0.489 P=0.461 | |LOGISTIC REGRESSION| P=0.387 P=0.239 P=0.499 P=0.250 |P=0.586N P=0.123 P=0.493 P=0.459 | |COCH-ARM / FISHERS | P=0.383 P=0.253 P=0.505 P=0.253 |P=0.591N P=0.121 P=0.500 P=0.495 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 4/50 (8%) 5/50 (10%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 13.3% 11.6% 13.0% 11.2% |0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 1/15 (7%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 590 660 654 605 |--- --- --- 712 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.553N P=0.549N P=0.579N P=0.566N |P=0.181 (e) (e) P=0.415 | |POLY 3 | P=0.516N P=0.551N P=0.617N P=0.530N |P=0.237 (e) (e) P=0.471 | |POLY 1.5 | P=0.505N P=0.528N P=0.617N P=0.513N |P=0.242 (e) (e) P=0.480 | |POLY 6 | P=0.531N P=0.578N P=0.616N P=0.551N |P=0.230 (e) (e) P=0.460 | |LOGISTIC REGRESSION| P=0.518N P=0.533N P=0.612N P=0.506N |P=0.217 (e) (e) P=0.450 | |COCH-ARM / FISHERS | P=0.493N P=0.487N P=0.617N P=0.487N |P=0.253 (e) (e) P=0.495 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 48/49 (98%) 49/50 (98%) 50/50 (100%) 50/50 (100%)|48/50 (96%) 47/50 (94%) 47/50 (94%) 45/49 (92%) | |POLY-3 ADJUSTED (b)| 99.2% 100.0% 100.0% 100.0% |99.7% 98.9% 99.2% 97.6% | |TERMINAL (d) | 13/13 (100%) 13/13 (100%) 15/15 (100%) 13/13 (100%)|19/19 (100%) 17/17 (100%) 21/21 (100%) 11/11 (100%) | |FIRST INCIDENCE | 338 306 394 310 |497 497 310 215 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.339 P=0.350 P=0.453N P=0.334 |P=0.051 P=0.439 P=0.514N P=0.084 | |POLY 3 | P=0.981 P=0.948 P=0.941 P=0.941 |P=0.343N P=0.950N P=0.997N P=0.493N | |POLY 1.5 | P=0.811 P=0.791 P=0.723 P=0.723 |P=0.274N P=0.638N P=0.788N P=0.328N | |POLY 6 | P=1.000 P=1.000 P=1.000 P=1.000 |P=0.958N P=1.000N P=1.000N P=0.991N | |LOGISTIC REGRESSION| P=0.495 P=0.500 P=0.511 P=0.447 |P=0.601 (e) P=0.646 P=0.659N | |COCH-ARM / FISHERS | P=0.434 P=0.747 P=0.495 P=0.495 |P=0.336N P=0.500N P=0.500N P=0.329N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 1/50 (2%) 4/50 (8%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 5.5% 2.9% 10.6% 5.7% |5.0% 2.6% 2.7% 5.9% | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 3/15 (20%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 2/11 (18%) | |FIRST INCIDENCE | 671 647 702 618 |642 700 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.645 P=0.533N P=0.400 P=0.669 |P=0.354 P=0.497N P=0.521N P=0.555 | |POLY 3 | P=0.621N P=0.519N P=0.352 P=0.685 |P=0.449 P=0.514N P=0.525N P=0.635 | |POLY 1.5 | P=0.616N P=0.511N P=0.350 P=0.691 |P=0.466 P=0.507N P=0.517N P=0.655 | |POLY 6 | P=0.628N P=0.525N P=0.356 P=0.680 |P=0.428 P=0.521N P=0.532N P=0.609 | |LOGISTIC REGRESSION| P=0.642N P=0.523N P=0.368 P=0.678 |P=0.426 P=0.504N P=0.517N P=0.626 | |COCH-ARM / FISHERS | P=0.612N P=0.492N P=0.349 P=0.684N |P=0.493 P=0.500N P=0.500N P=0.684 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Larynx | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 8/50 (16%) 4/49 (8%) 11/50 (22%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 8.1% 22.4% 10.6% 29.2% |7.5% 2.6% 0.0% 2.9% | |TERMINAL (d) | 1/13 (8%) 2/13 (15%) 1/15 (7%) 2/13 (15%) |2/19 (11%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 684 590 654 523 |506 613 --- 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.026 * P=0.093 P=0.540 P=0.024 * |P=0.629N P=0.334N P=0.114N P=0.426N | |POLY 3 | P=0.025 * P=0.082 P=0.511 P=0.017 * |P=0.562N P=0.317N P=0.132N P=0.362N | |POLY 1.5 | P=0.025 * P=0.086 P=0.500 P=0.018 * |P=0.553N P=0.312N P=0.128N P=0.344N | |POLY 6 | P=0.026 * P=0.083 P=0.530 P=0.019 * |P=0.574N P=0.321N P=0.134N P=0.382N | |LOGISTIC REGRESSION| P=0.023 * P=0.075 P=0.527 P=0.017 * |P=0.534N P=0.301N P=0.120N P=0.315N | |COCH-ARM / FISHERS | P=0.029 * P=0.100 P=0.489 P=0.020 * |P=0.539N P=0.309N P=0.121N P=0.316N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Larynx | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 4/49 (8%) 12/50 (24%) |4/50 (8%) 5/50 (10%) 3/50 (6%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 10.7% 8.7% 10.6% 31.5% |10.0% 12.9% 8.0% 8.6% | |TERMINAL (d) | 1/13 (8%) 1/13 (8%) 1/15 (7%) 2/13 (15%) |2/19 (11%) 3/17 (18%) 2/21 (10%) 1/11 (9%) | |FIRST INCIDENCE | 590 621 654 523 |589 687 646 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.002 ** P=0.536N P=0.598N P=0.031 * |P=0.617 P=0.469 P=0.491N P=0.631 | |POLY 3 | P<0.001 ** P=0.543N P=0.642N P=0.022 * |P=0.482N P=0.476 P=0.537N P=0.580N | |POLY 1.5 | P<0.001 ** P=0.529N P=0.641 P=0.023 * |P=0.460N P=0.487 P=0.526N P=0.555N | |POLY 6 | P<0.001 ** P=0.555N P=0.632N P=0.025 * |P=0.508N P=0.465 P=0.546N P=0.607N | |LOGISTIC REGRESSION| P<0.001 ** P=0.543N P=0.631N P=0.024 * |P=0.502N P=0.477 P=0.530N P=0.561N | |COCH-ARM / FISHERS | P=0.002 ** P=0.500N P=0.631 P=0.027 * |P=0.421N P=0.500 P=0.500N P=0.511N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Larynx | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/49 (4%) 10/50 (20%) |10/50 (20%) 5/50 (10%) 7/50 (14%) 11/49 (22%) | |POLY-3 ADJUSTED (b)| 2.7% 5.8% 5.4% 26.6% |24.5% 12.9% 17.8% 30.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 1/15 (7%) 2/13 (15%) |6/19 (32%) 3/17 (18%) 2/21 (10%) 2/11 (18%) | |FIRST INCIDENCE | 684 621 671 523 |497 660 547 476 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.493 P=0.525 P=0.006 ** |P=0.038 * P=0.177N P=0.296N P=0.215 | |POLY 3 | P<0.001 ** P=0.478 P=0.504 P=0.003 ** |P=0.110 P=0.149N P=0.324N P=0.385 | |POLY 1.5 | P<0.001 ** P=0.484 P=0.499 P=0.004 ** |P=0.121 P=0.141N P=0.322N P=0.413 | |POLY 6 | P<0.001 ** P=0.476 P=0.514 P=0.004 ** |P=0.104 P=0.157N P=0.312N P=0.369 | |LOGISTIC REGRESSION| P<0.001 ** P=0.479 P=0.514 P=0.005 ** |P=0.108 P=0.144N P=0.319N P=0.390 | |COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.492 P=0.004 ** |P=0.150 P=0.131N P=0.298N P=0.479 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Larynx | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/49 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 7.9% 2.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 720 --- 654 715 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.689 P=0.541N P=0.339 P=0.738 |(e) (e) (e) (e) | |POLY 3 | P=0.654N P=0.515N P=0.315 P=0.751 |(e) (e) (e) (e) | |POLY 1.5 | P=0.651N P=0.510N P=0.306 P=0.754 |(e) (e) (e) (e) | |POLY 6 | P=0.657N P=0.518N P=0.331 P=0.748 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.667N P=0.517N P=0.307 P=0.752 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.650N P=0.500N P=0.301 P=0.753N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Larynx: Epiglottis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 6/50 (12%) 4/49 (8%) 5/50 (10%) |4/50 (8%) 2/50 (4%) 0/50 (0%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 17.1% 10.6% 13.9% |9.7% 5.2% 0.0% 8.7% | |TERMINAL (d) | 0/13 (0%) 2/13 (15%) 1/15 (7%) 1/13 (8%) |1/19 (5%) 1/17 (6%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- 621 654 605 |497 688 --- 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.256 P=0.019 * P=0.080 P=0.029 * |P=0.361 P=0.355N P=0.074N P=0.624N | |POLY 3 | P=0.278 P=0.012 * P=0.062 P=0.027 * |P=0.428 P=0.366N P=0.073N P=0.592N | |POLY 1.5 | P=0.283 P=0.013 * P=0.060 P=0.028 * |P=0.441 P=0.354N P=0.069N P=0.563N | |POLY 6 | P=0.280 P=0.011 * P=0.066 P=0.027 * |P=0.413 P=0.380N P=0.076N P=0.623N | |LOGISTIC REGRESSION| P=0.270 P=0.013 * P=0.066 P=0.030 * |P=0.463 P=0.330N P=0.049N* P=0.490N | |COCH-ARM / FISHERS | P=0.297 P=0.013 * P=0.056 P=0.028 * |P=0.466 P=0.339N P=0.059N P=0.511N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Larynx: Epiglottis | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/49 (4%) 4/50 (8%) |4/50 (8%) 1/50 (2%) 1/50 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.9% 5.3% 11.2% |10.0% 2.6% 2.7% 0.0% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 0/15 (0%) 2/13 (15%) |2/19 (11%) 1/17 (6%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | --- 733 (T) 654 605 |589 734 (T) 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.037 * P=0.500 P=0.260 P=0.058 |P=0.212N P=0.206N P=0.177N P=0.121N | |POLY 3 | P=0.045 * P=0.486 P=0.242 P=0.055 |P=0.156N P=0.192N P=0.201N P=0.083N | |POLY 1.5 | P=0.046 * P=0.490 P=0.237 P=0.057 |P=0.149N P=0.186N P=0.194N P=0.075N | |POLY 6 | P=0.045 * P=0.482 P=0.251 P=0.054 |P=0.165N P=0.199N P=0.207N P=0.094N | |LOGISTIC REGRESSION| P=0.042 * P=0.500 P=0.235 P=0.057 |P=0.166N P=0.188N P=0.196N P=0.079N | |COCH-ARM / FISHERS | P=0.048 * P=0.500 P=0.242 P=0.059 |P=0.141N P=0.181N P=0.181N P=0.061N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Larynx: Epiglottis | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 3/50 (6%) |4/50 (8%) 6/50 (12%) 1/50 (2%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 8.4% |10.0% 15.6% 2.7% 8.6% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 1/13 (8%) |2/19 (11%) 5/17 (29%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | --- --- --- 602 |589 660 734 (T) 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.008 ** (e) (e) P=0.118 |P=0.597 P=0.301 P=0.167N P=0.638 | |POLY 3 | P=0.008 ** (e) (e) P=0.112 |P=0.487N P=0.345 P=0.199N P=0.575N | |POLY 1.5 | P=0.008 ** (e) (e) P=0.114 |P=0.470N P=0.356 P=0.193N P=0.553N | |POLY 6 | P=0.008 ** (e) (e) P=0.112 |P=0.504N P=0.334 P=0.203N P=0.596N | |LOGISTIC REGRESSION| P=0.009 ** (e) (e) P=0.119 |P=0.531N P=0.341 P=0.198N P=0.562N | |COCH-ARM / FISHERS | P=0.009 ** (e) (e) P=0.121 |P=0.441N P=0.370 P=0.181N P=0.511N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 5/50 (10%) |2/50 (4%) 2/50 (4%) 5/50 (10%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 5.9% 0.0% 13.8% |5.0% 5.2% 13.2% 8.6% | |TERMINAL (d) | 0/13 (0%) 2/13 (15%) 0/15 (0%) 2/13 (15%) |1/19 (5%) 0/17 (0%) 3/21 (14%) 1/11 (9%) | |FIRST INCIDENCE | --- 733 (T) --- 523 |677 660 630 677 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.006 ** P=0.235 (e) P=0.033 * |P=0.383 P=0.667 P=0.220 P=0.347 | |POLY 3 | P=0.006 ** P=0.220 (e) P=0.028 * |P=0.497 P=0.686 P=0.194 P=0.440 | |POLY 1.5 | P=0.007 ** P=0.226 (e) P=0.029 * |P=0.525 P=0.689 P=0.200 P=0.462 | |POLY 6 | P=0.006 ** P=0.216 (e) P=0.028 * |P=0.464 P=0.684 P=0.192 P=0.414 | |LOGISTIC REGRESSION| P=0.007 ** P=0.235 (e) P=0.033 * |P=0.482 P=0.684 P=0.190 P=0.403 | |COCH-ARM / FISHERS | P=0.008 ** P=0.247 (e) P=0.028 * |P=0.573 P=0.691N P=0.218 P=0.500 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 21/50 (42%) 23/50 (46%) 21/50 (42%) 15/50 (30%) |38/50 (76%) 36/50 (72%) 38/50 (76%) 34/50 (68%) | |POLY-3 ADJUSTED (b)| 52.1% 60.5% 51.5% 41.6% |82.4% 81.8% 85.8% 82.0% | |TERMINAL (d) | 10/13 (77%) 10/13 (77%) 10/15 (67%) 9/13 (69%) |17/19 (90%) 15/17 (88%) 20/21 (95%) 10/11 (91%) | |FIRST INCIDENCE | 534 548 562 602 |497 422 339 422 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.103N P=0.353 P=0.427N P=0.170N |P=0.091 P=0.529 P=0.545N P=0.143 | |POLY 3 | P=0.102N P=0.287 P=0.567N P=0.232N |P=0.531N P=0.584N P=0.437 P=0.598N | |POLY 1.5 | P=0.080N P=0.326 P=0.576N P=0.191N |P=0.408N P=0.492N P=0.490 P=0.448N | |POLY 6 | P=0.154N P=0.262 P=0.540N P=0.301N |P=0.537 P=0.560 P=0.385 P=0.498 | |LOGISTIC REGRESSION| P=0.075N P=0.262 P=0.529N P=0.195N |P=0.507N P=0.481N P=0.438 P=0.547N | |COCH-ARM / FISHERS | P=0.064N P=0.420 P=0.580N P=0.149N |P=0.234N P=0.410N P=0.592N P=0.252N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 3/50 (6%) 6/50 (12%) 9/50 (18%) |5/50 (10%) 7/50 (14%) 8/50 (16%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 16.4% 8.8% 16.0% 25.4% |12.6% 17.7% 20.7% 5.7% | |TERMINAL (d) | 6/13 (46%) 3/13 (23%) 6/15 (40%) 8/13 (62%) |4/19 (21%) 5/17 (29%) 4/21 (19%) 1/11 (9%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 540 |699 478 534 534 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.044 * P=0.209N P=0.521N P=0.231 |P=0.192N P=0.313 P=0.299 P=0.426N | |POLY 3 | P=0.083 P=0.273N P=0.608N P=0.252 |P=0.099N P=0.376 P=0.256 P=0.266N | |POLY 1.5 | P=0.089 P=0.265N P=0.614N P=0.266 |P=0.086N P=0.378 P=0.258 P=0.248N | |POLY 6 | P=0.075 P=0.277N P=0.595N P=0.239 |P=0.118N P=0.376 P=0.265 P=0.289N | |LOGISTIC REGRESSION| P=0.058 P=0.209N P=0.521N P=0.223 |P=0.089N P=0.356 P=0.236 P=0.296N | |COCH-ARM / FISHERS | P=0.095 P=0.243N P=0.620N P=0.288 |P=0.067N P=0.380 P=0.277 P=0.218N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 9/50 (18%) 10/50 (20%) 10/50 (20%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 23.1% 25.4% 25.9% 26.9% |0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 3/13 (23%) 4/13 (31%) 5/15 (33%) 3/13 (23%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 566 590 604 523 |--- --- --- 709 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.442 P=0.539 P=0.589 P=0.457 |P=0.193 (e) (e) P=0.428 | |POLY 3 | P=0.467 P=0.517 P=0.490 P=0.451 |P=0.239 (e) (e) P=0.473 | |POLY 1.5 | P=0.475 P=0.546 P=0.494 P=0.469 |P=0.246 (e) (e) P=0.483 | |POLY 6 | P=0.463 P=0.485 P=0.483 P=0.435 |P=0.232 (e) (e) P=0.462 | |LOGISTIC REGRESSION| P=0.443 P=0.541 P=0.526 P=0.472 |P=0.221 (e) (e) P=0.453 | |COCH-ARM / FISHERS | P=0.484 P=0.602N P=0.500 P=0.500 |P=0.257 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 4/50 (8%) 5/50 (10%) 4/50 (8%) |2/50 (4%) 3/50 (6%) 3/50 (6%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 15.9% 11.3% 13.3% 11.1% |5.1% 7.7% 8.0% 2.9% | |TERMINAL (d) | 2/13 (15%) 0/13 (0%) 3/15 (20%) 1/13 (8%) |2/19 (11%) 2/17 (12%) 2/21 (10%) 1/11 (9%) | |FIRST INCIDENCE | 645 590 702 547 |734 (T) 585 646 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.480N P=0.445N P=0.433N P=0.433N |P=0.469N P=0.452 P=0.532 P=0.690N | |POLY 3 | P=0.447N P=0.409N P=0.501N P=0.395N |P=0.334N P=0.492 P=0.477 P=0.548N | |POLY 1.5 | P=0.441N P=0.399N P=0.500N P=0.386N |P=0.313N P=0.496 P=0.482 P=0.530N | |POLY 6 | P=0.454N P=0.416N P=0.504N P=0.404N |P=0.361N P=0.491 P=0.477 P=0.569N | |LOGISTIC REGRESSION| P=0.461N P=0.409N P=0.459N P=0.394N |P=0.354N P=0.482 P=0.470 P=0.690N | |COCH-ARM / FISHERS | P=0.435N P=0.370N P=0.500N P=0.370N |P=0.280N P=0.500 P=0.500 P=0.500N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Fatty Change | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 8/50 (16%) 8/50 (16%) 7/50 (14%) |12/50 (24%) 19/50 (38%) 11/50 (22%) 12/50 (24%) | |POLY-3 ADJUSTED (b)| 12.9% 21.7% 19.9% 18.8% |28.3% 43.7% 25.9% 30.6% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |1/19 (5%) 2/17 (12%) 0/21 (0%) 1/11 (9%) | |FIRST INCIDENCE | 544 350 443 539 |588 497 339 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.505 P=0.246 P=0.328 P=0.334 |P=0.537 P=0.111 P=0.556N P=0.363 | |POLY 3 | P=0.536 P=0.235 P=0.296 P=0.348 |P=0.430N P=0.098 P=0.496N P=0.505 | |POLY 1.5 | P=0.547 P=0.248 P=0.287 P=0.359 |P=0.389N P=0.097 P=0.502N P=0.535 | |POLY 6 | P=0.527 P=0.227 P=0.312 P=0.342 |P=0.480N P=0.105 P=0.490N P=0.470 | |LOGISTIC REGRESSION| P=0.580 P=0.319 P=0.259 P=0.417 |P=0.250N P=0.100 P=0.426N P=0.560N | |COCH-ARM / FISHERS | P=0.566 P=0.277 P=0.277 P=0.380 |P=0.318N P=0.097 P=0.500N P=0.592N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |3/50 (6%) 3/50 (6%) 3/50 (6%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 2.7% 5.8% 7.9% 5.7% |7.5% 7.7% 8.0% 11.4% | |TERMINAL (d) | 1/13 (8%) 1/13 (8%) 1/15 (7%) 2/13 (15%) |1/19 (5%) 2/17 (12%) 2/21 (10%) 1/11 (9%) | |FIRST INCIDENCE | 733 (T) 625 601 733 (T) |582 422 639 677 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.599 P=0.484 P=0.342 P=0.500 |P=0.247 P=0.629 P=0.659 P=0.352 | |POLY 3 | P=0.602 P=0.479 P=0.319 P=0.482 |P=0.356 P=0.651 P=0.632 P=0.425 | |POLY 1.5 | P=0.610 P=0.484 P=0.312 P=0.489 |P=0.381 P=0.657 P=0.641 P=0.452 | |POLY 6 | P=0.593 P=0.477 P=0.331 P=0.476 |P=0.329 P=0.644 P=0.626 P=0.394 | |LOGISTIC REGRESSION| P=0.599 P=0.469 P=0.317 P=0.500 |P=0.381 P=0.659N P=0.643 P=0.434 | |COCH-ARM / FISHERS | P=0.618 P=0.500 P=0.309 P=0.500 |P=0.426 P=0.661N P=0.661N P=0.500 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 0.0% |7.5% 2.6% 0.0% 2.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |1/19 (5%) 0/17 (0%) 0/21 (0%) 1/11 (9%) | |FIRST INCIDENCE | 647 --- --- --- |621 687 --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.701N P=0.522N P=0.487N P=0.546N |P=0.642N P=0.324N P=0.130N P=0.444N | |POLY 3 | P=0.661N P=0.516N P=0.497N P=0.512N |P=0.558N P=0.320N P=0.132N P=0.362N | |POLY 1.5 | P=0.660N P=0.511N P=0.498N P=0.507N |P=0.547N P=0.313N P=0.128N P=0.339N | |POLY 6 | P=0.663N P=0.521N P=0.495N P=0.517N |P=0.574N P=0.327N P=0.136N P=0.391N | |LOGISTIC REGRESSION| P=0.661N P=0.504N P=0.501N P=0.501N |P=0.571N P=0.308N P=0.124N P=0.350N | |COCH-ARM / FISHERS | P=0.660N P=0.500N P=0.500N P=0.500N |P=0.531N P=0.309N P=0.121N P=0.309N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |10/50 (20%) 9/50 (18%) 6/50 (12%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 0.0% |24.1% 22.8% 15.6% 5.8% | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |4/19 (21%) 3/17 (18%) 3/21 (14%) 1/11 (9%) | |FIRST INCIDENCE | 733 (T) --- --- --- |590 548 534 704 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.668N P=0.500N P=0.471N P=0.500N |P=0.066N P=0.548N P=0.218N P=0.065N | |POLY 3 | P=0.662N P=0.514N P=0.495N P=0.510N |P=0.028N* P=0.550N P=0.251N P=0.029N* | |POLY 1.5 | P=0.660N P=0.510N P=0.498N P=0.506N |P=0.022N* P=0.527N P=0.237N P=0.021N* | |POLY 6 | P=0.666N P=0.518N P=0.491N P=0.513N |P=0.040N* P=0.579N P=0.267N P=0.042N* | |LOGISTIC REGRESSION| P=0.668N (e) (e) (e) |P=0.024N* P=0.521N P=0.226N P=0.025N* | |COCH-ARM / FISHERS | P=0.660N P=0.500N P=0.500N P=0.500N |P=0.016N* P=0.500N P=0.207N P=0.014N* | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 4/50 (8%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 4/50 (8%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 10.3% 2.8% |2.5% 2.6% 10.2% 5.7% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 1/11 (9%) | |FIRST INCIDENCE | 590 --- 590 621 |660 606 310 554 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.502N P=0.265N P=0.372 P=0.532N |P=0.501 P=0.745 P=0.178 P=0.401 | |POLY 3 | P=0.467N P=0.258N P=0.350 P=0.522N |P=0.527 P=0.756 P=0.172 P=0.456 | |POLY 1.5 | P=0.465N P=0.251N P=0.343 P=0.513N |P=0.549 P=0.758 P=0.174 P=0.472 | |POLY 6 | P=0.470N P=0.266N P=0.362 P=0.531N |P=0.500 P=0.754 P=0.173 P=0.436 | |LOGISTIC REGRESSION| P=0.463N P=0.213N P=0.331 P=0.476N |P=0.644N P=0.759N P=0.229 P=0.496 | |COCH-ARM / FISHERS | P=0.466N P=0.247N P=0.339 P=0.500N |P=0.589 P=0.753N P=0.181 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Regeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 5/50 (10%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 11.2% 13.1% 0.0% |5.1% 2.6% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 2/15 (13%) 0/13 (0%) |1/19 (5%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 729 566 566 --- |716 590 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.089N P=0.173 P=0.136 P=0.500N |P=0.388N P=0.529N P=0.234N P=0.369N | |POLY 3 | P=0.090N P=0.167 P=0.108 P=0.510N |P=0.320N P=0.507N P=0.250N P=0.269N | |POLY 1.5 | P=0.086N P=0.169 P=0.105 P=0.506N |P=0.312N P=0.504N P=0.247N P=0.257N | |POLY 6 | P=0.094N P=0.171 P=0.115 P=0.514N |P=0.331N P=0.508N P=0.252N P=0.284N | |LOGISTIC REGRESSION| P=0.086N P=0.177 P=0.111 P=0.506N |P=0.320N P=0.506N P=0.247N P=0.315N | |COCH-ARM / FISHERS | P=0.083N P=0.181 P=0.102 P=0.500N |P=0.302N P=0.500N P=0.247N P=0.247N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Vacuolization Cytoplasmic Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 0.0% |7.4% 0.0% 5.3% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 726 --- --- --- |581 --- 547 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.664N P=0.529N P=0.500N P=0.514N |P=0.280N P=0.143N P=0.512N P=0.185N | |POLY 3 | P=0.662N P=0.514N P=0.495N P=0.510N |P=0.240N P=0.128N P=0.531N P=0.149N | |POLY 1.5 | P=0.660N P=0.510N P=0.498N P=0.506N |P=0.229N P=0.124N P=0.522N P=0.137N | |POLY 6 | P=0.665N P=0.518N P=0.491N P=0.514N |P=0.255N P=0.133N P=0.539N P=0.166N | |LOGISTIC REGRESSION| P=0.668N P=0.515N P=0.485N P=0.508N |P=0.204N P=0.117N P=0.484N P=0.110N | |COCH-ARM / FISHERS | P=0.660N P=0.500N P=0.500N P=0.500N |P=0.213N P=0.121N P=0.500N P=0.121N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 28/50 (56%) 27/50 (54%) 32/50 (64%) 30/50 (60%) |15/50 (30%) 12/50 (24%) 7/50 (14%) 13/50 (26%) | |POLY-3 ADJUSTED (b)| 64.0% 65.8% 71.0% 70.4% |36.0% 29.1% 17.9% 34.6% | |TERMINAL (d) | 7/13 (54%) 7/13 (54%) 9/15 (60%) 7/13 (54%) |7/19 (37%) 3/17 (18%) 1/21 (5%) 1/11 (9%) | |FIRST INCIDENCE | 534 524 450 520 |506 497 603 519 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.361 P=0.505 P=0.465 P=0.358 |P=0.163 P=0.414N P=0.067N P=0.380 | |POLY 3 | P=0.377 P=0.525 P=0.308 P=0.334 |P=0.342 P=0.330N P=0.053N P=0.543N | |POLY 1.5 | P=0.397 P=0.560 P=0.288 P=0.360 |P=0.377 P=0.328N P=0.052N P=0.499N | |POLY 6 | P=0.372 P=0.512 P=0.351 P=0.335 |P=0.312 P=0.330N P=0.051N P=0.579N | |LOGISTIC REGRESSION| P=0.387 P=0.565 P=0.279 P=0.362 |P=0.372 P=0.339N P=0.055N P=0.541N | |COCH-ARM / FISHERS | P=0.425 P=0.500N P=0.270 P=0.420 |P=0.448 P=0.326N P=0.045N* P=0.412N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver: Bile Duct | | Inflammation Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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% 5.3% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- --- 590 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.574N (e) P=0.254 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.565N (e) P=0.245 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.564N (e) P=0.241 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.566N (e) P=0.252 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.565N (e) P=0.236 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.564N (e) P=0.247 (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver: Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 14/50 (28%) 16/50 (32%) 13/50 (26%) |6/50 (12%) 13/50 (26%) 8/50 (16%) 17/50 (34%) | |POLY-3 ADJUSTED (b)| 31.4% 34.0% 37.3% 33.4% |14.5% 30.0% 19.9% 42.3% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 1/15 (7%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 2/11 (18%) | |FIRST INCIDENCE | 506 306 513 533 |506 497 354 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.510N P=0.418 P=0.410 P=0.503 |P=0.007 ** P=0.071 P=0.338 P=0.004 ** | |POLY 3 | P=0.553N P=0.493 P=0.365 P=0.519 |P=0.008 ** P=0.070 P=0.362 P=0.004 ** | |POLY 1.5 | P=0.512N P=0.493 P=0.347 P=0.545 |P=0.010 * P=0.066 P=0.366 P=0.004 ** | |POLY 6 | P=0.559 P=0.493 P=0.397 P=0.500 |P=0.007 ** P=0.079 P=0.369 P=0.003 ** | |LOGISTIC REGRESSION| P=0.414N P=0.524N P=0.306 P=0.564N |P=0.026 * P=0.067 P=0.434 P=0.011 * | |COCH-ARM / FISHERS | P=0.448N P=0.500 P=0.330 P=0.590N |P=0.016 * P=0.062 P=0.387 P=0.008 ** | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Hyperplasia Atypical | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/49 (4%) 5/50 (10%) 18/50 (36%) |0/50 (0%) 0/50 (0%) 9/50 (18%) 16/50 (32%) | |POLY-3 ADJUSTED (b)| 0.0% 5.9% 13.0% 46.7% |0.0% 0.0% 23.9% 43.1% | |TERMINAL (d) | 0/13 (0%) 2/13 (15%) 2/15 (13%) 9/13 (69%) |0/19 (0%) 0/17 (0%) 7/21 (33%) 6/11 (55%) | |FIRST INCIDENCE | --- 733 (T) 590 519 |--- --- 674 476 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.235 P=0.046 * P<0.001 ** |P<0.001 ** (e) P=0.003 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.220 P=0.033 * P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.224 P=0.032 * P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.216 P=0.036 * P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.235 P=0.035 * P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.242 P=0.028 * P<0.001 ** |P<0.001 ** (e) P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 43/49 (88%) 50/50 (100%) 50/50 (100%)|11/50 (22%) 46/50 (92%) 49/50 (98%) 50/50 (100%) | |POLY-3 ADJUSTED (b)| 8.1% 93.5% 100.0% 100.0% |26.7% 96.9% 99.8% 100.0% | |TERMINAL (d) | 2/13 (15%) 12/13 (92%) 15/15 (100%) 13/13 (100%)|5/19 (26%) 17/17 (100%) 21/21 (100%) 11/11 (100%) | |FIRST INCIDENCE | 567 393 394 310 |506 310 198 215 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.7% 5.7% |0.0% 0.0% 5.3% 2.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 1/15 (7%) 2/13 (15%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | --- --- 733 (T) 733 (T) |--- --- 678 677 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.116 (e) P=0.529 P=0.235 |P=0.471 (e) P=0.231 P=0.466 | |POLY 3 | P=0.125 (e) P=0.505 P=0.225 |P=0.500 (e) P=0.225 P=0.474 | |POLY 1.5 | P=0.127 (e) P=0.502 P=0.230 |P=0.516 (e) P=0.228 P=0.483 | |POLY 6 | P=0.122 (e) P=0.509 P=0.220 |P=0.484 (e) P=0.224 P=0.463 | |LOGISTIC REGRESSION| (e) (e) P=0.529 P=0.235 |P=0.506 (e) P=0.223 P=0.479 | |COCH-ARM / FISHERS | P=0.130 (e) P=0.500 P=0.247 |P=0.546 (e) P=0.247 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 5/49 (10%) 3/50 (6%) 7/50 (14%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 10.6% 14.3% 7.9% 19.5% |2.5% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 1/15 (7%) 2/13 (15%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 590 621 660 605 |703 --- --- 712 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.153 P=0.451 P=0.460N P=0.235 |P=0.423 P=0.508N P=0.517N P=0.679 | |POLY 3 | P=0.154 P=0.452 P=0.495N P=0.226 |P=0.480 P=0.507N P=0.512N P=0.730 | |POLY 1.5 | P=0.164 P=0.463 P=0.497N P=0.240 |P=0.489 P=0.504N P=0.509N P=0.742 | |POLY 6 | P=0.143 P=0.442 P=0.491N P=0.214 |P=0.469 P=0.510N P=0.515N P=0.716 | |LOGISTIC REGRESSION| P=0.151 P=0.455 P=0.491N P=0.227 |P=0.459 P=0.507N P=0.513N P=0.714 | |COCH-ARM / FISHERS | P=0.179 P=0.487 P=0.500N P=0.262 |P=0.503 P=0.500N P=0.500N P=0.753N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Proteinosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 22/49 (45%) 50/50 (100%) 49/50 (98%) |1/50 (2%) 24/50 (48%) 47/50 (94%) 49/50 (98%) | |POLY-3 ADJUSTED (b)| 0.0% 55.3% 100.0% 98.6% |2.5% 57.4% 96.1% 99.3% | |TERMINAL (d) | 0/13 (0%) 6/13 (46%) 15/15 (100%) 13/13 (100%)|1/19 (5%) 11/17 (65%) 20/21 (95%) 11/11 (100%) | |FIRST INCIDENCE | --- 393 394 310 |734 (T) 559 198 215 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 5.6% |0.0% 2.6% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 684 --- --- 520 |--- 563 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.153 P=0.509N P=0.500N P=0.481 |P=0.693N P=0.482 (e) (e) | |POLY 3 | P=0.161 P=0.516N P=0.496N P=0.492 |P=0.678N P=0.497 (e) (e) | |POLY 1.5 | P=0.161 P=0.512N P=0.498N P=0.494 |P=0.673N P=0.498 (e) (e) | |POLY 6 | P=0.162 P=0.520N P=0.493N P=0.492 |P=0.683N P=0.496 (e) (e) | |LOGISTIC REGRESSION| P=0.171 P=0.516N P=0.494N P=0.534 |P=0.633N P=0.501 (e) (e) | |COCH-ARM / FISHERS | P=0.161 P=0.505N P=0.500N P=0.500 |P=0.669N P=0.500 (e) (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 28 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 16/49 (33%) 21/50 (42%) 21/50 (42%) |14/50 (28%) 9/50 (18%) 17/50 (34%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 31.8% 43.8% 49.9% 53.7% |34.1% 22.7% 42.7% 37.7% | |TERMINAL (d) | 6/13 (46%) 9/13 (69%) 6/15 (40%) 9/13 (69%) |6/19 (32%) 4/17 (24%) 10/21 (48%) 3/11 (27%) | |FIRST INCIDENCE | 567 532 566 422 |581 559 534 506 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.096 P=0.203 P=0.108 P=0.043 * |P=0.100 P=0.241N P=0.352 P=0.223 | |POLY 3 | P=0.106 P=0.192 P=0.068 P=0.033 * |P=0.319 P=0.184N P=0.281 P=0.460 | |POLY 1.5 | P=0.112 P=0.202 P=0.053 P=0.036 * |P=0.361 P=0.177N P=0.291 P=0.505 | |POLY 6 | P=0.102 P=0.190 P=0.113 P=0.035 * |P=0.279 P=0.194N P=0.280 P=0.413 | |LOGISTIC REGRESSION| P=0.076 P=0.148 P=0.049 * P=0.022 * |P=0.287 P=0.191N P=0.258 P=0.407 | |COCH-ARM / FISHERS | P=0.122 P=0.232 P=0.044 * P=0.044 * |P=0.446 P=0.171N P=0.333 P=0.588N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/49 (4%) 34/50 (68%) 41/50 (82%) |0/50 (0%) 1/50 (2%) 36/50 (72%) 41/50 (82%) | |POLY-3 ADJUSTED (b)| 0.0% 5.8% 78.9% 90.9% |0.0% 2.6% 82.7% 94.5% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 14/15 (93%) 13/13 (100%)|0/19 (0%) 1/17 (6%) 19/21 (91%) 11/11 (100%) | |FIRST INCIDENCE | --- 548 443 422 |--- 734 (T) 310 476 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.237 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.478 P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.223 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.494 P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.226 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.497 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.222 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.492 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.233 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.478 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.242 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 29 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung: Artery, Mediastinum | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/49 (6%) 2/50 (4%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 10.6% 8.7% 5.3% 14.0% |0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 590 660 660 605 |--- --- --- 712 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.243 P=0.546N P=0.313N P=0.442 |P=0.181 (e) (e) P=0.415 | |POLY 3 | P=0.261 P=0.548N P=0.331N P=0.466 |P=0.239 (e) (e) P=0.473 | |POLY 1.5 | P=0.270 P=0.535N P=0.334N P=0.479 |P=0.246 (e) (e) P=0.483 | |POLY 6 | P=0.252 P=0.563N P=0.325N P=0.455 |P=0.232 (e) (e) P=0.462 | |LOGISTIC REGRESSION| P=0.258 P=0.538N P=0.334N P=0.471 |P=0.218 (e) (e) P=0.450 | |COCH-ARM / FISHERS | P=0.281 P=0.511N P=0.339N P=0.500 |P=0.257 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Infiltration Cellular Plasma Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/46 (4%) 1/43 (2%) 1/46 (2%) 3/44 (7%) |0/43 (0%) 0/45 (0%) 0/45 (0%) 0/47 (0%) | |POLY-3 ADJUSTED (b)| 5.7% 3.3% 2.9% 9.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/11 (0%) 0/14 (0%) 0/10 (0%) |0/16 (0%) 0/17 (0%) 0/17 (0%) 0/9 (0%) | |FIRST INCIDENCE | 506 548 674 310 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.232 P=0.519N P=0.484N P=0.466 |(e) (e) (e) (e) | |POLY 3 | P=0.232 P=0.546N P=0.503N P=0.450 |(e) (e) (e) (e) | |POLY 1.5 | P=0.239 P=0.538N P=0.502N P=0.463 |(e) (e) (e) (e) | |POLY 6 | P=0.224 P=0.556N P=0.503N P=0.435 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.298 P=0.441N P=0.508N P=0.622 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.246 P=0.526N P=0.500N P=0.479 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 30 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Galactocele | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/41 (2%) 2/42 (5%) 1/42 (2%) 3/40 (8%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 3.3% 6.9% 3.0% 10.2% |2.5% 0.0% 5.3% 0.0% | |TERMINAL (d) | 0/11 (0%) 1/9 (11%) 1/14 (7%) 0/12 (0%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 544 574 733 (T) 557 |716 --- 646 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.235 P=0.469 P=0.731N P=0.262 |P=0.507N P=0.518N P=0.500 P=0.614N | |POLY 3 | P=0.230 P=0.485 P=0.742N P=0.291 |P=0.436N P=0.506N P=0.482 P=0.528N | |POLY 1.5 | P=0.231 P=0.494 P=0.747N P=0.291 |P=0.423N P=0.503N P=0.486 P=0.517N | |POLY 6 | P=0.234 P=0.470 P=0.736N P=0.296 |P=0.452N P=0.509N P=0.481 P=0.540N | |LOGISTIC REGRESSION| P=0.239 P=0.525 P=0.754 P=0.313 |P=0.439N P=0.508N P=0.479 P=0.555N | |COCH-ARM / FISHERS | P=0.235 P=0.509 P=0.747N P=0.298 |P=0.400N P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mesentery: Artery | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/5 (60%) 2/10 (20%) 2/14 (14%) 2/7 (29%) |0/6 (0%) 0/14 (0%) 0/6 (0%) 0/11 (0%) | |POLY-3 ADJUSTED (b)| 67.4% 27.6% 18.5% 35.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/2 (0%) 0/2 (0%) 0/1 (0%) |0/1 (0%) 0/6 (0%) 0/4 (0%) 0/1 (0%) | |FIRST INCIDENCE | 647 660 660 605 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.595N P=0.535N P=0.454N P=0.528N |(e) (e) (e) (e) | |POLY 3 | P=0.690N P=0.216N P=0.077N P=0.353N |(e) (e) (e) (e) | |POLY 1.5 | P=0.672 P=0.193N P=0.072N P=0.337N |(e) (e) (e) (e) | |POLY 6 | P=0.677N P=0.241N P=0.089N P=0.376N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.647 P=0.216N P=0.093N P=0.343N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.641 P=0.167N P=0.084N P=0.311N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 31 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/5 (60%) 7/10 (70%) 11/14 (79%) 5/7 (71%) |6/6 (100%) 13/14 (93%) 6/6 (100%) 11/11 (100%) | |POLY-3 ADJUSTED (b)| 63.0% 84.9% 83.9% 73.5% |100.0% 92.9% 100.0% 100.0% | |TERMINAL (d) | 0/0 (0%) 2/2 (100%) 2/2 (100%) 1/1 (100%) |1/1 (100%) 5/6 (83%) 4/4 (100%) 1/1 (100%) | |FIRST INCIDENCE | 621 566 560 523 |588 478 462 478 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.467N P=0.312 P=0.101 P=0.460 |P=0.026 * P=0.298 (e) (e) | |POLY 3 | P=0.578N P=0.406 P=0.376 P=0.601 |P=0.623 P=0.666N (e) (e) | |POLY 1.5 | P=0.618N P=0.473 P=0.395 P=0.588 |P=0.623 P=0.666N (e) (e) | |POLY 6 | P=0.529N P=0.346 P=0.345 P=0.626 |P=0.623 P=0.666N (e) (e) | |LOGISTIC REGRESSION| P=0.666 P=0.424 P=0.438 P=0.595 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.660 P=0.566 P=0.397 P=0.576 |P=0.627 P=0.700N (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 5/48 (10%) 10/49 (20%) 8/50 (16%) |3/50 (6%) 4/50 (8%) 9/49 (18%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 25.8% 14.5% 24.9% 21.6% |7.5% 10.2% 23.6% 8.8% | |TERMINAL (d) | 2/13 (15%) 2/13 (15%) 2/15 (13%) 1/13 (8%) |0/19 (0%) 1/17 (6%) 4/21 (19%) 1/11 (9%) | |FIRST INCIDENCE | 534 590 513 520 |589 590 534 688 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.539 P=0.189N P=0.535N P=0.463N |P=0.543N P=0.466 P=0.069 P=0.476 | |POLY 3 | P=0.568N P=0.178N P=0.568N P=0.435N |P=0.412N P=0.486 P=0.044 * P=0.587 | |POLY 1.5 | P=0.557N P=0.167N P=0.592N P=0.422N |P=0.375N P=0.492 P=0.047 * P=0.612 | |POLY 6 | P=0.576N P=0.197N P=0.527N P=0.444N |P=0.458N P=0.481 P=0.044 * P=0.557 | |LOGISTIC REGRESSION| P=0.557N P=0.166N P=0.576 P=0.422N |P=0.380N P=0.496 P=0.048 * P=0.589 | |COCH-ARM / FISHERS | P=0.540N P=0.150N P=0.579 P=0.398N |P=0.316N P=0.500 P=0.056 P=0.651 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 32 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Nose | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 8/48 (17%) 8/49 (16%) 7/50 (14%) |2/50 (4%) 7/50 (14%) 4/49 (8%) 6/49 (12%) | |POLY-3 ADJUSTED (b)| 10.5% 21.6% 20.3% 18.6% |5.0% 17.4% 10.6% 16.4% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 1/15 (7%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 567 548 513 520 |607 509 603 476 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.482 P=0.163 P=0.226 P=0.246 |P=0.229 P=0.082 P=0.301 P=0.095 | |POLY 3 | P=0.510 P=0.158 P=0.189 P=0.251 |P=0.275 P=0.077 P=0.309 P=0.102 | |POLY 1.5 | P=0.516 P=0.155 P=0.179 P=0.253 |P=0.290 P=0.078 P=0.312 P=0.110 | |POLY 6 | P=0.510 P=0.168 P=0.209 P=0.258 |P=0.259 P=0.079 P=0.314 P=0.095 | |LOGISTIC REGRESSION| P=0.563 P=0.175 P=0.162 P=0.290 |P=0.355 P=0.083 P=0.331 P=0.162 | |COCH-ARM / FISHERS | P=0.531 P=0.159 P=0.168 P=0.262 |P=0.322 P=0.080 P=0.329 P=0.128 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/48 (4%) 1/49 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 2.7% 5.8% 2.7% 5.7% |0.0% 0.0% 0.0% 5.8% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 688 614 642 605 |--- --- --- 554 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.481 P=0.477 P=0.737N P=0.509 |P=0.026 * (e) (e) P=0.180 | |POLY 3 | P=0.489 P=0.476 P=0.760N P=0.486 |P=0.038 * (e) (e) P=0.208 | |POLY 1.5 | P=0.496 P=0.479 P=0.760 P=0.491 |P=0.040 * (e) (e) P=0.217 | |POLY 6 | P=0.484 P=0.475 P=0.755N P=0.484 |P=0.036 * (e) (e) P=0.200 | |LOGISTIC REGRESSION| P=0.497 P=0.474 P=0.760 P=0.487 |P=0.047 * (e) (e) P=0.238 | |COCH-ARM / FISHERS | P=0.507 P=0.485 P=0.747 P=0.500 |P=0.044 * (e) (e) P=0.242 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 33 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 26/48 (54%) 32/49 (65%) 25/50 (50%) |39/50 (78%) 38/50 (76%) 33/49 (67%) 32/49 (65%) | |POLY-3 ADJUSTED (b)| 43.8% 64.6% 70.8% 56.8% |82.1% 80.4% 72.5% 73.7% | |TERMINAL (d) | 7/13 (54%) 9/13 (69%) 7/15 (47%) 3/13 (23%) |14/19 (74%) 13/17 (77%) 12/21 (57%) 7/11 (64%) | |FIRST INCIDENCE | 534 524 394 422 |302 422 310 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.424 P=0.075 P=0.049 * P=0.132 |P=0.291 P=0.481 P=0.277N P=0.352 | |POLY 3 | P=0.470N P=0.037 * P=0.006 ** P=0.151 |P=0.278N P=0.523N P=0.186N P=0.227N | |POLY 1.5 | P=0.516N P=0.040 * P=0.004 ** P=0.129 |P=0.229N P=0.516N P=0.187N P=0.190N | |POLY 6 | P=0.401N P=0.038 * P=0.016 * P=0.205 |P=0.339N P=0.523N P=0.177N P=0.268N | |LOGISTIC REGRESSION| P=0.548 P=0.043 * P=0.003 ** P=0.127 |P=0.163N P=0.507N P=0.173N P=0.160N | |COCH-ARM / FISHERS | P=0.552 P=0.054 P=0.003 ** P=0.113 |P=0.138N P=0.500N P=0.168N P=0.119N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Metaplasia Respiratory | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/48 (4%) 1/49 (2%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 2/49 (4%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 5.8% 2.7% 5.7% |0.0% 5.2% 5.4% 2.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 1/11 (9%) | |FIRST INCIDENCE | 534 614 642 605 |--- 660 646 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.579 P=0.666 P=0.481N P=0.689 |P=0.647 P=0.225 P=0.244 P=0.391 | |POLY 3 | P=0.587 P=0.665 P=0.503N P=0.675 |P=0.670N P=0.232 P=0.222 P=0.470 | |POLY 1.5 | P=0.595 P=0.669 P=0.505N P=0.682 |P=0.654N P=0.234 P=0.224 P=0.480 | |POLY 6 | P=0.580 P=0.661 P=0.498N P=0.670 |P=0.681 P=0.231 P=0.223 P=0.459 | |LOGISTIC REGRESSION| P=0.609 P=0.685 P=0.513N P=0.688N |P=0.678N P=0.232 P=0.223 P=0.391 | |COCH-ARM / FISHERS | P=0.607 P=0.676 P=0.508N P=0.691N |P=0.626N P=0.247 P=0.242 P=0.495 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 34 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |7/50 (14%) 8/50 (16%) 10/50 (20%) 5/49 (10%) | |POLY-3 ADJUSTED (b)| |17.2% 20.5% 26.3% 14.0% | |TERMINAL (d) | |2/19 (11%) 4/17 (24%) 7/21 (33%) 0/11 (0%) | |FIRST INCIDENCE | |581 628 609 554 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.478N P=0.445 P=0.319 P=0.583N | |POLY 3 | |P=0.269N P=0.464 P=0.236 P=0.471N | |POLY 1.5 | |P=0.250N P=0.481 P=0.256 P=0.445N | |POLY 6 | |P=0.290N P=0.447 P=0.218 P=0.500N | |LOGISTIC REGRESSION| |P=0.285N P=0.473 P=0.247 P=0.414N | |COCH-ARM / FISHERS | |P=0.211N P=0.500 P=0.298 P=0.394N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pancreas | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 24/49 (49%) 29/49 (59%) 25/50 (50%) 27/50 (54%) |15/50 (30%) 13/50 (26%) 21/50 (42%) 14/49 (29%) | |POLY-3 ADJUSTED (b)| 58.8% 71.8% 58.8% 62.0% |35.7% 31.9% 49.3% 36.5% | |TERMINAL (d) | 8/13 (62%) 12/13 (92%) 9/15 (60%) 4/13 (31%) |6/19 (32%) 4/17 (24%) 8/21 (38%) 3/11 (27%) | |FIRST INCIDENCE | 566 532 450 519 |506 497 339 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.393 P=0.181 P=0.488N P=0.306 |P=0.296 P=0.507N P=0.182 P=0.291 | |POLY 3 | P=0.498N P=0.137 P=0.593N P=0.470 |P=0.520N P=0.449N P=0.139 P=0.561 | |POLY 1.5 | P=0.559N P=0.157 P=0.569 P=0.418 |P=0.490N P=0.431N P=0.138 P=0.587 | |POLY 6 | P=0.374N P=0.117 P=0.573N P=0.576 |P=0.548N P=0.470N P=0.149 P=0.539 | |LOGISTIC REGRESSION| P=0.454 P=0.121 P=0.570 P=0.343 |P=0.449N P=0.428N P=0.140 P=0.570N | |COCH-ARM / FISHERS | P=0.512 P=0.209 P=0.540 P=0.383 |P=0.417N P=0.412N P=0.149 P=0.526N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 35 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pancreas | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 3/49 (6%) 2/50 (4%) 3/50 (6%) |4/50 (8%) 3/50 (6%) 1/50 (2%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 8.2% 8.7% 5.3% 8.5% |10.0% 7.7% 2.7% 2.9% | |TERMINAL (d) | 2/13 (15%) 2/13 (15%) 1/15 (7%) 2/13 (15%) |2/19 (11%) 2/17 (12%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 566 660 660 519 |607 422 734 (T) 556 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.551 P=0.643 P=0.451N P=0.654 |P=0.352N P=0.533N P=0.176N P=0.290N | |POLY 3 | P=0.570 P=0.634 P=0.485N P=0.650 |P=0.265N P=0.513N P=0.200N P=0.225N | |POLY 1.5 | P=0.578 P=0.643 P=0.488N P=0.658 |P=0.254N P=0.506N P=0.194N P=0.210N | |POLY 6 | P=0.561 P=0.626 P=0.479N P=0.643 |P=0.279N P=0.523N P=0.206N P=0.244N | |LOGISTIC REGRESSION| P=0.562 P=0.629 P=0.479N P=0.652 |P=0.243N P=0.501N P=0.197N P=0.199N | |COCH-ARM / FISHERS | P=0.588 P=0.661N P=0.490N P=0.651N |P=0.234N P=0.500N P=0.181N P=0.187N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pancreas | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 3/49 (6%) 2/50 (4%) 1/50 (2%) |3/50 (6%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 11.1% 8.7% 5.3% 2.9% |7.6% 0.0% 2.7% 0.0% | |TERMINAL (d) | 2/13 (15%) 1/13 (8%) 2/15 (13%) 1/13 (8%) |2/19 (11%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 713 660 733 (T) 733 (T) |699 --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.209N P=0.536N P=0.287N P=0.183N |P=0.357N P=0.135N P=0.289N P=0.215N | |POLY 3 | P=0.207N P=0.528N P=0.318N P=0.187N |P=0.272N P=0.124N P=0.327N P=0.147N | |POLY 1.5 | P=0.201N P=0.519N P=0.323N P=0.182N |P=0.265N P=0.121N P=0.321N P=0.138N | |POLY 6 | P=0.214N P=0.533N P=0.309N P=0.192N |P=0.282N P=0.126N P=0.330N P=0.159N | |LOGISTIC REGRESSION| P=0.203N P=0.547N P=0.292N P=0.178N |P=0.320N P=0.125N P=0.321N P=0.178N | |COCH-ARM / FISHERS | P=0.193N P=0.500N P=0.329N P=0.175N |P=0.254N P=0.121N P=0.309N P=0.125N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 36 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pancreas: Artery | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/49 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 5.5% 0.0% 0.0% 2.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 684 --- --- 733 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.637 P=0.268N P=0.233N P=0.526N |(e) (e) (e) (e) | |POLY 3 | P=0.653 P=0.251N P=0.229N P=0.514N |(e) (e) (e) (e) | |POLY 1.5 | P=0.655 P=0.246N P=0.231N P=0.506N |(e) (e) (e) (e) | |POLY 6 | P=0.651 P=0.256N P=0.226N P=0.525N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.643 P=0.254N P=0.223N P=0.521N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.656 P=0.247N P=0.242N P=0.492N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pancreas: Artery | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 2/49 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 8.2% 5.9% 2.6% 2.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 647 708 660 715 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.403N P=0.532N P=0.288N P=0.356N |(e) (e) (e) (e) | |POLY 3 | P=0.379N P=0.532N P=0.292N P=0.321N |(e) (e) (e) (e) | |POLY 1.5 | P=0.371N P=0.521N P=0.295N P=0.312N |(e) (e) (e) (e) | |POLY 6 | P=0.389N P=0.548N P=0.288N P=0.333N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.382N P=0.537N P=0.291N P=0.323N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.360N P=0.500N P=0.301N P=0.301N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 37 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Parathyroid Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 13/47 (28%) 13/48 (27%) 17/47 (36%) 16/48 (33%) |0/47 (0%) 3/42 (7%) 3/47 (6%) 3/46 (7%) | |POLY-3 ADJUSTED (b)| 34.3% 36.7% 43.6% 42.9% |0.0% 9.5% 8.6% 9.4% | |TERMINAL (d) | 2/12 (17%) 5/13 (39%) 3/14 (21%) 5/13 (39%) |0/18 (0%) 0/12 (0%) 2/19 (11%) 1/10 (10%) | |FIRST INCIDENCE | 534 306 394 519 |--- 700 660 677 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.312 P=0.520 P=0.371 P=0.294 |P=0.204 P=0.124 P=0.121 P=0.064 | |POLY 3 | P=0.344 P=0.513 P=0.270 P=0.293 |P=0.332 P=0.091 P=0.108 P=0.094 | |POLY 1.5 | P=0.357 P=0.552 P=0.262 P=0.315 |P=0.351 P=0.094 P=0.111 P=0.101 | |POLY 6 | P=0.331 P=0.468 P=0.289 P=0.271 |P=0.314 P=0.088 P=0.107 P=0.088 | |LOGISTIC REGRESSION| P=0.354 P=0.567 P=0.258 P=0.324 |P=0.308 P=0.087 P=0.108 P=0.083 | |COCH-ARM / FISHERS | P=0.373 P=0.566N P=0.254 P=0.353 |P=0.387 P=0.101 P=0.121 P=0.117 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pituitary Gland | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/49 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.9% 0.0% 2.9% |0.0% 0.0% 5.3% 2.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- 524 --- 733 (T) |--- --- 609 674 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.485 P=0.492 (e) P=0.500 |P=0.513 (e) P=0.216 P=0.480 | |POLY 3 | P=0.487 P=0.493 (e) P=0.494 |P=0.498 (e) P=0.227 P=0.471 | |POLY 1.5 | P=0.492 P=0.495 (e) P=0.498 |P=0.512 (e) P=0.229 P=0.480 | |POLY 6 | P=0.482 P=0.493 (e) P=0.491 |P=0.484 (e) P=0.228 P=0.462 | |LOGISTIC REGRESSION| P=0.504 P=0.570 (e) P=0.500 |P=0.535 (e) P=0.240 P=0.479 | |COCH-ARM / FISHERS | P=0.500 P=0.500 (e) P=0.505 |P=0.540 (e) P=0.247 P=0.495 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 38 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 5.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 703 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.018 * (e) (e) P=0.153 | |POLY 3 | (e) (e) (e) (e) |P=0.037 * (e) (e) P=0.205 | |POLY 1.5 | (e) (e) (e) (e) |P=0.039 * (e) (e) P=0.215 | |POLY 6 | (e) (e) (e) (e) |P=0.034 * (e) (e) P=0.195 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.026 * (e) (e) P=0.177 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.242 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 17/49 (35%) 12/49 (24%) 15/50 (30%) 12/50 (24%) |5/50 (10%) 3/50 (6%) 7/50 (14%) 9/49 (18%) | |POLY-3 ADJUSTED (b)| 42.6% 32.0% 36.4% 31.2% |11.8% 7.5% 18.2% 24.0% | |TERMINAL (d) | 6/13 (46%) 4/13 (31%) 5/15 (33%) 3/13 (23%) |0/19 (0%) 0/17 (0%) 2/21 (10%) 2/11 (18%) | |FIRST INCIDENCE | 566 548 394 523 |302 422 534 215 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.368N P=0.276N P=0.321N P=0.267N |P=0.038 * P=0.379N P=0.360 P=0.110 | |POLY 3 | P=0.301N P=0.225N P=0.360N P=0.200N |P=0.054 P=0.383N P=0.312 P=0.126 | |POLY 1.5 | P=0.288N P=0.213N P=0.370N P=0.189N |P=0.062 P=0.373N P=0.331 P=0.145 | |POLY 6 | P=0.316N P=0.241N P=0.348N P=0.214N |P=0.045 * P=0.392N P=0.302 P=0.107 | |LOGISTIC REGRESSION| P=0.282N P=0.209N P=0.381N P=0.186N |P=0.136 P=0.303N P=0.433 P=0.329 | |COCH-ARM / FISHERS | P=0.271N P=0.188N P=0.388N P=0.172N |P=0.079 P=0.357N P=0.380 P=0.183 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 39 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Preputial Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 3/50 (6%) 4/49 (8%) | | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 7.7% 11.3% | | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 2/13 (15%) | | |FIRST INCIDENCE | 636 --- 394 605 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.073 P=0.534N P=0.317 P=0.159 | | |POLY 3 | P=0.078 P=0.522N P=0.324 P=0.163 | | |POLY 1.5 | P=0.078 P=0.516N P=0.316 P=0.167 | | |POLY 6 | P=0.079 P=0.528N P=0.334 P=0.160 | | |LOGISTIC REGRESSION| P=0.077 P=0.503N P=0.286 P=0.166 | | |COCH-ARM / FISHERS | P=0.077 P=0.505N P=0.309 P=0.175 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/49 (8%) 8/50 (16%) 3/49 (6%) | | |POLY-3 ADJUSTED (b)| 10.8% 11.7% 20.5% 8.6% | | |TERMINAL (d) | 1/13 (8%) 1/13 (8%) 2/15 (13%) 1/13 (8%) | | |FIRST INCIDENCE | 647 587 601 645 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.314N P=0.593 P=0.243 P=0.551N | | |POLY 3 | P=0.302N P=0.601 P=0.195 P=0.531N | | |POLY 1.5 | P=0.296N P=0.608 P=0.186 P=0.524N | | |POLY 6 | P=0.313N P=0.601 P=0.214 P=0.539N | | |LOGISTIC REGRESSION| P=0.303N P=0.587 P=0.193 P=0.538N | | |COCH-ARM / FISHERS | P=0.294N P=0.631 P=0.178 P=0.511N | | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 40 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Prostate | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 9/48 (19%) 11/50 (22%) 7/50 (14%) | | |POLY-3 ADJUSTED (b)| 31.6% 25.2% 27.9% 19.9% | | |TERMINAL (d) | 6/13 (46%) 4/13 (31%) 3/15 (20%) 6/13 (46%) | | |FIRST INCIDENCE | 621 548 590 621 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.215N P=0.372N P=0.389N P=0.168N | | |POLY 3 | P=0.214N P=0.360N P=0.457N P=0.185N | | |POLY 1.5 | P=0.192N P=0.357N P=0.479N P=0.171N | | |POLY 6 | P=0.251N P=0.362N P=0.418N P=0.206N | | |LOGISTIC REGRESSION| P=0.201N P=0.391N P=0.451N P=0.178N | | |COCH-ARM / FISHERS | P=0.165N P=0.350N P=0.500N P=0.154N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/48 (2%) 6/50 (12%) 2/50 (4%) | | |POLY-3 ADJUSTED (b)| 8.1% 2.9% 15.4% 5.7% | | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 1/15 (7%) 1/13 (8%) | | |FIRST INCIDENCE | 684 532 601 668 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.453N P=0.325N P=0.299 P=0.516N | | |POLY 3 | P=0.440N P=0.326N P=0.265 P=0.523N | | |POLY 1.5 | P=0.431N P=0.324N P=0.253 P=0.514N | | |POLY 6 | P=0.450N P=0.327N P=0.288 P=0.530N | | |LOGISTIC REGRESSION| P=0.440N P=0.329N P=0.257 P=0.531N | | |COCH-ARM / FISHERS | P=0.415N P=0.324N P=0.243 P=0.500N | | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 41 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Seminal Vesicle | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/45 (4%) 1/47 (2%) 1/48 (2%) 0/50 (0%) | | |POLY-3 ADJUSTED (b)| 5.9% 3.0% 2.8% 0.0% | | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 1/15 (7%) 0/13 (0%) | | |FIRST INCIDENCE | 647 708 733 (T) --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.276N P=0.536N P=0.469N P=0.281N | | |POLY 3 | P=0.250N P=0.504N P=0.476N P=0.230N | | |POLY 1.5 | P=0.245N P=0.497N P=0.476N P=0.223N | | |POLY 6 | P=0.257N P=0.515N P=0.476N P=0.239N | | |LOGISTIC REGRESSION| P=0.255N P=0.508N P=0.467N P=0.231N | | |COCH-ARM / FISHERS | P=0.237N P=0.484N P=0.476N P=0.222N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 5.3% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 2/15 (13%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 733 (T) --- 733 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.408N P=0.500N P=0.551 P=0.500N |(e) (e) (e) (e) | |POLY 3 | P=0.400N P=0.517N P=0.508 P=0.510N |(e) (e) (e) (e) | |POLY 1.5 | P=0.398N P=0.513N P=0.504 P=0.506N |(e) (e) (e) (e) | |POLY 6 | P=0.403N P=0.519N P=0.516 P=0.513N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.408N (e) P=0.551 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.398N P=0.505N P=0.500 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 42 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 7.8% 5.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 1/15 (7%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- --- 443 621 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.287 (e) P=0.138 P=0.226 |(e) (e) (e) (e) | |POLY 3 | P=0.311 (e) P=0.126 P=0.227 |(e) (e) (e) (e) | |POLY 1.5 | P=0.312 (e) P=0.123 P=0.231 |(e) (e) (e) (e) | |POLY 6 | P=0.312 (e) P=0.132 P=0.225 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.312 (e) P=0.116 P=0.226 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.311 (e) P=0.121 P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Spleen | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 12/50 (24%) 17/50 (34%) 12/50 (24%) |4/50 (8%) 6/50 (12%) 5/50 (10%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 32.8% 33.1% 42.9% 33.2% |10.1% 15.1% 13.1% 2.9% | |TERMINAL (d) | 4/13 (31%) 3/13 (23%) 9/15 (60%) 7/13 (54%) |2/19 (11%) 2/17 (12%) 2/21 (10%) 0/11 (0%) | |FIRST INCIDENCE | 506 574 566 605 |677 523 605 730 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.457N P=0.545N P=0.372 P=0.541N |P=0.153N P=0.329 P=0.492 P=0.350N | |POLY 3 | P=0.475N P=0.589 P=0.235 P=0.585 |P=0.099N P=0.368 P=0.474 P=0.228N | |POLY 1.5 | P=0.434N P=0.574N P=0.244 P=0.566N |P=0.087N P=0.369 P=0.479 P=0.211N | |POLY 6 | P=0.537N P=0.572 P=0.227 P=0.536 |P=0.118N P=0.371 P=0.479 P=0.249N | |LOGISTIC REGRESSION| P=0.451N P=0.578N P=0.281 P=0.570N |P=0.086N P=0.358 P=0.463 P=0.270N | |COCH-ARM / FISHERS | P=0.393N P=0.500N P=0.257 P=0.500N |P=0.069N P=0.370 P=0.500 P=0.187N | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 43 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 6/50 (12%) 1/50 (2%) |5/50 (10%) 2/50 (4%) 6/50 (12%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 10.5% 5.7% 15.4% 2.8% |12.0% 5.1% 15.2% 2.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 1/17 (6%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | 566 534 621 645 |497 422 448 684 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.184N P=0.387N P=0.412 P=0.225N |P=0.187N P=0.247N P=0.468 P=0.163N | |POLY 3 | P=0.158N P=0.370N P=0.383 P=0.200N |P=0.168N P=0.240N P=0.464 P=0.152N | |POLY 1.5 | P=0.151N P=0.360N P=0.376 P=0.192N |P=0.149N P=0.229N P=0.474 P=0.133N | |POLY 6 | P=0.168N P=0.380N P=0.400 P=0.211N |P=0.193N P=0.256N P=0.456 P=0.178N | |LOGISTIC REGRESSION| P=0.145N P=0.293N P=0.370 P=0.174N |P=0.090N P=0.201N P=0.569 P=0.084N | |COCH-ARM / FISHERS | P=0.146N P=0.339N P=0.370 P=0.181N |P=0.120N P=0.218N P=0.500 P=0.107N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Spleen | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 2.7% 5.8% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 701 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.104 (e) P=0.483 P=0.217 | |POLY 3 | (e) (e) (e) (e) |P=0.107 (e) P=0.489 P=0.208 | |POLY 1.5 | (e) (e) (e) (e) |P=0.112 (e) P=0.492 P=0.216 | |POLY 6 | (e) (e) (e) (e) |P=0.102 (e) P=0.488 P=0.200 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.113 (e) P=0.488 P=0.226 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.124 (e) P=0.500 P=0.242 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 44 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Spleen | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 5.4% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 506 --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.434N P=0.247N P=0.228N P=0.244N |(e) (e) (e) (e) | |POLY 3 | P=0.427N P=0.257N P=0.235N P=0.252N |(e) (e) (e) (e) | |POLY 1.5 | P=0.426N P=0.250N P=0.236N P=0.246N |(e) (e) (e) (e) | |POLY 6 | P=0.429N P=0.262N P=0.232N P=0.257N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.426N P=0.223N P=0.242N P=0.225N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.429N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Spleen | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 5/50 (10%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.9% 12.6% 0.0% |0.0% 2.6% 2.7% 0.0% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- 642 513 --- |--- 631 603 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.264N P=0.472 P=0.042 * (e) |P=0.532N P=0.483 P=0.500 (e) | |POLY 3 | P=0.241N P=0.488 P=0.037 * (e) |P=0.537N P=0.496 P=0.491 (e) | |POLY 1.5 | P=0.239N P=0.491 P=0.034 * (e) |P=0.526N P=0.498 P=0.493 (e) | |POLY 6 | P=0.243N P=0.486 P=0.043 * (e) |P=0.549N P=0.495 P=0.491 (e) | |LOGISTIC REGRESSION| P=0.237N P=0.498 P=0.029 * (e) |P=0.490N P=0.503 P=0.520 (e) | |COCH-ARM / FISHERS | P=0.243N P=0.500 P=0.028 * (e) |P=0.508N P=0.500 P=0.500 (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 45 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 0.0% |0.0% 2.6% 2.7% 5.6% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 1/21 (5%) 0/11 (0%) | |FIRST INCIDENCE | --- --- 642 --- |--- 478 734 (T) 519 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.770N (e) P=0.512 (e) |P=0.197 P=0.500 P=0.520 P=0.211 | |POLY 3 | P=0.744N (e) P=0.510 (e) |P=0.225 P=0.498 P=0.488 P=0.213 | |POLY 1.5 | P=0.742N (e) P=0.507 (e) |P=0.235 P=0.499 P=0.491 P=0.221 | |POLY 6 | P=0.745N (e) P=0.515 (e) |P=0.215 P=0.497 P=0.487 P=0.205 | |LOGISTIC REGRESSION| P=0.741N (e) P=0.503 (e) |P=0.297 P=0.482 P=0.520 P=0.278 | |COCH-ARM / FISHERS | P=0.741N (e) P=0.505 (e) |P=0.254 P=0.500 P=0.500 P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Stomach, Forestomach | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 5.5% 5.8% 5.3% 5.7% |0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 647 660 660 605 |--- --- --- 712 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.610 P=0.645 P=0.664N P=0.646 |P=0.181 (e) (e) P=0.415 | |POLY 3 | P=0.642 P=0.676 P=0.680N P=0.685 |P=0.239 (e) (e) P=0.473 | |POLY 1.5 | P=0.647 P=0.683 P=0.683N P=0.691 |P=0.246 (e) (e) P=0.483 | |POLY 6 | P=0.636 P=0.670 P=0.674N P=0.680 |P=0.232 (e) (e) P=0.462 | |LOGISTIC REGRESSION| P=0.642 P=0.672 P=0.683N P=0.686 |P=0.218 (e) (e) P=0.450 | |COCH-ARM / FISHERS | P=0.647N P=0.684N P=0.684N P=0.684N |P=0.257 (e) (e) P=0.500 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 46 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Stomach, Forestomach | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/49 (14%) 10/50 (20%) 9/50 (18%) 11/50 (22%) |4/50 (8%) 7/50 (14%) 3/50 (6%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 18.4% 25.9% 22.4% 28.2% |9.9% 17.2% 7.8% 11.4% | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 1/15 (7%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 1/11 (9%) | |FIRST INCIDENCE | 544 393 560 520 |607 497 462 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.255 P=0.235 P=0.453 P=0.203 |P=0.600 P=0.248 P=0.540N P=0.463 | |POLY 3 | P=0.286 P=0.303 P=0.440 P=0.225 |P=0.552N P=0.262 P=0.525N P=0.562 | |POLY 1.5 | P=0.289 P=0.300 P=0.425 P=0.224 |P=0.516N P=0.262 P=0.519N P=0.593 | |POLY 6 | P=0.288 P=0.318 P=0.466 P=0.235 |P=0.598N P=0.265 P=0.529N P=0.523 | |LOGISTIC REGRESSION| P=0.310 P=0.366 P=0.406 P=0.248 |P=0.447N P=0.269 P=0.473N P=0.582 | |COCH-ARM / FISHERS | P=0.296 P=0.314 P=0.410 P=0.232 |P=0.459N P=0.262 P=0.500N P=0.643N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/49 (16%) 6/49 (12%) 8/50 (16%) 8/50 (16%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 21.4% 17.2% 20.5% 22.1% |5.0% 2.6% 5.3% 8.7% | |TERMINAL (d) | 2/13 (15%) 2/13 (15%) 2/15 (13%) 2/13 (15%) |1/19 (5%) 1/17 (6%) 1/21 (5%) 1/11 (9%) | |FIRST INCIDENCE | 590 621 590 605 |660 734 (T) 630 534 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.434 P=0.447N P=0.535N P=0.546 |P=0.175 P=0.536N P=0.686N P=0.340 | |POLY 3 | P=0.469 P=0.437N P=0.574N P=0.586 |P=0.272 P=0.513N P=0.675 P=0.438 | |POLY 1.5 | P=0.483 P=0.419N P=0.582N P=0.600 |P=0.286 P=0.507N P=0.679 P=0.457 | |POLY 6 | P=0.457 P=0.458N P=0.558N P=0.575 |P=0.256 P=0.520N P=0.673 P=0.416 | |LOGISTIC REGRESSION| P=0.448 P=0.443N P=0.570N P=0.569 |P=0.268 P=0.514N P=0.677 P=0.451 | |COCH-ARM / FISHERS | P=0.500 P=0.387N P=0.590N P=0.590N |P=0.311 P=0.500N P=0.691N P=0.490 | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 47 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Stomach, Glandular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 9/49 (18%) 13/50 (26%) 13/50 (26%) |3/50 (6%) 6/50 (12%) 2/50 (4%) 4/49 (8%) | |POLY-3 ADJUSTED (b)| 10.8% 23.4% 30.4% 31.9% |7.3% 14.7% 5.3% 11.2% | |TERMINAL (d) | 1/13 (8%) 0/13 (0%) 0/15 (0%) 1/13 (8%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 534 393 450 519 |506 497 603 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.096 P=0.109 P=0.034 * P=0.020 * |P=0.494 P=0.230 P=0.520N P=0.421 | |POLY 3 | P=0.113 P=0.121 P=0.028 * P=0.020 * |P=0.515 P=0.237 P=0.535N P=0.424 | |POLY 1.5 | P=0.105 P=0.116 P=0.022 * P=0.018 * |P=0.538 P=0.240 P=0.524N P=0.448 | |POLY 6 | P=0.132 P=0.133 P=0.042 * P=0.027 * |P=0.487 P=0.236 P=0.542N P=0.397 | |LOGISTIC REGRESSION| P=0.124 P=0.153 P=0.015 * P=0.025 * |P=0.569N P=0.252 P=0.448N P=0.587 | |COCH-ARM / FISHERS | P=0.100 P=0.116 P=0.017 * P=0.017 * |P=0.576 P=0.243 P=0.500N P=0.489 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Testes | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 5/50 (10%) 5/50 (10%) | | |POLY-3 ADJUSTED (b)| 2.7% 5.7% 12.8% 13.7% | | |TERMINAL (d) | 1/13 (8%) 1/13 (8%) 1/15 (7%) 0/13 (0%) | | |FIRST INCIDENCE | 733 (T) 306 394 614 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.144 P=0.498 P=0.130 P=0.094 | | |POLY 3 | P=0.156 P=0.484 P=0.113 P=0.096 | | |POLY 1.5 | P=0.156 P=0.489 P=0.108 P=0.097 | | |POLY 6 | P=0.165 P=0.482 P=0.123 P=0.100 | | |LOGISTIC REGRESSION| P=0.163 P=0.550 P=0.102 P=0.096 | | |COCH-ARM / FISHERS | P=0.158 P=0.500 P=0.102 P=0.102 | | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 48 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Testes: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/50 (8%) 5/50 (10%) 4/50 (8%) | | |POLY-3 ADJUSTED (b)| 8.0% 11.4% 12.9% 11.0% | | |TERMINAL (d) | 1/13 (8%) 1/13 (8%) 0/15 (0%) 0/13 (0%) | | |FIRST INCIDENCE | 544 594 562 557 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.531 P=0.458 P=0.402 P=0.454 | | |POLY 3 | P=0.573 P=0.463 P=0.372 P=0.479 | | |POLY 1.5 | P=0.579 P=0.473 P=0.364 P=0.486 | | |POLY 6 | P=0.570 P=0.459 P=0.389 P=0.478 | | |LOGISTIC REGRESSION| P=0.585 P=0.492 P=0.354 P=0.516 | | |COCH-ARM / FISHERS | P=0.586 P=0.500 P=0.357 P=0.500 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Testes: Interstitial Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 6/50 (12%) | | |POLY-3 ADJUSTED (b)| 5.3% 8.3% 5.1% 15.6% | | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) | | |FIRST INCIDENCE | 566 393 443 422 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.068 P=0.468 P=0.688N P=0.129 | | |POLY 3 | P=0.070 P=0.482 P=0.682N P=0.136 | | |POLY 1.5 | P=0.069 P=0.486 P=0.687N P=0.134 | | |POLY 6 | P=0.073 P=0.481 P=0.677N P=0.142 | | |LOGISTIC REGRESSION| P=0.066 P=0.663 P=0.697 P=0.196 | | |COCH-ARM / FISHERS | P=0.068 P=0.500 P=0.691N P=0.134 | | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 49 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 26/46 (57%) 28/46 (61%) 33/49 (67%) 29/50 (58%) |41/50 (82%) 41/49 (84%) 38/48 (79%) 33/49 (67%) | |POLY-3 ADJUSTED (b)| 65.1% 70.5% 75.7% 66.0% |87.2% 87.0% 86.0% 76.1% | |TERMINAL (d) | 9/13 (69%) 10/13 (77%) 13/15 (87%) 8/13 (62%) |18/19 (95%) 13/17 (77%) 19/21 (91%) 7/11 (64%) | |FIRST INCIDENCE | 338 524 443 310 |497 478 339 418 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.413 P=0.357 P=0.312 P=0.314 |P=0.331 P=0.409 P=0.377N P=0.349 | |POLY 3 | P=0.371N P=0.383 P=0.184 P=0.561 |P=0.062N P=0.616N P=0.563N P=0.121N | |POLY 1.5 | P=0.389N P=0.379 P=0.181 P=0.538 |P=0.045N* P=0.588 P=0.525N P=0.102N | |POLY 6 | P=0.336N P=0.404 P=0.201 P=0.603N |P=0.083N P=0.548N P=0.618N P=0.136N | |LOGISTIC REGRESSION| P=0.469N P=0.372 P=0.202 P=0.515 |P=0.058N P=0.500 P=0.555N P=0.139N | |COCH-ARM / FISHERS | P=0.418N P=0.416 P=0.191 P=0.524 |P=0.026N* P=0.518 P=0.460N P=0.074N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Tooth | | Developmental Malformation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/2 (100%) 1/1 (100%) 0/0 (0%) 3/3 (100%) |0/1 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 0.0% 100.0% |0.0% 0.0% 100.0% 0.0% | |TERMINAL (d) | 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/1 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) | |FIRST INCIDENCE | 590 647 --- 310 |--- --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=1.000 (e) P=0.500 (e) | |POLY 3 | (e) (e) (e) (e) |(e) (e) P=1.000N (e) | |POLY 1.5 | (e) (e) (e) (e) |(e) (e) P=1.000 (e) | |POLY 6 | (e) (e) (e) (e) |(e) (e) P=1.000N (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.250 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=1.000 (e) P=0.500 (e) | |=================================================================================================================================| Date: 02/17/99 EXPERIMENT: 05180 TEST: 06 Page 50 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Trachea | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/50 (0%) 2/49 (4%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 5.5% 0.0% 5.3% 8.5% |0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/13 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | 647 --- 654 645 |--- --- --- 712 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.192 P=0.275N P=0.664N P=0.440 |P=0.181 (e) (e) P=0.415 | |POLY 3 | P=0.232 P=0.251N P=0.684N P=0.486 |P=0.237 (e) (e) P=0.471 | |POLY 1.5 | P=0.234 P=0.245N P=0.689N P=0.494 |P=0.242 (e) (e) P=0.480 | |POLY 6 | P=0.229 P=0.258N P=0.676N P=0.478 |P=0.230 (e) (e) P=0.460 | |LOGISTIC REGRESSION| P=0.217 P=0.251N P=0.689N P=0.477 |P=0.217 (e) (e) P=0.450 | |COCH-ARM / FISHERS | P=0.234 P=0.242N P=0.691N P=0.510 |P=0.253 (e) (e) P=0.495 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.01 0.1 1.0 |CONTROL 0.01 0.1 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Urinary Bladder | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 5.7% 0.0% 0.0% |0.0% 2.6% 0.0% 0.0% | |TERMINAL (d) | 0/13 (0%) 1/13 (8%) 0/15 (0%) 0/13 (0%) |0/19 (0%) 0/17 (0%) 0/21 (0%) 0/11 (0%) | |FIRST INCIDENCE | --- 204 --- --- |--- 585 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.447N P=0.240 (e) (e) |P=0.699N P=0.486 (e) (e) | |POLY 3 | P=0.461N P=0.234 (e) (e) |P=0.681N P=0.497 (e) (e) | |POLY 1.5 | P=0.453N P=0.239 (e) (e) |P=0.677N P=0.498 (e) (e) | |POLY 6 | P=0.470N P=0.230 (e) (e) |P=0.686N P=0.496 (e) (e) | |LOGISTIC REGRESSION| P=0.457N P=0.374 (e) (e) |P=0.648N P=0.503 (e) (e) | |COCH-ARM / FISHERS | P=0.439N P=0.258 (e) (e) |P=0.673N P=0.500 (e) (e) | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Poly-3 adjusted lifetime tumor incidence. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).