TDMS Study 05180-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest GALLIUM ARSENIDE DATE: 03/09/99 EXPERIMENT: 05180 TEST: 07 TIME: 14:25:49 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62033B PATHOLOGIST: MILLER, RODNEY CAS: 1303-00-0000 ------------------------------------------------------------------------------------------------------------------------------------ 2 YEAR CHRONIC MICE REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest GALLIUM ARSENIDE DATE: 03/09/99 EXPERIMENT: 05180 TEST: 07 TIME: 14:25:49 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62033B PATHOLOGIST: MILLER, RODNEY CAS: 1303-00-0000 Mice(B6C3F1) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED. --------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Heart Islets, Pancreatic Kidney Liver Lung Ovary Pituitary Gland Spleen Testes Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest GALLIUM ARSENIDE DATE: 03/09/99 EXPERIMENT: 05180 TEST: 07 TIME: 14:25:49 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62033B PATHOLOGIST: MILLER, RODNEY CAS: 1303-00-0000 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF GALLIUM ARSENIDE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Harderian Gland Carcinoma or Adenoma =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Liver Hepatocellular Carcinoma Stomach, Forestomach Squamous Cell Papilloma Thyroid Gland: Follicular Cell Carcinoma Carcinoma or Adenoma All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Malignant and Benign Tumors =============================================================== Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 1 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Bone Marrow | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 2/50 (4%) 1/48 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.6% 2.2% |2.2% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |1/36 (3%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- --- 502 665 |735 (T) 672 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.212 (e) P=0.237 P=0.500 |P=0.236N P=0.759 P=0.530N P=0.543N | |POLY 3 | P=0.216 (e) P=0.242 P=0.507 |P=0.220N P=0.757N P=0.520N P=0.513N | |POLY 1.5 | P=0.212 (e) P=0.243 P=0.505 |P=0.216N P=0.759N P=0.513N P=0.507N | |POLY 6 | P=0.219 (e) P=0.242 P=0.510 |P=0.224N P=0.755N P=0.526N P=0.519N | |LOGISTIC REGRESSION| P=0.147 (e) P=0.220 P=0.475 |P=0.214N P=0.762N (e) (e) | |COCH-ARM / FISHERS | P=0.201 (e) P=0.253 P=0.495 |P=0.208N P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 6/50 (12%) 8/50 (16%) 8/50 (16%) |2/50 (4%) 3/50 (6%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 9.1% 12.9% 17.8% 17.3% |4.4% 6.6% 4.9% 4.8% | |TERMINAL (d) | 4/35 (11%) 3/38 (8%) 3/34 (9%) 4/34 (12%) |1/36 (3%) 2/34 (6%) 1/31 (3%) 2/29 (7%) | |FIRST INCIDENCE | 733 (T) 609 548 561 |633 659 643 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.139 P=0.429 P=0.176 P=0.179 |P=0.569N P=0.497 P=0.639 P=0.626 | |POLY 3 | P=0.164 P=0.405 P=0.189 P=0.201 |P=0.524N P=0.504 P=0.658 P=0.668 | |POLY 1.5 | P=0.161 P=0.395 P=0.185 P=0.195 |P=0.506N P=0.500 P=0.670 P=0.679 | |POLY 6 | P=0.167 P=0.419 P=0.197 P=0.209 |P=0.543N P=0.506 P=0.647 P=0.655 | |LOGISTIC REGRESSION| P=0.147 P=0.397 P=0.178 P=0.184 |P=0.505N P=0.500 P=0.693 P=0.680 | |COCH-ARM / FISHERS | P=0.149 P=0.370 P=0.178 P=0.178 |P=0.483N P=0.500 P=0.691N P=0.691N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 2 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 4/50 (8%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.3% 2.2% 6.9% 8.9% |6.6% 2.2% 2.5% 0.0% | |TERMINAL (d) | 0/35 (0%) 1/38 (3%) 2/34 (6%) 4/34 (12%) |2/36 (6%) 1/34 (3%) 1/31 (3%) 0/29 (0%) | |FIRST INCIDENCE | 686 733 (T) 645 733 (T) |617 735 (T) 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.056 P=0.746N P=0.290 P=0.173 |P=0.121N P=0.320N P=0.360N P=0.155N | |POLY 3 | P=0.064 P=0.752N P=0.299 P=0.185 |P=0.105N P=0.305N P=0.345N P=0.132N | |POLY 1.5 | P=0.065 P=0.754N P=0.302 P=0.185 |P=0.099N P=0.306N P=0.331N P=0.126N | |POLY 6 | P=0.062 P=0.749N P=0.294 P=0.183 |P=0.110N P=0.304N P=0.358N P=0.139N | |LOGISTIC REGRESSION| P=0.065 P=0.757N P=0.303 P=0.186 |P=0.102N P=0.305N P=0.328N P=0.121N | |COCH-ARM / FISHERS | P=0.065 P=0.753N P=0.309 P=0.181 |P=0.093N P=0.309N P=0.309N P=0.121N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 7/50 (14%) 10/50 (20%) 12/50 (24%) |5/50 (10%) 4/50 (8%) 3/50 (6%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 11.4% 15.1% 22.2% 26.0% |11.0% 8.8% 7.3% 4.8% | |TERMINAL (d) | 4/35 (11%) 4/38 (11%) 5/34 (15%) 8/34 (24%) |3/36 (8%) 3/34 (9%) 2/31 (7%) 2/29 (7%) | |FIRST INCIDENCE | 686 609 548 561 |617 659 643 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.030 * P=0.443 P=0.129 P=0.057 |P=0.228N P=0.513N P=0.441N P=0.297N | |POLY 3 | P=0.036 * P=0.416 P=0.138 P=0.063 |P=0.189N P=0.500N P=0.417N P=0.250N | |POLY 1.5 | P=0.035 * P=0.406 P=0.135 P=0.061 |P=0.173N P=0.502N P=0.397N P=0.235N | |POLY 6 | P=0.036 * P=0.429 P=0.144 P=0.066 |P=0.207N P=0.501N P=0.437N P=0.268N | |LOGISTIC REGRESSION| P=0.033 * P=0.408 P=0.131 P=0.060 |P=0.172N P=0.500N P=0.377N P=0.227N | |COCH-ARM / FISHERS | P=0.033 * P=0.380 P=0.131 P=0.054 |P=0.154N P=0.500N P=0.357N P=0.218N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 3 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.6% 4.3% 0.0% 2.2% |0.0% 0.0% 0.0% 2.4% | |TERMINAL (d) | 2/35 (6%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 733 (T) 481 --- 710 |--- --- --- 707 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.272N P=0.667N P=0.245N P=0.497N |P=0.171 (e) (e) P=0.478 | |POLY 3 | P=0.270N P=0.669N P=0.242N P=0.491N |P=0.178 (e) (e) P=0.488 | |POLY 1.5 | P=0.267N P=0.676N P=0.239N P=0.492N |P=0.182 (e) (e) P=0.493 | |POLY 6 | P=0.274N P=0.659N P=0.245N P=0.490N |P=0.174 (e) (e) P=0.482 | |LOGISTIC REGRESSION| P=0.275N P=0.647 (e) P=0.492N |P=0.180 (e) (e) P=0.492 | |COCH-ARM / FISHERS | P=0.263N P=0.691N P=0.247N P=0.500N |P=0.186 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Intestine Small: Site Unspecified | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.6% 4.3% 0.0% 2.2% |0.0% 0.0% 0.0% 2.4% | |TERMINAL (d) | 2/35 (6%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 733 (T) 481 --- 710 |--- --- --- 707 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.272N P=0.667N P=0.245N P=0.497N |P=0.171 (e) (e) P=0.478 | |POLY 3 | P=0.270N P=0.669N P=0.242N P=0.491N |P=0.178 (e) (e) P=0.488 | |POLY 1.5 | P=0.267N P=0.676N P=0.239N P=0.492N |P=0.182 (e) (e) P=0.493 | |POLY 6 | P=0.274N P=0.659N P=0.245N P=0.490N |P=0.174 (e) (e) P=0.482 | |LOGISTIC REGRESSION| P=0.275N P=0.647 (e) P=0.492N |P=0.180 (e) (e) P=0.492 | |COCH-ARM / FISHERS | P=0.263N P=0.691N P=0.247N P=0.500N |P=0.186 (e) (e) P=0.500 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 4 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/48 (0%) 3/49 (6%) 0/47 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 7.1% 0.0% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/36 (0%) 3/34 (9%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- --- 733 (T) --- |707 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.458 (e) P=0.116 (e) |P=0.372N P=0.495N P=0.527N P=0.522N | |POLY 3 | P=0.484 (e) P=0.113 (e) |P=0.364N P=0.498N P=0.520N P=0.518N | |POLY 1.5 | P=0.478 (e) P=0.114 (e) |P=0.361N P=0.500N P=0.514N P=0.514N | |POLY 6 | P=0.488 (e) P=0.111 (e) |P=0.367N P=0.498N P=0.526N P=0.523N | |LOGISTIC REGRESSION| (e) (e) P=0.116 (e) |P=0.362N P=0.500N P=0.515N P=0.514N | |COCH-ARM / FISHERS | P=0.458 (e) P=0.117 (e) |P=0.356N P=0.500N P=0.500N P=0.510N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.3% 4.4% 7.0% 2.2% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/35 (0%) 2/38 (5%) 2/34 (6%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 570 733 (T) 692 599 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.576N P=0.524 P=0.296 P=0.750N |(e) (e) (e) (e) | |POLY 3 | P=0.553N P=0.511 P=0.294 P=0.756N |(e) (e) (e) (e) | |POLY 1.5 | P=0.552N P=0.509 P=0.300 P=0.756N |(e) (e) (e) (e) | |POLY 6 | P=0.556N P=0.514 P=0.288 P=0.756N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.561N P=0.485 P=0.305 P=0.714 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.558N P=0.500 P=0.309 P=0.753N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 5 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 18/50 (36%) 19/50 (38%) 17/50 (34%) |11/50 (22%) 10/50 (20%) 12/50 (24%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 35.1% 36.5% 42.4% 37.5% |24.5% 22.0% 29.3% 23.3% | |TERMINAL (d) | 13/35 (37%) 11/38 (29%) 15/34 (44%) 14/34 (41%) |11/36 (31%) 9/34 (27%) 10/31 (32%) 8/29 (28%) | |FIRST INCIDENCE | 457 473 502 656 |735 (T) 715 629 505 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.409 P=0.525 P=0.313 P=0.477 |P=0.347 P=0.556N P=0.338 P=0.487 | |POLY 3 | P=0.412 P=0.527 P=0.306 P=0.490 |P=0.503 P=0.487N P=0.400 P=0.547N | |POLY 1.5 | P=0.452 P=0.493 P=0.323 P=0.504 |P=0.537 P=0.497N P=0.432 P=0.526N | |POLY 6 | P=0.364 P=0.568 P=0.289 P=0.474 |P=0.468 P=0.479N P=0.375 P=0.569N | |LOGISTIC REGRESSION| P=0.495 P=0.371 P=0.330 P=0.531 |P=0.427 P=0.537N P=0.337 P=0.592N | |COCH-ARM / FISHERS | P=0.492 P=0.417 P=0.338 P=0.500 |P=0.509N P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 9/50 (18%) 12/50 (24%) 17/50 (34%) |12/50 (24%) 11/50 (22%) 4/50 (8%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 29.0% 19.1% 26.9% 35.3% |26.3% 23.7% 9.7% 18.6% | |TERMINAL (d) | 7/35 (20%) 6/38 (16%) 8/34 (24%) 9/34 (27%) |8/36 (22%) 5/34 (15%) 2/31 (7%) 2/29 (7%) | |FIRST INCIDENCE | 561 478 573 406 |633 659 629 628 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.085 P=0.191N P=0.532N P=0.276 |P=0.225N P=0.523N P=0.065N P=0.388N | |POLY 3 | P=0.108 P=0.195N P=0.505N P=0.333 |P=0.140N P=0.479N P=0.040N* P=0.269N | |POLY 1.5 | P=0.103 P=0.204N P=0.500N P=0.312 |P=0.124N P=0.493N P=0.035N* P=0.250N | |POLY 6 | P=0.111 P=0.186N P=0.511N P=0.350 |P=0.159N P=0.463N P=0.046N* P=0.287N | |LOGISTIC REGRESSION| P=0.088 P=0.224N P=0.508N P=0.245 |P=0.130N P=0.497N P=0.040N* P=0.266N | |COCH-ARM / FISHERS | P=0.090 P=0.235N P=0.500N P=0.257 |P=0.105N P=0.500N P=0.027N* P=0.227N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 6 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 26/50 (52%) 23/50 (46%) 27/50 (54%) 30/50 (60%) |21/50 (42%) 19/50 (38%) 14/50 (28%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 55.7% 46.6% 58.0% 61.8% |46.1% 40.8% 33.9% 41.1% | |TERMINAL (d) | 17/35 (49%) 15/38 (40%) 19/34 (56%) 19/34 (56%) |17/36 (47%) 12/34 (35%) 11/31 (36%) 10/29 (35%) | |FIRST INCIDENCE | 457 473 502 406 |633 659 629 505 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.117 P=0.252N P=0.455 P=0.299 |P=0.507 P=0.478N P=0.243N P=0.523 | |POLY 3 | P=0.129 P=0.244N P=0.494 P=0.344 |P=0.357N P=0.383N P=0.172N P=0.395N | |POLY 1.5 | P=0.134 P=0.269N P=0.502 P=0.332 |P=0.316N P=0.405N P=0.146N P=0.371N | |POLY 6 | P=0.121 P=0.221N P=0.487 P=0.353 |P=0.401N P=0.355N P=0.197N P=0.417N | |LOGISTIC REGRESSION| P=0.127 P=0.365N P=0.494 P=0.280 |P=0.401N P=0.398N P=0.201N P=0.440N | |COCH-ARM / FISHERS | P=0.128 P=0.345N P=0.500 P=0.273 |P=0.268N P=0.419N P=0.104N P=0.341N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 26/50 (52%) 23/50 (46%) 27/50 (54%) 30/50 (60%) |21/50 (42%) 19/50 (38%) 14/50 (28%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 55.7% 46.6% 58.0% 61.8% |46.1% 40.8% 33.9% 41.1% | |TERMINAL (d) | 17/35 (49%) 15/38 (40%) 19/34 (56%) 19/34 (56%) |17/36 (47%) 12/34 (35%) 11/31 (36%) 10/29 (35%) | |FIRST INCIDENCE | 457 473 502 406 |633 659 629 505 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.117 P=0.252N P=0.455 P=0.299 |P=0.507 P=0.478N P=0.243N P=0.523 | |POLY 3 | P=0.129 P=0.244N P=0.494 P=0.344 |P=0.357N P=0.383N P=0.172N P=0.395N | |POLY 1.5 | P=0.134 P=0.269N P=0.502 P=0.332 |P=0.316N P=0.405N P=0.146N P=0.371N | |POLY 6 | P=0.121 P=0.221N P=0.487 P=0.353 |P=0.401N P=0.355N P=0.197N P=0.417N | |LOGISTIC REGRESSION| P=0.127 P=0.365N P=0.494 P=0.280 |P=0.401N P=0.398N P=0.201N P=0.440N | |COCH-ARM / FISHERS | P=0.128 P=0.345N P=0.500 P=0.273 |P=0.268N P=0.419N P=0.104N P=0.341N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 7 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Liver | | Hepatocholangiocarcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 4.3% 0.0% 0.0% |0.0% 0.0% 2.4% 4.7% | |TERMINAL (d) | 0/35 (0%) 1/38 (3%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- 481 --- --- |--- --- 553 490 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.268N P=0.251 (e) (e) |P=0.054 (e) P=0.487 P=0.219 | |POLY 3 | P=0.254N P=0.251 (e) (e) |P=0.055 (e) P=0.483 P=0.227 | |POLY 1.5 | P=0.256N P=0.247 (e) (e) |P=0.057 (e) P=0.488 P=0.232 | |POLY 6 | P=0.253N P=0.255 (e) (e) |P=0.052 (e) P=0.479 P=0.222 | |LOGISTIC REGRESSION| P=0.283N P=0.176 (e) (e) |P=0.059 (e) P=0.563 P=0.250 | |COCH-ARM / FISHERS | P=0.264N P=0.247 (e) (e) |P=0.060 (e) P=0.500 P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 10/50 (20%) 11/50 (22%) 7/50 (14%) |6/50 (12%) 4/50 (8%) 1/50 (2%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 29.4% 21.6% 25.6% 15.3% |13.3% 8.8% 2.5% 7.1% | |TERMINAL (d) | 11/35 (31%) 8/38 (21%) 10/34 (29%) 5/34 (15%) |4/36 (11%) 4/34 (12%) 1/31 (3%) 2/29 (7%) | |FIRST INCIDENCE | 686 659 729 555 |617 735 (T) 735 (T) 595 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.160N P=0.244N P=0.443N P=0.119N |P=0.231N P=0.403N P=0.089N P=0.345N | |POLY 3 | P=0.111N P=0.271N P=0.437N P=0.085N |P=0.179N P=0.369N P=0.075N P=0.273N | |POLY 1.5 | P=0.112N P=0.283N P=0.420N P=0.089N |P=0.168N P=0.372N P=0.068N P=0.260N | |POLY 6 | P=0.113N P=0.256N P=0.458N P=0.081N |P=0.191N P=0.369N P=0.082N P=0.288N | |LOGISTIC REGRESSION| P=0.122N P=0.257N P=0.460N P=0.093N |P=0.184N P=0.361N P=0.075N P=0.258N | |COCH-ARM / FISHERS | P=0.119N P=0.318N P=0.408N P=0.105N |P=0.154N P=0.370N P=0.056N P=0.243N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 8 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 6/50 (12%) 6/50 (12%) 6/50 (12%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 6.8% 13.0% 13.6% 13.3% |2.2% 0.0% 7.3% 6.9% | |TERMINAL (d) | 3/35 (9%) 4/38 (11%) 3/34 (9%) 5/34 (15%) |1/36 (3%) 0/34 (0%) 2/31 (7%) 1/29 (3%) | |FIRST INCIDENCE | 733 (T) 705 393 699 |735 (T) --- 659 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.254 P=0.294 P=0.234 P=0.230 |P=0.059 P=0.511N P=0.255 P=0.267 | |POLY 3 | P=0.296 P=0.267 P=0.244 P=0.255 |P=0.071 P=0.498N P=0.273 P=0.295 | |POLY 1.5 | P=0.298 P=0.260 P=0.245 P=0.254 |P=0.075 P=0.500N P=0.283 P=0.301 | |POLY 6 | P=0.292 P=0.276 P=0.242 P=0.256 |P=0.066 P=0.497N P=0.265 P=0.288 | |LOGISTIC REGRESSION| P=0.290 P=0.274 P=0.242 P=0.249 |P=0.084 (e) P=0.268 P=0.331 | |COCH-ARM / FISHERS | P=0.289 P=0.243 P=0.243 P=0.243 |P=0.078 P=0.500N P=0.309 P=0.309 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 14/50 (28%) 16/50 (32%) 13/50 (26%) |7/50 (14%) 4/50 (8%) 4/50 (8%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 34.0% 30.2% 36.3% 28.3% |15.5% 8.8% 9.8% 13.6% | |TERMINAL (d) | 13/35 (37%) 11/38 (29%) 12/34 (35%) 10/34 (29%) |5/36 (14%) 4/34 (12%) 3/31 (10%) 3/29 (10%) | |FIRST INCIDENCE | 686 659 393 555 |617 735 (T) 659 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.503N P=0.395N P=0.458 P=0.440N |P=0.426 P=0.294N P=0.356N P=0.605 | |POLY 3 | P=0.392N P=0.438N P=0.498 P=0.362N |P=0.527 P=0.260N P=0.322N P=0.520N | |POLY 1.5 | P=0.394N P=0.455N P=0.505 P=0.373N |P=0.543 P=0.263N P=0.301N P=0.509N | |POLY 6 | P=0.395N P=0.415N P=0.486 P=0.351N |P=0.510 P=0.259N P=0.340N P=0.535N | |LOGISTIC REGRESSION| P=0.416N P=0.420N P=0.466 P=0.380N |P=0.552 P=0.253N P=0.322N P=0.471N | |COCH-ARM / FISHERS | P=0.414N P=0.500N P=0.500 P=0.412N |P=0.558 P=0.262N P=0.262N P=0.500N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 9 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 2.2% 2.5% 4.7% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |1/36 (3%) 0/34 (0%) 1/31 (3%) 1/29 (3%) | |FIRST INCIDENCE | --- --- --- --- |735 (T) 715 735 (T) 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.286 P=0.757 P=0.728 P=0.447 | |POLY 3 | (e) (e) (e) (e) |P=0.319 P=0.758N P=0.738 P=0.481 | |POLY 1.5 | (e) (e) (e) (e) |P=0.330 P=0.760N P=0.746 P=0.489 | |POLY 6 | (e) (e) (e) (e) |P=0.309 P=0.756N P=0.731 P=0.472 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.319 P=0.760N P=0.728 P=0.488 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.344 P=0.753N P=0.753N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Mesentery | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.5% 0.0% 0.0% 0.0% |0.0% 0.0% 2.4% 0.0% | |TERMINAL (d) | 1/35 (3%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 570 --- --- --- |--- --- 629 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.166N P=0.226N P=0.243N P=0.241N |P=0.629 (e) P=0.471 (e) | |POLY 3 | P=0.167N P=0.230N P=0.245N P=0.234N |P=0.626 (e) P=0.482 (e) | |POLY 1.5 | P=0.165N P=0.231N P=0.241N P=0.234N |P=0.637 (e) P=0.488 (e) | |POLY 6 | P=0.169N P=0.228N P=0.249N P=0.236N |P=0.613 (e) P=0.478 (e) | |LOGISTIC REGRESSION| P=0.164N P=0.257N P=0.238N P=0.253N |P=0.659 (e) P=0.528 (e) | |COCH-ARM / FISHERS | P=0.160N P=0.247N P=0.247N P=0.247N |P=0.649 (e) P=0.500 (e) | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 10 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |2/49 (4%) 1/50 (2%) 1/50 (2%) 3/46 (7%) | |POLY-3 ADJUSTED (b)| |4.4% 2.2% 2.5% 7.6% | |TERMINAL (d) | |1/36 (3%) 1/34 (3%) 1/31 (3%) 1/28 (4%) | |FIRST INCIDENCE | |639 735 (T) 735 (T) 505 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.233 P=0.506N P=0.551N P=0.435 | |POLY 3 | |P=0.245 P=0.499N P=0.537N P=0.442 | |POLY 1.5 | |P=0.255 P=0.499N P=0.523N P=0.452 | |POLY 6 | |P=0.236 P=0.499N P=0.549N P=0.432 | |LOGISTIC REGRESSION| |P=0.292 P=0.493N P=0.517N P=0.614 | |COCH-ARM / FISHERS | |P=0.269 P=0.492N P=0.492N P=0.470 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) |3/46 (7%) 7/48 (15%) 5/50 (10%) 7/47 (15%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |7.2% 16.1% 12.1% 17.7% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/33 (0%) 0/34 (0%) |1/33 (3%) 6/34 (18%) 3/31 (10%) 6/29 (21%) | |FIRST INCIDENCE | --- --- --- --- |729 701 483 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.170 P=0.167 P=0.310 P=0.109 | |POLY 3 | (e) (e) (e) (e) |P=0.204 P=0.173 P=0.350 P=0.133 | |POLY 1.5 | (e) (e) (e) (e) |P=0.224 P=0.170 P=0.364 P=0.144 | |POLY 6 | (e) (e) (e) (e) |P=0.186 P=0.178 P=0.339 P=0.124 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.198 P=0.177 P=0.371 P=0.119 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.261 P=0.176 P=0.405 P=0.167 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 11 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) |3/46 (7%) 7/48 (15%) 6/50 (12%) 7/47 (15%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |7.2% 16.1% 14.5% 17.7% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/33 (0%) 0/34 (0%) |1/33 (3%) 6/34 (18%) 4/31 (13%) 6/29 (21%) | |FIRST INCIDENCE | --- --- --- --- |729 701 483 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.158 P=0.167 P=0.205 P=0.109 | |POLY 3 | (e) (e) (e) (e) |P=0.189 P=0.173 P=0.235 P=0.133 | |POLY 1.5 | (e) (e) (e) (e) |P=0.210 P=0.170 P=0.249 P=0.144 | |POLY 6 | (e) (e) (e) (e) |P=0.171 P=0.178 P=0.225 P=0.124 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.183 P=0.177 P=0.247 P=0.119 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.247 P=0.176 P=0.287 P=0.167 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) |0/46 (0%) 0/48 (0%) 2/50 (4%) 0/47 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.9% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/33 (0%) 0/34 (0%) |0/33 (0%) 0/34 (0%) 1/31 (3%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 659 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.504 (e) P=0.216 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.501 (e) P=0.232 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.518 (e) P=0.239 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.484 (e) P=0.227 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.533 (e) P=0.243 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.539 (e) P=0.269 (e) | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 12 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) |0/46 (0%) 0/48 (0%) 2/50 (4%) 0/47 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.8% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/33 (0%) 0/34 (0%) |0/33 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 365 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.524 (e) P=0.222 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.498 (e) P=0.237 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.516 (e) P=0.242 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.480 (e) P=0.234 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.569 (e) P=0.461 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.539 (e) P=0.269 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/47 (0%) 0/47 (0%) |0/46 (0%) 0/48 (0%) 4/50 (8%) 0/47 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 9.5% 0.0% | |TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/33 (0%) 0/34 (0%) |0/33 (0%) 0/34 (0%) 1/31 (3%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 365 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.394 (e) P=0.055 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.370 (e) P=0.061 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.394 (e) P=0.063 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.346 (e) P=0.059 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.467 (e) P=0.116 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.427 (e) P=0.069 (e) | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 13 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Skin | | Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |4/50 (8%) 4/50 (8%) 2/50 (4%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |8.7% 8.8% 4.8% 9.2% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 4/34 (12%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- --- |533 735 (T) 365 412 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.540 P=0.627 P=0.396N P=0.589 | |POLY 3 | (e) (e) (e) (e) |P=0.550N P=0.636 P=0.385N P=0.614 | |POLY 1.5 | (e) (e) (e) (e) |P=0.534N P=0.637 P=0.368N P=0.627 | |POLY 6 | (e) (e) (e) (e) |P=0.566N P=0.631 P=0.404N P=0.600 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.484N P=0.643N P=0.259N P=0.602N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.514N P=0.643N P=0.339N P=0.643N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/49 (4%) 1/47 (2%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 4.5% 0.0% 4.6% 2.3% |0.0% 4.4% 4.9% 0.0% | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 1/34 (3%) 2/31 (7%) 0/29 (0%) | |FIRST INCIDENCE | 570 --- 502 665 |--- 672 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.605 P=0.230N P=0.684 P=0.500N |P=0.482N P=0.239 P=0.206 (e) | |POLY 3 | P=0.601 P=0.231N P=0.683 P=0.508N |P=0.458N P=0.241 P=0.216 (e) | |POLY 1.5 | P=0.599 P=0.232N P=0.686 P=0.510N |P=0.446N P=0.238 P=0.223 (e) | |POLY 6 | P=0.600 P=0.230N P=0.679 P=0.507N |P=0.470N P=0.243 P=0.209 (e) | |LOGISTIC REGRESSION| P=0.544 P=0.269N P=0.678 P=0.584N |P=0.459N P=0.238 P=0.206 (e) | |COCH-ARM / FISHERS | P=0.592 P=0.247N P=0.684 P=0.523N |P=0.430N P=0.247 P=0.247 (e) | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 14 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 2.3% 0.0% 0.0% 2.2% |0.0% 0.0% 0.0% 7.1% | |TERMINAL (d) | 1/35 (3%) 0/38 (0%) 0/34 (0%) 1/34 (3%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 3/29 (10%) | |FIRST INCIDENCE | 733 (T) --- --- 733 (T) |--- --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.520 P=0.484N P=0.506N P=0.755 |P=0.007 ** (e) (e) P=0.085 | |POLY 3 | P=0.530 P=0.491N P=0.504N P=0.755N |P=0.009 ** (e) (e) P=0.108 | |POLY 1.5 | P=0.532 P=0.493N P=0.502N P=0.755N |P=0.009 ** (e) (e) P=0.112 | |POLY 6 | P=0.526 P=0.488N P=0.507N P=0.755N |P=0.008 ** (e) (e) P=0.102 | |LOGISTIC REGRESSION| P=0.520 (e) (e) P=0.755 |(e) (e) (e) P=0.085 | |COCH-ARM / FISHERS | P=0.536 P=0.500N P=0.500N P=0.753N |P=0.011 * (e) (e) P=0.121 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.7% 0.0% | | |TERMINAL (d) | 0/35 (0%) 0/38 (0%) 2/34 (6%) 0/34 (0%) | | |FIRST INCIDENCE | --- --- 733 (T) --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.520 (e) P=0.232 (e) | | |POLY 3 | P=0.544 (e) P=0.232 (e) | | |POLY 1.5 | P=0.544 (e) P=0.235 (e) | | |POLY 6 | P=0.542 (e) P=0.229 (e) | | |LOGISTIC REGRESSION| (e) (e) P=0.232 (e) | | |COCH-ARM / FISHERS | P=0.536 (e) P=0.247 (e) | | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 15 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/48 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 2.3% 2.2% 0.0% 0.0% |2.2% 0.0% 0.0% 4.9% | |TERMINAL (d) | 1/35 (3%) 1/38 (3%) 0/34 (0%) 0/34 (0%) |1/36 (3%) 0/34 (0%) 0/31 (0%) 2/28 (7%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- --- |735 (T) --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.219N P=0.743N P=0.506N P=0.506N |P=0.159 P=0.511N P=0.530N P=0.412 | |POLY 3 | P=0.216N P=0.751N P=0.504N P=0.498N |P=0.188 P=0.498N P=0.520N P=0.470 | |POLY 1.5 | P=0.215N P=0.753N P=0.502N P=0.500N |P=0.195 P=0.500N P=0.513N P=0.480 | |POLY 6 | P=0.217N P=0.747N P=0.507N P=0.497N |P=0.182 P=0.497N P=0.526N P=0.458 | |LOGISTIC REGRESSION| P=0.219N P=0.743N (e) (e) |P=0.159 (e) (e) P=0.412 | |COCH-ARM / FISHERS | P=0.213N P=0.753N P=0.500N P=0.510N |P=0.204 P=0.500N P=0.500N P=0.492 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 2.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.8% | |TERMINAL (d) | 1/35 (3%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/28 (0%) | |FIRST INCIDENCE | 733 (T) --- --- --- |--- --- --- 628 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.362N P=0.484N P=0.506N P=0.506N |P=0.037 * (e) (e) P=0.214 | |POLY 3 | P=0.370N P=0.491N P=0.504N P=0.498N |P=0.037 * (e) (e) P=0.220 | |POLY 1.5 | P=0.366N P=0.493N P=0.502N P=0.500N |P=0.039 * (e) (e) P=0.225 | |POLY 6 | P=0.374N P=0.488N P=0.507N P=0.497N |P=0.036 * (e) (e) P=0.215 | |LOGISTIC REGRESSION| P=0.362N (e) (e) (e) |P=0.042 * (e) (e) P=0.239 | |COCH-ARM / FISHERS | P=0.356N P=0.500N P=0.500N P=0.510N |P=0.042 * (e) (e) P=0.242 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 16 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/48 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 4/49 (8%) | |POLY-3 ADJUSTED (b)| 4.6% 2.2% 0.0% 0.0% |2.2% 0.0% 0.0% 9.6% | |TERMINAL (d) | 2/35 (6%) 1/38 (3%) 0/34 (0%) 0/34 (0%) |1/36 (3%) 0/34 (0%) 0/31 (0%) 2/28 (7%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- --- |735 (T) --- --- 628 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.113N P=0.471N P=0.245N P=0.245N |P=0.014 * P=0.511N P=0.530N P=0.129 | |POLY 3 | P=0.111N P=0.484N P=0.242N P=0.235N |P=0.016 * P=0.498N P=0.520N P=0.156 | |POLY 1.5 | P=0.110N P=0.488N P=0.239N P=0.238N |P=0.018 * P=0.500N P=0.513N P=0.163 | |POLY 6 | P=0.112N P=0.479N P=0.245N P=0.233N |P=0.015 * P=0.497N P=0.526N P=0.149 | |LOGISTIC REGRESSION| P=0.113N P=0.471N (e) (e) |P=0.018 * (e) (e) P=0.157 | |COCH-ARM / FISHERS | P=0.108N P=0.500N P=0.247N P=0.258N |P=0.021 * P=0.500N P=0.500N P=0.175 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |1/50 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |2.2% 4.4% 4.9% 4.8% | |TERMINAL (d) | |1/36 (3%) 2/34 (6%) 1/31 (3%) 2/29 (7%) | |FIRST INCIDENCE | |735 (T) 735 (T) 560 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.363 P=0.480 P=0.458 P=0.424 | |POLY 3 | |P=0.406 P=0.504 P=0.470 P=0.478 | |POLY 1.5 | |P=0.422 P=0.501 P=0.479 P=0.487 | |POLY 6 | |P=0.389 P=0.506 P=0.463 P=0.467 | |LOGISTIC REGRESSION| |P=0.416 P=0.480 P=0.505 P=0.424 | |COCH-ARM / FISHERS | |P=0.442 P=0.500 P=0.500 P=0.500 | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 17 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |1/50 (2%) 2/50 (4%) 3/50 (6%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |2.2% 4.4% 7.2% 4.8% | |TERMINAL (d) | |1/36 (3%) 2/34 (6%) 1/31 (3%) 2/29 (7%) | |FIRST INCIDENCE | |735 (T) 735 (T) 560 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.332 P=0.480 P=0.266 P=0.424 | |POLY 3 | |P=0.370 P=0.504 P=0.278 P=0.478 | |POLY 1.5 | |P=0.387 P=0.501 P=0.286 P=0.487 | |POLY 6 | |P=0.351 P=0.506 P=0.272 P=0.467 | |LOGISTIC REGRESSION| |P=0.393 P=0.480 P=0.316 P=0.424 | |COCH-ARM / FISHERS | |P=0.409 P=0.500 P=0.309 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.5% 2.2% 0.0% 0.0% |0.0% 2.2% 4.9% 0.0% | |TERMINAL (d) | 1/35 (3%) 1/38 (3%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 1/34 (3%) 2/31 (7%) 0/29 (0%) | |FIRST INCIDENCE | 561 733 (T) --- --- |--- 735 (T) 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.112N P=0.481N P=0.248N P=0.243N |P=0.644N P=0.489 P=0.206 (e) | |POLY 3 | P=0.108N P=0.489N P=0.245N P=0.234N |P=0.613N P=0.502 P=0.216 (e) | |POLY 1.5 | P=0.107N P=0.491N P=0.241N P=0.234N |P=0.602N P=0.500 P=0.223 (e) | |POLY 6 | P=0.110N P=0.486N P=0.249N P=0.236N |P=0.625N P=0.503 P=0.209 (e) | |LOGISTIC REGRESSION| P=0.105N P=0.518N P=0.239N P=0.255N |(e) P=0.489 P=0.206 (e) | |COCH-ARM / FISHERS | P=0.105N P=0.500N P=0.247N P=0.247N |P=0.588N P=0.500 P=0.247 (e) | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 18 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 6/50 (12%) 3/50 (6%) |1/50 (2%) 2/50 (4%) 3/50 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 6.7% 4.4% 13.6% 6.6% |2.2% 4.4% 7.3% 0.0% | |TERMINAL (d) | 1/35 (3%) 2/38 (5%) 2/34 (6%) 1/34 (3%) |1/36 (3%) 1/34 (3%) 2/31 (7%) 0/29 (0%) | |FIRST INCIDENCE | 570 733 (T) 502 599 |735 (T) 672 629 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.383 P=0.470N P=0.236 P=0.658N |P=0.382N P=0.492 P=0.256 P=0.543N | |POLY 3 | P=0.410 P=0.487N P=0.236 P=0.651N |P=0.351N P=0.505 P=0.273 P=0.513N | |POLY 1.5 | P=0.410 P=0.489N P=0.240 P=0.652N |P=0.336N P=0.502 P=0.283 P=0.507N | |POLY 6 | P=0.408 P=0.485N P=0.232 P=0.651N |P=0.368N P=0.509 P=0.266 P=0.519N | |LOGISTIC REGRESSION| P=0.394 P=0.506N P=0.242 P=0.638 |P=0.335N P=0.501 P=0.276 (e) | |COCH-ARM / FISHERS | P=0.403 P=0.500N P=0.243 P=0.661N |P=0.318N P=0.500 P=0.309 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 6/50 (12%) 3/50 (6%) |1/50 (2%) 3/50 (6%) 5/50 (10%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 11.1% 6.5% 13.6% 6.6% |2.2% 6.6% 12.2% 0.0% | |TERMINAL (d) | 2/35 (6%) 3/38 (8%) 2/34 (6%) 1/34 (3%) |1/36 (3%) 2/34 (6%) 4/31 (13%) 0/29 (0%) | |FIRST INCIDENCE | 561 733 (T) 502 599 |735 (T) 672 629 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.465N P=0.326N P=0.478 P=0.362N |P=0.400N P=0.296 P=0.074 P=0.543N | |POLY 3 | P=0.436N P=0.347N P=0.484 P=0.350N |P=0.359N P=0.311 P=0.081 P=0.513N | |POLY 1.5 | P=0.433N P=0.347N P=0.493 P=0.348N |P=0.339N P=0.307 P=0.088 P=0.507N | |POLY 6 | P=0.440N P=0.348N P=0.474 P=0.353N |P=0.381N P=0.314 P=0.077 P=0.519N | |LOGISTIC REGRESSION| P=0.445N P=0.370N P=0.500 P=0.392N |P=0.353N P=0.308 P=0.080 (e) | |COCH-ARM / FISHERS | P=0.436N P=0.357N P=0.500 P=0.357N |P=0.317N P=0.309 P=0.102 P=0.500N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 19 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 6.8% 0.0% 0.0% 2.2% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/35 (6%) 0/38 (0%) 0/34 (0%) 0/34 (0%) |0/36 (0%) 0/34 (0%) 0/31 (0%) 0/29 (0%) | |FIRST INCIDENCE | 647 --- --- 716 |439 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.339N P=0.111N P=0.132N P=0.306N |P=0.356N P=0.504N P=0.517N P=0.504N | |POLY 3 | P=0.339N P=0.112N P=0.124N P=0.298N |P=0.356N P=0.501N P=0.523N P=0.516N | |POLY 1.5 | P=0.335N P=0.114N P=0.121N P=0.298N |P=0.354N P=0.502N P=0.516N P=0.509N | |POLY 6 | P=0.345N P=0.110N P=0.127N P=0.300N |P=0.358N P=0.501N P=0.530N P=0.523N | |LOGISTIC REGRESSION| P=0.326N P=0.117N P=0.122N P=0.299N |P=0.357N P=0.427N P=0.390N P=0.543N | |COCH-ARM / FISHERS | P=0.327N P=0.121N P=0.121N P=0.309N |P=0.351N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |3/50 (6%) 8/50 (16%) 11/50 (22%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 2.3% 2.2% 4.7% 2.2% |6.6% 17.2% 26.6% 23.1% | |TERMINAL (d) | 1/35 (3%) 1/38 (3%) 2/34 (6%) 1/34 (3%) |1/36 (3%) 4/34 (12%) 9/31 (29%) 4/29 (14%) | |FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |639 533 581 595 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.543 P=0.743N P=0.490 P=0.755 |P=0.026 * P=0.107 P=0.012 * P=0.026 * | |POLY 3 | P=0.571 P=0.751N P=0.493 P=0.755N |P=0.035 * P=0.105 P=0.011 * P=0.027 * | |POLY 1.5 | P=0.572 P=0.753N P=0.497 P=0.755N |P=0.042 * P=0.102 P=0.013 * P=0.030 * | |POLY 6 | P=0.567 P=0.747N P=0.488 P=0.755N |P=0.030 * P=0.108 P=0.009 ** P=0.025 * | |LOGISTIC REGRESSION| P=0.543 P=0.743N P=0.490 P=0.755 |P=0.046 * P=0.101 P=0.014 * P=0.035 * | |COCH-ARM / FISHERS | P=0.569 P=0.753N P=0.500 P=0.753N |P=0.056 P=0.100 P=0.020 * P=0.036 * | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 20 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 30/50 (60%) 28/50 (56%) 33/50 (66%) 28/50 (56%) |22/50 (44%) 24/50 (48%) 26/50 (52%) 22/50 (44%) | |POLY-3 ADJUSTED (b)| 64.5% 56.1% 71.0% 59.5% |47.7% 52.4% 60.6% 49.7% | |TERMINAL (d) | 24/35 (69%) 17/38 (45%) 24/34 (71%) 20/34 (59%) |16/36 (44%) 21/34 (62%) 19/31 (61%) 17/29 (59%) | |FIRST INCIDENCE | 457 473 502 555 |617 659 483 505 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.447 P=0.287N P=0.302 P=0.462N |P=0.210 P=0.351 P=0.118 P=0.273 | |POLY 3 | P=0.509 P=0.262N P=0.323 P=0.386N |P=0.461 P=0.404 P=0.154 P=0.510 | |POLY 1.5 | P=0.527N P=0.306N P=0.334 P=0.384N |P=0.510 P=0.405 P=0.187 P=0.543 | |POLY 6 | P=0.461 P=0.212N P=0.320 P=0.387N |P=0.408 P=0.393 P=0.131 P=0.468 | |LOGISTIC REGRESSION| P=0.485N P=0.423N P=0.320 P=0.373N |P=0.402 P=0.451 P=0.142 P=0.494 | |COCH-ARM / FISHERS | P=0.493N P=0.420N P=0.339 P=0.420N |P=0.507N P=0.421 P=0.274 P=0.580N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 23/50 (46%) 20/50 (40%) 26/50 (52%) 29/50 (58%) |26/50 (52%) 23/50 (46%) 26/50 (52%) 26/50 (52%) | |POLY-3 ADJUSTED (b)| 50.1% 41.3% 55.3% 59.0% |53.8% 48.1% 56.9% 54.2% | |TERMINAL (d) | 14/35 (40%) 13/38 (34%) 15/34 (44%) 16/34 (47%) |15/36 (42%) 12/34 (35%) 16/31 (52%) 8/29 (28%) | |FIRST INCIDENCE | 561 478 393 406 |439 533 281 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.061 P=0.259N P=0.324 P=0.205 |P=0.183 P=0.402N P=0.338 P=0.333 | |POLY 3 | P=0.073 P=0.258N P=0.383 P=0.252 |P=0.380 P=0.362N P=0.460 P=0.563 | |POLY 1.5 | P=0.066 P=0.278N P=0.375 P=0.225 |P=0.403 P=0.365N P=0.508 P=0.576 | |POLY 6 | P=0.081 P=0.243N P=0.390 P=0.278 |P=0.357 P=0.358N P=0.406 P=0.551 | |LOGISTIC REGRESSION| P=0.050 P=0.330N P=0.339 P=0.162 |P=0.437 P=0.344N P=0.555N P=0.518N | |COCH-ARM / FISHERS | P=0.051 P=0.343N P=0.345 P=0.158 |P=0.408 P=0.345N P=0.579N P=0.579N | |=================================================================================================================================| Date: 03/09/99 EXPERIMENT: 05180 TEST: 07 Page 21 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GALLIUM ARSENIDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 0.1 0.5 1.0 |CONTROL 0.1 0.5 1.0 | | | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 40/50 (80%) 37/50 (74%) 45/50 (90%) 41/50 (82%) |36/50 (72%) 36/50 (72%) 40/50 (80%) 39/50 (78%) | |POLY-3 ADJUSTED (b)| 83.9% 74.0% 91.8% 82.0% |74.3% 75.1% 84.5% 80.3% | |TERMINAL (d) | 28/35 (80%) 25/38 (66%) 30/34 (88%) 25/34 (74%) |24/36 (67%) 24/34 (71%) 26/31 (84%) 20/29 (69%) | |FIRST INCIDENCE | 457 473 393 406 |439 533 281 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.196 P=0.205N P=0.194 P=0.476 |P=0.047 * P=0.498 P=0.092 P=0.110 | |POLY 3 | P=0.300 P=0.171N P=0.186 P=0.510N |P=0.202 P=0.555 P=0.158 P=0.320 | |POLY 1.5 | P=0.277 P=0.200N P=0.165 P=0.554N |P=0.218 P=0.552 P=0.185 P=0.330 | |POLY 6 | P=0.323 P=0.149N P=0.216 P=0.470N |P=0.185 P=0.560 P=0.131 P=0.311 | |LOGISTIC REGRESSION| P=0.211 P=0.288N P=0.123 P=0.535 |P=0.176 P=0.587 P=0.192 P=0.315 | |COCH-ARM / FISHERS | P=0.209 P=0.318N P=0.131 P=0.500 |P=0.208 P=0.588N P=0.241 P=0.322 | |=================================================================================================================================| (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).