TDMS Study 05184-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest GLUTARALDEHYDE DATE: 07/13/98 EXPERIMENT: 05184 TEST: 06 TIME: 08:41:09 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55425C PATHOLOGIST: GRUMBEIN, S. CAS: 111-30-8 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest GLUTARALDEHYDE DATE: 07/13/98 EXPERIMENT: 05184 TEST: 06 TIME: 08:41:09 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55425C PATHOLOGIST: GRUMBEIN, S. CAS: 111-30-8 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF GLUTARALDEHYDE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Kidney Cyst Kidney: Papilla Inflammation Liver Eosinophilic Focus Fatty Change Nose: Respiratory Epithelium Degeneration Hyaline Metaplasia =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Liver Eosinophilic Focus Lung: Alveolar Epithelium Hyperplasia Lymph Node, Mesenteric Hyperplasia Lymphoid Nose Inflammation Nose: Respiratory Epithelium Degeneration Hyaline Metaplasia Pituitary Gland: Pars Distalis Hyperplasia Spleen Hyperplasia Lymphoid Thyroid Gland: Follicular Cell Hyperplasia =============================================================== Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 10/47 (21%) 9/49 (18%) 18/50 (36%) 12/49 (24%) |2/50 (4%) 2/49 (4%) 7/49 (14%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 23.7% 22.5% 40.0% 26.0% |4.4% 4.4% 15.3% 2.3% | |TERMINAL (d) | 8/31 (26%) 7/27 (26%) 17/40 (43%) 8/38 (21%) |1/34 (3%) 1/37 (3%) 6/35 (17%) 0/32 (0%) | |FIRST INCIDENCE | 359 588 715 558 |616 706 502 723 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.525 P=0.585 P=0.198 P=0.575 |P=0.535N P=0.663N P=0.091 P=0.512N | |POLY 3 | P=0.382 P=0.553N P=0.079 P=0.501 |P=0.529N P=0.692N P=0.083 P=0.511N | |POLY 1.5 | P=0.333 P=0.518N P=0.077 P=0.476 |P=0.515N P=0.692 P=0.081 P=0.505N | |POLY 6 | P=0.450 P=0.588N P=0.089 P=0.538 |P=0.546N P=0.687N P=0.084 P=0.516N | |LOGISTIC REGRESSION| P=0.353 P=0.509N P=0.097 P=0.436 |P=0.497N P=0.684 P=0.069 P=0.499N | |COCH-ARM / FISHERS | P=0.276 P=0.459N P=0.084 P=0.448 |P=0.498N P=0.684 P=0.075 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 32/47 (68%) 26/49 (53%) 31/50 (62%) 34/49 (69%) |2/50 (4%) 2/49 (4%) 1/49 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 76.6% 62.6% 66.6% 75.0% |4.5% 4.4% 2.2% 4.6% | |TERMINAL (d) | 27/31 (87%) 20/27 (74%) 27/40 (68%) 31/38 (82%) |1/34 (3%) 2/37 (5%) 1/35 (3%) 1/32 (3%) | |FIRST INCIDENCE | 602 402 470 641 |708 735 (T) 735 (T) 723 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.201N P=0.388N P=0.055N P=0.205N |P=0.602 P=0.659N P=0.487N P=0.681 | |POLY 3 | P=0.446 P=0.107N P=0.204N P=0.532N |P=0.582N P=0.691N P=0.497N P=0.686 | |POLY 1.5 | P=0.374 P=0.099N P=0.263N P=0.580N |P=0.578N P=0.693 P=0.499N P=0.690 | |POLY 6 | P=0.535 P=0.132N P=0.140N P=0.479N |P=0.586N P=0.685N P=0.494N P=0.682 | |LOGISTIC REGRESSION| P=0.515N P=0.217N P=0.237N P=0.368N |P=0.599N P=0.681N P=0.492N P=0.684 | |COCH-ARM / FISHERS | P=0.294 P=0.097N P=0.340N P=0.533 |P=0.575N P=0.684 P=0.508N P=0.691N | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/47 (4%) 2/49 (4%) 2/50 (4%) 2/49 (4%) |3/50 (6%) 1/49 (2%) 5/48 (10%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 4.9% 5.1% 4.4% 4.5% |6.7% 2.2% 11.1% 2.3% | |TERMINAL (d) | 2/31 (7%) 0/27 (0%) 2/40 (5%) 2/38 (5%) |3/34 (9%) 0/37 (0%) 4/35 (11%) 0/31 (0%) | |FIRST INCIDENCE | 733 (T) 707 733 (T) 733 (T) |735 (T) 706 502 660 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.482N P=0.644 P=0.600N P=0.620N |P=0.411N P=0.269N P=0.372 P=0.334N | |POLY 3 | P=0.550N P=0.682 P=0.659N P=0.660N |P=0.399N P=0.300N P=0.360 P=0.319N | |POLY 1.5 | P=0.563N P=0.692 P=0.666N P=0.668N |P=0.390N P=0.305N P=0.352 P=0.316N | |POLY 6 | P=0.535N P=0.670 P=0.647N P=0.650N |P=0.408N P=0.293N P=0.368 P=0.321N | |LOGISTIC REGRESSION| P=0.513N P=0.662 P=0.600N P=0.620N |P=0.379N P=0.290N P=0.334 P=0.321N | |COCH-ARM / FISHERS | P=0.582N P=0.676N P=0.668N P=0.676N |P=0.380N P=0.316N P=0.335 P=0.316N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Epididymis | | Granuloma Sperm | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | | |POLY-3 ADJUSTED (b)| 4.7% 0.0% 0.0% 2.2% | | |TERMINAL (d) | 1/31 (3%) 0/27 (0%) 0/40 (0%) 0/38 (0%) | | |FIRST INCIDENCE | 573 --- --- 672 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.418N P=0.263N P=0.212N P=0.460N | | |POLY 3 | P=0.440N P=0.249N P=0.223N P=0.477N | | |POLY 1.5 | P=0.447N P=0.241N P=0.226N P=0.483N | | |POLY 6 | P=0.431N P=0.260N P=0.217N P=0.468N | | |LOGISTIC REGRESSION| P=0.477N P=0.212N P=0.229N P=0.518N | | |COCH-ARM / FISHERS | P=0.458N P=0.237N P=0.237N P=0.492N | | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Heart: Atrium | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |1/34 (3%) 0/37 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |704 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.118N P=0.214N P=0.231N P=0.246N | |POLY 3 | (e) (e) (e) (e) |P=0.114N P=0.235N P=0.231N P=0.243N | |POLY 1.5 | (e) (e) (e) (e) |P=0.114N P=0.238N P=0.233N P=0.240N | |POLY 6 | (e) (e) (e) (e) |P=0.114N P=0.232N P=0.231N P=0.246N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.115N P=0.235N P=0.231N P=0.243N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.253N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/47 (6%) 2/48 (4%) 1/50 (2%) 6/48 (13%) |1/50 (2%) 0/48 (0%) 2/49 (4%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 7.3% 5.2% 2.2% 13.2% |2.2% 0.0% 4.4% 2.3% | |TERMINAL (d) | 2/31 (7%) 1/27 (4%) 0/40 (0%) 5/38 (13%) |1/34 (3%) 0/37 (0%) 1/35 (3%) 1/32 (3%) | |FIRST INCIDENCE | 688 706 470 558 |735 (T) --- 524 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.188 P=0.556N P=0.248N P=0.339 |P=0.479 P=0.483N P=0.509 P=0.748 | |POLY 3 | P=0.143 P=0.530N P=0.267N P=0.294 |P=0.480 P=0.499N P=0.509 P=0.753 | |POLY 1.5 | P=0.132 P=0.514N P=0.275N P=0.278 |P=0.487 P=0.502N P=0.504 P=0.754 | |POLY 6 | P=0.154 P=0.547N P=0.256N P=0.309 |P=0.472 P=0.494N P=0.514 P=0.751 | |LOGISTIC REGRESSION| P=0.114 P=0.546N P=0.285N P=0.266 |P=0.502 (e) P=0.448 P=0.748 | |COCH-ARM / FISHERS | P=0.117 P=0.490N P=0.285N P=0.254 |P=0.497 P=0.510N P=0.492 P=0.747 | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 4/49 (8%) 2/50 (4%) 0/49 (0%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 10.2% 4.4% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 3/27 (11%) 2/40 (5%) 0/38 (0%) |0/34 (0%) 0/37 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 707 733 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.254N P=0.048 * P=0.296 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.308N P=0.053 P=0.254 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.316N P=0.057 P=0.250 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.297N P=0.049 * P=0.263 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.277N P=0.048 * P=0.296 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.330N P=0.061 P=0.258 (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Kidney | | Hydronephrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 3/49 (6%) 2/50 (4%) 1/49 (2%) |0/50 (0%) 0/49 (0%) 1/49 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 4.7% 7.3% 4.4% 2.2% |0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/27 (0%) 1/40 (3%) 0/38 (0%) |0/34 (0%) 0/37 (0%) 1/35 (3%) 0/32 (0%) | |FIRST INCIDENCE | 616 402 702 327 |--- --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.275N P=0.474 P=0.630N P=0.474N |P=0.686 (e) P=0.506 (e) | |POLY 3 | P=0.279N P=0.490 P=0.670N P=0.471N |P=0.679 (e) P=0.502 (e) | |POLY 1.5 | P=0.289N P=0.498 P=0.675N P=0.479N |P=0.685 (e) P=0.501 (e) | |POLY 6 | P=0.269N P=0.480 P=0.660N P=0.464N |P=0.674 (e) P=0.504 (e) | |LOGISTIC REGRESSION| P=0.384N P=0.642 P=0.682N P=0.562N |(e) (e) P=0.506 (e) | |COCH-ARM / FISHERS | P=0.305N P=0.510 P=0.676N P=0.492N |P=0.692 (e) P=0.495 (e) | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) |1/50 (2%) 2/49 (4%) 3/49 (6%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 4.4% 6.6% 4.6% | |TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |0/34 (0%) 2/37 (5%) 2/35 (6%) 2/32 (6%) | |FIRST INCIDENCE | --- --- --- --- |664 735 (T) 570 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.370 P=0.525 P=0.321 P=0.480 | |POLY 3 | (e) (e) (e) (e) |P=0.382 P=0.502 P=0.312 P=0.485 | |POLY 1.5 | (e) (e) (e) (e) |P=0.389 P=0.499 P=0.308 P=0.489 | |POLY 6 | (e) (e) (e) (e) |P=0.374 P=0.507 P=0.315 P=0.481 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.396 P=0.498 P=0.264 P=0.489 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.397 P=0.492 P=0.301 P=0.492 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Kidney | | Metaplasia Osseous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 1/49 (2%) 2/50 (4%) 0/49 (0%) |1/50 (2%) 0/49 (0%) 0/49 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 2.5% 4.4% 0.0% |2.2% 0.0% 0.0% 4.6% | |TERMINAL (d) | 0/31 (0%) 1/27 (4%) 2/40 (5%) 0/38 (0%) |0/34 (0%) 0/37 (0%) 0/35 (0%) 2/32 (6%) | |FIRST INCIDENCE | --- 733 (T) 733 (T) --- |704 --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.545N P=0.472 P=0.296 (e) |P=0.227 P=0.470N P=0.489N P=0.486 | |POLY 3 | P=0.586N P=0.488 P=0.254 (e) |P=0.238 P=0.498N P=0.498N P=0.486 | |POLY 1.5 | P=0.597N P=0.495 P=0.250 (e) |P=0.240 P=0.500N P=0.500N P=0.490 | |POLY 6 | P=0.574N P=0.481 P=0.263 (e) |P=0.235 P=0.495N P=0.497N P=0.483 | |LOGISTIC REGRESSION| (e) P=0.472 P=0.296 (e) |P=0.233 P=0.504N P=0.505N P=0.485 | |COCH-ARM / FISHERS | P=0.612N P=0.505 P=0.258 (e) |P=0.243 P=0.505N P=0.505N P=0.492 | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 44/48 (92%) 43/49 (88%) 46/50 (92%) 47/49 (96%) |20/50 (40%) 14/49 (29%) 19/49 (39%) 16/49 (33%) | |POLY-3 ADJUSTED (b)| 96.5% 91.8% 96.6% 98.0% |43.7% 30.4% 39.6% 35.9% | |TERMINAL (d) | 31/31 (100%) 27/27 (100%) 40/40 (100%) 38/38 (100%)|16/34 (47%) 10/37 (27%) 12/35 (34%) 10/32 (31%) | |FIRST INCIDENCE | 516 364 470 504 |558 551 502 542 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.064N P=0.276 P=0.056N P=0.195N |P=0.460N P=0.099N P=0.453N P=0.339N | |POLY 3 | P=0.251 P=0.275N P=0.745 P=0.590 |P=0.388N P=0.134N P=0.423N P=0.295N | |POLY 1.5 | P=0.194 P=0.307N P=0.676 P=0.441 |P=0.381N P=0.143N P=0.461N P=0.291N | |POLY 6 | P=0.378 P=0.272N P=0.792N P=0.791 |P=0.394N P=0.121N P=0.383N P=0.296N | |LOGISTIC REGRESSION| P=0.313 P=0.557N P=0.644 P=0.508 |P=0.380N P=0.139N P=0.540N P=0.305N | |COCH-ARM / FISHERS | P=0.180 P=0.383N P=0.619 P=0.329 |P=0.376N P=0.162N P=0.532N P=0.291N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Kidney: Papilla | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/50 (0%) 2/49 (4%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |0/34 (0%) 0/37 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- 327 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.054 (e) (e) P=0.253 |(e) (e) (e) (e) | |POLY 3 | P=0.052 (e) (e) P=0.261 |(e) (e) (e) (e) | |POLY 1.5 | P=0.049 * (e) (e) P=0.253 |(e) (e) (e) (e) | |POLY 6 | P=0.055 (e) (e) P=0.269 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.021 * (e) (e) P=0.173 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.253 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Larynx: Glands | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/47 (11%) 3/49 (6%) 3/50 (6%) 3/50 (6%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 11.9% 7.6% 6.7% 6.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/31 (7%) 3/27 (11%) 3/40 (8%) 2/38 (5%) |0/34 (0%) 0/37 (0%) 0/35 (0%) 0/31 (0%) | |FIRST INCIDENCE | 602 733 (T) 733 (T) 558 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.214N P=0.429N P=0.272N P=0.285N |(e) (e) (e) (e) | |POLY 3 | P=0.258N P=0.394N P=0.320N P=0.307N |(e) (e) (e) (e) | |POLY 1.5 | P=0.271N P=0.369N P=0.323N P=0.313N |(e) (e) (e) (e) | |POLY 6 | P=0.245N P=0.427N P=0.313N P=0.304N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.282N P=0.347N P=0.324N P=0.352N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.291N P=0.334N P=0.323N P=0.323N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 8/50 (16%) 4/50 (8%) 6/49 (12%) |2/50 (4%) 4/48 (8%) 5/50 (10%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 11.8% 19.3% 8.9% 13.4% |4.5% 8.9% 10.9% 4.6% | |TERMINAL (d) | 4/31 (13%) 5/27 (19%) 4/40 (10%) 6/38 (16%) |1/34 (3%) 3/37 (8%) 4/35 (11%) 1/32 (3%) | |FIRST INCIDENCE | 626 402 733 (T) 733 (T) |701 714 719 707 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.361N P=0.212 P=0.358N P=0.619N |P=0.558N P=0.381 P=0.233 P=0.682 | |POLY 3 | P=0.498N P=0.260 P=0.462N P=0.541 |P=0.533N P=0.339 P=0.227 P=0.686 | |POLY 1.5 | P=0.519N P=0.273 P=0.475N P=0.524 |P=0.523N P=0.332 P=0.225 P=0.690 | |POLY 6 | P=0.474N P=0.245 P=0.441N P=0.559 |P=0.543N P=0.349 P=0.228 P=0.682 | |LOGISTIC REGRESSION| P=0.505N P=0.280 P=0.440N P=0.572 |P=0.544N P=0.348 P=0.230 P=0.686 | |COCH-ARM / FISHERS | P=0.548N P=0.290 P=0.487N P=0.500 |P=0.512N P=0.319 P=0.218 P=0.691N | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 8 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/49 (18%) 6/50 (12%) 9/50 (18%) 7/49 (14%) |2/50 (4%) 1/48 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 21.4% 14.9% 20.0% 15.5% |4.4% 2.2% 0.0% 0.0% | |TERMINAL (d) | 8/31 (26%) 5/27 (19%) 9/40 (23%) 6/38 (16%) |1/34 (3%) 1/37 (3%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE | 723 598 733 (T) 673 |614 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.218N P=0.389N P=0.367N P=0.242N |P=0.106N P=0.486N P=0.234N P=0.254N | |POLY 3 | P=0.348N P=0.313N P=0.541N P=0.332N |P=0.101N P=0.501N P=0.233N P=0.244N | |POLY 1.5 | P=0.385N P=0.297N P=0.563N P=0.357N |P=0.101N P=0.506N P=0.234N P=0.241N | |POLY 6 | P=0.305N P=0.332N P=0.504N P=0.303N |P=0.102N P=0.495N P=0.233N P=0.248N | |LOGISTIC REGRESSION| P=0.291N P=0.360N P=0.383N P=0.285N |P=0.100N P=0.528N P=0.253N P=0.236N | |COCH-ARM / FISHERS | P=0.438N P=0.274N P=0.584N P=0.393N |P=0.100N P=0.515N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/49 (14%) 6/50 (12%) 5/50 (10%) 3/49 (6%) |6/50 (12%) 6/48 (13%) 4/50 (8%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 16.7% 15.0% 11.1% 6.7% |13.4% 13.3% 8.7% 0.0% | |TERMINAL (d) | 7/31 (23%) 5/27 (19%) 5/40 (13%) 3/38 (8%) |5/34 (15%) 5/37 (14%) 4/35 (11%) 0/32 (0%) | |FIRST INCIDENCE | 733 (T) 685 733 (T) 733 (T) |704 672 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.043N* P=0.605N P=0.212N P=0.085N |P=0.013N* P=0.557N P=0.349N P=0.021N* | |POLY 3 | P=0.083N P=0.535N P=0.330N P=0.130N |P=0.011N* P=0.615N P=0.353N P=0.016N* | |POLY 1.5 | P=0.095N P=0.515N P=0.348N P=0.141N |P=0.011N* P=0.614 P=0.357N P=0.016N* | |POLY 6 | P=0.071N P=0.558N P=0.303N P=0.118N |P=0.012N* P=0.598N P=0.351N P=0.017N* | |LOGISTIC REGRESSION| P=0.054N P=0.596N P=0.212N P=0.085N |P=0.012N* P=0.598N P=0.345N P=0.019N* | |COCH-ARM / FISHERS | P=0.114N P=0.484N P=0.365N P=0.159N |P=0.011N* P=0.591 P=0.370N P=0.013N* | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 9 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Liver | | Fatty Change | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |0/50 (0%) 0/48 (0%) 3/50 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.5% |0.0% 0.0% 6.4% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 2/38 (5%) |0/34 (0%) 0/37 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- 733 (T) |--- --- 640 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.064 (e) (e) P=0.284 |P=0.527 (e) P=0.137 (e) | |POLY 3 | P=0.049 * (e) (e) P=0.252 |P=0.515 (e) P=0.127 (e) | |POLY 1.5 | P=0.047 * (e) (e) P=0.246 |P=0.528 (e) P=0.124 (e) | |POLY 6 | P=0.052 (e) (e) P=0.260 |P=0.502 (e) P=0.131 (e) | |LOGISTIC REGRESSION| (e) (e) (e) P=0.284 |P=0.545 (e) P=0.091 (e) | |COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.247 |P=0.543 (e) P=0.121 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.8% 5.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/31 (7%) 2/27 (7%) 0/40 (0%) 0/38 (0%) |0/34 (0%) 0/37 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE | 733 (T) 733 (T) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.058N P=0.645 P=0.184N P=0.195N |(e) (e) (e) (e) | |POLY 3 | P=0.079N P=0.676 P=0.222N P=0.222N |(e) (e) (e) (e) | |POLY 1.5 | P=0.082N P=0.686 P=0.227N P=0.228N |(e) (e) (e) (e) | |POLY 6 | P=0.077N P=0.664 P=0.213N P=0.215N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.058N P=0.645 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.086N P=0.684N P=0.242N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 10 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/50 (2%) 0/50 (0%) 2/49 (4%) |1/50 (2%) 1/48 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.4% 2.5% 0.0% 4.4% |2.2% 2.2% 2.2% 4.6% | |TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |0/34 (0%) 0/37 (0%) 0/35 (0%) 2/32 (6%) | |FIRST INCIDENCE | 684 598 --- 558 |681 527 570 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.412 P=0.734 P=0.475N P=0.539 |P=0.334 P=0.755N P=0.753N P=0.483 | |POLY 3 | P=0.389 P=0.751 P=0.487N P=0.526 |P=0.343 P=0.757N P=0.753N P=0.491 | |POLY 1.5 | P=0.379 P=0.757 P=0.492N P=0.516 |P=0.349 P=0.759 P=0.755N P=0.495 | |POLY 6 | P=0.401 P=0.745 P=0.480N P=0.539 |P=0.335 P=0.752N P=0.751N P=0.485 | |LOGISTIC REGRESSION| P=0.324 P=0.743N P=0.498N P=0.466 |P=0.362 P=0.683 P=0.713 P=0.492 | |COCH-ARM / FISHERS | P=0.364 P=0.747N P=0.495N P=0.500 |P=0.356 P=0.742 P=0.753N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/50 (4%) 0/50 (0%) 1/49 (2%) |1/50 (2%) 0/48 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 4.9% 0.0% 2.2% |2.2% 0.0% 4.3% 2.3% | |TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |1/34 (3%) 0/37 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 539 --- 672 |735 (T) --- 687 588 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.580 P=0.226 (e) P=0.515 |P=0.485 P=0.483N P=0.519 P=0.749 | |POLY 3 | P=0.560 P=0.229 (e) P=0.514 |P=0.489 P=0.499N P=0.512 P=0.758 | |POLY 1.5 | P=0.551 P=0.234 (e) P=0.508 |P=0.495 P=0.502N P=0.508 P=0.759 | |POLY 6 | P=0.570 P=0.224 (e) P=0.522 |P=0.482 P=0.494N P=0.516 P=0.758 | |LOGISTIC REGRESSION| P=0.507 P=0.262 (e) P=0.488 |P=0.511 (e) P=0.506 P=0.763 | |COCH-ARM / FISHERS | P=0.538 P=0.253 (e) P=0.500 |P=0.504 P=0.510N P=0.500 P=0.753N | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 11 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Lung | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/49 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 0.0% 4.3% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |1/34 (3%) 0/37 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |735 (T) --- 687 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.474N P=0.483N P=0.519 P=0.512N | |POLY 3 | (e) (e) (e) (e) |P=0.472N P=0.498N P=0.512 P=0.504N | |POLY 1.5 | (e) (e) (e) (e) |P=0.466N P=0.500N P=0.508 P=0.502N | |POLY 6 | (e) (e) (e) (e) |P=0.479N P=0.494N P=0.516 P=0.507N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.463N (e) P=0.506 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.459N P=0.505N P=0.500 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/48 (6%) 3/50 (6%) 5/50 (10%) 2/50 (4%) |4/50 (8%) 4/49 (8%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.2% 7.5% 11.1% 4.4% |9.0% 8.9% 0.0% 0.0% | |TERMINAL (d) | 3/31 (10%) 2/27 (7%) 5/40 (13%) 2/38 (5%) |3/34 (9%) 4/37 (11%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE | 733 (T) 685 733 (T) 733 (T) |734 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.301N P=0.602 P=0.502 P=0.407N |P=0.016N* P=0.598N P=0.062N P=0.074N | |POLY 3 | P=0.377N P=0.646 P=0.399 P=0.460N |P=0.013N* P=0.637N P=0.057N P=0.063N | |POLY 1.5 | P=0.396N P=0.660 P=0.388 P=0.469N |P=0.013N* P=0.643 P=0.058N P=0.062N | |POLY 6 | P=0.355N P=0.630 P=0.419 P=0.449N |P=0.013N* P=0.627N P=0.056N P=0.064N | |LOGISTIC REGRESSION| P=0.337N P=0.615 P=0.502 P=0.407N |P=0.015N* P=0.605N P=0.059N P=0.069N | |COCH-ARM / FISHERS | P=0.424N P=0.641N P=0.381 P=0.480N |P=0.014N* P=0.631 P=0.059N P=0.059N | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 12 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Lymph Node, Bronchial | | Infiltration Cellular Plasma Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/34 (0%) 0/28 (0%) 0/35 (0%) 0/37 (0%) |2/29 (7%) 0/32 (0%) 0/37 (0%) 0/36 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |7.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/24 (0%) 0/17 (0%) 0/30 (0%) 0/31 (0%) |0/19 (0%) 0/25 (0%) 0/25 (0%) 0/23 (0%) | |FIRST INCIDENCE | --- --- --- --- |507 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.118N P=0.237N P=0.232N P=0.250N | |POLY 3 | (e) (e) (e) (e) |P=0.089N P=0.210N P=0.186N P=0.200N | |POLY 1.5 | (e) (e) (e) (e) |P=0.090N P=0.211N P=0.183N P=0.194N | |POLY 6 | (e) (e) (e) (e) |P=0.089N P=0.210N P=0.190N P=0.208N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.116N P=0.294N P=0.255N P=0.210N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.093N P=0.222N P=0.189N P=0.195N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/46 (0%) 0/44 (0%) 0/47 (0%) 0/47 (0%) |4/47 (9%) 0/48 (0%) 1/46 (2%) 0/46 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |9.4% 0.0% 2.4% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/25 (0%) 0/38 (0%) 0/36 (0%) |4/33 (12%) 0/37 (0%) 1/33 (3%) 0/30 (0%) | |FIRST INCIDENCE | --- --- --- --- |735 (T) --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.045N* P=0.049N* P=0.178N P=0.075N | |POLY 3 | (e) (e) (e) (e) |P=0.041N* P=0.053N P=0.177N P=0.067N | |POLY 1.5 | (e) (e) (e) (e) |P=0.040N* P=0.054N P=0.179N P=0.065N | |POLY 6 | (e) (e) (e) (e) |P=0.042N* P=0.051N P=0.175N P=0.069N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.045N* (e) P=0.178N (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.041N* P=0.056N P=0.187N P=0.061N | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 13 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Mesentery: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/2 (0%) 0/2 (0%) 0/3 (0%) 0/5 (0%) |2/12 (17%) 0/6 (0%) 0/5 (0%) 0/6 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |18.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/1 (0%) 0/3 (0%) |0/6 (0%) 0/4 (0%) 0/3 (0%) 0/2 (0%) | |FIRST INCIDENCE | --- --- --- --- |507 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.119N P=0.247N P=0.240N P=0.252N | |POLY 3 | (e) (e) (e) (e) |P=0.205N P=0.396N P=0.455N P=0.386N | |POLY 1.5 | (e) (e) (e) (e) |P=0.204N P=0.397N P=0.451N P=0.391N | |POLY 6 | (e) (e) (e) (e) |P=0.206N P=0.393N P=0.458N P=0.381N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.198N P=0.431N P=0.485N P=0.431N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/2 (50%) 2/2 (100%) 2/3 (67%) 5/5 (100%) |9/12 (75%) 5/6 (83%) 3/5 (60%) 4/6 (67%) | |POLY-3 ADJUSTED (b)| 55.2% 100.0% 66.7% 100.0% |84.1% 84.8% 69.0% 68.7% | |TERMINAL (d) | 1/1 (100%) 1/1 (100%) 0/1 (0%) 3/3 (100%) |5/6 (83%) 4/4 (100%) 3/3 (100%) 2/2 (100%) | |FIRST INCIDENCE | 733 (T) 685 504 672 |614 610 735 (T) 707 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.192 P=0.480 P=0.546 P=0.256 |P=0.417N P=0.300N P=0.142N P=0.438N | |POLY 3 | P=0.262 P=0.569 P=0.715 P=0.380 |P=0.302N P=0.758 P=0.522N P=0.459N | |POLY 1.5 | P=0.234 P=0.533 P=0.693 P=0.329 |P=0.339N P=0.685 P=0.496N P=0.504N | |POLY 6 | P=0.317 P=0.650 P=0.755 P=0.507 |P=0.279N P=0.764N P=0.593N P=0.430N | |LOGISTIC REGRESSION| P=0.200 (e) P=0.787 P=0.265 |P=0.142N P=0.735N P=0.338N P=0.291N | |COCH-ARM / FISHERS | P=0.202 P=0.500 P=0.700 P=0.286 |P=0.396N P=0.593 P=0.472N P=0.561N | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 14 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/48 (13%) 4/50 (8%) 3/50 (6%) 5/50 (10%) |6/50 (12%) 7/49 (14%) 13/50 (26%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 14.2% 9.8% 6.5% 11.0% |13.3% 15.5% 27.7% 30.0% | |TERMINAL (d) | 5/31 (16%) 3/27 (11%) 1/40 (3%) 4/38 (11%) |3/34 (9%) 6/37 (16%) 7/35 (20%) 4/32 (13%) | |FIRST INCIDENCE | 516 476 516 723 |664 708 666 502 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.325N P=0.443N P=0.171N P=0.372N |P=0.015 * P=0.564 P=0.091 P=0.048 * | |POLY 3 | P=0.405N P=0.394N P=0.201N P=0.448N |P=0.018 * P=0.501 P=0.072 P=0.043 * | |POLY 1.5 | P=0.422N P=0.373N P=0.212N P=0.458N |P=0.017 * P=0.496 P=0.068 P=0.041 * | |POLY 6 | P=0.385N P=0.418N P=0.183N P=0.436N |P=0.020 * P=0.508 P=0.076 P=0.047 * | |LOGISTIC REGRESSION| P=0.449N P=0.356N P=0.227N P=0.444N |P=0.017 * P=0.511 P=0.067 P=0.041 * | |COCH-ARM / FISHERS | P=0.445N P=0.344N P=0.223N P=0.471N |P=0.017 * P=0.484 P=0.062 P=0.039 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/49 (2%) 3/50 (6%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 2.4% 2.5% 0.0% 4.4% |0.0% 2.2% 6.4% 6.9% | |TERMINAL (d) | 1/31 (3%) 0/27 (0%) 0/40 (0%) 1/38 (3%) |0/34 (0%) 1/37 (3%) 0/35 (0%) 3/32 (9%) | |FIRST INCIDENCE | 733 (T) 706 --- 723 |--- 735 (T) 502 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.442 P=0.735 P=0.449N P=0.570 |P=0.058 P=0.517 P=0.132 P=0.110 | |POLY 3 | P=0.395 P=0.752 P=0.485N P=0.531 |P=0.063 P=0.502 P=0.129 P=0.115 | |POLY 1.5 | P=0.387 P=0.759 P=0.489N P=0.524 |P=0.065 P=0.500 P=0.126 P=0.117 | |POLY 6 | P=0.404 P=0.744 P=0.478N P=0.539 |P=0.060 P=0.506 P=0.133 P=0.112 | |LOGISTIC REGRESSION| P=0.414 P=0.744 (e) P=0.550 |P=0.073 P=0.517 P=0.056 P=0.110 | |COCH-ARM / FISHERS | P=0.375 P=0.742N P=0.490N P=0.515 |P=0.069 P=0.495 P=0.121 P=0.121 | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 15 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 1/50 (2%) 5/50 (10%) 2/50 (4%) |11/50 (22%) 10/49 (20%) 15/50 (30%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 2.4% 2.5% 11.1% 4.3% |24.6% 22.1% 32.4% 22.1% | |TERMINAL (d) | 1/31 (3%) 0/27 (0%) 4/40 (10%) 1/38 (3%) |10/34 (29%) 7/37 (19%) 12/35 (34%) 7/32 (22%) | |FIRST INCIDENCE | 733 (T) 706 715 589 |708 708 672 401 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.409 P=0.735 P=0.172 P=0.557 |P=0.483 P=0.410N P=0.280 P=0.550N | |POLY 3 | P=0.370 P=0.752 P=0.120 P=0.535 |P=0.513N P=0.486N P=0.276 P=0.489N | |POLY 1.5 | P=0.347 P=0.759 P=0.115 P=0.526 |P=0.508N P=0.499N P=0.268 P=0.489N | |POLY 6 | P=0.399 P=0.744 P=0.129 P=0.545 |P=0.524N P=0.464N P=0.285 P=0.490N | |LOGISTIC REGRESSION| P=0.347 P=0.744 P=0.142 P=0.506 |P=0.543 P=0.434N P=0.277 P=0.509N | |COCH-ARM / FISHERS | P=0.314 P=0.742N P=0.112 P=0.515 |P=0.515N P=0.521N P=0.247 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/48 (10%) 3/50 (6%) 6/50 (12%) 10/50 (20%) |16/50 (32%) 35/49 (71%) 32/50 (64%) 30/50 (60%) | |POLY-3 ADJUSTED (b)| 11.8% 7.5% 13.3% 21.5% |35.8% 72.6% 67.3% 60.9% | |TERMINAL (d) | 3/31 (10%) 3/27 (11%) 6/40 (15%) 8/38 (21%) |15/34 (44%) 27/37 (73%) 25/35 (71%) 16/32 (50%) | |FIRST INCIDENCE | 602 733 (T) 733 (T) 558 |708 463 524 401 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.104 P=0.436N P=0.601N P=0.225 |P=0.017 * P<0.001 ** P=0.002 ** P=0.006 ** | |POLY 3 | P=0.063 P=0.388N P=0.543 P=0.176 |P=0.071 P<0.001 ** P<0.001 ** P=0.011 * | |POLY 1.5 | P=0.054 P=0.365N P=0.534 P=0.165 |P=0.048 * P<0.001 ** P<0.001 ** P=0.007 ** | |POLY 6 | P=0.074 P=0.417N P=0.559 P=0.188 |P=0.112 P<0.001 ** P=0.002 ** P=0.017 * | |LOGISTIC REGRESSION| P=0.060 P=0.384N P=0.555 P=0.151 |P=0.027 * P<0.001 ** P=0.002 ** P=0.005 ** | |COCH-ARM / FISHERS | P=0.044 * P=0.335N P=0.529 P=0.150 |P=0.028 * P<0.001 ** P<0.001 ** P=0.004 ** | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 16 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 5/50 (10%) 6/50 (12%) 9/50 (18%) |7/50 (14%) 11/49 (22%) 16/50 (32%) 21/50 (42%) | |POLY-3 ADJUSTED (b)| 4.8% 12.0% 13.1% 19.3% |15.5% 24.2% 33.2% 44.6% | |TERMINAL (d) | 2/31 (7%) 2/27 (7%) 4/40 (10%) 4/38 (11%) |4/34 (12%) 10/37 (27%) 9/35 (26%) 9/32 (28%) | |FIRST INCIDENCE | 733 (T) 402 516 589 |664 672 502 502 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.057 P=0.182 P=0.218 P=0.059 |P<0.001 ** P=0.282 P=0.048 * P=0.004 ** | |POLY 3 | P=0.033 * P=0.215 P=0.164 P=0.040 * |P<0.001 ** P=0.217 P=0.038 * P=0.002 ** | |POLY 1.5 | P=0.027 * P=0.223 P=0.155 P=0.035 * |P<0.001 ** P=0.213 P=0.034 * P<0.001 ** | |POLY 6 | P=0.040 * P=0.207 P=0.180 P=0.046 * |P<0.001 ** P=0.224 P=0.043 * P=0.002 ** | |LOGISTIC REGRESSION| P=0.019 * P=0.266 P=0.151 P=0.033 * |P<0.001 ** P=0.228 P=0.026 * P=0.002 ** | |COCH-ARM / FISHERS | P=0.022 * P=0.235 P=0.148 P=0.030 * |P<0.001 ** P=0.204 P=0.028 * P=0.002 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Nose: Turbinate | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 3/49 (6%) 1/50 (2%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.4% 0.0% |0.0% 6.6% 2.2% 8.8% | |TERMINAL (d) | 0/31 (0%) 0/27 (0%) 1/40 (3%) 0/38 (0%) |0/34 (0%) 2/37 (5%) 0/35 (0%) 1/32 (3%) | |FIRST INCIDENCE | --- --- 516 --- |--- 708 704 502 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.625 (e) P=0.265 (e) |P=0.064 P=0.141 P=0.511 P=0.061 | |POLY 3 | P=0.639 (e) P=0.258 (e) |P=0.074 P=0.121 P=0.506 P=0.062 | |POLY 1.5 | P=0.624 (e) P=0.252 (e) |P=0.074 P=0.119 P=0.504 P=0.062 | |POLY 6 | P=0.656 (e) P=0.267 (e) |P=0.075 P=0.125 P=0.508 P=0.063 | |LOGISTIC REGRESSION| P=0.576 (e) P=0.247 (e) |P=0.078 P=0.125 P=0.500 P=0.053 | |COCH-ARM / FISHERS | P=0.602 (e) P=0.258 (e) |P=0.073 P=0.117 P=0.500 P=0.059 | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 17 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |16/49 (33%) 12/47 (26%) 18/49 (37%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| |35.8% 27.2% 38.8% 40.0% | |TERMINAL (d) | |13/34 (38%) 11/36 (31%) 13/35 (37%) 14/32 (44%) | |FIRST INCIDENCE | |532 672 524 502 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.169 P=0.197N P=0.462 P=0.351 | |POLY 3 | |P=0.247 P=0.259N P=0.469 P=0.425 | |POLY 1.5 | |P=0.262 P=0.270N P=0.453 P=0.437 | |POLY 6 | |P=0.230 P=0.244N P=0.486 P=0.411 | |LOGISTIC REGRESSION| |P=0.243 P=0.240N P=0.450 P=0.419 | |COCH-ARM / FISHERS | |P=0.277 P=0.294N P=0.416 P=0.445 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Pancreas: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/47 (0%) 0/49 (0%) 1/50 (2%) 0/48 (0%) |1/50 (2%) 0/48 (0%) 2/49 (4%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% 0.0% |2.2% 0.0% 4.4% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/27 (0%) 1/40 (3%) 0/38 (0%) |1/34 (3%) 0/37 (0%) 2/35 (6%) 0/32 (0%) | |FIRST INCIDENCE | --- --- 733 (T) --- |735 (T) --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.728 (e) P=0.551 (e) |P=0.483N P=0.483N P=0.510 P=0.512N | |POLY 3 | P=0.733 (e) P=0.519 (e) |P=0.477N P=0.499N P=0.504 P=0.507N | |POLY 1.5 | P=0.720 (e) P=0.515 (e) |P=0.471N P=0.502N P=0.501 P=0.506N | |POLY 6 | P=0.746 (e) P=0.526 (e) |P=0.483N P=0.494N P=0.507 P=0.509N | |LOGISTIC REGRESSION| (e) (e) P=0.551 (e) |P=0.483N (e) P=0.510 (e) | |COCH-ARM / FISHERS | P=0.698 (e) P=0.515 (e) |P=0.463N P=0.510N P=0.492 P=0.505N | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 18 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/46 (4%) 1/47 (2%) 2/48 (4%) 4/47 (9%) |19/49 (39%) 24/49 (49%) 23/49 (47%) 28/50 (56%) | |POLY-3 ADJUSTED (b)| 5.0% 2.6% 4.7% 9.1% |41.6% 50.6% 49.2% 61.1% | |TERMINAL (d) | 1/30 (3%) 1/27 (4%) 2/38 (5%) 4/37 (11%) |14/34 (41%) 18/37 (49%) 16/35 (46%) 20/32 (63%) | |FIRST INCIDENCE | 684 733 (T) 733 (T) 733 (T) |507 463 570 502 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.248 P=0.541N P=0.617N P=0.425 |P=0.037 * P=0.329 P=0.334 P=0.046 * | |POLY 3 | P=0.200 P=0.517N P=0.667N P=0.381 |P=0.046 * P=0.253 P=0.299 P=0.045 * | |POLY 1.5 | P=0.188 P=0.507N P=0.674N P=0.368 |P=0.055 P=0.238 P=0.293 P=0.052 | |POLY 6 | P=0.213 P=0.527N P=0.656N P=0.393 |P=0.038 * P=0.274 P=0.305 P=0.038 * | |LOGISTIC REGRESSION| P=0.225 P=0.522N P=0.660N P=0.400 |P=0.060 P=0.211 P=0.293 P=0.052 | |COCH-ARM / FISHERS | P=0.168 P=0.492N P=0.675N P=0.349 |P=0.069 P=0.208 P=0.270 P=0.065 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 2/49 (4%) 2/50 (4%) 0/47 (0%) | | |POLY-3 ADJUSTED (b)| 4.8% 5.1% 4.4% 0.0% | | |TERMINAL (d) | 1/31 (3%) 1/27 (4%) 2/40 (5%) 0/36 (0%) | | |FIRST INCIDENCE | 716 588 733 (T) --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.123N P=0.649 P=0.603N P=0.206N | | |POLY 3 | P=0.150N P=0.675 P=0.667N P=0.231N | | |POLY 1.5 | P=0.157N P=0.685 P=0.674N P=0.235N | | |POLY 6 | P=0.142N P=0.664 P=0.655N P=0.226N | | |LOGISTIC REGRESSION| P=0.154N P=0.689 P=0.641N P=0.223N | | |COCH-ARM / FISHERS | P=0.166N P=0.684N P=0.676N P=0.253N | | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 19 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Skin: Prepuce | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/48 (13%) 7/50 (14%) 4/50 (8%) 5/48 (10%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 13.7% 16.3% 8.9% 10.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/31 (7%) 2/27 (7%) 2/40 (5%) 1/37 (3%) |0/34 (0%) 0/37 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE | 359 420 702 327 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.267N P=0.441 P=0.280N P=0.439N |(e) (e) (e) (e) | |POLY 3 | P=0.314N P=0.487 P=0.348N P=0.463N |(e) (e) (e) (e) | |POLY 1.5 | P=0.332N P=0.503 P=0.351N P=0.478N |(e) (e) (e) (e) | |POLY 6 | P=0.294N P=0.469 P=0.337N P=0.446N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.484N P=0.556N P=0.350N P=0.613 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.356N P=0.532 P=0.344N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 12/48 (25%) 14/48 (29%) 12/50 (24%) 7/48 (15%) |11/50 (22%) 8/48 (17%) 8/48 (17%) 12/49 (24%) | |POLY-3 ADJUSTED (b)| 27.0% 30.9% 25.5% 14.9% |22.9% 17.1% 17.6% 26.2% | |TERMINAL (d) | 2/31 (7%) 1/27 (4%) 8/40 (20%) 1/38 (3%) |2/34 (6%) 3/37 (8%) 4/35 (11%) 3/32 (9%) | |FIRST INCIDENCE | 532 402 492 504 |248 492 570 401 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.055N P=0.335 P=0.425N P=0.121N |P=0.335 P=0.280N P=0.296N P=0.472 | |POLY 3 | P=0.062N P=0.431 P=0.529N P=0.123N |P=0.325 P=0.329N P=0.354N P=0.444 | |POLY 1.5 | P=0.070N P=0.425 P=0.539N P=0.132N |P=0.338 P=0.334N P=0.349N P=0.457 | |POLY 6 | P=0.056N P=0.433 P=0.516N P=0.114N |P=0.313 P=0.322N P=0.360N P=0.434 | |LOGISTIC REGRESSION| P=0.229N P=0.595 P=0.568N P=0.303N |P=0.451 P=0.513N P=0.461N P=0.539 | |COCH-ARM / FISHERS | P=0.085N P=0.409 P=0.547N P=0.153N |P=0.359 P=0.341N P=0.341N P=0.478 | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 20 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Spleen | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 2/48 (4%) 0/50 (0%) 0/48 (0%) |4/50 (8%) 2/48 (4%) 1/48 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 5.0% 0.0% 0.0% |9.0% 4.5% 2.2% 0.0% | |TERMINAL (d) | 0/31 (0%) 1/27 (4%) 0/40 (0%) 0/38 (0%) |4/34 (12%) 2/37 (5%) 1/35 (3%) 0/32 (0%) | |FIRST INCIDENCE | --- 402 --- --- |735 (T) 735 (T) 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.378N P=0.225 (e) (e) |P=0.032N* P=0.298N P=0.170N P=0.070N | |POLY 3 | P=0.397N P=0.226 (e) (e) |P=0.032N* P=0.334N P=0.179N P=0.065N | |POLY 1.5 | P=0.399N P=0.231 (e) (e) |P=0.031N* P=0.342N P=0.183N P=0.064N | |POLY 6 | P=0.395N P=0.222 (e) (e) |P=0.032N* P=0.324N P=0.174N P=0.065N | |LOGISTIC REGRESSION| P=0.495N P=0.287 (e) (e) |P=0.032N* P=0.298N P=0.170N (e) | |COCH-ARM / FISHERS | P=0.404N P=0.247 (e) (e) |P=0.031N* P=0.359N P=0.194N P=0.061N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 1/49 (2%) 1/50 (2%) 0/48 (0%) |1/50 (2%) 0/49 (0%) 1/48 (2%) 1/48 (2%) | |POLY-3 ADJUSTED (b)| 4.8% 2.5% 2.2% 0.0% |2.2% 0.0% 2.2% 2.3% | |TERMINAL (d) | 2/31 (7%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |1/34 (3%) 0/37 (0%) 0/35 (0%) 1/32 (3%) | |FIRST INCIDENCE | 733 (T) 364 516 --- |735 (T) --- 640 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.132N P=0.530N P=0.444N P=0.195N |P=0.519 P=0.483N P=0.752N P=0.748 | |POLY 3 | P=0.138N P=0.512N P=0.468N P=0.221N |P=0.523 P=0.498N P=0.759N P=0.752 | |POLY 1.5 | P=0.143N P=0.504N P=0.477N P=0.227N |P=0.526 P=0.500N P=0.758 P=0.752 | |POLY 6 | P=0.131N P=0.522N P=0.454N P=0.214N |P=0.519 P=0.494N P=0.755N P=0.751 | |LOGISTIC REGRESSION| P=0.201N P=0.434N P=0.489N (e) |P=0.529 (e) P=0.744 P=0.748 | |COCH-ARM / FISHERS | P=0.151N P=0.492N P=0.485N P=0.247N |P=0.529 P=0.505N P=0.742 P=0.742 | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 21 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 1/49 (2%) 0/50 (0%) 0/48 (0%) |0/50 (0%) 1/49 (2%) 2/48 (4%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 4.8% 2.5% 0.0% 0.0% |0.0% 2.2% 4.5% 0.0% | |TERMINAL (d) | 1/31 (3%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |0/34 (0%) 1/37 (3%) 1/35 (3%) 0/32 (0%) | |FIRST INCIDENCE | 626 364 --- --- |--- 735 (T) 640 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.089N P=0.525N P=0.207N P=0.208N |P=0.637N P=0.517 P=0.248 (e) | |POLY 3 | P=0.094N P=0.516N P=0.222N P=0.223N |P=0.627N P=0.502 P=0.238 (e) | |POLY 1.5 | P=0.096N P=0.506N P=0.225N P=0.228N |P=0.625N P=0.500 P=0.235 (e) | |POLY 6 | P=0.092N P=0.528N P=0.216N P=0.218N |P=0.629N P=0.506 P=0.243 (e) | |LOGISTIC REGRESSION| P=0.122N P=0.405N P=0.230N P=0.256N |P=0.626N P=0.517 P=0.213 (e) | |COCH-ARM / FISHERS | P=0.099N P=0.492N P=0.237N P=0.247N |P=0.626N P=0.495 P=0.237 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Infiltration Cellular Mixed Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/46 (0%) 2/47 (4%) 0/50 (0%) 0/48 (0%) |0/50 (0%) 0/48 (0%) 1/48 (2%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 5.3% 0.0% 0.0% |0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 0/31 (0%) 2/27 (7%) 0/40 (0%) 0/38 (0%) |0/34 (0%) 0/37 (0%) 1/35 (3%) 0/32 (0%) | |FIRST INCIDENCE | --- 733 (T) --- --- |--- --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.350N P=0.208 (e) (e) |P=0.686 (e) P=0.506 (e) | |POLY 3 | P=0.396N P=0.224 (e) (e) |P=0.682 (e) P=0.500 (e) | |POLY 1.5 | P=0.395N P=0.231 (e) (e) |P=0.686 (e) P=0.497 (e) | |POLY 6 | P=0.398N P=0.216 (e) (e) |P=0.677 (e) P=0.502 (e) | |LOGISTIC REGRESSION| (e) P=0.208 (e) (e) |(e) (e) P=0.506 (e) | |COCH-ARM / FISHERS | P=0.395N P=0.253 (e) (e) |P=0.690 (e) P=0.490 (e) | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 22 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 14/48 (29%) 9/49 (18%) 11/49 (22%) 19/49 (39%) |26/50 (52%) 24/48 (50%) 30/50 (60%) 37/50 (74%) | |POLY-3 ADJUSTED (b)| 33.6% 22.9% 25.0% 42.1% |56.7% 53.4% 63.8% 82.4% | |TERMINAL (d) | 13/31 (42%) 8/27 (30%) 10/39 (26%) 18/38 (47%) |22/34 (65%) 23/37 (62%) 25/35 (71%) 29/32 (91%) | |FIRST INCIDENCE | 723 723 715 672 |614 714 570 631 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.279 P=0.270N P=0.122N P=0.435 |P<0.001 ** P=0.258N P=0.336 P=0.008 ** | |POLY 3 | P=0.124 P=0.204N P=0.261N P=0.273 |P=0.002 ** P=0.456N P=0.311 P=0.004 ** | |POLY 1.5 | P=0.103 P=0.183N P=0.282N P=0.248 |P=0.003 ** P=0.467N P=0.304 P=0.008 ** | |POLY 6 | P=0.153 P=0.229N P=0.226N P=0.310 |P<0.001 ** P=0.443N P=0.313 P=0.002 ** | |LOGISTIC REGRESSION| P=0.209 P=0.256N P=0.141N P=0.353 |P<0.001 ** P=0.346N P=0.331 P=0.004 ** | |COCH-ARM / FISHERS | P=0.082 P=0.156N P=0.300N P=0.217 |P=0.007 ** P=0.502N P=0.273 P=0.019 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Tooth | | Developmental Malformation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 12/13 (92%) 17/17 (100%) 10/10 (100%) 19/19 (100%)|0/0 (0%) 1/1 (100%) 0/0 (0%) 1/1 (100%) | |POLY-3 ADJUSTED (b)| 92.3% 100.0% 100.0% 100.0% |0.0% 100.0% 0.0% 100.0% | |TERMINAL (d) | 9/10 (90%) 14/14 (100%) 9/9 (100%) 17/17 (100%)|0/0 (0%) 1/1 (100%) 0/0 (0%) 1/1 (100%) | |FIRST INCIDENCE | 602 666 504 558 |--- 735 (T) --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.437N P=0.419 P=0.445N P=0.648N |(e) (e) (e) (e) | |POLY 3 | P=0.278 P=0.446 P=0.552 P=0.424 |(e) (e) (e) (e) | |POLY 1.5 | P=0.278 P=0.446 P=0.552 P=0.424 |(e) (e) (e) (e) | |POLY 6 | P=0.278 P=0.446 P=0.552 P=0.424 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.278 P=0.433 P=0.565 P=0.406 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 23 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Tooth | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/13 (15%) 0/17 (0%) 0/10 (0%) 1/19 (5%) |0/0 (0%) 0/1 (0%) 0/0 (0%) 0/1 (0%) | |POLY-3 ADJUSTED (b)| 15.5% 0.0% 0.0% 5.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/10 (10%) 0/14 (0%) 0/9 (0%) 0/17 (0%) |0/0 (0%) 0/1 (0%) 0/0 (0%) 0/1 (0%) | |FIRST INCIDENCE | 602 --- --- 723 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.394N P=0.222N P=0.246N P=0.414N |(e) (e) (e) (e) | |POLY 3 | P=0.387N P=0.174N P=0.308N P=0.373N |(e) (e) (e) (e) | |POLY 1.5 | P=0.388N P=0.173N P=0.302N P=0.371N |(e) (e) (e) (e) | |POLY 6 | P=0.385N P=0.177N P=0.312N P=0.375N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.367N P=0.287N P=0.207N P=0.358N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.389N P=0.179N P=0.308N P=0.356N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Urinary Bladder | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/47 (6%) 1/48 (2%) 1/50 (2%) 1/47 (2%) |0/48 (0%) 0/48 (0%) 0/48 (0%) 0/47 (0%) | |POLY-3 ADJUSTED (b)| 7.1% 2.6% 2.2% 2.2% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/27 (0%) 1/40 (3%) 0/38 (0%) |0/34 (0%) 0/37 (0%) 0/35 (0%) 0/31 (0%) | |FIRST INCIDENCE | 454 706 733 (T) 504 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.212N P=0.345N P=0.274N P=0.295N |(e) (e) (e) (e) | |POLY 3 | P=0.214N P=0.338N P=0.282N P=0.283N |(e) (e) (e) (e) | |POLY 1.5 | P=0.224N P=0.322N P=0.285N P=0.291N |(e) (e) (e) (e) | |POLY 6 | P=0.204N P=0.357N P=0.277N P=0.276N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.322N P=0.239N P=0.278N P=0.629N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.240N P=0.301N P=0.285N P=0.308N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 24 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Uterus | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 1/48 (2%) 1/49 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| |4.5% 2.2% 2.2% 0.0% | |TERMINAL (d) | |2/34 (6%) 1/37 (3%) 1/35 (3%) 0/32 (0%) | |FIRST INCIDENCE | |735 (T) 735 (T) 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.163N P=0.470N P=0.490N P=0.252N | |POLY 3 | |P=0.161N P=0.498N P=0.496N P=0.245N | |POLY 1.5 | |P=0.159N P=0.504N P=0.499N P=0.244N | |POLY 6 | |P=0.163N P=0.490N P=0.493N P=0.246N | |LOGISTIC REGRESSION| |P=0.163N P=0.470N P=0.490N (e) | |COCH-ARM / FISHERS | |P=0.155N P=0.515N P=0.508N P=0.253N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |3/50 (6%) 7/48 (15%) 3/49 (6%) 5/49 (10%) | |POLY-3 ADJUSTED (b)| |6.7% 15.6% 6.6% 11.6% | |TERMINAL (d) | |2/34 (6%) 7/37 (19%) 3/35 (9%) 4/32 (13%) | |FIRST INCIDENCE | |614 735 (T) 735 (T) 685 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.412 P=0.189 P=0.649N P=0.329 | |POLY 3 | |P=0.445 P=0.155 P=0.661N P=0.333 | |POLY 1.5 | |P=0.453 P=0.151 P=0.661 P=0.339 | |POLY 6 | |P=0.438 P=0.161 P=0.660N P=0.328 | |LOGISTIC REGRESSION| |P=0.433 P=0.162 P=0.663N P=0.338 | |COCH-ARM / FISHERS | |P=0.461 P=0.142 P=0.651 P=0.346 | |=================================================================================================================================| Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 25 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - GLUTARALDEHYDE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB | | | | | |=================================================================================================================================| | | |Uterus | | Infiltration Cellular Polymorphonuclear | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |3/50 (6%) 1/48 (2%) 0/49 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| |6.5% 2.2% 0.0% 2.3% | |TERMINAL (d) | |0/34 (0%) 1/37 (3%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE | |248 735 (T) --- 701 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.212N P=0.288N P=0.120N P=0.317N | |POLY 3 | |P=0.206N P=0.314N P=0.122N P=0.328N | |POLY 1.5 | |P=0.205N P=0.317N P=0.122N P=0.323N | |POLY 6 | |P=0.208N P=0.309N P=0.122N P=0.333N | |LOGISTIC REGRESSION| |P=0.214N P=0.464N P=0.217N P=0.325N | |COCH-ARM / FISHERS | |P=0.203N P=0.324N P=0.125N P=0.316N | |=================================================================================================================================| (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).