TDMS Study 93026-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest DECALIN DATE: 08/28/01 EXPERIMENT: 93026 TEST: 07 TIME: 09:21:58 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C93026 PATHOLOGIST: RENNE, ROGER CAS: 91-17-8 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#1/RATS REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 002 CONTROL INCLUDE 004 25 PPM INCLUDE 007 100 PPM INCLUDE 009 400 PPM NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest DECALIN DATE: 08/28/01 EXPERIMENT: 93026 TEST: 07 TIME: 09:21:58 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C93026 PATHOLOGIST: RENNE, ROGER CAS: 91-17-8 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF DECALIN =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Brain Hemorrhage Eye Atrophy Eye: Lens Cataract Kidney Nephropathy Chronic Kidney: Pelvis Mineralization Larynx Foreign Body Inflammation Lung: Alveolus Infiltration Cellular Histiocyte Proteinosis Lung: Interstitium Fibrosis Pleura Inflammation Chronic Spleen Fibrosis Thyroid Gland: C-Cell Hyperplasia =============================================================== Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 0/48 (0%) 2/49 (4%) 2/49 (4%) | |POLY-3 RATE (b) | 3/44.73 0/45.50 2/46.14 2/40.74 | |POLY-3 PERCENT (g) | 6.7% 0.0% 4.3% 4.9% | |TERMINAL (d) | 2/32 (6%) 0/35 (0%) 2/39 (5%) 2/28 (7%) | |FIRST INCIDENCE | 680 --- 734 (T) 734 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.486 P=0.107N P=0.420N P=0.558N | |POLY 3 | P=0.510 P=0.116N P=0.486N P=0.543N | |POLY 1.5 | P=0.533 P=0.120N P=0.496N P=0.527N | |POLY 6 | P=0.480 P=0.110N P=0.472N P=0.563N | |LOGISTIC REGRESSION| P=0.486 P=0.118N P=0.472N P=0.566N | |COCH-ARM / FISHERS | P=0.565 P=0.129N P=0.510N P=0.510N | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/50 (14%) 7/48 (15%) 11/49 (22%) 8/49 (16%) | |POLY-3 RATE (b) | 7/44.73 7/45.91 11/46.14 8/41.55 | |POLY-3 PERCENT (g) | 15.7% 15.3% 23.8% 19.3% | |TERMINAL (d) | 6/32 (19%) 4/35 (11%) 11/39 (28%) 5/28 (18%) | |FIRST INCIDENCE | 680 638 734 (T) 634 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.309 P=0.536N P=0.367 P=0.389 | |POLY 3 | P=0.405 P=0.593N P=0.237 P=0.438 | |POLY 1.5 | P=0.446 P=0.613 P=0.222 P=0.458 | |POLY 6 | P=0.357 P=0.566N P=0.258 P=0.415 | |LOGISTIC REGRESSION| P=0.348 P=0.585N P=0.309 P=0.403 | |COCH-ARM / FISHERS | P=0.501 P=0.581 P=0.204 P=0.483 | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 2/48 (4%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 3/44.85 2/45.50 0/46.14 0/40.74 | |POLY-3 PERCENT (g) | 6.7% 4.4% 0.0% 0.0% | |TERMINAL (d) | 1/32 (3%) 2/35 (6%) 0/39 (0%) 0/28 (0%) | |FIRST INCIDENCE | 666 734 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.121N P=0.464N P=0.103N P=0.160N | |POLY 3 | P=0.109N P=0.493N P=0.114N P=0.136N | |POLY 1.5 | P=0.104N P=0.503N P=0.117N P=0.130N | |POLY 6 | P=0.115N P=0.482N P=0.109N P=0.146N | |LOGISTIC REGRESSION| P=0.105N P=0.498N P=0.124N P=0.132N | |COCH-ARM / FISHERS | P=0.098N P=0.520N P=0.125N P=0.125N | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Brain | | Compression | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 6/50 (12%) 5/49 (10%) 6/49 (12%) 3/50 (6%) | |POLY-3 RATE (b) | 6/46.18 5/45.84 6/46.58 3/42.76 | |POLY-3 PERCENT (g) | 13.0% 10.9% 12.9% 7.0% | |TERMINAL (d) | 2/32 (6%) 4/35 (11%) 4/39 (10%) 0/28 (0%) | |FIRST INCIDENCE | 525 728 665 538 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.309N P=0.448N P=0.527N P=0.311N | |POLY 3 | P=0.254N P=0.505N P=0.615N P=0.281N | |POLY 1.5 | P=0.232N P=0.508N P=0.617 P=0.264N | |POLY 6 | P=0.283N P=0.500N P=0.600N P=0.304N | |LOGISTIC REGRESSION| P=0.156N P=0.570N P=0.554 P=0.175N | |COCH-ARM / FISHERS | P=0.203N P=0.514N P=0.606 P=0.243N | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 1/49 (2%) 3/49 (6%) 6/50 (12%) | |POLY-3 RATE (b) | 1/44.52 1/46.08 3/47.21 6/43.72 | |POLY-3 PERCENT (g) | 2.3% 2.2% 6.4% 13.7% | |TERMINAL (d) | 1/32 (3%) 0/35 (0%) 1/39 (3%) 0/28 (0%) | |FIRST INCIDENCE | 734 (T) 663 349 492 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.008 ** P=0.745N P=0.351 P=0.048 * | |POLY 3 | P=0.011 * P=0.753N P=0.327 P=0.052 | |POLY 1.5 | P=0.013 * P=0.758N P=0.315 P=0.054 | |POLY 6 | P=0.010 * P=0.746N P=0.341 P=0.051 | |LOGISTIC REGRESSION| P=0.040 * P=0.753 P=0.237 P=0.073 | |COCH-ARM / FISHERS | P=0.015 * P=0.747 P=0.301 P=0.056 | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Clitoral Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/48 (4%) 3/49 (6%) 2/49 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 2/43.41 3/45.92 2/46.14 1/41.60 | |POLY-3 PERCENT (g) | 4.6% 6.5% 4.3% 2.4% | |TERMINAL (d) | 2/31 (7%) 2/35 (6%) 2/39 (5%) 1/28 (4%) | |FIRST INCIDENCE | 734 (T) 708 734 (T) 734 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.376N P=0.558 P=0.610N P=0.536N | |POLY 3 | P=0.334N P=0.526 P=0.672N P=0.515N | |POLY 1.5 | P=0.317N P=0.518 P=0.679N P=0.503N | |POLY 6 | P=0.354N P=0.539 P=0.660N P=0.529N | |LOGISTIC REGRESSION| P=0.379N P=0.555 P=0.610N P=0.536N | |COCH-ARM / FISHERS | P=0.293N P=0.510 P=0.684N P=0.485N | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Clitoral Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/48 (6%) 3/49 (6%) 1/49 (2%) 3/50 (6%) | |POLY-3 RATE (b) | 3/43.66 3/45.84 1/46.14 3/41.60 | |POLY-3 PERCENT (g) | 6.9% 6.6% 2.2% 7.2% | |TERMINAL (d) | 2/31 (7%) 2/35 (6%) 1/39 (3%) 3/28 (11%) | |FIRST INCIDENCE | 666 728 734 (T) 734 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.476 P=0.610N P=0.242N P=0.609 | |POLY 3 | P=0.537 P=0.640N P=0.286N P=0.640 | |POLY 1.5 | P=0.557 P=0.646N P=0.292N P=0.657 | |POLY 6 | P=0.511 P=0.629N P=0.276N P=0.619 | |LOGISTIC REGRESSION| P=0.487 P=0.632N P=0.288N P=0.617 | |COCH-ARM / FISHERS | P=0.586 P=0.651N P=0.301N P=0.641N | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Eye | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/1 (0%) 2/2 (100%) 0/5 (0%) 0/4 (0%) | |POLY-3 RATE (b) | 0/1.00 2/2.00 0/4.75 0/3.46 | |POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 0.0% | |TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/4 (0%) 0/3 (0%) | |FIRST INCIDENCE | --- 638 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.434N P=0.253 (e) (e) | |POLY 3 | P<0.001N** P=1.000N (e) (e) | |POLY 1.5 | P<0.001N** P=1.000N (e) (e) | |POLY 6 | P<0.001N** P=1.000N (e) (e) | |LOGISTIC REGRESSION| P=0.129N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.221N P=0.333 (e) (e) | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Eye: Lens | | Cataract | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/1 (100%) 0/2 (0%) 3/5 (60%) 2/4 (50%) | |POLY-3 RATE (b) | 1/1.00 0/1.39 3/5.00 2/3.46 | |POLY-3 PERCENT (g) | 100.0% 0.0% 60.0% 57.8% | |TERMINAL (d) | 1/1 (100%) 0/0 (0%) 2/4 (50%) 2/3 (67%) | |FIRST INCIDENCE | 734 (T) --- 666 734 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.683N P=1.000N P=0.743 P=0.718N | |POLY 3 | P=0.710 P<0.001N** P=0.631N P=0.652N | |POLY 1.5 | P=0.690 P<0.001N** P=0.631N P=0.618N | |POLY 6 | P=0.700N P=0.574N P=0.631N P=0.691N | |LOGISTIC REGRESSION| P=0.732 (e) (e) P=0.718N | |COCH-ARM / FISHERS | P=0.674 P=0.333N P=0.667N P=0.600N | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Heart: Atrium | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 2/44.52 2/46.62 1/46.35 0/41.60 | |POLY-3 PERCENT (g) | 4.5% 4.3% 2.2% 0.0% | |TERMINAL (d) | 2/32 (6%) 0/35 (0%) 0/39 (0%) 0/28 (0%) | |FIRST INCIDENCE | 734 (T) 722 680 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.192N P=0.642N P=0.443N P=0.268N | |POLY 3 | P=0.175N P=0.677N P=0.486N P=0.252N | |POLY 1.5 | P=0.167N P=0.684N P=0.495N P=0.245N | |POLY 6 | P=0.185N P=0.668N P=0.473N P=0.262N | |LOGISTIC REGRESSION| P=0.171N P=0.661N P=0.494N (e) | |COCH-ARM / FISHERS | P=0.156N P=0.691N P=0.508N P=0.247N | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/46 (4%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 1/44.52 2/43.79 1/46.14 0/41.60 | |POLY-3 PERCENT (g) | 2.3% 4.6% 2.2% 0.0% | |TERMINAL (d) | 1/32 (3%) 2/35 (6%) 1/39 (3%) 0/28 (0%) | |FIRST INCIDENCE | 734 (T) 734 (T) 734 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.275N P=0.531 P=0.717N P=0.527N | |POLY 3 | P=0.251N P=0.494 P=0.753N P=0.514N | |POLY 1.5 | P=0.242N P=0.485 P=0.758N P=0.507N | |POLY 6 | P=0.262N P=0.507 P=0.745N P=0.522N | |LOGISTIC REGRESSION| P=0.275N P=0.531 P=0.717N (e) | |COCH-ARM / FISHERS | P=0.231N P=0.468 P=0.747 P=0.500N | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 43/50 (86%) 45/46 (98%) 48/49 (98%) 48/50 (96%) | |POLY-3 RATE (b) | 43/47.48 45/46.00 48/48.11 48/49.14 | |POLY-3 PERCENT (g) | 90.6% 97.8% 99.8% 97.7% | |TERMINAL (d) | 31/32 (97%) 34/35 (97%) 39/39 (100%) 28/28 (100%) | |FIRST INCIDENCE | 561 533 617 492 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** P=0.421N P=0.343N P=0.042 * | |POLY 3 | P=0.245 P=0.122 P=0.029 * P=0.114 | |POLY 1.5 | P=0.231 P=0.076 P=0.024 * P=0.094 | |POLY 6 | P=0.273 P=0.218 P=0.052 P=0.156 | |LOGISTIC REGRESSION| P=0.057 P=0.110 P=0.068 P=0.027 * | |COCH-ARM / FISHERS | P=0.223 P=0.039 * P=0.032 * P=0.080 | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Kidney: Cortex, Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 4/46 (9%) 4/49 (8%) 2/50 (4%) | |POLY-3 RATE (b) | 1/44.52 4/43.79 4/46.19 2/41.60 | |POLY-3 PERCENT (g) | 2.3% 9.1% 8.7% 4.8% | |TERMINAL (d) | 1/32 (3%) 4/35 (11%) 3/39 (8%) 2/28 (7%) | |FIRST INCIDENCE | 734 (T) 734 (T) 722 734 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.617N P=0.206 P=0.245 P=0.453 | |POLY 3 | P=0.537N P=0.173 P=0.190 P=0.476 | |POLY 1.5 | P=0.514N P=0.166 P=0.182 P=0.487 | |POLY 6 | P=0.567N P=0.184 P=0.201 P=0.462 | |LOGISTIC REGRESSION| P=0.621 P=0.206 P=0.220 P=0.453 | |COCH-ARM / FISHERS | P=0.485N P=0.156 P=0.175 P=0.500 | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Kidney: Papilla | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 2/46 (4%) 4/49 (8%) 4/50 (8%) | |POLY-3 RATE (b) | 3/44.95 2/43.79 4/46.14 4/41.92 | |POLY-3 PERCENT (g) | 6.7% 4.6% 8.7% 9.5% | |TERMINAL (d) | 1/32 (3%) 2/35 (6%) 4/39 (10%) 3/28 (11%) | |FIRST INCIDENCE | 666 734 (T) 734 (T) 644 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.254 P=0.463N P=0.588 P=0.426 | |POLY 3 | P=0.324 P=0.512N P=0.514 P=0.462 | |POLY 1.5 | P=0.351 P=0.522N P=0.503 P=0.479 | |POLY 6 | P=0.291 P=0.499N P=0.528 P=0.439 | |LOGISTIC REGRESSION| P=0.315 P=0.534N P=0.514 P=0.472 | |COCH-ARM / FISHERS | P=0.385 P=0.540N P=0.489 P=0.500 | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Kidney: Pelvis | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/50 (22%) 16/46 (35%) 19/49 (39%) 18/50 (36%) | |POLY-3 RATE (b) | 11/46.35 16/43.97 19/46.19 18/43.66 | |POLY-3 PERCENT (g) | 23.7% 36.4% 41.1% 41.2% | |TERMINAL (d) | 5/32 (16%) 13/35 (37%) 18/39 (46%) 14/28 (50%) | |FIRST INCIDENCE | 525 706 722 478 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.048 * P=0.279 P=0.176 P=0.053 | |POLY 3 | P=0.135 P=0.138 P=0.056 P=0.057 | |POLY 1.5 | P=0.173 P=0.132 P=0.055 P=0.072 | |POLY 6 | P=0.092 P=0.145 P=0.057 P=0.039 * | |LOGISTIC REGRESSION| P=0.138 P=0.130 P=0.066 P=0.091 | |COCH-ARM / FISHERS | P=0.224 P=0.122 P=0.055 P=0.093 | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Kidney: Pelvis, Transitional Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/46 (4%) 2/49 (4%) 2/50 (4%) | |POLY-3 RATE (b) | 0/44.52 2/43.86 2/46.14 2/41.60 | |POLY-3 PERCENT (g) | 0.0% 4.6% 4.3% 4.8% | |TERMINAL (d) | 0/32 (0%) 0/35 (0%) 2/39 (5%) 2/28 (7%) | |FIRST INCIDENCE | --- 722 734 (T) 734 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.300 P=0.274 P=0.283 P=0.209 | |POLY 3 | P=0.361 P=0.234 P=0.245 P=0.222 | |POLY 1.5 | P=0.378 P=0.228 P=0.240 P=0.229 | |POLY 6 | P=0.339 P=0.242 P=0.253 P=0.213 | |LOGISTIC REGRESSION| P=0.302 P=0.241 P=0.283 P=0.209 | |COCH-ARM / FISHERS | P=0.400 P=0.227 P=0.242 P=0.247 | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Larynx | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/49 (0%) 3/48 (6%) | |POLY-3 RATE (b) | 0/44.52 1/45.86 0/46.14 3/41.05 | |POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 7.3% | |TERMINAL (d) | 0/32 (0%) 0/35 (0%) 0/39 (0%) 1/28 (4%) | |FIRST INCIDENCE | --- 722 --- 580 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.027 * P=0.538 (e) P=0.110 | |POLY 3 | P=0.033 * P=0.506 (e) P=0.104 | |POLY 1.5 | P=0.035 * P=0.502 (e) P=0.108 | |POLY 6 | P=0.031 * P=0.512 (e) P=0.101 | |LOGISTIC REGRESSION| P=0.057 P=0.509 (e) P=0.128 | |COCH-ARM / FISHERS | P=0.038 * P=0.495 (e) P=0.114 | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Larynx | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/49 (0%) 4/48 (8%) | |POLY-3 RATE (b) | 0/44.52 2/45.86 0/46.14 4/41.05 | |POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 9.7% | |TERMINAL (d) | 0/32 (0%) 1/35 (3%) 0/39 (0%) 2/28 (7%) | |FIRST INCIDENCE | --- 722 --- 580 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.018 * P=0.271 (e) P=0.054 | |POLY 3 | P=0.024 * P=0.244 (e) P=0.050 | |POLY 1.5 | P=0.026 * P=0.239 (e) P=0.052 | |POLY 6 | P=0.023 * P=0.250 (e) P=0.048 * | |LOGISTIC REGRESSION| P=0.039 * P=0.256 (e) P=0.066 | |COCH-ARM / FISHERS | P=0.029 * P=0.242 (e) P=0.054 | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Larynx | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 4/49 (8%) 2/49 (4%) 2/48 (4%) | |POLY-3 RATE (b) | 2/44.70 4/45.81 2/46.14 2/40.17 | |POLY-3 PERCENT (g) | 4.5% 8.7% 4.3% 5.0% | |TERMINAL (d) | 1/32 (3%) 4/35 (11%) 2/39 (5%) 1/28 (4%) | |FIRST INCIDENCE | 688 734 (T) 734 (T) 706 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.550N P=0.382 P=0.630N P=0.647 | |POLY 3 | P=0.506N P=0.349 P=0.682N P=0.655 | |POLY 1.5 | P=0.488N P=0.340 P=0.690N P=0.666 | |POLY 6 | P=0.526N P=0.360 P=0.672N P=0.642 | |LOGISTIC REGRESSION| P=0.553N P=0.370 P=0.676N P=0.650 | |COCH-ARM / FISHERS | P=0.466N P=0.329 P=0.684 P=0.676 | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/48 (4%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/44.52 2/45.08 0/46.14 1/41.60 | |POLY-3 PERCENT (g) | 2.3% 4.4% 0.0% 2.4% | |TERMINAL (d) | 1/32 (3%) 2/35 (6%) 0/39 (0%) 1/28 (4%) | |FIRST INCIDENCE | 734 (T) 734 (T) --- 734 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.662N P=0.531 P=0.461N P=0.732 | |POLY 3 | P=0.605N P=0.504 P=0.493N P=0.746 | |POLY 1.5 | P=0.598N P=0.497 P=0.498N P=0.752 | |POLY 6 | P=0.614N P=0.515 P=0.486N P=0.736 | |LOGISTIC REGRESSION| P=0.662N P=0.531 (e) P=0.732 | |COCH-ARM / FISHERS | P=0.587N P=0.485 P=0.505N P=0.753N | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 2/48 (4%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/44.52 2/45.08 1/46.14 0/41.60 | |POLY-3 PERCENT (g) | 0.0% 4.4% 2.2% 0.0% | |TERMINAL (d) | 0/32 (0%) 2/35 (6%) 1/39 (3%) 0/28 (0%) | |FIRST INCIDENCE | --- 734 (T) 734 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.411N P=0.258 P=0.539 (e) | |POLY 3 | P=0.379N P=0.240 P=0.507 (e) | |POLY 1.5 | P=0.371N P=0.235 P=0.502 (e) | |POLY 6 | P=0.390N P=0.247 P=0.514 (e) | |LOGISTIC REGRESSION| (e) P=0.258 P=0.539 (e) | |COCH-ARM / FISHERS | P=0.362N P=0.237 P=0.495 (e) | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/50 (14%) 5/48 (10%) 4/49 (8%) 2/50 (4%) | |POLY-3 RATE (b) | 7/44.52 5/45.49 4/46.14 2/42.27 | |POLY-3 PERCENT (g) | 15.7% 11.0% 8.7% 4.7% | |TERMINAL (d) | 7/32 (22%) 4/35 (11%) 4/39 (10%) 0/28 (0%) | |FIRST INCIDENCE | 734 (T) 613 734 (T) 566 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.132N P=0.317N P=0.156N P=0.115N | |POLY 3 | P=0.104N P=0.364N P=0.240N P=0.091N | |POLY 1.5 | P=0.093N P=0.382N P=0.255N P=0.085N | |POLY 6 | P=0.119N P=0.337N P=0.221N P=0.097N | |LOGISTIC REGRESSION| P=0.099N P=0.348N P=0.156N P=0.099N | |COCH-ARM / FISHERS | P=0.080N P=0.409N P=0.274N P=0.080N | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 9/50 (18%) 6/48 (13%) 6/49 (12%) 7/50 (14%) | |POLY-3 RATE (b) | 9/45.08 6/45.21 6/46.40 7/42.53 | |POLY-3 PERCENT (g) | 20.0% 13.3% 12.9% 16.5% | |TERMINAL (d) | 7/32 (22%) 4/35 (11%) 5/39 (13%) 5/28 (18%) | |FIRST INCIDENCE | 652 706 665 538 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.469 P=0.233N P=0.180N P=0.510N | |POLY 3 | P=0.570N P=0.284N P=0.266N P=0.441N | |POLY 1.5 | P=0.537N P=0.298N P=0.282N P=0.419N | |POLY 6 | P=0.536 P=0.266N P=0.246N P=0.473N | |LOGISTIC REGRESSION| P=0.572N P=0.266N P=0.261N P=0.441N | |COCH-ARM / FISHERS | P=0.495N P=0.318N P=0.303N P=0.393N | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 2/48 (4%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/44.52 2/45.12 0/46.14 0/41.60 | |POLY-3 PERCENT (g) | 4.5% 4.4% 0.0% 0.0% | |TERMINAL (d) | 2/32 (6%) 1/35 (3%) 0/39 (0%) 0/28 (0%) | |FIRST INCIDENCE | 734 (T) 722 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.178N P=0.652N P=0.196N P=0.268N | |POLY 3 | P=0.161N P=0.689N P=0.229N P=0.252N | |POLY 1.5 | P=0.156N P=0.690 P=0.235N P=0.245N | |POLY 6 | P=0.168N P=0.677N P=0.222N P=0.262N | |LOGISTIC REGRESSION| P=0.178N P=0.656N (e) (e) | |COCH-ARM / FISHERS | P=0.149N P=0.676 P=0.253N P=0.247N | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Liver | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 0/48 (0%) 2/49 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 3/45.23 0/45.08 2/47.04 0/41.60 | |POLY-3 PERCENT (g) | 6.6% 0.0% 4.3% 0.0% | |TERMINAL (d) | 1/32 (3%) 0/35 (0%) 1/39 (3%) 0/28 (0%) | |FIRST INCIDENCE | 525 --- 349 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.220N P=0.110N P=0.454N P=0.145N | |POLY 3 | P=0.218N P=0.119N P=0.482N P=0.134N | |POLY 1.5 | P=0.205N P=0.122N P=0.493N P=0.127N | |POLY 6 | P=0.237N P=0.115N P=0.469N P=0.144N | |LOGISTIC REGRESSION| P=0.137N P=0.157N P=0.600N P=0.106N | |COCH-ARM / FISHERS | P=0.189N P=0.129N P=0.510N P=0.121N | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 9/50 (18%) 14/50 (28%) 8/49 (16%) 14/50 (28%) | |POLY-3 RATE (b) | 9/45.38 14/47.00 8/46.40 14/42.17 | |POLY-3 PERCENT (g) | 19.8% 29.8% 17.2% 33.2% | |TERMINAL (d) | 6/32 (19%) 11/35 (31%) 7/39 (18%) 11/28 (39%) | |FIRST INCIDENCE | 561 638 666 634 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.083 P=0.247 P=0.353N P=0.096 | |POLY 3 | P=0.154 P=0.193 P=0.480N P=0.117 | |POLY 1.5 | P=0.186 P=0.184 P=0.497N P=0.139 | |POLY 6 | P=0.120 P=0.206 P=0.456N P=0.092 | |LOGISTIC REGRESSION| P=0.118 P=0.198 P=0.490N P=0.105 | |COCH-ARM / FISHERS | P=0.233 P=0.171 P=0.518N P=0.171 | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 0/44.52 0/46.53 1/46.14 2/41.70 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 4.8% | |TERMINAL (d) | 0/32 (0%) 0/35 (0%) 1/39 (3%) 1/28 (4%) | |FIRST INCIDENCE | --- --- 734 (T) 708 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.062 (e) P=0.539 P=0.206 | |POLY 3 | P=0.085 (e) P=0.507 P=0.223 | |POLY 1.5 | P=0.090 (e) P=0.502 P=0.229 | |POLY 6 | P=0.078 (e) P=0.514 P=0.214 | |LOGISTIC REGRESSION| P=0.068 (e) P=0.539 P=0.211 | |COCH-ARM / FISHERS | P=0.098 (e) P=0.495 P=0.247 | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Lung: Alveolus | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 21/50 (42%) 26/50 (52%) 29/49 (59%) 29/50 (58%) | |POLY-3 RATE (b) | 21/46.95 26/47.15 29/46.85 29/45.24 | |POLY-3 PERCENT (g) | 44.7% 55.2% 61.9% 64.1% | |TERMINAL (d) | 13/32 (41%) 21/35 (60%) 26/39 (67%) 18/28 (64%) | |FIRST INCIDENCE | 359 638 617 492 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.017 * P=0.365 P=0.308 P=0.039 * | |POLY 3 | P=0.078 P=0.207 P=0.068 P=0.043 * | |POLY 1.5 | P=0.102 P=0.208 P=0.064 P=0.056 | |POLY 6 | P=0.057 P=0.212 P=0.075 P=0.032 * | |LOGISTIC REGRESSION| P=0.070 P=0.243 P=0.080 P=0.069 | |COCH-ARM / FISHERS | P=0.143 P=0.212 P=0.065 P=0.081 | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Lung: Alveolus | | Proteinosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 11/50 (22%) 16/50 (32%) 15/49 (31%) 23/50 (46%) | |POLY-3 RATE (b) | 11/45.13 16/46.76 15/46.19 23/43.02 | |POLY-3 PERCENT (g) | 24.4% 34.2% 32.5% 53.5% | |TERMINAL (d) | 9/32 (28%) 13/35 (37%) 14/39 (36%) 18/28 (64%) | |FIRST INCIDENCE | 561 708 722 590 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** P=0.273 P=0.450 P=0.002 ** | |POLY 3 | P=0.004 ** P=0.209 P=0.265 P=0.003 ** | |POLY 1.5 | P=0.006 ** P=0.199 P=0.248 P=0.005 ** | |POLY 6 | P=0.002 ** P=0.225 P=0.291 P=0.002 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.245 P=0.330 P=0.003 ** | |COCH-ARM / FISHERS | P=0.011 * P=0.184 P=0.228 P=0.010 * | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Lung: Interstitium | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 16/50 (32%) 24/50 (48%) 23/49 (47%) 28/50 (56%) | |POLY-3 RATE (b) | 16/45.52 24/47.12 23/46.85 28/44.51 | |POLY-3 PERCENT (g) | 35.2% 50.9% 49.1% 62.9% | |TERMINAL (d) | 10/32 (31%) 20/35 (57%) 20/39 (51%) 19/28 (68%) | |FIRST INCIDENCE | 652 638 617 492 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003 ** P=0.160 P=0.310 P=0.005 ** | |POLY 3 | P=0.017 * P=0.089 P=0.123 P=0.005 ** | |POLY 1.5 | P=0.024 * P=0.084 P=0.109 P=0.008 ** | |POLY 6 | P=0.011 * P=0.096 P=0.143 P=0.003 ** | |LOGISTIC REGRESSION| P=0.008 ** P=0.115 P=0.146 P=0.005 ** | |COCH-ARM / FISHERS | P=0.038 * P=0.076 P=0.094 P=0.013 * | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Lung: Interstitium | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 6/50 (12%) 6/49 (12%) 4/50 (8%) | |POLY-3 RATE (b) | 1/44.57 6/46.65 6/46.19 4/41.71 | |POLY-3 PERCENT (g) | 2.2% 12.9% 13.0% 9.6% | |TERMINAL (d) | 0/32 (0%) 4/35 (11%) 5/39 (13%) 3/28 (11%) | |FIRST INCIDENCE | 722 708 722 706 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.375 P=0.085 P=0.099 P=0.143 | |POLY 3 | P=0.456 P=0.063 P=0.062 P=0.158 | |POLY 1.5 | P=0.485 P=0.061 P=0.058 P=0.168 | |POLY 6 | P=0.418 P=0.068 P=0.067 P=0.147 | |LOGISTIC REGRESSION| P=0.380 P=0.073 P=0.078 P=0.139 | |COCH-ARM / FISHERS | P=0.521 P=0.056 P=0.053 P=0.181 | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Lymph Node, Bronchial | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/2 (0%) 2/10 (20%) 0/7 (0%) 1/5 (20%) | |POLY-3 RATE (b) | 0/1.88 2/8.95 0/6.49 1/4.29 | |POLY-3 PERCENT (g) | 0.0% 22.4% 0.0% 23.3% | |TERMINAL (d) | 0/0 (0%) 1/5 (20%) 0/4 (0%) 1/3 (33%) | |FIRST INCIDENCE | --- 728 --- 734 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.663 P=0.523 (e) P=1.000 | |POLY 3 | P=0.594 P=0.618 (e) P=0.662 | |POLY 1.5 | P=0.600 P=0.621 (e) P=0.666 | |POLY 6 | P=0.591 P=0.618 (e) P=0.660 | |LOGISTIC REGRESSION| P=0.649 P=0.842 (e) P=1.000 | |COCH-ARM / FISHERS | P=0.614 P=0.682 (e) P=0.714 | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/45 (2%) 2/46 (4%) 0/49 (0%) 1/44 (2%) | |POLY-3 RATE (b) | 1/41.74 2/43.54 0/46.14 1/36.55 | |POLY-3 PERCENT (g) | 2.4% 4.6% 0.0% 2.7% | |TERMINAL (d) | 0/31 (0%) 1/33 (3%) 0/39 (0%) 0/25 (0%) | |FIRST INCIDENCE | 561 533 --- 700 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.635N P=0.510 P=0.500N P=0.743 | |POLY 3 | P=0.631N P=0.515 P=0.480N P=0.730 | |POLY 1.5 | P=0.622N P=0.512 P=0.481N P=0.741 | |POLY 6 | P=0.640N P=0.519 P=0.478N P=0.717 | |LOGISTIC REGRESSION| P=0.511N P=0.414 P=0.498N P=0.728N | |COCH-ARM / FISHERS | P=0.609N P=0.508 P=0.479N P=0.747 | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Mammary Gland | | Galactocele | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 5/49 (10%) 1/50 (2%) | |POLY-3 RATE (b) | 3/44.52 1/46.57 5/46.14 1/41.73 | |POLY-3 PERCENT (g) | 6.7% 2.2% 10.8% 2.4% | |TERMINAL (d) | 3/32 (9%) 0/35 (0%) 5/39 (13%) 0/28 (0%) | |FIRST INCIDENCE | 734 (T) 722 734 (T) 700 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.403N P=0.267N P=0.468 P=0.353N | |POLY 3 | P=0.366N P=0.289N P=0.376 P=0.329N | |POLY 1.5 | P=0.342N P=0.296N P=0.363 P=0.318N | |POLY 6 | P=0.397N P=0.280N P=0.395 P=0.342N | |LOGISTIC REGRESSION| P=0.404N P=0.263N P=0.468 P=0.354N | |COCH-ARM / FISHERS | P=0.314N P=0.309N P=0.346 P=0.309N | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Mesentery | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 26/26 (100%) 20/20 (100%) 20/20 (100%) 16/17 (94%) | |POLY-3 RATE (b) | 26/26.00 20/20.00 20/20.00 16/17.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 94.1% | |TERMINAL (d) | 18/18 (100%) 14/14 (100%) 17/17 (100%) 10/11 (91%) | |FIRST INCIDENCE | 525 706 349 478 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.467N (e) (e) P=0.361N | |POLY 3 | P=0.179N (e) (e) P=0.415N | |POLY 1.5 | P=0.179N (e) (e) P=0.415N | |POLY 6 | P=0.179N (e) (e) P=0.415N | |LOGISTIC REGRESSION| (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.179N (e) (e) P=0.395N | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Nose | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 4/48 (8%) 3/49 (6%) 1/49 (2%) | |POLY-3 RATE (b) | 1/44.57 4/45.08 3/46.14 1/41.09 | |POLY-3 PERCENT (g) | 2.2% 8.9% 6.5% 2.4% | |TERMINAL (d) | 0/32 (0%) 4/35 (11%) 3/39 (8%) 0/28 (0%) | |FIRST INCIDENCE | 722 734 (T) 734 (T) 634 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.394N P=0.216 P=0.379 P=0.723 | |POLY 3 | P=0.346N P=0.182 P=0.318 P=0.742 | |POLY 1.5 | P=0.331N P=0.176 P=0.309 P=0.749 | |POLY 6 | P=0.366N P=0.191 P=0.330 P=0.735 | |LOGISTIC REGRESSION| P=0.367N P=0.214 P=0.351 P=0.760N | |COCH-ARM / FISHERS | P=0.311N P=0.168 P=0.301 P=0.747 | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 5/48 (10%) 7/49 (14%) 3/49 (6%) | |POLY-3 RATE (b) | 3/44.64 5/45.08 7/46.30 3/41.85 | |POLY-3 PERCENT (g) | 6.7% 11.1% 15.1% 7.2% | |TERMINAL (d) | 1/32 (3%) 5/35 (14%) 6/39 (15%) 0/28 (0%) | |FIRST INCIDENCE | 716 734 (T) 694 538 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.516N P=0.416 P=0.245 P=0.597 | |POLY 3 | P=0.438N P=0.362 P=0.172 P=0.633 | |POLY 1.5 | P=0.416N P=0.351 P=0.162 P=0.642 | |POLY 6 | P=0.467N P=0.377 P=0.187 P=0.622 | |LOGISTIC REGRESSION| P=0.424N P=0.411 P=0.195 P=0.650N | |COCH-ARM / FISHERS | P=0.387N P=0.335 P=0.151 P=0.651 | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Nose: Goblet Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 1/48 (2%) 5/49 (10%) 2/49 (4%) | |POLY-3 RATE (b) | 1/44.52 1/45.08 5/46.30 2/41.34 | |POLY-3 PERCENT (g) | 2.3% 2.2% 10.8% 4.8% | |TERMINAL (d) | 1/32 (3%) 1/35 (3%) 4/39 (10%) 1/28 (4%) | |FIRST INCIDENCE | 734 (T) 734 (T) 694 538 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.421 P=0.742N P=0.151 P=0.469 | |POLY 3 | P=0.452 P=0.758N P=0.111 P=0.474 | |POLY 1.5 | P=0.475 P=0.758 P=0.105 P=0.483 | |POLY 6 | P=0.420 P=0.751N P=0.119 P=0.463 | |LOGISTIC REGRESSION| P=0.490 P=0.742N P=0.124 P=0.514 | |COCH-ARM / FISHERS | P=0.504 P=0.742 P=0.098 P=0.492 | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Nose: Nasolacrimal Duct | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 1/48 (2%) 1/49 (2%) 3/49 (6%) | |POLY-3 RATE (b) | 3/44.82 1/45.08 1/46.19 3/40.74 | |POLY-3 PERCENT (g) | 6.7% 2.2% 2.2% 7.4% | |TERMINAL (d) | 2/32 (6%) 1/35 (3%) 0/39 (0%) 3/28 (11%) | |FIRST INCIDENCE | 652 734 (T) 722 734 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.292 P=0.285N P=0.252N P=0.592 | |POLY 3 | P=0.343 P=0.303N P=0.295N P=0.618 | |POLY 1.5 | P=0.363 P=0.310N P=0.303N P=0.634 | |POLY 6 | P=0.320 P=0.294N P=0.284N P=0.596 | |LOGISTIC REGRESSION| P=0.318 P=0.309N P=0.307N P=0.600 | |COCH-ARM / FISHERS | P=0.388 P=0.324N P=0.316N P=0.651 | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 1/48 (2%) 1/49 (2%) 2/49 (4%) | |POLY-3 RATE (b) | 0/44.52 1/45.08 1/46.14 2/41.22 | |POLY-3 PERCENT (g) | 0.0% 2.2% 2.2% 4.9% | |TERMINAL (d) | 0/32 (0%) 1/35 (3%) 1/39 (3%) 1/28 (4%) | |FIRST INCIDENCE | --- 734 (T) 734 (T) 590 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.164 P=0.518 P=0.539 P=0.215 | |POLY 3 | P=0.195 P=0.502 P=0.507 P=0.220 | |POLY 1.5 | P=0.203 P=0.498 P=0.502 P=0.226 | |POLY 6 | P=0.184 P=0.509 P=0.514 P=0.213 | |LOGISTIC REGRESSION| P=0.220 P=0.518 P=0.539 P=0.248 | |COCH-ARM / FISHERS | P=0.214 P=0.490 P=0.495 P=0.242 | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 2/48 (4%) 2/49 (4%) 1/49 (2%) | |POLY-3 RATE (b) | 1/44.60 2/45.08 2/46.14 1/40.89 | |POLY-3 PERCENT (g) | 2.2% 4.4% 4.3% 2.5% | |TERMINAL (d) | 0/32 (0%) 2/35 (6%) 2/39 (5%) 0/28 (0%) | |FIRST INCIDENCE | 716 734 (T) 734 (T) 694 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.597N P=0.533 P=0.558 P=0.723 | |POLY 3 | P=0.549N P=0.504 P=0.512 P=0.741 | |POLY 1.5 | P=0.533N P=0.496 P=0.504 P=0.748 | |POLY 6 | P=0.568N P=0.514 P=0.523 P=0.733 | |LOGISTIC REGRESSION| P=0.582N P=0.527 P=0.535 P=0.748 | |COCH-ARM / FISHERS | P=0.514N P=0.485 P=0.492 P=0.747 | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Oral Mucosa: Pharyngeal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/1 (0%) 0/0 (0%) 0/0 (0%) 2/2 (100%) | |POLY-3 RATE (b) | 0/0.93 0/0.00 0/0.00 2/2.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) | |FIRST INCIDENCE | --- --- --- 492 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.183 (e) (e) P=0.468 | |POLY 3 | (e) (e) (e) P=1.000 | |POLY 1.5 | (e) (e) (e) P=1.000 | |POLY 6 | (e) (e) (e) P=1.000 | |LOGISTIC REGRESSION| P=0.317 (e) (e) P=0.448 | |COCH-ARM / FISHERS | P=0.224 (e) (e) P=0.333 | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 4/50 (8%) 6/49 (12%) 3/50 (6%) | |POLY-3 RATE (b) | 3/44.52 4/46.53 6/46.40 3/42.69 | |POLY-3 PERCENT (g) | 6.7% 8.6% 12.9% 7.0% | |TERMINAL (d) | 3/32 (9%) 4/35 (11%) 5/39 (13%) 1/28 (4%) | |FIRST INCIDENCE | 734 (T) 734 (T) 665 561 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.586N P=0.549 P=0.343 P=0.613 | |POLY 3 | P=0.513N P=0.524 P=0.263 P=0.643 | |POLY 1.5 | P=0.492N P=0.514 P=0.249 P=0.652 | |POLY 6 | P=0.540N P=0.537 P=0.282 P=0.632 | |LOGISTIC REGRESSION| P=0.490N P=0.549 P=0.284 P=0.645N | |COCH-ARM / FISHERS | P=0.466N P=0.500 P=0.233 P=0.661N | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Pituitary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 4/49 (8%) 3/49 (6%) 0/50 (0%) | |POLY-3 RATE (b) | 1/44.57 4/45.81 3/46.14 0/41.60 | |POLY-3 PERCENT (g) | 2.2% 8.7% 6.5% 0.0% | |TERMINAL (d) | 0/32 (0%) 4/35 (11%) 3/39 (8%) 0/28 (0%) | |FIRST INCIDENCE | 722 734 (T) 734 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.167N P=0.216 P=0.379 P=0.533N | |POLY 3 | P=0.149N P=0.187 P=0.318 P=0.514N | |POLY 1.5 | P=0.138N P=0.181 P=0.309 P=0.507N | |POLY 6 | P=0.163N P=0.195 P=0.330 P=0.522N | |LOGISTIC REGRESSION| P=0.171N P=0.215 P=0.351 P=0.525N | |COCH-ARM / FISHERS | P=0.127N P=0.175 P=0.301 P=0.500N | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/44.57 0/45.81 0/46.14 0/41.60 | |POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/32 (3%) 0/35 (0%) 0/39 (0%) 0/28 (0%) | |FIRST INCIDENCE | 722 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.344N P=0.209N P=0.198N P=0.273N | |POLY 3 | P=0.323N P=0.231N P=0.230N P=0.253N | |POLY 1.5 | P=0.316N P=0.235N P=0.235N P=0.246N | |POLY 6 | P=0.331N P=0.225N P=0.222N P=0.262N | |LOGISTIC REGRESSION| P=0.337N P=0.218N P=0.214N P=0.269N | |COCH-ARM / FISHERS | P=0.307N P=0.253N P=0.253N P=0.247N | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 7/50 (14%) 9/49 (18%) 8/49 (16%) 5/50 (10%) | |POLY-3 RATE (b) | 7/45.03 9/45.97 8/46.80 5/42.08 | |POLY-3 PERCENT (g) | 15.6% 19.6% 17.1% 11.9% | |TERMINAL (d) | 5/32 (16%) 7/35 (20%) 6/39 (15%) 4/28 (14%) | |FIRST INCIDENCE | 666 706 617 590 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.356N P=0.473 P=0.585N P=0.479N | |POLY 3 | P=0.271N P=0.409 P=0.532 P=0.427N | |POLY 1.5 | P=0.242N P=0.396 P=0.511 P=0.405N | |POLY 6 | P=0.313N P=0.428 P=0.561 P=0.458N | |LOGISTIC REGRESSION| P=0.269N P=0.435 P=0.500 P=0.432N | |COCH-ARM / FISHERS | P=0.207N P=0.376 P=0.483 P=0.380N | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Pleura | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 15/20 (75%) 17/25 (68%) 23/25 (92%) 27/28 (96%) | |POLY-3 RATE (b) | 15/18.82 17/24.66 23/25.00 27/27.30 | |POLY-3 PERCENT (g) | 79.7% 69.0% 92.0% 98.9% | |TERMINAL (d) | 11/13 (85%) 13/20 (65%) 20/22 (91%) 19/19 (100%) | |FIRST INCIDENCE | 561 708 617 589 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.002 ** P=0.252N P=0.582N P=0.044 * | |POLY 3 | P=0.005 ** P=0.326N P=0.227 P=0.028 * | |POLY 1.5 | P=0.006 ** P=0.355N P=0.186 P=0.029 * | |POLY 6 | P=0.005 ** P=0.305N P=0.271 P=0.029 * | |LOGISTIC REGRESSION| P=0.006 ** P=0.278N P=0.223 P=0.039 * | |COCH-ARM / FISHERS | P=0.011 * P=0.429N P=0.126 P=0.039 * | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Pleura: Mesothelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/20 (10%) 7/25 (28%) 8/25 (32%) 2/28 (7%) | |POLY-3 RATE (b) | 2/18.17 7/24.38 8/24.34 2/25.65 | |POLY-3 PERCENT (g) | 11.0% 28.7% 32.9% 7.8% | |TERMINAL (d) | 0/13 (0%) 7/20 (35%) 7/22 (32%) 0/19 (0%) | |FIRST INCIDENCE | 652 734 (T) 722 634 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.166N P=0.185 P=0.151 P=0.629 | |POLY 3 | P=0.095N P=0.154 P=0.096 P=0.566N | |POLY 1.5 | P=0.090N P=0.146 P=0.089 P=0.564N | |POLY 6 | P=0.102N P=0.161 P=0.101 P=0.571N | |LOGISTIC REGRESSION| P=0.102N P=0.156 P=0.098 P=0.590N | |COCH-ARM / FISHERS | P=0.093N P=0.130 P=0.078 P=0.558N | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Spleen | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/49 (0%) 3/50 (6%) | |POLY-3 RATE (b) | 1/44.52 0/45.79 0/46.14 3/42.51 | |POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 7.1% | |TERMINAL (d) | 1/32 (3%) 0/35 (0%) 0/39 (0%) 1/28 (4%) | |FIRST INCIDENCE | 734 (T) --- --- 561 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.032 * P=0.482N P=0.461N P=0.267 | |POLY 3 | P=0.042 * P=0.494N P=0.493N P=0.288 | |POLY 1.5 | P=0.045 * P=0.498N P=0.498N P=0.296 | |POLY 6 | P=0.039 * P=0.489N P=0.486N P=0.279 | |LOGISTIC REGRESSION| P=0.070 (e) (e) P=0.327 | |COCH-ARM / FISHERS | P=0.050 P=0.505N P=0.505N P=0.309 | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 1/49 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 1/44.78 0/45.79 1/46.19 2/42.08 | |POLY-3 PERCENT (g) | 2.2% 0.0% 2.2% 4.8% | |TERMINAL (d) | 0/32 (0%) 0/35 (0%) 0/39 (0%) 1/28 (4%) | |FIRST INCIDENCE | 666 --- 722 589 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.184 P=0.495N P=0.731N P=0.456 | |POLY 3 | P=0.217 P=0.496N P=0.754N P=0.478 | |POLY 1.5 | P=0.228 P=0.499N P=0.759N P=0.488 | |POLY 6 | P=0.203 P=0.491N P=0.747N P=0.465 | |LOGISTIC REGRESSION| P=0.276 P=0.537N P=0.750 P=0.524 | |COCH-ARM / FISHERS | P=0.242 P=0.505N P=0.747 P=0.500 | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Spleen | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 3/50 (6%) 0/49 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/44.91 0/45.79 0/46.14 0/41.60 | |POLY-3 PERCENT (g) | 6.7% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/32 (3%) 0/35 (0%) 0/39 (0%) 0/28 (0%) | |FIRST INCIDENCE | 639 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.216N P=0.108N P=0.100N P=0.155N | |POLY 3 | P=0.198N P=0.115N P=0.114N P=0.133N | |POLY 1.5 | P=0.192N P=0.118N P=0.118N P=0.126N | |POLY 6 | P=0.206N P=0.111N P=0.109N P=0.142N | |LOGISTIC REGRESSION| P=0.179N P=0.128N P=0.128N P=0.123N | |COCH-ARM / FISHERS | P=0.186N P=0.125N P=0.125N P=0.121N | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/50 (4%) 2/47 (4%) 1/49 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 2/44.95 2/44.79 1/47.04 0/40.74 | |POLY-3 PERCENT (g) | 4.5% 4.5% 2.1% 0.0% | |TERMINAL (d) | 1/32 (3%) 1/35 (3%) 0/39 (0%) 0/28 (0%) | |FIRST INCIDENCE | 609 728 349 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.183N P=0.659N P=0.475N P=0.273N | |POLY 3 | P=0.177N P=0.693 P=0.484N P=0.260N | |POLY 1.5 | P=0.168N P=0.684 P=0.493N P=0.251N | |POLY 6 | P=0.188N P=0.684N P=0.474N P=0.270N | |LOGISTIC REGRESSION| P=0.109N P=0.657 P=0.585N P=0.229N | |COCH-ARM / FISHERS | P=0.155N P=0.668 P=0.508N P=0.253N | |=================================================================================================================================| Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 15/50 (30%) 7/49 (14%) 6/49 (12%) 6/50 (12%) | |POLY-3 RATE (b) | 15/44.90 7/46.33 6/46.30 6/41.60 | |POLY-3 PERCENT (g) | 33.4% 15.1% 13.0% 14.4% | |TERMINAL (d) | 12/32 (38%) 5/35 (14%) 5/39 (13%) 6/28 (21%) | |FIRST INCIDENCE | 666 613 694 734 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.183N P=0.029N* P=0.008N** P=0.051N | |POLY 3 | P=0.128N P=0.034N* P=0.017N* P=0.032N* | |POLY 1.5 | P=0.107N P=0.039N* P=0.020N* P=0.027N* | |POLY 6 | P=0.161N P=0.027N* P=0.013N* P=0.041N* | |LOGISTIC REGRESSION| P=0.162N P=0.032N* P=0.012N* P=0.047N* | |COCH-ARM / FISHERS | P=0.086N P=0.050N P=0.027N* P=0.024N* | |=================================================================================================================================| | | | | | Females | |Dose | CONTROL 25 PPM 100 PPM 400 PPM | | | | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/50 (0%) 3/49 (6%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/44.52 3/45.81 0/46.14 1/41.70 | |POLY-3 PERCENT (g) | 0.0% 6.6% 0.0% 2.4% | |TERMINAL (d) | 0/32 (0%) 3/35 (9%) 0/39 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 734 (T) --- 708 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.691 P=0.137 (e) P=0.464 | |POLY 3 | P=0.634N P=0.124 (e) P=0.487 | |POLY 1.5 | P=0.629N P=0.120 (e) P=0.493 | |POLY 6 | P=0.640N P=0.129 (e) P=0.479 | |LOGISTIC REGRESSION| P=0.687N P=0.137 (e) P=0.487 | |COCH-ARM / FISHERS | P=0.620N P=0.117 (e) P=0.500 | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Number of tumor-bearing animals / Poly-3 number (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. (g) Poly-3 adjusted lifetime tumor incidence. (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).