TDMS Study 88004-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest DIVINYLBENZENE DATE: 08/14/03 EXPERIMENT: 88004 TEST: 06 TIME: 13:09:59 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88004B PATHOLOGIST: GRUMBEIN, SONDR CAS: 1321-74-0 ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 MICE REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest DIVINYLBENZENE DATE: 08/14/03 EXPERIMENT: 88004 TEST: 06 TIME: 13:09:59 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88004B PATHOLOGIST: GRUMBEIN, SONDR CAS: 1321-74-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF DIVINYLBENZENE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Eye: Cornea Mineralization Heart Cardiomyopathy Kidney Metaplasia Osseous Nephropathy Liver Eosinophilic Focus Vacuolization Cytoplasmic Focal Lung: Alveolar Epithelium Hyperplasia Lung: Bronchiole Hyperplasia Atypical Nose Inflammation Nose: Glands, Respiratory Epithelium Metaplasia Nose: Olfactory Epithelium Atrophy Degeneration Hyaline Nose: Olfactory Epithelium, Respiratory Epithelium Metaplasia Pancreas: Duct Cyst Testes Atrophy =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex Hypertrophy Eye: Cornea Mineralization Heart: Artery Inflammation Chronic Kidney Nephropathy Liver Clear Cell Focus Eosinophilic Focus Lung: Alveolus Infiltration Cellular Histiocyte Lung: Bronchiole Hyperplasia Atypical Mesentery: Fat Necrosis Nose Inflammation Nose: Glands, Respiratory Epithelium Metaplasia Nose: Olfactory Epithelium Atrophy Degeneration Hyaline Nose: Olfactory Epithelium, Respiratory Epithelium Metaplasia Pituitary Gland: Pars Distalis Angiectasis Hyperplasia Uterus: Endometrium Hyperplasia Cystic =============================================================== Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/49 (18%) 10/49 (20%) 6/50 (12%) 5/50 (10%) |1/50 (2%) 2/50 (4%) 5/50 (10%) 4/50 (8%) | |POLY-3 RATE (b) | 9/45.45 10/45.74 6/46.79 5/47.18 |1/42.71 2/44.99 5/43.99 4/46.93 | |POLY-3 PERCENT (g) | 19.8% 21.9% 12.8% 10.6% |2.3% 4.5% 11.4% 8.5% | |TERMINAL (d) | 9/41 (22%) 9/38 (24%) 5/42 (12%) 5/43 (12%) |1/33 (3%) 2/35 (6%) 5/38 (13%) 4/42 (10%) | |FIRST INCIDENCE | 729 (T) 672 624 729 (T) |731 (T) 731 (T) 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.087N P=0.431 P=0.270N P=0.166N |P=0.291 P=0.521 P=0.137 P=0.258 | |POLY 3 | P=0.101N P=0.506 P=0.266N P=0.172N |P=0.229 P=0.518 P=0.108 P=0.209 | |POLY 1.5 | P=0.104N P=0.502 P=0.270N P=0.177N |P=0.209 P=0.513 P=0.105 P=0.195 | |POLY 6 | P=0.096N P=0.511 P=0.260N P=0.164N |P=0.258 P=0.521 P=0.112 P=0.227 | |LOGISTIC REGRESSION| P=0.094N P=0.495 P=0.269N P=0.166N |P=0.291 P=0.521 P=0.137 P=0.258 | |COCH-ARM / FISHERS | P=0.108N P=0.500 P=0.274N P=0.183N |P=0.190 P=0.500 P=0.102 P=0.181 | |ORDER RESTRICTED | P=0.140N (e) (e) (e) |P=0.116 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 24/49 (49%) 25/49 (51%) 26/50 (52%) 24/50 (48%) |0/50 (0%) 3/50 (6%) 2/50 (4%) 8/50 (16%) | |POLY-3 RATE (b) | 24/45.98 25/46.04 26/46.55 24/47.18 |0/42.71 3/44.99 2/43.99 8/47.04 | |POLY-3 PERCENT (g) | 52.2% 54.3% 55.9% 50.9% |0.0% 6.7% 4.6% 17.0% | |TERMINAL (d) | 23/41 (56%) 22/38 (58%) 25/42 (60%) 24/43 (56%) |0/33 (0%) 3/35 (9%) 2/38 (5%) 7/42 (17%) | |FIRST INCIDENCE | 565 641 696 729 (T) |--- 731 (T) 731 (T) 704 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.328N P=0.363 P=0.467 P=0.490N |P=0.005 ** P=0.131 P=0.270 P=0.013 * | |POLY 3 | P=0.441N P=0.503 P=0.442 P=0.532N |P=0.002 ** P=0.128 P=0.244 P=0.006 ** | |POLY 1.5 | P=0.448N P=0.497 P=0.448 P=0.538N |P=0.002 ** P=0.126 P=0.241 P=0.005 ** | |POLY 6 | P=0.427N P=0.512 P=0.440 P=0.518N |P=0.003 ** P=0.130 P=0.248 P=0.007 ** | |LOGISTIC REGRESSION| P=0.363N P=0.514 P=0.471 P=0.468N |P=0.005 ** P=0.131 P=0.270 P=0.010 * | |COCH-ARM / FISHERS | P=0.457N P=0.500 P=0.460 P=0.541N |P=0.002 ** P=0.121 P=0.247 P=0.003 ** | |ORDER RESTRICTED | P=0.586N (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/49 (4%) 0/50 (0%) 2/50 (4%) |1/49 (2%) 1/50 (2%) 0/49 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 1/45.45 2/45.52 0/46.42 2/47.18 |1/41.71 1/44.99 0/43.89 2/46.93 | |POLY-3 PERCENT (g) | 2.2% 4.4% 0.0% 4.2% |2.4% 2.2% 0.0% 4.3% | |TERMINAL (d) | 1/41 (2%) 2/38 (5%) 0/42 (0%) 2/43 (5%) |1/32 (3%) 1/35 (3%) 0/38 (0%) 2/42 (5%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |731 (T) 731 (T) --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.482 P=0.473 P=0.495N P=0.517 |P=0.400 P=0.742N P=0.466N P=0.595 | |POLY 3 | P=0.467 P=0.501 P=0.496N P=0.513 |P=0.349 P=0.744N P=0.490N P=0.541 | |POLY 1.5 | P=0.464 P=0.500 P=0.496N P=0.510 |P=0.339 P=0.747N P=0.493N P=0.526 | |POLY 6 | P=0.471 P=0.501 P=0.495N P=0.518 |P=0.362 P=0.741N P=0.485N P=0.560 | |LOGISTIC REGRESSION| P=0.482 P=0.473 (e) P=0.517 |P=0.400 P=0.742N (e) P=0.595 | |COCH-ARM / FISHERS | P=0.461 P=0.500 P=0.495N P=0.508 |P=0.330 P=0.747N P=0.500N P=0.508 | |ORDER RESTRICTED | P=0.429 (e) (e) (e) |P=0.310 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Granuloma Sperm | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | |POLY-3 RATE (b) | 1/45.69 2/46.49 0/46.42 0/47.18 | | |POLY-3 PERCENT (g) | 2.2% 4.3% 0.0% 0.0% | | |TERMINAL (d) | 1/41 (2%) 1/38 (3%) 0/42 (0%) 0/43 (0%) | | |FIRST INCIDENCE | 729 (T) 556 --- --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.220N P=0.485 P=0.495N P=0.490N | | |POLY 3 | P=0.224N P=0.506 P=0.497N P=0.494N | | |POLY 1.5 | P=0.226N P=0.503 P=0.498N P=0.496N | | |POLY 6 | P=0.222N P=0.508 P=0.495N P=0.490N | | |LOGISTIC REGRESSION| P=0.240N P=0.504 (e) (e) | | |COCH-ARM / FISHERS | P=0.228N P=0.500 P=0.500N P=0.500N | | |ORDER RESTRICTED | P=0.165N (e) (e) (e) | | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Eye | | Cataract | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/47 (0%) 0/47 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 1/49 (2%) | |POLY-3 RATE (b) | 0/45.34 0/44.53 0/44.18 0/47.18 |1/42.71 2/44.99 0/43.99 1/46.76 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 4.5% 0.0% 2.1% | |TERMINAL (d) | 0/41 (0%) 0/38 (0%) 0/41 (0%) 0/43 (0%) |1/33 (3%) 2/35 (6%) 0/38 (0%) 1/42 (2%) | |FIRST INCIDENCE | --- --- --- --- |731 (T) 731 (T) --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.506N P=0.521 P=0.472N P=0.707N | |POLY 3 | (e) (e) (e) (e) |P=0.560N P=0.518 P=0.494N P=0.740N | |POLY 1.5 | (e) (e) (e) (e) |P=0.570N P=0.513 P=0.497N P=0.751N | |POLY 6 | (e) (e) (e) (e) |P=0.548N P=0.521 P=0.490N P=0.727N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.506N P=0.521 (e) P=0.707N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.584N P=0.500 P=0.500N P=0.747 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.366N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Eye: Cornea | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/47 (4%) 1/47 (2%) 1/50 (2%) |1/50 (2%) 3/50 (6%) 0/50 (0%) 3/49 (6%) | |POLY-3 RATE (b) | 0/45.34 2/44.60 1/44.18 1/47.18 |1/42.71 3/44.99 0/43.99 3/47.76 | |POLY-3 PERCENT (g) | 0.0% 4.5% 2.3% 2.1% |2.3% 6.7% 0.0% 6.3% | |TERMINAL (d) | 0/41 (0%) 1/38 (3%) 1/41 (2%) 1/43 (2%) |1/33 (3%) 3/35 (9%) 0/38 (0%) 1/42 (2%) | |FIRST INCIDENCE | --- 711 729 (T) 729 (T) |731 (T) 731 (T) --- 200 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.648 P=0.229 P=0.500 P=0.510 |P=0.392 P=0.326 P=0.472N P=0.378 | |POLY 3 | P=0.645 P=0.233 P=0.495 P=0.508 |P=0.347 P=0.324 P=0.494N P=0.347 | |POLY 1.5 | P=0.641 P=0.232 P=0.494 P=0.506 |P=0.329 P=0.319 P=0.497N P=0.328 | |POLY 6 | P=0.649 P=0.235 P=0.496 P=0.510 |P=0.368 P=0.327 P=0.490N P=0.369 | |LOGISTIC REGRESSION| P=0.645 P=0.233 P=0.500 P=0.510 |P=0.276 P=0.326 (e) P=0.240 | |COCH-ARM / FISHERS | P=0.638 P=0.237 P=0.490 P=0.505 |P=0.302 P=0.309 P=0.500N P=0.301 | |ORDER RESTRICTED | P=0.264 (e) (e) (e) |P=0.265 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Eye: Cornea | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/47 (0%) 0/47 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 6/49 (12%) | |POLY-3 RATE (b) | 0/45.34 0/44.53 0/44.18 2/47.18 |0/42.71 0/44.99 0/43.99 6/46.76 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.2% |0.0% 0.0% 0.0% 12.8% | |TERMINAL (d) | 0/41 (0%) 0/38 (0%) 0/41 (0%) 2/43 (5%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 6/42 (14%) | |FIRST INCIDENCE | --- --- --- 729 (T) |--- --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.049 * (e) (e) P=0.249 |P<0.001 ** (e) (e) P=0.034 * | |POLY 3 | P=0.046 * (e) (e) P=0.246 |P<0.001 ** (e) (e) P=0.021 * | |POLY 1.5 | P=0.045 * (e) (e) P=0.244 |P<0.001 ** (e) (e) P=0.018 * | |POLY 6 | P=0.046 * (e) (e) P=0.249 |P<0.001 ** (e) (e) P=0.025 * | |LOGISTIC REGRESSION| (e) (e) (e) P=0.249 |(e) (e) (e) P=0.034 * | |COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.253 |P<0.001 ** (e) (e) P=0.012 * | |ORDER RESTRICTED | P=0.033 * (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Harderian Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/49 (4%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 4/50 (8%) 2/50 (4%) 3/50 (6%) | |POLY-3 RATE (b) | 2/45.69 2/45.04 3/46.42 2/47.18 |1/42.99 4/45.64 2/44.07 3/46.93 | |POLY-3 PERCENT (g) | 4.4% 4.4% 6.5% 4.2% |2.3% 8.8% 4.5% 6.4% | |TERMINAL (d) | 2/41 (5%) 2/38 (5%) 3/42 (7%) 2/43 (5%) |0/33 (0%) 3/35 (9%) 1/38 (3%) 3/42 (7%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |658 515 711 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.565N P=0.667 P=0.511 P=0.678N |P=0.547 P=0.199 P=0.535 P=0.386 | |POLY 3 | P=0.584N P=0.689 P=0.507 P=0.682N |P=0.495 P=0.197 P=0.509 P=0.338 | |POLY 1.5 | P=0.590N P=0.687 P=0.504 P=0.687N |P=0.474 P=0.192 P=0.505 P=0.323 | |POLY 6 | P=0.576N P=0.689 P=0.510 P=0.676N |P=0.522 P=0.200 P=0.514 P=0.356 | |LOGISTIC REGRESSION| P=0.565N P=0.667 P=0.511 P=0.678N |P=0.458 P=0.160 P=0.505 P=0.327 | |COCH-ARM / FISHERS | P=0.599N P=0.684 P=0.500 P=0.691N |P=0.450 P=0.181 P=0.500 P=0.309 | |ORDER RESTRICTED | P=0.642 (e) (e) (e) |P=0.301 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 5/49 (10%) 5/50 (10%) 5/50 (10%) |3/50 (6%) 6/50 (12%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 14/46.28 5/45.52 5/46.42 5/47.18 |3/43.23 6/45.73 1/44.07 1/46.93 | |POLY-3 PERCENT (g) | 30.3% 11.0% 10.8% 10.6% |6.9% 13.1% 2.3% 2.1% | |TERMINAL (d) | 12/41 (29%) 5/38 (13%) 5/42 (12%) 5/43 (12%) |2/33 (6%) 4/35 (11%) 0/38 (0%) 1/42 (2%) | |FIRST INCIDENCE | 620 729 (T) 729 (T) 729 (T) |576 613 711 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.055N P=0.030N* P=0.019N* P=0.016N* |P=0.072N P=0.272 P=0.273N P=0.241N | |POLY 3 | P=0.063N P=0.019N* P=0.017N* P=0.016N* |P=0.084N P=0.270 P=0.298N P=0.277N | |POLY 1.5 | P=0.066N P=0.020N* P=0.018N* P=0.017N* |P=0.091N P=0.262 P=0.301N P=0.289N | |POLY 6 | P=0.060N P=0.019N* P=0.017N* P=0.015N* |P=0.076N P=0.277 P=0.293N P=0.261N | |LOGISTIC REGRESSION| P=0.059N P=0.020N* P=0.018N* P=0.016N* |P=0.100N P=0.241 P=0.304N P=0.304N | |COCH-ARM / FISHERS | P=0.073N P=0.022N* P=0.020N* P=0.020N* |P=0.102N P=0.243 P=0.309N P=0.309N | |ORDER RESTRICTED | P=0.005N** (e) (e) (e) |P=0.084N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Heart: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/45.69 0/45.52 0/46.42 0/47.18 |2/42.71 0/44.99 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |4.7% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |2/33 (6%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- |731 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.488N P=0.515N P=0.495N P=0.490N |P=0.230N P=0.225N P=0.208N P=0.187N | |POLY 3 | P=0.502N P=0.501N P=0.497N P=0.494N |P=0.266N P=0.226N P=0.230N P=0.217N | |POLY 1.5 | P=0.500N P=0.502N P=0.498N P=0.496N |P=0.265N P=0.229N P=0.233N P=0.226N | |POLY 6 | P=0.503N P=0.500N P=0.495N P=0.490N |P=0.266N P=0.223N P=0.226N P=0.206N | |LOGISTIC REGRESSION| P=0.488N (e) (e) (e) |P=0.230N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.499N P=0.505N P=0.500N P=0.500N |P=0.262N P=0.247N P=0.247N P=0.247N | |ORDER RESTRICTED | P=0.115N (e) (e) (e) |P=0.023N* (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/45.69 0/45.94 2/46.42 0/47.18 |0/41.88 0/44.99 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 2.2% 0.0% 4.3% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 0/38 (0%) 2/42 (5%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.420N P=0.515N P=0.508 P=0.490N |(e) (e) (e) (e) | |POLY 3 | P=0.431N P=0.499N P=0.505 P=0.494N |(e) (e) (e) (e) | |POLY 1.5 | P=0.435N P=0.500N P=0.503 P=0.496N |(e) (e) (e) (e) | |POLY 6 | P=0.425N P=0.499N P=0.508 P=0.490N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.420N (e) P=0.508 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.441N P=0.500N P=0.500 P=0.500N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.319N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 1/45.90 2/46.01 1/47.14 0/47.18 |0/41.88 0/44.99 1/44.64 0/46.93 | |POLY-3 PERCENT (g) | 2.2% 4.4% 2.1% 0.0% |0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 0/41 (0%) 1/38 (3%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 676 711 479 --- |--- --- 512 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.229N P=0.488 P=0.755N P=0.486N |P=0.778N (e) P=0.509 (e) | |POLY 3 | P=0.234N P=0.501 P=0.755N P=0.494N |P=0.766N (e) P=0.513 (e) | |POLY 1.5 | P=0.236N P=0.500 P=0.757N P=0.497N |P=0.772N (e) P=0.509 (e) | |POLY 6 | P=0.231N P=0.500 P=0.753N P=0.492N |P=0.758N (e) P=0.517 (e) | |LOGISTIC REGRESSION| P=0.263N P=0.500 P=0.729 P=0.513N |P=0.741N (e) P=0.479 (e) | |COCH-ARM / FISHERS | P=0.238N P=0.500 P=0.753N P=0.500N |P=0.778N (e) P=0.505 (e) | |ORDER RESTRICTED | P=0.220N (e) (e) (e) |P=0.393 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 1/46.08 0/45.94 0/46.42 0/47.18 |0/41.88 2/45.74 2/45.55 0/46.93 | |POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |0.0% 4.4% 4.4% 0.0% | |TERMINAL (d) | 0/41 (0%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 620 --- --- --- |--- 506 334 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.496N P=0.491N P=0.496N P=0.491N |P=0.363N P=0.260 P=0.245 (e) | |POLY 3 | P=0.500N P=0.501N P=0.499N P=0.495N |P=0.336N P=0.257 P=0.256 (e) | |POLY 1.5 | P=0.500N P=0.500N P=0.499N P=0.497N |P=0.351N P=0.253 P=0.251 (e) | |POLY 6 | P=0.499N P=0.502N P=0.498N P=0.493N |P=0.317N P=0.261 P=0.262 (e) | |LOGISTIC REGRESSION| P=0.531N P=0.480N P=0.526N P=0.530N |P=0.301N P=0.158 P=0.176 (e) | |COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.500N P=0.500N |P=0.370N P=0.253 P=0.253 (e) | |ORDER RESTRICTED | P=0.116N (e) (e) (e) |P=0.272N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Metaplasia Osseous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 3/50 (6%) 5/50 (10%) 1/50 (2%) |2/49 (4%) 3/50 (6%) 3/50 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 7/45.90 3/46.26 5/46.42 1/47.18 |2/42.96 3/45.01 3/43.99 1/46.93 | |POLY-3 PERCENT (g) | 15.3% 6.5% 10.8% 2.1% |4.7% 6.7% 6.8% 2.1% | |TERMINAL (d) | 6/41 (15%) 2/38 (5%) 5/42 (12%) 1/43 (2%) |0/33 (0%) 2/35 (6%) 3/38 (8%) 1/42 (2%) | |FIRST INCIDENCE | 676 641 729 (T) 729 (T) |352 725 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.042N* P=0.187N P=0.363N P=0.029N* |P=0.231N P=0.527 P=0.545 P=0.447N | |POLY 3 | P=0.046N* P=0.154N P=0.371N P=0.027N* |P=0.269N P=0.521 P=0.511 P=0.469N | |POLY 1.5 | P=0.047N* P=0.156N P=0.374N P=0.029N* |P=0.283N P=0.519 P=0.509 P=0.481N | |POLY 6 | P=0.043N* P=0.153N P=0.369N P=0.026N* |P=0.249N P=0.521 P=0.515 P=0.454N | |LOGISTIC REGRESSION| P=0.045N* P=0.156N P=0.361N P=0.027N* |P=0.302N P=0.434 P=0.494 P=0.525N | |COCH-ARM / FISHERS | P=0.051N P=0.159N P=0.380N P=0.030N* |P=0.295N P=0.510 P=0.510 P=0.492N | |ORDER RESTRICTED | P=0.015N* (e) (e) (e) |P=0.314N (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 8 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 45/50 (90%) 43/50 (86%) 40/50 (80%) 34/50 (68%) |25/49 (51%) 31/50 (62%) 22/50 (44%) 17/50 (34%) | |POLY-3 RATE (b) | 45/48.46 43/48.07 40/49.25 34/49.11 |25/45.56 31/47.71 22/46.52 17/47.30 | |POLY-3 PERCENT (g) | 92.9% 89.5% 81.2% 69.2% |54.9% 65.0% 47.3% 35.9% | |TERMINAL (d) | 39/41 (95%) 36/38 (95%) 34/42 (81%) 31/43 (72%) |16/33 (49%) 23/35 (66%) 16/38 (42%) 14/42 (33%) | |FIRST INCIDENCE | 517 556 479 452 |366 506 501 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.531 P=0.137N P=0.005N** |P=0.002N** P=0.283 P=0.211N P=0.017N* | |POLY 3 | P<0.001N** P=0.403N P=0.071N P=0.002N** |P=0.006N** P=0.213 P=0.301N P=0.050N | |POLY 1.5 | P<0.001N** P=0.400N P=0.090N P=0.003N** |P=0.008N** P=0.207 P=0.307N P=0.057N | |POLY 6 | P<0.001N** P=0.403N P=0.055N P<0.001N** |P=0.004N** P=0.209 P=0.292N P=0.041N* | |LOGISTIC REGRESSION| P<0.001N** P=0.333N P=0.113N P=0.005N** |P=0.008N** P=0.195 P=0.306N P=0.056N | |COCH-ARM / FISHERS | P=0.003N** P=0.380N P=0.131N P=0.006N** |P=0.010N* P=0.184 P=0.309N P=0.065N | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.012N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/45.69 1/45.94 0/46.42 0/47.18 |0/41.88 0/44.99 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 4.4% 2.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/41 (5%) 1/38 (3%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.175N P=0.527N P=0.233N P=0.228N |(e) (e) (e) (e) | |POLY 3 | P=0.184N P=0.498N P=0.234N P=0.230N |(e) (e) (e) (e) | |POLY 1.5 | P=0.185N P=0.499N P=0.235N P=0.233N |(e) (e) (e) (e) | |POLY 6 | P=0.182N P=0.498N P=0.232N P=0.226N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.175N P=0.527N (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.186N P=0.500N P=0.247N P=0.247N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.070N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 9 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 6/50 (12%) 7/50 (14%) 4/50 (8%) |4/49 (8%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 3/45.69 6/46.04 7/46.64 4/47.18 |4/42.26 2/45.69 0/43.99 2/46.93 | |POLY-3 PERCENT (g) | 6.6% 13.0% 15.0% 8.5% |9.5% 4.4% 0.0% 4.3% | |TERMINAL (d) | 3/41 (7%) 5/38 (13%) 6/42 (14%) 4/43 (9%) |3/33 (9%) 0/35 (0%) 0/38 (0%) 2/42 (5%) | |FIRST INCIDENCE | 729 (T) 702 672 729 (T) |625 515 --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.455N P=0.212 P=0.171 P=0.526 |P=0.335N P=0.311N P=0.053N P=0.243N | |POLY 3 | P=0.487N P=0.246 P=0.166 P=0.517 |P=0.391N P=0.302N P=0.055N P=0.290N | |POLY 1.5 | P=0.497N P=0.244 P=0.163 P=0.510 |P=0.399N P=0.309N P=0.056N P=0.307N | |POLY 6 | P=0.473N P=0.246 P=0.170 P=0.527 |P=0.380N P=0.298N P=0.053N P=0.271N | |LOGISTIC REGRESSION| P=0.470N P=0.237 P=0.167 P=0.526 |P=0.407N P=0.347N P=0.058N P=0.295N | |COCH-ARM / FISHERS | P=0.512N P=0.243 P=0.159 P=0.500 |P=0.404N P=0.329N P=0.056N P=0.329N | |ORDER RESTRICTED | P=0.305 (e) (e) (e) |P=0.073N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 11/50 (22%) 6/50 (12%) 5/50 (10%) |4/49 (8%) 2/50 (4%) 3/50 (6%) 0/50 (0%) | |POLY-3 RATE (b) | 9/45.69 11/45.94 6/46.42 5/47.18 |4/42.16 2/45.01 3/43.99 0/46.93 | |POLY-3 PERCENT (g) | 19.7% 24.0% 12.9% 10.6% |9.5% 4.4% 6.8% 0.0% | |TERMINAL (d) | 9/41 (22%) 11/38 (29%) 6/42 (14%) 5/43 (12%) |3/33 (9%) 1/35 (3%) 3/38 (8%) 0/42 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |658 725 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.067N P=0.325 P=0.268N P=0.166N |P=0.046N* P=0.315N P=0.434N P=0.041N* | |POLY 3 | P=0.083N P=0.406 P=0.275N P=0.175N |P=0.057N P=0.307N P=0.477N P=0.048N* | |POLY 1.5 | P=0.089N P=0.403 P=0.281N P=0.183N |P=0.062N P=0.312N P=0.481N P=0.052N | |POLY 6 | P=0.077N P=0.405 P=0.270N P=0.165N |P=0.051N P=0.305N P=0.470N P=0.043N* | |LOGISTIC REGRESSION| P=0.067N P=0.325 P=0.268N P=0.166N |P=0.052N P=0.302N P=0.465N P=0.051N | |COCH-ARM / FISHERS | P=0.097N P=0.402 P=0.288N P=0.194N |P=0.067N P=0.329N P=0.489N P=0.056N | |ORDER RESTRICTED | P=0.110N (e) (e) (e) |P=0.028N* (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 10 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 7/50 (14%) 0/50 (0%) 2/50 (4%) |12/49 (24%) 8/50 (16%) 3/50 (6%) 4/50 (8%) | |POLY-3 RATE (b) | 8/46.08 7/45.94 0/46.42 2/47.18 |12/43.01 8/45.01 3/43.99 4/47.06 | |POLY-3 PERCENT (g) | 17.4% 15.2% 0.0% 4.2% |27.9% 17.8% 6.8% 8.5% | |TERMINAL (d) | 7/41 (17%) 7/38 (18%) 0/42 (0%) 2/43 (5%) |9/33 (27%) 7/35 (20%) 3/38 (8%) 3/42 (7%) | |FIRST INCIDENCE | 620 729 (T) --- 729 (T) |450 725 731 (T) 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.023N* P=0.557N P=0.005N** P=0.042N* |P=0.014N* P=0.188N P=0.007N** P=0.010N* | |POLY 3 | P=0.025N* P=0.503N P=0.003N** P=0.041N* |P=0.023N* P=0.189N P=0.008N** P=0.015N* | |POLY 1.5 | P=0.026N* P=0.502N P=0.004N** P=0.043N* |P=0.028N* P=0.193N P=0.009N** P=0.018N* | |POLY 6 | P=0.024N* P=0.507N P=0.003N** P=0.039N* |P=0.019N* P=0.190N P=0.008N** P=0.011N* | |LOGISTIC REGRESSION| P=0.025N* P=0.496N P=0.005N** P=0.042N* |P=0.023N* P=0.176N P=0.010N* P=0.020N* | |COCH-ARM / FISHERS | P=0.030N* P=0.500N P=0.003N** P=0.046N* |P=0.034N* P=0.212N P=0.010N* P=0.024N* | |ORDER RESTRICTED | P=0.006N** (e) (e) (e) |P=0.004N** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Fatty Change | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |2/49 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/45.69 2/45.94 1/46.42 0/47.18 |2/42.08 1/45.56 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 0.0% 4.4% 2.2% 0.0% |4.8% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/41 (0%) 2/38 (5%) 1/42 (2%) 0/43 (0%) |1/33 (3%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) --- |681 550 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.364N P=0.222 P=0.505 (e) |P=0.166N P=0.476N P=0.213N P=0.189N | |POLY 3 | P=0.374N P=0.238 P=0.503 (e) |P=0.181N P=0.472N P=0.227N P=0.214N | |POLY 1.5 | P=0.378N P=0.238 P=0.502 (e) |P=0.183N P=0.478N P=0.229N P=0.222N | |POLY 6 | P=0.369N P=0.238 P=0.505 (e) |P=0.177N P=0.469N P=0.224N P=0.204N | |LOGISTIC REGRESSION| (e) P=0.222 P=0.505 (e) |P=0.188N P=0.537N P=0.228N P=0.222N | |COCH-ARM / FISHERS | P=0.383N P=0.247 P=0.500 (e) |P=0.184N P=0.492N P=0.242N P=0.242N | |ORDER RESTRICTED | P=0.320N (e) (e) (e) |P=0.060N (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 11 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/46.34 0/45.94 1/46.42 0/47.18 |0/41.88 1/44.99 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 4.3% 0.0% 2.2% 0.0% |0.0% 2.2% 0.0% 0.0% | |TERMINAL (d) | 1/41 (2%) 0/38 (0%) 1/42 (2%) 0/43 (0%) |0/33 (0%) 1/35 (3%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 517 --- 729 (T) --- |--- 731 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.266N P=0.248N P=0.494N P=0.235N |P=0.565N P=0.512 (e) (e) | |POLY 3 | P=0.270N P=0.239N P=0.499N P=0.233N |P=0.587N P=0.514 (e) (e) | |POLY 1.5 | P=0.273N P=0.239N P=0.500N P=0.235N |P=0.591N P=0.512 (e) (e) | |POLY 6 | P=0.267N P=0.240N P=0.499N P=0.231N |P=0.582N P=0.516 (e) (e) | |LOGISTIC REGRESSION| P=0.295N P=0.215N P=0.523N P=0.266N |(e) P=0.512 (e) (e) | |COCH-ARM / FISHERS | P=0.276N P=0.247N P=0.500N P=0.247N |P=0.600N P=0.505 (e) (e) | |ORDER RESTRICTED | P=0.072N (e) (e) (e) |P=0.374N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 2/45.95 1/45.94 2/46.42 1/47.18 |0/41.88 0/44.99 0/43.99 1/46.93 | |POLY-3 PERCENT (g) | 4.4% 2.2% 4.3% 2.1% |0.0% 0.0% 0.0% 2.1% | |TERMINAL (d) | 1/41 (2%) 1/38 (3%) 2/42 (5%) 1/43 (2%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 1/42 (2%) | |FIRST INCIDENCE | 662 729 (T) 729 (T) 729 (T) |--- --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.449N P=0.518N P=0.685N P=0.481N |P=0.254 (e) (e) P=0.548 | |POLY 3 | P=0.469N P=0.500N P=0.690N P=0.491N |P=0.234 (e) (e) P=0.523 | |POLY 1.5 | P=0.473N P=0.500N P=0.691N P=0.495N |P=0.228 (e) (e) P=0.514 | |POLY 6 | P=0.463N P=0.502N P=0.689N P=0.486N |P=0.242 (e) (e) P=0.533 | |LOGISTIC REGRESSION| P=0.467N P=0.500N P=0.692N P=0.500N |(e) (e) (e) P=0.548 | |COCH-ARM / FISHERS | P=0.479N P=0.500N P=0.691N P=0.500N |P=0.222 (e) (e) P=0.505 | |ORDER RESTRICTED | P=0.431N (e) (e) (e) |P=0.142 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 12 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |1/49 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 1/45.69 2/46.38 2/47.51 2/48.39 |1/42.76 0/44.99 3/44.72 1/47.06 | |POLY-3 PERCENT (g) | 2.2% 4.3% 4.2% 4.1% |2.3% 0.0% 6.7% 2.1% | |TERMINAL (d) | 1/41 (2%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 1/38 (3%) 0/42 (0%) | |FIRST INCIDENCE | 729 (T) 641 479 452 |366 --- 512 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.516 P=0.497 P=0.510 P=0.510 |P=0.634 P=0.496N P=0.338 P=0.731N | |POLY 3 | P=0.526 P=0.505 P=0.514 P=0.520 |P=0.626 P=0.490N P=0.321 P=0.739N | |POLY 1.5 | P=0.516 P=0.503 P=0.508 P=0.512 |P=0.609 P=0.491N P=0.317 P=0.747N | |POLY 6 | P=0.538 P=0.508 P=0.520 P=0.529 |P=0.651 P=0.489N P=0.329 P=0.727N | |LOGISTIC REGRESSION| P=0.412 P=0.500 P=0.449 P=0.427 |P=0.602 (e) P=0.278 P=0.763 | |COCH-ARM / FISHERS | P=0.500 P=0.500 P=0.500 P=0.500 |P=0.596 P=0.495N P=0.316 P=0.747N | |ORDER RESTRICTED | P=0.478 (e) (e) (e) |P=0.282 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Tension Lipidosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |1/49 (2%) 5/50 (10%) 2/50 (4%) 4/50 (8%) | |POLY-3 RATE (b) | 2/45.69 1/46.06 2/46.42 1/47.18 |1/41.97 5/45.10 2/43.99 4/47.91 | |POLY-3 PERCENT (g) | 4.4% 2.2% 4.3% 2.1% |2.4% 11.1% 4.6% 8.4% | |TERMINAL (d) | 2/41 (5%) 0/38 (0%) 2/42 (5%) 1/43 (2%) |0/33 (0%) 3/35 (9%) 2/38 (5%) 3/42 (7%) | |FIRST INCIDENCE | 729 (T) 697 729 (T) 729 (T) |710 709 731 (T) 200 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.450N P=0.515N P=0.686N P=0.483N |P=0.449 P=0.126 P=0.548 P=0.244 | |POLY 3 | P=0.468N P=0.497N P=0.688N P=0.489N |P=0.405 P=0.118 P=0.516 P=0.222 | |POLY 1.5 | P=0.473N P=0.499N P=0.690N P=0.494N |P=0.380 P=0.115 P=0.513 P=0.207 | |POLY 6 | P=0.463N P=0.496N P=0.686N P=0.483N |P=0.434 P=0.120 P=0.522 P=0.239 | |LOGISTIC REGRESSION| P=0.459N P=0.498N P=0.686N P=0.483N |P=0.333 P=0.121 P=0.526 P=0.155 | |COCH-ARM / FISHERS | P=0.479N P=0.500N P=0.691N P=0.500N |P=0.343 P=0.107 P=0.508 P=0.187 | |ORDER RESTRICTED | P=0.428N (e) (e) (e) |P=0.204 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 13 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Liver | | Vacuolization Cytoplasmic Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 2/45.69 0/45.94 0/46.42 0/47.18 |0/41.88 0/44.99 0/43.99 1/47.91 | |POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 2.1% | |TERMINAL (d) | 2/41 (5%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- 200 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.251N P=0.255N P=0.233N P=0.228N |P=0.221 (e) (e) P=0.500 | |POLY 3 | P=0.261N P=0.236N P=0.234N P=0.230N |P=0.237 (e) (e) P=0.527 | |POLY 1.5 | P=0.261N P=0.237N P=0.235N P=0.233N |P=0.231 (e) (e) P=0.518 | |POLY 6 | P=0.260N P=0.236N P=0.232N P=0.226N |P=0.246 (e) (e) P=0.537 | |LOGISTIC REGRESSION| P=0.251N (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.262N P=0.247N P=0.247N P=0.247N |P=0.222 (e) (e) P=0.505 | |ORDER RESTRICTED | P=0.027N* (e) (e) (e) |P=0.146 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 5/49 (10%) 5/49 (10%) 7/49 (14%) |4/50 (8%) 3/50 (6%) 4/50 (8%) 8/49 (16%) | |POLY-3 RATE (b) | 1/45.45 5/45.84 5/46.05 7/46.83 |4/43.19 3/44.99 4/43.99 8/46.92 | |POLY-3 PERCENT (g) | 2.2% 10.9% 10.9% 15.0% |9.3% 6.7% 9.1% 17.1% | |TERMINAL (d) | 1/41 (2%) 4/38 (11%) 5/42 (12%) 6/43 (14%) |2/33 (6%) 3/35 (9%) 4/38 (11%) 6/42 (14%) | |FIRST INCIDENCE | 729 (T) 641 729 (T) 719 |660 731 (T) 731 (T) 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.093 P=0.092 P=0.109 P=0.040 * |P=0.136 P=0.472N P=0.578N P=0.316 | |POLY 3 | P=0.075 P=0.103 P=0.104 P=0.033 * |P=0.075 P=0.478N P=0.634N P=0.220 | |POLY 1.5 | P=0.072 P=0.102 P=0.103 P=0.032 * |P=0.065 P=0.483N P=0.637N P=0.197 | |POLY 6 | P=0.080 P=0.104 P=0.106 P=0.035 * |P=0.090 P=0.478N P=0.628N P=0.248 | |LOGISTIC REGRESSION| P=0.081 P=0.103 P=0.109 P=0.039 * |P=0.092 P=0.472N P=0.625N P=0.213 | |COCH-ARM / FISHERS | P=0.068 P=0.102 P=0.102 P=0.030 * |P=0.056 P=0.500N P=0.643N P=0.168 | |ORDER RESTRICTED | P=0.026 * (e) (e) (e) |P=0.122 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 14 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolus | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 4/49 (8%) 5/49 (10%) 1/49 (2%) |3/50 (6%) 6/50 (12%) 9/50 (18%) 17/49 (35%) | |POLY-3 RATE (b) | 2/45.45 4/45.52 5/46.05 1/46.79 |3/43.00 6/44.99 9/43.99 17/48.75 | |POLY-3 PERCENT (g) | 4.4% 8.8% 10.9% 2.1% |7.0% 13.3% 20.5% 34.9% | |TERMINAL (d) | 2/41 (5%) 4/38 (11%) 5/42 (12%) 1/43 (2%) |1/33 (3%) 6/35 (17%) 9/38 (24%) 13/42 (31%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |676 731 (T) 731 (T) 200 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.204N P=0.302 P=0.226 P=0.483N |P<0.001 ** P=0.277 P=0.100 P=0.005 ** | |POLY 3 | P=0.219N P=0.338 P=0.221 P=0.490N |P<0.001 ** P=0.264 P=0.063 P<0.001 ** | |POLY 1.5 | P=0.226N P=0.337 P=0.219 P=0.494N |P<0.001 ** P=0.259 P=0.062 P<0.001 ** | |POLY 6 | P=0.210N P=0.338 P=0.224 P=0.484N |P<0.001 ** P=0.265 P=0.065 P=0.002 ** | |LOGISTIC REGRESSION| P=0.204N P=0.302 P=0.226 P=0.483N |P<0.001 ** P=0.273 P=0.074 P<0.001 ** | |COCH-ARM / FISHERS | P=0.234N P=0.339 P=0.218 P=0.500N |P<0.001 ** P=0.243 P=0.061 P<0.001 ** | |ORDER RESTRICTED | P=0.196N (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Lung: Bronchiole | | Hyperplasia Atypical | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 38/49 (78%) 46/49 (94%) 46/49 (94%) |0/50 (0%) 39/50 (78%) 45/50 (90%) 48/49 (98%) | |POLY-3 RATE (b) | 0/45.45 38/46.48 46/48.63 46/48.04 |0/42.71 39/46.37 45/47.11 48/49.00 | |POLY-3 PERCENT (g) | 0.0% 81.8% 94.6% 95.8% |0.0% 84.1% 95.5% 98.0% | |TERMINAL (d) | 0/41 (0%) 34/38 (90%) 40/42 (95%) 43/43 (100%)|0/33 (0%) 35/35 (100%) 38/38 (100%) 41/42 (98%) | |FIRST INCIDENCE | --- 600 479 452 |--- 537 359 200 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 15 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 10/11 (91%) 4/4 (100%) 4/4 (100%) 5/5 (100%) |17/17 (100%) 15/16 (94%) 3/4 (75%) 5/5 (100%) | |POLY-3 RATE (b) | 10/11.00 4/4.00 4/4.00 5/5.00 |17/17.00 15/15.43 3/4.00 5/5.00 | |POLY-3 PERCENT (g) | 90.9% 100.0% 100.0% 100.0% |100.0% 97.2% 75.0% 100.0% | |TERMINAL (d) | 8/9 (89%) 4/4 (100%) 4/4 (100%) 4/4 (100%) |12/12 (100%) 9/9 (100%) 3/4 (75%) 4/4 (100%) | |FIRST INCIDENCE | 536 729 (T) 729 (T) 598 |586 515 731 (T) 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.581 P=0.419N P=0.412N P=0.610N |P=0.032N* P=0.547 P=0.009N** (e) | |POLY 3 | P=0.574 P=0.697 P=0.697 P=0.654 |P=0.807N P=0.899N P=0.193N (e) | |POLY 1.5 | P=0.574 P=0.697 P=0.697 P=0.654 |P=0.796N P=0.687N P=0.193N (e) | |POLY 6 | P=0.574 P=0.697 P=0.697 P=0.654 |P=0.810N P=1.000N P=0.193N (e) | |LOGISTIC REGRESSION| (e) P=0.419N P=0.412N (e) |P=0.756N P=0.908N P=0.009N** (e) | |COCH-ARM / FISHERS | P=0.579 P=0.733 P=0.733 P=0.688 |P=0.773N P=0.485N P=0.190N (e) | |ORDER RESTRICTED | P=0.326 (e) (e) (e) |P=0.254N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 47/50 (94%) 49/49 (100%) 49/50 (98%) |1/50 (2%) 50/50 (100%) 49/50 (98%) 49/49 (100%) | |POLY-3 RATE (b) | 3/45.69 47/48.94 49/49.00 49/50.00 |1/42.71 50/50.00 49/49.34 49/49.00 | |POLY-3 PERCENT (g) | 6.6% 96.0% 100.0% 98.0% |2.3% 100.0% 99.3% 100.0% | |TERMINAL (d) | 3/41 (7%) 38/38 (100%) 42/42 (100%) 42/43 (98%) |1/33 (3%) 35/35 (100%) 38/38 (100%) 42/42 (100%) | |FIRST INCIDENCE | 729 (T) 543 479 452 |731 (T) 506 334 200 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 16 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Nose: Glands, Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 50/50 (100%) 49/49 (100%) 50/50 (100%)|3/50 (6%) 50/50 (100%) 50/50 (100%) 49/49 (100%) | |POLY-3 RATE (b) | 12/46.08 50/50.00 49/49.00 50/50.00 |3/42.71 50/50.00 50/50.00 49/49.00 | |POLY-3 PERCENT (g) | 26.0% 100.0% 100.0% 100.0% |7.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 11/41 (27%) 38/38 (100%) 42/42 (100%) 43/43 (100%)|3/33 (9%) 35/35 (100%) 38/38 (100%) 42/42 (100%) | |FIRST INCIDENCE | 620 338 479 452 |731 (T) 506 334 200 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |8/50 (16%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 14/46.08 0/45.94 0/46.05 0/47.18 |8/43.38 0/44.99 0/43.99 0/46.76 | |POLY-3 PERCENT (g) | 30.4% 0.0% 0.0% 0.0% |18.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 13/41 (32%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |6/33 (18%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 620 --- --- --- |596 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |P=0.008N** P=0.004N** P=0.003N** P=0.002N** | |POLY 3 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |P=0.008N** P=0.003N** P=0.003N** P=0.002N** | |POLY 1.5 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |P=0.009N** P=0.003N** P=0.003N** P=0.003N** | |POLY 6 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |P=0.007N** P=0.003N** P=0.003N** P=0.002N** | |LOGISTIC REGRESSION| P<0.001N** P<0.001N** P<0.001N** P<0.001N** |P=0.011N* P=0.004N** P=0.004N** P=0.004N** | |COCH-ARM / FISHERS | P<0.001N** P<0.001N** P<0.001N** P<0.001N** |P=0.012N* P=0.003N** P=0.003N** P=0.003N** | |ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P<0.001N** (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 17 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 50/50 (100%) 48/49 (98%) 11/50 (22%) |2/50 (4%) 50/50 (100%) 40/50 (80%) 8/49 (16%) | |POLY-3 RATE (b) | 5/45.69 50/50.00 48/49.00 11/47.99 |2/43.17 50/50.00 40/50.00 8/47.74 | |POLY-3 PERCENT (g) | 10.9% 100.0% 98.0% 22.9% |4.6% 100.0% 80.0% 16.8% | |TERMINAL (d) | 5/41 (12%) 38/38 (100%) 41/42 (98%) 9/43 (21%) |1/33 (3%) 35/35 (100%) 28/38 (74%) 7/42 (17%) | |FIRST INCIDENCE | 729 (T) 338 479 452 |596 506 334 200 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P<0.001 ** P<0.001 ** P=0.106 |P<0.001N** P<0.001 ** P<0.001 ** P=0.093 | |POLY 3 | P<0.001N** P<0.001 ** P<0.001 ** P=0.102 |P<0.001N** P<0.001 ** P<0.001 ** P=0.064 | |POLY 1.5 | P<0.001N** P<0.001 ** P<0.001 ** P=0.095 |P<0.001N** P<0.001 ** P<0.001 ** P=0.055 | |POLY 6 | P<0.001N** P<0.001 ** P<0.001 ** P=0.110 |P<0.001N** P<0.001 ** P<0.001 ** P=0.076 | |LOGISTIC REGRESSION| P<0.001N** P<0.001 ** P<0.001 ** P=0.090 |P<0.001N** P<0.001 ** P<0.001 ** P=0.031 * | |COCH-ARM / FISHERS | P<0.001N** P<0.001 ** P<0.001 ** P=0.086 |P<0.001N** P<0.001 ** P<0.001 ** P=0.043 * | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium, Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 50/50 (100%) 49/49 (100%) 50/50 (100%)|0/50 (0%) 50/50 (100%) 50/50 (100%) 49/49 (100%) | |POLY-3 RATE (b) | 1/45.69 50/50.00 49/49.00 50/50.00 |0/42.71 50/50.00 50/50.00 49/49.00 | |POLY-3 PERCENT (g) | 2.2% 100.0% 100.0% 100.0% |0.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 1/41 (2%) 38/38 (100%) 42/42 (100%) 43/43 (100%)|0/33 (0%) 35/35 (100%) 38/38 (100%) 42/42 (100%) | |FIRST INCIDENCE | 729 (T) 338 479 452 |--- 506 334 200 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 18 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/48 (4%) 3/50 (6%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | |2/41.05 3/44.99 0/42.99 0/45.93 | |POLY-3 PERCENT (g) | |4.9% 6.7% 0.0% 0.0% | |TERMINAL (d) | |1/33 (3%) 3/35 (9%) 0/37 (0%) 0/41 (0%) | |FIRST INCIDENCE | |709 731 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.080N P=0.529 P=0.213N P=0.195N | |POLY 3 | |P=0.090N P=0.542 P=0.227N P=0.213N | |POLY 1.5 | |P=0.094N P=0.536 P=0.229N P=0.221N | |POLY 6 | |P=0.085N P=0.544 P=0.224N P=0.203N | |LOGISTIC REGRESSION| |P=0.082N P=0.548 P=0.224N P=0.207N | |COCH-ARM / FISHERS | |P=0.100N P=0.520 P=0.242N P=0.242N | |ORDER RESTRICTED | |P=0.078N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |9/48 (19%) 14/50 (28%) 10/49 (20%) 9/49 (18%) | |POLY-3 RATE (b) | |9/41.82 14/46.03 10/44.32 9/45.93 | |POLY-3 PERCENT (g) | |21.5% 30.4% 22.6% 19.6% | |TERMINAL (d) | |7/33 (21%) 10/35 (29%) 7/37 (19%) 9/41 (22%) | |FIRST INCIDENCE | |450 515 501 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.184N P=0.224 P=0.597N P=0.414N | |POLY 3 | |P=0.273N P=0.240 P=0.557 P=0.516N | |POLY 1.5 | |P=0.303N P=0.228 P=0.541 P=0.548N | |POLY 6 | |P=0.235N P=0.250 P=0.578 P=0.476N | |LOGISTIC REGRESSION| |P=0.299N P=0.226 P=0.527 P=0.518N | |COCH-ARM / FISHERS | |P=0.332N P=0.200 P=0.520 P=0.584N | |ORDER RESTRICTED | |P=0.374N (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 19 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/50 (0%) |0/48 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/45.45 0/45.42 0/46.42 0/47.18 |0/41.16 2/45.79 1/43.99 0/46.93 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 2.3% 0.0% | |TERMINAL (d) | 0/41 (0%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 1/38 (3%) 0/42 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 515 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.348N P=0.264 P=0.528 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.348N P=0.261 P=0.513 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.360N P=0.257 P=0.511 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.334N P=0.264 P=0.516 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.383N P=0.158 P=0.528 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.377N P=0.258 P=0.510 (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.322N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/48 (0%) 0/50 (0%) 0/50 (0%) |0/48 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 2/45.45 0/45.42 0/46.42 0/47.18 |0/41.16 0/44.99 2/43.99 0/46.93 | |POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% |0.0% 0.0% 4.6% 0.0% | |TERMINAL (d) | 2/41 (5%) 0/38 (0%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 2/38 (5%) 0/42 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- |--- --- 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.251N P=0.255N P=0.233N P=0.228N |P=0.625N (e) P=0.270 (e) | |POLY 3 | P=0.259N P=0.237N P=0.232N P=0.229N |P=0.649N (e) P=0.252 (e) | |POLY 1.5 | P=0.258N P=0.239N P=0.233N P=0.231N |P=0.660N (e) P=0.250 (e) | |POLY 6 | P=0.259N P=0.236N P=0.232N P=0.226N |P=0.633N (e) P=0.255 (e) | |LOGISTIC REGRESSION| P=0.251N (e) (e) (e) |(e) (e) P=0.270 (e) | |COCH-ARM / FISHERS | P=0.258N P=0.253N P=0.242N P=0.242N |P=0.671N (e) P=0.258 (e) | |ORDER RESTRICTED | P=0.027N* (e) (e) (e) |P=0.261 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 20 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/47 (0%) 0/46 (0%) |3/47 (6%) 0/50 (0%) 0/49 (0%) 0/45 (0%) | |POLY-3 RATE (b) | 0/43.90 0/44.39 0/44.18 0/44.12 |3/39.88 0/44.99 0/42.99 0/42.76 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |7.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/38 (0%) 0/41 (0%) 0/41 (0%) |3/31 (10%) 0/35 (0%) 0/37 (0%) 0/38 (0%) | |FIRST INCIDENCE | --- --- --- --- |731 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.129N P=0.100N P=0.091N P=0.087N | |POLY 3 | (e) (e) (e) (e) |P=0.156N P=0.098N P=0.105N P=0.106N | |POLY 1.5 | (e) (e) (e) (e) |P=0.156N P=0.101N P=0.108N P=0.115N | |POLY 6 | (e) (e) (e) (e) |P=0.155N P=0.096N P=0.102N P=0.097N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.129N (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.156N P=0.110N P=0.113N P=0.129N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.006N** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 1/47 (2%) 2/47 (4%) 1/46 (2%) |8/47 (17%) 16/50 (32%) 6/49 (12%) 5/45 (11%) | |POLY-3 RATE (b) | 2/43.90 1/44.39 2/44.18 1/44.12 |8/40.15 16/46.07 6/43.59 5/42.77 | |POLY-3 PERCENT (g) | 4.6% 2.3% 4.5% 2.3% |19.9% 34.7% 13.8% 11.7% | |TERMINAL (d) | 2/40 (5%) 1/38 (3%) 2/41 (5%) 1/41 (2%) |7/31 (23%) 12/35 (34%) 5/37 (14%) 4/38 (11%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |660 613 536 729 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.462N P=0.518N P=0.686N P=0.491N |P=0.023N* P=0.093 P=0.273N P=0.161N | |POLY 3 | P=0.481N P=0.496N P=0.692N P=0.498N |P=0.036N* P=0.097 P=0.323N P=0.234N | |POLY 1.5 | P=0.486N P=0.500N P=0.692 P=0.505N |P=0.046N* P=0.087 P=0.335N P=0.263N | |POLY 6 | P=0.475N P=0.494N P=0.688N P=0.491N |P=0.027N* P=0.107 P=0.307N P=0.204N | |LOGISTIC REGRESSION| P=0.462N P=0.518N P=0.686N P=0.491N |P=0.042N* P=0.093 P=0.328N P=0.187N | |COCH-ARM / FISHERS | P=0.492N P=0.508N P=0.684 P=0.516N |P=0.065N P=0.070 P=0.354N P=0.305N | |ORDER RESTRICTED | P=0.441N (e) (e) (e) |P=0.048N* (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 21 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | | |POLY-3 RATE (b) | 1/45.69 3/45.94 2/46.42 1/47.18 | | |POLY-3 PERCENT (g) | 2.2% 6.5% 4.3% 2.1% | | |TERMINAL (d) | 1/41 (2%) 3/38 (8%) 2/42 (5%) 1/43 (2%) | | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.391N P=0.278 P=0.508 P=0.751N | | |POLY 3 | P=0.409N P=0.307 P=0.505 P=0.753N | | |POLY 1.5 | P=0.415N P=0.306 P=0.503 P=0.756N | | |POLY 6 | P=0.401N P=0.307 P=0.508 P=0.750N | | |LOGISTIC REGRESSION| P=0.391N P=0.278 P=0.508 P=0.751N | | |COCH-ARM / FISHERS | P=0.422N P=0.309 P=0.500 P=0.753N | | |ORDER RESTRICTED | P=0.452N (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | |POLY-3 RATE (b) | 0/45.69 0/45.94 2/46.42 0/47.18 | | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.3% 0.0% | | |TERMINAL (d) | 0/41 (0%) 0/38 (0%) 2/42 (5%) 0/43 (0%) | | |FIRST INCIDENCE | --- --- 729 (T) --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.657N (e) P=0.244 (e) | | |POLY 3 | P=0.666N (e) P=0.241 (e) | | |POLY 1.5 | P=0.670N (e) P=0.239 (e) | | |POLY 6 | P=0.661N (e) P=0.242 (e) | | |LOGISTIC REGRESSION| (e) (e) P=0.244 (e) | | |COCH-ARM / FISHERS | P=0.675N (e) P=0.247 (e) | | |ORDER RESTRICTED | P=0.250 (e) (e) (e) | | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 22 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Skin | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |3/50 (6%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 3/46.50 1/45.94 0/46.42 2/47.74 |3/44.03 2/45.29 0/43.99 1/47.06 | |POLY-3 PERCENT (g) | 6.5% 2.2% 0.0% 4.2% |6.8% 4.4% 0.0% 2.1% | |TERMINAL (d) | 1/41 (2%) 1/38 (3%) 0/42 (0%) 1/43 (2%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | 609 729 (T) --- 558 |479 656 --- 697 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.624N P=0.315N P=0.121N P=0.484N |P=0.242N P=0.475N P=0.116N P=0.260N | |POLY 3 | P=0.636N P=0.310N P=0.119N P=0.488N |P=0.268N P=0.487N P=0.119N P=0.282N | |POLY 1.5 | P=0.640N P=0.308N P=0.119N P=0.493N |P=0.274N P=0.490N P=0.119N P=0.293N | |POLY 6 | P=0.631N P=0.314N P=0.120N P=0.483N |P=0.258N P=0.487N P=0.118N P=0.268N | |LOGISTIC REGRESSION| P=0.613 P=0.301N P=0.130N P=0.555N |P=0.286N P=0.603N P=0.129N P=0.334N | |COCH-ARM / FISHERS | P=0.645 P=0.309N P=0.121N P=0.500N |P=0.280N P=0.500N P=0.121N P=0.309N | |ORDER RESTRICTED | P=0.180N (e) (e) (e) |P=0.096N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/48 (0%) 1/50 (2%) 0/50 (0%) |3/49 (6%) 3/50 (6%) 3/49 (6%) 1/49 (2%) | |POLY-3 RATE (b) | 1/45.87 0/45.42 1/46.42 0/47.18 |3/42.34 3/45.80 3/44.40 1/46.87 | |POLY-3 PERCENT (g) | 2.2% 0.0% 2.2% 0.0% |7.1% 6.6% 6.8% 2.1% | |TERMINAL (d) | 0/41 (0%) 0/38 (0%) 1/42 (2%) 0/43 (0%) |1/33 (3%) 1/35 (3%) 2/38 (5%) 0/42 (0%) | |FIRST INCIDENCE | 609 --- 729 (T) --- |625 506 334 704 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.454N P=0.496N P=0.758N P=0.496N |P=0.170N P=0.622N P=0.617N P=0.238N | |POLY 3 | P=0.458N P=0.502N P=0.758N P=0.494N |P=0.190N P=0.626N P=0.640N P=0.270N | |POLY 1.5 | P=0.458N P=0.503N P=0.757N P=0.495N |P=0.203N P=0.633N P=0.648N P=0.285N | |POLY 6 | P=0.456N P=0.502N P=0.759N P=0.493N |P=0.174N P=0.622N P=0.633N P=0.254N | |LOGISTIC REGRESSION| P=0.447N P=0.643N P=0.754N P=0.476N |P=0.240N P=0.640 P=0.645 P=0.306N | |COCH-ARM / FISHERS | P=0.458N P=0.505N P=0.747N P=0.495N |P=0.218N P=0.651N P=0.661N P=0.309N | |ORDER RESTRICTED | P=0.246N (e) (e) (e) |P=0.249N (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 23 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 4/50 (8%) 2/49 (4%) 4/50 (8%) |3/50 (6%) 5/50 (10%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/45.45 4/47.16 2/46.78 4/47.18 |3/44.63 5/45.81 0/43.99 1/46.93 | |POLY-3 PERCENT (g) | 2.2% 8.5% 4.3% 8.5% |6.7% 10.9% 0.0% 2.1% | |TERMINAL (d) | 1/41 (2%) 2/38 (5%) 0/42 (0%) 4/43 (9%) |0/33 (0%) 1/35 (3%) 0/38 (0%) 1/42 (2%) | |FIRST INCIDENCE | 729 (T) 338 572 729 (T) |366 550 --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.295 P=0.173 P=0.511 P=0.194 |P=0.106N P=0.400 P=0.121N P=0.269N | |POLY 3 | P=0.275 P=0.190 P=0.510 P=0.190 |P=0.115N P=0.371 P=0.121N P=0.288N | |POLY 1.5 | P=0.272 P=0.189 P=0.506 P=0.188 |P=0.121N P=0.366 P=0.121N P=0.297N | |POLY 6 | P=0.280 P=0.191 P=0.516 P=0.194 |P=0.107N P=0.376 P=0.120N P=0.273N | |LOGISTIC REGRESSION| P=0.240 P=0.221 P=0.487 P=0.194 |P=0.127N P=0.188 P=0.125N P=0.331N | |COCH-ARM / FISHERS | P=0.269 P=0.187 P=0.500 P=0.187 |P=0.128N P=0.357 P=0.121N P=0.309N | |ORDER RESTRICTED | P=0.156 (e) (e) (e) |P=0.061N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/50 (4%) 0/49 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/45.45 2/45.94 0/46.05 1/47.74 |0/42.71 0/44.99 0/43.99 0/46.93 | |POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 2.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/41 (0%) 2/38 (5%) 0/42 (0%) 0/43 (0%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | --- 729 (T) --- 558 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.631 P=0.222 (e) P=0.504 |(e) (e) (e) (e) | |POLY 3 | P=0.628 P=0.240 (e) P=0.510 |(e) (e) (e) (e) | |POLY 1.5 | P=0.624 P=0.240 (e) P=0.507 |(e) (e) (e) (e) | |POLY 6 | P=0.633 P=0.239 (e) P=0.513 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.608 P=0.222 (e) P=0.566 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.620 P=0.253 (e) P=0.505 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.326 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 24 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/50 (2%) 0/49 (0%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 1/45.45 1/46.26 0/46.05 3/47.18 |1/42.91 0/44.99 0/43.99 2/46.94 | |POLY-3 PERCENT (g) | 2.2% 2.2% 0.0% 6.4% |2.3% 0.0% 0.0% 4.3% | |TERMINAL (d) | 1/41 (2%) 0/38 (0%) 0/42 (0%) 3/43 (7%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 1/42 (2%) | |FIRST INCIDENCE | 729 (T) 639 --- 729 (T) |681 --- --- 729 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.141 P=0.757 P=0.495N P=0.322 |P=0.238 P=0.485N P=0.485N P=0.582 | |POLY 3 | P=0.129 P=0.757N P=0.497N P=0.319 |P=0.194 P=0.491N P=0.495N P=0.531 | |POLY 1.5 | P=0.128 P=0.757N P=0.499N P=0.316 |P=0.189 P=0.493N P=0.497N P=0.517 | |POLY 6 | P=0.131 P=0.756N P=0.496N P=0.324 |P=0.203 P=0.489N P=0.492N P=0.548 | |LOGISTIC REGRESSION| P=0.127 P=0.752N (e) P=0.322 |P=0.199 P=0.506N P=0.501N P=0.525 | |COCH-ARM / FISHERS | P=0.126 P=0.747N P=0.500N P=0.316 |P=0.186 P=0.500N P=0.500N P=0.500 | |ORDER RESTRICTED | P=0.110 (e) (e) (e) |P=0.151 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/50 (4%) 1/49 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/45.45 2/46.01 1/46.56 1/47.18 |0/42.71 1/45.56 1/44.59 0/46.93 | |POLY-3 PERCENT (g) | 0.0% 4.4% 2.2% 2.1% |0.0% 2.2% 2.2% 0.0% | |TERMINAL (d) | 0/41 (0%) 1/38 (3%) 0/42 (0%) 1/43 (2%) |0/33 (0%) 0/35 (0%) 0/38 (0%) 0/42 (0%) | |FIRST INCIDENCE | --- 711 572 729 (T) |--- 550 536 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.643 P=0.229 P=0.504 P=0.510 |P=0.531N P=0.509 P=0.504 (e) | |POLY 3 | P=0.636 P=0.240 P=0.505 P=0.507 |P=0.512N P=0.513 P=0.509 (e) | |POLY 1.5 | P=0.633 P=0.240 P=0.503 P=0.506 |P=0.523N P=0.509 P=0.505 (e) | |POLY 6 | P=0.641 P=0.239 P=0.508 P=0.510 |P=0.499N P=0.516 P=0.514 (e) | |LOGISTIC REGRESSION| P=0.621 P=0.239 P=0.511 P=0.510 |P=0.496N P=0.359 P=0.480 (e) | |COCH-ARM / FISHERS | P=0.630 P=0.253 P=0.500 P=0.505 |P=0.536N P=0.500 P=0.500 (e) | |ORDER RESTRICTED | P=0.274 (e) (e) (e) |P=0.397N (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 25 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Testes | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | | |POLY-3 RATE (b) | 2/46.34 0/45.94 0/46.42 0/47.18 | | |POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% | | |TERMINAL (d) | 1/41 (2%) 0/38 (0%) 0/42 (0%) 0/43 (0%) | | |FIRST INCIDENCE | 517 --- --- --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.257N P=0.248N P=0.237N P=0.235N | | |POLY 3 | P=0.259N P=0.239N P=0.237N P=0.233N | | |POLY 1.5 | P=0.259N P=0.239N P=0.237N P=0.235N | | |POLY 6 | P=0.257N P=0.240N P=0.236N P=0.231N | | |LOGISTIC REGRESSION| P=0.287N P=0.215N P=0.260N P=0.266N | | |COCH-ARM / FISHERS | P=0.262N P=0.247N P=0.247N P=0.247N | | |ORDER RESTRICTED | P=0.028N* (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/49 (4%) 1/50 (2%) 0/50 (0%) |1/49 (2%) 2/49 (4%) 0/50 (0%) 1/48 (2%) | |POLY-3 RATE (b) | 0/45.45 2/45.52 1/46.42 0/47.18 |1/41.88 2/44.20 0/43.99 1/45.76 | |POLY-3 PERCENT (g) | 0.0% 4.4% 2.2% 0.0% |2.4% 4.5% 0.0% 2.2% | |TERMINAL (d) | 0/41 (0%) 2/38 (5%) 1/42 (2%) 0/43 (0%) |1/33 (3%) 1/35 (3%) 0/38 (0%) 1/41 (2%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) --- |731 (T) 693 --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.364N P=0.222 P=0.505 (e) |P=0.512N P=0.529 P=0.472N P=0.713N | |POLY 3 | P=0.373N P=0.238 P=0.504 (e) |P=0.562N P=0.519 P=0.490N P=0.740N | |POLY 1.5 | P=0.375N P=0.237 P=0.504 (e) |P=0.572N P=0.513 P=0.493N P=0.751N | |POLY 6 | P=0.369N P=0.238 P=0.505 (e) |P=0.550N P=0.523 P=0.487N P=0.728N | |LOGISTIC REGRESSION| (e) P=0.222 P=0.505 (e) |P=0.544N P=0.519 (e) P=0.713N | |COCH-ARM / FISHERS | P=0.378N P=0.247 P=0.505 (e) |P=0.585N P=0.500 P=0.495N P=0.747 | |ORDER RESTRICTED | P=0.318N (e) (e) (e) |P=0.365N (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 26 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Tooth: Incisor | | Dysplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 41/41 (100%) 43/43 (100%) 41/41 (100%) 35/35 (100%)|9/9 (100%) 13/13 (100%) 8/8 (100%) 15/15 (100%) | |POLY-3 RATE (b) | 41/41.00 43/43.00 41/41.00 35/35.00 |9/9.00 13/13.00 8/8.00 15/15.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% |100.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 35/35 (100%) 37/37 (100%) 38/38 (100%) 31/31 (100%)|8/8 (100%) 10/10 (100%) 8/8 (100%) 14/14 (100%) | |FIRST INCIDENCE | 517 556 624 598 |681 550 731 (T) 725 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) | |ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |0/49 (0%) 1/50 (2%) 2/50 (4%) 1/49 (2%) | |POLY-3 RATE (b) | |0/41.88 1/44.99 2/43.99 1/46.76 | |POLY-3 PERCENT (g) | |0.0% 2.2% 4.6% 2.1% | |TERMINAL (d) | |0/33 (0%) 1/35 (3%) 2/38 (5%) 1/42 (2%) | |FIRST INCIDENCE | |--- 731 (T) 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.593 P=0.512 P=0.270 P=0.548 | |POLY 3 | |P=0.569 P=0.514 P=0.248 P=0.522 | |POLY 1.5 | |P=0.548 P=0.512 P=0.246 P=0.513 | |POLY 6 | |P=0.593 P=0.516 P=0.252 P=0.533 | |LOGISTIC REGRESSION| |(e) P=0.512 P=0.270 P=0.548 | |COCH-ARM / FISHERS | |P=0.523 P=0.505 P=0.253 P=0.500 | |ORDER RESTRICTED | |P=0.237 (e) (e) (e) | |=================================================================================================================================| Date: 08/14/03 EXPERIMENT: 88004 TEST: 06 Page 27 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 10 PPM 30 PPM 100 PPM |CONTROL 10 PPM 30 PPM 100 PPM | | | | | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/49 (4%) 8/50 (16%) 5/50 (10%) 8/49 (16%) | |POLY-3 RATE (b) | |2/41.88 8/45.96 5/44.44 8/46.78 | |POLY-3 PERCENT (g) | |4.8% 17.4% 11.3% 17.1% | |TERMINAL (d) | |2/33 (6%) 5/35 (14%) 4/38 (11%) 7/42 (17%) | |FIRST INCIDENCE | |731 (T) 537 600 725 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.261 P=0.062 P=0.269 P=0.103 | |POLY 3 | |P=0.183 P=0.062 P=0.240 P=0.066 | |POLY 1.5 | |P=0.160 P=0.058 P=0.234 P=0.057 | |POLY 6 | |P=0.214 P=0.066 P=0.250 P=0.079 | |LOGISTIC REGRESSION| |P=0.167 P=0.056 P=0.236 P=0.103 | |COCH-ARM / FISHERS | |P=0.135 P=0.049 * P=0.226 P=0.046 * | |ORDER RESTRICTED | |P=0.062 (e) (e) (e) | |=================================================================================================================================| (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).