TDMS Study 88004-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest DIVINYLBENZENE DATE: 12/17/03 EXPERIMENT: 88004 TEST: 05 TIME: 11:48:39 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88004B PATHOLOGIST: RENNE, ROGER CAS: 1321-74-0 ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 RATS REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest DIVINYLBENZENE DATE: 12/17/03 EXPERIMENT: 88004 TEST: 05 TIME: 11:48:39 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88004B PATHOLOGIST: RENNE, ROGER CAS: 1321-74-0 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF DIVINYLBENZENE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Heart Cardiomyopathy Kidney Nephropathy Chronic Liver Hepatodiaphragmatic Nodule Lung Inflammation Chronic Focal Mesentery Necrosis Nose Foreign Body Inflammation Nose: Glands Dilatation Nose: Goblet Cell Hyperplasia Nose: Olfactory Epithelium Degeneration Hyperplasia Basal Cell Pancreas: Acinus Atrophy Stomach, Forestomach Ulcer Thyroid Gland: C-Cell Hyperplasia Trachea: Glands Degeneration Cystic =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Cortex Vacuolization Cytoplasmic Clitoral Gland Cyst Heart Cardiomyopathy Kidney Nephropathy Chronic Kidney: Cortex Infarct Liver Clear Cell Focus Lung Inflammation Chronic Focal Nose Inflammation Nose: Glands Dilatation Nose: Olfactory Epithelium Degeneration Degeneration Hyaline Hyperplasia Basal Cell Nose: Respiratory Epithelium Degeneration Hyaline =============================================================== Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 1/43.25 0/45.38 0/44.07 2/45.12 |0/42.30 0/43.50 0/43.84 1/38.02 | |POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 4.4% |0.0% 0.0% 0.0% 2.6% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 1/32 (3%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 704 --- --- 680 |--- --- --- 653 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.250 P=0.463N P=0.489N P=0.525 |P=0.159 (e) (e) P=0.448 | |POLY 3 | P=0.245 P=0.490N P=0.496N P=0.515 |P=0.184 (e) (e) P=0.479 | |POLY 1.5 | P=0.247 P=0.496N P=0.499N P=0.509 |P=0.190 (e) (e) P=0.489 | |POLY 6 | P=0.242 P=0.483N P=0.493N P=0.520 |P=0.174 (e) (e) P=0.461 | |LOGISTIC REGRESSION| P=0.249 P=0.495N P=0.497N P=0.511 |P=0.209 (e) (e) P=0.506 | |COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 |P=0.198 (e) (e) P=0.500 | |ORDER RESTRICTED | P=0.140 (e) (e) (e) |P=0.103 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 2/46.30 0/44.07 0/44.93 |0/42.30 1/43.67 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 4.3% 0.0% 0.0% |0.0% 2.3% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 393 --- --- |--- 688 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.402N P=0.258 (e) (e) |P=0.631N P=0.500 (e) (e) | |POLY 3 | P=0.387N P=0.253 (e) (e) |P=0.563N P=0.506 (e) (e) | |POLY 1.5 | P=0.395N P=0.245 (e) (e) |P=0.565N P=0.505 (e) (e) | |POLY 6 | P=0.378N P=0.263 (e) (e) |P=0.561N P=0.506 (e) (e) | |LOGISTIC REGRESSION| P=0.439N P=0.270 (e) (e) |P=0.574N P=0.501 (e) (e) | |COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |P=0.567N P=0.500 (e) (e) | |ORDER RESTRICTED | P=0.254N (e) (e) (e) |P=0.405N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 8/50 (16%) 7/50 (14%) 6/50 (12%) |14/50 (28%) 5/50 (10%) 7/50 (14%) 12/50 (24%) | |POLY-3 RATE (b) | 8/43.25 8/45.64 7/44.58 6/45.14 |14/43.88 5/44.22 7/43.92 12/38.63 | |POLY-3 PERCENT (g) | 18.5% 17.5% 15.7% 13.3% |31.9% 11.3% 15.9% 31.1% | |TERMINAL (d) | 7/31 (23%) 6/35 (17%) 4/32 (13%) 4/32 (13%) |8/33 (24%) 2/30 (7%) 6/33 (18%) 8/22 (36%) | |FIRST INCIDENCE | 704 682 661 680 |437 638 712 626 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.304N P=0.494N P=0.464N P=0.357N |P=0.214 P=0.037N* P=0.077N P=0.348 | |POLY 3 | P=0.283N P=0.562N P=0.474N P=0.353N |P=0.425 P=0.016N* P=0.064N P=0.562N | |POLY 1.5 | P=0.289N P=0.588N P=0.490N P=0.365N |P=0.466 P=0.017N* P=0.065N P=0.491N | |POLY 6 | P=0.280N P=0.526N P=0.452N P=0.340N |P=0.369 P=0.017N* P=0.066N P=0.511 | |LOGISTIC REGRESSION| P=0.282N P=0.505N P=0.462N P=0.338N |P=0.393 P=0.019N* P=0.059N P=0.576N | |COCH-ARM / FISHERS | P=0.305N P=0.607N P=0.500N P=0.387N |P=0.524 P=0.020N* P=0.070N P=0.410N | |ORDER RESTRICTED | P=0.404N (e) (e) (e) |P=0.120N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 13/50 (26%) 8/50 (16%) 15/50 (30%) |1/50 (2%) 1/50 (2%) 5/50 (10%) 2/50 (4%) | |POLY-3 RATE (b) | 12/45.00 13/46.24 8/45.08 15/45.98 |1/42.30 1/43.50 5/44.10 2/38.02 | |POLY-3 PERCENT (g) | 26.7% 28.1% 17.8% 32.6% |2.4% 2.3% 11.3% 5.3% | |TERMINAL (d) | 7/31 (23%) 7/35 (20%) 5/32 (16%) 10/32 (31%) |1/33 (3%) 1/30 (3%) 1/33 (3%) 1/22 (5%) | |FIRST INCIDENCE | 506 569 544 614 |731 (T) 731 (T) 711 653 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.342 P=0.547N P=0.216N P=0.382 |P=0.169 P=0.741 P=0.117 P=0.377 | |POLY 3 | P=0.336 P=0.532 P=0.222N P=0.347 |P=0.230 P=0.755N P=0.111 P=0.463 | |POLY 1.5 | P=0.336 P=0.509 P=0.228N P=0.340 |P=0.261 P=0.756N P=0.107 P=0.480 | |POLY 6 | P=0.333 P=0.564 P=0.214N P=0.353 |P=0.184 P=0.756N P=0.113 P=0.432 | |LOGISTIC REGRESSION| P=0.339 P=0.509 P=0.227N P=0.339 |P=0.214 P=0.741 P=0.112 P=0.441 | |COCH-ARM / FISHERS | P=0.327 P=0.500 P=0.227N P=0.326 |P=0.302 P=0.753N P=0.102 P=0.500 | |ORDER RESTRICTED | P=0.285 (e) (e) (e) |P=0.176 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Brain | | Compression | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 10/49 (20%) 5/50 (10%) 8/50 (16%) 6/50 (12%) |9/50 (18%) 10/50 (20%) 11/50 (22%) 7/50 (14%) | |POLY-3 RATE (b) | 10/44.31 5/45.88 8/45.62 6/45.59 |9/44.18 10/44.13 11/44.69 7/40.47 | |POLY-3 PERCENT (g) | 22.6% 10.9% 17.5% 13.2% |20.4% 22.7% 24.6% 17.3% | |TERMINAL (d) | 3/30 (10%) 2/35 (6%) 2/32 (6%) 2/32 (6%) |3/33 (9%) 5/30 (17%) 8/33 (24%) 1/22 (5%) | |FIRST INCIDENCE | 506 654 586 614 |501 670 582 529 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.257N P=0.099N P=0.365N P=0.191N |P=0.510 P=0.455 P=0.423 P=0.571N | |POLY 3 | P=0.245N P=0.113N P=0.370N P=0.186N |P=0.407N P=0.499 P=0.411 P=0.467N | |POLY 1.5 | P=0.242N P=0.119N P=0.379N P=0.188N |P=0.369N P=0.504 P=0.410 P=0.432N | |POLY 6 | P=0.252N P=0.105N P=0.359N P=0.188N |P=0.476N P=0.481 P=0.406 P=0.531N | |LOGISTIC REGRESSION| P=0.259N P=0.125N P=0.378N P=0.222N |P=0.334N P=0.510 P=0.408 P=0.345N | |COCH-ARM / FISHERS | P=0.248N P=0.122N P=0.379N P=0.194N |P=0.322N P=0.500 P=0.402 P=0.393N | |ORDER RESTRICTED | P=0.174N (e) (e) (e) |P=0.443N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 2/50 (4%) 6/50 (12%) 3/50 (6%) | |POLY-3 RATE (b) | 0/42.15 1/45.65 0/44.07 1/45.01 |2/43.34 2/44.06 6/45.50 3/39.24 | |POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 2.2% |4.6% 4.5% 13.2% 7.6% | |TERMINAL (d) | 0/30 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 654 --- 710 |501 642 500 525 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.408 P=0.529 (e) P=0.512 |P=0.246 P=0.670N P=0.161 P=0.472 | |POLY 3 | P=0.421 P=0.516 (e) P=0.513 |P=0.260 P=0.688N P=0.149 P=0.455 | |POLY 1.5 | P=0.417 P=0.509 (e) P=0.510 |P=0.291 P=0.689N P=0.143 P=0.476 | |POLY 6 | P=0.426 P=0.525 (e) P=0.517 |P=0.213 P=0.692N P=0.154 P=0.418 | |LOGISTIC REGRESSION| P=0.405 P=0.505 (e) P=0.514 |P=0.428 P=0.649 P=0.103 P=0.591 | |COCH-ARM / FISHERS | P=0.408 P=0.505 (e) P=0.505 |P=0.331 P=0.691N P=0.134 P=0.500 | |ORDER RESTRICTED | P=0.265 (e) (e) (e) |P=0.246 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |3/50 (6%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | |3/42.30 0/43.50 1/43.91 0/37.73 | |POLY-3 PERCENT (g) | |7.1% 0.0% 2.3% 0.0% | |TERMINAL (d) | |3/33 (9%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | |731 (T) --- 715 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.121N P=0.138N P=0.304N P=0.200N | |POLY 3 | |P=0.091N P=0.113N P=0.292N P=0.140N | |POLY 1.5 | |P=0.089N P=0.115N P=0.297N P=0.130N | |POLY 6 | |P=0.093N P=0.114N P=0.288N P=0.160N | |LOGISTIC REGRESSION| |P=0.114N (e) P=0.290N (e) | |COCH-ARM / FISHERS | |P=0.086N P=0.121N P=0.309N P=0.121N | |ORDER RESTRICTED | |P=0.029N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |1/50 (2%) 3/50 (6%) 2/50 (4%) 2/50 (4%) | |POLY-3 RATE (b) | |1/42.30 3/43.50 2/43.84 2/37.82 | |POLY-3 PERCENT (g) | |2.4% 6.9% 4.6% 5.3% | |TERMINAL (d) | |1/33 (3%) 3/30 (10%) 2/33 (6%) 1/22 (5%) | |FIRST INCIDENCE | |731 (T) 731 (T) 731 (T) 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.347 P=0.271 P=0.500 P=0.366 | |POLY 3 | |P=0.441 P=0.315 P=0.512 P=0.461 | |POLY 1.5 | |P=0.468 P=0.313 P=0.508 P=0.479 | |POLY 6 | |P=0.397 P=0.312 P=0.515 P=0.429 | |LOGISTIC REGRESSION| |P=0.346 P=0.271 P=0.500 P=0.385 | |COCH-ARM / FISHERS | |P=0.500 P=0.309 P=0.500 P=0.500 | |ORDER RESTRICTED | |P=0.405 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | |2/42.30 1/43.50 1/43.84 0/37.73 | |POLY-3 PERCENT (g) | |4.7% 2.3% 2.3% 0.0% | |TERMINAL (d) | |2/33 (6%) 1/30 (3%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | |731 (T) 731 (T) 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.207N P=0.533N P=0.500N P=0.331N | |POLY 3 | |P=0.168N P=0.490N P=0.488N P=0.263N | |POLY 1.5 | |P=0.162N P=0.493N P=0.492N P=0.251N | |POLY 6 | |P=0.177N P=0.493N P=0.485N P=0.287N | |LOGISTIC REGRESSION| |P=0.207N P=0.533N P=0.500N (e) | |COCH-ARM / FISHERS | |P=0.153N P=0.500N P=0.500N P=0.247N | |ORDER RESTRICTED | |P=0.139N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Eye: Lens | | Cataract | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/48 (2%) 3/48 (6%) 1/49 (2%) |1/50 (2%) 3/48 (6%) 4/49 (8%) 1/49 (2%) | |POLY-3 RATE (b) | 2/43.52 1/44.87 3/43.35 1/43.97 |1/42.30 3/42.33 4/43.73 1/37.33 | |POLY-3 PERCENT (g) | 4.6% 2.2% 6.9% 2.3% |2.4% 7.1% 9.2% 2.7% | |TERMINAL (d) | 1/31 (3%) 1/35 (3%) 2/32 (6%) 0/32 (0%) |1/33 (3%) 3/30 (10%) 3/33 (9%) 1/22 (5%) | |FIRST INCIDENCE | 623 729 (T) 544 724 |731 (T) 731 (T) 614 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.471N P=0.461N P=0.515 P=0.485N |P=0.511 P=0.271 P=0.184 P=0.669 | |POLY 3 | P=0.478N P=0.489N P=0.498 P=0.496N |P=0.575 P=0.305 P=0.188 P=0.732 | |POLY 1.5 | P=0.477N P=0.500N P=0.489 P=0.500N |P=0.563N P=0.301 P=0.182 P=0.744 | |POLY 6 | P=0.483N P=0.476N P=0.510 P=0.494N |P=0.511 P=0.305 P=0.194 P=0.711 | |LOGISTIC REGRESSION| P=0.483N P=0.520N P=0.482 P=0.508N |P=0.565 P=0.271 P=0.183 P=0.669 | |COCH-ARM / FISHERS | P=0.479N P=0.515N P=0.480 P=0.508N |P=0.527N P=0.293 P=0.175 P=0.747 | |ORDER RESTRICTED | P=0.458N (e) (e) (e) |P=0.341 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 5/50 (10%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | |POLY-3 RATE (b) | 7/43.15 5/45.38 1/44.07 1/44.93 |0/42.30 0/43.50 0/43.84 3/38.21 | |POLY-3 PERCENT (g) | 16.2% 11.0% 2.3% 2.2% |0.0% 0.0% 0.0% 7.9% | |TERMINAL (d) | 7/31 (23%) 5/35 (14%) 1/32 (3%) 1/32 (3%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 2/22 (9%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- 589 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.008N** P=0.292N P=0.027N* P=0.027N* |P=0.005 ** (e) (e) P=0.076 | |POLY 3 | P=0.008N** P=0.343N P=0.027N* P=0.025N* |P=0.010 * (e) (e) P=0.101 | |POLY 1.5 | P=0.008N** P=0.364N P=0.029N* P=0.027N* |P=0.010 * (e) (e) P=0.109 | |POLY 6 | P=0.008N** P=0.317N P=0.025N* P=0.024N* |P=0.009 ** (e) (e) P=0.088 | |LOGISTIC REGRESSION| P=0.008N** P=0.292N P=0.027N* P=0.027N* |P=0.011 * (e) (e) P=0.107 | |COCH-ARM / FISHERS | P=0.010N* P=0.380N P=0.030N* P=0.030N* |P=0.012 * (e) (e) P=0.121 | |ORDER RESTRICTED | P=0.009N** (e) (e) (e) |P=0.005 ** (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Heart: Atrium | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 2/43.71 1/45.38 2/44.60 1/45.47 |0/42.30 1/43.50 2/43.88 0/37.73 | |POLY-3 PERCENT (g) | 4.6% 2.2% 4.5% 2.2% |0.0% 2.3% 4.6% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 1/32 (3%) 0/32 (0%) |0/33 (0%) 1/30 (3%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | 561 728 568 562 |--- 731 (T) 722 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.440N P=0.464N P=0.683N P=0.483N |P=0.610 P=0.481 P=0.243 (e) | |POLY 3 | P=0.437N P=0.487N P=0.687N P=0.486N |P=0.621 P=0.506 P=0.245 (e) | |POLY 1.5 | P=0.438N P=0.495N P=0.692N P=0.491N |P=0.641N P=0.504 P=0.242 (e) | |POLY 6 | P=0.438N P=0.476N P=0.681N P=0.482N |P=0.563 P=0.504 P=0.247 (e) | |LOGISTIC REGRESSION| P=0.469N P=0.501N P=0.686N P=0.614N |P=0.615 P=0.481 P=0.246 (e) | |COCH-ARM / FISHERS | P=0.444N P=0.500N P=0.691N P=0.500N |P=0.616N P=0.500 P=0.247 (e) | |ORDER RESTRICTED | P=0.425N (e) (e) (e) |P=0.334 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/48 (2%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.38 1/44.37 2/44.07 2/44.93 |0/42.30 0/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 2.3% 2.3% 4.5% 4.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 1/34 (3%) 2/32 (6%) 2/32 (6%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 666 729 (T) 729 (T) 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.341 P=0.742N P=0.510 P=0.516 |(e) (e) (e) (e) | |POLY 3 | P=0.349 P=0.756N P=0.506 P=0.512 |(e) (e) (e) (e) | |POLY 1.5 | P=0.348 P=0.760 P=0.501 P=0.508 |(e) (e) (e) (e) | |POLY 6 | P=0.348 P=0.748N P=0.510 P=0.515 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.348 P=0.757 P=0.508 P=0.514 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.342 P=0.742 P=0.500 P=0.500 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.449 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 37/50 (74%) 41/49 (84%) 41/50 (82%) 45/49 (92%) |19/50 (38%) 21/50 (42%) 19/49 (39%) 10/50 (20%) | |POLY-3 RATE (b) | 37/46.60 41/47.56 41/47.29 45/48.00 |19/45.20 21/44.85 19/44.49 10/39.39 | |POLY-3 PERCENT (g) | 79.4% 86.2% 86.7% 93.8% |42.0% 46.8% 42.7% 25.4% | |TERMINAL (d) | 27/31 (87%) 31/35 (89%) 29/32 (91%) 31/32 (97%) |13/33 (39%) 15/30 (50%) 16/33 (49%) 5/22 (23%) | |FIRST INCIDENCE | 506 569 544 513 |437 543 374 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.092 P=0.532N P=0.381 P=0.160 |P=0.173N P=0.331 P=0.570N P=0.225N | |POLY 3 | P=0.025 * P=0.263 P=0.238 P=0.027 * |P=0.052N P=0.402 P=0.560 P=0.080N | |POLY 1.5 | P=0.021 * P=0.216 P=0.212 P=0.022 * |P=0.033N* P=0.413 P=0.560 P=0.057N | |POLY 6 | P=0.031 * P=0.355 P=0.294 P=0.035 * |P=0.099N P=0.378 P=0.550 P=0.133N | |LOGISTIC REGRESSION| P=0.024 * P=0.305 P=0.249 P=0.030 * |P=0.033N* P=0.446 P=0.572 P=0.050N | |COCH-ARM / FISHERS | P=0.019 * P=0.176 P=0.235 P=0.017 * |P=0.019N* P=0.419 P=0.551 P=0.038N* | |ORDER RESTRICTED | P=0.019 * (e) (e) (e) |P=0.052N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney: Cortex | | Infarct | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 1/43.16 1/45.90 0/44.07 0/43.95 |0/42.30 0/43.50 0/43.33 2/38.38 | |POLY-3 PERCENT (g) | 2.3% 2.2% 0.0% 0.0% |0.0% 0.0% 0.0% 5.2% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 1/22 (5%) | |FIRST INCIDENCE | 725 569 --- --- |--- --- --- 516 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.237N P=0.740N P=0.500N P=0.500N |P=0.037 * (e) (e) P=0.209 | |POLY 3 | P=0.237N P=0.747N P=0.496N P=0.496N |P=0.042 * (e) (e) P=0.216 | |POLY 1.5 | P=0.238N P=0.754N P=0.499N P=0.499N |P=0.043 * (e) (e) P=0.226 | |POLY 6 | P=0.237N P=0.737N P=0.492N P=0.494N |P=0.040 * (e) (e) P=0.198 | |LOGISTIC REGRESSION| P=0.241N P=0.725 P=0.488N P=0.493N |P=0.060 (e) (e) P=0.256 | |COCH-ARM / FISHERS | P=0.237N P=0.747 P=0.500N P=0.505N |P=0.047 * (e) (e) P=0.247 | |ORDER RESTRICTED | P=0.247N (e) (e) (e) |P=0.023 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney: Cortex, Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/49 (4%) 0/50 (0%) 2/49 (4%) |1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.15 2/45.37 0/44.07 2/44.25 |1/42.30 1/43.64 0/43.33 0/37.73 | |POLY-3 PERCENT (g) | 2.3% 4.4% 0.0% 4.5% |2.4% 2.3% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 2/35 (6%) 0/32 (0%) 0/32 (0%) |1/33 (3%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- 674 |731 (T) 696 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.476 P=0.543 P=0.494N P=0.528 |P=0.283N P=0.750 P=0.500N P=0.581N | |POLY 3 | P=0.476 P=0.518 P=0.496N P=0.509 |P=0.237N P=0.754N P=0.495N P=0.523N | |POLY 1.5 | P=0.472 P=0.507 P=0.499N P=0.503 |P=0.238N P=0.756N P=0.498N P=0.512N | |POLY 6 | P=0.480 P=0.531 P=0.492N P=0.515 |P=0.234N P=0.755N P=0.493N P=0.542N | |LOGISTIC REGRESSION| P=0.470 P=0.543 (e) P=0.503 |P=0.256N P=0.758N (e) (e) | |COCH-ARM / FISHERS | P=0.465 P=0.492 P=0.500N P=0.492 |P=0.236N P=0.753N P=0.505N P=0.500N | |ORDER RESTRICTED | P=0.418 (e) (e) (e) |P=0.274N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Larynx | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 2/49 (4%) 3/50 (6%) 2/49 (4%) |0/50 (0%) 1/50 (2%) 3/49 (6%) 0/50 (0%) | |POLY-3 RATE (b) | 1/42.69 2/45.37 3/44.21 2/43.95 |0/42.30 1/43.58 3/43.39 0/37.73 | |POLY-3 PERCENT (g) | 2.3% 4.4% 6.8% 4.6% |0.0% 2.3% 6.9% 0.0% | |TERMINAL (d) | 1/31 (3%) 2/35 (6%) 2/32 (6%) 2/32 (6%) |0/33 (0%) 0/30 (0%) 2/33 (6%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 694 729 (T) |--- 711 715 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.400 P=0.543 P=0.322 P=0.511 |P=0.531 P=0.488 P=0.125 (e) | |POLY 3 | P=0.413 P=0.521 P=0.318 P=0.510 |P=0.549 P=0.506 P=0.123 (e) | |POLY 1.5 | P=0.411 P=0.512 P=0.314 P=0.507 |P=0.589 P=0.504 P=0.120 (e) | |POLY 6 | P=0.412 P=0.533 P=0.323 P=0.513 |P=0.477 P=0.505 P=0.125 (e) | |LOGISTIC REGRESSION| P=0.400 P=0.543 P=0.323 P=0.511 |P=0.560 P=0.505 P=0.126 (e) | |COCH-ARM / FISHERS | P=0.404 P=0.500 P=0.316 P=0.500 |P=0.633 P=0.500 P=0.117 (e) | |ORDER RESTRICTED | P=0.367 (e) (e) (e) |P=0.228 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Larynx | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/49 (2%) 1/50 (2%) 1/49 (2%) |0/50 (0%) 2/50 (4%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/42.69 1/45.37 1/44.07 1/43.95 |0/42.30 2/43.58 1/43.39 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 2.2% 2.3% 2.3% |0.0% 4.6% 2.3% 0.0% | |TERMINAL (d) | 0/31 (0%) 1/35 (3%) 1/32 (3%) 1/32 (3%) |0/33 (0%) 1/30 (3%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |--- 711 715 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.381 P=0.524 P=0.506 P=0.506 |P=0.558N P=0.223 P=0.506 (e) | |POLY 3 | P=0.393 P=0.512 P=0.506 P=0.506 |P=0.494N P=0.244 P=0.505 (e) | |POLY 1.5 | P=0.391 P=0.507 P=0.504 P=0.504 |P=0.479N P=0.242 P=0.502 (e) | |POLY 6 | P=0.394 P=0.519 P=0.509 P=0.507 |P=0.522N P=0.242 P=0.508 (e) | |LOGISTIC REGRESSION| (e) P=0.524 P=0.506 P=0.506 |P=0.523N P=0.239 P=0.505 (e) | |COCH-ARM / FISHERS | P=0.384 P=0.500 P=0.505 P=0.500 |P=0.462N P=0.247 P=0.495 (e) | |ORDER RESTRICTED | P=0.332 (e) (e) (e) |P=0.341 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/49 (10%) 1/50 (2%) 1/50 (2%) |5/50 (10%) 7/50 (14%) 6/50 (12%) 0/50 (0%) | |POLY-3 RATE (b) | 2/43.15 5/45.65 1/44.07 1/44.93 |5/42.68 7/43.90 6/43.84 0/37.73 | |POLY-3 PERCENT (g) | 4.6% 11.0% 2.3% 2.2% |11.7% 15.9% 13.7% 0.0% | |TERMINAL (d) | 2/31 (7%) 4/35 (11%) 1/32 (3%) 1/32 (3%) |4/33 (12%) 6/30 (20%) 6/33 (18%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 654 729 (T) 729 (T) |625 617 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.192N P=0.270 P=0.489N P=0.489N |P=0.069N P=0.331 P=0.502 P=0.075N | |POLY 3 | P=0.177N P=0.239 P=0.493N P=0.486N |P=0.045N* P=0.398 P=0.519 P=0.042N* | |POLY 1.5 | P=0.182N P=0.226 P=0.498N P=0.491N |P=0.035N* P=0.394 P=0.513 P=0.036N* | |POLY 6 | P=0.172N P=0.258 P=0.486N P=0.481N |P=0.067N P=0.393 P=0.519 P=0.054N | |LOGISTIC REGRESSION| P=0.183N P=0.252 P=0.489N P=0.489N |P=0.050N P=0.396 P=0.529 P=0.049N* | |COCH-ARM / FISHERS | P=0.192N P=0.210 P=0.500N P=0.500N |P=0.027N* P=0.380 P=0.500 P=0.028N* | |ORDER RESTRICTED | P=0.175N (e) (e) (e) |P=0.033N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/49 (4%) 4/50 (8%) 8/50 (16%) |5/50 (10%) 7/50 (14%) 6/50 (12%) 9/50 (18%) | |POLY-3 RATE (b) | 2/43.15 2/45.37 4/45.35 8/45.45 |5/42.68 7/43.67 6/44.06 9/40.10 | |POLY-3 PERCENT (g) | 4.6% 4.4% 8.8% 17.6% |11.7% 16.0% 13.6% 22.4% | |TERMINAL (d) | 2/31 (7%) 2/35 (6%) 2/32 (6%) 7/32 (22%) |4/33 (12%) 6/30 (20%) 5/33 (15%) 3/22 (14%) | |FIRST INCIDENCE | 729 (T) 729 (T) 460 569 |625 688 673 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.011 * P=0.651N P=0.352 P=0.052 |P=0.053 P=0.327 P=0.503 P=0.086 | |POLY 3 | P=0.012 * P=0.676N P=0.360 P=0.053 |P=0.137 P=0.395 P=0.522 P=0.155 | |POLY 1.5 | P=0.011 * P=0.686N P=0.348 P=0.051 |P=0.153 P=0.392 P=0.515 P=0.173 | |POLY 6 | P=0.012 * P=0.662N P=0.374 P=0.056 |P=0.115 P=0.387 P=0.526 P=0.126 | |LOGISTIC REGRESSION| P=0.011 * P=0.651N P=0.343 P=0.055 |P=0.127 P=0.391 P=0.527 P=0.180 | |COCH-ARM / FISHERS | P=0.011 * P=0.684 P=0.339 P=0.046 * |P=0.172 P=0.380 P=0.500 P=0.194 | |ORDER RESTRICTED | P=0.020 * (e) (e) (e) |P=0.145 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/49 (2%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.17 1/45.90 3/44.85 2/45.50 |0/42.30 0/43.50 1/43.88 0/37.73 | |POLY-3 PERCENT (g) | 2.3% 2.2% 6.7% 4.4% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 1/32 (3%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 722 569 460 562 |--- --- 722 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.333 P=0.740N P=0.321 P=0.520 |P=0.655 (e) P=0.506 (e) | |POLY 3 | P=0.341 P=0.747N P=0.319 P=0.518 |P=0.635 (e) P=0.507 (e) | |POLY 1.5 | P=0.337 P=0.754N P=0.312 P=0.511 |P=0.663 (e) P=0.505 (e) | |POLY 6 | P=0.342 P=0.737N P=0.327 P=0.525 |P=0.584 (e) P=0.509 (e) | |LOGISTIC REGRESSION| P=0.303 P=0.724 P=0.310 P=0.471 |P=0.669 (e) P=0.508 (e) | |COCH-ARM / FISHERS | P=0.327 P=0.747 P=0.309 P=0.500 |P=0.694 (e) P=0.500 (e) | |ORDER RESTRICTED | P=0.340 (e) (e) (e) |P=0.389 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/49 (4%) 3/50 (6%) 3/50 (6%) |4/50 (8%) 3/50 (6%) 0/50 (0%) 3/50 (6%) | |POLY-3 RATE (b) | 1/43.35 2/45.64 3/44.58 3/45.44 |4/43.26 3/43.78 0/43.84 3/38.90 | |POLY-3 PERCENT (g) | 2.3% 4.4% 6.7% 6.6% |9.3% 6.9% 0.0% 7.7% | |TERMINAL (d) | 0/31 (0%) 1/35 (3%) 0/32 (0%) 1/32 (3%) |1/33 (3%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 675 659 661 638 |477 703 --- 529 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.242 P=0.540 P=0.337 P=0.334 |P=0.488N P=0.524N P=0.065N P=0.624N | |POLY 3 | P=0.243 P=0.518 P=0.315 P=0.322 |P=0.388N P=0.493N P=0.058N P=0.558N | |POLY 1.5 | P=0.239 P=0.507 P=0.309 P=0.316 |P=0.381N P=0.494N P=0.059N P=0.531N | |POLY 6 | P=0.246 P=0.531 P=0.324 P=0.329 |P=0.396N P=0.500N P=0.059N P=0.604N | |LOGISTIC REGRESSION| P=0.225 P=0.481 P=0.305 P=0.290 |P=0.339N P=0.507N P=0.068N P=0.460N | |COCH-ARM / FISHERS | P=0.230 P=0.492 P=0.309 P=0.309 |P=0.371N P=0.500N P=0.059N P=0.500N | |ORDER RESTRICTED | P=0.280 (e) (e) (e) |P=0.227N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.37 3/44.07 0/44.93 |0/42.30 0/43.50 1/43.92 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 6.8% 0.0% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 3/32 (9%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- --- 729 (T) --- |--- --- 711 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.538 (e) P=0.126 (e) |P=0.659 (e) P=0.516 (e) | |POLY 3 | P=0.554 (e) P=0.122 (e) |P=0.635 (e) P=0.507 (e) | |POLY 1.5 | P=0.551 (e) P=0.120 (e) |P=0.663 (e) P=0.505 (e) | |POLY 6 | P=0.554 (e) P=0.125 (e) |P=0.584 (e) P=0.509 (e) | |LOGISTIC REGRESSION| (e) (e) P=0.126 (e) |P=0.680 (e) P=0.507 (e) | |COCH-ARM / FISHERS | P=0.541 (e) P=0.121 (e) |P=0.694 (e) P=0.500 (e) | |ORDER RESTRICTED | P=0.166 (e) (e) (e) |P=0.390 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver: Periportal | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) |3/50 (6%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 0/43.15 0/45.37 2/44.07 0/44.93 |3/43.09 2/43.61 1/43.84 2/38.18 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% |7.0% 4.6% 2.3% 5.2% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 2/32 (6%) 0/32 (0%) |2/33 (6%) 1/30 (3%) 1/33 (3%) 1/22 (5%) | |FIRST INCIDENCE | --- --- 729 (T) --- |436 703 731 (T) 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.594 (e) P=0.245 (e) |P=0.522N P=0.530N P=0.308N P=0.619N | |POLY 3 | P=0.608 (e) P=0.242 (e) |P=0.431N P=0.495N P=0.299N P=0.555N | |POLY 1.5 | P=0.605 (e) P=0.239 (e) |P=0.421N P=0.495N P=0.301N P=0.530N | |POLY 6 | P=0.608 (e) P=0.246 (e) |P=0.445N P=0.499N P=0.298N P=0.596N | |LOGISTIC REGRESSION| (e) (e) P=0.245 (e) |P=0.398N P=0.513N P=0.319N P=0.478N | |COCH-ARM / FISHERS | P=0.596 (e) P=0.247 (e) |P=0.404N P=0.500N P=0.309N P=0.500N | |ORDER RESTRICTED | P=0.252 (e) (e) (e) |P=0.394N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver: Portal | | Bile Stasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 0/43.15 0/45.37 0/44.07 0/44.93 |1/42.88 3/43.61 2/43.84 1/38.18 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 6.9% 4.6% 2.6% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 2/30 (7%) 2/33 (6%) 0/22 (0%) | |FIRST INCIDENCE | --- --- --- --- |549 703 731 (T) 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.583N P=0.295 P=0.508 P=0.749 | |POLY 3 | (e) (e) (e) (e) |P=0.523N P=0.311 P=0.508 P=0.734 | |POLY 1.5 | (e) (e) (e) (e) |P=0.501N P=0.310 P=0.505 P=0.747 | |POLY 6 | (e) (e) (e) (e) |P=0.559N P=0.307 P=0.508 P=0.712 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.481N P=0.301 P=0.493 P=0.722N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.474N P=0.309 P=0.500 P=0.753N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.467 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 4/50 (8%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 2/43.58 1/45.38 4/45.21 4/45.50 |1/43.09 1/43.50 1/44.53 1/38.72 | |POLY-3 PERCENT (g) | 4.6% 2.2% 8.9% 8.8% |2.3% 2.3% 2.3% 2.6% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 2/32 (6%) 2/32 (6%) |0/33 (0%) 1/30 (3%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 612 728 114 562 |437 731 (T) 497 151 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.166 P=0.464N P=0.358 P=0.363 |P=0.614 P=0.750 P=0.755N P=0.760 | |POLY 3 | P=0.169 P=0.486N P=0.354 P=0.357 |P=0.595 P=0.759N P=0.753N P=0.737 | |POLY 1.5 | P=0.168 P=0.494N P=0.348 P=0.350 |P=0.614 P=0.759N P=0.756N P=0.749 | |POLY 6 | P=0.168 P=0.475N P=0.361 P=0.363 |P=0.563 P=0.760 P=0.752N P=0.713 | |LOGISTIC REGRESSION| P=0.132 P=0.501N P=0.370 P=0.315 |P=0.432N P=0.725 P=0.725 (e) | |COCH-ARM / FISHERS | P=0.160 P=0.500N P=0.339 P=0.339 |P=0.634 P=0.753N P=0.753N P=0.753N | |ORDER RESTRICTED | P=0.226 (e) (e) (e) |P=0.707 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lung | | Inflammation Chronic Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 5/50 (10%) 14/50 (28%) |27/50 (54%) 22/50 (44%) 26/50 (52%) 33/50 (66%) | |POLY-3 RATE (b) | 4/44.22 4/45.38 5/44.07 14/45.09 |27/43.93 22/44.39 26/45.99 33/43.70 | |POLY-3 PERCENT (g) | 9.1% 8.8% 11.3% 31.1% |61.5% 49.6% 56.5% 75.5% | |TERMINAL (d) | 2/31 (7%) 3/35 (9%) 5/32 (16%) 13/32 (41%) |22/33 (67%) 14/30 (47%) 20/33 (61%) 17/22 (77%) | |FIRST INCIDENCE | 536 728 729 (T) 687 |437 670 374 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.587N P=0.514 P=0.011 * |P<0.001 ** P=0.349N P=0.485N P=0.004 ** | |POLY 3 | P<0.001 ** P=0.629N P=0.498 P=0.008 ** |P=0.039 * P=0.174N P=0.395N P=0.104 | |POLY 1.5 | P<0.001 ** P=0.639N P=0.495 P=0.008 ** |P=0.045 * P=0.185N P=0.432N P=0.118 | |POLY 6 | P<0.001 ** P=0.616N P=0.501 P=0.008 ** |P=0.032 * P=0.174N P=0.369N P=0.083 | |LOGISTIC REGRESSION| P<0.001 ** P=0.643 P=0.501 P=0.012 * |P=0.016 * P=0.153N P=0.432N P=0.055 | |COCH-ARM / FISHERS | P<0.001 ** P=0.643N P=0.500 P=0.009 ** |P=0.062 P=0.212N P=0.500N P=0.154 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.031 * (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 8/50 (16%) 6/50 (12%) 6/50 (12%) |4/50 (8%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 4/43.49 8/45.41 6/44.21 6/46.31 |4/42.30 2/43.64 3/43.84 1/37.73 | |POLY-3 PERCENT (g) | 9.2% 17.6% 13.6% 13.0% |9.5% 4.6% 6.8% 2.7% | |TERMINAL (d) | 2/31 (7%) 6/35 (17%) 5/32 (16%) 3/32 (9%) |4/33 (12%) 1/30 (3%) 3/33 (9%) 1/22 (5%) | |FIRST INCIDENCE | 638 722 694 513 |731 (T) 696 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.445 P=0.248 P=0.394 P=0.404 |P=0.271N P=0.374N P=0.500N P=0.318N | |POLY 3 | P=0.491 P=0.197 P=0.379 P=0.409 |P=0.196N P=0.322N P=0.480N P=0.214N | |POLY 1.5 | P=0.474 P=0.185 P=0.372 P=0.395 |P=0.181N P=0.327N P=0.487N P=0.197N | |POLY 6 | P=0.507 P=0.213 P=0.388 P=0.424 |P=0.221N P=0.324N P=0.477N P=0.248N | |LOGISTIC REGRESSION| P=0.456 P=0.228 P=0.393 P=0.334 |P=0.263N P=0.339N P=0.500N P=0.318N | |COCH-ARM / FISHERS | P=0.442 P=0.178 P=0.370 P=0.370 |P=0.162N P=0.339N P=0.500N P=0.181N | |ORDER RESTRICTED | P=0.353 (e) (e) (e) |P=0.165N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/43.15 1/45.38 1/44.10 2/44.93 |1/42.92 1/43.50 0/43.84 1/38.36 | |POLY-3 PERCENT (g) | 0.0% 2.2% 2.3% 4.5% |2.3% 2.3% 0.0% 2.6% | |TERMINAL (d) | 0/31 (0%) 1/35 (3%) 0/32 (0%) 2/32 (6%) |0/33 (0%) 1/30 (3%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 729 (T) 722 729 (T) |533 731 (T) --- 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.150 P=0.524 P=0.512 P=0.245 |P=0.637N P=0.760 P=0.491N P=0.743N | |POLY 3 | P=0.161 P=0.510 P=0.504 P=0.246 |P=0.618N P=0.758N P=0.496N P=0.735 | |POLY 1.5 | P=0.159 P=0.504 P=0.501 P=0.243 |P=0.617N P=0.758N P=0.497N P=0.747 | |POLY 6 | P=0.162 P=0.518 P=0.508 P=0.249 |P=0.616N P=0.761 P=0.496N P=0.713 | |LOGISTIC REGRESSION| P=0.150 P=0.524 P=0.511 P=0.245 |P=0.544N P=0.744 P=0.540N P=0.701N | |COCH-ARM / FISHERS | P=0.153 P=0.500 P=0.500 P=0.247 |P=0.616N P=0.753N P=0.500N P=0.753N | |ORDER RESTRICTED | P=0.126 (e) (e) (e) |P=0.559N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolus | | Infiltration Cellular Focal Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 12/50 (24%) 11/50 (22%) 4/50 (8%) |8/50 (16%) 3/50 (6%) 6/50 (12%) 5/50 (10%) | |POLY-3 RATE (b) | 9/43.15 12/46.68 11/45.21 4/45.58 |8/43.80 3/43.67 6/44.56 5/38.52 | |POLY-3 PERCENT (g) | 20.9% 25.7% 24.3% 8.8% |18.3% 6.9% 13.5% 13.0% | |TERMINAL (d) | 9/31 (29%) 9/35 (26%) 9/32 (28%) 3/32 (9%) |5/33 (15%) 2/30 (7%) 5/33 (15%) 2/22 (9%) | |FIRST INCIDENCE | 729 (T) 106 114 513 |437 688 481 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.066N P=0.423 P=0.431 P=0.101N |P=0.552N P=0.128N P=0.383N P=0.488N | |POLY 3 | P=0.050N P=0.385 P=0.446 P=0.094N |P=0.423N P=0.098N P=0.373N P=0.362N | |POLY 1.5 | P=0.056N P=0.353 P=0.428 P=0.102N |P=0.393N P=0.097N P=0.377N P=0.322N | |POLY 6 | P=0.046N* P=0.430 P=0.469 P=0.085N |P=0.467N P=0.102N P=0.372N P=0.433N | |LOGISTIC REGRESSION| P=0.070N P=0.317 P=0.406 P=0.098N |P=0.363N P=0.102N P=0.397N P=0.287N | |COCH-ARM / FISHERS | P=0.068N P=0.312 P=0.402 P=0.117N |P=0.351N P=0.100N P=0.387N P=0.277N | |ORDER RESTRICTED | P=0.057N (e) (e) (e) |P=0.269N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/19 (0%) 0/23 (0%) 0/25 (0%) 0/38 (0%) |2/32 (6%) 1/37 (3%) 0/44 (0%) 0/34 (0%) | |POLY-3 RATE (b) | 0/16.52 0/21.53 0/22.26 0/33.09 |2/27.90 1/31.37 0/39.22 0/24.83 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |7.2% 3.2% 0.0% 0.0% | |TERMINAL (d) | 0/11 (0%) 0/14 (0%) 0/17 (0%) 0/22 (0%) |0/19 (0%) 1/19 (5%) 0/29 (0%) 0/13 (0%) | |FIRST INCIDENCE | --- --- --- --- |437 731 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.099N P=0.488N P=0.233N P=0.223N | |POLY 3 | (e) (e) (e) (e) |P=0.080N P=0.459N P=0.164N P=0.263N | |POLY 1.5 | (e) (e) (e) (e) |P=0.083N P=0.454N P=0.166N P=0.245N | |POLY 6 | (e) (e) (e) (e) |P=0.075N P=0.467N P=0.162N P=0.292N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.052N P=0.501N P=0.228N P=0.112N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.085N P=0.445N P=0.174N P=0.231N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.091N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/49 (0%) 1/50 (2%) 3/50 (6%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 1/42.15 0/45.37 1/44.07 3/44.93 |2/42.30 1/43.50 2/44.09 0/37.73 | |POLY-3 PERCENT (g) | 2.4% 0.0% 2.3% 6.7% |4.7% 2.3% 4.5% 0.0% | |TERMINAL (d) | 1/30 (3%) 0/35 (0%) 1/32 (3%) 3/32 (9%) |2/33 (6%) 1/30 (3%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |731 (T) 731 (T) 666 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.096 P=0.469N P=0.748N P=0.327 |P=0.280N P=0.533N P=0.689N P=0.331N | |POLY 3 | P=0.099 P=0.485N P=0.751N P=0.328 |P=0.230N P=0.490N P=0.679N P=0.263N | |POLY 1.5 | P=0.100 P=0.491N P=0.754N P=0.323 |P=0.217N P=0.493N P=0.684N P=0.251N | |POLY 6 | P=0.097 P=0.477N P=0.746N P=0.334 |P=0.252N P=0.493N P=0.675N P=0.287N | |LOGISTIC REGRESSION| P=0.096 (e) P=0.748N P=0.327 |P=0.244N P=0.533N P=0.682N (e) | |COCH-ARM / FISHERS | P=0.100 P=0.500N P=0.747N P=0.316 |P=0.200N P=0.500N P=0.691N P=0.247N | |ORDER RESTRICTED | P=0.093 (e) (e) (e) |P=0.177N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Deep Cervical | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/11 (0%) 0/5 (0%) 0/11 (0%) 0/6 (0%) |0/6 (0%) 3/10 (30%) 0/9 (0%) 1/8 (13%) | |POLY-3 RATE (b) | 0/8.29 0/3.96 0/9.61 0/4.98 |0/4.78 3/8.77 0/7.24 1/5.96 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 34.2% 0.0% 16.8% | |TERMINAL (d) | 0/3 (0%) 0/2 (0%) 0/6 (0%) 0/3 (0%) |0/2 (0%) 1/5 (20%) 0/3 (0%) 1/1 (100%) | |FIRST INCIDENCE | --- --- --- --- |--- 703 --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.475 P=0.168 (e) P=0.362 | |POLY 3 | (e) (e) (e) (e) |P=0.619N P=0.222 (e) P=0.545 | |POLY 1.5 | (e) (e) (e) (e) |P=0.616N P=0.208 (e) P=0.552 | |POLY 6 | (e) (e) (e) (e) |P=0.622N P=0.251 (e) P=0.530 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.558 P=0.249 (e) P=0.362 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.609N P=0.214 (e) P=0.571 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.356 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Galactocele | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/35 (9%) 2/43 (5%) 6/47 (13%) 3/48 (6%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 3/29.94 2/39.40 6/41.77 3/43.14 |1/42.30 2/44.29 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 10.0% 5.1% 14.4% 7.0% |2.4% 4.5% 0.0% 0.0% | |TERMINAL (d) | 2/21 (10%) 2/30 (7%) 4/30 (13%) 1/30 (3%) |1/33 (3%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 704 729 (T) 586 680 |731 (T) 487 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.561 P=0.355N P=0.381 P=0.560N |P=0.218N P=0.492 P=0.500N P=0.581N | |POLY 3 | P=0.518N P=0.376N P=0.427 P=0.486N |P=0.194N P=0.516 P=0.493N P=0.523N | |POLY 1.5 | P=0.520N P=0.388N P=0.414 P=0.494N |P=0.191N P=0.511 P=0.495N P=0.512N | |POLY 6 | P=0.520N P=0.362N P=0.442 P=0.479N |P=0.199N P=0.516 P=0.491N P=0.542N | |LOGISTIC REGRESSION| P=0.516N P=0.343N P=0.422 P=0.480N |P=0.171N P=0.475 (e) (e) | |COCH-ARM / FISHERS | P=0.528N P=0.402N P=0.410 P=0.502N |P=0.188N P=0.500 P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.503 (e) (e) (e) |P=0.200N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Mesentery | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/12 (58%) 13/13 (100%) 18/18 (100%) 9/11 (82%) |14/15 (93%) 20/20 (100%) 16/17 (94%) 6/6 (100%) | |POLY-3 RATE (b) | 7/11.61 13/13.00 18/18.00 9/10.61 |14/14.32 20/20.00 16/16.92 6/6.00 | |POLY-3 PERCENT (g) | 60.3% 100.0% 100.0% 84.8% |97.8% 100.0% 94.6% 100.0% | |TERMINAL (d) | 5/8 (63%) 10/10 (100%) 11/11 (100%) 6/6 (100%) |10/10 (100%) 13/13 (100%) 13/13 (100%) 4/4 (100%) | |FIRST INCIDENCE | 704 393 544 633 |437 543 497 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.152 P=0.132 P=0.018 * P=0.192 |P=0.223N P=0.305 P=0.481N P=0.386N | |POLY 3 | P=0.117 P=0.010 * P=0.002 ** P=0.200 |P=0.774N P=0.973 P=0.696N P=0.996 | |POLY 1.5 | P=0.136 P=0.010 * P=0.002 ** P=0.211 |P=0.745 P=0.728 P=0.740N P=0.896 | |POLY 6 | P=0.088 P=0.013 * P=0.003 ** P=0.180 |P=0.735N P=1.000 P=0.654N P=1.000 | |LOGISTIC REGRESSION| P=0.180 P=0.017 * P=0.006 ** P=0.110 |P=0.655 P=0.826 P=0.681N P=0.859 | |COCH-ARM / FISHERS | P=0.182 P=0.015 * P=0.006 ** P=0.222 |P=0.576 P=0.429 P=0.726 P=0.714 | |ORDER RESTRICTED | P=0.004 ** (e) (e) (e) |P=0.570N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Nose | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 1/48 (2%) 3/50 (6%) 0/49 (0%) |1/50 (2%) 5/50 (10%) 1/49 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 5/43.83 1/44.87 3/44.12 0/43.95 |1/42.30 5/43.57 1/43.33 0/37.33 | |POLY-3 PERCENT (g) | 11.4% 2.2% 6.8% 0.0% |2.4% 11.5% 2.3% 0.0% | |TERMINAL (d) | 3/31 (10%) 1/35 (3%) 2/32 (6%) 0/32 (0%) |1/33 (3%) 4/30 (13%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | 543 729 (T) 717 --- |731 (T) 715 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.037N* P=0.082N P=0.337N P=0.032N* |P=0.211N P=0.084 P=0.762 P=0.581N | |POLY 3 | P=0.038N* P=0.096N P=0.352N P=0.030N* |P=0.158N P=0.107 P=0.755N P=0.525N | |POLY 1.5 | P=0.037N* P=0.102N P=0.357N P=0.031N* |P=0.147N P=0.106 P=0.759N P=0.515N | |POLY 6 | P=0.039N* P=0.088N P=0.346N P=0.029N* |P=0.179N P=0.105 P=0.753N P=0.543N | |LOGISTIC REGRESSION| P=0.037N* P=0.113N P=0.350N P=0.036N* |P=0.205N P=0.091 P=0.762 (e) | |COCH-ARM / FISHERS | P=0.038N* P=0.112N P=0.357N P=0.030N* |P=0.139N P=0.102 P=0.747 P=0.505N | |ORDER RESTRICTED | P=0.010N* (e) (e) (e) |P=0.095N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 9/48 (19%) 17/50 (34%) 10/49 (20%) |5/50 (10%) 12/50 (24%) 8/49 (16%) 7/49 (14%) | |POLY-3 RATE (b) | 5/43.83 9/44.87 17/45.47 10/44.79 |5/43.26 12/43.84 8/43.82 7/38.50 | |POLY-3 PERCENT (g) | 11.4% 20.1% 37.4% 22.3% |11.6% 27.4% 18.3% 18.2% | |TERMINAL (d) | 3/31 (10%) 9/35 (26%) 9/32 (28%) 8/32 (25%) |3/33 (9%) 9/30 (30%) 7/33 (21%) 4/22 (18%) | |FIRST INCIDENCE | 543 729 (T) 586 513 |437 688 582 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.118 P=0.265 P=0.009 ** P=0.153 |P=0.273 P=0.042 * P=0.283 P=0.198 | |POLY 3 | P=0.119 P=0.204 P=0.003 ** P=0.137 |P=0.432 P=0.053 P=0.283 P=0.298 | |POLY 1.5 | P=0.115 P=0.190 P=0.003 ** P=0.132 |P=0.476 P=0.054 P=0.275 P=0.328 | |POLY 6 | P=0.120 P=0.223 P=0.004 ** P=0.141 |P=0.359 P=0.050 P=0.288 P=0.247 | |LOGISTIC REGRESSION| P=0.113 P=0.219 P=0.004 ** P=0.127 |P=0.446 P=0.060 P=0.271 P=0.352 | |COCH-ARM / FISHERS | P=0.109 P=0.172 P=0.004 ** P=0.122 |P=0.531 P=0.054 P=0.264 P=0.365 | |ORDER RESTRICTED | P=0.024 * (e) (e) (e) |P=0.206 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Nose: Glands | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 30/48 (63%) 48/50 (96%) 46/49 (94%) |0/50 (0%) 17/50 (34%) 38/49 (78%) 44/49 (90%) | |POLY-3 RATE (b) | 3/43.15 30/46.54 48/48.52 46/48.18 |0/42.30 17/44.95 38/46.70 44/46.60 | |POLY-3 PERCENT (g) | 7.0% 64.5% 98.9% 95.5% |0.0% 37.8% 81.4% 94.4% | |TERMINAL (d) | 3/31 (10%) 22/35 (63%) 32/32 (100%) 32/32 (100%)|0/33 (0%) 11/30 (37%) 28/33 (85%) 21/22 (96%) | |FIRST INCIDENCE | 729 (T) 569 460 513 |--- 561 493 523 | |-------------------| | | |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: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Nose: Goblet Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/48 (6%) 7/50 (14%) 16/49 (33%) |1/50 (2%) 3/50 (6%) 1/49 (2%) 4/49 (8%) | |POLY-3 RATE (b) | 1/43.15 3/44.87 7/44.07 16/44.30 |1/42.66 3/44.37 1/43.33 4/37.71 | |POLY-3 PERCENT (g) | 2.3% 6.7% 15.9% 36.1% |2.3% 6.8% 2.3% 10.6% | |TERMINAL (d) | 1/31 (3%) 3/35 (9%) 7/32 (22%) 15/32 (47%) |0/33 (0%) 2/30 (7%) 1/33 (3%) 2/22 (9%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 633 |631 374 731 (T) 653 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.349 P=0.034 * P<0.001 ** |P=0.086 P=0.297 P=0.755N P=0.098 | |POLY 3 | P<0.001 ** P=0.319 P=0.032 * P<0.001 ** |P=0.132 P=0.319 P=0.757N P=0.142 | |POLY 1.5 | P<0.001 ** P=0.307 P=0.031 * P<0.001 ** |P=0.143 P=0.316 P=0.760N P=0.156 | |POLY 6 | P<0.001 ** P=0.335 P=0.033 * P<0.001 ** |P=0.117 P=0.316 P=0.756N P=0.120 | |LOGISTIC REGRESSION| P<0.001 ** P=0.349 P=0.034 * P<0.001 ** |P=0.166 P=0.258 P=0.757 P=0.148 | |COCH-ARM / FISHERS | P<0.001 ** P=0.293 P=0.030 * P<0.001 ** |P=0.157 P=0.309 P=0.747 P=0.175 | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.082 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Nose: Nasolacrimal Duct | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 6/48 (13%) 1/50 (2%) 4/49 (8%) |3/50 (6%) 1/50 (2%) 3/49 (6%) 1/49 (2%) | |POLY-3 RATE (b) | 2/43.15 6/45.76 1/44.07 4/44.56 |3/42.96 1/44.37 3/44.30 1/37.70 | |POLY-3 PERCENT (g) | 4.6% 13.1% 2.3% 9.0% |7.0% 2.3% 6.8% 2.7% | |TERMINAL (d) | 2/31 (7%) 3/35 (9%) 1/32 (3%) 2/32 (6%) |2/33 (6%) 0/30 (0%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 393 729 (T) 569 |515 374 374 626 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.480 P=0.178 P=0.489N P=0.357 |P=0.385N P=0.319N P=0.652N P=0.388N | |POLY 3 | P=0.504 P=0.152 P=0.493N P=0.352 |P=0.367N P=0.293N P=0.648N P=0.353N | |POLY 1.5 | P=0.493 P=0.139 P=0.498N P=0.343 |P=0.348N P=0.296N P=0.656N P=0.334N | |POLY 6 | P=0.514 P=0.170 P=0.486N P=0.361 |P=0.395N P=0.296N P=0.643N P=0.387N | |LOGISTIC REGRESSION| P=0.473 P=0.103 P=0.489N P=0.335 |P=0.239N P=0.368N P=0.612 P=0.298N | |COCH-ARM / FISHERS | P=0.477 P=0.121 P=0.500N P=0.329 |P=0.321N P=0.309N P=0.651 P=0.316N | |ORDER RESTRICTED | P=0.346 (e) (e) (e) |P=0.297N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 47/48 (98%) 49/50 (98%) 49/49 (100%)|0/50 (0%) 50/50 (100%) 49/49 (100%) 48/49 (98%) | |POLY-3 RATE (b) | 0/43.15 47/48.00 49/49.00 49/49.00 |0/42.30 50/50.00 49/49.00 48/48.01 | |POLY-3 PERCENT (g) | 0.0% 97.9% 100.0% 100.0% |0.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 0/31 (0%) 34/35 (97%) 32/32 (100%) 32/32 (100%)|0/33 (0%) 30/30 (100%) 33/33 (100%) 22/22 (100%) | |FIRST INCIDENCE | --- 393 460 513 |--- 374 374 516 | |-------------------| | | |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 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/48 (0%) 2/50 (4%) 1/49 (2%) |10/50 (20%) 14/50 (28%) 15/49 (31%) 4/49 (8%) | |POLY-3 RATE (b) | 4/43.66 0/44.87 2/44.46 1/44.16 |10/44.20 14/44.13 15/44.55 4/38.51 | |POLY-3 PERCENT (g) | 9.2% 0.0% 4.5% 2.3% |22.6% 31.7% 33.7% 10.4% | |TERMINAL (d) | 2/31 (7%) 0/35 (0%) 1/32 (3%) 0/32 (0%) |6/33 (18%) 10/30 (33%) 11/33 (33%) 1/22 (5%) | |FIRST INCIDENCE | 612 --- 619 674 |437 617 493 525 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.196N P=0.053N P=0.326N P=0.169N |P=0.196N P=0.199 P=0.198 P=0.197N | |POLY 3 | P=0.207N P=0.057N P=0.329N P=0.175N |P=0.104N P=0.234 P=0.177 P=0.116N | |POLY 1.5 | P=0.204N P=0.060N P=0.335N P=0.178N |P=0.078N P=0.240 P=0.171 P=0.098N | |POLY 6 | P=0.213N P=0.052N P=0.321N P=0.172N |P=0.161N P=0.219 P=0.182 P=0.154N | |LOGISTIC REGRESSION| P=0.203N P=0.068N P=0.337N P=0.187N |P=0.070N P=0.255 P=0.167 P=0.074N | |COCH-ARM / FISHERS | P=0.201N P=0.064N P=0.339N P=0.187N |P=0.055N P=0.241 P=0.163 P=0.080N | |ORDER RESTRICTED | P=0.072N (e) (e) (e) |P=0.033N* (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Hyperplasia Basal Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 21/48 (44%) 44/50 (88%) 48/49 (98%) |0/50 (0%) 25/50 (50%) 42/49 (86%) 45/49 (92%) | |POLY-3 RATE (b) | 0/43.15 21/45.70 44/47.74 48/48.84 |0/42.30 25/47.06 42/47.42 45/47.52 | |POLY-3 PERCENT (g) | 0.0% 46.0% 92.2% 98.3% |0.0% 53.1% 88.6% 94.7% | |TERMINAL (d) | 0/31 (0%) 16/35 (46%) 30/32 (94%) 32/32 (100%)|0/33 (0%) 16/30 (53%) 31/33 (94%) 20/22 (91%) | |FIRST INCIDENCE | --- 654 460 513 |--- 374 374 516 | |-------------------| | | |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 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/48 (2%) 0/50 (0%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/43.15 1/44.87 0/44.07 2/44.54 |0/42.30 0/43.50 0/43.33 0/37.33 | |POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 1/35 (3%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 729 (T) --- 614 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.144 P=0.524 (e) P=0.259 |(e) (e) (e) (e) | |POLY 3 | P=0.145 P=0.508 (e) P=0.244 |(e) (e) (e) (e) | |POLY 1.5 | P=0.143 P=0.501 (e) P=0.240 |(e) (e) (e) (e) | |POLY 6 | P=0.148 P=0.516 (e) P=0.249 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.135 P=0.524 (e) P=0.192 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.139 P=0.490 (e) P=0.242 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.079 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |5/50 (10%) 3/50 (6%) 4/49 (8%) 0/49 (0%) | |POLY-3 RATE (b) | 0/43.15 0/44.87 0/44.07 0/43.95 |5/42.53 3/44.18 4/43.82 0/37.33 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |11.8% 6.8% 9.1% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) |3/33 (9%) 1/30 (3%) 3/33 (9%) 0/22 (0%) | |FIRST INCIDENCE | --- --- --- --- |687 542 582 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.070N P=0.392N P=0.494N P=0.086N | |POLY 3 | (e) (e) (e) (e) |P=0.051N P=0.335N P=0.481N P=0.042N* | |POLY 1.5 | (e) (e) (e) (e) |P=0.044N* P=0.341N P=0.493N P=0.037N* | |POLY 6 | (e) (e) (e) (e) |P=0.065N P=0.337N P=0.473N P=0.054N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.041N* P=0.347N P=0.490N P=0.058N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.037N* P=0.357N P=0.513N P=0.030N* | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.032N* (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |6/50 (12%) 6/50 (12%) 11/50 (22%) 4/50 (8%) | |POLY-3 RATE (b) | |6/42.98 6/44.05 11/44.35 4/37.91 | |POLY-3 PERCENT (g) | |14.0% 13.6% 24.8% 10.6% | |TERMINAL (d) | |5/33 (15%) 5/30 (17%) 8/33 (24%) 3/22 (14%) | |FIRST INCIDENCE | |501 561 614 684 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.473 P=0.574 P=0.151 P=0.602N | |POLY 3 | |P=0.508N P=0.604N P=0.155 P=0.450N | |POLY 1.5 | |P=0.449N P=0.608N P=0.151 P=0.412N | |POLY 6 | |P=0.496 P=0.609N P=0.159 P=0.515N | |LOGISTIC REGRESSION| |P=0.500N P=0.609N P=0.159 P=0.467N | |COCH-ARM / FISHERS | |P=0.376N P=0.620N P=0.143 P=0.370N | |ORDER RESTRICTED | |P=0.319N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 18/49 (37%) 27/50 (54%) 21/50 (42%) |3/50 (6%) 5/49 (10%) 2/50 (4%) 4/50 (8%) | |POLY-3 RATE (b) | 15/44.99 18/46.02 27/47.39 21/47.53 |3/42.47 5/43.90 2/43.84 4/38.91 | |POLY-3 PERCENT (g) | 33.3% 39.1% 57.0% 44.2% |7.1% 11.4% 4.6% 10.3% | |TERMINAL (d) | 11/31 (36%) 13/35 (37%) 16/32 (50%) 12/32 (38%) |2/33 (6%) 3/30 (10%) 2/33 (6%) 2/22 (9%) | |FIRST INCIDENCE | 543 654 460 567 |687 374 731 (T) 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.127 P=0.497 P=0.032 * P=0.212 |P=0.376 P=0.326 P=0.500N P=0.352 | |POLY 3 | P=0.141 P=0.361 P=0.016 * P=0.194 |P=0.492 P=0.374 P=0.486N P=0.452 | |POLY 1.5 | P=0.125 P=0.339 P=0.013 * P=0.176 |P=0.514 P=0.366 P=0.490N P=0.475 | |POLY 6 | P=0.163 P=0.393 P=0.022 * P=0.219 |P=0.453 P=0.375 P=0.484N P=0.408 | |LOGISTIC REGRESSION| P=0.107 P=0.371 P=0.013 * P=0.148 |P=0.552 P=0.337 P=0.481N P=0.491 | |COCH-ARM / FISHERS | P=0.104 P=0.310 P=0.013 * P=0.149 |P=0.541 P=0.346 P=0.500N P=0.500 | |ORDER RESTRICTED | P=0.066 (e) (e) (e) |P=0.478 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/49 (4%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/43.15 2/45.37 3/44.07 0/44.93 |0/42.30 0/42.90 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 2.3% 4.4% 6.8% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 2/35 (6%) 3/32 (9%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.337N P=0.543 P=0.316 P=0.494N |(e) (e) (e) (e) | |POLY 3 | P=0.321N P=0.518 P=0.313 P=0.492N |(e) (e) (e) (e) | |POLY 1.5 | P=0.326N P=0.507 P=0.308 P=0.495N |(e) (e) (e) (e) | |POLY 6 | P=0.319N P=0.531 P=0.319 P=0.489N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.337N P=0.543 P=0.316 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.335N P=0.492 P=0.309 P=0.500N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.188N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/49 (2%) |6/50 (12%) 6/50 (12%) 1/50 (2%) 5/50 (10%) | |POLY-3 RATE (b) | 1/43.15 1/45.65 1/44.07 1/43.95 |6/43.70 6/44.92 1/43.84 5/39.70 | |POLY-3 PERCENT (g) | 2.3% 2.2% 2.3% 2.3% |13.7% 13.4% 2.3% 12.6% | |TERMINAL (d) | 1/31 (3%) 0/35 (0%) 1/32 (3%) 1/32 (3%) |4/33 (12%) 3/30 (10%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) 654 729 (T) 729 (T) |436 542 731 (T) 540 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.634N P=0.731N P=0.755N P=0.755N |P=0.486N P=0.596 P=0.060N P=0.590 | |POLY 3 | P=0.635N P=0.748N P=0.756N P=0.757N |P=0.375N P=0.602N P=0.055N P=0.567N | |POLY 1.5 | P=0.634 P=0.755N P=0.759N P=0.759N |P=0.360N P=0.607N P=0.055N P=0.538N | |POLY 6 | P=0.635 P=0.738N P=0.752N P=0.754N |P=0.396N P=0.603N P=0.055N P=0.614N | |LOGISTIC REGRESSION| P=0.634N P=0.762N P=0.755N P=0.755N |P=0.281N P=0.585 P=0.063N P=0.448N | |COCH-ARM / FISHERS | P=0.628 P=0.753N P=0.753N P=0.747 |P=0.338N P=0.620N P=0.056N P=0.500N | |ORDER RESTRICTED | P=0.737N (e) (e) (e) |P=0.266N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 8/50 (16%) 9/50 (18%) 8/49 (16%) |4/50 (8%) 8/50 (16%) 4/50 (8%) 7/50 (14%) | |POLY-3 RATE (b) | 5/44.04 8/45.48 9/45.32 8/44.74 |4/42.92 8/44.28 4/44.25 7/39.50 | |POLY-3 PERCENT (g) | 11.4% 17.6% 19.9% 17.9% |9.3% 18.1% 9.0% 17.7% | |TERMINAL (d) | 2/31 (7%) 7/35 (20%) 7/32 (22%) 6/32 (19%) |3/33 (9%) 5/30 (17%) 3/33 (9%) 2/22 (9%) | |FIRST INCIDENCE | 589 704 460 513 |533 561 614 563 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.274 P=0.356 P=0.214 P=0.303 |P=0.164 P=0.158 P=0.636N P=0.136 | |POLY 3 | P=0.282 P=0.296 P=0.207 P=0.285 |P=0.284 P=0.191 P=0.627N P=0.213 | |POLY 1.5 | P=0.276 P=0.283 P=0.199 P=0.278 |P=0.308 P=0.187 P=0.632N P=0.234 | |POLY 6 | P=0.281 P=0.313 P=0.215 P=0.289 |P=0.248 P=0.188 P=0.623N P=0.179 | |LOGISTIC REGRESSION| P=0.263 P=0.298 P=0.194 P=0.257 |P=0.318 P=0.184 P=0.639N P=0.257 | |COCH-ARM / FISHERS | P=0.258 P=0.277 P=0.194 P=0.264 |P=0.340 P=0.178 P=0.643N P=0.262 | |ORDER RESTRICTED | P=0.274 (e) (e) (e) |P=0.213 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 1/50 (2%) 2/50 (4%) 1/49 (2%) | | |POLY-3 RATE (b) | 1/41.16 1/46.37 2/45.57 1/43.93 | | |POLY-3 PERCENT (g) | 2.4% 2.2% 4.4% 2.3% | | |TERMINAL (d) | 1/30 (3%) 0/35 (0%) 0/32 (0%) 1/31 (3%) | | |FIRST INCIDENCE | 729 (T) 106 114 729 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.590 P=0.743N P=0.510 P=0.755N | | |POLY 3 | P=0.603 P=0.734N P=0.535 P=0.746N | | |POLY 1.5 | P=0.601 P=0.741N P=0.527 P=0.750N | | |POLY 6 | P=0.603 P=0.724N P=0.546 P=0.743N | | |LOGISTIC REGRESSION| P=0.461 P=0.663N P=0.629 P=0.755N | | |COCH-ARM / FISHERS | P=0.595 P=0.742N P=0.515 P=0.747N | | |ORDER RESTRICTED | P=0.602 (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 4/50 (8%) 1/50 (2%) 1/49 (2%) | | |POLY-3 RATE (b) | 1/41.16 4/45.43 1/44.58 1/43.93 | | |POLY-3 PERCENT (g) | 2.4% 8.8% 2.2% 2.3% | | |TERMINAL (d) | 1/30 (3%) 3/35 (9%) 0/32 (0%) 1/31 (3%) | | |FIRST INCIDENCE | 729 (T) 717 578 729 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.375N P=0.229 P=0.751N P=0.755N | | |POLY 3 | P=0.347N P=0.210 P=0.743N P=0.746N | | |POLY 1.5 | P=0.355N P=0.200 P=0.748N P=0.750N | | |POLY 6 | P=0.339N P=0.224 P=0.736N P=0.743N | | |LOGISTIC REGRESSION| P=0.359N P=0.241 P=0.751N P=0.755N | | |COCH-ARM / FISHERS | P=0.367N P=0.194 P=0.742N P=0.747N | | |ORDER RESTRICTED | P=0.329N (e) (e) (e) | | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 1/50 (2%) 4/50 (8%) 2/50 (4%) | | |POLY-3 RATE (b) | 5/43.70 1/45.38 4/44.79 2/45.01 | | |POLY-3 PERCENT (g) | 11.4% 2.2% 8.9% 4.4% | | |TERMINAL (d) | 3/31 (10%) 1/35 (3%) 0/32 (0%) 1/32 (3%) | | |FIRST INCIDENCE | 623 729 (T) 578 710 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.272N P=0.081N P=0.472N P=0.203N | | |POLY 3 | P=0.269N P=0.093N P=0.485N P=0.204N | | |POLY 1.5 | P=0.268N P=0.098N P=0.494N P=0.208N | | |POLY 6 | P=0.274N P=0.086N P=0.472N P=0.201N | | |LOGISTIC REGRESSION| P=0.269N P=0.097N P=0.500N P=0.204N | | |COCH-ARM / FISHERS | P=0.273N P=0.102N P=0.500N P=0.218N | | |ORDER RESTRICTED | P=0.146N (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Cyst Epithelial Inclusion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 4/43.45 1/45.38 3/44.58 2/45.07 |0/42.30 2/43.50 0/43.84 1/37.73 | |POLY-3 PERCENT (g) | 9.2% 2.2% 6.7% 4.4% |0.0% 4.6% 0.0% 2.7% | |TERMINAL (d) | 2/31 (7%) 1/35 (3%) 2/32 (6%) 1/32 (3%) |0/33 (0%) 2/30 (7%) 0/33 (0%) 1/22 (5%) | |FIRST INCIDENCE | 675 729 (T) 578 694 |--- 731 (T) --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.370N P=0.145N P=0.478N P=0.317N |P=0.446 P=0.217 (e) P=0.419 | |POLY 3 | P=0.367N P=0.165N P=0.486N P=0.320N |P=0.506 P=0.243 (e) P=0.477 | |POLY 1.5 | P=0.366N P=0.173N P=0.495N P=0.326N |P=0.522 P=0.242 (e) P=0.488 | |POLY 6 | P=0.371N P=0.156N P=0.476N P=0.315N |P=0.478 P=0.241 (e) P=0.458 | |LOGISTIC REGRESSION| P=0.364N P=0.159N P=0.498N P=0.317N |(e) P=0.217 (e) P=0.419 | |COCH-ARM / FISHERS | P=0.371N P=0.181N P=0.500N P=0.339N |P=0.539 P=0.247 (e) P=0.500 | |ORDER RESTRICTED | P=0.264N (e) (e) (e) |P=0.304 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 28 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/43.16 1/45.38 2/44.07 0/44.93 |0/42.30 1/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 4.6% 2.2% 4.5% 0.0% |0.0% 2.3% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 1/35 (3%) 2/32 (6%) 0/32 (0%) |0/33 (0%) 1/30 (3%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 725 729 (T) 729 (T) --- |--- 731 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.201N P=0.458N P=0.685N P=0.236N |P=0.625N P=0.481 (e) (e) | |POLY 3 | P=0.196N P=0.483N P=0.687N P=0.228N |P=0.563N P=0.506 (e) (e) | |POLY 1.5 | P=0.196N P=0.492N P=0.691N P=0.231N |P=0.565N P=0.504 (e) (e) | |POLY 6 | P=0.197N P=0.469N P=0.680N P=0.225N |P=0.561N P=0.504 (e) (e) | |LOGISTIC REGRESSION| P=0.196N P=0.450N P=0.676N P=0.226N |(e) P=0.481 (e) (e) | |COCH-ARM / FISHERS | P=0.200N P=0.500N P=0.691N P=0.247N |P=0.567N P=0.500 (e) (e) | |ORDER RESTRICTED | P=0.148N (e) (e) (e) |P=0.405N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Inflammation Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.38 2/44.36 0/44.93 |0/42.30 0/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 1/32 (3%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- --- 653 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.598 (e) P=0.251 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.609 (e) P=0.243 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.607 (e) P=0.239 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.609 (e) P=0.248 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.595 (e) P=0.238 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.253 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 29 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 0/45.38 2/44.33 0/44.93 |1/43.09 0/43.50 1/43.84 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% |2.3% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 1/32 (3%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | --- --- 661 --- |436 --- 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.600 (e) P=0.249 (e) |P=0.441N P=0.504N P=0.758 P=0.504N | |POLY 3 | P=0.609 (e) P=0.243 (e) |P=0.425N P=0.498N P=0.757N P=0.526N | |POLY 1.5 | P=0.607 (e) P=0.239 (e) |P=0.417N P=0.498N P=0.758N P=0.514N | |POLY 6 | P=0.609 (e) P=0.248 (e) |P=0.434N P=0.501N P=0.757N P=0.546N | |LOGISTIC REGRESSION| P=0.596 (e) P=0.238 (e) |P=0.342N P=0.541N P=0.733 P=0.369N | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.405N P=0.500N P=0.753N P=0.500N | |ORDER RESTRICTED | P=0.253 (e) (e) (e) |P=0.279N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Accessory Spleen | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/49 (6%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 3/45.90 0/44.07 1/45.40 |2/42.42 1/43.67 1/43.84 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 6.5% 0.0% 2.2% |4.7% 2.3% 2.3% 0.0% | |TERMINAL (d) | 0/31 (0%) 2/35 (6%) 0/32 (0%) 0/32 (0%) |1/33 (3%) 0/30 (0%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | --- 569 --- 589 |703 688 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.632N P=0.142 (e) P=0.504 |P=0.209N P=0.514N P=0.494N P=0.331N | |POLY 3 | P=0.610N P=0.130 (e) P=0.510 |P=0.169N P=0.490N P=0.488N P=0.264N | |POLY 1.5 | P=0.619N P=0.124 (e) P=0.506 |P=0.162N P=0.492N P=0.492N P=0.251N | |POLY 6 | P=0.600N P=0.139 (e) P=0.514 |P=0.178N P=0.492N P=0.487N P=0.288N | |LOGISTIC REGRESSION| P=0.625 P=0.101 (e) P=0.401 |P=0.175N P=0.492N P=0.486N P=0.292N | |COCH-ARM / FISHERS | P=0.631N P=0.117 (e) P=0.500 |P=0.153N P=0.500N P=0.500N P=0.247N | |ORDER RESTRICTED | P=0.275 (e) (e) (e) |P=0.139N (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 30 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 6/49 (12%) 4/50 (8%) 1/50 (2%) |3/50 (6%) 1/50 (2%) 3/50 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 2/43.33 6/46.11 4/44.41 1/45.40 |3/42.30 1/43.50 3/43.86 1/37.82 | |POLY-3 PERCENT (g) | 4.6% 13.0% 9.0% 2.2% |7.1% 2.3% 6.8% 2.6% | |TERMINAL (d) | 1/31 (3%) 2/35 (6%) 2/32 (6%) 0/32 (0%) |3/33 (9%) 1/30 (3%) 2/33 (6%) 0/22 (0%) | |FIRST INCIDENCE | 682 605 676 589 |731 (T) 731 (T) 726 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.232N P=0.188 P=0.368 P=0.485N |P=0.449N P=0.339N P=0.660N P=0.455N | |POLY 3 | P=0.207N P=0.154 P=0.348 P=0.484N |P=0.359N P=0.295N P=0.646N P=0.346N | |POLY 1.5 | P=0.215N P=0.142 P=0.341 P=0.490N |P=0.339N P=0.298N P=0.651N P=0.327N | |POLY 6 | P=0.201N P=0.170 P=0.358 P=0.478N |P=0.389N P=0.297N P=0.643N P=0.382N | |LOGISTIC REGRESSION| P=0.232N P=0.128 P=0.345 P=0.532N |P=0.444N P=0.339N P=0.653N P=0.435N | |COCH-ARM / FISHERS | P=0.231N P=0.128 P=0.339 P=0.500N |P=0.313N P=0.309N P=0.661N P=0.309N | |ORDER RESTRICTED | P=0.170N (e) (e) (e) |P=0.290N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/49 (4%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 0/43.15 2/45.46 1/44.60 1/45.45 |2/42.39 1/44.10 1/44.09 2/39.01 | |POLY-3 PERCENT (g) | 0.0% 4.4% 2.2% 2.2% |4.7% 2.3% 2.3% 5.1% | |TERMINAL (d) | 0/31 (0%) 1/35 (3%) 0/32 (0%) 0/32 (0%) |1/33 (3%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 708 568 569 |710 542 666 516 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.505 P=0.275 P=0.509 P=0.509 |P=0.497 P=0.508N P=0.488N P=0.636 | |POLY 3 | P=0.526 P=0.249 P=0.507 P=0.510 |P=0.524 P=0.486N P=0.486N P=0.664 | |POLY 1.5 | P=0.517 P=0.242 P=0.503 P=0.507 |P=0.538 P=0.490N P=0.491N P=0.679 | |POLY 6 | P=0.535 P=0.258 P=0.512 P=0.514 |P=0.503 P=0.487N P=0.483N P=0.634 | |LOGISTIC REGRESSION| P=0.487 P=0.257 P=0.540 P=0.374 |P=0.590N P=0.513N P=0.492N P=0.660N | |COCH-ARM / FISHERS | P=0.502 P=0.242 P=0.500 P=0.500 |P=0.556 P=0.500N P=0.500N P=0.691N | |ORDER RESTRICTED | P=0.280 (e) (e) (e) |P=0.493 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 31 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hyperplasia Focal Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.15 1/45.37 0/44.07 0/44.93 |0/42.30 2/43.50 0/43.84 0/37.73 | |POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |0.0% 4.6% 0.0% 0.0% | |TERMINAL (d) | 0/31 (0%) 1/35 (3%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 2/30 (7%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 729 (T) --- --- |--- 731 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.569N P=0.524 (e) (e) |P=0.476N P=0.217 (e) (e) | |POLY 3 | P=0.555N P=0.510 (e) (e) |P=0.414N P=0.243 (e) (e) | |POLY 1.5 | P=0.560N P=0.504 (e) (e) |P=0.409N P=0.242 (e) (e) | |POLY 6 | P=0.550N P=0.518 (e) (e) |P=0.424N P=0.241 (e) (e) | |LOGISTIC REGRESSION| (e) P=0.524 (e) (e) |(e) P=0.217 (e) (e) | |COCH-ARM / FISHERS | P=0.566N P=0.495 (e) (e) |P=0.405N P=0.247 (e) (e) | |ORDER RESTRICTED | P=0.383N (e) (e) (e) |P=0.276N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/49 (2%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 3/43.58 1/45.90 1/44.07 1/45.07 |0/42.30 0/43.50 0/43.84 1/38.33 | |POLY-3 PERCENT (g) | 6.9% 2.2% 2.3% 2.2% |0.0% 0.0% 0.0% 2.6% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 1/32 (3%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 666 569 729 (T) 694 |--- --- --- 540 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.240N P=0.273N P=0.297N P=0.290N |P=0.195 (e) (e) P=0.505 | |POLY 3 | P=0.245N P=0.287N P=0.301N P=0.293N |P=0.185 (e) (e) P=0.480 | |POLY 1.5 | P=0.243N P=0.297N P=0.305N P=0.297N |P=0.191 (e) (e) P=0.490 | |POLY 6 | P=0.249N P=0.275N P=0.297N P=0.290N |P=0.176 (e) (e) P=0.463 | |LOGISTIC REGRESSION| P=0.245N P=0.356N P=0.301N P=0.305N |P=0.262 (e) (e) P=0.560 | |COCH-ARM / FISHERS | P=0.240N P=0.316N P=0.309N P=0.309N |P=0.198 (e) (e) P=0.500 | |ORDER RESTRICTED | P=0.175N (e) (e) (e) |P=0.104 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 32 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/48 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 1/49 (2%) 1/49 (2%) | |POLY-3 RATE (b) | 4/43.82 1/44.95 1/44.12 0/44.93 |1/43.03 1/43.67 1/43.43 1/37.93 | |POLY-3 PERCENT (g) | 9.1% 2.2% 2.3% 0.0% |2.3% 2.3% 2.3% 2.6% | |TERMINAL (d) | 1/31 (3%) 0/35 (0%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 589 708 717 --- |477 688 704 551 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.035N* P=0.151N P=0.175N P=0.063N |P=0.591 P=0.753N P=0.744N P=0.751N | |POLY 3 | P=0.034N* P=0.171N P=0.176N P=0.057N |P=0.588 P=0.757N P=0.759N P=0.732 | |POLY 1.5 | P=0.034N* P=0.179N P=0.179N P=0.058N |P=0.605 P=0.758N P=0.760 P=0.743 | |POLY 6 | P=0.035N* P=0.161N P=0.173N P=0.056N |P=0.559 P=0.760N P=0.757N P=0.711 | |LOGISTIC REGRESSION| P=0.034N* P=0.203N P=0.179N P=0.066N |P=0.572N P=0.724 P=0.727 P=0.703N | |COCH-ARM / FISHERS | P=0.034N* P=0.194N P=0.181N P=0.059N |P=0.627 P=0.753N P=0.747 P=0.747 | |ORDER RESTRICTED | P=0.011N* (e) (e) (e) |P=0.702 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/48 (4%) 2/50 (4%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 1/49 (2%) 1/49 (2%) | |POLY-3 RATE (b) | 0/43.15 2/45.49 2/44.13 2/44.06 |0/42.30 0/43.50 1/43.36 1/37.96 | |POLY-3 PERCENT (g) | 0.0% 4.4% 4.5% 4.5% |0.0% 0.0% 2.3% 2.6% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | --- 569 722 708 |--- --- 722 540 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.244 P=0.268 P=0.250 P=0.253 |P=0.197 (e) P=0.506 P=0.505 | |POLY 3 | P=0.253 P=0.249 P=0.242 P=0.242 |P=0.204 (e) P=0.505 P=0.478 | |POLY 1.5 | P=0.249 P=0.240 P=0.239 P=0.239 |P=0.217 (e) P=0.502 P=0.487 | |POLY 6 | P=0.256 P=0.261 P=0.246 P=0.245 |P=0.184 (e) P=0.508 P=0.462 | |LOGISTIC REGRESSION| P=0.239 P=0.177 P=0.249 P=0.244 |P=0.260 (e) P=0.507 P=0.554 | |COCH-ARM / FISHERS | P=0.240 P=0.237 P=0.247 P=0.242 |P=0.232 (e) P=0.495 P=0.495 | |ORDER RESTRICTED | P=0.192 (e) (e) (e) |P=0.230 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 33 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/48 (4%) 1/50 (2%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 1/49 (2%) 0/49 (0%) | |POLY-3 RATE (b) | 1/43.38 2/44.95 1/44.33 0/43.95 |0/42.30 0/43.50 1/43.35 0/37.36 | |POLY-3 PERCENT (g) | 2.3% 4.5% 2.3% 0.0% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 666 710 661 --- |--- --- 726 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.242N P=0.545 P=0.752N P=0.485N |P=0.657 (e) P=0.506 (e) | |POLY 3 | P=0.242N P=0.512 P=0.756N P=0.497N |P=0.636 (e) P=0.505 (e) | |POLY 1.5 | P=0.245N P=0.501 P=0.759N P=0.500N |P=0.662 (e) P=0.502 (e) | |POLY 6 | P=0.240N P=0.526 P=0.752N P=0.496N |P=0.587 (e) P=0.507 (e) | |LOGISTIC REGRESSION| P=0.250N P=0.493 P=0.761N P=0.522N |P=0.663 (e) P=0.507 (e) | |COCH-ARM / FISHERS | P=0.249N P=0.485 P=0.753N P=0.505N |P=0.692 (e) P=0.495 (e) | |ORDER RESTRICTED | P=0.230N (e) (e) (e) |P=0.388 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Testes: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | |POLY-3 RATE (b) | 0/43.15 0/45.38 2/44.28 0/44.93 | | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% | | |TERMINAL (d) | 0/31 (0%) 0/35 (0%) 1/32 (3%) 0/32 (0%) | | |FIRST INCIDENCE | --- --- 676 --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.604 (e) P=0.255 (e) | | |POLY 3 | P=0.609 (e) P=0.243 (e) | | |POLY 1.5 | P=0.607 (e) P=0.239 (e) | | |POLY 6 | P=0.609 (e) P=0.248 (e) | | |LOGISTIC REGRESSION| P=0.598 (e) P=0.240 (e) | | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) | | |ORDER RESTRICTED | P=0.252 (e) (e) (e) | | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 34 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Testes: Germinal Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 12/50 (24%) 11/50 (22%) 9/50 (18%) | | |POLY-3 RATE (b) | 16/44.05 12/45.85 11/45.18 9/45.47 | | |POLY-3 PERCENT (g) | 36.3% 26.2% 24.3% 19.8% | | |TERMINAL (d) | 10/31 (32%) 10/35 (29%) 5/32 (16%) 8/32 (25%) | | |FIRST INCIDENCE | 589 605 578 562 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.080N P=0.159N P=0.176N P=0.075N | | |POLY 3 | P=0.061N P=0.207N P=0.156N P=0.063N | | |POLY 1.5 | P=0.064N P=0.232N P=0.172N P=0.069N | | |POLY 6 | P=0.061N P=0.179N P=0.138N P=0.059N | | |LOGISTIC REGRESSION| P=0.061N P=0.180N P=0.164N P=0.061N | | |COCH-ARM / FISHERS | P=0.073N P=0.252N P=0.184N P=0.083N | | |ORDER RESTRICTED | P=0.054N (e) (e) (e) | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Testes: Interstitial Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 6/50 (12%) 2/50 (4%) 3/50 (6%) | | |POLY-3 RATE (b) | 7/44.87 6/46.08 2/44.10 3/45.47 | | |POLY-3 PERCENT (g) | 15.6% 13.0% 4.5% 6.6% | | |TERMINAL (d) | 4/31 (13%) 4/35 (11%) 1/32 (3%) 2/32 (6%) | | |FIRST INCIDENCE | 506 605 722 562 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.080N P=0.431N P=0.082N P=0.151N | | |POLY 3 | P=0.076N P=0.479N P=0.082N P=0.151N | | |POLY 1.5 | P=0.076N P=0.494N P=0.082N P=0.153N | | |POLY 6 | P=0.078N P=0.457N P=0.082N P=0.150N | | |LOGISTIC REGRESSION| P=0.082N P=0.506N P=0.079N P=0.205N | | |COCH-ARM / FISHERS | P=0.078N P=0.500N P=0.080N P=0.159N | | |ORDER RESTRICTED | P=0.083N (e) (e) (e) | | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 35 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 9/50 (18%) 7/49 (14%) |5/50 (10%) 8/50 (16%) 6/50 (12%) 1/50 (2%) | |POLY-3 RATE (b) | 2/43.73 4/45.48 9/44.10 7/44.48 |5/42.30 8/43.99 6/44.03 1/38.34 | |POLY-3 PERCENT (g) | 4.6% 8.8% 20.4% 15.7% |11.8% 18.2% 13.6% 2.6% | |TERMINAL (d) | 1/31 (3%) 3/35 (9%) 8/32 (25%) 6/32 (19%) |5/33 (15%) 5/30 (17%) 4/33 (12%) 0/22 (0%) | |FIRST INCIDENCE | 543 704 722 569 |731 (T) 666 704 535 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.052 P=0.393 P=0.032 * P=0.091 |P=0.141N P=0.234 P=0.510 P=0.192N | |POLY 3 | P=0.054 P=0.355 P=0.025 * P=0.082 |P=0.079N P=0.300 P=0.528 P=0.124N | |POLY 1.5 | P=0.053 P=0.344 P=0.025 * P=0.080 |P=0.067N P=0.293 P=0.518 P=0.113N | |POLY 6 | P=0.053 P=0.371 P=0.026 * P=0.084 |P=0.106N P=0.301 P=0.536 P=0.148N | |LOGISTIC REGRESSION| P=0.053 P=0.339 P=0.030 * P=0.074 |P=0.087N P=0.282 P=0.527 P=0.129N | |COCH-ARM / FISHERS | P=0.050 P=0.339 P=0.026 * P=0.075 |P=0.056N P=0.277 P=0.500 P=0.102N | |ORDER RESTRICTED | P=0.036 * (e) (e) (e) |P=0.066N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 1/49 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/43.15 2/45.38 2/44.07 1/43.95 |0/42.30 1/43.50 0/43.84 1/37.73 | |POLY-3 PERCENT (g) | 0.0% 4.4% 4.5% 2.3% |0.0% 2.3% 0.0% 2.7% | |TERMINAL (d) | 0/31 (0%) 2/35 (6%) 2/32 (6%) 1/32 (3%) |0/33 (0%) 1/30 (3%) 0/33 (0%) 1/22 (5%) | |FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |--- 731 (T) --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.467 P=0.265 P=0.245 P=0.506 |P=0.326 P=0.481 (e) P=0.419 | |POLY 3 | P=0.482 P=0.248 P=0.242 P=0.504 |P=0.378 P=0.506 (e) P=0.477 | |POLY 1.5 | P=0.476 P=0.242 P=0.239 P=0.501 |P=0.391 P=0.504 (e) P=0.488 | |POLY 6 | P=0.487 P=0.257 P=0.246 P=0.506 |P=0.357 P=0.504 (e) P=0.458 | |LOGISTIC REGRESSION| (e) P=0.265 P=0.245 P=0.506 |(e) P=0.481 (e) P=0.419 | |COCH-ARM / FISHERS | P=0.462 P=0.247 P=0.247 P=0.495 |P=0.405 P=0.500 (e) P=0.500 | |ORDER RESTRICTED | P=0.236 (e) (e) (e) |P=0.229 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 36 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Tongue: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) |1/1 (100%) 0/1 (0%) 3/3 (100%) 2/3 (67%) | |POLY-3 RATE (b) | 0/1.00 1/1.00 0/0.00 0/0.00 |1/1.00 0/0.94 3/3.00 2/3.00 | |POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 0.0% |100.0% 0.0% 100.0% 66.7% | |TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |1/1 (100%) 0/0 (0%) 2/2 (100%) 0/1 (0%) | |FIRST INCIDENCE | --- 682 --- --- |731 (T) --- 722 563 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.571N P=0.530 (e) (e) |P=0.205 P=1.000N (e) P=0.418 | |POLY 3 | (e) P=1.000N (e) (e) |P=0.649N P=1.000N (e) P=0.691N | |POLY 1.5 | (e) P=1.000N (e) (e) |P=0.663N P=1.000N (e) P=0.691N | |POLY 6 | (e) P=1.000N (e) (e) |P=0.623N P=1.000N (e) P=0.691N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.486N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.921 P=0.500 (e) (e) |P=0.668N P=0.500N (e) P=0.750N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.483N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Trachea: Glands | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 5/49 (10%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 1/43.15 0/45.37 0/44.07 5/44.36 |0/42.30 0/43.50 1/43.84 1/38.18 | |POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 11.3% |0.0% 0.0% 2.3% 2.6% | |TERMINAL (d) | 1/31 (3%) 0/35 (0%) 0/32 (0%) 4/32 (13%) |0/33 (0%) 0/30 (0%) 1/33 (3%) 0/22 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 614 |--- --- 731 (T) 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.008 ** P=0.476N P=0.494N P=0.114 |P=0.189 (e) P=0.500 P=0.480 | |POLY 3 | P=0.007 ** P=0.490N P=0.496N P=0.107 |P=0.204 (e) P=0.507 P=0.480 | |POLY 1.5 | P=0.007 ** P=0.496N P=0.499N P=0.104 |P=0.218 (e) P=0.505 P=0.489 | |POLY 6 | P=0.007 ** P=0.482N P=0.492N P=0.111 |P=0.182 (e) P=0.509 P=0.462 | |LOGISTIC REGRESSION| P=0.008 ** (e) (e) P=0.107 |P=0.243 (e) P=0.500 P=0.530 | |COCH-ARM / FISHERS | P=0.008 ** P=0.505N P=0.500N P=0.098 |P=0.236 (e) P=0.500 P=0.500 | |ORDER RESTRICTED | P=0.003 ** (e) (e) (e) |P=0.232 (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 37 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Urinary Bladder | | Calculus Micro Observation Only | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/49 (4%) 4/50 (8%) 4/49 (8%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 4/44.03 2/45.42 4/44.60 4/44.28 |0/42.30 0/43.50 0/43.33 0/37.33 | |POLY-3 PERCENT (g) | 9.1% 4.4% 9.0% 9.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/31 (7%) 1/35 (3%) 2/32 (6%) 3/32 (9%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 589 717 578 638 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.464 P=0.298N P=0.626N P=0.621N |(e) (e) (e) (e) | |POLY 3 | P=0.457 P=0.323N P=0.636N P=0.640N |(e) (e) (e) (e) | |POLY 1.5 | P=0.458 P=0.333N P=0.642N P=0.642 |(e) (e) (e) (e) | |POLY 6 | P=0.452 P=0.311N P=0.630N P=0.638N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.453 P=0.366N P=0.643N P=0.622 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.455 P=0.349N P=0.643N P=0.631 |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.539 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Urinary Bladder | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/49 (2%) 1/50 (2%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 2/43.75 1/45.87 1/44.10 0/43.95 |0/42.30 0/43.50 0/43.33 0/37.33 | |POLY-3 PERCENT (g) | 4.6% 2.2% 2.3% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/31 (3%) 0/35 (0%) 0/32 (0%) 0/32 (0%) |0/33 (0%) 0/30 (0%) 0/33 (0%) 0/22 (0%) | |FIRST INCIDENCE | 536 582 723 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.154N P=0.481N P=0.493N P=0.234N |(e) (e) (e) (e) | |POLY 3 | P=0.157N P=0.484N P=0.497N P=0.236N |(e) (e) (e) (e) | |POLY 1.5 | P=0.157N P=0.493N P=0.500N P=0.238N |(e) (e) (e) (e) | |POLY 6 | P=0.159N P=0.471N P=0.493N P=0.235N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.159N P=0.597N P=0.496N P=0.286N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.155N P=0.508N P=0.500N P=0.253N |(e) (e) (e) (e) | |ORDER RESTRICTED | P=0.116N (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 12/17/03 EXPERIMENT: 88004 TEST: 05 Page 38 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIVINYLBENZENE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 100 PPM 200 PPM 400 PPM |CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | |2/43.47 1/43.50 1/43.84 2/38.13 | |POLY-3 PERCENT (g) | |4.6% 2.3% 2.3% 5.3% | |TERMINAL (d) | |0/33 (0%) 1/30 (3%) 1/33 (3%) 1/22 (5%) | |FIRST INCIDENCE | |437 731 (T) 731 (T) 617 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.465 P=0.505N P=0.497N P=0.619 | |POLY 3 | |P=0.514 P=0.500N P=0.497N P=0.646 | |POLY 1.5 | |P=0.532 P=0.498N P=0.498N P=0.668 | |POLY 6 | |P=0.489 P=0.506N P=0.499N P=0.608 | |LOGISTIC REGRESSION| |P=0.594 P=0.558N P=0.546N P=0.647N | |COCH-ARM / FISHERS | |P=0.556 P=0.500N P=0.500N P=0.691N | |ORDER RESTRICTED | |P=0.476 (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).