TDMS Study 05160-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: TSI Mason Research 1-CHLORO-2-PROPANOL DATE: 08/01/97 EXPERIMENT: 05160 TEST: 06 TIME: 15:09:56 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-05300 ROUTE: DOSED WATER NTP C#: 61983C PATHOLOGIST: F. VOELKER CAS: 127-00-4 Mice(B6C3F1) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: TSI Mason Research 1-CHLORO-2-PROPANOL DATE: 08/01/97 EXPERIMENT: 05160 TEST: 06 TIME: 15:09:56 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-05300 ROUTE: DOSED WATER NTP C#: 61983C PATHOLOGIST: F. VOELKER CAS: 127-00-4 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF 1-CHLORO-2-PROPANOL =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Adrenal Cortex Hypertrophy Focal Kidney Mineralization Nephropathy Acute Liver Clear Cell Focus Eosinophilic Focus Necrosis Lung Inflammation Chronic Lymph Node: Iliac Pigmentation Seminal Vesicle Inflammation Chronic =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Adrenal Medulla Hyperplasia Heart Cardiomyopathy Kidney Nephropathy Chronic Kidney: Renal Tubule Accumulation, Hyaline Droplet Lymph Node: Iliac Hyperplasia Lymphoid Pituitary Gland: Pars Distalis Hyperplasia Stomach, Forestomach Hyperplasia =============================================================== Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.3% 0.0% |0.0% 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 2/29 (7%) 0/39 (0%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 1/32 (3%) | |FIRST INCIDENCE | --- --- 729 (T) --- |--- --- --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.574 (e) P=0.171 (e) |P=0.197 (e) (e) P=0.500 | |POLY 3 | P=0.616 (e) P=0.251 (e) |P=0.230 (e) (e) P=0.551 | |POLY 1.5 | P=0.609 (e) P=0.244 (e) |P=0.219 (e) (e) P=0.534 | |POLY 6 | P=0.623 (e) P=0.261 (e) |P=0.245 (e) (e) P=0.575 | |LOGISTIC REGRESSION| (e) (e) P=0.171 (e) |(e) (e) (e) P=0.500 | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.198 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 25/50 (50%) 21/50 (42%) 17/50 (34%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 39.5% 52.5% 54.0% 37.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 16/40 (40%) 25/44 (57%) 18/29 (62%) 15/39 (39%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | 518 729 (T) 519 556 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.432N P=0.204 P=0.047 * P=0.531N |(e) (e) (e) (e) | |POLY 3 | P=0.343N P=0.150 P=0.141 P=0.523N |(e) (e) (e) (e) | |POLY 1.5 | P=0.326N P=0.138 P=0.186 P=0.516N |(e) (e) (e) (e) | |POLY 6 | P=0.367N P=0.158 P=0.102 P=0.537N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.368N P=0.179 P=0.118 P=0.509N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.288N P=0.113 P=0.341 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex: Capsule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 39/50 (78%) 42/50 (84%) 38/50 (76%) 38/50 (76%) |48/50 (96%) 50/50 (100%) 49/50 (98%) 48/50 (96%) | |POLY-3 ADJUSTED (b)| 80.6% 85.7% 83.8% 80.0% |98.0% 100.0% 98.0% 96.0% | |TERMINAL (d) | 31/40 (78%) 38/44 (86%) 24/29 (83%) 32/39 (82%) |32/32 (100%) 32/32 (100%) 35/36 (97%) 30/32 (94%) | |FIRST INCIDENCE | 380 471 189 233 |264 449 50 77 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.441 P=0.526N P=0.066 P=0.562N |P=0.500 P=0.394 P=0.411N P=0.474 | |POLY 3 | P=0.446N P=0.344 P=0.453 P=0.579N |P=0.247N P=0.506 P=0.763 P=0.506N | |POLY 1.5 | P=0.403N P=0.336 P=0.487 P=0.545N |P=0.255N P=0.490 P=0.753 P=0.515N | |POLY 6 | P=0.502N P=0.349 P=0.427 P=0.597 |P=0.243N P=0.514 P=0.764N P=0.502N | |LOGISTIC REGRESSION| P=0.392N P=0.385 P=0.482 P=0.509N |P=0.527N P=0.425 P=0.456 P=0.645 | |COCH-ARM / FISHERS | P=0.331N P=0.306 P=0.500N P=0.500N |P=0.469N P=0.247 P=0.500 P=0.691N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.8% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 1/32 (3%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 734 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.047 * (e) (e) P=0.243 | |POLY 3 | (e) (e) (e) (e) |P=0.052 (e) (e) P=0.258 | |POLY 1.5 | (e) (e) (e) (e) |P=0.050 (e) (e) P=0.250 | |POLY 6 | (e) (e) (e) (e) |P=0.056 (e) (e) P=0.270 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.222 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 3 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone | | Fibrous Osteodystrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |8/50 (16%) 6/50 (12%) 5/50 (10%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.3% |17.8% 13.5% 11.5% 9.6% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 1/39 (3%) |6/32 (19%) 6/32 (19%) 5/36 (14%) 3/32 (9%) | |FIRST INCIDENCE | --- --- --- 729 (T) |683 735 (T) 735 (T) 616 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.194 (e) (e) P=0.495 |P=0.134N P=0.394N P=0.220N P=0.195N | |POLY 3 | P=0.215 (e) (e) P=0.549 |P=0.173N P=0.408N P=0.312N P=0.226N | |POLY 1.5 | P=0.209 (e) (e) P=0.532 |P=0.166N P=0.391N P=0.301N P=0.212N | |POLY 6 | P=0.221 (e) (e) P=0.566 |P=0.179N P=0.434N P=0.328N P=0.239N | |LOGISTIC REGRESSION| (e) (e) (e) P=0.495 |P=0.176N P=0.421N P=0.300N P=0.215N | |COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.139N P=0.387N P=0.277N P=0.178N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.6% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 0/32 (0%) 2/36 (6%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.599 (e) P=0.264 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.594 (e) P=0.262 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.591 (e) P=0.253 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.603 (e) P=0.274 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.264 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.595 (e) P=0.247 (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 4 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Depletion Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 449 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.423N P=0.244 (e) (e) | |POLY 3 | (e) (e) (e) (e) |P=0.456N P=0.266 (e) (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.439N P=0.258 (e) (e) | |POLY 6 | (e) (e) (e) (e) |P=0.476N P=0.278 (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.361N P=0.165 (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.405N P=0.247 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow: Myeloid Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 1/44 (2%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 700 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.429N P=0.260 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.430N P=0.273 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.421N P=0.260 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.442N P=0.285 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.417N P=0.246 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 5 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Brain: Thalamus | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/50 (60%) 25/50 (50%) 23/50 (46%) 26/50 (52%) |22/50 (44%) 27/49 (55%) 22/50 (44%) 22/50 (44%) | |POLY-3 ADJUSTED (b)| 64.2% 51.0% 56.0% 54.9% |48.0% 60.1% 48.6% 50.0% | |TERMINAL (d) | 25/40 (63%) 21/44 (48%) 16/29 (55%) 20/39 (51%) |19/32 (59%) 20/31 (65%) 17/36 (47%) 15/32 (47%) | |FIRST INCIDENCE | 380 471 377 246 |465 594 393 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.465N P=0.118N P=0.525 P=0.331N |P=0.408N P=0.169 P=0.431N P=0.548 | |POLY 3 | P=0.312N P=0.137N P=0.294N P=0.242N |P=0.470N P=0.173 P=0.570 P=0.518 | |POLY 1.5 | P=0.305N P=0.160N P=0.238N P=0.252N |P=0.467N P=0.189 P=0.568 P=0.522 | |POLY 6 | P=0.323N P=0.118N P=0.367N P=0.235N |P=0.454N P=0.160 P=0.576 P=0.532 | |LOGISTIC REGRESSION| P=0.321N P=0.174N P=0.250N P=0.276N |P=0.501N P=0.164 P=0.545 P=0.488 | |COCH-ARM / FISHERS | P=0.283N P=0.211N P=0.115N P=0.273N |P=0.383N P=0.183 P=0.580N P=0.580N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |2/50 (4%) 1/49 (2%) 3/48 (6%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| |4.5% 2.3% 7.0% 2.4% | |TERMINAL (d) | |2/32 (6%) 1/32 (3%) 3/36 (8%) 1/32 (3%) | |FIRST INCIDENCE | |735 (T) 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.468N P=0.500N P=0.554 P=0.500N | |POLY 3 | |P=0.525N P=0.537N P=0.502 P=0.561N | |POLY 1.5 | |P=0.513N P=0.522N P=0.496 P=0.543N | |POLY 6 | |P=0.537N P=0.558N P=0.510 P=0.583N | |LOGISTIC REGRESSION| |P=0.468N P=0.500N P=0.554 P=0.500N | |COCH-ARM / FISHERS | |P=0.482N P=0.508N P=0.480 P=0.508N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 6 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 3/50 (6%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 6.3% 0.0% 6.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 2/44 (5%) 0/29 (0%) 3/39 (8%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 729 (T) 700 --- 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.294 P=0.341 P=0.564N P=0.296 |(e) (e) (e) (e) | |POLY 3 | P=0.317 P=0.346 P=0.627N P=0.325 |(e) (e) (e) (e) | |POLY 1.5 | P=0.319 P=0.332 P=0.586N P=0.318 |(e) (e) (e) (e) | |POLY 6 | P=0.313 P=0.360 P=0.672N P=0.331 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.296 P=0.330 (e) P=0.296 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.324 P=0.309 P=0.500N P=0.309 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Spermatocele | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.2% 2.6% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 2/44 (5%) 0/29 (0%) 0/39 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 729 (T) 608 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.481N P=0.260 P=0.465 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.483N P=0.273 P=0.559 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.476N P=0.260 P=0.537 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.494N P=0.285 P=0.583 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.464N P=0.260 P=0.530 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.461N P=0.247 P=0.500 (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 7 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |5/50 (10%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 13.5% 4.2% 5.3% 4.5% |11.1% 4.5% 0.0% 4.8% | |TERMINAL (d) | 6/40 (15%) 2/44 (5%) 1/29 (3%) 2/39 (5%) |1/32 (3%) 1/32 (3%) 0/36 (0%) 1/32 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 700 729 (T) |670 575 --- 616 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.145N P=0.106N P=0.259N P=0.141N |P=0.151N P=0.235N P=0.036N* P=0.249N | |POLY 3 | P=0.135N P=0.119N P=0.221N P=0.145N |P=0.154N P=0.231N P=0.039N* P=0.267N | |POLY 1.5 | P=0.128N P=0.124N P=0.192N P=0.141N |P=0.150N P=0.221N P=0.036N* P=0.252N | |POLY 6 | P=0.143N P=0.116N P=0.255N P=0.151N |P=0.158N P=0.246N P=0.043N* P=0.283N | |LOGISTIC REGRESSION| P=0.142N P=0.106N P=0.236N P=0.141N |P=0.139N P=0.217N P=0.035N* P=0.231N | |COCH-ARM / FISHERS | P=0.114N P=0.134N P=0.134N P=0.134N |P=0.137N P=0.218N P=0.028N* P=0.218N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Heart | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 2.3% 4.5% 2.4% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 1/32 (3%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 735 (T) 393 629 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.351 P=0.500 P=0.240 P=0.481 | |POLY 3 | (e) (e) (e) (e) |P=0.360 P=0.548 P=0.264 P=0.551 | |POLY 1.5 | (e) (e) (e) (e) |P=0.359 P=0.532 P=0.255 P=0.533 | |POLY 6 | (e) (e) (e) (e) |P=0.365 P=0.571 P=0.278 P=0.574 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.420 P=0.500 P=0.261 P=0.514 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.366 P=0.500 P=0.247 P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 8 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Heart | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.4% 0.0% 0.0% 0.0% |2.2% 2.2% 4.6% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 0/32 (0%) 1/36 (3%) 0/32 (0%) | |FIRST INCIDENCE | 464 --- --- --- |726 662 633 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.129N P=0.230N P=0.292N P=0.250N |P=0.389N P=0.748 P=0.511 P=0.517N | |POLY 3 | P=0.135N P=0.244N P=0.341N P=0.270N |P=0.422N P=0.786 P=0.523 P=0.580N | |POLY 1.5 | P=0.127N P=0.241N P=0.305N P=0.258N |P=0.407N P=0.774N P=0.515 P=0.556N | |POLY 6 | P=0.143N P=0.247N P=0.382N P=0.283N |P=0.438N P=0.796 P=0.535 P=0.611N | |LOGISTIC REGRESSION| P=0.095N P=0.302N P=0.182N P=0.226N |P=0.369N P=0.762 P=0.497 P=0.519N | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.366N P=0.753N P=0.500 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Intestine Small, Jejunum: Peyer's Patch | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/44 (0%) 0/47 (0%) |2/46 (4%) 1/45 (2%) 1/47 (2%) 1/46 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.8% 2.5% 2.4% 2.6% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |2/32 (6%) 1/32 (3%) 1/36 (3%) 1/32 (3%) | |FIRST INCIDENCE | --- --- --- --- |735 (T) 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.403N P=0.500N P=0.459N P=0.500N | |POLY 3 | (e) (e) (e) (e) |P=0.450N P=0.539N P=0.526N P=0.569N | |POLY 1.5 | (e) (e) (e) (e) |P=0.440N P=0.525N P=0.514N P=0.550N | |POLY 6 | (e) (e) (e) (e) |P=0.460N P=0.557N P=0.540N P=0.588N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.403N P=0.500N P=0.459N P=0.500N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.406N P=0.508N P=0.492N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 9 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 48/50 (96%) 47/50 (94%) 45/50 (90%) 47/50 (94%) |28/50 (56%) 30/50 (60%) 30/50 (60%) 31/50 (62%) | |POLY-3 ADJUSTED (b)| 96.1% 94.0% 93.8% 94.0% |58.6% 60.7% 64.8% 70.3% | |TERMINAL (d) | 39/40 (98%) 41/44 (93%) 27/29 (93%) 36/39 (92%) |20/32 (63%) 18/32 (56%) 24/36 (67%) 24/32 (75%) | |FIRST INCIDENCE | 220 335 92 233 |264 449 50 150 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.311 P=0.164N P=0.057 P=0.578N |P=0.309 P=0.423 P=0.558N P=0.313 | |POLY 3 | P=0.428N P=0.490N P=0.483N P=0.490N |P=0.126 P=0.499 P=0.344 P=0.169 | |POLY 1.5 | P=0.429N P=0.495N P=0.457N P=0.495N |P=0.175 P=0.484 P=0.372 P=0.217 | |POLY 6 | P=0.421N P=0.480N P=0.486N P=0.480N |P=0.087 P=0.517 P=0.318 P=0.127 | |LOGISTIC REGRESSION| P=0.429N P=0.541N P=0.343N P=0.488N |P=0.279 P=0.409 P=0.407 P=0.274 | |COCH-ARM / FISHERS | P=0.404N P=0.500N P=0.218N P=0.500N |P=0.322 P=0.420 P=0.420 P=0.342 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 13/50 (26%) 10/50 (20%) 15/50 (30%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 24.0% 27.3% 26.1% 33.7% |2.2% 0.0% 2.3% 0.0% | |TERMINAL (d) | 9/40 (23%) 13/44 (30%) 8/29 (28%) 14/39 (36%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | 501 729 (T) 519 652 |733 --- 697 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.170 P=0.509 P=0.399 P=0.228 |P=0.414N P=0.506N P=0.757N P=0.500N | |POLY 3 | P=0.187 P=0.458 P=0.536 P=0.225 |P=0.456N P=0.550N P=0.784 P=0.580N | |POLY 1.5 | P=0.204 P=0.443 P=0.580 P=0.233 |P=0.442N P=0.529N P=0.776 P=0.556N | |POLY 6 | P=0.168 P=0.469 P=0.489 P=0.214 |P=0.471N P=0.581N P=0.795 P=0.611N | |LOGISTIC REGRESSION| P=0.199 P=0.452 P=0.565 P=0.239 |P=0.419N P=0.511N P=0.757 P=0.518N | |COCH-ARM / FISHERS | P=0.244 P=0.408 P=0.500N P=0.247 |P=0.405N P=0.500N P=0.753N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 10 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Hydronephrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.5% 2.1% 7.7% 2.2% |2.2% 0.0% 6.8% 2.4% | |TERMINAL (d) | 2/40 (5%) 1/44 (2%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 1/32 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 408 617 |732 --- 540 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.499N P=0.467N P=0.403 P=0.503N |P=0.446 P=0.506N P=0.296 P=0.757 | |POLY 3 | P=0.500N P=0.497N P=0.477 P=0.527N |P=0.455 P=0.550N P=0.325 P=0.780 | |POLY 1.5 | P=0.492N P=0.498N P=0.480 P=0.519N |P=0.455 P=0.529N P=0.318 P=0.773 | |POLY 6 | P=0.509N P=0.498N P=0.474 P=0.538N |P=0.459 P=0.581N P=0.337 P=0.791 | |LOGISTIC REGRESSION| P=0.454N P=0.467N P=0.549 P=0.500N |P=0.478 P=0.510N P=0.312 P=0.744 | |COCH-ARM / FISHERS | P=0.474N P=0.500N P=0.500 P=0.500N |P=0.469 P=0.500N P=0.309 P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Metaplasia Osseous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 0.0% 2.3% 2.4% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |1/32 (3%) 0/32 (0%) 0/36 (0%) 1/32 (3%) | |FIRST INCIDENCE | --- --- --- --- |698 --- 697 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.514N P=0.243N P=0.502N P=0.513N | |POLY 3 | (e) (e) (e) (e) |P=0.539N P=0.267N P=0.541N P=0.565N | |POLY 1.5 | (e) (e) (e) (e) |P=0.530N P=0.253N P=0.529N P=0.546N | |POLY 6 | (e) (e) (e) (e) |P=0.549N P=0.288N P=0.558N P=0.587N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.522N P=0.238N P=0.507N P=0.530N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.500N P=0.247N P=0.500N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 11 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 5/50 (10%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 12.3% 4.4% |2.2% 2.2% 0.0% 2.4% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |1/32 (3%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- 377 556 |735 (T) 691 --- 681 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.107 (e) P=0.026 * P=0.242 |P=0.634N P=0.757N P=0.477N P=0.749 | |POLY 3 | P=0.107 (e) P=0.028 * P=0.266 |P=0.651N P=0.786 P=0.561N P=0.781 | |POLY 1.5 | P=0.106 (e) P=0.028 * P=0.256 |P=0.641N P=0.775N P=0.541N P=0.773 | |POLY 6 | P=0.108 (e) P=0.028 * P=0.276 |P=0.663N P=0.797 P=0.587N P=0.792 | |LOGISTIC REGRESSION| P=0.122 (e) P=0.070 P=0.243 |P=0.627N P=0.763N (e) P=0.752 | |COCH-ARM / FISHERS | P=0.108 (e) P=0.028 * P=0.247 |P=0.616N P=0.753N P=0.500N P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 6/50 (12%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 2.1% 14.6% 2.2% |0.0% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | 578 700 377 657 |--- 575 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.453 P=0.740N P=0.045 * P=0.758 |P=0.582N P=0.500 (e) (e) | |POLY 3 | P=0.468 P=0.765N P=0.048 * P=0.783 |P=0.626N P=0.548 (e) (e) | |POLY 1.5 | P=0.471 P=0.763N P=0.049 * P=0.775 |P=0.607N P=0.532 (e) (e) | |POLY 6 | P=0.462 P=0.768N P=0.046 * P=0.789 |P=0.648N P=0.570 (e) (e) | |LOGISTIC REGRESSION| P=0.538 P=0.729 P=0.123 P=0.758N |P=0.534N P=0.441 (e) (e) | |COCH-ARM / FISHERS | P=0.477 P=0.753N P=0.056 P=0.753N |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 12 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 42/50 (84%) 45/50 (90%) 38/50 (76%) 46/50 (92%) |16/50 (32%) 6/50 (12%) 9/50 (18%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 86.7% 90.8% 91.1% 96.2% |35.8% 13.5% 20.6% 25.7% | |TERMINAL (d) | 36/40 (90%) 41/44 (93%) 29/29 (100%) 38/39 (97%) |13/32 (41%) 6/32 (19%) 8/36 (22%) 8/32 (25%) | |FIRST INCIDENCE | 220 335 458 443 |721 735 (T) 655 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.070 P=0.511N P=0.062 P=0.182 |P=0.296N P=0.015N* P=0.048N* P=0.200N | |POLY 3 | P=0.056 P=0.371 P=0.373 P=0.083 |P=0.335N P=0.013N* P=0.092N P=0.224N | |POLY 1.5 | P=0.078 P=0.329 P=0.541 P=0.085 |P=0.335N P=0.012N* P=0.090N P=0.217N | |POLY 6 | P=0.049 * P=0.422 P=0.220 P=0.100 |P=0.328N P=0.015N* P=0.095N P=0.228N | |LOGISTIC REGRESSION| P=0.135 P=0.305 P=0.607 P=0.156 |P=0.380N P=0.017N* P=0.094N P=0.244N | |COCH-ARM / FISHERS | P=0.259 P=0.277 P=0.227N P=0.178 |P=0.299N P=0.014N* P=0.083N P=0.184N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Accumulation, Hyaline Droplet | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.7% 6.5% 2.3% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |1/32 (3%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |670 449 697 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.063N P=0.648 P=0.313N P=0.138N | |POLY 3 | (e) (e) (e) (e) |P=0.067N P=0.668N P=0.341N P=0.155N | |POLY 1.5 | (e) (e) (e) (e) |P=0.062N P=0.660N P=0.330N P=0.144N | |POLY 6 | (e) (e) (e) (e) |P=0.072N P=0.679N P=0.356N P=0.170N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.044N* P=0.621 P=0.311N P=0.131N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.052N P=0.661N P=0.309N P=0.121N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 13 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 9.0% 0.0% 0.0% 2.3% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/40 (10%) 0/44 (0%) 0/29 (0%) 1/39 (3%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.147N P=0.052N P=0.111N P=0.187N |(e) (e) (e) (e) | |POLY 3 | P=0.147N P=0.057N P=0.107N P=0.196N |(e) (e) (e) (e) | |POLY 1.5 | P=0.139N P=0.058N P=0.090N P=0.190N |(e) (e) (e) (e) | |POLY 6 | P=0.157N P=0.057N P=0.128N P=0.205N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.147N (e) (e) P=0.187N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.125N P=0.059N P=0.059N P=0.181N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 11/50 (22%) 6/50 (12%) 3/50 (6%) |2/50 (4%) 3/50 (6%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 4.5% 23.1% 16.0% 6.8% |4.5% 6.8% 4.6% 4.8% | |TERMINAL (d) | 2/40 (5%) 11/44 (25%) 6/29 (21%) 3/39 (8%) |2/32 (6%) 3/32 (9%) 2/36 (6%) 2/32 (6%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |735 (T) 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.419N P=0.013 * P=0.053 P=0.488 |P=0.517N P=0.500 P=0.652N P=0.696 | |POLY 3 | P=0.375N P=0.011 * P=0.098 P=0.520 |P=0.574N P=0.520 P=0.708 P=0.697 | |POLY 1.5 | P=0.367N P=0.009 ** P=0.106 P=0.513 |P=0.561N P=0.518 P=0.702 P=0.694 | |POLY 6 | P=0.389N P=0.012 * P=0.089 P=0.525 |P=0.587N P=0.524 P=0.716 P=0.704 | |LOGISTIC REGRESSION| P=0.419N P=0.013 * P=0.053 P=0.488 |P=0.517N P=0.500 P=0.652N P=0.696 | |COCH-ARM / FISHERS | P=0.351N P=0.007 ** P=0.134 P=0.500 |P=0.523N P=0.500 P=0.691N P=0.691N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 14 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/50 (54%) 34/50 (68%) 33/50 (66%) 29/50 (58%) |29/50 (58%) 24/50 (48%) 29/50 (58%) 31/50 (62%) | |POLY-3 ADJUSTED (b)| 60.5% 70.0% 78.4% 62.9% |64.5% 53.2% 65.3% 70.6% | |TERMINAL (d) | 26/40 (65%) 31/44 (71%) 24/29 (83%) 25/39 (64%) |26/32 (81%) 21/32 (66%) 25/36 (69%) 22/32 (69%) | |FIRST INCIDENCE | 714 471 377 443 |673 582 645 569 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.290 P=0.254 P=0.002 ** P=0.365 |P=0.226 P=0.189N P=0.344N P=0.383 | |POLY 3 | P=0.523 P=0.228 P=0.053 P=0.502 |P=0.172 P=0.189N P=0.571 P=0.358 | |POLY 1.5 | P=0.506 P=0.178 P=0.062 P=0.466 |P=0.167 P=0.181N P=0.564 P=0.349 | |POLY 6 | P=0.535 P=0.283 P=0.049 * P=0.534 |P=0.206 P=0.205N P=0.590 P=0.403 | |LOGISTIC REGRESSION| P=0.407 P=0.220 P=0.018 * P=0.403 |P=0.084 P=0.255N P=0.453 P=0.213 | |COCH-ARM / FISHERS | P=0.510 P=0.109 P=0.154 P=0.420 |P=0.242 P=0.212N P=0.580N P=0.419 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 4.5% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 703 622 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.643N P=0.500 P=0.237 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.676N P=0.548 P=0.263 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.660N P=0.532 P=0.254 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.682 P=0.571 P=0.277 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.600N P=0.501 P=0.246 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.616N P=0.500 P=0.247 (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 15 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.4% 2.1% 0.0% 2.3% |2.2% 2.3% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 1/44 (2%) 0/29 (0%) 1/39 (3%) |0/32 (0%) 1/32 (3%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | 464 729 (T) --- 729 (T) |670 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.392N P=0.476N P=0.291N P=0.508N |P=0.247N P=0.750 P=0.529N P=0.535N | |POLY 3 | P=0.404N P=0.501N P=0.340N P=0.535N |P=0.273N P=0.784 P=0.561N P=0.580N | |POLY 1.5 | P=0.392N P=0.500N P=0.305N P=0.523N |P=0.262N P=0.775N P=0.541N P=0.555N | |POLY 6 | P=0.418N P=0.502N P=0.382N P=0.550N |P=0.287N P=0.793 P=0.587N P=0.611N | |LOGISTIC REGRESSION| P=0.361N P=0.561N P=0.189N P=0.495N |P=0.241N P=0.762N P=0.498N P=0.498N | |COCH-ARM / FISHERS | P=0.366N P=0.500N P=0.247N P=0.500N |P=0.236N P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.5% 10.3% 2.7% 6.7% |0.0% 4.5% 0.0% 2.4% | |TERMINAL (d) | 2/40 (5%) 4/44 (9%) 1/29 (3%) 2/39 (5%) |0/32 (0%) 1/32 (3%) 0/36 (0%) 1/32 (3%) | |FIRST INCIDENCE | 729 (T) 471 729 (T) 556 |--- 575 --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.562 P=0.255 P=0.612N P=0.495 |P=0.534 P=0.240 (e) P=0.500 | |POLY 3 | P=0.589N P=0.261 P=0.615N P=0.524 |P=0.546 P=0.265 (e) P=0.551 | |POLY 1.5 | P=0.581N P=0.246 P=0.579N P=0.515 |P=0.543 P=0.257 (e) P=0.534 | |POLY 6 | P=0.592 P=0.275 P=0.653N P=0.531 |P=0.552 P=0.277 (e) P=0.575 | |LOGISTIC REGRESSION| P=0.570N P=0.204 P=0.612N P=0.499 |P=0.540 P=0.219 (e) P=0.500 | |COCH-ARM / FISHERS | P=0.562N P=0.218 P=0.500N P=0.500 |P=0.539 P=0.247 (e) P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 16 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 3/50 (6%) 1/50 (2%) 3/50 (6%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 13.0% 6.2% 2.6% 6.7% |2.2% 6.7% 2.3% 0.0% | |TERMINAL (d) | 3/40 (8%) 1/44 (2%) 0/29 (0%) 1/39 (3%) |0/32 (0%) 1/32 (3%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | 464 335 377 652 |670 575 633 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.220N P=0.219N P=0.111N P=0.264N |P=0.224N P=0.302 P=0.742 P=0.535N | |POLY 3 | P=0.214N P=0.223N P=0.107N P=0.269N |P=0.241N P=0.327 P=0.783 P=0.580N | |POLY 1.5 | P=0.202N P=0.228N P=0.088N P=0.260N |P=0.228N P=0.323 P=0.775 P=0.555N | |POLY 6 | P=0.226N P=0.220N P=0.131N P=0.280N |P=0.255N P=0.333 P=0.793 P=0.611N | |LOGISTIC REGRESSION| P=0.151N P=0.347N P=0.032N* P=0.238N |P=0.188N P=0.288 P=0.758N P=0.498N | |COCH-ARM / FISHERS | P=0.178N P=0.243N P=0.056N P=0.243N |P=0.200N P=0.309 P=0.753N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 4.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- 189 246 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.071 (e) P=0.488 P=0.240 |(e) (e) (e) (e) | |POLY 3 | P=0.073 (e) P=0.557 P=0.267 |(e) (e) (e) (e) | |POLY 1.5 | P=0.072 (e) P=0.536 P=0.257 |(e) (e) (e) (e) | |POLY 6 | P=0.074 (e) P=0.582 P=0.277 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.062 (e) P=0.874 P=0.251 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.070 (e) P=0.500 P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 17 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |4/50 (8%) 3/50 (6%) 6/50 (12%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 4.2% 2.7% 4.5% |8.9% 6.7% 13.9% 7.2% | |TERMINAL (d) | 0/40 (0%) 1/44 (2%) 1/29 (3%) 2/39 (5%) |3/32 (9%) 2/32 (6%) 6/36 (17%) 2/32 (6%) | |FIRST INCIDENCE | --- 665 729 (T) 729 (T) |673 594 735 (T) 664 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.225 P=0.263 P=0.436 P=0.233 |P=0.506N P=0.506N P=0.429 P=0.523N | |POLY 3 | P=0.247 P=0.273 P=0.560 P=0.264 |P=0.567N P=0.518N P=0.364 P=0.565N | |POLY 1.5 | P=0.247 P=0.261 P=0.537 P=0.254 |P=0.552N P=0.505N P=0.366 P=0.547N | |POLY 6 | P=0.247 P=0.286 P=0.586 P=0.273 |P=0.580N P=0.537N P=0.363 P=0.583N | |LOGISTIC REGRESSION| P=0.233 P=0.233 P=0.436 P=0.233 |P=0.547N P=0.498N P=0.342 P=0.538N | |COCH-ARM / FISHERS | P=0.245 P=0.247 P=0.500 P=0.247 |P=0.500N P=0.500N P=0.370 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 4/50 (8%) 5/50 (10%) |4/50 (8%) 2/50 (4%) 2/50 (4%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 4.5% 4.2% 10.6% 11.1% |8.7% 4.5% 4.6% 9.4% | |TERMINAL (d) | 2/40 (5%) 2/44 (5%) 2/29 (7%) 4/39 (10%) |1/32 (3%) 0/32 (0%) 2/36 (6%) 2/32 (6%) | |FIRST INCIDENCE | 729 (T) 729 (T) 637 543 |465 594 735 (T) 150 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.098 P=0.660N P=0.212 P=0.212 |P=0.478 P=0.356N P=0.328N P=0.610 | |POLY 3 | P=0.107 P=0.686N P=0.297 P=0.232 |P=0.481 P=0.364N P=0.385N P=0.619 | |POLY 1.5 | P=0.108 P=0.688N P=0.306 P=0.226 |P=0.485 P=0.349N P=0.369N P=0.628 | |POLY 6 | P=0.105 P=0.684N P=0.289 P=0.237 |P=0.478 P=0.385N P=0.406N P=0.613 | |LOGISTIC REGRESSION| P=0.104 P=0.660N P=0.251 P=0.215 |P=0.567 P=0.392N P=0.326N P=0.578N | |COCH-ARM / FISHERS | P=0.113 P=0.691N P=0.339 P=0.218 |P=0.500 P=0.339N P=0.339N P=0.643N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 18 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.5% |2.2% 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 2/39 (5%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- 729 (T) |677 --- --- 150 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.045 * (e) (e) P=0.233 |P=0.581 P=0.510N P=0.520N P=0.746 | |POLY 3 | P=0.047 * (e) (e) P=0.264 |P=0.620 P=0.550N P=0.561N P=0.781 | |POLY 1.5 | P=0.046 * (e) (e) P=0.254 |P=0.609 P=0.529N P=0.541N P=0.774 | |POLY 6 | P=0.048 * (e) (e) P=0.273 |P=0.633 P=0.581N P=0.587N P=0.790 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.233 |P=0.670N P=0.505N P=0.499N P=0.699N | |COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |P=0.595 P=0.500N P=0.500N P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 5/50 (10%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 11.1% 10.5% 5.3% 6.8% |0.0% 2.3% 0.0% 2.4% | |TERMINAL (d) | 4/40 (10%) 5/44 (11%) 1/29 (3%) 3/39 (8%) |0/32 (0%) 1/32 (3%) 0/36 (0%) 1/32 (3%) | |FIRST INCIDENCE | 547 729 (T) 714 729 (T) |--- 735 (T) --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.268N P=0.571N P=0.353N P=0.368N |P=0.407 P=0.500 (e) P=0.500 | |POLY 3 | P=0.256N P=0.606N P=0.331N P=0.384N |P=0.424 P=0.548 (e) P=0.551 | |POLY 1.5 | P=0.244N P=0.613N P=0.293N P=0.374N |P=0.417 P=0.532 (e) P=0.534 | |POLY 6 | P=0.271N P=0.602N P=0.375N P=0.398N |P=0.434 P=0.571 (e) P=0.575 | |LOGISTIC REGRESSION| P=0.247N P=0.610N P=0.276N P=0.359N |(e) P=0.500 (e) P=0.500 | |COCH-ARM / FISHERS | P=0.220N P=0.630N P=0.218N P=0.357N |P=0.405 P=0.500 (e) P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 19 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/49 (2%) 2/49 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 4.5% 2.1% 2.7% 0.0% |2.2% 2.3% 4.7% 4.7% | |TERMINAL (d) | 2/40 (5%) 1/44 (2%) 1/29 (3%) 0/39 (0%) |1/32 (3%) 1/31 (3%) 1/35 (3%) 1/32 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |735 (T) 735 (T) 540 150 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.175N P=0.467N P=0.612N P=0.244N |P=0.338 P=0.755 P=0.521 P=0.500 | |POLY 3 | P=0.174N P=0.497N P=0.615N P=0.267N |P=0.337 P=0.782 P=0.517 P=0.517 | |POLY 1.5 | P=0.167N P=0.498N P=0.579N P=0.257N |P=0.336 P=0.774 P=0.508 P=0.511 | |POLY 6 | P=0.182N P=0.498N P=0.653N P=0.280N |P=0.341 P=0.792 P=0.529 P=0.528 | |LOGISTIC REGRESSION| P=0.175N P=0.467N P=0.612N (e) |P=0.396 P=0.755 P=0.497 P=0.565 | |COCH-ARM / FISHERS | P=0.153N P=0.500N P=0.500N P=0.247N |P=0.339 P=0.747 P=0.492 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/49 (14%) 8/50 (16%) 3/50 (6%) 5/50 (10%) |1/49 (2%) 2/48 (4%) 3/47 (6%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 16.0% 16.8% 7.9% 11.2% |2.3% 4.6% 7.2% 2.4% | |TERMINAL (d) | 7/40 (18%) 7/44 (16%) 1/29 (3%) 4/39 (10%) |0/31 (0%) 2/32 (6%) 3/35 (9%) 1/32 (3%) | |FIRST INCIDENCE | 729 (T) 700 637 657 |732 735 (T) 735 (T) 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.278N P=0.579 P=0.313N P=0.397N |P=0.567N P=0.504 P=0.345 P=0.760N | |POLY 3 | P=0.238N P=0.579 P=0.247N P=0.383N |P=0.608 P=0.524 P=0.310 P=0.782 | |POLY 1.5 | P=0.228N P=0.559 P=0.215N P=0.377N |P=0.610 P=0.516 P=0.304 P=0.774 | |POLY 6 | P=0.251N P=0.596 P=0.283N P=0.392N |P=0.610 P=0.535 P=0.318 P=0.793 | |LOGISTIC REGRESSION| P=0.247N P=0.583 P=0.247N P=0.381N |P=0.588N P=0.489 P=0.301 P=0.751 | |COCH-ARM / FISHERS | P=0.207N P=0.517 P=0.151N P=0.365N |P=0.576N P=0.492 P=0.293 P=0.753N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 20 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Iliac | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/4 (0%) 0/5 (0%) 0/2 (0%) 0/3 (0%) |0/8 (0%) 0/12 (0%) 2/15 (13%) 0/9 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 15.0% 0.0% | |TERMINAL (d) | 0/3 (0%) 0/5 (0%) 0/2 (0%) 0/3 (0%) |0/1 (0%) 0/4 (0%) 2/11 (18%) 0/4 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.703N (e) P=0.814 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.617 (e) P=0.412 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.609 (e) P=0.396 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.638 (e) P=0.447 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.814 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.617 (e) P=0.415 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Iliac | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/4 (0%) 0/5 (0%) 0/2 (0%) 0/3 (0%) |2/8 (25%) 2/12 (17%) 2/15 (13%) 0/9 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |27.5% 21.7% 15.0% 0.0% | |TERMINAL (d) | 0/3 (0%) 0/5 (0%) 0/2 (0%) 0/3 (0%) |1/1 (100%) 1/4 (25%) 2/11 (18%) 0/4 (0%) | |FIRST INCIDENCE | --- --- --- --- |721 704 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.048N* P=0.470N P=0.131N P=0.114N | |POLY 3 | (e) (e) (e) (e) |P=0.153N P=0.658N P=0.484N P=0.290N | |POLY 1.5 | (e) (e) (e) (e) |P=0.142N P=0.613N P=0.470N P=0.254N | |POLY 6 | (e) (e) (e) (e) |P=0.168N P=0.708N P=0.499N P=0.342N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.107N P=0.653N P=0.339N P=0.224N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.535N P=0.435N P=0.206N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 21 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Iliac | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/4 (75%) 1/5 (20%) 0/2 (0%) 0/3 (0%) |0/8 (0%) 0/12 (0%) 0/15 (0%) 0/9 (0%) | |POLY-3 ADJUSTED (b)| 75.0% 20.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/3 (67%) 1/5 (20%) 0/2 (0%) 0/3 (0%) |0/1 (0%) 0/4 (0%) 0/11 (0%) 0/4 (0%) | |FIRST INCIDENCE | 380 729 (T) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.049N* P=0.152N P=0.179N P=0.110N |(e) (e) (e) (e) | |POLY 3 | P=0.031N* P=0.152N P=0.159N P=0.061N |(e) (e) (e) (e) | |POLY 1.5 | P=0.031N* P=0.152N P=0.159N P=0.061N |(e) (e) (e) (e) | |POLY 6 | P=0.031N* P=0.152N P=0.159N P=0.061N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.152N (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.052N P=0.167N P=0.200N P=0.114N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Renal | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/4 (0%) 0/5 (0%) 1/2 (50%) 0/3 (0%) |0/8 (0%) 0/12 (0%) 4/15 (27%) 0/9 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 50.0% 0.0% |0.0% 0.0% 29.1% 0.0% | |TERMINAL (d) | 0/3 (0%) 0/5 (0%) 1/2 (50%) 0/3 (0%) |0/1 (0%) 0/4 (0%) 3/11 (27%) 0/4 (0%) | |FIRST INCIDENCE | --- --- 729 (T) --- |--- --- 622 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.665 (e) P=0.419 (e) |P=0.667N (e) P=0.353 (e) | |POLY 3 | P=0.727 (e) P=0.445 (e) |P=0.472 (e) P=0.163 (e) | |POLY 1.5 | P=0.708 (e) P=0.410 (e) |P=0.476 (e) P=0.154 (e) | |POLY 6 | P=0.736 (e) P=0.465 (e) |P=0.479 (e) P=0.186 (e) | |LOGISTIC REGRESSION| (e) (e) P=0.419 (e) |P=0.487 (e) P=0.150 (e) | |COCH-ARM / FISHERS | P=0.640 (e) P=0.333 (e) |P=0.514 (e) P=0.154 (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 22 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/4 (100%) 2/2 (100%) 6/6 (100%) 8/8 (100%) |19/20 (95%) 17/19 (89%) 14/16 (88%) 11/12 (92%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 100.0% 100.0% |95.9% 93.3% 91.5% 91.7% | |TERMINAL (d) | 3/3 (100%) 1/1 (100%) 6/6 (100%) 5/5 (100%) |15/15 (100%) 14/14 (100%) 13/13 (100%) 8/9 (89%) | |FIRST INCIDENCE | 380 700 729 (T) 568 |593 662 633 569 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.263N P=0.524N P=0.201N P=0.361N | |POLY 3 | (e) (e) (e) (e) |P=0.438N P=0.665N P=0.587N P=0.615N | |POLY 1.5 | (e) (e) (e) (e) |P=0.462N P=0.575N P=0.500N P=0.629N | |POLY 6 | (e) (e) (e) (e) |P=0.386N P=0.819N P=0.765N P=0.587N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.612 P=0.582N P=0.498N P=0.657N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.483N P=0.480N P=0.415N P=0.617N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose | | Inflammation Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 9.0% 0.0% 0.0% 2.3% |0.0% 0.0% 0.0% 2.4% | |TERMINAL (d) | 4/40 (10%) 0/44 (0%) 0/29 (0%) 1/39 (3%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 729 (T) |--- --- --- 616 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.147N P=0.052N P=0.111N P=0.187N |P=0.190 (e) (e) P=0.486 | |POLY 3 | P=0.147N P=0.057N P=0.107N P=0.196N |P=0.229 (e) (e) P=0.551 | |POLY 1.5 | P=0.139N P=0.058N P=0.090N P=0.190N |P=0.218 (e) (e) P=0.533 | |POLY 6 | P=0.157N P=0.057N P=0.128N P=0.205N |P=0.243 (e) (e) P=0.574 | |LOGISTIC REGRESSION| P=0.147N (e) (e) P=0.187N |P=0.214 (e) (e) P=0.517 | |COCH-ARM / FISHERS | P=0.125N P=0.059N P=0.059N P=0.181N |P=0.198 (e) (e) P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 23 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 2/49 (4%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |0.0% 4.6% 0.0% 4.8% | |TERMINAL (d) | |0/32 (0%) 2/32 (6%) 0/36 (0%) 1/32 (3%) | |FIRST INCIDENCE | |--- 735 (T) --- 701 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.243 P=0.238 (e) P=0.231 | |POLY 3 | |P=0.252 P=0.260 (e) P=0.258 | |POLY 1.5 | |P=0.250 P=0.252 (e) P=0.250 | |POLY 6 | |P=0.256 P=0.272 (e) P=0.270 | |LOGISTIC REGRESSION| |P=0.225 P=0.238 (e) P=0.221 | |COCH-ARM / FISHERS | |P=0.249 P=0.242 (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |11/50 (22%) 9/49 (18%) 9/50 (18%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| |24.4% 20.3% 20.6% 26.2% | |TERMINAL (d) | |9/32 (28%) 6/32 (19%) 8/36 (22%) 9/32 (28%) | |FIRST INCIDENCE | |673 691 633 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.492 P=0.411N P=0.318N P=0.580 | |POLY 3 | |P=0.441 P=0.427N P=0.443N P=0.539 | |POLY 1.5 | |P=0.454 P=0.414N P=0.431N P=0.553 | |POLY 6 | |P=0.429 P=0.444N P=0.460N P=0.525 | |LOGISTIC REGRESSION| |P=0.414 P=0.427N P=0.437N P=0.513 | |COCH-ARM / FISHERS | |P=0.507 P=0.421N P=0.402N P=0.595N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 24 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/50 (2%) 1/49 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| |2.2% 2.3% 4.6% 0.0% | |TERMINAL (d) | |1/32 (3%) 1/32 (3%) 1/36 (3%) 0/32 (0%) | |FIRST INCIDENCE | |735 (T) 735 (T) 633 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.370N P=0.762 P=0.525 P=0.500N | |POLY 3 | |P=0.420N P=0.783 P=0.524 P=0.580N | |POLY 1.5 | |P=0.405N P=0.775 P=0.515 P=0.556N | |POLY 6 | |P=0.436N P=0.793 P=0.536 P=0.611N | |LOGISTIC REGRESSION| |P=0.380N P=0.762 P=0.496 (e) | |COCH-ARM / FISHERS | |P=0.365N P=0.747 P=0.500 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 6.7% 2.1% 5.3% 4.4% |2.2% 2.3% 0.0% 7.2% | |TERMINAL (d) | 3/40 (8%) 0/44 (0%) 1/29 (3%) 1/39 (3%) |1/32 (3%) 1/32 (3%) 0/36 (0%) 3/32 (9%) | |FIRST INCIDENCE | 729 (T) 700 714 443 |735 (T) 735 (T) --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.538N P=0.274N P=0.643N P=0.509N |P=0.158 P=0.762 P=0.477N P=0.304 | |POLY 3 | P=0.530N P=0.296N P=0.620N P=0.517N |P=0.164 P=0.786 P=0.561N P=0.308 | |POLY 1.5 | P=0.520N P=0.299N P=0.584N P=0.511N |P=0.161 P=0.775N P=0.541N P=0.305 | |POLY 6 | P=0.542N P=0.294N P=0.659N P=0.526N |P=0.168 P=0.796 P=0.587N P=0.314 | |LOGISTIC REGRESSION| P=0.505N P=0.279N P=0.630N P=0.498N |P=0.158 P=0.762 (e) P=0.304 | |COCH-ARM / FISHERS | P=0.500N P=0.309N P=0.500N P=0.500N |P=0.160 P=0.753N P=0.500N P=0.309 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 25 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 4.4% 0.0% 0.0% 0.0% |0.0% 2.3% 0.0% 4.8% | |TERMINAL (d) | 1/40 (3%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 1/32 (3%) 0/36 (0%) 2/32 (6%) | |FIRST INCIDENCE | 380 --- --- --- |--- 735 (T) --- 735 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.126N P=0.229N P=0.285N P=0.245N |P=0.138 P=0.500 (e) P=0.238 | |POLY 3 | P=0.135N P=0.244N P=0.341N P=0.270N |P=0.147 P=0.548 (e) P=0.258 | |POLY 1.5 | P=0.127N P=0.241N P=0.306N P=0.258N |P=0.144 P=0.532 (e) P=0.250 | |POLY 6 | P=0.143N P=0.247N P=0.382N P=0.283N |P=0.152 P=0.571 (e) P=0.270 | |LOGISTIC REGRESSION| P=0.089N P=0.320N P=0.161N P=0.221N |(e) P=0.500 (e) P=0.238 | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.140 P=0.500 (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) |2/49 (4%) 1/49 (2%) 1/47 (2%) 2/46 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 2.3% 2.4% 5.2% | |TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/29 (0%) 0/37 (0%) |2/32 (6%) 0/32 (0%) 1/35 (3%) 1/30 (3%) | |FIRST INCIDENCE | --- --- --- --- |735 (T) 663 735 (T) 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.525 P=0.505N P=0.469N P=0.663 | |POLY 3 | (e) (e) (e) (e) |P=0.527 P=0.527N P=0.556N P=0.673 | |POLY 1.5 | (e) (e) (e) (e) |P=0.524 P=0.513N P=0.544N P=0.670 | |POLY 6 | (e) (e) (e) (e) |P=0.533 P=0.546N P=0.571N P=0.680 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.509 P=0.499N P=0.469N P=0.648 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.531 P=0.500N P=0.516N P=0.667 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 26 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/49 (6%) 2/49 (4%) 0/47 (0%) |0/49 (0%) 1/49 (2%) 0/47 (0%) 0/46 (0%) | |POLY-3 ADJUSTED (b)| 4.4% 6.3% 5.4% 0.0% |0.0% 2.3% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 2/43 (5%) 1/29 (3%) 0/37 (0%) |0/32 (0%) 1/32 (3%) 0/35 (0%) 0/30 (0%) | |FIRST INCIDENCE | 501 335 645 --- |--- 735 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.163N P=0.523 P=0.593 P=0.248N |P=0.576N P=0.500 (e) (e) | |POLY 3 | P=0.162N P=0.535 P=0.661 P=0.278N |P=0.639N P=0.545 (e) (e) | |POLY 1.5 | P=0.156N P=0.521 P=0.666 P=0.267N |P=0.620N P=0.530 (e) (e) | |POLY 6 | P=0.171N P=0.547 P=0.657 P=0.293N |P=0.660N P=0.565 (e) (e) | |LOGISTIC REGRESSION| P=0.132N P=0.368 P=0.698 P=0.261N |(e) P=0.500 (e) (e) | |COCH-ARM / FISHERS | P=0.146N P=0.490 P=0.684 P=0.263N |P=0.578N P=0.500 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/49 (0%) 0/47 (0%) |5/49 (10%) 3/49 (6%) 8/47 (17%) 10/46 (22%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 0.0% |11.2% 6.8% 19.5% 25.9% | |TERMINAL (d) | 1/40 (3%) 0/43 (0%) 0/29 (0%) 0/37 (0%) |4/32 (13%) 2/32 (6%) 7/35 (20%) 8/30 (27%) | |FIRST INCIDENCE | 729 (T) --- --- --- |587 594 697 569 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.327N P=0.486N P=0.564N P=0.516N |P=0.027 * P=0.359N P=0.323 P=0.105 | |POLY 3 | P=0.353N P=0.526N P=0.633N P=0.557N |P=0.017 * P=0.376N P=0.235 P=0.078 | |POLY 1.5 | P=0.339N P=0.518N P=0.592N P=0.540N |P=0.018 * P=0.362N P=0.238 P=0.083 | |POLY 6 | P=0.370N P=0.535N P=0.678N P=0.578N |P=0.016 * P=0.394N P=0.232 P=0.075 | |LOGISTIC REGRESSION| P=0.327N (e) (e) (e) |P=0.017 * P=0.356N P=0.228 P=0.078 | |COCH-ARM / FISHERS | P=0.312N P=0.505N P=0.505N P=0.515N |P=0.027 * P=0.357N P=0.249 P=0.104 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 27 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/50 (60%) 33/50 (66%) 26/50 (52%) 30/50 (60%) | | |POLY-3 ADJUSTED (b)| 65.7% 67.3% 64.8% 65.0% | | |TERMINAL (d) | 28/40 (70%) 29/44 (66%) 20/29 (69%) 25/39 (64%) | | |FIRST INCIDENCE | 464 471 458 543 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.437 P=0.576 P=0.233 P=0.526 | | |POLY 3 | P=0.482N P=0.528 P=0.572N P=0.565N | | |POLY 1.5 | P=0.470N P=0.460 P=0.492N P=0.579N | | |POLY 6 | P=0.494N P=0.593N P=0.580 P=0.548N | | |LOGISTIC REGRESSION| P=0.514N P=0.466 P=0.543 P=0.575 | | |COCH-ARM / FISHERS | P=0.413N P=0.339 P=0.273N P=0.581N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 13/50 (26%) 9/50 (18%) 12/50 (24%) | | |POLY-3 ADJUSTED (b)| 15.5% 27.0% 22.8% 26.5% | | |TERMINAL (d) | 6/40 (15%) 11/44 (25%) 5/29 (17%) 9/39 (23%) | | |FIRST INCIDENCE | 547 645 458 556 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.178 P=0.161 P=0.201 P=0.151 | | |POLY 3 | P=0.206 P=0.140 P=0.300 P=0.159 | | |POLY 1.5 | P=0.212 P=0.127 P=0.322 P=0.156 | | |POLY 6 | P=0.200 P=0.153 P=0.278 P=0.161 | | |LOGISTIC REGRESSION| P=0.211 P=0.122 P=0.340 P=0.151 | | |COCH-ARM / FISHERS | P=0.230 P=0.105 P=0.393 P=0.154 | | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 28 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/49 (0%) 3/50 (6%) | | |POLY-3 ADJUSTED (b)| 6.7% 2.1% 0.0% 6.8% | | |TERMINAL (d) | 3/40 (8%) 1/44 (2%) 0/28 (0%) 2/39 (5%) | | |FIRST INCIDENCE | 729 (T) 729 (T) --- 700 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.486 P=0.272N P=0.191N P=0.648 | | |POLY 3 | P=0.507 P=0.297N P=0.196N P=0.679 | | |POLY 1.5 | P=0.512 P=0.300N P=0.170N P=0.673 | | |POLY 6 | P=0.502 P=0.296N P=0.229N P=0.684 | | |LOGISTIC REGRESSION| P=0.490 P=0.272N (e) P=0.655 | | |COCH-ARM / FISHERS | P=0.525 P=0.309N P=0.125N P=0.661N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Seminal Vesicle | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 9/50 (18%) 8/50 (16%) 2/50 (4%) | | |POLY-3 ADJUSTED (b)| 6.7% 18.9% 20.8% 4.5% | | |TERMINAL (d) | 2/40 (5%) 8/44 (18%) 6/29 (21%) 2/39 (5%) | | |FIRST INCIDENCE | 578 700 519 729 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.305N P=0.090 P=0.041 * P=0.509N | | |POLY 3 | P=0.274N P=0.077 P=0.064 P=0.530N | | |POLY 1.5 | P=0.263N P=0.071 P=0.072 P=0.519N | | |POLY 6 | P=0.291N P=0.082 P=0.056 P=0.544N | | |LOGISTIC REGRESSION| P=0.269N P=0.071 P=0.070 P=0.501N | | |COCH-ARM / FISHERS | P=0.246N P=0.061 P=0.100 P=0.500N | | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 29 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 8/50 (16%) 5/50 (10%) 6/50 (12%) |13/49 (27%) 9/50 (18%) 16/50 (32%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 19.2% 16.1% 12.8% 13.5% |28.7% 19.8% 35.0% 25.2% | |TERMINAL (d) | 6/40 (15%) 4/44 (9%) 2/29 (7%) 5/39 (13%) |7/32 (22%) 5/32 (16%) 9/36 (25%) 7/32 (22%) | |FIRST INCIDENCE | 220 335 458 652 |465 582 540 150 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.267N P=0.437N P=0.358N P=0.308N |P=0.536 P=0.262N P=0.395 P=0.444N | |POLY 3 | P=0.270N P=0.455N P=0.332N P=0.336N |P=0.537 P=0.237N P=0.344 P=0.458N | |POLY 1.5 | P=0.250N P=0.471N P=0.291N P=0.322N |P=0.547N P=0.221N P=0.341 P=0.434N | |POLY 6 | P=0.291N P=0.439N P=0.373N P=0.350N |P=0.525 P=0.257N P=0.354 P=0.484N | |LOGISTIC REGRESSION| P=0.180N P=0.515 P=0.135N P=0.280N |P=0.490N P=0.217N P=0.348 P=0.374N | |COCH-ARM / FISHERS | P=0.204N P=0.500N P=0.194N P=0.288N |P=0.492N P=0.218N P=0.353 P=0.385N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 6.3% 0.0% 0.0% |0.0% 6.7% 2.3% 0.0% | |TERMINAL (d) | 1/40 (3%) 3/44 (7%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 2/32 (6%) 1/36 (3%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- 712 735 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.175N P=0.340 P=0.564N P=0.505N |P=0.368N P=0.116 P=0.523 (e) | |POLY 3 | P=0.168N P=0.346 P=0.627N P=0.551N |P=0.417N P=0.137 P=0.554 (e) | |POLY 1.5 | P=0.162N P=0.332 P=0.586N P=0.534N |P=0.400N P=0.134 P=0.537 (e) | |POLY 6 | P=0.176N P=0.359 P=0.672N P=0.572N |P=0.435N P=0.142 P=0.577 (e) | |LOGISTIC REGRESSION| P=0.175N P=0.340 (e) (e) |P=0.386N P=0.117 P=0.523 (e) | |COCH-ARM / FISHERS | P=0.153N P=0.309 P=0.500N P=0.500N |P=0.362N P=0.125 P=0.505 (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 30 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Spleen: Lymphoid Follicle | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.2% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 0/39 (0%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- 458 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.578 (e) P=0.197 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.615 (e) P=0.252 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.608 (e) P=0.245 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.621 (e) P=0.261 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.620 (e) P=0.275 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 3/50 (6%) 0/49 (0%) 2/50 (4%) |3/50 (6%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 8.9% 6.3% 0.0% 4.5% |6.7% 4.5% 0.0% 0.0% | |TERMINAL (d) | 3/40 (8%) 3/44 (7%) 0/29 (0%) 2/39 (5%) |2/32 (6%) 1/32 (3%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | 547 729 (T) --- 729 (T) |714 703 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.227N P=0.451N P=0.107N P=0.346N |P=0.041N* P=0.513N P=0.112N P=0.129N | |POLY 3 | P=0.221N P=0.478N P=0.107N P=0.360N |P=0.047N* P=0.524N P=0.142N P=0.155N | |POLY 1.5 | P=0.210N P=0.480N P=0.090N P=0.349N |P=0.045N* P=0.510N P=0.134N P=0.143N | |POLY 6 | P=0.234N P=0.477N P=0.129N P=0.375N |P=0.050N P=0.544N P=0.152N P=0.169N | |LOGISTIC REGRESSION| P=0.206N P=0.488N P=0.069N P=0.330N |P=0.044N* P=0.511N P=0.127N P=0.137N | |COCH-ARM / FISHERS | P=0.190N P=0.489N P=0.059N P=0.329N |P=0.039N* P=0.500N P=0.121N P=0.121N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 31 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 3/50 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.3% |2.2% 4.5% 6.8% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 1/39 (3%) |0/32 (0%) 1/32 (3%) 1/36 (3%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- 729 (T) |714 703 622 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.194 (e) (e) P=0.495 |P=0.358N P=0.484 P=0.312 P=0.522N | |POLY 3 | P=0.216 (e) (e) P=0.548 |P=0.397N P=0.527 P=0.323 P=0.580N | |POLY 1.5 | P=0.210 (e) (e) P=0.533 |P=0.381N P=0.520 P=0.316 P=0.555N | |POLY 6 | P=0.222 (e) (e) P=0.562 |P=0.414N P=0.535 P=0.333 P=0.611N | |LOGISTIC REGRESSION| (e) (e) (e) P=0.495 |P=0.341N P=0.498 P=0.307 P=0.513N | |COCH-ARM / FISHERS | P=0.200 (e) (e) P=0.505 |P=0.337N P=0.500 P=0.309 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 1/50 (2%) 1/50 (2%) 2/49 (4%) |5/50 (10%) 2/50 (4%) 2/48 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 6.5% 2.1% 2.6% 4.4% |10.9% 4.5% 4.6% 4.8% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 1/39 (3%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | 464 710 519 246 |264 662 543 616 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.493N P=0.289N P=0.357N P=0.504N |P=0.223N P=0.242N P=0.240N P=0.261N | |POLY 3 | P=0.505N P=0.303N P=0.417N P=0.523N |P=0.221N P=0.240N P=0.254N P=0.274N | |POLY 1.5 | P=0.494N P=0.301N P=0.378N P=0.511N |P=0.214N P=0.227N P=0.247N P=0.258N | |POLY 6 | P=0.521N P=0.307N P=0.460N P=0.541N |P=0.227N P=0.256N P=0.263N P=0.290N | |LOGISTIC REGRESSION| P=0.437N P=0.421N P=0.145N P=0.573N |P=0.154N P=0.253N P=0.231N P=0.188N | |COCH-ARM / FISHERS | P=0.476N P=0.301N P=0.301N P=0.500N |P=0.189N P=0.218N P=0.235N P=0.218N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 32 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Testes: Germinal Epithelium | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.1% 2.7% 4.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 1/44 (2%) 0/29 (0%) 1/39 (3%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 729 (T) 700 700 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.141 P=0.519 P=0.439 P=0.232 |(e) (e) (e) (e) | |POLY 3 | P=0.156 P=0.548 P=0.560 P=0.264 |(e) (e) (e) (e) | |POLY 1.5 | P=0.155 P=0.531 P=0.537 P=0.255 |(e) (e) (e) (e) | |POLY 6 | P=0.157 P=0.564 P=0.585 P=0.274 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.146 P=0.519 P=0.471 P=0.236 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.153 P=0.500 P=0.500 P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 6.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 0/44 (0%) 0/29 (0%) 3/39 (8%) |0/32 (0%) 0/32 (0%) 0/36 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) --- --- 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.079 P=0.481N P=0.564N P=0.296 |(e) (e) (e) (e) | |POLY 3 | P=0.082 P=0.521N P=0.627N P=0.325 |(e) (e) (e) (e) | |POLY 1.5 | P=0.082 P=0.514N P=0.586N P=0.318 |(e) (e) (e) (e) | |POLY 6 | P=0.081 P=0.530N P=0.672N P=0.331 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.079 (e) (e) P=0.296 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.086 P=0.500N P=0.500N P=0.309 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 33 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 9/50 (18%) 3/50 (6%) 5/50 (10%) |13/50 (26%) 6/50 (12%) 15/50 (30%) 13/50 (26%) | |POLY-3 ADJUSTED (b)| 13.5% 18.8% 8.0% 11.3% |29.0% 13.5% 33.9% 31.1% | |TERMINAL (d) | 6/40 (15%) 8/44 (18%) 3/29 (10%) 4/39 (10%) |11/32 (34%) 5/32 (16%) 13/36 (36%) 11/32 (34%) | |FIRST INCIDENCE | 729 (T) 665 729 (T) 700 |683 710 543 642 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.328N P=0.360 P=0.420N P=0.519N |P=0.292 P=0.064N P=0.532 P=0.581 | |POLY 3 | P=0.297N P=0.349 P=0.366N P=0.519N |P=0.228 P=0.064N P=0.404 P=0.522 | |POLY 1.5 | P=0.286N P=0.328 P=0.327N P=0.513N |P=0.238 P=0.059N P=0.403 P=0.538 | |POLY 6 | P=0.311N P=0.370 P=0.413N P=0.529N |P=0.223 P=0.071N P=0.406 P=0.510 | |LOGISTIC REGRESSION| P=0.318N P=0.349 P=0.420N P=0.520N |P=0.204 P=0.073N P=0.366 P=0.470 | |COCH-ARM / FISHERS | P=0.262N P=0.288 P=0.243N P=0.500N |P=0.296 P=0.062N P=0.412 P=0.590N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Tooth | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/4 (100%) 3/3 (100%) 4/4 (100%) 7/7 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 100.0% 100.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/4 (100%) 3/3 (100%) 4/4 (100%) 7/7 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 34 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Urinary Bladder | | Inflammation Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/49 (6%) 1/50 (2%) |0/48 (0%) 0/49 (0%) 1/48 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 7.7% 2.3% |0.0% 0.0% 2.4% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/29 (0%) 1/39 (3%) |0/32 (0%) 0/31 (0%) 0/35 (0%) 0/32 (0%) | |FIRST INCIDENCE | 578 --- 408 729 (T) |--- --- 697 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.455 P=0.483N P=0.270 P=0.757 |P=0.681 (e) P=0.489 (e) | |POLY 3 | P=0.465 P=0.521N P=0.286 P=0.782 |P=0.714 (e) P=0.548 (e) | |POLY 1.5 | P=0.466 P=0.513N P=0.287 P=0.775 |P=0.706 (e) P=0.532 (e) | |POLY 6 | P=0.462 P=0.529N P=0.285 P=0.788 |P=0.727 (e) P=0.569 (e) | |LOGISTIC REGRESSION| P=0.515 P=0.571N P=0.454 P=0.760N |P=0.694 (e) P=0.500 (e) | |COCH-ARM / FISHERS | P=0.469 P=0.500N P=0.301 P=0.753N |P=0.696 (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/50 (2%) 1/50 (2%) 0/50 (0%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| |2.2% 2.2% 0.0% 7.2% | |TERMINAL (d) | |1/32 (3%) 0/32 (0%) 0/36 (0%) 2/32 (6%) | |FIRST INCIDENCE | |735 (T) 707 --- 606 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.155 P=0.754 P=0.477N P=0.302 | |POLY 3 | |P=0.164 P=0.786 P=0.561N P=0.311 | |POLY 1.5 | |P=0.161 P=0.775N P=0.541N P=0.307 | |POLY 6 | |P=0.168 P=0.796 P=0.587N P=0.318 | |LOGISTIC REGRESSION| |P=0.149 P=0.760 (e) P=0.289 | |COCH-ARM / FISHERS | |P=0.160 P=0.753N P=0.500N P=0.309 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 06 Page 35 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 250 PPM 500 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |41/50 (82%) 46/50 (92%) 43/50 (86%) 44/50 (88%) | |POLY-3 ADJUSTED (b)| |86.9% 95.5% 90.5% 96.2% | |TERMINAL (d) | |29/32 (91%) 31/32 (97%) 33/36 (92%) 32/32 (100%) | |FIRST INCIDENCE | |465 538 393 466 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.350 P=0.206 P=0.491N P=0.272 | |POLY 3 | |P=0.121 P=0.120 P=0.416 P=0.101 | |POLY 1.5 | |P=0.133 P=0.137 P=0.385 P=0.115 | |POLY 6 | |P=0.131 P=0.109 P=0.445 P=0.106 | |LOGISTIC REGRESSION| |P=0.089 P=0.120 P=0.308 P=0.076 | |COCH-ARM / FISHERS | |P=0.361 P=0.117 P=0.393 P=0.288 | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Poly-3 adjusted lifetime tumor incidence. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).