TDMS Study 05197-11 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest 2-BUTOXYETHANOL DATE: 02/23/98 EXPERIMENT: 05197 TEST: 11 TIME: 08:59:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15318 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62077D PATHOLOGIST: GRUMBEIN, S. CAS: 111-76-0002 Rats(FISCHER 344) ----------------------------- 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 PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest 2-BUTOXYETHANOL DATE: 02/23/98 EXPERIMENT: 05197 TEST: 11 TIME: 08:59:35 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15318 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62077D PATHOLOGIST: GRUMBEIN, S. CAS: 111-76-0002 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF 2-BUTOXYETHANOL =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Clitoral/Preputial Gland Carcinoma or Adenoma Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) Papilloma Squamous or Papilloma Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Oral Mucosa Squamous Cell Papilloma Skin Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, malignant or NOS), or Trichoepithelioma Sarcoma Testes Adenoma All Organs Malignant Tumors =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Pheochromocytoma: Benign, Complex, Malignant, NOS Mammary Gland Fibroadenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Skin Squamous Cell Papilloma All Organs Malignant Tumors Malignant and Benign Tumors =============================================================== Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 1 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.1% 0.0% 2.6% 0.0% |2.3% 0.0% 5.1% 0.0% | |TERMINAL (d) | 1/19 (5%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |1/29 (3%) 0/27 (0%) 2/23 (9%) 0/21 (0%) | |FIRST INCIDENCE | 597 --- 542 --- |730 (T) --- 730 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.173N P=0.305N P=0.497N P=0.214N |P=0.547N P=0.514N P=0.419 P=0.564N | |POLY 3 | P=0.177N P=0.251N P=0.501N P=0.230N |P=0.475N P=0.501N P=0.469 P=0.509N | |POLY 1.5 | P=0.183N P=0.244N P=0.506N P=0.234N |P=0.468N P=0.500N P=0.480 P=0.504N | |POLY 6 | P=0.165N P=0.265N P=0.488N P=0.223N |P=0.488N P=0.503N P=0.455 P=0.518N | |LOGISTIC REGRESSION| P=0.193N P=0.240N P=0.496N P=0.238N |P=0.547N (e) P=0.419 (e) | |COCH-ARM / FISHERS | P=0.189N P=0.247N P=0.508N P=0.247N |P=0.461N P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 20/50 (40%) 13/49 (27%) 16/50 (32%) |3/50 (6%) 4/50 (8%) 1/49 (2%) 7/49 (14%) | |POLY-3 ADJUSTED (b)| 36.5% 50.3% 32.8% 38.3% |6.9% 9.2% 2.6% 16.7% | |TERMINAL (d) | 7/19 (37%) 6/11 (55%) 6/21 (29%) 9/24 (38%) |1/29 (3%) 1/27 (4%) 1/22 (5%) 1/21 (5%) | |FIRST INCIDENCE | 558 533 658 611 |554 584 730 (T) 638 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.136N P=0.040 * P=0.315N P=0.431N |P=0.068 P=0.484 P=0.385N P=0.119 | |POLY 3 | P=0.424N P=0.140 P=0.452N P=0.522 |P=0.090 P=0.499 P=0.353N P=0.138 | |POLY 1.5 | P=0.447N P=0.170 P=0.455N P=0.509 |P=0.096 P=0.501 P=0.337N P=0.144 | |POLY 6 | P=0.370N P=0.097 P=0.427N P=0.556 |P=0.084 P=0.493 P=0.372N P=0.129 | |LOGISTIC REGRESSION| P=0.334N P=0.127 P=0.403N P=0.570 |P=0.103 P=0.497 P=0.324N P=0.158 | |COCH-ARM / FISHERS | P=0.462N P=0.201 P=0.437N P=0.500 |P=0.104 P=0.500 P=0.316N P=0.151 | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 2 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/49 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 5.4% 7.7% 0.0% |0.0% 0.0% 0.0% 2.5% | |TERMINAL (d) | 0/19 (0%) 0/11 (0%) 1/21 (5%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/22 (0%) 0/21 (0%) | |FIRST INCIDENCE | --- 630 622 --- |--- --- --- 612 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.451N P=0.190 P=0.142 (e) |P=0.202 (e) (e) P=0.500 | |POLY 3 | P=0.506N P=0.227 P=0.119 (e) |P=0.191 (e) (e) P=0.489 | |POLY 1.5 | P=0.519N P=0.232 P=0.116 (e) |P=0.194 (e) (e) P=0.493 | |POLY 6 | P=0.481N P=0.217 P=0.128 (e) |P=0.187 (e) (e) P=0.481 | |LOGISTIC REGRESSION| P=0.520N P=0.225 P=0.117 (e) |P=0.196 (e) (e) P=0.499 | |COCH-ARM / FISHERS | P=0.531N P=0.247 P=0.117 (e) |P=0.196 (e) (e) P=0.495 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 21/50 (42%) 15/49 (31%) 16/50 (32%) |3/50 (6%) 4/50 (8%) 1/49 (2%) 8/49 (16%) | |POLY-3 ADJUSTED (b)| 36.5% 52.4% 37.5% 38.3% |6.9% 9.2% 2.6% 18.9% | |TERMINAL (d) | 7/19 (37%) 6/11 (55%) 7/21 (33%) 9/24 (38%) |1/29 (3%) 1/27 (4%) 1/22 (5%) 1/21 (5%) | |FIRST INCIDENCE | 558 533 622 611 |554 584 730 (T) 612 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.130N P=0.028 * P=0.467N P=0.431N |P=0.034 * P=0.484 P=0.385N P=0.076 | |POLY 3 | P=0.413N P=0.100 P=0.557 P=0.522 |P=0.044 * P=0.499 P=0.353N P=0.086 | |POLY 1.5 | P=0.437N P=0.123 P=0.548 P=0.509 |P=0.047 * P=0.501 P=0.337N P=0.090 | |POLY 6 | P=0.358N P=0.069 P=0.595 P=0.556 |P=0.041 * P=0.493 P=0.372N P=0.081 | |LOGISTIC REGRESSION| P=0.330N P=0.091 P=0.587N P=0.570 |P=0.053 P=0.497 P=0.324N P=0.101 | |COCH-ARM / FISHERS | P=0.453N P=0.149 P=0.560 P=0.500 |P=0.052 P=0.500 P=0.316N P=0.094 | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 3 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Brain | | Glioma Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.1% 0.0% 0.0% 0.0% |0.0% 0.0% 2.5% 0.0% | |TERMINAL (d) | 1/19 (5%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 646 --- --- --- |--- --- 247 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.097N P=0.307N P=0.222N P=0.202N |P=0.694 (e) P=0.500 (e) | |POLY 3 | P=0.109N P=0.250N P=0.238N P=0.229N |P=0.679 (e) P=0.487 (e) | |POLY 1.5 | P=0.112N P=0.243N P=0.240N P=0.233N |P=0.687 (e) P=0.492 (e) | |POLY 6 | P=0.104N P=0.264N P=0.232N P=0.221N |P=0.663 (e) P=0.480 (e) | |LOGISTIC REGRESSION| P=0.109N P=0.255N P=0.235N P=0.228N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.694 (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.1% 2.7% 0.0% 2.5% |0.0% 2.3% 2.5% 0.0% | |TERMINAL (d) | 1/19 (5%) 1/11 (9%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 646 729 (T) --- 647 |--- 652 247 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.293N P=0.632N P=0.222N P=0.442N |P=0.599N P=0.505 P=0.500 (e) | |POLY 3 | P=0.357N P=0.521N P=0.238N P=0.486N |P=0.608N P=0.501 P=0.487 (e) | |POLY 1.5 | P=0.363N P=0.510N P=0.240N P=0.493N |P=0.601N P=0.501 P=0.492 (e) | |POLY 6 | P=0.346N P=0.542N P=0.232N P=0.472N |P=0.621N P=0.499 P=0.480 (e) | |LOGISTIC REGRESSION| P=0.346N P=0.552N P=0.235N P=0.495N |P=0.576N P=0.491 (e) (e) | |COCH-ARM / FISHERS | P=0.366N P=0.500N P=0.247N P=0.500N |P=0.595N P=0.500 P=0.500 (e) | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 4 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/46 (7%) 1/47 (2%) 5/50 (10%) 5/43 (12%) |6/46 (13%) 3/45 (7%) 4/44 (9%) 4/48 (8%) | |POLY-3 ADJUSTED (b)| 8.4% 2.9% 12.5% 14.4% |14.9% 7.8% 11.8% 10.1% | |TERMINAL (d) | 1/16 (6%) 1/11 (9%) 2/21 (10%) 2/19 (11%) |5/27 (19%) 1/23 (4%) 3/20 (15%) 3/20 (15%) | |FIRST INCIDENCE | 610 729 (T) 370 519 |688 722 722 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.249 P=0.386N P=0.439 P=0.427 |P=0.558N P=0.303N P=0.549N P=0.538N | |POLY 3 | P=0.141 P=0.314N P=0.417 P=0.336 |P=0.385N P=0.262N P=0.479N P=0.374N | |POLY 1.5 | P=0.132 P=0.305N P=0.408 P=0.328 |P=0.371N P=0.257N P=0.448N P=0.358N | |POLY 6 | P=0.164 P=0.333N P=0.440 P=0.355 |P=0.411N P=0.275N P=0.519N P=0.405N | |LOGISTIC REGRESSION| P=0.126 P=0.306N P=0.404 P=0.322 |P=0.491N P=0.293N P=0.567N P=0.449N | |COCH-ARM / FISHERS | P=0.124 P=0.300N P=0.405 P=0.319 |P=0.355N P=0.254N P=0.399N P=0.343N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/46 (11%) 1/47 (2%) 2/50 (4%) 1/43 (2%) |3/46 (7%) 1/45 (2%) 3/44 (7%) 2/48 (4%) | |POLY-3 ADJUSTED (b)| 14.0% 2.9% 5.2% 3.0% |7.5% 2.6% 8.7% 5.0% | |TERMINAL (d) | 1/16 (6%) 1/11 (9%) 1/21 (5%) 1/19 (5%) |2/27 (7%) 1/23 (4%) 1/20 (5%) 1/20 (5%) | |FIRST INCIDENCE | 564 729 (T) 701 729 (T) |722 730 (T) 583 663 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.055N P=0.190N P=0.171N P=0.076N |P=0.567 P=0.349N P=0.560 P=0.611N | |POLY 3 | P=0.089N P=0.104N P=0.180N P=0.112N |P=0.523N P=0.320N P=0.594 P=0.503N | |POLY 1.5 | P=0.094N P=0.099N P=0.185N P=0.115N |P=0.513N P=0.316N P=0.611 P=0.492N | |POLY 6 | P=0.079N P=0.115N P=0.168N P=0.105N |P=0.541N P=0.329N P=0.576 P=0.525N | |LOGISTIC REGRESSION| P=0.078N P=0.110N P=0.168N P=0.105N |P=0.529N P=0.351N P=0.603 P=0.549N | |COCH-ARM / FISHERS | P=0.099N P=0.097N P=0.185N P=0.118N |P=0.502N P=0.317N P=0.640 P=0.480N | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 5 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/46 (17%) 2/47 (4%) 7/50 (14%) 6/43 (14%) |9/46 (20%) 3/45 (7%) 7/44 (16%) 6/48 (13%) | |POLY-3 ADJUSTED (b)| 21.9% 5.8% 17.5% 17.3% |22.4% 7.8% 20.2% 15.0% | |TERMINAL (d) | 2/16 (13%) 2/11 (18%) 3/21 (14%) 3/19 (16%) |7/27 (26%) 1/23 (4%) 4/20 (20%) 4/20 (20%) | |FIRST INCIDENCE | 564 729 (T) 370 519 |688 722 583 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.364N P=0.114N P=0.389N P=0.295N |P=0.518 P=0.093N P=0.608N P=0.488N | |POLY 3 | P=0.559N P=0.049N* P=0.421N P=0.425N |P=0.395N P=0.066N P=0.521N P=0.285N | |POLY 1.5 | P=0.546 P=0.044N* P=0.430N P=0.433N |P=0.381N P=0.064N P=0.487N P=0.270N | |POLY 6 | P=0.516N P=0.060N P=0.399N P=0.409N |P=0.421N P=0.072N P=0.559N P=0.316N | |LOGISTIC REGRESSION| P=0.549 P=0.049N* P=0.429N P=0.424N |P=0.468N P=0.083N P=0.589N P=0.370N | |COCH-ARM / FISHERS | P=0.527 P=0.042N* P=0.429N P=0.440N |P=0.366N P=0.064N P=0.430N P=0.257N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/50 (4%) 4/50 (8%) 4/50 (8%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 12.7% 5.4% 10.3% 9.9% |2.3% 0.0% 0.0% 2.4% | |TERMINAL (d) | 2/19 (11%) 0/11 (0%) 2/21 (10%) 3/24 (13%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 1/21 (5%) | |FIRST INCIDENCE | 610 561 694 654 |718 --- --- 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.366N P=0.349N P=0.438N P=0.379N |P=0.519 P=0.519N P=0.555N P=0.677 | |POLY 3 | P=0.524N P=0.234N P=0.507N P=0.480N |P=0.585 P=0.501N P=0.522N P=0.751 | |POLY 1.5 | P=0.540N P=0.225N P=0.509N P=0.490N |P=0.589 P=0.500N P=0.515N P=0.756 | |POLY 6 | P=0.490N P=0.256N P=0.493N P=0.460N |P=0.579 P=0.504N P=0.529N P=0.740 | |LOGISTIC REGRESSION| P=0.489N P=0.234N P=0.473N P=0.451N |P=0.546 P=0.505N P=0.533N P=0.712 | |COCH-ARM / FISHERS | P=0.554N P=0.218N P=0.500N P=0.500N |P=0.594 P=0.500N P=0.505N P=0.753N | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 6 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 10.3% 2.7% 0.0% 7.5% |0.0% 2.3% 0.0% 0.0% | |TERMINAL (d) | 2/19 (11%) 1/11 (9%) 0/21 (0%) 3/24 (13%) |0/29 (0%) 1/27 (4%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 673 729 (T) --- 729 (T) |--- 730 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.347N P=0.328N P=0.053N P=0.388N |P=0.617N P=0.486 (e) (e) | |POLY 3 | P=0.483N P=0.195N P=0.060N P=0.483N |P=0.576N P=0.499 (e) (e) | |POLY 1.5 | P=0.493N P=0.187N P=0.061N P=0.491N |P=0.572N P=0.500 (e) (e) | |POLY 6 | P=0.464N P=0.215N P=0.056N P=0.466N |P=0.582N P=0.497 (e) (e) | |LOGISTIC REGRESSION| P=0.395N P=0.235N P=0.056N P=0.422N |(e) P=0.486 (e) (e) | |COCH-ARM / FISHERS | P=0.500N P=0.181N P=0.059N P=0.500N |P=0.567N P=0.500 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 3/50 (6%) 4/50 (8%) 7/50 (14%) |1/50 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 22.7% 8.0% 10.3% 17.3% |2.3% 2.3% 0.0% 2.4% | |TERMINAL (d) | 4/19 (21%) 1/11 (9%) 2/21 (10%) 6/24 (25%) |0/29 (0%) 1/27 (4%) 0/23 (0%) 1/21 (5%) | |FIRST INCIDENCE | 610 561 694 654 |718 730 (T) --- 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.253N P=0.185N P=0.091N P=0.240N |P=0.606 P=0.742 P=0.555N P=0.677 | |POLY 3 | P=0.452N P=0.069N P=0.117N P=0.371N |P=0.626N P=0.760 P=0.522N P=0.751 | |POLY 1.5 | P=0.470N P=0.063N P=0.120N P=0.382N |P=0.622N P=0.760N P=0.515N P=0.756 | |POLY 6 | P=0.414N P=0.082N P=0.108N P=0.350N |P=0.632N P=0.757 P=0.529N P=0.740 | |LOGISTIC REGRESSION| P=0.376N P=0.081N P=0.096N P=0.306N |P=0.627 P=0.754 P=0.533N P=0.712 | |COCH-ARM / FISHERS | P=0.485N P=0.061N P=0.117N P=0.393N |P=0.616N P=0.753N P=0.505N P=0.753N | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 7 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 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)| 2.6% 5.3% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 702 536 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.164N P=0.441 P=0.476N P=0.461N |(e) (e) (e) (e) | |POLY 3 | P=0.184N P=0.488 P=0.500N P=0.492N |(e) (e) (e) (e) | |POLY 1.5 | P=0.186N P=0.495 P=0.502N P=0.496N |(e) (e) (e) (e) | |POLY 6 | P=0.180N P=0.473 P=0.494N P=0.485N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.189N P=0.504 P=0.492N P=0.483N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.6% 5.3% 0.0% 0.0% |0.0% 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 702 536 --- --- |--- --- --- 617 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.164N P=0.441 P=0.476N P=0.461N |P=0.199 (e) (e) P=0.495 | |POLY 3 | P=0.184N P=0.488 P=0.500N P=0.492N |P=0.194 (e) (e) P=0.493 | |POLY 1.5 | P=0.186N P=0.495 P=0.502N P=0.496N |P=0.197 (e) (e) P=0.497 | |POLY 6 | P=0.180N P=0.473 P=0.494N P=0.485N |P=0.190 (e) (e) P=0.485 | |LOGISTIC REGRESSION| P=0.189N P=0.504 P=0.492N P=0.483N |P=0.199 (e) (e) P=0.503 | |COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.198 (e) (e) P=0.500 | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 8 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 5.4% 0.0% 2.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/19 (0%) 1/11 (9%) 0/21 (0%) 1/24 (4%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 708 617 --- 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.410N P=0.394 P=0.475N P=0.711N |(e) (e) (e) (e) | |POLY 3 | P=0.494N P=0.485 P=0.500N P=0.753N |(e) (e) (e) (e) | |POLY 1.5 | P=0.497N P=0.493 P=0.502N P=0.757N |(e) (e) (e) (e) | |POLY 6 | P=0.486N P=0.469 P=0.494N P=0.744N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.467N P=0.473 P=0.489N P=0.728N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.500N P=0.753N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 8.1% 0.0% 4.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/19 (0%) 1/11 (9%) 0/21 (0%) 1/24 (4%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 708 617 --- 666 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.553N P=0.212 P=0.475N P=0.566 |(e) (e) (e) (e) | |POLY 3 | P=0.572 P=0.290 P=0.500N P=0.516 |(e) (e) (e) (e) | |POLY 1.5 | P=0.563 P=0.298 P=0.502N P=0.508 |(e) (e) (e) (e) | |POLY 6 | P=0.588 P=0.274 P=0.494N P=0.531 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.586 P=0.273 P=0.489N P=0.528 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.556 P=0.309 P=0.500N P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 9 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 8.1% 0.0% 4.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/19 (0%) 1/11 (9%) 0/21 (0%) 1/24 (4%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 708 617 --- 666 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.553N P=0.212 P=0.475N P=0.566 |(e) (e) (e) (e) | |POLY 3 | P=0.572 P=0.290 P=0.500N P=0.516 |(e) (e) (e) (e) | |POLY 1.5 | P=0.563 P=0.298 P=0.502N P=0.508 |(e) (e) (e) (e) | |POLY 6 | P=0.588 P=0.274 P=0.494N P=0.531 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.586 P=0.273 P=0.489N P=0.528 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.556 P=0.309 P=0.500N P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 4/50 (8%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 5.5% 10.1% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/19 (5%) 2/11 (18%) 3/21 (14%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/20 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 472 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.252N P=0.310 P=0.199 P=0.453N |(e) (e) (e) (e) | |POLY 3 | P=0.341N P=0.482 P=0.183 P=0.492N |(e) (e) (e) (e) | |POLY 1.5 | P=0.357N P=0.491 P=0.179 P=0.496N |(e) (e) (e) (e) | |POLY 6 | P=0.311N P=0.463 P=0.194 P=0.484N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.339N P=0.310 P=0.179 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.373N P=0.500 P=0.181 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 10 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 5/50 (10%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 8.2% 12.7% 2.5% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/19 (5%) 2/11 (18%) 4/21 (19%) 1/24 (4%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/20 (0%) | |FIRST INCIDENCE | 729 (T) 723 472 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.365N P=0.146 P=0.117 P=0.710N |(e) (e) (e) (e) | |POLY 3 | P=0.508N P=0.285 P=0.104 P=0.752N |(e) (e) (e) (e) | |POLY 1.5 | P=0.526N P=0.296 P=0.101 P=0.756N |(e) (e) (e) (e) | |POLY 6 | P=0.472N P=0.266 P=0.112 P=0.743N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.474N P=0.169 P=0.104 P=0.710N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.544N P=0.309 P=0.102 P=0.753N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 4/50 (8%) 4/50 (8%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 2.7% 0.0% 0.0% |6.9% 9.1% 9.8% 7.2% | |TERMINAL (d) | 0/19 (0%) 1/11 (9%) 0/21 (0%) 0/24 (0%) |2/29 (7%) 0/27 (0%) 1/23 (4%) 1/21 (5%) | |FIRST INCIDENCE | --- 729 (T) --- --- |638 606 462 663 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.503N P=0.391 (e) (e) |P=0.499 P=0.484 P=0.405 P=0.551 | |POLY 3 | P=0.571N P=0.490 (e) (e) |P=0.571N P=0.507 P=0.464 P=0.642 | |POLY 1.5 | P=0.569N P=0.495 (e) (e) |P=0.554N P=0.505 P=0.477 P=0.653 | |POLY 6 | P=0.574N P=0.479 (e) (e) |P=0.544 P=0.508 P=0.450 P=0.622 | |LOGISTIC REGRESSION| (e) P=0.391 (e) (e) |P=0.524N P=0.496 P=0.535 P=0.644 | |COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.537N P=0.500 P=0.500 P=0.661N | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 11 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |23/50 (46%) 24/50 (48%) 20/50 (40%) 15/50 (30%) | |POLY-3 ADJUSTED (b)| 7.7% 2.7% 7.6% 2.5% |49.9% 53.5% 48.2% 33.9% | |TERMINAL (d) | 1/19 (5%) 0/11 (0%) 1/21 (5%) 1/24 (4%) |14/29 (48%) 15/27 (56%) 12/23 (52%) 5/21 (24%) | |FIRST INCIDENCE | 641 677 565 729 (T) |508 584 462 462 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.225N P=0.417N P=0.622N P=0.248N |P=0.259N P=0.411 P=0.482 P=0.296N | |POLY 3 | P=0.289N P=0.325N P=0.661N P=0.294N |P=0.043N* P=0.445 P=0.522N P=0.088N | |POLY 1.5 | P=0.302N P=0.315N P=0.660 P=0.300N |P=0.038N* P=0.473 P=0.451N P=0.079N | |POLY 6 | P=0.266N P=0.347N P=0.647N P=0.283N |P=0.057N P=0.401 P=0.570 P=0.110N | |LOGISTIC REGRESSION| P=0.293N P=0.330N P=0.662 P=0.281N |P=0.048N* P=0.501 P=0.455N P=0.074N | |COCH-ARM / FISHERS | P=0.313N P=0.309N P=0.661N P=0.309N |P=0.036N* P=0.500 P=0.343N P=0.074N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |25/50 (50%) 27/50 (54%) 23/50 (46%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 7.7% 5.4% 7.6% 2.5% |53.8% 58.9% 54.3% 40.4% | |TERMINAL (d) | 1/19 (5%) 1/11 (9%) 1/21 (5%) 1/24 (4%) |15/29 (52%) 15/27 (56%) 13/23 (57%) 6/21 (29%) | |FIRST INCIDENCE | 641 677 565 729 (T) |508 584 462 462 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.176N P=0.652N P=0.622N P=0.248N |P=0.355N P=0.352 P=0.383 P=0.403N | |POLY 3 | P=0.242N P=0.527N P=0.661N P=0.294N |P=0.070N P=0.386 P=0.568 P=0.137N | |POLY 1.5 | P=0.254N P=0.513N P=0.660 P=0.300N |P=0.060N P=0.404 P=0.532N P=0.122N | |POLY 6 | P=0.222N P=0.555N P=0.647N P=0.283N |P=0.095N P=0.360 P=0.481 P=0.169N | |LOGISTIC REGRESSION| P=0.237N P=0.549N P=0.662 P=0.281N |P=0.068N P=0.423 P=0.524N P=0.114N | |COCH-ARM / FISHERS | P=0.263N P=0.500N P=0.661N P=0.309N |P=0.054N P=0.421 P=0.421N P=0.113N | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 12 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 10.1% 0.0% 2.6% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/19 (5%) 0/11 (0%) 1/21 (5%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 609 --- 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.030N* P=0.088N P=0.166N P=0.054N |(e) (e) (e) (e) | |POLY 3 | P=0.032N* P=0.070N P=0.185N P=0.058N |(e) (e) (e) (e) | |POLY 1.5 | P=0.035N* P=0.065N P=0.185N P=0.059N |(e) (e) (e) (e) | |POLY 6 | P=0.028N* P=0.081N P=0.181N P=0.055N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.038N* P=0.061N P=0.180N P=0.065N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.039N* P=0.059N P=0.181N P=0.059N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 10.1% 0.0% 2.6% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/19 (5%) 0/11 (0%) 1/21 (5%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 609 --- 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.030N* P=0.088N P=0.166N P=0.054N |(e) (e) (e) (e) | |POLY 3 | P=0.032N* P=0.070N P=0.185N P=0.058N |(e) (e) (e) (e) | |POLY 1.5 | P=0.035N* P=0.065N P=0.185N P=0.059N |(e) (e) (e) (e) | |POLY 6 | P=0.028N* P=0.081N P=0.181N P=0.055N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.038N* P=0.061N P=0.180N P=0.065N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.039N* P=0.059N P=0.181N P=0.059N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 13 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.5% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 609 --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.045N* P=0.130N P=0.117N P=0.113N |(e) (e) (e) (e) | |POLY 3 | P=0.041N* P=0.133N P=0.123N P=0.115N |(e) (e) (e) (e) | |POLY 1.5 | P=0.043N* P=0.125N P=0.122N P=0.117N |(e) (e) (e) (e) | |POLY 6 | P=0.037N* P=0.148N P=0.120N P=0.112N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.047N* P=0.115N P=0.111N P=0.127N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.047N* P=0.121N P=0.121N P=0.121N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 0.0% 7.8% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/19 (5%) 0/11 (0%) 3/21 (14%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.379N P=0.609N P=0.338 P=0.453N |(e) (e) (e) (e) | |POLY 3 | P=0.470N P=0.510N P=0.304 P=0.492N |(e) (e) (e) (e) | |POLY 1.5 | P=0.486N P=0.505N P=0.302 P=0.496N |(e) (e) (e) (e) | |POLY 6 | P=0.440N P=0.521N P=0.315 P=0.484N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.379N (e) P=0.338 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.309 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 14 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/49 (49%) 29/49 (59%) 24/48 (50%) 25/47 (53%) |33/50 (66%) 32/50 (64%) 30/49 (61%) 20/49 (41%) | |POLY-3 ADJUSTED (b)| 55.2% 65.0% 55.8% 59.0% |72.8% 69.1% 69.5% 45.6% | |TERMINAL (d) | 6/18 (33%) 7/11 (64%) 10/20 (50%) 14/23 (61%) |22/29 (76%) 19/27 (70%) 16/23 (70%) 9/21 (43%) | |FIRST INCIDENCE | 520 479 340 495 |575 584 496 462 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.164N P=0.090 P=0.466N P=0.405N |P=0.160N P=0.517 P=0.340 P=0.181N | |POLY 3 | P=0.522 P=0.223 P=0.562 P=0.442 |P=0.002N** P=0.430N P=0.452N P=0.005N** | |POLY 1.5 | P=0.510 P=0.222 P=0.550 P=0.432 |P=0.003N** P=0.457N P=0.426N P=0.006N** | |POLY 6 | P=0.545 P=0.211 P=0.580 P=0.457 |P=0.003N** P=0.404N P=0.480N P=0.005N** | |LOGISTIC REGRESSION| P=0.488 P=0.224 P=0.542 P=0.419 |P=0.006N** P=0.502N P=0.586N P=0.012N* | |COCH-ARM / FISHERS | P=0.500 P=0.209 P=0.541 P=0.418 |P=0.004N** P=0.500N P=0.388N P=0.010N* | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 0/49 (0%) 4/50 (8%) 2/50 (4%) | | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 10.3% 5.0% | | |TERMINAL (d) | 1/18 (6%) 0/11 (0%) 3/21 (14%) 2/24 (8%) | | |FIRST INCIDENCE | 729 (T) --- 708 729 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.403 P=0.598N P=0.225 P=0.601 | | |POLY 3 | P=0.275 P=0.508N P=0.186 P=0.524 | | |POLY 1.5 | P=0.258 P=0.504N P=0.183 P=0.515 | | |POLY 6 | P=0.309 P=0.517N P=0.197 P=0.540 | | |LOGISTIC REGRESSION| P=0.379 (e) P=0.225 P=0.601 | | |COCH-ARM / FISHERS | P=0.244 P=0.500N P=0.187 P=0.508 | | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 15 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.2% 2.7% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/19 (11%) 1/11 (9%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.069N P=0.690N P=0.215N P=0.187N |(e) (e) (e) (e) | |POLY 3 | P=0.097N P=0.518N P=0.236N P=0.227N |(e) (e) (e) (e) | |POLY 1.5 | P=0.099N P=0.509N P=0.239N P=0.232N |(e) (e) (e) (e) | |POLY 6 | P=0.092N P=0.537N P=0.228N P=0.218N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.069N P=0.690N (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.2% 2.7% 0.0% 0.0% |2.3% 2.3% 0.0% 0.0% | |TERMINAL (d) | 2/19 (11%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |1/29 (3%) 1/27 (4%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 729 (T) 638 --- --- |730 (T) 730 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.078N P=0.639N P=0.215N P=0.187N |P=0.287N P=0.746 P=0.546N P=0.564N | |POLY 3 | P=0.097N P=0.515N P=0.236N P=0.227N |P=0.244N P=0.760 P=0.518N P=0.509N | |POLY 1.5 | P=0.099N P=0.507N P=0.239N P=0.232N |P=0.241N P=0.760N P=0.511N P=0.504N | |POLY 6 | P=0.093N P=0.530N P=0.228N P=0.218N |P=0.248N P=0.758 P=0.526N P=0.518N | |LOGISTIC REGRESSION| P=0.089N P=0.547N (e) (e) |P=0.287N P=0.746 (e) (e) | |COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |P=0.235N P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 16 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous | | Tumor (benign, malignant or NOS), or Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 10.4% 5.4% 0.0% 0.0% |2.3% 2.3% 0.0% 0.0% | |TERMINAL (d) | 4/19 (21%) 1/11 (9%) 0/21 (0%) 0/24 (0%) |1/29 (3%) 1/27 (4%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 729 (T) 638 --- --- |730 (T) 730 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.009N** P=0.570N P=0.048N* P=0.035N* |P=0.287N P=0.746 P=0.546N P=0.564N | |POLY 3 | P=0.015N* P=0.355N P=0.059N P=0.054N |P=0.244N P=0.760 P=0.518N P=0.509N | |POLY 1.5 | P=0.016N* P=0.346N P=0.061N P=0.057N |P=0.241N P=0.760N P=0.511N P=0.504N | |POLY 6 | P=0.013N* P=0.375N P=0.054N P=0.048N* |P=0.248N P=0.758 P=0.526N P=0.518N | |LOGISTIC REGRESSION| P=0.011N* P=0.440N (e) (e) |P=0.287N P=0.746 (e) (e) | |COCH-ARM / FISHERS | P=0.018N* P=0.339N P=0.059N P=0.059N |P=0.235N P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor | | (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 8/50 (16%) 6/50 (12%) 8/50 (16%) 4/50 (8%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 20.3% 15.8% 19.8% 9.8% |6.9% 2.3% 0.0% 4.8% | |TERMINAL (d) | 6/19 (32%) 1/11 (9%) 5/21 (24%) 3/24 (13%) |2/29 (7%) 1/27 (4%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 529 579 340 617 |710 730 (T) --- 695 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.070N P=0.570 P=0.538N P=0.097N |P=0.569N P=0.337N P=0.172N P=0.645N | |POLY 3 | P=0.145N P=0.410N P=0.590N P=0.156N |P=0.457N P=0.307N P=0.135N P=0.520N | |POLY 1.5 | P=0.162N P=0.398N P=0.603N P=0.167N |P=0.452N P=0.305N P=0.129N P=0.509N | |POLY 6 | P=0.117N P=0.431N P=0.555N P=0.136N |P=0.465N P=0.311N P=0.143N P=0.540N | |LOGISTIC REGRESSION| P=0.156N P=0.447N P=0.606 P=0.138N |P=0.516N P=0.320N P=0.153N P=0.577N | |COCH-ARM / FISHERS | P=0.178N P=0.387N P=0.607N P=0.178N |P=0.444N P=0.309N P=0.121N P=0.500N | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 17 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 5.1% 5.4% 5.2% 9.9% |0.0% 2.3% 0.0% 2.4% | |TERMINAL (d) | 1/19 (5%) 0/11 (0%) 2/21 (10%) 3/24 (13%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 1/21 (5%) | |FIRST INCIDENCE | 646 617 729 (T) 638 |--- 708 --- 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.353 P=0.620 P=0.662N P=0.425 |P=0.323 P=0.476 (e) P=0.436 | |POLY 3 | P=0.241 P=0.680 P=0.693 P=0.355 |P=0.391 P=0.500 (e) P=0.491 | |POLY 1.5 | P=0.231 P=0.687 P=0.690 P=0.346 |P=0.399 P=0.500 (e) P=0.496 | |POLY 6 | P=0.263 P=0.665 P=0.689N P=0.374 |P=0.378 P=0.498 (e) P=0.482 | |LOGISTIC REGRESSION| P=0.260 P=0.689 P=0.676N P=0.371 |P=0.368 P=0.498 (e) P=0.436 | |COCH-ARM / FISHERS | P=0.221 P=0.691N P=0.691N P=0.339 |P=0.405 P=0.500 (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 3/50 (6%) 5/50 (10%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 7.6% 5.4% 7.8% 12.2% |0.0% 2.3% 0.0% 2.4% | |TERMINAL (d) | 1/19 (5%) 0/11 (0%) 3/21 (14%) 3/24 (13%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 1/21 (5%) | |FIRST INCIDENCE | 609 617 729 (T) 576 |--- 708 --- 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.338 P=0.573N P=0.627N P=0.441 |P=0.323 P=0.476 (e) P=0.436 | |POLY 3 | P=0.229 P=0.525N P=0.656 P=0.379 |P=0.391 P=0.500 (e) P=0.491 | |POLY 1.5 | P=0.217 P=0.512N P=0.655 P=0.368 |P=0.399 P=0.500 (e) P=0.496 | |POLY 6 | P=0.256 P=0.549N P=0.664 P=0.401 |P=0.378 P=0.498 (e) P=0.482 | |LOGISTIC REGRESSION| P=0.227 P=0.499N P=0.655N P=0.363 |P=0.368 P=0.498 (e) P=0.436 | |COCH-ARM / FISHERS | P=0.205 P=0.500N P=0.661N P=0.357 |P=0.405 P=0.500 (e) P=0.500 | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 18 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 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)| 2.6% 0.0% 2.6% 4.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/19 (0%) 0/11 (0%) 1/21 (5%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 609 --- 729 (T) 576 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.291 P=0.505N P=0.749N P=0.515 |(e) (e) (e) (e) | |POLY 3 | P=0.270 P=0.513N P=0.759 P=0.518 |(e) (e) (e) (e) | |POLY 1.5 | P=0.258 P=0.506N P=0.758 P=0.509 |(e) (e) (e) (e) | |POLY 6 | P=0.293 P=0.525N P=0.759N P=0.534 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.239 P=0.496N P=0.762 P=0.480 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.247 P=0.500N P=0.753N P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 3/50 (6%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.6% 8.0% 9.9% 7.4% |4.6% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/19 (11%) 0/11 (0%) 1/21 (5%) 2/24 (8%) |1/29 (3%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 529 579 340 617 |710 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.477N P=0.563 P=0.529 P=0.590N |P=0.153N P=0.262N P=0.301N P=0.326N | |POLY 3 | P=0.567N P=0.645 P=0.515 P=0.647N |P=0.115N P=0.238N P=0.258N P=0.247N | |POLY 1.5 | P=0.573 P=0.654 P=0.504 P=0.655N |P=0.115N P=0.237N P=0.250N P=0.242N | |POLY 6 | P=0.536N P=0.630 P=0.539 P=0.630N |P=0.114N P=0.241N P=0.268N P=0.258N | |LOGISTIC REGRESSION| P=0.544 P=0.658N P=0.530 P=0.654N |P=0.132N P=0.243N P=0.273N P=0.275N | |COCH-ARM / FISHERS | P=0.558 P=0.661N P=0.500 P=0.661N |P=0.115N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 19 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin | | Lipoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 2.7% 5.2% 0.0% |0.0% 0.0% 2.5% 0.0% | |TERMINAL (d) | 1/19 (5%) 0/11 (0%) 2/21 (10%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 729 (T) 576 729 (T) --- |--- --- 589 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.285N P=0.704 P=0.535 P=0.453N |P=0.692 (e) P=0.476 (e) | |POLY 3 | P=0.348N P=0.753 P=0.500 P=0.492N |P=0.680 (e) P=0.484 (e) | |POLY 1.5 | P=0.358N P=0.757 P=0.497 P=0.496N |P=0.688 (e) P=0.490 (e) | |POLY 6 | P=0.328N P=0.744 P=0.512 P=0.484N |P=0.664 (e) P=0.478 (e) | |LOGISTIC REGRESSION| P=0.343N P=0.762N P=0.535 (e) |P=0.719 (e) P=0.564 (e) | |COCH-ARM / FISHERS | P=0.366N P=0.753N P=0.500 P=0.500N |P=0.694 (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin | | Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | --- --- --- 576 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.053 (e) (e) P=0.251 |(e) (e) (e) (e) | |POLY 3 | P=0.049 * (e) (e) P=0.251 |(e) (e) (e) (e) | |POLY 1.5 | P=0.047 * (e) (e) P=0.244 |(e) (e) (e) (e) | |POLY 6 | P=0.054 (e) (e) P=0.264 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.040 * (e) (e) P=0.223 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 20 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 4/50 (8%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.6% 2.7% 10.3% 2.5% |0.0% 0.0% 0.0% 4.8% | |TERMINAL (d) | 0/19 (0%) 0/11 (0%) 4/21 (19%) 1/24 (4%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 708 723 729 (T) 729 (T) |--- --- --- 695 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.513N P=0.673 P=0.211 P=0.711N |P=0.031 * (e) (e) P=0.179 | |POLY 3 | P=0.563 P=0.749 P=0.176 P=0.753N |P=0.043 * (e) (e) P=0.228 | |POLY 1.5 | P=0.544 P=0.755 P=0.175 P=0.757N |P=0.044 * (e) (e) P=0.233 | |POLY 6 | P=0.599 P=0.738 P=0.184 P=0.744N |P=0.041 * (e) (e) P=0.218 | |LOGISTIC REGRESSION| P=0.542N P=0.713 P=0.210 P=0.728N |P=0.040 * (e) (e) P=0.212 | |COCH-ARM / FISHERS | P=0.526 P=0.753N P=0.181 P=0.753N |P=0.046 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell | | Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 8/50 (16%) 4/50 (8%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 10.2% 10.6% 19.8% 9.8% |4.6% 0.0% 0.0% 4.8% | |TERMINAL (d) | 2/19 (11%) 0/11 (0%) 5/21 (24%) 3/24 (13%) |1/29 (3%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 529 579 340 617 |710 --- --- 695 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.430N P=0.500 P=0.220 P=0.547N |P=0.398 P=0.262N P=0.301N P=0.569 | |POLY 3 | P=0.544 P=0.622 P=0.184 P=0.627N |P=0.489 P=0.238N P=0.258N P=0.679 | |POLY 1.5 | P=0.520 P=0.633 P=0.178 P=0.635N |P=0.494 P=0.237N P=0.250N P=0.687 | |POLY 6 | P=0.545N P=0.602 P=0.201 P=0.607N |P=0.482 P=0.241N P=0.268N P=0.663 | |LOGISTIC REGRESSION| P=0.513 P=0.634 P=0.177 P=0.622N |P=0.455 P=0.243N P=0.273N P=0.646 | |COCH-ARM / FISHERS | P=0.500 P=0.643N P=0.178 P=0.643N |P=0.500 P=0.247N P=0.247N P=0.691N | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 21 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/50 (8%) 8/50 (16%) 4/50 (8%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 10.2% 10.6% 19.8% 9.8% |4.6% 0.0% 0.0% 4.8% | |TERMINAL (d) | 2/19 (11%) 0/11 (0%) 5/21 (24%) 3/24 (13%) |1/29 (3%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 529 579 340 617 |710 --- --- 695 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.430N P=0.500 P=0.220 P=0.547N |P=0.398 P=0.262N P=0.301N P=0.569 | |POLY 3 | P=0.544 P=0.622 P=0.184 P=0.627N |P=0.489 P=0.238N P=0.258N P=0.679 | |POLY 1.5 | P=0.520 P=0.633 P=0.178 P=0.635N |P=0.494 P=0.237N P=0.250N P=0.687 | |POLY 6 | P=0.545N P=0.602 P=0.201 P=0.607N |P=0.482 P=0.241N P=0.268N P=0.663 | |LOGISTIC REGRESSION| P=0.513 P=0.634 P=0.177 P=0.622N |P=0.455 P=0.243N P=0.273N P=0.646 | |COCH-ARM / FISHERS | P=0.500 P=0.643N P=0.178 P=0.643N |P=0.500 P=0.247N P=0.247N P=0.691N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Skin: Sebaceous Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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%) 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) | 0/19 (0%) 0/11 (0%) 1/21 (5%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | --- --- 708 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.664 (e) P=0.265 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.626 (e) P=0.237 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.611 (e) P=0.235 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.655 (e) P=0.245 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.645 (e) P=0.257 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 22 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 41/50 (82%) 42/50 (84%) 44/50 (88%) 41/50 (82%) | | |POLY-3 ADJUSTED (b)| 89.9% 92.1% 93.4% 88.2% | | |TERMINAL (d) | 19/19 (100%) 11/11 (100%) 21/21 (100%) 22/24 (92%) | | |FIRST INCIDENCE | 529 533 370 481 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.045N* P=0.056 P=0.550N P=0.183N | | |POLY 3 | P=0.399N P=0.501 P=0.386 P=0.529N | | |POLY 1.5 | P=0.479N P=0.502 P=0.321 P=0.567N | | |POLY 6 | P=0.251N P=0.529 P=0.551 P=0.445N | | |LOGISTIC REGRESSION| P=0.512N P=0.367 P=0.167 P=0.573N | | |COCH-ARM / FISHERS | P=0.552 P=0.500 P=0.288 P=0.602N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 3/46 (7%) 7/48 (15%) 10/48 (21%) |6/50 (12%) 2/48 (4%) 5/49 (10%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 17.9% 8.7% 18.4% 25.5% |13.8% 4.8% 12.6% 11.9% | |TERMINAL (d) | 5/19 (26%) 1/11 (9%) 5/21 (24%) 9/24 (38%) |3/29 (10%) 0/27 (0%) 3/23 (13%) 2/21 (10%) | |FIRST INCIDENCE | 648 533 658 611 |688 701 694 612 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.324 P=0.360N P=0.525N P=0.478 |P=0.348 P=0.167N P=0.591 P=0.567 | |POLY 3 | P=0.120 P=0.204N P=0.597 P=0.292 |P=0.514 P=0.145N P=0.564N P=0.523N | |POLY 1.5 | P=0.110 P=0.198N P=0.584 P=0.278 |P=0.527 P=0.145N P=0.543N P=0.511N | |POLY 6 | P=0.144 P=0.221N P=0.611N P=0.323 |P=0.490 P=0.146N P=0.592N P=0.549N | |LOGISTIC REGRESSION| P=0.179 P=0.237N P=0.585N P=0.383 |P=0.475 P=0.146N P=0.608N P=0.542N | |COCH-ARM / FISHERS | P=0.104 P=0.195N P=0.581 P=0.266 |P=0.540 P=0.148N P=0.514N P=0.500N | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 23 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/46 (0%) 3/48 (6%) 2/48 (4%) |0/50 (0%) 0/48 (0%) 2/49 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.6% 0.0% 8.0% 5.2% |0.0% 0.0% 5.0% 4.9% | |TERMINAL (d) | 1/19 (5%) 0/11 (0%) 2/21 (10%) 2/24 (8%) |0/29 (0%) 0/27 (0%) 1/23 (4%) 2/21 (10%) | |FIRST INCIDENCE | 729 (T) --- 703 729 (T) |--- --- 649 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.379 P=0.609N P=0.348 P=0.582 |P=0.057 (e) P=0.203 P=0.170 | |POLY 3 | P=0.263 P=0.525N P=0.295 P=0.501 |P=0.080 (e) P=0.219 P=0.227 | |POLY 1.5 | P=0.249 P=0.521N P=0.291 P=0.493 |P=0.084 (e) P=0.224 P=0.232 | |POLY 6 | P=0.292 P=0.534N P=0.307 P=0.517 |P=0.072 (e) P=0.212 P=0.217 | |LOGISTIC REGRESSION| P=0.348 (e) P=0.332 P=0.582 |P=0.075 (e) P=0.224 P=0.170 | |COCH-ARM / FISHERS | P=0.237 P=0.521N P=0.293 P=0.485 |P=0.089 (e) P=0.242 P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 3/46 (7%) 9/48 (19%) 11/48 (23%) |6/50 (12%) 2/48 (4%) 7/49 (14%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 17.9% 8.7% 23.6% 28.1% |13.8% 4.8% 17.5% 14.3% | |TERMINAL (d) | 5/19 (26%) 1/11 (9%) 6/21 (29%) 10/24 (42%) |3/29 (10%) 0/27 (0%) 4/23 (17%) 3/21 (14%) | |FIRST INCIDENCE | 648 533 658 611 |688 701 649 612 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.237 P=0.360N P=0.491 P=0.382 |P=0.199 P=0.167N P=0.340 P=0.427 | |POLY 3 | P=0.066 P=0.204N P=0.370 P=0.208 |P=0.341 P=0.145N P=0.435 P=0.598 | |POLY 1.5 | P=0.060 P=0.198N P=0.359 P=0.198 |P=0.356 P=0.145N P=0.455 P=0.610 | |POLY 6 | P=0.084 P=0.221N P=0.400 P=0.234 |P=0.315 P=0.146N P=0.409 P=0.573 | |LOGISTIC REGRESSION| P=0.113 P=0.237N P=0.425 P=0.293 |P=0.307 P=0.146N P=0.396 P=0.572 | |COCH-ARM / FISHERS | P=0.057 P=0.195N P=0.359 P=0.190 |P=0.371 P=0.148N P=0.484 P=0.620N | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 24 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/46 (0%) 0/48 (0%) 3/48 (6%) |1/50 (2%) 0/48 (0%) 0/49 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.6% 0.0% 0.0% 7.7% |2.3% 0.0% 0.0% 2.4% | |TERMINAL (d) | 1/19 (5%) 0/11 (0%) 0/21 (0%) 3/24 (13%) |1/29 (3%) 0/27 (0%) 0/23 (0%) 1/21 (5%) | |FIRST INCIDENCE | 729 (T) --- --- 729 (T) |730 (T) --- --- 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.159 P=0.609N P=0.480N P=0.390 |P=0.527 P=0.514N P=0.546N P=0.689 | |POLY 3 | P=0.089 P=0.525N P=0.505N P=0.305 |P=0.587 P=0.507N P=0.518N P=0.751 | |POLY 1.5 | P=0.086 P=0.521N P=0.508N P=0.298 |P=0.591 P=0.507N P=0.512N P=0.756 | |POLY 6 | P=0.095 P=0.534N P=0.499N P=0.321 |P=0.579 P=0.508N P=0.526N P=0.741 | |LOGISTIC REGRESSION| P=0.159 (e) (e) P=0.390 |P=0.527 (e) (e) P=0.689 | |COCH-ARM / FISHERS | P=0.085 P=0.521N P=0.510N P=0.293 |P=0.597 P=0.510N P=0.505N P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/46 (0%) 1/48 (2%) 3/48 (6%) |2/50 (4%) 0/48 (0%) 0/49 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 5.2% 0.0% 2.7% 7.7% |4.6% 0.0% 0.0% 4.8% | |TERMINAL (d) | 2/19 (11%) 0/11 (0%) 1/21 (5%) 3/24 (13%) |2/29 (7%) 0/27 (0%) 0/23 (0%) 1/21 (5%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |730 (T) --- --- 662 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.385 P=0.364N P=0.465N P=0.608 |P=0.425 P=0.254N P=0.290N P=0.605 | |POLY 3 | P=0.255 P=0.265N P=0.509N P=0.501 |P=0.492 P=0.245N P=0.258N P=0.680 | |POLY 1.5 | P=0.245 P=0.260N P=0.514N P=0.491 |P=0.497 P=0.245N P=0.251N P=0.687 | |POLY 6 | P=0.275 P=0.275N P=0.498N P=0.522 |P=0.485 P=0.246N P=0.266N P=0.666 | |LOGISTIC REGRESSION| P=0.385 (e) P=0.465N P=0.608 |P=0.465 (e) (e) P=0.655 | |COCH-ARM / FISHERS | P=0.237 P=0.269N P=0.515N P=0.480 |P=0.503 P=0.258N P=0.253N P=0.691N | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 25 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Urinary Bladder | | Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/18 (6%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 687 --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.090N P=0.325N P=0.211N P=0.190N |(e) (e) (e) (e) | |POLY 3 | P=0.108N P=0.243N P=0.231N P=0.223N |(e) (e) (e) (e) | |POLY 1.5 | P=0.110N P=0.237N P=0.234N P=0.228N |(e) (e) (e) (e) | |POLY 6 | P=0.103N P=0.255N P=0.223N P=0.213N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.098N P=0.268N P=0.216N P=0.205N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.113N P=0.242N P=0.242N P=0.242N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | |6/50 (12%) 3/50 (6%) 6/50 (12%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |13.7% 7.0% 15.2% 4.8% | |TERMINAL (d) | |5/29 (17%) 3/27 (11%) 5/23 (22%) 1/21 (5%) | |FIRST INCIDENCE | |554 730 (T) 705 662 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.298N P=0.272N P=0.458 P=0.226N | |POLY 3 | |P=0.182N P=0.249N P=0.549 P=0.149N | |POLY 1.5 | |P=0.173N P=0.245N P=0.576 P=0.141N | |POLY 6 | |P=0.202N P=0.257N P=0.517 P=0.164N | |LOGISTIC REGRESSION| |P=0.216N P=0.247N P=0.525 P=0.147N | |COCH-ARM / FISHERS | |P=0.162N P=0.243N P=0.620N P=0.134N | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 26 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.5% 2.7% 5.1% 0.0% |0.0% 2.3% 0.0% 2.4% | |TERMINAL (d) | 0/19 (0%) 0/11 (0%) 0/21 (0%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 1/21 (5%) | |FIRST INCIDENCE | 520 652 617 --- |--- 691 --- 730 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.329N P=0.758 P=0.502 P=0.521N |P=0.347 P=0.494 (e) P=0.436 | |POLY 3 | P=0.352N P=0.748 P=0.499 P=0.495N |P=0.391 P=0.500 (e) P=0.491 | |POLY 1.5 | P=0.360N P=0.754 P=0.496 P=0.498N |P=0.399 P=0.501 (e) P=0.496 | |POLY 6 | P=0.335N P=0.736 P=0.510 P=0.489N |P=0.378 P=0.498 (e) P=0.482 | |LOGISTIC REGRESSION| P=0.374N P=0.764 P=0.518 P=0.545N |P=0.382 P=0.500 (e) P=0.436 | |COCH-ARM / FISHERS | P=0.366N P=0.753N P=0.500 P=0.500N |P=0.405 P=0.500 (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or | | Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 29/50 (58%) 31/50 (62%) 33/50 (66%) 30/50 (60%) |18/50 (36%) 21/50 (42%) 23/50 (46%) 24/50 (48%) | |POLY-3 ADJUSTED (b)| 63.6% 69.4% 73.5% 64.6% |38.5% 44.3% 51.5% 51.2% | |TERMINAL (d) | 11/19 (58%) 6/11 (55%) 14/21 (67%) 11/24 (46%) |9/29 (31%) 7/27 (26%) 8/23 (35%) 5/21 (24%) | |FIRST INCIDENCE | 354 533 387 444 |400 495 390 533 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.174N P=0.136 P=0.446 P=0.366N |P=0.059 P=0.320 P=0.107 P=0.086 | |POLY 3 | P=0.541 P=0.352 P=0.204 P=0.547 |P=0.117 P=0.358 P=0.145 P=0.149 | |POLY 1.5 | P=0.499 P=0.378 P=0.213 P=0.518 |P=0.122 P=0.352 P=0.162 P=0.150 | |POLY 6 | P=0.459N P=0.328 P=0.232 P=0.571N |P=0.116 P=0.364 P=0.136 P=0.150 | |LOGISTIC REGRESSION| P=0.486 P=0.420 P=0.258 P=0.489 |P=0.165 P=0.333 P=0.256 P=0.191 | |COCH-ARM / FISHERS | P=0.471 P=0.419 P=0.268 P=0.500 |P=0.133 P=0.341 P=0.208 P=0.156 | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 27 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 4/50 (8%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.6% 2.7% 10.1% 4.9% |0.0% 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/19 (0%) 0/11 (0%) 2/21 (10%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | 597 652 461 589 |--- --- --- 685 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.403 P=0.755 P=0.202 P=0.532 |P=0.183 (e) (e) P=0.471 | |POLY 3 | P=0.349 P=0.749 P=0.181 P=0.516 |P=0.193 (e) (e) P=0.492 | |POLY 1.5 | P=0.330 P=0.755 P=0.178 P=0.508 |P=0.196 (e) (e) P=0.496 | |POLY 6 | P=0.387 P=0.737 P=0.192 P=0.531 |P=0.188 (e) (e) P=0.483 | |LOGISTIC REGRESSION| P=0.302 P=0.757N P=0.185 P=0.486 |P=0.197 (e) (e) P=0.499 | |COCH-ARM / FISHERS | P=0.313 P=0.753N P=0.181 P=0.500 |P=0.198 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Malignant | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 7.6% 2.5% |0.0% 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/19 (0%) 0/11 (0%) 1/21 (5%) 0/24 (0%) |0/29 (0%) 0/27 (0%) 0/23 (0%) 0/21 (0%) | |FIRST INCIDENCE | --- --- 461 589 |--- --- --- 685 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.294 (e) P=0.137 P=0.505 |P=0.183 (e) (e) P=0.471 | |POLY 3 | P=0.279 (e) P=0.122 P=0.511 |P=0.193 (e) (e) P=0.492 | |POLY 1.5 | P=0.262 (e) P=0.119 P=0.505 |P=0.196 (e) (e) P=0.496 | |POLY 6 | P=0.314 (e) P=0.130 P=0.520 |P=0.188 (e) (e) P=0.483 | |LOGISTIC REGRESSION| P=0.232 (e) P=0.128 P=0.484 |P=0.197 (e) (e) P=0.499 | |COCH-ARM / FISHERS | P=0.247 (e) P=0.121 P=0.500 |P=0.198 (e) (e) P=0.500 | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 28 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 49/50 (98%) 49/50 (98%) 49/50 (98%) 49/50 (98%) |42/50 (84%) 43/50 (86%) 40/50 (80%) 37/50 (74%) | |POLY-3 ADJUSTED (b)| 99.8% 99.5% 98.7% 99.5% |88.1% 91.3% 88.9% 78.9% | |TERMINAL (d) | 19/19 (100%) 11/11 (100%) 21/21 (100%) 24/24 (100%)|25/29 (86%) 25/27 (93%) 21/23 (91%) 17/21 (81%) | |FIRST INCIDENCE | 520 479 340 481 |508 584 462 462 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.055N P=0.095 P=0.384N P=0.193N |P=0.271 P=0.361 P=0.217 P=0.323 | |POLY 3 | P=0.748N P=0.999N P=0.771N P=1.000N |P=0.059N P=0.418 P=0.588 P=0.163N | |POLY 1.5 | P=0.666N P=0.910N P=0.734N P=0.928N |P=0.063N P=0.462 P=0.581N P=0.156N | |POLY 6 | P=0.918N P=1.000N P=0.933N P=1.000N |P=0.068N P=0.361 P=0.494 P=0.191N | |LOGISTIC REGRESSION| P=0.651N (e) P=0.674 (e) |P=0.107N P=0.543 P=0.545 P=0.187N | |COCH-ARM / FISHERS | P=0.634 P=0.753N P=0.753N P=0.753N |P=0.080N P=0.500 P=0.398N P=0.163N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 41/50 (82%) 40/50 (80%) 41/50 (82%) 38/50 (76%) |26/50 (52%) 26/50 (52%) 30/50 (60%) 32/50 (64%) | |POLY-3 ADJUSTED (b)| 85.5% 84.9% 88.4% 80.1% |54.7% 54.1% 63.2% 67.1% | |TERMINAL (d) | 16/19 (84%) 8/11 (73%) 17/21 (81%) 16/24 (67%) |14/29 (48%) 9/27 (33%) 9/23 (39%) 9/21 (43%) | |FIRST INCIDENCE | 354 465 387 444 |400 495 247 533 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.046N* P=0.166 P=0.403N P=0.141N |P=0.038 * P=0.496 P=0.127 P=0.063 | |POLY 3 | P=0.270N P=0.588N P=0.455 P=0.328N |P=0.085 P=0.555N P=0.261 P=0.148 | |POLY 1.5 | P=0.282N P=0.548N P=0.490 P=0.328N |P=0.086 P=0.566N P=0.260 P=0.147 | |POLY 6 | P=0.222N P=0.628 P=0.477 P=0.300N |P=0.090 P=0.539N P=0.278 P=0.158 | |LOGISTIC REGRESSION| P=0.248N P=0.505N P=0.567 P=0.306N |P=0.130 P=0.579N P=0.379 P=0.180 | |COCH-ARM / FISHERS | P=0.275N P=0.500N P=0.602N P=0.312N |P=0.096 P=0.579N P=0.273 P=0.156 | |=================================================================================================================================| Date: 02/23/98 EXPERIMENT: 05197 TEST: 11 Page 29 Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - 2-BUTOXYETHANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | CONTROL 31.2 PPM 62.5 PPM 125 PPM |CONTROL 31.2 PPM 62.5 PPM 125 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # |# # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) 50/50 (100%)|47/50 (94%) 48/50 (96%) 50/50 (100%) 48/50 (96%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 100.0% 100.0% |94.0% 96.0% 100.0% 97.4% | |TERMINAL (d) | 19/19 (100%) 11/11 (100%) 21/21 (100%) 24/24 (100%)|26/29 (90%) 25/27 (93%) 23/23 (100%) 20/21 (95%) | |FIRST INCIDENCE | 354 465 340 444 |400 495 247 462 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.049 * P=0.375 P=0.064 P=0.078 | |POLY 3 | (e) (e) (e) (e) |P=0.212 P=0.500 P=0.119 P=0.363 | |POLY 1.5 | (e) (e) (e) (e) |P=0.263 P=0.500 P=0.119 P=0.411 | |POLY 6 | (e) (e) (e) (e) |P=0.177 P=0.500 P=0.119 P=0.326 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.386 (e) (e) P=0.496 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.373 P=0.500 P=0.121 P=0.500 | |=================================================================================================================================| (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).