Document gEaB3x23wmmRLRmZnoo25qYE9

pr&ect no: g6?OaT FILE c :. 9ru3u&tAAol BIO - T E S T J!aJmat(yuje6, Snc. 1810 FRONTAGE ROAD NORTHBROOK. ILLINOIS 60062 l 0 13 REPORT TO MONSANTO COMPANY NINETY-DAY SUBACUTE ORAL TOXICITY STUDY WITH AROCLOR 1221 IN BEAGLE DOGS D ECEMBER 30, 1971 . IBT NO. C9885 ,, ft DSW 036738 STLCOPCB4020562 tOXlCOLOCY (ENVIRONMENTAL SCIENCES CHEMISTRY PLANT SCIENCES medical sciences BIO - T E S T 1010 FRONTAGE ROAD NORTHBROOK. ILLINOIS 60062 December 30, 1971 One. area code 3i? TELEPHONE J030 Mr. Elmer P. Wheeler Monsanto Company 800 North L/indberg Boulevard St. Louis, Missouri 63166 Dear Mr. V,"heeler: Re: 1BT No. C9885 - Ninety-Day Subacute Oral Toxicity Study with Aroclor 1221 in Beagle Dogs We are submitting herewith our laboratory report dated December 30, 1971, prepared in connection with the above study. Very truly yours JCC/bb J. C. Calandra President OSW 036739 STLCOPCB4020563 ... jBI O - T E S T Id&uiiorte*, Dm O y' ` r , REPORT TO MONSANTO COMPANY NINETY-DAY SUBACUTE ORAL TOXICITY STUDY WITH AROCLOR 1221 IN BEAGLE DOGS DECEMBER 30, 1971 IBT NO. C9885 I. Introduction A sample identified as Aroclor 1221, Lot No. AM-14, was received from Monsanto Company for the purpose of conducting a 90-day subacute oral toxicity study using purebred beagle dogs. The following report presents the results of the investigation. QSW 036740 STLCOPCB4020564 Hwfuihial B l O - T E S T laU^aio^kS, 9nc. 2 II. Summary Ninety-day oral administration of Aroclor 1221 to purebred beagle dogs at dietary levels of 1 ppm (Days 1-28) and 300 ppm (Days 29-90), 10 and 100 ppm revealed no significant abnormalities in the following parameters. Body Weights Food Consumption Behavioral Reactions Mortality Hematologic Studies Blood Chemistry Studies Urine Analyses Gross Pathologic Studies Histopathologic Studies Respectfully submitted, INDUSTRA1L BIO-TEST LABORATORIES, INC. Report prepared by: ^/LUO?>.. ^ Bruce R. Burtner, PiY.B. Assistant Toxicologist Dog Toxicity - Report approved by: Dennis C. Lindberg, Bi S Senior Group Leader Dog Toxicity Paul L. Wright, Pn. D. Section Head, Toxicology trm/jg DSW 036741 STLCOPCB4020565 ytidutbiial B I O - T E S T 2ahyiaU>U&i, 9hc. 3 III, Procedure A. Organization The 90-day toxicity study utilized an untreated control group and three test groups, each consisting of eight purebred beagle dogs (four males and four females). The beagles were all eligible for A. K. C. registration and had been previously immunized against rabies, dis temper, infectious canine hepatitis and leptospirosis. . All dogs were acquired from our own (IBTL) colony and were under observation for two weeks prior to the start of the investigation, during which time they were reimmunized and rendered clinically free of any existing parasitic infestation. . During the investigation, the selected animals were housed in kennels equipped with outside runs, four dogs of the same sex and group being accommodated in a single kennel. The material to be tested, Aroclor 1221, was incorporated into a stock diet and fed to the dogs seven days a week at three graded dietary levels. The levels were originally 1, 10 and 100 parts per million of test material in the diet. After 28 days of testing, the lowest level was in creased from 1 to 300 parts per million. An outline of the test organization and diet composition is pre sented in Table I. . yj DSW 036742 STLCOPCB4020566 7* X S 3 1 *0 1 8 p v y v W n Group UC I II HI ;d TABLE I TEST MATERIAL: Aroclorl221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Test Organization and Diet Composition Number of Animals Male Female Dose Level (ppm) <%) 44 No nc None 4 4 (Days 1-28) 1 0. 0001 (Days 29-90) 300 0. 03 44 10 0. 001 .4 4 100 0. 01 o Stock Ration* (%) 100.0 99.9999 99.97 99.999 99.99 * Wayne Dog Meal, Allied Mills, Inc. , Chicago, Illinois. DSW 0 3 6 7 4 3 >> Dtiduihial B I O - T E S T laioJiaivU&i, 9nc. 5 B. Parameters Investigated ' Initially, the body weight of each dog in every group was deter mined and recorded. Thereafter, weighings were conducted weekly for the duration of the test. At the beginning of each week, the appropriate dietary con stituents for each of the groups were thoroughly blended in a Hobart mixer. Preweighed amounts were distributed into self-feeding units \ and maintained in excess of the animals' consumption. One such unit was available to the dogs in each kennel for three hours each day. During these three-hour intervals, food was consumed on an ad libitum basis. At the end of each seven-day period, all unconsumed food was collected and weighed. Food consumption was then calculated and re corded. Water was available to the animals at all times. The dogs were under observation during the investigation and were examined daily for clinical signs or symptoms indicative of systemic toxicity. The following determinations were conducted upon each dog from the untreated control group and three test groups just prior to the inception of the study and after 45 and 90 days of testing: OSW 036744 STLCOPCB4020568 Stidnihial B I O - T E S T lalxt-iaiyiieA-, 9nc. 6 Hematologic Studies total leukocyte count erythrocyte count hemoglobin hematocrit differential leukocyte count Blood Chemistry Studies i ' blood urea nitrogen serum glucose serum alkaline phosphatase serum glutamic-oxalacetic transaminase serum glutamic-pyruvic transaminase Urine Analyses albumin glucose pH specific gravity . microscopic elements - leukocytes erythrocytes crystals At the conclusion of the investigation, the dogs from each group were sacrificed by electric shock. All major tissues and or gans were examined grossly. The weights of the following organs were obtained: liver, kidneys, heart, brain, spleen, gonads, adrenal glands, thyroid gland and pituitary gland. The following tissues and organs excised from these animals were examined histologically (Hematoxylin-Eosin Stain): DSW 036745 STLCOPCB4020569 UhdutUial B I O - T E S T XalmatMieA, !)nc. 7 Adrenal Glands Aorta (thoracic) Bone Marrow (sternum) Brain (cerebrum, cerebellum, pons) Caecum Colon Esophagus Gall Bladder Gonads Heart Kidneys Liver Lungs Lymph Nodes (cervical, mesenteric) Muscle (skeletal) Pancreas Peripheral Nerve (sciatic) Pituitary Gland Prostate Gland Salivary Gland (submaxillary) Small Intestine (duodenum, jejunum, ileum) . Spinal Cord Spleen Stomach (cardia, fundus, pylorus) Trachea Thyroid Gland Uterus Urinary Bladder In addition, individual samples of liver, fat and muscle were saved (frozen) for chemical residue analyses. \, osw 036746 STLCOPCB4020570 Unduikial B i 0 T E S T Ja&MafoUeS, !>tto. 8 IV. Results A. Body Weight Data The body weight data are presented in Tables il and III, No significant deviations from normally expected body weight gains for dogs of this age were noted. \. DSW 036747 STLCOPCB4020571 tr n i T 1 S3 1 '0 1 S W TABLE II TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Body Weight Data for Males, kilograms Age at Dietary Inception Overall Level Dog of Test Body Weights at Week Indicated Weight up (ppm) Number (months) 0 1 2 3 4 5 6 7 8 9 10 11 12 13 Gain Z None * 1 2 3 4 Mean 5.8 6.5 6. 2 5. 5 6. 0 7.4 7_5 7. 5 7. 0 7. 2 8. 0 8.4 7. 0 7.9 7.5 7. 8 8.2 7.9 8. 0 7.4 7.6 7. 5 7.3 8. 1 8.4 8. 3 8. 1 9.0 8. 1 8.4 8.7 8.7 9. 1 6.7 6. 7 7. 1 7.2 7. 5 7.8 8. 0 7.9 8. 2 8. 1 8.4 8.2 8.7 8.6 8. 3 8.4 8. 5 8. 3 9.0 9. 3 9.3 9.6 10.2 9.7 10. 1 10.3 10.6 10.6 7.4 7.6 7.6 7.4 8. 0 8.4 8. 5 8. 2 8. 8 8.4 8.7 8.8 9.0 9. 1 0.6 1. 7 1.9 2. 3 1. 7 1 Days 1-28) 300 Days 29-90) 9 10 11 12 Mean 6.2 6. 2 5.8 6.2 6. 1 6.9 6.9 6. 7 6. 5 6. 5 6.4 -6. 7 7. 0 6.8 6.7 6. 9 7. 1 7.6 7.6 8. 1 9.2 8.4 9.5 9.3 9.6 9.6 9. 7 10. 2 10.4 11.0 11.6 10. 8 11. 0 7.4 6.9 7. 0 6.5 6. 8 7. 0 7. 2 7. 0 7. 7 7.5 8. 1 7.8 7.4 8. 0 . 6.5 6.9 7. 2 7.2 7. 3 7.2 7.2 7. 2 8. 2 8. 5 8.5 8.5 8.6 8.6 7.2 7. 2 7. 3 7.4 7. 5 7.6 7. 7 7. 7 8. 2 8.3 8.6 8.8 8.6 8.8 0.7 2/9 0.6 2. 1 1.6 10 17 6.2 8. 2 8.9 9.2 9.7 9. 8 9.9 10. 3 10.4 10.9 10. 8 10.9 11.4 11.6 11. 8 3.6 o 18 5.8 7. 7 7. 9 7. 9 8. 2 8. 2 8.4 8.6 8.9 9. 3 9.2 9.6 9.3 9.7 9.9 2. 2 Co s: 19 6.2 9.3 9.6 9.8 10.2 10.3 10.3 10.2 10.6 11. 1 11. 1 11.6 11.7 12. 1 12. 3 3. 0 * 20 6.2 7. 5 7.4 7. 1 7.7 7.6 8. 1 8. 5 7.5 8. 5 7. 9 8. 1 8.7 9. 1 9.3 1. 8 C/> o U) Mean o 6. 1 8.2 8.4 8. 5 9.0 9.0 9.2 9.4- 9.4 10. 0 9. 8 10.0 10. 3 10.6 10.8 2.6 H o1o" "OD0O oIsU) 100 -J> OD 25 26 27 28 Mean 5.8 5. 8 5.8 5. 8 578------- 7. 5 6. 7 6. 0 8. 7 7. 2 7.9 7. 0 6.9 9.4 7. 8 8. 0 8.4 8. 5 7. 1 7. 5 7. 5 7. 2 8. 0 8. 0 9.9 10. 7 10. 5 8. 0 "XT 8.6 8.7 8. 0 8.4 11. 0 9. 0 8. 7 8. 1 8. 8 11. 7 9. 3 9.0 8. 2 9.0 11. 7 9. 5 9.3 8. 7 9.5 12. 3 10. 0 9. 0 8. 7 9.5 12.4 9. 9 9.4 8.9 9.8 12. 8 10. 2 9.5 8.9 9.9 13. 0 10. 3 9.6 -9. 1 10. 1 13. 3 10. 5 9.6 9.6 10.3 13. 3 10. 7 2. 1 2. 9 4. 3 4.6 3. 5 o o ^nJuil/Ual B IO -T E S T STLCOPCB4020573 TABLE III TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Body Weight Data for Females, kilograms Dietary Level xp (ppm) Dog Age at Inception of Test Number (months) 0 1 2 Overall Body Weights at Week Indicated Weight 34 5 6 7 8 9 10 11 12 13 Gain None 5 6 7 8 Mean 6.2 6.2 5. 8 5. 8 6. 0 6. 3 6.9 7. 0 7.0 7.6 8. 1 8. 8 8. 7 8.9 9. 1 8.6 8.6 9.0 9.3 6.9 7.0 6. 7 6.5 7. 0 7.4 7. 6 7. 7 8. 1 8. 1 8. 1 8.2 8. 3 8.4 4.4 4. 7 . 4. 7 4.4 5. 0 5. 3 5.4 5.4 5.8 5.8 5.9 6.0 6. 1 6.2 4.9 5. 2 5. 3 5. 0 5.7 5. 7 6. 0 6. 2 6.7 6.6 6.7 7. 0 7.0 7.2 5.6 6. 0 5.9 5.7 6. 3 6. 6 7.0 7. 0 7.4 7.4 7.3 7.4 7.6 7. 8 3. 0 1. 5 1. 8 2. 3 2. 2 1 Days 1-28) 300 Days 29-90) 13 ' 14 15 16 Mean 6.2 6.0 6. 0 5. 8 6.0 5. 3 5.6 5. 6 5.8 6. 0 6. 2 ^6.4 6. 5 7.0 7. 1 7.3 7.3 7.5 7. 8 7. 2 7.6 7. 8 8. 0 8.4 8.6 8. 8 9.2 9.4 9.4 9.8 10.0 10. 0 10. 3 4.9 5. 2 5.4 5. 5 6. 0 6.4 6. 8 7. 3 7.6 7.6 8.2 8.2 8. 3 8.6 5. 2 5. 7 5.8 6.0 6. 3 6.6 6. 9 7. 1 7. 5 7. 8 7.6 7. 7 7. 7 7. 8 5.6 6. 0 6. 2 6. 3 6. 7 7. 0 7. 2 7. 5 7.9 8.0 8. 2 8.3 8.4 8.6 2. 5 3. 1 3. 7 2. 6 3. 0 10 21 22 Co/> 23 a: 24 Mean o U) ioo Z 29 30 31 32 Mean 6.2 6.2 6.2 6. 0 6. 2 6. 0 6. 0 6. 2 5. 8 6. 0 6. 0 5.6 6. 1 6.3 6. 3 6.4 6. 7 6. 7 6.6 6. 5 7. 1 7.0 6.8 7. 7 7. 3 7. 3 7. 3 7. 7 7. 7 7.9 8. 1 8.4 8. 5 8. 5 8.4 8.4 8.6 8.9 7. 3 7. 5 7. 3 7. 7 7. 8 8. 1 8.2 8. 5 8.7 8.3 8.4 8.5 8.6 8.6 6. 5 6.8 6. 8 7. 5 7.6 7. 8 - 8.6 8. 2 8.4 8.9 9. 1 8.6 8.4 8. 8 6. 8 6. 8 6.9 7. 3 7.4 7.6 7. 9 8. 0 8. 0 8. 0 8.2 8. 1 8. 1 8.4 6. 9 4.5 6. 9 '6.5 6.2 7. 1 4. 7 7. 2 6.9 6. 5 6. 9 4. 9 7. 3 6. 8 6. 9 7. 2 5.4 7. 9' 7. 3 7. 0 I 7. 5 5.6 8. 0 7.6 7. 2 7. 7 6. 0 8. 2 7. 7 7. 4 8. 0 6.4 8. 3 7.6 7.6 8. 1 6.6 8.2 7. 7 7. 7 8. 3 6. 9 8. 5 7. 7 7. 8 8.4 7. 0 8.8 7.9 8. 0 8.5 7. 0 9.0 7. 9 8. 1 8.5 9.0 7. 1 '7.4 9.0 9.2 8. 0 8.6 8. 2 8. 6 8.7 7.4 9.0 8.4 8. 4 1.7 1.6 1. 3 2. 3 1.6 1. 8 2.9 2. 1 I. 9 2, 2 o !)h4^oI B I O - T E S T Xa&onatotiei, 9nc. 11 B. Food Consumption Data Food consumption data are presented in Table IV. The amount of food consumed by test animals was essentially the same as untreated controls. ' DSW 036750 STLCOPCB4020574 Dtiduihlal B 1 O - T E S T lahona&yuel, 9hc. 12 Week 1 2 3 4 5 6 7 8 TABLE IV TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Food Consumption Data Sex: Group: Dietary Level (ppm): Mean Food Consumed During Week Indicated (g/kg of body weight) Males Females UC I II III UC I 11 III None * 10 100 None * 10 100 256 246 244 300 375 367 298 358 250 229 211 312 318 322 305 290 256 280 255 314 346 365 301 328 281. 250 250 288 321 328 334 337 29 2 '260 258 314 352 332 335 351 274 273 247 293 318 312 294 365 201 244 207 279 336 310 297 188 290 280 198 240 318 237 284 352 * 1 ppm Days 1-28, 300 ppm Days 29-90. DSW 036751 STLCOPCB4020575 9hAh,i1MoI B I O - T E S T JaUteivdM, 9*c. 13 TABLE IV continued TEST MATERIAL: Aroclorl221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Food Consumption Data Week Sex; Group: Dietary Level (ppm): Mean Food Consumed During Week Indicated (g/kg of body weight) Males Females UC l None * II III 10 100 UC I None * II III 10 100 9 214 238 204 347 321 2 94 269 300 10 264 267 282 235 270 268 268 241 11 287 227 272 255 304 277 278 305 12 280 235 274 281 345 271 296 308 13 I Mean 269 '202 262 198 263 248 243 273 340 238 300 286 328 302 296 308 # 1 ppm Days 1-28, 300 ppm Days 29-90. DSW 036752 STLCOPCB4020576 ^ndn^Ual B 1 O - T E S T lahonaivtiei, 9mc. 14 C. Reactions No untoward behavioral reactions were noted among any of the test animals. D. Mortality No fatalities occurred at any of the levels tested, E. Hematologic Studies The results of these determinations are presented in Tables V through IX. No significant abnormalities were noted at any of the levels tested. c o . DSW 036753 STLCOPCB4020577 ^iuLoiMal BI O - T E $ T Jlabo-'iai&ilcl; Due. 15 TABLE V TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Hematologic Studies: Total Leukocyte Count, thousands /mrn Group Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 UC None 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8-F 14. 0 19.6 18. 2 17. 2 23. 7 13. 0 25.9 23. 0 14. 5 19. 1 12. 8 21.2 19. 2 11. 9 27. 1 17. 9 . 10.9 10.6 15. 1 17.4 16.4 11. 2 19. 2 14.4 cI 1 9-M " 23. 6 17. 3 ' 13. 2 (Days 1-23) 10-M 19. 6 19.6 14. 8 300 11-M 20. 9 14. 8 11. 5 (Days 29-90) 12-M 18. 2 15. 8 14. 4 13- F 21.6 17. 9 13. 3 14 - F 21. 7 17. 2 17. 2 15- F 13. 5 15. 1 15. 8 16-F 21.5 14.4 18. 7 II 10 17-M 16. 3 18. 3 14. 8 18-M 16. 1 15.6 14. 2 19-M 18. 5 18. 7 13. 1 20- M 14. 9 12. 8 12. 4 21-F 17.4 12. 5 11.6 22- F 36. 5 16. 2 16. 5 23-F 21. 8 13. 5 15. 5 24- F 22. 8 12. 5 12.6 III 100 25-M 14. 8 12. 9 14. 8 26 - M 14. 0 14. 8 20. 1 27-M 28-M 29- F 12.9 15. 3 15. 2 12. 9 19. 5 14. 3 23.4 17. 3 15. 0 30- F 20. 1 16. 3 16. 2 31-F 29. 1 15.9 16. 7 32- F 13. 9 12. 0 11. 5 DSW 036754 STLCOPCB4020578 fnJuihkd B I O - T E S T la&Mat&u&i, 9hc. 16 TAB LE VI TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Hematologic Studies: Erythrocyte Count, millions /mm^ Group Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 UC None I1 (Days 1-28) 300 (Days 29-90) 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8-F 9-M ' 10-M 11-M 12-M 13-F 14- F 15- F 16- F 6. 49 5.66 5. 33 5.60 5.67 6. 21 6. 16 5. 95 6. 34 5. 84 5. 71 6. 12 6. 34 6. 12 5. 54 5. 62 6. 26 5. 13 5.49 5.69 6.60 6.68 6. 13 6. 32 5. 80 5. 6 1 5.49 5. 77 5.94 6.51 5. 75 5.69 5. 50 5. 50 5. 76 5. 77 6.49 6.77 6.41 6. 76 - 5. 52 5. 70 5. 52 5. 90 6. 08 6.49 5. 96 6. 36 II 10 17-M 5. 78 5. 92 6. 20 18-M 5.43 5. 58 6. 17 19-M t 6. 12 6.54 5.71 20-M 5.45 5. 72 5.42 21-F 6.37 6.58 6. 25 22- F 5.93 6. 03 6.54 23-F 5.87 6.49 6. 31 24-F 5. 89 6.62 6.83 III 100 25-M . 5.46 5.98 5. 75 26-M 5.48 5. 48 5. 15 27-M 5. 57 5.59 5. 38 28-M 5.44 6.45 5. 92 29-F 5. 78 6. 36 6. 13 O 00 in 30-F 5.47 6. 18 31-F 6. 22 7. 22 7. 16 32- F 6. 16 6.70 6.48 DSW 036755 STLCOPCB4020579 tyndwiiAial B10 - T E S T lalpyiatviieA., 9nc. 17 o TABLE VII TEST MATERIAL: Aroclorl221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Hematologic Studies: Hemoglobin, gm/100 ml Group Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 UC None 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8- F . 15. 7 14. 2 11.9 13.4 13. 2 14. 2 14.4 12. 8 14. 5 12. 3 12.6 13. 5 14.6 15.4 14. 7 14. 2 13. 3 12.9 12. 2 12. 9 14. 3 14. 8 15. 0 15. 2 I1 (Days 1-28} 300 (Days 29-90) , 9-M 10-M 11-M 12-M 13-F 14-F 15- F'. 16-F 00 CO r* 12. 8 14. 2 14. 0 14.4 13. 9 14. 0 13. 0 12. 3 13.2 13. 1 13. 2 13. 8 - 14.9 13. 2. 13. 0 13. 0 13.6 12. 7 13. 9 14. 0 14.4 13.8 13. 8 II 10 17-M 18-M 19-M 20-M 21-F 22- F 23-F 24-F 13.6 13. 0 13. 6 12. 3 15. 0 13. 8 14. 1 14. 0 13. 8 13. 5 14. 0 13.2 15. 0 13.6 15. 2 14. 9 13. 9 13. 7 13. 3 12. 5 13. 8 15.2 14. 9 15. 0 III 100 25-M 26-M 27-M 28-M 29- F 30-F 31-F 32-F 13. 2 13. 0 12. 7 11. 3 14. 0 13. 0 14.4 14.6 14.2 13. 3 12.9 13.6 14.9 13. 9 16. 1 15.5 13.6 12. 7 11.6 12.9 14.4 14. 0 16. 7 14.9 DSW 036756 STLCOPCB4020580 Dndiuiual B I O - T E S T JabrtaU>u&l, 9hc. 18 Group UC I II III TABLE VIII TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Hematologic Studies; Hematocrit, percent Dietary Level (ppm) Dog Number and Sex Days: . 0 45 90 None 1-M 46 43 37 2-M 38 35 36 3-M 36 36 38 4-M 39 39 39 5-F 39 44 43 6-F 43 46 46 7-F 42 44 45 8-F 38 42 46 1 (Days 1-28) 300 (Days 29-90) 9-M 10-M '' 11-M 12-M 13-F 14- F 15- F 16-F 37 40 40 41 40 41 38 36 35 36 38 - 38 38 38 38 39 39 41 44 43 39 41 38 41 10 17-M 40 40 42 18-M 38 39 40 19-M 39 42 39 20-M 36 38 36 21-F 43 44 42 22-F 41 41 43 23- F 42 46 44 24-F 41 45 46 100 25-M. 38 41 39 26-M 39 39 36 27-M 36 37 36 28-M 33 41 38 29-F 41 44 42 30-F 38 40 43 31-F 42 49 48 '32-F 42 45 44 DSW 03675? STLCOPCB4020581 ' $wtiUbUal B I O - T E S T lalmat&Uei, Due, 19 TABLE IX TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Hematologic Studies: Differential Leukocyte Count, percent - Neutrophils Group Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 UC None 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8-F 68 71 71 55 49 45 62 72 55 77 54 65 55 43 74 51 58 55 59 68 54 46 55 54 cI 1 (Days 1-28) 0 1 9-M 57 65 57 68 57 59 300 11-M 68 68 52 (Days 29-90) 12-M 59 37 57 13-F 42 56 56 14- F 77 61 55 15-F 49 58 53 16-F 50 6 5 65 II 10 17-M 67 63 63 18-M 63 66 62 19-M 76 51 52 20-M 55 63 58 21-F 63 49 60 22- F 50 41 56 23- F 66 59 58 24- F 60 60 77 III 100 25-M . 76 53 66 26-M 62 66 74 27-M 59 65 56 28-M 55 51 55 29-F 6 5 58 66 30-F 49 66 76 31-F 71 60 68 '32-F 55 49 60 osw 036758 STLCOPCB4020582 StifUui-Uial B I O - T E S T lalt&tedoMcl, hie. 20 ( c TABLE IX continued TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Hematologic Studies: Differential Leukocyte Count, percent - Lymphocytes Group Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 UC None I1 (Days 1-28} 300 (Days 29-90) t O 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8- F 9-M 1 l-M 12-M 13-F 14- F 15- F 16-F 32 23 25 41 49 54 36 20 37 27 29 36 52 19 49 44 39 34 17 35 36 34 31 23 38 39 49 49 22 40 40 39 32 ' 41 37 38 30 42 58 36 41 35 29 40 42 43 30 35 II 10 17-M 29 30 29 18-M 35 29 34 19-M 22 34 42 20-M 40 26 30 2 1-F 34 48 37 22- F 48 47 38 23- F 26 35 37 24-F 34 34 17 III 100 25-M 20 42 29 26-M 34 28 23 27-M 35 30 40 28-M . 34 40 38 29-F 30 39 30 30- F 49 30 23 31-F 24 35 26 '32-F 36 46 37 QSW 036759 STLCOPCB4020583 UtidMOiial B I O - T E S T lab&iatMieA; !)nc. 21 TABLE IX continued TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Hematologic Studies: Differential Leukocyte Count, percent - Monocytes Group Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 UC None 1 - MI 0 0 0 2-M 0 0 0 3-M 0 0 0 4-M 0 0 0 5-F 0 0 0 6-F 0 1 0 7-F 0 0 0 8-F . 0 0 0 I 1 9-M 0 0 0 ( (Days 1-28) 10-M 0 0 0 300 11-M 0 0 0 (Days 29-90) 12-M 0 0 0 13-F 0 0 0 14-F 0 0 0 15-F 0 0 0 16 -F 0 0 0 II 10 17-M 0 0 0 18-M 2 0 0 19-M 0 0 0 20-M 0 0 0 21-F 0 0 0 22- F 0 1 0 23- F 1 0 1 24-F 0 0 0 III 100 25-M 1 0 0 26-M 0 0 0 27-M 0 1 0 28-M 0 0 0 29-F 0 0 0 30- F 0 1 0 3 1-F 0 0 0 32- F 0 0 0 STLCOPCB4020584 ' Jtulwlfoial B I O - T E S T Xalmclvuei; Due. 22 TABLE IX continued TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Hematologic Studies: Differential Leukocyte Count, percent - Eosinophils Group Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 UC None I1 (Days 1-25) 300 (Days 29-90) 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8- F 9-M 10-M 11 -M 12 - M 13-F 14- F 15-F 16-F ' 0 6 4 4 2 0 2 8 6 3 3 5 6 4 2 6 6 6 10 4 7 7 3 9 8 10 7 9 7 5 5 7 3 "2 63 26 .5 7 39 10 5 04 50 II 10 17-M 4 7 8 18-M 0 5 4 19-M 1 15 6 20-M 5 11 12 21-F 3 3 3 22-F 2 10 6 23- F 6 6 4 24 -F 6 6 6 III 100 25-M 3 5 5 26-M 4 6 3 27-M 6 4 4 28-M 11 9 7 29- F 5 3 4 30- F 2 3 1 31-F 5 5 6 32- F 8 5 3 DSW 036761 STLCOPCB4020585 !)nduitnkil BI O ~ T E S T labytatoMei, 9hc. 23 TABLE IX continued TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Hematologic Studies: Differential Leukocyte Count, percent - Basophils Dog Dietary Number GroupLevel (ppm)and Sex Days; _______ 04590 UC None 1-M 0 0 0 2-M 0 0 0 3-M 0 0 0 4-M 0 0 0 5- F 0 0 0 6-F I 0 0 7-F 0 1 0 8- F 0 0 0 I 1 9-M 0 0 0 (Days 1-231 10-M 2 0 0 300 1 1-M 0 0 0 (Days 29-90) 12-M 0 0 0 13-F 0 0 0 14- F 0 0 0 15- F 0 0 0 16-F 0 0 0 II 10 17-M 0 00 18-M 0 00 19-M 1 0 0 20-M 0 0 0 21-F 0 0 0 22- F 0 1 0 23-F 1 0 0 24- F 0 0 0 III 100 25-M 2 6-M 27-M 28-M 29- F 30- F 31-F 32- F 0 0 0 0 0 0 0 1 00 00 00 00 00 00 00 00 DSW 036762 STLCOPCB4020586 ^(Liihicd B I O T E S T lalma&ni&t, 9nc. 24 F. Blood Chemistry Studies The results of these determinations are presented in Tables X through XIV. No significant abnormalities were noted at any of the levels tested. C DSW 036763 STLCOPCB4020587 .. !)H<LiPual B I O - T E S T lalxyiG&yiiat, 9m. 25 TABLE X TEST MATERIAL: Aroclorl221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Blood Chemistry Studies: Blood Urea Nitrogen mg/100 ml Group UC Dietary Level (ppm) None Dog Number and Sex 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8-F Days: 0 45 90 8 16 13 7 13 10 7 14 11 8 15 12 12 18 15 10 16 13 11 14 13 16 18 ` 14 I 1 9-M 8 19 16 (Days 1-23) 10-M 15 20 17 300 11-M 6 13 10 (Days 29-90) 12 - M 8 14 10 13-F 12 16 13 14-F 10 13 12 15- F 16 14 11 16 - F 9 14 13 II 10 17-M 11 14 14 18-M 8 10 11 19-M 8 12 10 20-M 8 17 13 21-F 14 20 17 22- F 11 14 12 23-F 8 11 12 24-F 10 13 10 III 100 25-M 7 8 9 26-M 8 10 17 27 - M 11 14 15 28-M 8 12 13 29-F 8 13 11 30- F 13 16 14 3 1-F 9 17 11 32-F 10 14 16 Nnfar Ool rv5 mr>f r i r. mr'llinrl liv Rneckelt and Gochman. DSW 036764 STLCOPCB4020588 Htvlipiliial- B I O - T E S T J.ab&'udtyiiM, 9tic. 26 TABLE XI TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Blood Chemistry Studies: Serum Glucose, mg/100 ml Group UC Dietary Level (ppm) None Dog Number and Sex 1-M 2-M 3-M 4-M 5-F 6- F 7-F 8-F Days: 0 45 90 114 97 99 108 91 97 109 83 101 121 103 104 97 157 92 96 85 92 101 91 102 107 104 . 1 12 I 1 9-M .. 1 12 95 109 (Days 1-2S) 10-M 115 104 ' 102 300 (Days 29-90) 11-M 12 - M 120 110 99 101 97 97 13-F 108 103 106 14-F 103 99 104 15-F 112 109 111 16-F 112 103 112 noII 10 17-M 103 109 18-M 102 79 104 19-M 114 95 86 20- M 101 77 93 21-F 108 91 106 22- F 102 85 97 23-F 108 108 109 24- F 109 104 121 III 100 25-M 122 104 115 26-M 116 106 118 27-M 109 85 101 28-M 114 111 104 29- F 126 108 111 30- F 105 103 117 31-F 32- F 113 no 77 112 79 97 Note: Colorimetric method by Roeckclt and Gochman. DSW 036765 STLCOPCB4020589 ^nduiiAid BIO-TEST JlaiuyiciiytieA, 9nc. 27 TABLE XII TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Blood Chemistry Studies; Serum Alkaline Phosphatase, King-Armstrong Units/100 ml Group Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 UC None 1- M 2-M 3- M 4-M 5-F 6- F 7-F 8-F 8. 2 5. 3 5.4 7. 3 7. 2 5. 4 5. 5 5. 1 5. 0 6. 9 6. 5 6. 5 7. 4 6. 2 4.6 6. 7 6. 2 6. 0 9.4 8. 5 . 6. 0 8. 5 7. 0 6. 2 I 1 9-M ' 7.9 4. 8 6. 0 (Days I-2ci 10-M 6. 0 5. 1 3. 8 30C 1 1-M 7. 0 5. 3 4. 0 (Days 29-90) 12-M 6. 2 5. 3 4. 6 13-F 8. 2 8. 0 6. 5 14- F 6. 8 5. 8 4. 4 15- F 12. 5 1 1. 1 9.4 16-F 12. 9 11.4 8. 4 II 10 17-M 10. 2 8. 5 7.6 18-M 19-M 9. 1 8. 0 9.5 8. 5 6. 2 7. 1 20- M 6. 3 4.4 4.6 21-F 6. 2 7. 2 5.4 22- F 6. 7 6. 0 5. 6 23-F 8. 8 8. 7 6. 7 24-F 11. 8 10. 5 8. 0 III 100 25-M . 10. 7 10. 3 14. 7 26-M 6. 9 6. 7 8.4 27-M 6. 0 4. 8 5.4 28-M 8. 0 7. 2 5. 8 29-F 10. 4 9. 2 10. 3 30-F 9. 5 8. 7 8. 7 31 - F 11. 0 4.4 7. 1 32-F 6. 5 7. 7 5. 0 DSW 036766 STLCOPCB4020590 Hkdtuiwd B l O - T E S T labyiaiyiiej., 9hc. 28 TABLE XIII ` TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Blood Chemistry Studies: Serum Glutamic-Oxalacetic Transaminase, Dade Units/ml Group Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 UC None 1-M 2-M 3-M 4-M 5-F 6-F 7- F 8-F 16 15 18 15 18 21 21 21 14 24 14 28 19 30 22 27 28 30 26 29 31 28 27 ' 32 I 1 9-M 23 19 - 32 (Days 1-28) 10 - M 17 15 16 300 11-M 20 16 15 (Days 29-90) 12-M 17 19 22 13 - F 23 30 28 14-F . 22 27 32 15-F 20 33 38 16- F 19 24 20 II 10 17-M 17 26 25 18-M 22 24 31 19-M 27 25 28 20 -M 22 17 27 2 1- F 16 25 23 22- F 21 23 25 23- F 25 28 28 24-F 23 24 21 III 100 25-M 15 22 25 26-M 21 24 28 27-M 21 22 21 28-M 22 31 36 29- F 21 24 31 30- F 19 27 22 31-F 19 17 33 32-F 18 24 27 .. 4 _ . IT 1 n ^ v! p <-i ( 11 /> rl T r* vwl win DSW 036767 STLCOPCB4020591 Jndu'il'jal BI O - T E S T 9hc. 29 TABLE XIV TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Blood Chemistry Studies: Serum Glutamic-Pyruvic Transaminase,. Dade Units/ml Group Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 UC None 1-M 30 29 25 2-M 16 14 26 3-M 26 24 21 4-M 34 41 41 5-F 30 53 31 6-F 23 37 29 7-F 18 23 . 20 8-F 40 29 56 \, rI 1 9-M 30 32 38 (Days 1-2S) 10-M 28 29 31 300 11-M 33 22 29 (Days 29-90) 12-M 20 17 52 13-F 32 38 38 14- F 35 32 35 15-F 28 39 29 16-F 18 25 24 11 10 17-M 26 30 25 18-M 21 21 25 19-M 32 22 27 20- M 27 30 38 21-F 34 39 39 22- F 31 35 38 23-F 24 30 37 24- F 30 39 42 III 100 25-M 23 27 31 26-M 26 30 36 27-M 30 30 25 28-M 28 43 38 29-F 31 4 1 46 30-F 24 42 43 31-F 17 39 33 '32-F 34 24 43 036768 osw STLCOPCB4020592 9>uLy'Mial B I O - T E S T laUnaimi^i, Unc. 30 G. Urine Analyses The results of the urine analyses are presented in Tables XV through XIX. No significant abnormalities were noted at any of the levels tested. \. ( DSW 036769 STLCOPCB4020593 Dtidu-ii/ual B IO - T E S T Ja-lwAa&yiiM, 9hc. 31 Group UC I II III TABLE XV TEST MATERIAL: Aroclorl221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Urine Analyses; Albumin, mg /100 ml Dietary Level (ppm) Dog Number and Sex Day s: 0 45 90 None 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8-F , 0 11-50 51-200 0 11-50 11-50 0 11-50 11-50 0 11-50 11-50 0 1-10 11-50 0 1-10 11-50 0 1-10 11-50 0 1-10 1-10 1 (Days 1-2S) 300 (Days 29-90) ' 9-M 10-M 11-M 12-M 13-F 14-F 15- F 16-F 0 1-10 1-10 0 11-50 11-50 0 1-10 1-10 0 1-10 11-50 0 1-10 . 11-50 0 0 11-50 0 0 1-10 0 0 1-10 10 17-M 0 1-10 1-10 18-M 0 1-10 11-50 19-M 0 1-10 11-50 20-M 0 1-10 11-50 21-F 0 0 0 22- F 0 0 1-10 23- F 0 0 1-10 24-F 0 1-10 1-10 100 25-M 0 1-10 1-10 26-M 0 1-10 1-10 27-M 0 1-10 0 28-M 0 1-10 1-10 29- F 0 1-10 1-10 30-F 0 1-10 1 - 10 31-F 0 1-10 1-10 32- F 0 1-10 1-10 DSW 036770 STLCOPCB4020594 B I O - T E S T laJxMi&u&i., 9hc. 32 Group UC I II III TABLE XVI TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Urine Analyses: Glucose, mg/ 100 ml Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 None 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8-F 0 0 0 0 0 0 0 0 00 00 00 00 00 00 0 0 00 1 9-M 0 0 0 (Days 1-2S) 10-M 0 0 0 300 11-M 0 0 0 (Days 29-90) 12-M 0 0 0 13-F 0 0 0 14-F 0 0 0 15-F 0 0 0 16-F 0 0 0 10 ' 17-M 0 0 0 18-M 0 0 0 19-M 0 0 0 20-M 0 0 0 2 1-F 0 0 0 22- F 0 0 0 23- F 0 0 0 24- F 0 0 0 100 25-M . 0 0 0 26-M 0 0 0 27-M 0 0 0 28-M 0 0 0 29-F 0 0 0 30- F 0 0 0 3 1-F 0 0 0 32- F 0 0 0 DSW 036771 STLCOPCB4020595 PriduilucU BI O - T E S T jtaluMai&ii&l, Dnc. 33 TABLE XVII TEST MATERIAL: Aroclorl22 1 90-Day Subacute Oral Toxicity Study - Beagle Dogs Urine Analyses: pH Group Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 UC None 1-M 7 8 9 2-M 7 7 9 3-M 7 7 9 4-M 6 7 9 5-F 6 8 8 6-F 7 8 9 7-F 7 7 9 8-F 7 7 8 I 1' 9-M ' 8 6 '6 ( (Days 1-2S) 300 10-M 7 8 6 11 - M 8 8 6 (Days 29-90) 12- M 6 8 9 13-F 7 8 9 14- F 6 8 8 15-F 6 8 8 16-F 8 8 8 II 10 . 17-M 6 7 6 18- M 8 7 8 19-M 6 9 9 20-M 6 9 9 21-F 6 7 6 22- F 8 8 7 23-F 6 8 6 24-F 6 8 6 III 100 25-M 6 8 9 26-M . 8 8 9 27-M 6 7 6 28-M 8 8 9 29- F 6 7 8 30- F 5 6 6 31-F 6 8 7 32- F 7 6 7 DSW 036772 STLCOPCB4020596 . . 9nduikial B l O - T E S T lalvyiaityiiei, 3tic. 34 Group UC I II III TABLE XVIII TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Urine Analyses: Specific Gravity Dietary Level (ppm) None 1 (Days 1- 2 ) 300 (Days 29-90) Dog Number and Sex 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8-F 9-M " 10-M 11 - M 12-M 13-F 14- F 15- F 16-F Days: 0 45 90 1. 005 1. 005 1. 032 1. 019 1. 012 1. 015 1. 019 1. 022 1. 038 1. 041 1. 045 1.010 1. 022 1. 026 1. 012 . 1. 032 1.019 1. 010 1. 022 1. 029 1. 022 1. 015 1. 019 1. 015 1.050 1. 032 1. 038 1. 012 1. 032 1. 026 1. 005 1.019 1. 050 1. 024 1. 052 1.015 1. 010 1. 007 1. 007 1. 012 ' 1.022 1. 029 1. 036 1. 024 1. 022 1. 012 1. 012 1. 022 10 17-M 1.024 1.019 1.019 18-M 1. 019 1. 024 1. 022 19-M 1. 026 1. 029 1.015 20-M 1. 022 1. 048 1. 015 21 - F 1. 032 1. 007 1. 015 22- F 23-F 1. 019 1. 032 1. 024 1.017 1. 019 1. 022 24- F 1. 034 1. 032 1. 019 100 25-M 1. 038 1. 007 1. 007 26-M L 024 1. 007 1. 012 27-M 1. 012 1. 007 1. 002 28-M 1. 026 1. 010 1. 002 29- F 1. 026 1. 015 1. 019 30- F 1. 017 1. 007 1. 015 3 1-F 1.048 1. 015 1.005 32- F 1. 038 1. 036 1. 005 DSW 036773 STLCOPCB4020597 Daditiliial BI O * T E S T Jahyuit/ytiei, 9no. 35 TABLE XIX TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Urine Analyses: Microscopic Elements, , average per high power field - Leukocytes Group Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 UC None 1-M 0 0 0 2-M 0 0 2 3-M 0 0 0 4-M 0 0 0 5-F 0 6-8 20 6-F 0 0 5 7-F 0 0 . 20 8-F 0 3-5 3 I 1 9-M 0 0 0 C (Days 1-2S) 10-M 0 0 0 300 11-M 0 0 2 (Days 29-90) 1 2-M 0 0 5 13-F 0 40-50 8 14- F 0 0 3 15- F 0 0 30 16-F 0 0 15 II 10 17-M 0 0 0 18-M 0 0 0 19-M 0 0 0 20-M 0 12-15 0 2 1 - F 0 3-4 0 22-F 0 40-50 8 23- F 0 12-15 0 24-F 0 6-8 20 III 100 25-M . 0 3-5 0 26-M 0 0 5 27-M 0 0 0 28-M 0 0 0 29- F 0 0 8 30- F 0 15-20 30 3 1-F 0 0 10 32-F 0 90-100 3 osw 036774 STLCOPCB4020598 yaduipual B I O - T E S T XaivyudoAi&i, 9nc. 36 Group UC I II III TABLE XIX continued TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Urine Analyses: Microscopic Elements average per high power field - Erythrocytes Dietary Level (ppm) Dog Number and Sex Days: 0 45 90 None 1-M 0 0 4 2-M 0 0 1 3-M 0 6-8 0 4-M 0 0 0 5-F 0 0 2 6-F 0 0 0 7-F 0 0 2 8-F 0 0 0 1 (Days 3-2?) 30G (Days 29-90) 9-M 10 - M 11-M 12-M 13-F 14- F 15- F 16-F ' 0 0 0 0 0 0 0 0 0 ' 50 00 00 00 00 00 02 00 10 17-M 0 0 0 18-M 0 0 0 19-M 0 0 0 20-M 0 0 0 2 1-F 0 0 0 22- F 0 0 0 23-F 0 0 0 24- F 0 0 8 100 25-M . 0 0 0 26-M 0 0 0 27-M 0 0 0 28- M 0 0 0 29-F 0 0 0 30-F 0 0 0 31-F 0 0 0 32-F 0 0 2 036775 STLCOPCB4020599 DtuiuliiiaL BIO-TEST JalwiaLyueA, Dnc. 37 Group UC I 11 III ' TABLE XIX continued TEST MATERIAL: Aroclor 122 1 90-Day Subacute Oral Toxicity Study - Beagle Dogs Urine Analyses: Microscopic Elements, average per high power field - Crystals Dietary Level (ppm) None Dog Number and Sex 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8-F Day s: 0 45 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1-3 4 1-3 1-3 1-3 1-3 . 1-3 1-3 90 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1 (Days 1-23} 3C0 (Days 29-90} 9-M 10-M 11 - M 12-M 13-F 14 - F 15-F 16-F ' 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1-3 ` 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1-3 1-3 10 17-M 1-3 1-3 1-3 18 - M 1-3 1-3 1-3 19-M 1-3 1-3 1-3 20-M 1-3 1-3 1-3 2 1-F 1-3 1-3 1-3 22- F 1-3 1-3 1-3 23-F 1-3 1-3 1-3 24- F 1-3 1-3 1-3 100 25-M 1-3 1-3 1-3 26-M 1-3 1-3 1-3 27-M 1-3 1-3 1-3 28-M 1-3 1-3 1-3 29- F 1-3 1-3 1-3 30-F 1-3 1-3 1-3 31-F 1-3 1-3 1-3 32-F 1-3 1-3 1-3 DSW 036776 STLCOPCB4020600 SnduiiAial B I O - T E S T JlohvuztoJueA, 9nc. 38 H. Pathologic Findings ! Organ Weight Data The organ weight data are presented in Tables XX through XXVIII. The organ to body weight ratios derived from these data fall within limits considered normal for the beagle. DSW 036777 STLCOPCB4020601 .. 9nJ,iUhUzL B I O - T E S T lal&iaiMiei-, Dhc. 39 TABLE XX TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Organ Weight Data: Liver Group UC Dietary Level (ppm) None Dog Number and Sex 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8- F Organ Weight (r) 318. 4 335.4 299.4 315. 0 278. 2 277. 8 211.7 234. 1 Organ/Body Weight Ratio (g/1000 g) 39. 8 36. 8 34. 8 29. 7 29. 9 33. 1 34. 1 32. 5 . I 1 9-M 328. 9 (Days 1-28) 10-M 455.4 300 11 - M 278. 8 (Days 29-90) 12-M 281. 2 13-F 259. 3 14 - F 330. 7 15- F 314. 9 16 -F 304. 8 43. 3 41.4 34. 8 32. 7 33. 2 32. 1 36. 6 39. 1 ' II 10 17-M 458. 3 18-M 244. 6 19-M 374. 8 20-M 342. 7 21 -F 280. 2 22- F 304. 9 23- F 296. 9 24-F 337. 9 38. 8 24. 7 30. 5 36. 8 36.4 34. 2 34. 5 38.4 III 100 25-M 306.9 26-M 245. 4 27- M 335. 8 28- M 403. 7 29-F 278. 2 30- F 254. 1 31 - F 250. 5 32- F 358. 9 32. 0 25. 6 32. 6 30.4 32. 0 34. 3 27. 8 42. 7 DSW 036778 STLCOPCB4020602 9nJy-+iUial B I 0 - T E S T la!to\aimiei; 9nc. 40 TABLE XXI TEST MATERIAL: Aroclor 122 1 90-Day Subacute Oral Toxicity Study - Beagle Dogs Organ Weight Data: Kidneys Group UC Dietary Level (ppm) None Dog Number and Sex 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8-F Organ Weight (g) 47. 3 46. 6 53. 0 56. 3 41.2 47. 1 33. 7 38. 2 Organ/Body Weight Ratio (E/1000 g) 5. 91 5. 12 6. 16 5.31 4. 43 5. 61 5. 44 5. 30 ' I* 1 (Days 1-28) 300 (Days 29-90) 9-M 10-M 11 - M 12-M 13-F 14 - F 15-F 16-F 4 3. 2 52. 9 42. 8 52. 8 36. 1 50. 2 48. 7 36. 2 5.68 4. 81 5. 35 6. 14 4.63 4. 87 5. 66 4.64 11 10 17-M . 61.9 18-M 53. 4 19-M 70. 3 20-M 50. 0 21-F 35.4 22-F 52. 8 23-F 48. 7 24-F 48. 7 5. 24 5. 39 5. 72 5. 38 4.60 5. 93 5.66 5. 53 III 100 25 -M 56. 9 26-M 48. 1 27-M 53. 5 28-M 72. 4 29-F 46.4 30-F 33. 7* 31-F 43. 3 32- F 46. 7 5. 93 5. 01 5. 19 5.44 5. 33 4. 55 4. 81 5. 56 DSW 036779 STLCOPCB4020603 DiuLtikial B i O T E S T labonaivueA, 9nc. 41 TABLE XXII TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Organ Weight Data: Heart Group UC Dietary Level (ppm) Hone Dog Number and Sex 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8-F Organ W eight (g) 68. 3 61. 5 56.6 79. 6 72. 8 69. 4 47. 7 54. 5 Organ/Body Weight Ratio (g/1000 g) 8. 54 6. 76 6. 58 7. 51 7. 83 8. 26 7.69 7. 57 ' I 1 9-M 53. 1 (Days 1-2S) 10-M 76. 7 300 11-M 53. 7 (Days 29-90) 12-M 59. 1 13-F 61. 4 14-F 90.4 15-F 54. 9 16 - F 54. 0 6. 99 6. 97 6. 71 6. 87 7. 87 8. 78 6. 38 6. 92 II 10 17-M 83. 8 18-M 77. 1 19-M 85. 5 20-M ' 76. 5 2 1-F 64. 9 22- F 82. 2 23- F 87. 9 24-F 71. 1 7. 10 7. 79 6.95 8. 22 8.43 9. 24 10. 2 8. 08 III 100 25-M 75. 1 26 -M 66..7 27-M 78. 2 28-M 105.4 29-F 72. 3 30-F 57.6 31-F 67.2 32-F 73. 3 7. 82 6.95 7. 59 7.92 8. 31 7. 78 7.47 8. 73 DSw 036780 STLCOPCB4020604 . findttikial B I O - T E $ T lalmcdvu&i, !)mc. 42 TABLE XXIII TEST MATERIAL: Aroclorl221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Organ Weight Data: Brain Group UC I Dietary Level (ppm) None 1 (Days 1-2S) 300 (Days 29-90) Dog Number and Sex 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8-F 9-M 10-M 11-M 12-M 13- F 14-F 15 - F 16-F Organ Weight (B) 69. 3 80. 5 74.6 75. 9 82.6 73. 3 64. 5 72. 1 74.4 79.4 68. 5 72. 5 66. 1 78. 3 63. 8 68. 7 Organ/Body Weight Ratio (g/1000 g) 8. 66 8. 85 8.67 7. 16 8. 88 8. 73 10.4 10. 0 9. 79 7. 22 8. 56 8. 43 8.47 7.60 7.42 8. 81 " II 10 17-M 75. 1 18-M 73. 9 19-M 93.4 20-M 77. 4 21-F 77. 0 22- F 73. 9 23- F 78. 2 24- F 67. 8 6. 36 7.46 7. 59 8. 32 10. 0 8. 30 9.09 7. 70 III 100 25-M 73. 1 26 -M 69. 7 27-M 71.6 28-M 81. 0 29-F 70.6 30-F 63. 8 31-F 72.4 32 - F 74. 2 7.61 7. 26 6.95 6. 09 8. 11 8.62 8. 04 8. 83 DSW 036781 STLCOPCB4020605 . 9ruuiiAial BI O - T E S T 9nc. 43 TABLE XXIV TEST MATERIAL: Aroclor 122 1 90-Day Subacute Oral Toxicity Study - Beagle Dogs Organ Weight Data: Spleen Group UC Dietary Level (ppm) None Dog Number and Sex 1 ~M 2-M 3-M 4-M 5-F 6-F 7- F 8- F Organ Weight (R) Organ/Body Weight Ratio (R/1000 g) 19. 2 27.4 17. 2 23. 6 23. 1 20. 0 15. 8 15. 3 2.40 3. 01 2. 00 2. 23 2. 48 2. 38 2. 55 2. 12 I 1 9-M 11.2 (Days 1-28) 10-M 17. 2 300 1 1-M 11.9 (Days 29-90: 12-M 18. 7 13-F 17. 2 14-F 25. 7 15- F 16. 3 16 - F 14. 8 1.47 1. 56 1. 49 2. 17 2. 20 2. 50 1.90 1. 90 . II 10 17-M 30. 2 18-M 26. 2 19-M 35.4 20-M 28. 1 21-F 19. 3 22- F 22.4 23-F 17. 9 24-F 21. 3 2. 56 2.65 2. 88 3. 02 2. 51 2. 52 2. 08 2.42 III 100 25-M 18. 0 26-M 15.2 27- M 14. 4 28-M 26. 3 29-F 15. 8 30 -F 17. 1 3 1-F 25. 2 32- F 18. 3 1. 87 1. 58 1. 40 1. 98 1. 82 2. 31 2. 80 2. 18 DSW 036782 STLCOPCB4020606 frubtil'Ual B I O - T E S T lalxviaiMieJ., 9m. 44 TABLE XXV TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Organ Weight Data: Gonads Group UC Dietary Level (ppm) None Dog Number and Sex 1 -M 2-M 3-M 4-M 5-F 6-F 7- F 8-F Organ V/ eight (S) Organ/Body I (g/1000 4.9 18. 2 4. 5 5. 8 0.627 0.486 0. 573 0. 460 0.612 2. 00 0. 523 0. 547 0. 0670 0.0570 0.0920 0. 0630 I 1 9-M 10.6 (Days 1-28) 10-M 24. 7 300 11-M 15. 7 (Days 29-90) 12-M 4. 5 13 - F 1. 145 14-F 0. 712 15-F 0.695 16-F 0. 648 1. 39 2. 24 1. 96 0. 523 0. 146 0. 0690 0.0800 0.0830 II 10 17-M 22. 0 1. 86 18-M 5. 0 0. 505 19-M 18. 6 1. 51 0 1 5. 2 0. 559 21-F 0. 708 0. 0910 22- F 0.657 0.0730 23-F 0. 74 2 0. 0860 24-F 0. 750 0.0850 III 100 25-M 5. 1 0. 531 26 -M 8. 0 0. 833 27-M 5. 2 0. 504 28-M 8. 7 0.654 29 -F 0. 713 0.0810 30- F 0. 56 1 0. 0620 3 1-F 0. 561 0.0620 32-F 0. 532 0. 0630 DSW 036783 STLCOPCB4020607 $Kdtiiinial B I O - T E S T XalmaitydeA, 9hc. 45 TABLE XXVI TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Organ Weight Data: Adrenal Glands Group UC Dietary Level (ppm) None Dog Number and Sex Organ Weight (g) 1 -M 2-M 3-M 4-M 5- F 6-F 7-F 8-F 1. 042 1. 110 0. 754 1.073 1. 188 1. 122 0. 831 0. 808 Organ/Body Weight Ratio (g/1000 g) 0. 130 0. 121 0.0870 0. 101 0. 127 0. 133 0. 134 0.112 I 1 9-M 1.098 (Days 1-28) 10-M 1. 060 300 11-M 1. 095 (Days 29-90) 12-M 0. 930 13-F 14 - F 0. 9U 1. 333 15- F 1. 073 16-F 0. 930 o' 0. 0960 0. 136 0. 108 0. 116 0. 129 0. 124 0. 119 11 10 17-M 1. 293 0. 109 18-M 1. 056 0. 106 19-M 1. 180 0.0950 20-M 0. 868 0.0930 21-F 1. 040 0. 135 22- F 1. 268 0. 142 23-F 0. 898 0. 104 24-F 1. 159 0. 131 III 100 25 -M 1. 278 0. 133 26 - M 1. 167 0. 121 27-M 1.043 0. 101 28-M 1. 150 0. 0860 29-F 1. 024 0.117 30-F 0. 834 0. 112 31-F 0. 974 0. 108 32-F 0.902 0. 107 DSW 036784 STLCOPCB4020608 ^nJluilAial BIO-TEST J^akyiaityiiei-, 9nc. 46 TABLE XXVII TEST MATERIAL: Aroclor 1221 Group UC 90-Day Subacute Oral Toxicity Study - Beagle Dogs Organ Weight Data: Thyroid Gland Dietary Level (ppm) None Dog Organ Number Weight and Sex ......(ft) Organ/Body I (g/1000 1 -M 2-M 3-M 4-M 5-F 6-F 7-F 8-F 1. 017 0. 894 0. 768 1.438 0. 782 1.082 0. 870 0,663 0. 127 0.0980 0.0890 0. 135 0.0840 0. 128 0. 140 0.0920 I 1 9-M 0. 836 (Days 1-2$) 10-M 1. 028 300 11 - M 1. 293 (Days 29-90) 12-M 0. 902 13-F 0. 640 14-F 0. 883 15-F 0. 903 16-F 1. 062 0. 109 0.0930 0. 161 0. 104 0.0820 0.0850 0. 104 0. 136 II 10 17-M . 1.630 0. 138 18-M 0.937 0. 0940 19-M 0.690 0. 0560 20-M 0. 888 0.0950 21-F 0. 749 0.0970 22 - F 1. 082 0. 121 23- F 0. 809 0.0940 24-F 0. 807 0.0910 III 100 25-M 1. 727 0. 179 26-M 0.953 0. 0990 27-M 1. 330 0. 129 28-M 1.222 0.0910 29-F 0.680 0. 0780 30-F 0. 770 0. 104 3 1-F 0. 967 0. 107 32-F 1. 221 0. 145 DSW 036785 STLCOPCB4020609 induikial B J O - T E S T laUwkntei, 9hc. 47 TABLE XXVIII TEST MATERIAL: Aroclor 1221 90-Day Subacute Ora] Toxicity Stanly - Beagle Dogs Organ Weight Data; Pituitary Gland Group UC Dietary Level (ppm) None Dog Number and Sex Organ Weight Organ/Body Weight Ratio (g)______________(g/1000 g)____________ 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8-F 0. 087 0. 106 0. 093 0. 063 0. 080 0. 095 0. 062 0. 073 0. 0100 0.0116 0.0108 0.00594 0.00860 0.01 13 0. 0100 0.0101 I 1 9-M 0. 033 (Days 1-28] 10-M 0. 095 300 11-M 0. 082 (Days 29-90) 12-M 0. 107 13-F 0. 084 14- F 0. 067 15-F 0. 060 16-F 0. 073 0.00434 0.00864 0.0102 0.0124 0.0108 0. 00650 0. 00698 0.00936 II 10 17-M 0. 084 0.00712 18-M 0. 103 0.0104 19-M 0. 113 0.009 19 20-M 0. 083 0,00892 2 1-F 0. 120 0.0156 22- F 0. 072 0.00809 23 - F 0. 082 0.00953 24-F 0. 092 0.0104 III 100 25-M 0. 090 0.00938 26-M 0. 078 0.00812 27-M 0. 063 0.006 12 28-M 0. 092 0.00692 29- F 0. 073 0.00839 30- F 0. 068 0.00919 31-F 0. 038 0.00422 32- F 0.083 0.00988 DSW 036786 STLCOPCB4020610 fhiduihial B I O - T E S T laluyiaityuei, 9hc. 48 Z. Gross and Histologic Findings The gross and histologic findings are presented in Tables XXIX through XXXII. All tissues and organs not mentioned were normal. The grading system used is as follows: 4 = minimal/trace 44 = mild 444 = moderate 4444 = severe DSW 036787 STLCOPCB4020611 2'tiditikid B I O - T E S T laluyudfr-uel, 9m. 49 IBT No. C9885 Monsanto December 11, 1971 I have completed a histopathologic evaluation of a series of dog tissues from IBT No. C9885. There are no changes which can be attributed to the compound. The lesions described arc those of spon taneous disease and are not compound related. The bladder hyperplasia was mild, was associated with focal cystitis and was found in only one animal. There was no evidence of bladder hyperplasia in any of the other animals. Ward R. Richter, D. V. M. , M. S. Diplomate, American College of Veterinary Pathologists ( c . DSN 036788 STLCOPCB4020612 0SnduAbdal B I - T ES T lalfMaivOU, 9w. DSW 0 3 6 7 8 9 oo Dog Number and Sex 1-M 2-M 3-M 4-M 5-F 6-F 7-F 8-F Organ Kidney Liver Spleen 'Lung s Kidney Liver - TABLE XXIX TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Gross and Histologic Findings Untreated Control Group Gross - Petechiae - " -- Grade - - 4-4-4* - -- Histologic Grade Proteinaceous tubular 4 casts Focal congestion + Siderofibrotic nodules + Focal hemorrhages + Focal interstitial 4 lymphocytic infiltration -- Focal sinusoidal + infiltrations of lymphoidal cells ** <_n O wc `varwfvwfoj- j. s 3 - O I 9 I oo TABLE XXX TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity Study - Beagle Dogs Gross and Histologic Findings Test Group I: 1 pprn (Days 1-28), 300 ppm (Days 29-90) Dog Number and Sex_______ OrganGrossGradeHistologicGrade 9-M 10 -M 11 -M 1Z-M 13-F 14-F 15-F 16-F - Lungs .-- - Urinary bladder - Lung s - . Peribronchiole lymphoid infiltration + Hyperplasia, focal cystitis Focal interstitial pneumonia -f+ o 0~I Sl o* OJ O' -o vO o Ul STLCOPCB4020614 91 nduitual B I 0 - T ES T lalatotviiai., 9hc. STLCOPCB4020615 o Dog Number and Sex 17-M 18 -M 19 -M 20 -M 21 -F 22 -F 23 -F 24-F Organ - Liver Brain - Lung s TABLE XXXI TEST MATERIAL: Aroclor 1221 90-Day Subacute Oral Toxicity .Study - Beagle Dogs Gross and Histologic Findings Test Group II: 10 ppm ' o Gross . -` - - - - Grade - * - -. - - . Histologic Grade - Centrolobular hypertrophy Focal hemorrhage - terminal artifact - - - Focal interstitial pneumonia - + - + o in o IP O' "-J SO k cn >r is a i- o i8 p m , Dog Number and Sex 25-M 26 -M 27-M 28-M 29-F 30 -F 31-F 32 -F Organ Liver , Liver - TABLE XXXII TEST MATERIAL: Aroclor 1221 90-Day Subacute Or;d Toxicity Study - Beagle Dogs Gross and Histologic Findings Test Group HI: 100 ppm Gross -' - -- * Grade . - - - -- - Histologic Grade Focal lymphoid infiltration Bile duct hyperplasia with lymphoid infiltration - - + - DSW 0 3 6 7 9 2 U1 U>