Document 2NNN6GKONbd0ezNzbge4O0bn7

.... no. kYl ')/-C ? REPORT FiLE ~ k* ' - ~ ' 9tv$u&Oual BIO -TEST J}<zl)<>>icUo-'iie&, J)+i$. 1010 FRONTAGE ROAD NORTHBROOK. ILLINOIS 60062 V .^ REPORT TO MONSANTO COMPANY TWO-YEAR CHRONIC ORAL TOXICITY WITH . AROCLOR 1251 CP?8$*S IN ALBINO RATS NOVEMBER 12, 1971 IBT NO. B7298 t | i i j DSW 036029 * *s* STLCOPCB4019853 JtvfoiMxd BIO - T E S T 1810 FRONTAGE ROAD NORTHBROOK. ILLINOIS 60062 3nc. November 12, 1971 Mr. Elmer P. Wheeler Monsanto Company 800 North Lindbergh Boulevard St. Louis, Missouri 63166 Dear Mr. Wheeler: Re: IBT No. B7293 - Two-Year Chronic Oral Toxicity Study with Aroclor 1254 in Albino Rats We are submitting herewith our laboratory report dated November 12, 1971, prepared in connection with the above study. Very truly yours JCC/kjl J. C. Calandra President DSw 036030 STLCOPCB4019854 BIOTEST %:c. REPORT TO MONSANTO COMPANY TWO-YEAR CHRONIC ORAL TOXICITY WITH AROCLOR 1254 IN ALBINO RATS NOVEMBER 12, 1971 IBT NO. B7298 I. Introduction ' At the request of Monsanto Company, a two-year chronic oral . toxicity study was conducted using albino rats to determine the potential toxicity of Aroclor 1254, Lot No, AK-38. The following report represents the results of this investigation. DSW 036031 STLCOPCB4019855 Di'Juitual' B 1 O -JT E s T Xakyiat&ues, Sue. Z il. Summary A two-year chronic toxicity study was conducted using albino rats fed diets containing 1 (T-I), JO (T-II) or 100 (T-III) ppm Aroclor 1Z54. Food consuniption was not altered in any test group. Body weight gains of test and control animals did not differ after 3 or 1 2 months of testing. After 24 months females fed 100 ppm Aroclor 1254 had gained less weight than the control females. Weight gains of the male rats did not differ from the controls. The number of animals dying and the time at which death occurred did not differ among test and control groups. Hematological and clinical blood chemistry studies conducted after 3, 6, 9, 12, 18, or 24 months did not reveal any affects related to Aroclor 1254. Urine analyses failed to reveal any difference between test and control rats. . , I At sacrifice after 3, 6, or 12 months on test, organ weights, organ to body weight and organ to brain weight ratios disclosed several randomly occurring intergroup differences. The lack of any consistent dose related response and the absence of any deleterious histopathologic change confirm that these differences were not related to the ingestion of Aroclor 1254. i At the final sacrifice after 24 months on test, the absolute liver weight i and liver to body weight or brain weight ratios were significantly elevated i in both T-III males and females. Histologic examinations of the livers I .. i from the T-III group revealed several animals with vacuolar change. DSW 036032 4 STLCOPCB4019856 B 1 0 - T E S T lakyiai&uci, 9*t&. 3 This lesion is morphologically indicative of fatty degeneration. Specific fat stains confirmed the presence of fat in these vacuoles. Focal hypertrophy and focal hyperplasia were also found in the livers from animals fed Aroclor 1254. Hyperplasia of the urinary bladder was found in animals from the control group and from each of the test groups. This hyperplasia was usually associated with cystitis. None of the tumors found could be related to the ingestion of Aroclor 1254 and are considered normal for a random population of rats this age. Respectfully submitted, INDUSTRIAL BIO-TEST LABORATORIES, INC. Report prepared by: Philips.'. Smith, B. S. Assistant Toxicologist Rat Toxicity Report approved by: Jam B. Plank SeennVV, Group Leader Rat Toxicity Paul L. Wright, Ph. D. Section Head, Toxicology M. L. Kcplnirru r, Ph Manager, Toxicology November 12, 1971 bb: hp OSW 036033 STLCOPCB4019857 huh;dual B I O - T E S T Jah>iaiyiicd, jW 4 9~ III. Procedure A. Experimental Animals The animals employed in the test were Charles River Strain* albino rats. Four hundred rats (200 male and 200 female) were selected for the experiment, ear-punched with the animal number assigned and housed individually in standard wire-bottomed steel rat cages. Each cage bore a color-coded card identifying the rat with respect to project number, dietary level assignment, individual number and sex. B- Organization of Groups A structural outline of the experiment is given in Table I. TABLE I TEST MATERIAL: Aroclor 1254 O .................... ,,. ' Two-Year Chronic Oral Toxicity Study - Albino Rats Outline of Experiment Group Number of Animals Male F emales Dietary Level (ppm) Control T-I 50 50 None Administered / 50 50 1 T-II 50 50 10 T-III 50 50 100 * Charles River Breeding Laboratories, North Wilmington, Mass. 9 DSW 036034 STLCOPCB4019858 jjudniMici B 1 O - T E S T Xahyiat&'iici, 9nc. 5C C. Diets, Feeding and Food Consumption ' All diets were prepared in the central diet room of this laboratory. The basic ration from which all diets were constructed was a standard, pulverized stock rat ration*. The diet for any given test group was prepared by blending the calculated amount of Aroclor 1254 with a pre-weighed portion of the stock ration in a Hobart mixer. Fresh diets were prepared each week and every rat was offered an amount of food sufficient for ad libitum feeding. Food consumption was recorded for five rats of each sex in every group weekly for the first three months and monthly for the next nine months. Thereafter, periodic spot checks were made. . D. Body Weights and Weight Gains Initially, the body weight of each rat in every group was determined and recorded. Thereafter, individual weighings were made weekly t for the first 13 weeks and monthly thereafter until the conclusion of the ' investigation. E. Mortality and Reactions , Checks for mortality and abnormal behavioral reactions were made daily throughout the investigation. ; F. Hematologic Studies and Urine Analyses i Blood studies, including determinations of hemoglobin concentra tion, hematocrit value, erythrocyte count and both total and differential * Purina Rat Chow, Ralston Purina Co. St. Louis. Mo. DSW 036035 STLCOPCB4019859 B I O - T c S T Jahyiat&'uM, Due. 6 leukocyte counts, were conducted upon five males and five females from both the control and 100 ppm groups. Urine analyses for the presence of glucose, albumin, micro scopic elements, and determinations of pi I and specific gravity were con ducted upon urine samples at the same time intervals and from the same animals as those employed for the blood studies. These studies were conducted after 3, 6, 9, 12, 18, and 24 months of feeding. G. Clinical Blood Chemistry Studies Determinations of blood urea nitrogen concentration (BUN), serum alkaline phosphatase activity (SAP), fasted blood glucose concen tration and serum glutamic-pyruvic transaminase activity (SGPT) were conducted after 3, 6, 9, 12, 18, and 24 months of feeding upon the same rats as were the routine blood studies. H. Pathologic Studies When an animal succumbed during the test period, a gross autopsy was performed. In those case when postmortem autolysis was not ad vanced, representative tissues were taken and preserved in ten percent formalin solution for possible future histopathologic study. After 3, 6, and 12 months of testing, five animals of each sex from each group were sacrificed and subjected to complete gross pathologic examinations. Absolute organ weights were recorded and organ to body weight and organ to brain weight ratios computed. The following organs were DSN 036036 STLCOPCB4019860 ' Utidaihuil B I O * T E S T la&tviaioMeS, 9*tc. I included: liver, kidneys, spleen, gonads, heart and brain. These data were then subjected to statistical analysis. An Analysis of Variance was conducted first and significant effects disclosed by that treatment were further studies by "t"-tests. Complete microscopic examinations were conducted upon the tissues and organs from all control and 100 ppm group animals sacrificed after 3, 6, or 12 months of testing. The following tissues and organs were included in the examinations: heart, trachea, lungs, liver, pancreas, esophagus, stomach, small intestine (duodenum, jejunum and ileum), caecum, colon, spleen, lymph nodes, kidneys, urinary bladder, gonads, prostate gland, seminal vesicles, uterus, pituitary gland, adrenal glands, salivary glands, thyroid gland, parathyroid glands, skeletal muscle, sternum, bone, peripheral nerve, spinal cord'and brain (cerebrum, cerebellum and pons). The aforementioned tissues were prepared and stained with Hematoxylin-Eosin stain. After two years of feeding, all surviving animals were sacrificed and subjected to complete gross pathologic examination. The absolute weights of the liver, kidneys, spleen, gonads, heart and brain were recorded immediately after sacrifice. Microscopic examinations were conducted upon tissues and organs from selected animals dying during the experiment and upon all animals from the final sacrifice. OSW 036037 STLCOPCB4019861 SaJuii'ual B I O - T E S T lulpyiala lic.i, !)nc. 8 Tissues and organs examined were the same as those previouslymentioned. I, Tumor Incidence and Classification A tabulation of the incidence of tumor formation in each group was made at the conclusion of the investigation. In addition, tumor data for individual animals including location, weight, size and pathologic classification were recorded. 1 DSW 036038 STLCOPCB4019862 B I O - T fc b I lalmaklicl, `Jnc. IV. Results A. Body Weights and Weight Gains The male and female body weight data are assembled in Table II. The data in this table also include the 3, 12 and 24 month total weight gains. ^t G O DSW 036039 STLCOPCB4019863  . Dietary Level of Aroclor 1254 (ppm) Sex Control M F 1M F 10 M F 100 M F # TABLE II TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Body Weight and Total Weight Gain Data Summary of Mean Values Body Weight (grams) Week: 0 1 2 3 4 5 6 7 8 9 10 11 12 13 133 203 245 313 362 373 391 409 424 440 440 449 467 474 136 1T8 190 219 244 254 259 265 270 276 281 278 290 288 133 206 253 322 364 373 396 425 ' 436 457 470 483 490 509 136 171 190 213 235 246 248 250 259 270 270 274 279 285 133 209 251 325 375 394 402 410 432 453 470 488 494 508 136 171 194 220 243 263 289 293 281 272 276 274 280 288 133 207 260 324 365 375 295 419 428 440 450 469 480 486 136 174 197 223 242 254 276 290 281 268 270 274 277 280 90-Day Total Weight Gain (grams /rat) 341 152 376 149 376 152 ' 353 144 STLCOPCB4019864 IDTS ar o OJ O' o -p o < Dietary Level of Aroclor 1254 (pnm) Sex Control M F 1M F ' 10 M F 100 M F 4 498' 297 522 289 529 300 495 29 2 TABLE II continued TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Body Weight and Total Weight Gain Data Summary of Mean Values 56 Body Weight (grams) Month: 7 8 9 10 11 533 565 593 622 642 667 688 310 322 333 345 359 374 383 550 581 604 633. 658 680 715 295 307 322 333 340 354 367 567 593 . 621 642 667 681 ' 700 308 321 330 341 354 367 380 521 541 562 586 608 627 642 300 306 316 321 326 332 340 12-Month Total Weight Gain 12 (grams/rat) 701 568 390 254 725 592 380 244 726 593 392 256 664 531 347 211 STLCOPCB4019865 o O1'! V CUJ O' o * QO Dietary Level of Aroclor 1254 (ppm) Sex Control M F 1M F 10 M F 100 M F * TABLE II continued TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rata Body Weight and Total Weight Gain Data Summary of Mean Values 13 14 15 16 Body Weight . 24-Month (grams) Total Weight Month: Gain 17 18 19 20 21 22 23 24 (grams/rat) 728 746 759 768 769 767 760 758 739 726 687 642 426 444 466 481 500 515 533 547 551 550 564 551 509 415 760 780 807 800 802 795 786 769 750 728 715 656 401 426 ' 476 483 493 510 521 532 537 542 553 540 746 774 824 780 804 ' 826 823 821 813 800 767 762 421 433 485 466 475 481 485 492 298 . 500 471 500 523 404 629 364 688 714 735 730 733 726 716 700 685 652 628 656 360 367 392 374 381 394 393 398 401 400 395 411 523 275** Statistically significant at the 99 percent confidence limit. STLCOPCB4019866 O, % O Os V B. Food Consumption The data obtained from the food consumption measurements conducted during the first 12 months of feeding are summarized in Table HI. These data revealed no significant difference between test and control rats. The periodic checks conducted during the remainder of the investigation also revealed no outstanding differences between test and control animals. DSW 036043 STLCOPCB4019867 B I O * T E S T laluyiatyiici, 'Jttc. TABLE III TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Food Consumption Data Summary of Mean Values Food Consumption Dietary Level of (grams/rat/seven days) Average Food Aroclor 1254 Week: Consumption Vs fep:n) Sex 1 2 3 4 5 6 7 8 9 10 11 12 13 (grams/rat/seven davsl^ Control M 94 160 175 163 137 137 225 197 204 188 191 194 196 F 73 140 144 107 104 133 208 154 165 151 146 150 151 174 140 1 M 112 148 156 168 148 214 160 193 218 186 184 187 189 F 87 117 108 U8 113 203 105 137 149 144 144 147 146 174 132 10 M 116 139 148 164 163 221 201 199 216 191 192 200 199 F 90 109 107 114 121 193 159 134 144 150 151 152 149 181 ' 136 100 M 116 172 163 185 231 185 189 198 185 197 189 189 121 F 89 141 98 129 129 190 .146 146 145 139 137 146 . 193 187 152 o ac * 6 ; 5 1 la b iy .a to -ti& i, lin e . STLCOPCB4019869 Dietary Level of Aroclor 1254 1 ~>pm) Sex Control M F 1M F 10 M F 100 M -F 4 196 148 189 141 190 139 179 148 TABLE III continued TEST MATERIAL: Aroclor 1254 ' Two-Year Chronic Oral Toxicity Study - Albino Rata Food Consumption Data Summary of Mean Values Food Consumption (grams/rat/seven days) Month: 5 6 7 8 9 10 11 12 189 168 147 163 184 179 170 187 154 136 121 138 152 160 141 127 181 184 198 190 1 90 197 152 190 159 147 162 145 150 151 123 126 191 189 196 190 188 191 186 163 138 148 148 150 145 138 142 149 168 190 179 187 182 197 180 188 141 144 162 163 151 148 141 137 . Average Food Consumption (grams/rat/seven days) 176 142 186 145 187 144 183 148 '{ E2 C c CsO: Ou U1 O' o 4U-i V ,N C. Mortality and Reactions A frequency distribution of natural deaths occurring during the investigation appears in Table IV. No untoward behavioral reactions were noted among any of the animals employed in the investigation. Q QSW 036046 STLCOPCB4019870 O vmTMwvnr a 9 , a I n *>// Dietary Level (ppm) Sex Control M F TM F 10 M F 100 M F TABLE IV TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Mortality Data Frequency Distribution of Deaths* Frequency Distribution of Deaths Months: 1-3 4-6 7-9 10-12 13-15 16-18 19-21 000 2 1 7 6 000 1 3 5 7 000 2 5 6 8 200 1 2 1 5 0 O' 0 1 3 5 8 011 4 2 3 4 00 1 3 2 5 7 102 4 4 2 4 22-24 9 3 9 3 10 7 9 6 Total Dead Number Te 25/35 19/35 30/35 14/35 27/35 22/35 27/35 23/35 * Does not include the five animals of each sex from every group sacrificed for interim pathologic studies. 00 z, o Oc' STLCOPCB4019871 t ) B l O * T C S ( JaMoialoiiei, Dhc, *7 18 D, Hematologic and Clinical Blood Chemistry Studies Mean male and female hematologic and clinical blood chemistry- data are summarized in Tables V through IX. Values for all parameters investigated were within the normal range for the albino rat. No significant differences between test and control values were observed. . DSW 036048 STLCOPCB4019872 CO CO STLCOPCB4019873 oo Dietary Level (pom) Control Sex M F TABLE V ' TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Hematologic Data Summary of Mean Values Total Leukocyte Count Erythrocyte Count (thousands /mm^) (millions /mm^) Month: Month: 3 6 9 12 18 24 3 6 9 12 18 14.0 15.4 10. 1 11. 1 9.9 11. 2 8. 1 8.2 8.7 8. 8 7.6 9. 1 9.4 6. 7 7.6 7.6 7.5 7. 7 7.3 . 7. 8 7, 7 24 6.5 6. 8 M 15. 1 15. 2 10.9 11.0 9.8 10. 2 7.5 7. 7 8. 1 7.7 8.0 8.0 100 F 11.6 12. 2 7.3 8. 7 6.6 11. 8 7.5 7.6 7. 7 6.9 7. 3 6. 4 o (/> Si a oj O' o vO ti I < t < i ! % STLCOPCB4019874 Dietary Level (com) Control Sex M F TABLE VI TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Hematologic Data Summary of Mean Values Hemoglobin Concentration (g/100 ml) Month: 3 6 9 12 18 24 3 17. 1 17. 7 15. 7 17.6 16. 1 13.6 51 16. 9 17.4 14. 1 16. 7 16.4 14.6 50 Hematocrit Value (%> Month: 6 9 12 18 ___ Zl 49 48 50 41 35 47 43 . 46 42 38 M 15.6 17. 6 13. 8 15.6 15. 7 15.3 47 47 42 44 41 40 100 F 16. 5 17. 8 13. 9 14.5 14.5 12. 7 48 47 42 . 40 37 32 D </> a: o U) 0oU1 o tt % H a B^ "1 9 | (1 STLCOPCB4019875 9O TABLE VII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Hematologic Data . . Summary of Mean Values Dietary Level (pnm) Sex 3 Differential Leukocyte Count (Number of Cells per Hundred) Lymphocytes Neutrophils Month: Month: 6 9 12 18 24 3 6 9 12 18 24 M 82.0 86. 6 80. 4 78. 8 79.0 65. 4 16. 0 11. 4 18. 6 20. 6 20. 0 32. 2 Control F 83.0 86.6 86. 8 89.0 70.2 61.4 15.4 11. 6 11. 8 - 10.0 29. 2 36.0 M 88. 2 79.6 85.8 85.2 69. 8 68.0 10. 8 20. 2 18. 8 14.2 29.0 30.2 100 F 92.2 92.0 79.6 84.6 79.0 61.0 7.4 7. 8 20.2 15.0 20.4 37.6 o 00 sc o UO)' oU1 l *rn> lttfpUK C . t J ` 1 O i TABLE VII continued TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Hematologic Data Summary of Mean Values Dietary Level (com) Sex 3 Differential Leukocyte Count (Number of Cells per Hundred) Monocytes Eosinophils Month: Month: 6 9 12 18 24 3 6 9 12 18 M 0.6 0. 0 0.0 0. 4 0. 2 1.2 1.4 2.0 1.0 0. 2 0.8 Control F 0.6 0. 0 0.0 0.0 0. 2 1.0 1. 0 1. 8 1.4 0. 2 0.6 24 1.6 1.6 o o o o o STLCOPCB4019876 100 o</0 s o U) OoU1' ho M 0.0 0. 0 0.0 0.0 0.0 0. 8 1.0 0. 2 0.4 0. 6 1.2 1.0 F 0.0 0. 0 1.0 0.4 0. 2 0.2 0.4 0.6 0.4 o o o o DSW 0 3 6 0 5 3 o Dietary Level (pom) Control Sex M F M 100 F o TABLE VII continued TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Hematologic Data Summary of Mean Values Differential Leukocyte Count (Number of Cells per Hundred) Basophils Month: 3 6 9 12 18 0.0 0. 0 0. 0 0. 0 0.0 0.0 0.0 0.0 0.0 24 0.0 o o o o 0.0 0.0 ' 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 STLCOPCB4019878 TABLE VIII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Hematologic Data Summary of Mean Values Dietary Level (ppm) Sex 3 Serum Glutamic-Pyruvic Transaminase Activity (Dade Units) Month: 6 9 12 18 24 3 Blood Urea Nitrogen Concentration (mgs %) Month: 6 9 12 18 M 38 48 45 45 42 36 17 15 12 10 14 Control F 33 39 38 42 32 30 14 16 15 9 13 24 15 11 M 33 32 43 ' 50 38 41 14 15 13 12 11 15 100 F 32 46 49 61 46 78 16 15 13 14 13 15 c cs/c> o OJ 0" o ui pw/f 'fm w vw qvT 3 I O H IK r 4 ( 5 O Dietary Level (ppm) Sex Control M F TABLE IX TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Hematologic Data Summary of Mean Values Fasted Blood Glucose Serum Alkaline Phosphatase Concentration Activity (mgs %) (King-Armstrong Units) Month; Month: 3 6 9 12 18 24 3 6 9 12 18 24 128 123 89 88 138 99 28.6 24. 7 21. 5 20. 3 16. 2 22.3 130 118 115 92 134 109 18.9 17. 8 10.6 11.9 16. 8 20. 2 M 109 113 129 128 124 115 35.4 23. 2 27.4 27. 1 14.6 23.5' 100 F 120 107 124 113 132 107 17. 1 18. 1 19. 3 16. 7 10.0 21.6 DSW 0 3 6 0 5 5 Snduliiial B l O * T E S T XabyiatoMel, 9hc. 26 E. Urine Analyses Mean male and female urine analyses data are summarized in Tables X through XII. No differences were noted between the urine from control and test animals at the intervals of examination. * 4 OSW 036056 STLCOPCB4019880 STLCOPCB4019881 o TABLE X TEST MATERIAL: Aroclor 1254 . Two-Year Chronic Oral Toxicity Study - Albino Rata Urine Analyses Data Summary of Mean Values Dietary Glucose A lbumin Level Month: Month: (ppm) Sex 3 6 9 12 18 24 3 6 9 12 18 24 Mn n n n n nn n t t +2 +3 Control F n ' n n n ' n n n n n n t +2 M n n n n n n n n t t t +2 100 F n n n n n n n n t t t +3 Key: o n = negative sc t = trace; less than 30 mg/100 ml urine +1 = 30 to 100 mg/ 100 ml urine 2 +2 = 100 to 300 mg/100 ml urine q +3 = 300 to 500 mg/100 ml urine ^ +4 = more than 500 mg/100 ml urine 1 i -pw/- 1 5 ^ 1 -0 1 9 n < fru tu iltia l B I O * T E 5 T Ja&yiato-iiel, 9nc. STLCOPCB4019882 GO O TABLE XI TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Urine Analyses Data Summary of Mean Values ary Microscopic Elements PH vel Month: Month: ScX 3 6 9 12 18 24 3 6 9 12 18 24 . 9fc nn n n +1 7 7 6 776 r. n n n t t 8 8 7 8 6 6 nn nt -- r. n n N t t7 76 t887 766 766 Key: is.' - Normal 0o0 n = negative SE t = trace; less than 5 per low power field o + 1 = 5 to 10 per low power field u + 2= 10 to 15 per low power field O' oU1 + 3 = more than 15 per low power field CE I I 00 ^nduit'uaL B I O T E 5 T la k y ia k iic l, 9*6. STLCOPCB4019883 Dietary Level (pom) Sex Control M F M 100 F O TABLE XII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Urine Analyses Data Summary of Mean Values Specific Gravity Month: 3 6 9 12 1.029 1.020 1.022 1.019 1.033 1.025 1.027 1.024 18 1. 042 1.032 1.018 1.020 1. 021 1.018 1.029 1.023 1.027 1.022 1.037 1.029 o 24 1. 051 1.039 1.027 1.031 c(/) x o bJ O' o U1 sD t nC c yrtfU(U/uu4` u v " t wv * u.utHA-K* luv, s*u+. *jkj F. Pathologic Studies 1. Three-Month Sacrifice . . a. Gross Pathologic Findings No outstanding differences were noted between test and control rats upon gross pathological examination. . b. Organ Weight and Organ to Body and Organ to Brain Weight Ratio Data The results of the statistical analyses conducted on absolute organ weights, organ to body weight and organ to brain weight ratios are summarized in Tables XIII through XVIII. Significant differences between a test group and the control group are designated by asterisks following the test values. Organ weights, organ to body weight and organ to brain weight ratios disclosed several randomly occurring intergroup differences. The lack of any consistent dose related response and the absence of any deleterious histopathologic change confirm that these differences were not related to the ingestion of Aroclor 1254. DSN 036060 STLCOPCB4019884 TABLE XIII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Three-Month Sacrifice Summary of Mean Values Organ: Liver Dietary Level of Aroclor 1254 (ppm) Organ Weight ' (g) Males Females Organ/Body Weight Ratio (g/100 g) Males Females Organ/Brain Weight Ratio (g/g) Males F emales Control 21.4 13.0 4.13 4. 16 1 24.0 13.5 4.34 4.34 10 22.8 13. 1 4.59 4.29 100 o Go s: 28.0* 13.8 5.25 4.89 o * Statistically significant difference at the 95 percent confidence level. ** Statistically significant difference at the 99 percent confidence level. O' o O' 10.3 11.7 10.9 14.6** 6.82 6.85 6.85 7.11 STLCOPCB4019885 Dietary Level of Aroclor 1254 (tom) Control 1 10 100 o cHI-/> OJ O' o oO O' o0 DO o CO 00 00>0 TABLE XIV TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Three-Month Sacrifice Summary of Mean Values Organ: Kidneys ' . Organ Weight (g) Males F emales Organ/Body Weight Ratio (g/100 g) Males Females Organ/Brain Weight Ratio (g/g) Males Females 4.03 4.30 4.05 4.21 2.49 2.62 2.61 2.74 0.782 0.778 . 0.821 0.792 0. 802 0.845 0. 852 0.975 .1.95 2.09 1.94 2.19 1.31 1.32 1.36 1.42 i 03 O m w I' I- > Oo TABLE XV TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Three-Month Sacrifice Summary of Mean Values Organ: Spleen Dietary Level . of Organ Weight Organ/Body Weight Ratio Organ/Brain Weight Ratio Aroclor 1254 (g) (g/100 g) (g/g) (pom)Malc3FemalesMales Females_______________ MalesFemales Control . 0.766 ' 0.578 0.150 0. 184 0.371 0.302 1 0.942 0.668 0.167 0.217 0.454 0.338 10 0.766 0. 586 0.154 0.191 0.368 0.308 100 0.814 0. 542 0.153 0.192 0.425 0.281 9090 TABLE XVI TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Three-Month Sacrifice ' Summary of Mean Values Organ: Gonads . Dietary Level of Organ Weight ' Aroclor 1254 (g) (oom) MalesFemalesMales Organ/Body Weight Ratio Organ/Brain Weight Ratio (g/100 g) (g/g) __________________ FemalesMalesFcmales Control 1 10 100 3.60 3.50 3.55 3.82 0. 114 0.134 0.110 0. 120 0.698 0.637 0.720 0.718 0.0370 0.0431 0.0361 0.0426 1.74 1.70 ' 1.70' 1.99 0.0599 0.0675 0.0568 0.0618 ' GSW G 36G 64 o O DUO o r co 00 00 t. STLCOPCB4019889 O Dietary Level of Aroclor 1254 (pom) Control 1 10 100 cOJ O' o O' U1 TABLE XVII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Three-Month Sacrifice Summary of Mean Values Organ: Heart Organ Weight (g) Males Females 1.59 1.56 1.05 1.02 ' 1.49 0.984 1.58 0.992 Organ/Body Weight Ratio (g/100 g) Males Females 0.307 0.339 0.283 0.332 0.302 0.322 0.297 0.352 Organ/Brain Weight Ratio (g/g) Males F emales 0.767 0.551 0.756 0. 516 0.713 0.515 0.817 0.512 (  TABLE XVIII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rata Organ Weight and Ratio Data Three-Month Sacrifice . Summary of Mean Values Organ: Brain Dietary Level of Organ Weight Organ/Body Weight Ratio Aroclor 1254 (g) (g/100 g) (ppm)MalesF emalesMales Females________ Final Body Weights of Sacrificed Rats (g) MalesF emales Control 2.07 1.91 0.402 0.616 518 314 1 10 c in SE 100 oU-' O' O O' O' 2.07 2.09 1.95 1.99 1.91 1.94 0.376 0.424 0.366 < 0.647 0.625 0.688 553 499- 434 311 307 281 STLCOPCB4019890 hiduitual B I O - T E S T la-hytaU'tui.i, flue. 4/ c. Histopathologic Findings Histopathologic examination of tissues and organs taken from all animals from both the control and 100 ppm groups was conducted. Tables XIX and XX list all histopathologic changes noted. All of the lesions noted in the microscopic examina tion of tissues were those of spontaneous disease and are not unusual for the albino rat. The most frequent findings were lesions in the trachea and lungs, indicating chronic murine pneumonia. These oc curred in the control as well as the rats fed Aroclor 1254. DSW 036067 STLCOPCB4019891 frtdHilucu u W - fr f TABLE XIX TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Three-Month Sacrifice Number of Animals Group: Control ' .... *..-- --------V' 1 ..................... 1 Organ Examined Findings Incidence Ave rage Grade 5 Males Trachea Lung Urinary Bladder Tracheitis Chronic respiratory disease Hype rplas ia 1 1 3 1.0 1.0 1.0 5 Females Lung Chronic respiratory disease 1 1.0 All other tissues and organs were normal histologically. Grading System 0.5 = minimal 1.0 = slight 2.0= mild 3.0 = mode rate 4.0 = severe 5.0 = extreme O DSN 036068 STLCOPCB4019892 jr. iv t TABLE XX 9 TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Three-Month Sacrifice Group: 100 ppm Number of Animals Organ Examined Findings 5 Males T rachea Lung Tracheitis Chronic respiratory disease 5 Females T rachea Tracheitis Ave rage Incidence G rade 1 1.0 3 1.0 1 1.0 All other tissues and organs were normal histologically. Grading System 0,5 = minimal 1.0 = slight 2.0 = mild 3.0 = moderate 4.0= severe 5.0 = ext reme DSW 036069 STLCOPCB4019893 fatduiPuai b I U - i t 5 I Zaaa-'iGl&'iic.i. ync. ty 2. Six-Month Sacrifice ' a* Gross Pathologic Findings No outstanding differences were noted between test and control animals. b. Organ Weight and Organ to Body and Organ to Brain Weight Ratio Data The results of the statistical analyses conducted on absolute organ weights, organ to body weight and organ to brain weight ratios are summarized in Tables XXI through XXVI. Organ weights, organ to body weight and organ to brain weight ratios disclosed several randomly occurring intergroup differences. The lack of any consistent dose related response and the absence of any deleterious histopathologic change confirm that these differences were not related to the ingestion of Aroclor 1254, i osw 036070 STLCOPCB4019894  TABLE XXI TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rata Organ Weight and Ratio Data Six-Month Sacrifice Summary of Mean Values Organ: Liver Dietary Level of Aroclor 1254 (Dom) Organ Weight (g) Males Females Organ/Body Weight Ratio (g/100 g) Males Females Control 22.9 13.1 3.74 3.77 1 16.1** 10.3* . 3.01** 3.11** c co . s: 10 100 12.9** 19.2 9.54* 12.4 2. 81 '** 4. 14 2.94** 4.40 o oj O' Statistically significant difference at the 95 percent confidence level. c "J Statistically significant difference at the 99 percent confidence level. Organ/Brain Weight Ratio (g/g) Males Females 11.7 6.71 7.45** 6.29** 5.54*' 4.99* 10.0 6.39 b& CP o * --i m to P STLCOPCB4019895 I i/ STLCOPCB4019896 99 . TABLE XXII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rata Organ Weight and Ratio Data Six-Month Sacrifice Summary of Mean Values Organ: Kidneys Dietary Level of Aroclor 1254 (oom) Organ Weight (g) Males Females Organ/Body Weight Ratio (g/100 g) Males Females Control 1 4.04 3.80 2.79 2.58 0.664 0^715 0.806 0.784 10 3.22** 2.50 0.703 0.780 o 100 s: 3.23- 2.43 0.700 0.861 o UJ O' * Statistically significant difference at the 95 percent confidence level. o K) Organ/Brain Weight Ratio <g/g) Males Females 2.06 1.43 1.75- 1.39 . 1.57* . 1.31 1.68* 1.25 yrr v CO O m <_n --Hi S' c' rsj STLCOPCB4019897 Dietary Level of Aroclor 1254 fnpm) Control 1 10 100 o u> oO' U! TABLE XXIII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Six-Month Sacrifice Summary of Mean Values . Organ: Spleen Organ Weight (g) MalesFemales Organ/Body Weight Ratio Organ/Brain Weight Ratio (g/100 g) (g/g) ' _______Males FemalesMalesFemales 0.752 0.830 0.684 0.602 0. 122 6. 155 0.196 0.182 0.384 0.384 0.350 0.324 . 0.588 0.594 0.128 0.184 0.287 0.311 0.684 0.512 0.150 0.180 0.356 0.264 i Q Dietary Level of Aroclor 1254 (ttm) Control 1 ' 10 100 O . TABLE XXIV TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Six-Month Sacrifice Summary of Mean Values Organ: Gonads Organ Weight (g) Males Females 3.55 0.0960 3.67 0.0922 3. 30 .0.0868 3.44 0. 104 Organ/Body Weight Ratio (g/100 g) Males Females 0.593 0.691 0.0279 0.0280 0.724 0.0272 0.747 0.0364 Organ/Brain Weight Ratio (g/g) Males Females 1.81 1.70 0.0492 0.0496 1.61 1.79 0.0454 0.0536 ` STLCOPCB4019898 o u> O' o ^1 r % * STLCOPCB4019899 O Dietary Level f Aroclor 1254 (pom) Control l 10 100 D C/I s: o U) O' o U1 TABLE XXV TEST MATERIAL: Aroclor 1254 . Two-Year Chronic Oral Toxicity Study - Albino Rats . Organ Weight and Ratio Data Six-Month Sacrifice Summary of Mean Values Organ: Heart Q ' . Organ Weight (g) Males Females 1.70 1.05 1.58 1.04 1.44 1.03 1.40 1,02 Organ/Body Weight Ratio (g/100 g) Males Females 0.282 0.302 0.298 0.314 0.316 0.320 ` 0.301 0.361 Organ/Brain Weight Ratio (g/g) Males Females 0.867 0.538 `0.731 0.702 0.559 0.539 0.729 0.526 \. m if `-pn>tsm r>tr*>nT l A - ( OA I I 9 Dietary Level of Aroclor 1254 (oom) Control 1 ` 10 . 100 9 TABLE XXVI TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Six-Month Sacrifice Summary of Mean Values Organ: Brain Organ Weight (g) Males Females 1.96 1.95 2.16 1.86 . Organ/Body Weight Ratio (g/100 g) Males Females 0.320 0.560 0.404* 0. 562 Final Body Weights of Sacrificed Rats Males U) Females 613 348 534 331 2.05 1.92 1.91 1.94 0.447** 0.414** o Oh CO > -- 0.593 459 322 464 285 STLCOPCB4019900 D 4 Statistically significant difference at the 95 percent confidence level. C/) ** Statistically significant difference at the 99 percent confidence level. ST uo> O' o & i DnJ.tlttial B 1 O - T E S T labonahniei, Due. t( c. Histopathologic Findings Histopathologic examination of tissues and organs taken from all animals from both the control and 100 ppm groups was conducted. Tables XXVII and XXVIII list all histopathologic changes noted. All of the lesions noted in the microscopic examination of tissues were those of spontaneous disease and are not unusual for the albino rat. The most frequent findings were lesions in the trachea and lungs, indicating chronic murine pneumonia. These occurred in the control as well as the rats fed Aroclor 1254. DSW 03607? STLCOPCB4019901 TABLE XXVII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Six-Month Sacrifice Group: Control Number of Animals Organ Examined Findings 5 Males Trachea Lung Liver Skeletal Muscle Tracheitis Focal tracheitis Focal pneumonitis Hyperemia Focal pericholangitis Focal inflammation 5 Females Trachea Lung Liver Kidney Focal tracheitis Hyperemia Hyperemia ' Pericholangitis Focal inflammation Average Incidence G rade 2 1.5 2 1.0 1 0.5 2 1.0 1 1.0 1 1.0 1 1.0 2 2.5 ' 1 1.0 1 0.5 1 1.0 - All other tissues and organs were normal histologically. Qrading System _ 0.5 = minimal 1.0 = slight 2.0 = mild 3.0 = moderate 4.0= severe 5.0 = extreme - i DSW 036078 STLCOPCB4019902 TABLE XXVIII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Six-Month Sacrifice Group: 100 ppm Number of Animals Organ Examined Findings Ave rage Incidence Grade 5 Males Trachea Lung Liver Kidney Tracheitis Focal tracheitis Focal pneumonitis Focal pericholangitis Focal nephritis 2 1 3 1 1 2.0 1.0 0.5 2.0 0.5 5 Females Heart Trachea Lung Kidney Myocarditis Focal tracheitis Focal pneumonitis Hyperemia Focal nephritis 1 3 4_ 1 2 0.5 0. 5 1.0 1.0 3.0 _ All other tissues and organs were normal histologically. Grading System 0.5 = minimal 1.0 = slight 2.0 = mild 3.0 = moderate 4.0= severe 5.0 = extreme ' DSW 036079 STLCOPCB4019903 B I O - T E S T lalpyiakiicl, 9hc. 3. Twelve-Month Sacrifice a* Gross Pathologic Findings Gross pathologic findings among test animals were not significantly different from those noted in control animals, b. Organ Weight and Ratio Data The mean organ weight and ratio data collected at the 12-month sacrifice are presented in Tables XXIX through XXXIV. Statistically significant differences, are designated by asterisks following the test group value. Organ weights, organ to body weight and organ to brain weight ratios disclosed several randomly occurring intergroup differences. The lack of any consistent dose related response and the absence of any deleterious histopathologic change confirm that these differences were not related to the ingestion of Aroclor 1254. DSW 036080 STLCOPCB4019904 STLCOPCB4019905 Dietary Level (mn! Control 1 10 100 TABLE XXIX TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Twelve-Month Sacrifice Organ Weight and Ratio Data Summary of Mean Values Organ Weight ' (g) Males Females Organ: Liver Organ/Body Weight Ratio (g/100 g) Males Females Organ/B rain Weight Ratio (g/g) Males Females . 22. 1 20.6 23. 5 27. 1* 15. 5 12. 9 14. 6 12. 2 3.79 3.09* 3. 52 4.58* 3. 52 3.41 4. 34 3.43 10. 8 9.89 11. 2 12. 7 7.72 7. 29 7.34 6. 30 * Statistically significant difference at the 95 percent confidence level. o0a0t o O' o CO . *- . . 1 i. fc- t a 0 t --i i; i 01 -{ rW l/ - TABLE XXX TEST MATERIAL: Aroclor 1254 . Two-Year Chronic Oral Toxicity Study - Albino Rats . Twelve-Month Sacrifice Organ Weight and Ratio Data Summary of Mean Values Organ: Kidneys Dietary Level (oom) Control 1 10 100 Organ Weight (g) . Males Females 4.04 4.09 4.64 4.39 3. 19 2.75 2. 76* 2. 78* Organ/Body Weight Ratio (g/lOOg) Males F emales 0.692 0.618 0.697 0. 740 0. 738 0.728 0.817 0.796 Organ/Brain Weight Ratio (g/g) Males F emales 1.97 1.98 2. 21 2.06 1.58 1. 55 1. 39 1.44 STLCOPCB4019906 * Statistically significant difference at the 95 percent confidence level. D oo SL O OJ O c CP fv \ V t B I O - T ES T talo-iici, 9ac. Dietary Level (oom) Control r 10 100 TABLE XXXI TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Twelve-Month Sacrifice Organ Weight and Ratio Data Summary of Mean Values Organ: Spleen . Organ Weight ' (g) Males Females Organ/Body Weight Ratio (g/100g) ' Males Females Organ/Brain Weight Ratio (g/g) Males Females 0.778 0.796 0.133 0.183 0. 380 0. 396 0. 714 0.904 0. 754 0.484* 0. 548 0. 976 0. 107 0.135 0. 126 0. 129 0. 161 0. 280 ' 0.344 0.430 0.352 0. 271 0.275 0.517 STLCOPCB4019907 * Statistically significant difference at the 95 percent confidence level. o ', i/> o O' o CD <_n b tJ a ih io l B I O - T E S T Xa&atafolici, % STLCOPCB4019908 Dietary Level (nnm) Control 1. 10 100 TABLE XXXII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Twelve-Month Sacrifice Organ Weight and Ratio Data Summary of Mean Values Organ: Gonads Organ Weight (g) Males F emales Organ/Body Weight Ratio (g/100 g) Males F emales 3.46 0. 116 0.592 0.0275 3.68 O.'lll 0.557 0.0294 3.68 0.0918 0. 550 . 0.0270 3.56 0. 121 0.603 0.0334 Organ/Brain Weight Ratio (g/g) Males F emales 1.70 0.0574 1.78 0.0624 1.75 0.0461 1.67 0.0624 C3 in o UJ O' o 03 4> * in 1nr U *r.>n ^ I'V O tw t'T r* "1 t o Dietary Level (com) Control 1 10 100 * O - TABLE XXXIII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Twelve-Month Sacrifice Organ Weight and Ratio Data Summary of Mean Values Organ: Heart . Organ Weight Organ/Body Weight Ratio (g) (g/100 g) Males Females . Males Females 1.71 1. 23 0. 293 0. 286 1.68 1.13 0. 255 0.301 1.84 1 08** 0. 275 0.322 1.69 1. 14 0. 284 0. 325 Organ/Brain Weight Ratio (g/g) Males F emales 0.835 0. 609 0.812 0. 635 0. 875 0.544* 0.795 0.589 STLCOPCB4019909 o * Statistically significant difference at the 95 percent confidence level. 21 ** Statistically significant difference at the 99 percent confidence level. o UJ O' c 00 m 1 Q 9 tu h til'U a l l l I U * I t b I XcUu-ytakyuci, TABLE XXXIV TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Twelve-Month Sacrifice Organ Weight and Ratio Data Summary of Mean Values Organ: Brain Organ Weight Organ/Body Weight Ratio Final Body Weight of Dietary Level (g) (g/100 g) Sacrificed Animals (grams) (pom)MalesFemalesMalesF emaleMalesFemales Control 1 10 100 2.04 2.08 2. 10 2. 14 2.02 1.78 : 1.99 1. 93 0. 35 0. 315 0. 315 0. 361 0. 474 0.475 0. 591 0. 552 584 665 669* 596 439 380 338*' 355 STLCOPCB4019910 * Statistically significant difference at the 95 percent confidence level. o oo X. c OJ O' o CD O' *- * ii CT O' B 1 O - T E S T lahyiatosiiel, Dhc, 57 C. Histopathologic Findings Histopathologic examination of tissues taken from each rat sacrificed from the control and 100 ppm groups after 12 months of testing was conducted. Tables XXXV and XXXVI list all histopathologic changes noted. OSW 03608? STLCOPCB4019911 jjiJuit'Ual B I O - T E S T lakyialo'uol, Hhc. DO TABLE XXXV TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Twelve-Month Sacrifice Group: Control Number of Animals 5 Males 5 Females Organ Examined Trachea Lung Urinary Bladder Trachea Lung Colon Findings Incidence Ave rage Grade Tracheitis Chronic respiratory disease Calculus 1 2 1 1.0 1.0 1.0 Tracheitis Chronic respiratory disease Paras ites 1. 1 1 1.0 1.0 l.o' All other tissues and organs were normal histologically. Grading System . 0.5 = minimal 1.0 = slight 2.0 = mild 3.0 = moderate 4.0= severe 5.0 = extreme t OSW 036088 STLCOPCB4019912  Dududwd B I O - T E S T lalmatvu&l, jVtc. by TABLE XXXVI TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Twelve-Month Sacrifice Group: 100 ppm . Number of Organ Animals Examined Findings 5 Males Lung Chronic respiratory disease 5 Females Heart Trachea Lung Adrenal Focal myocarditis Tracheitis Chronic respiratory disease Congestion o oo Average Incidence Grade 4 1. 0 1 1.0 1 1.0 1 1.0 1 1.0 O All other tissues and organs were normal histologically. Grading System 0. 5 = minimal 1.0 = slight 2.0 = mild 3.0 = moderate 4.0= severe 5. 0 = extreme . ' * * O DSW 036089 STLCOPCB4019913 HtuLuibual B 1 0 * T E S T Xabyiah'iei. 9hc. 60 4. Final Sacrifice a.. Gross Pathologic Findings Gross pathologic findings among test animals were not significantly different from those noted in control animals. b. Organ Weight and Ratio Data - The mean organ weight and ratio data collected at the final sacrifice are presented in Tables XXXVII through XLII. Statistically significant differences, are designated by asterisks following the test group value. Absolute liver weight, liver to body weight and liver to brain weight ratios were significantly elevated in both male and female rats fed 100 ppm Aroclor 1254. Other organ weights, organ to body weight and organ to brain weight ratios disclosed several randomly oc curring intergroup differences. The lack of any consistent dose related response and the absence of any deleterious histopathologic change confirm that these differences were not related to the ingestion of Aroclor 1254. DS^ 036090 STLCOPCB4019914 Oo `w t f e ic f p r 1 s 3 1 0 19 . Dietary Level (ppm) Control 1 10 100 TABLE XXXVII TEST MATERIAL: Arodor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data i Summary of Mean Values Final Sacrifice Organ: Liver Organ Weight (g) Males ' Females Organ/Body Weight Ratio (g/100 g) Males F emales 22. 0 16.3 3.47 3.05 19. 5 16. 1 2.. 99 3. 10 23.9 19. 5 3. 21 3. 84* 30.2** 32.1** 4.75** 8.62** * Statistically significant difference at the 95 percent confidence level. ' ** Statistically significant difference at the 99 percent confidence level. <o/> oOJ O' vO t-1 , *11 . _ Organ/Brain Weight Ratio (g/g) Males F emales 10. 10 8. 76* 8.42 8. 31 11.40* 10.30 14.10** 17. 10** cr- STLCOPCB4019915 Oo 0Qtuhtii/ual B 1 * T E S T Xab&iatc-'ucA, STLCOPCB4019916 Dietary Level (ppm) Control 1 10 100 TABLE XXXVIII . TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Summary of Mean Values Final Sacrifice Organ Weight (g) Males F emales Organ: Kidneys Organ/Body Weight Ratio (g/300 g) . Males Females 5. 57 3.48 0. 877 . 0.646 5. 52 3.68 0. 868 0. 706 5.63 3.47 ' 0. 761 0. 717 4. 74 3.44 0.749 0.899* FOrgan /Brain Weight Ratio (g/g) Males Females 2.57 1.79 2.48 1.88 2. 70 1.84 2. 21 1.82 * Statistically significant difference at the 95 percent confidence level. o c/> ST O OJ O' o vO N) aCv `w e p n -c p f 15 3 1 -0 1 9 Dietary Level (ppm) Control 1 10 100 TABLE XXXIX TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data i Summary of Mean Values Final Sacrifice Organ: Spleen Organ Weight <g) Males Females Organ/Body Weight Ratio (g/100g} Males Females 1. 15 0.96 0. 182 0.181 1. 26 1. 57 1.06 0.86 0. 189 0. 220 0. 237 0. 175 1.04 0.66 0. 164 0. 174 Organ/Brain Weight Ratio (g/g) Males Females 0. 520 0.492 0. 568 0.562 0. 749 0.462 0.489 0.352 STLCOPCB4019917 D (/! o Ui bo O' o vO OJ { 9 t'jHdtcUMal b I U I J I XalfO-'Mto-xkl, !/*c, . Dietary Level Ippml Control 1 10 100 TABLE XL TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats `. Organ Weight and Ratio Data t Summary of Mean Values Final Sacrifice . Organ Weight (g) Males Females 2. 52 0.123 Organ: Gonads Organ/Body Weight Ratio (g/100 g) Males Females 0.397 0.0222 Organ/Brain Weight Ratio (g/g) Males Females 1. 15 0.0628 3. 19 3. 28 0.204 0.135 ' 0.482 0.445 0.0390 0.0283 00 1. 43 0. 1010 0.0707 3. 44 0. 128 0. 547 0.0316 1. 60* 0.0666 * Statistically significant difference at the 95 percent confidence level. o taoc o Us O' o o p- oi STLCOPCB4019918 Q Dietary Level fpom) Control 1 10 100 TABLE XLI TEST MATERIAL: Arodor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats . Organ Weight and Ratio Data t Summary of Mean Values Final Sacrifice Organ: Heart Organ Weight Males (g) Females Organ /Body Weight Ratio (g/100 g) Males Females 1. 87 1.54 0. 294 0.288 1. 98 L 55 0.303 0. 302 2.08 1. 37 0.279 0. 282 1. 94 1.50 0. 304 0.386** o C), S' c? O m --< r sVk-. Organ/Brain Weight Ratio (g/g) Males Females 0. 860 0. 795 0. 889 0. 805 0.998* - 0.727 0.909 0.803 * Statistically significant difference at the 95 percent confidence level. Statistically significant difference at the 99 percent confidence level. </> o o I/O O oo CD oU O OJ O' o CO CO vO U1 Con Dietary Level (soni) Control 1 10 100 t TABLE XLH TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats * Organ Weight and Ratio Data t Summary of Mean Values ' Organ Weight -(g) Males ' Females Final Sacrifice Organ: Brain Organ/Body Weight Ratio (g/lOOg) Males Female Final Body Weight of Sacrificed Animals (grams) Males Females . 2. 18 2. 22 2.08 2. 13 1.95 1.94 1. 88 00 00 0.342 0. 347 0.279 0. 340 . 0.362 0. 376 0.388 . 0.486** 642 656 762 656 551 540 500 411** ft to O -4 m v> --4 ! &w- Statistically significant difference at the 99 percent confidence level. Dt C/0 s: o U) O' o vO O' O' O' f}nduiiMal B I O - T E S T Ja&naJa'Uei, Jhc. 67 c. Histopathologic Findings Histopathologic examination of tissues and organs taken from all animals sacrificed after 24 months on test was conducted. Tables XLIII through XLVI list all histopathologic changes noted. Table XL/VII contains the results of the histopathologic examination of the urinary bladders. Significant liver injury was found in animals fed 100 ppm Aroclor 1254 (T-III). The compound associated lesions consisted of vacuolar change, focal hypertrophy and focal hyperplasia. In addition, there were lesions of inflammation, necrosis, fibrosis and minor de generation, were more severe and frequent in the T-HI group. The vacuolar change was not seen in the control animals but was observed occasionally in livers from T-I (1 ppm) and T-II (10 ppm) animals. It was frequent in the T-III animals. This lesion is morphologically indicative of fatty degeneration. Formalin-frozen sections of livers from representative animals which displayed vacuolar changes were stained with Oil Red 0 to reveal the presence of fat. The vacuolar lesion in the cytoplasm of these cells was positively idenified as fat. '* - 4 . The hypertrophic changes found in the liver was focal and often limited to the central lobular area where groups of cells were swollen < to two or three times their normal size with clear pink homogeneous cyto plasm. The hyperplasia was associated with the same cells and appeared DSW 036097 STLCOPCB4019921 ^tuiudtUul BI O - T E S T loMAaU'ii&l, Dhc. 68 to be an extension of the hypertrophic lesion. The hyperplastic cells were also usually hypertrophic. The most severe examples of hyperplasia appeared as nodular growths with limited compression of the surrounding normal hepatic tissue. The minor lesions of degeneration, hepatitis, ductule cell proliferation, necrosis and focal lymphoid infiltration seen in the control animals and the T-I and T-II groups are lesions of spontaneous disease and are not related to the Aroclor 1254. This level of liver disease is not unusual in rats of this age. Hyperplasia of the transitional epithelium was present in the urinary bladder of animals from the control group and each of the test groups. This lesion was usually associated with cystitis. The most severe changes were associated with the presence of mineralized calculi in the bladder lumen. All of the other lesions in other tissues found in these animals are related to spontaneous disease and they are not unusual for old rats. W' --f ^ Donovan E. Gordon, D. V. M. , Ph. D. Diplomate, American College of Veterinary Pathologists DSW 036098 STLCOPCB4019922 0D tu b iliA ia l B I - T E S T 2 a lt& ia io \ici, Dnc, STLCOPCB4019923 ' TABLE xliii . :r i'iTEST MATERIAL: Aroclor 1254 ' 11 i .' - Two-Year Chronic Oral Toxicity Study - Albino Rats ' . Histopathologic Changes Number of Animals Organ Examined 11 Males o CO a: o U) O' o sO *0 ---------------- Heart Trachea Lung . Liver i Stomach Spleen; \ Kidney Testes, , Prostate Adrenal Gland 1 l Brain j, Eye . 1 j . .Final Sacrifice Group: Control . Findings ; Chronic focal myocarditis Tracheitis Chronic respiratory disease Focal degeneration > Puctile hyperplasia 1 Chronic gastritis . Hemosiderosis .j . Chronic nephritis Testicular degeneration j Periarteritis : Inflammation Telangiectasis ,j Nodular hyperplasia | 1 Focal fatty change ; !Focal encephalitis Inflammation 1 ' I . Incidence Average Grade 3 3 9 12 .1 3 8' 2 2 1 1 1 1 1 2 1.0 1. 0 1.0 1.0 1.0 1.0 1.0 1. 0 1.0 1.0 1.0 1.0 1.0 1.0 . 1.0 1.0 e  Number of Animals 14 Females in o O' o o I TABLE XL III continued TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Croup: Control Organ Examined Heart Trachea Lung Liver . - '' Stomach Colon Spleen Uterus Kidney Ovary Findings Chronic focal myocarditis Tracheitis Chronic respiratory disease Focal lymphoid infiltration Ductile hyperplasia Focal hepatitis Non-lipid vacuolar change Chronic gastritis Acanthosis - squamous epithelium Parasites Hemosiderosis Metritis Chronic nephritis Focal lymphoid infiltration Cyst , Incidence 7 3 13 3 2 1 2 3 5 1 4 3 6 1 1 o Average Grade 2.0 1. 0 1. 0 uo 1.0 1.0 0. 5 1.0 1.0 1.0 2.0 2.0 1. 0 1.0 1. 0 -vl JtuiaSl-ual D I U - t C 3 I Xa/jcnato-Uel, Number of Animals 14 Fcmales TABLE XLIII continued TEST MATERIAL: Aroclor 1254 , Two-Year .Chronic Oral Toxicity Study - Albino Rats ' Histopathologic Changes Final Sacrifice Group: Control* Organ Examined Adrenal Gland Salivary Gland Findings Telangiectasis Nodular hyperplasia Pheochromocytoma Chronic fibrosis and atrophy Incidence 9 4 1 1 All other tissues and organs were normal histologically. 0. 5 = 'minimal 1.0= slight Grading System 2. 0 = mild 3. 0 = moderate . 4. 0 = severe 5.0 = extreme o </> sc o O' o Average Grade 1.0 1.0 1.0 1.0 si ai - o i a m pr?u6 Q fy td m b u a l 0B I - T E S T la o & ia k 'u c l. Hue. ' I ' TABLE XLIV TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rata Histopathologic Changes Final Sacrifice Group: 1 ppm Number of Average AnimalsOrgan ExaminedFindingsIncidenceGrade Males o Co s: o OJ O' Heart Trachea Lung Liver Pancreas Stomach Spleen Kidney Testes Chronic focal myocarditis Tracheitis Chronic respiratory disease Congestion . Ductile hyperplasia Vacuolar change (fatty) Necrosis Chronic focal pancreatitis . Periarteritis Chronic gastritis Acanthosis Ulcer Hemosiderosis Chronic nephritis Testicular degeneration 5 6 9 1 1 1 1 .2 1 2' 2 1 5 8 2 1.0 1.0 1.0 1. 0 0. 5 1.0 3. 0 1.0 2. 0 1.0 1.0 I. 0 2.0 2. 0 1.0 STLCOPCB4019927 Number of Animals 11 Males TABLE XLIV continued TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 1 ppm - Organ Examined Testes (continued) Prostate Seminal Vesicle Pituitary Adrenal Gland - Parathyroid Gland Findings Periarteritis Focal calcification Inflammation Inflammation Congestion Nodular hyperplasia Hype rplasia Incidence 2 2 6 2 1 1 1 22 Females o o OJ O' (-- o OJ Heart Trachea Lung Liver Chronic focal myocarditis Tracheitis Chronic respiratory disease Focal lymphoid^infiltration 12 16 17 3 Average Grad 1.0 2. 0 2.0 2.0 1.0 1.0 1.0 1.0 1.0 2.0 1.0 -J ( < TE5 T jW 0 -u*t4&L, aL B I Number of Aninv.';-' 22 Fer.-.. 1 s CoC s: o (JJ O' -* O 4> TABLE XLIV continued TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 1 ppm ' Organ Examined Liver (continued) Stomach Colon Spleen Lymph Node Kidney Uterus Pituitary Adrenal Gland ' Findings Ductile hyperplasia Vacuolar change (fatty) Congestion Necrosis Focal inflammation and acanthosis Parasites Hemosiderosis Abscesses Chronic nephritis Focal calcification Metritis Hyperplasia Telangiectasis Nodular hyperplasia Congestion , Focal fatty change Incidence 2 3 1 1 4 2 8 1 8 3 6 4 17 1 1 3 All other tissues and organs were normal histologically. 0. 5 = minimal 1.0 = slight Grading System 2.0 = mild 3.0 = moderate 4.0 = severe 5.0 = extreme Average Grade 1.0 2.0 1.0 1.0 2.0 1.0* 2.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 j)n it(d u a l B I O - T E S T lalxyiaivUci, v w> 4) rMt V > rut O ooooootntnooooo --( '--' '--' O O ro --< .--I H rv] TE S T M A T E R IA L : A ro c lo r 1254 4tdoJ Pi .Os 43 m o oo B Xo H H d o couH 01 H K M x u u rt V Jh \ E a cu o a, o3 u a *0 V .5 Ert X W crWt r4t) U xo: da> rt u KH eu C 5 V( >H f-i O -a rhcuut c rt eVC d Cc 0 d >o* JK- Q. *-< o O A tn w M H o v> i o rt E Ec < 01 r--04 Vr-t* -5 INI DSW 036105 i STLCOPCB4019929 TABLE XLV continued V TEST MATERIAL: Aroclor 1254 ' Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 10 ppm ' Number of . Average AnimalsOrgan ExaminedFindings___________________________IncidenceGrade 12 Males Testes (continued) Prostate Seminal Vesicle Adrenal Gland. Thyroid Gland " Periarteritis Inflammation Inflammation Telangiectasis Focal fatty change Focal hyperplasia 1 3. 0 2 2.0 2 1.0 2 1.0 1 1. 0 1 1. 0 STLCOPCB4019930 12 Females a </> s: o OJ O' o O' i Heart Trachea Lung Liver Chronic focal myocarditis Tracheitis Chronic respiratory disease Focal lymphoid infiltration Vacuolar change (fatty) Nodular hyperplasia 3 7 12 4 1 1 1.0 1.0 1.0 1.0 1. 0 3.0 c STLCOPCB4019931 e i ' TABLE XLV continued TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 10 ppm ' Number of Animals__________ Organ Examined_______________________ Findings 12 Females o (A s. o u> O' o Liver (continued) Colon Spleen Lymph Node Kidney . Uterus Pituitary - Adrenal Gland Parathyroid Gland Thymus Ductile hyperplasia Telangiectasis Hepatoma Parasites Hemosiderosis Congestion Chronic nephritis Focal calcification Metritis Adenoma Hyperplasia Telangiectasis Hyperplasia Ab s c e s s T Incidence 2 1 1 1 2 1 3 2 1 3 1 9 1 1 All other tissues and organs were normal histologically. 0. 5 = minimal 1.0 = slight Grading System 2. 0 = mild 3.0 - moderate 4. 0 = severe 5.0 = extreme Average Grade 1.0 1.0 1.0 1.0 1.0 1.0 2.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 l A l l l i -tn r-irirp lttf Number of Animals 1 I Males to o U' o o <X> TABLE XLVI TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 100 ppm- Organ Examined Heart Trachea Lung Liver Small Intestine Spleen Lymph Node Findings Chronic focal myocarditis Tracheitis Chronic respiratory disease Edema Focal degeneration Vacuolar change (fatty) Ductile hyperplasia Hypertrophy Focal lymphoid infiltration Portal fibrosis Focal inflammation Hemosiderosis Congestion Incidence 3 4 10 3 2 .3 3 3 1 1 1 2 1 Average Grade 2. 0 1. 0 1.0 2. 0 1. 0 i:o 1.0 2. 0 1. 0 2. 0 1. 0 1. 0 1.0 STLCOPCB4019933 Number of Animals 11 Males TABLE XLVI continued TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 100 ppm Organ Examined Kidney Testes Prostate Adrenal Gland Thyroid Gland Findings Chronic nephritis Periarteritis Inflammation Telangiectasis Congestion ' Hyperplasia Incidence 8 1 5 2 1 .1 15 Females o sC/:> o OJ O' o vO Heart Trachea Lung Liver i Chronic focal myocarditis Tracheitis Chronic respiratory disease Edema Focal hypertrophy Hypertrophy Focal hyperpVlasia I 5' 6 13 l 1 5 1 Average Gradi 1. 0 1. o 2.0 1.0 1. 0 1. 0 1.0 1. 0 2. 0 2.0 1.0 3. 0 1.0 Number of Animals 15 Females o in ST. o O' o TABLE XLVI continued TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 100 ppnv Organ Examined Liver (continued) Stomach Spleen Kidney Uterus Pituitary Pituit Adrenal Gland Findings Ductile hyperplasia Vacuolar change (fatty) Nodular hyperplasia Hepatoma . Chronic gastritis Acanthosis Inflammation Hemoside rosis Chronic nephritis Focal calcification Metritis Hyperplasia Nodular hyperplasia Telangiectasis Nodular hyperplasia Congestion 1 Incidence 2 10 1 1 2 .4 1 5 5 1 3 4 1 3 1 1 All other tissues and organs were normal histologically. Grading System 0. 5 = minimal 1.0 = slight 2.0~ mild 3.0= moderate 4. 0 = severe 5. 0 = extreme Average Grade 1.0 1.0 1.0 1. 0 1.0 1.0 1.0 1.0 1.0 1.0 1. 0 1. 0 1. 0 1. 0 1. 0 1. 0 t no ^ ** # - A ft e ''.J u llu a l B 1O - T E S T lalxyiatai<&l, % DSW 0 3 6 1 1 1 TABLE XLVII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes of the Urinary Bladder Final Sacrifice Group C T-I {1 ppm) Sex M F M F Number Examined 11 14 10 19 Findings* Proteinaceous plug (34) Focal epithelial hyperplasia (62) Proteinaceous plug (326) Diffuse epithelial hyperplasia associated with diffuse cystitis (377) Incidence 1 1 1 1 T-U (10 ppm) M 13 v Diffuse epithelial hyperplasia and papilloma associated with focal cystitis (417) Diffuse epithelial hyperplasia associated with diffuse cystitis (419) F 13 None T-m (100 ppm) - M F 10 17 Focal epithelial hyperplasia associated wit)i focal cystitis (497) Focal epithelial hyperplasia (5) None ' * Individual animal numbers are shown in parenthesis. 1 1 1 1 Grading System 1.0.= minimal or trace 2.0 = mild 4. 0 = severe 5.0 = extreme 3.0 = moderate Average Grade 1 JS 3 4 2 2 1 * 00 , j./ D I O T t S 1 Xa&yiato'uei, Unc. 82 G. Detailed Description of Tumor Findings . Tumor data for individual animals including location, weight and pathologic classification are presented in Table XLVIII through LI. None of these tumors could be related to the ingestion of Aroclor 1254 and are considered normal for a random population of rats this age. i i DSW 036112 STLCOPCB4019936 Animal Number and Sex 1-M 2-M 46-F 47-F 48-F 5 0-F 52 -F 59-F a Co je: o 0" OJ 64-F 66-F ' . Location Abdomen Pancreas Abdomen Lymph node Abdomen Abdomen Abdomen Abdomen Adrenal gland Abdomen Abdomen - TABLE XLVIII TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Description of Tumor Findings Group: Control . Weight (grams) - 11.76 64. 98 35. 09 - L Size ' (cm) - -' 8x1x2 . 5x2x2 - 2x2x1 - 2x2x3 -- '88.92 - 13 x 11 x 4 230.00 . 13( x 11 x 4 Classification Mammary fibroadenoma Adenocarcinoma Mammary fibroadenoma Mammary fibroadenoma Reticulum cell sarcoma Mammary fibroadenoma Mammary fibroadenoma Mammary fibroadenoma Mammary fibroadenoma Pheochromocytoma Fibroadenoma Mammary adenoma Months on Test 24 24 24 24 24 7 24 24 24 24 B I U * I t S I jLadfOMHt'u cl, Animal Number c.nd Sex 1 1 -F -X' 11 ~F > V- 13-F Location Abdomen Abdomen Abdomen TABLE XLIX continued TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Description of Tumor Findings Group: 1 ppm Weight (grams) - Size (cm) - - .- Classification fS Mammary adenocarcinoma / V Mammary fibroadenoma . (A Lipoma . ' ;` L "" -n O m in Months on Test 24 24 24 o in 3C o OJ O' 4> 03 STLCOPCB4019938 0 TABLE XLIX TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Description of Tumor Findings Group: 1 ppm Animal Number and Sex Location Weight (grams) Size (cm) Classification 1-M Parathyroid gland - - K'Adenoma 2-M Pituitary - - y Chromophobe adenoma 3-F Abdomen - - U Mammary fibroadenoma V'"' 4-F Abdomen - - \y Mammary fibroadenoma '\y 5-F Abdomen Parathyroid gland 8. 97 2x2x2 i Mammary adenoma v' Adenoma u 6-F D Abdomen 8.86 3x2x2 7-F X Abdomen 65. 0 O UJ Dorsal cervical 209 13 x 8 x 2 O' region c/> P-- 8-F ui Pituitary oO Abdomen -_ ~ ^_ o O DO oU 9-F Abdomen - - I .. 11 CO 10-F ' CO Abdomen CO CO y Mammary fibroadenoma '' Mammary fibroadenoma V'' ^Fibroadenoma ; - i Chromophobe adenoma ^ v Mammary fibroadenoma ^ * Mammary fibroadenoma'-" Mammary fibroadenoma V Months on Test 24 23 24. 24 24 24 24 24 24 24 TABLE L TEST MATERIAL: Aroclor 1254 '' Two-Year Chronic Oral Toxicity Study - Albino Rats Description of Tumor Findings Group: 10 ppm Animal Number :.nc! Sex / Location Weight (grams) Size (cm) Classification 1-M 2-M Pancreas Parathyroid gland - - /'Adenoma is' - t/Adenoma 3-F 4-F 5-F 6-F ' 7-F 8-F 9-F o Oo ar o u o H-* O' 10-F 1 1 -F Abdomen Thyroid Abdomen Abdomen Abdomen Abdomen Pituitary Abdomen Pituitary Adrenal gland Abdomen -- * -- -- 86 7 x 8 x 3 29 5 x 5 x 2 -- 28 6 x 5 x 3 i -- 7. 8 23 * * - * 4x7x 1 1 ^Mammary fibroadenoma l' Adenoma /Mammary fibroadenoma , Mammary fibroadenoma V"" is Fibroadenoma ^Fibroadenoma V Chromophobe adenoma L''" /Fibroadenoma L-^ //Chromophobe adenoma t/Telangioma A-" ^ Fibroadenoma V'. I- 09 o H m yt Months on Test 24 24 . 24 24 24 24 24 24 22 O09' 24 24 { t ftid liii'ia L U I U - 1 fcb i XatWiatvOU, `Jnc, DSW & _ Animal Number and Sex 1-F 2-F 3-F * 4-M 5-M 6-F 7-M 8-F 9-F 10-F o OJ O' b-* -SJ Location Abdomen Abdomen Abdomen Pancreas Abdomen Abdomen Lymph node Pancreas Lymph node Abdomen TABLE LI TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats . Description of Tumor Findings Group: 100 ppm Weight (grams) 48.12 -' 13. 0 .- 52. 0 Size (cm) 5x4x3 18 x 4 x 3 1x2x1 3x3x3 -t 8x5x2 Classification 2/Fibroma ^ Mammary fibroadenoma v-"* is Mammary fibroadenoma /Adenoma r / FibroadenomA--'' Mammary fibroadenoma L/^ Reticulum cell sarcoma i/'Adenocarcinoma 2/Lymphosarcoma V Fibroadenoma * Months on Test 24 24 24 24 24 24 13 24 24 24 I 4* j I Animal Number and Sex 11-F 12-F 13-F 14-F 15-F Location Abdomen Abdomen Abdomen Abdomen Abdomen TABLE LI continued TEST MATERIAL: Aroclor 1254 Two-Year Chronic Oral Toxicity Study - Albino Rats Description of Tumor Findings Group: 100 ppm Weight (grams) 141. 9 42 - 209. 0 14. 63 Size (cm) 8x8x2 6x4x2 10 x 9 x 3 '- Classification KMammary fibroadenoma L'' Mammary fibroadenoma l--- U; Fibroadenoma V-"" / Mammary fibroadenoma"iX V Fibroadenoma ^ " cj O m cn Months on Te3t 24 24 24 24 24 . s r D C/0 s; o Uj o CD / l 03 03