Document RJNNg3q50rjD46XLJEO4XZ2xn

F1O-T E S T at&>Ue&, 9no. /f/ REPORT TO MONSANTO COMPANY TWO-YEAR CHRONIC ORAL TOXICITY WITH , AROCLOR 1242 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 1242, Lot No. AK-255. The following report presents the results of this investigation. * DSW 035058 STLCOPCB4018885 Usual B I O * T E S T laloaaia'iici, Hue. 2 (fi II. Summary A two-year chronic toxicity study was conducted using albino rats fed diets containing 1 (T-I), 10 (T-II) or 100 (T-III) ppm Aroclor 1242. Food consumption and body weight gains were not altered at any level ofAroclor 1242 fed. The number of animals dying and the time at which the deaths occurred did not vary among the 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 1242. Urine analyses failed to reveal any differences between test and control animals. 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 1242. At the final sacrifice after 24 months on test, the liver weights and liver to body weight or brain weight ratios were significantly elevated in females from the T-III group. Histologic examination of the livers from the T-IH group revealed several animals with vacuolar change. 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 1242. . DSW 035059 STLCOPCB4018886 B l O - T E S T laliOAobiiM, 9nc. 3 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. The incidences and types of all tumors were about the same in all groups, including the control group, and are considered normal for rats of this age. ' Respectfully submitted, INDUSTRIAL BIO-TEST LABORATORIES, INC. Report prepared by: Phliilliip S\ Smith, B. S. Assistant Toxicologist Rat Toxicity Report approved by: James B. Plank Senior Group Leader Rat Toxicity Paul L. Wright, Pn. D. Section Head, Toxicology M. L. Keplin^er, ItPJpfD. Manager, Toxicology November 12, 1971 lm:bb:hp:kjl /fj O OSW 035060 STLCOPCB4018887 SiwLtitniai B I O - T E $ T lalwiatanicA, Unc. 4 /ff 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 animal number and sex. B. Organization of Groups A structural outline of the experiment is given in Table I. TABLE I i TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Outline of Experiment Group Number of Animals Male Female .Dietary Level (ppm) Control 50 50 None Administered T-I T-II T-III 50 50 50 50 ' 50 50 1 10 100 * Charles River Breeding Laboratories, North Wilmington, Mass. DSW 035061 STLCOPCB4018888 fftim m-- *.n-r | >.,: :- aa 1 B I O - T E S T J.ab&'iato-iioi, 9nc. /ts 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 1242 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 deter mined and recorded. Thereafter, individual weighings were made weekly 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 Blood studies, including determinations of hemoglobin concentra tion, hematocrit value, erythrocyte count and both total and differential # Purina Rat Chow, Ralston Purina Company, St. Louis, Missouri. ' QSW 035062 STLCOPCB4018889 , B I O - T E S T laky'uitv'iicA, 9nc. 6 /fc leukocyte counts, were conducted upon five males and five females from both the control and 100 ppm groups. ,,y , . Urine analyses for the presence of glucose, ^albumin, micro- / ecopic elements, and determinations of pH 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. Clini'cal Blood Chemistry Studies i \- \ 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 cases 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. . DSW 035063 STLCOPCB4018890 ' Pitdatfolal B I O - T E S T laiiyiaUnicS, jW 7 tf? O Absolute organ weights were recorded and organ to body weight and organ to brain weight ratios computed. The following organs were 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 studied by "t"-tests. Complete microscopic examinations were conducted upon the tissues and organs from all control and 100 ppm group rats 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. OSW 035064 STLCOPCB4018891 ^nJuAinial B 1 O - T E S T laluyiai^'ue^. Due. /ft 8 Microscopic examinations were conducted upon tissues and organs from selected animals dying during the experiment and upon all animals from the final sacrifice. Tissues and organs examined were the same as those previously mentioned. 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. DSW 035065 STLCOPCB4018892 ' Utidiotiial B I O - T E S T lalxyiatyUc-i, Due. IV, Results _ ' A. Body Weights and Weight Gains The male and female body weight data are assembled in Table II, I The data in this table also include the 3, 12 and 24 month total weight gains. There were no significant effects attributable to the ingestion of the compound. /f O DSW 035066 STLCOPCB4018893 `w n r m o fo f 1 S 3 1 - O I 9 TABLE II TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Body Weight and Total Weight Gain Data Summary of Mean Values atary Level of .roclor 1242 (Dpm) Sex ntrol * M F Body Weight(grams) Week: 0 1 2 ` 3 4 5 6 7 8 9 10 11 12 13 133 203 245 313 362 373 391 409 424 440 440 449 467 474 136 178 190 219 244 254 259 265 270 276 281 278 290 288 1 M . 133 205 254 329 367 377 397 417 432 451 462 481 493 508 F ' 136 173 197 226 240 253 268 292 278 280 284 284 288 292 10 M 133 202 251 332 362 372 392 414 428 454 475 481 500 509 F 136 176 196 226 244 254 268 288 276 280 281 284 280 285 00 M 133 203 248 320 365 376 398 416 427 439 453 467 478 487 F 136 173 194 225 251 264 272 290 274 275 ? 79 285 283 286 90-Day Total Weight Gain (grams/rat) 341 152 375 156 376 149 354 150 STLCOPCB4018894 o to at o UT c O' *J 5u 3 `m w p w p ? 1 s 3 - 0 I 9i ietaxy Level of Aroclor 1242 (ppm) Sex ontrol M F 1M F 10 M 'F 100 M F 4 498 297 525 302 525 299 504 290 TABLE II continued TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Body Weight and Total Weight Gain Data Summary of Mean Values 5 '6 Body Weight (grams) Month: 78 9 10 11 533 565 593 622 642 667 688 310 322 333 345 359 374 383 555. 580 614 640 665 690 707 321 326 333 342 355 367 381 553 579 600 627 641 674 693 312 328 333 346 354 365 375 533 551 580 608 633 662 686 307 321 333' 347 360 374 388 12 701 390 743 388 ' 706 384 711 379 12-Month Total Weight Gain (grams / rat) 568 254 610 252 573 248 578 243 STLCOPCB4018895 D <s> o UJ o O' CD X s- 1 3 1" 0 I 9 etary Level of \roclor 1242 (ppm) Sex nntrol M F 1M F 10 M F 100 M F 13 728 426 767 428 740 393 724 428 TABLE II continued TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rata Body Weight and Total Weight Gain Data Summary of Mean Values Body Weight (grams) Month: 14 15 16 17 18 19 20 21 22 746 759 768 769 767 760 758 739 726 444 466 481 500 515 533 547 551 550 785 805 800 804 810 800 804 80 2 800 443 479 468 500 514 523 531 535 5 38 750 763 780 784 780 785 783 780 774 406 422 441 462 480 500 519 529 533 728 723 735 728 736 733 730 725 715 447 463 467 472 484 481 484 485 490 24-Month Total Weight Gain 23 24 (grams/rat) 687 642 564 551 509 415 80 8 759 535 532 626 396 796 734 537 547 601 411 743 *652_ 487 485 519 349 STLCOPCB4018896 o t/> 3E O Ui m o n sD huluii'ud B I O * T E S T XaUiatvucA, 9nc. 13 A6S> B. Food Consumption The data obtained from the food consumption measurements conducted during the first 12 months of feeding are summarized in Table III. 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 035070 k.. STLCOPCB4018897 TABLE HI TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Food Consumption Data 03 O m t/> Summary of Mean Values ___________________________________________________ _ S Food Consumption g tary Level of (grams/rat/seven days) Average Food roclor 1242 ' Week: Consumption (ppm) Sex 1 2 3 4 5 6 7 8 9 10 11 12 13 (grams/rat/seven daysf 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 129 154 165 201 120 191 206 210 232 185 188 189 190 ; F 91 109 120 164 110 166 124 137 172 140 145 148 145 167 136 10 M 113 132 142 201 120 193 183 184 184 192 196 . 191 193 F 96 114 147 131 1 10 149 102 124 166 144 143 138 144 171 131 100 M 117 149 185 230 161 172 199 172 227 192 186 190 190 F 89 118 129 189 98 114 142 135 180 145 142 139 140 182 135 o (Si o o o 3L> < STLCOPCB4018899 tary Level of roclor 1242 (ppm)___________Sex Control M F 1M F 10 M F 100 M F TABLE HI continued TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Food Consumption Data Summary of Mean Values 4_______ 5 Food Consumption (grams/rat/seven days) Average Food Month: Consumption 6 7 8 9 10 11 12_____ (grams/rat/seven days) 196 189 168 147 163 184 179 170 187 148 154 136 121 138 152 160 141 127 176 142 180 181 170 189 190 189 196 192 208 152 159 . 141 154 150 148 143 145 159 188 150 184 164 168 197 193 188 191 186 177 139 147 136 151 144 145 138 142 130 183 141 179 192 189 200 196 186 184 187 167 163 141 160 148 145 144 147 146 145 187 149 o 1s/r0 o UJ o d IM oufi 'j 'a iic jv w ifD f S 3 X - O I 9i X> B I O T E S T Ju/'-o-iaio-uci, Sue. * 16 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. Aa OSW 035073 STLCOPCB4018900 U ndiU lA ial B l O - T E 5 T Dietary Level (ppm) Sex Control M F 1M F 10 M F ' 100 M F TABLE IV TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rata 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 20 1 1 3 3 7 1 0 0 1 3 2 4 000 2 1 7 5 01 1 2 0 2 5 000 3 3 6 7 0 10 1 2 4 8 22-24 9 3 8 5. 8 5 10 9 Total Dead Number Tested^ 25/35 19/35 - 25/35 . 16/35 23/35 * 16/35 29/35 25/35 Dk c . STLCOPCB4018901 * Does not include the five animals of each sex from every group sacrificed for interim pathologic studies. o </> sc o UJ vn o i nrf MffiffllimMtMiil U HtvLtittial B I O - T E S T JidotaiMiei, 9*c. 18 AOi 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. QSW 035075 STLCOPCB4018902 1 S 3 ! d0i Dietary Level (ppm) Control- Sex M F 3 14. 0 9. 1 TABLE V TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Hematologic Data Summary of Mean Values Total Leukocyte Count (thousands /mm^) Month: . 6 9 12 18 15.4 10. 1 11. 1 9. 9 9.4 6.7 7. 6 8. 8 24 11. 2 7. 6 Erythnocyte Count (millions /mm^) Month: 36 9 12 18 8. 1 8.2 8.7 8. 8 7.6 7. 5 7.7 7.3 7. 8 7. 7 24 6. 5 6. 8 M 15.6 10.4 9.7 ' 12. 5 9. 4 9. 3 100 F 15.6 9.0 .7.7 7. 8 6. 2 6. 4 7. 7 8.0 8.0 7. 6 7. 4 7.6 7.6 7. 1 7.9 7.0 7.7 7. 2 ' c00 SC o OUJl o "J O' is $fnJUi/U/u a l B I O - T E S T STLCOPCB4018904 Dietary Level (ppm) Control 100 Sex M F 3 17. 1 16. 9 TABLE VI TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Hematologic Data Summary of Mean Values Hemoglobin Concentration (g/ 100 ml) Month:' 6 9 12 18 17. 7 15. 7 17. 6 16. 1 17.4 14. 1 16.7 16.4 24 13. 6 14. 6 Hematocrit Value (%) Month: 36 9 12 18 51 49 48 50 41 50 47 43 46 42 M 16.8 16. 9 14. 2 15.4 15.6 14.6 F 15. 8 16. 1 13.6 15. 7 15.5 14. 8 50 48 43 44 41 46 .48 41 41 40 24 35 38 37 37 o o OJ Uol oCm *sJ SJ 0B I - T E S T Dietary Level (ppm) Control 100 Sex 3 M 82. 0 F 83. 0 TABLE VII TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats 6 86.6 86.6 Hematologic Data Summary of Mean Values Differential Leukocyte Count (Number of Cells per Hundred) Lymphocytes Neutrophils Month: Month; 9 12 18 24 36 9 12 18 24 80.4 78.8 79. 0 65.4 16.0 11. 4 18. 6 20. 6 20.0 32. 2 86.8 89.0 70.2 61.4 15. 4 11. 6 11.8 10. 0 29. 2 36. 0 M 89. 6 84. 4 . 79-8 87.0 66.0 58.4 F 91. 4 86. 0 82.8 88.4 75.6 65.2 9.6 15. 2 18. 8 13. 2 33. 0 38. 8 8.4 13. 6 17. 2 11.2 23. 0 33. 6 o Co SE O U) Ul tv o~ cc V Dietary Level (ppm) Control 100 Sex 3 M 0.6 F 0. 6 M 0. 2 F 0.0 TABLE VII continued TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rat3 Hematologic Data CP O m Summary of Mean Values Differential Leukocyte Count (Number of Cells per Hundred) Monocytes Eosinophils Month: Month: 69 12 18 24 3 6 9 12 0.0 0.0. 0. 4 0. 2 1. 2 1.4 2. 0 1.0 0. 2 18 0. 8 r Ci S1- 24 r 1.6 0.0 0. 0 0. 0 0. 2 1.0 1. 0 1.8 1.4 0. 2 0. 6 1. 6 0. 0 0. 0 0. 4 0. 0 0. 8 0.0 . 0. 0 0. 2 0. 0 0. 2 0. 6 0. 4 1. 4 1.4 1.0 2. 0 0. 2 0.4 0. 0 0. 2 1.4 1.0 o<5/> C/> 1o--"1 o oOJ ' VJ1 O o0 X> 00 O M STLCOPCB4018907 Dietary Level (ppm) Control Sex M _* F TABLE VH continued TEST MATERIAL: Aroclor 1242 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 0.0 24 0.0 0.0 M 0.0 0.0 0.0 0. 0 0.0 0.0 100 F. 0.0 0.0 . 0.0 0.0 0.0 . 0.0 o CSot o Ut o CD m; to E ICNoI !| !j ! N bJLulM al BIO -TEST STLCOPCB4018908 9 Dietary Level (pom) Control TABLE VHI TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Clinical Blood Chemistry Data Summary of Mean Values Serum Glutamic-Pyruvic Transaminase Activity (Dade Units) Sex 3 Month: 6 9 12 18 24 Blood Urea Nitrogen Concentration (mgs %) Month: 3 6 9 12 18 M 38 48 45 45 31 36 17 15 12 10 14 F 33 39 38 42 32 30 14 16 15 9 13 M 33 35 36 57 39 32 100 F 39 41 53 40 52 46 15 15 13 14 12 17 14 14 11 11 24 15 11 20 14 a<%/>- o tv U> vor CO fruiutiAcal B IO -T E S T Xabyiaii STLCOPCB4018909 Dietary Level (ppm) Sex 3 M 128 Control F 130 M 121 100 F 125 TABLE IX TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Clinical Blood Chemistry Data Summary of Mean Values Fasted Blood Glucose Concentration (mgs %) Month: 6 9 12 18 24 Serum Alkaline Phosphatase Activity (King-Armstrong Units) Month: 3 6 9 12 18 24 123 89 118 115 88 138 99 92 134 109 28. 6 24.7 21.5 20. 3 16. 2 22. 3' 18. 9 17. 8 10. 6 11.9 16. 8 20. 2 123 129 145 125 115 118 124 121 135 116 26. 4 27.6 23. 2 20. 3 17.4 9.6 25. 8 11. 7 16. 7 11.6 13. 2 14. 2 C 1/5 a: c Uol tuon CD N> V ls\  Dtldai&Uai B I 0 - T E S T Xalto-Kiltyiici, $nc. 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. DSW 035083 STLCOPCB4018910 B I O - T E S T Ja/uyuiioiie i' , 9tv>, OSW 0 3 5 0 8 4 TABLE X TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Urine Analyses Data Summary of Mean Values Dietary Level (ppm) Control 100 Sex M F M F Glucose Month: 3 6 9 12 18 24 n n n n nn n n n n nn n .n n n n n n n n n nn Albumin Month: 3 6 9 12 18 24 n n t t +2 +3 n n n n t +2 n n t t +1 +4 n n t t t +3 Key: n = negative t = trace; less than 30 mg/100 ml urine + 1 - 30 to 100 mg/100 ml urine + 2 = 100 to 300 mg/ 100 ml urine + 3 = 300 to 500 mg/ 100 ml urine + 4 = more than 500 mg/100 ml urine v '^w p w ifD j i s a i - o i a TABLE XI TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Urine Analyses Data Summary of Mean Values Dietary Level (ppm) Control Sex M F Microscopic Elements Month: 3 6 9 12 18 NNNNN NNNNt 24 +1 t pH Mon th: 3 6 9 12 18 24 7 7 6 7 76 8 8 7 8 66 M N N N N Nt 7 7 7 8 66 100 F N N N N N t 7 7 6 7 66 035085 Key: N= Normal t = trace; less than 5 per low power field </> +1 = 5 to 10 per low power field + 2 = 10 to 15 per low power field + 3 = more than 15 per low power field DO o 00 CO raos V P aJj-uitial B IO - T E S T J.c Dietary Level (pom) Control 100 TABLE XH TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Urine Analyses Data Summary of Mean Values Sex M F M F 3 1.029 1. 020 1. 021 1.022 Specific Gravity Month: 69 1.022 1.033 1.019 1. 025 12 1.027 1. 024 18 1. 042 1.032 1.028 1.019 1.032 1.029 1. 024 . 1.029 ' 1.043 1.027 VK 24 ft 1. 051 ' 1. 039 1. 030 1. 038 C5 in C/> HI- oO oo a u> VJ1 c CD o DO o 00 CO tv 'O H'nduiliial B I O - T E S T lahmalaiiai, Due. 30 F. Pathologic Studies 1. Three-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 ^ ' I) The mean organ weight and ratio data collected at the three-month sacrifice are presented in Tables XIII through XVIII. \ Statistically significant differences are designated by asterisks following the test group value, 1 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 1242. DSW 03508? STLCOPCB4018914 Dietary Level - of Aroclor 1242 (Dom) Control 1 ` 10 100 TABLE Xni TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Three-Month Sacrifice . ' Summary o Mean Values Organ: Liver - Organ Weight <g> Males Females 21.4 13.0 22.3 12.4 23.3 14.4 25. 5 14.0 Organ/Body Weight Ratio (g/100 g) Males Females 4.13 4.16 4.31 3.92 4.41 4.31 4. 80 4.39 Organ/Brain Weight Ratio (g/g) Males Females o ' 00 DO ! 10.3 10.6 6. 59 11.9 7.93 15. 1 7.65 ' C3 O ***^ rr> cn c Va p DSW o ID vji O CD CD 90 % Dietary Level of Aroclor 1242 (oDm) Control 1 ' 10 100 TABLE XIV TEST MATERIAL: Aroclor 1242 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 4.03 2.49 4.06 2.46 4.14 2.75 4.24 2.61 Organ/Body Weight Ratio (g/100 g) Males F emales 0.782 0.802 0.784 0.772 0.786 0. 827 0.795 0. 817 Organ/Brain Weight Ratio (g/g) Males F emales 1.95 1.31 . 1.93 1.30 . 2.11 1.52 2.47 1.42 T--s. C3 0 1 --I Lr> --! OSW 0 3 5 0 8 9 o CO CO Dietary Level of Aroclor 1242 (t)Dm) Control 1 10 100 TABLE XV TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Three-Month Sacrifice ' Summary of Mean Values Organ: Spleen Organ Weight (g) Males F emales 0.766 . 0.578 0.768 0.544 0.756 0.596 0.814 0.528 Organ/Body Weight Ratio (g/100 g) Males F emales 0. 150 0. 184 0. 148 0. 171 0.143 0. 179 0.154 0. 166 Organ/Brain Weight Ratio (g/g) Males F emale s 0.371 0.302 0. 364 0.287 0.385 ,0.328 0.468 0.288 v-^ co 0 1 --*A m U~i DSW 0 3 5 0 9 0 u> 03 su STLCOPCB4018918 Dietary Level . of Aroclor 1242 (ppm) Control 1 10 100 TABLE XYI TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Three-Month Sacrifice . Summary of Mean Values Organ: Gonads Organ Weight (g) Males Females 3.60 0.114 3.51 0.143* 3.50 0. 112 3.49 0.112 Organ/Body Weight Ratio (g/100 g} Males Females 0.698 0.681 0.666 0.0370 0.0452 0.0336 0.656 0.0356 Organ/3rain Weight Ratio (g/g) Males Females 1.74 1.66 1.78 2.06 0.0599 0.0758 0.0616 0.0619 * Statistically significant diffe rence at the 95 percent confidence level. o (s/>: o \J\ on co 0 1 --1 K. u 30 1* STLCOPCB4018919 Dietary Level of Aroclor 1242 (ppm) Control 1 10 100 Ot/) sr o OJ Ui o *> TABLE XVH TEST MATERIAL: Aroclor 1242 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 F emales 1.59 1.05 1.58 1.02 1.55 1. 10 1.61 1.05 Organ/Body Weight Ratio (g/100 g) Males Females 0.307 0. 339 0.307 0.320 0.295 0. 331 0.302 0. 330 Organ/Brain Weight Ratio (g/g) Males F emales 0. 767 0. 551 . 0.752 0. 540 0.788. 0. 608 0.943 0.573 Vi CO O i/> --i Vi 0> V Dietary Level of Aroclor 1242 (ppm) Control 1 10 100 ow Ou> o vIOP TABLE XVin ' TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Three-Month Sacrifice Summary of Mean Values Organ: Brain Organ Weight (g) Males Females Organ/Body Weight Ratio (g/100 g) Males Females Total Body Weights of Sacrificed Rats (g) Males Females 2.07 2.12 1.97 1.82 . 1.91 1.89 1.83 >*-- CO -H* 0.402 0.410 0.375 0.345 0.616 0.597 0.545 0.576 518 520 . 527 534 314 318 334 319 V o o LO H Ko 0> o I- Duduibual B I O - T E S T lahota-kiiel, 9*ic. *?* 37 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 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 1242. DSW 035094 STLCOPCB4018921 H(ulndual B I O - T E S T laluyiaioiicd, Pnc. me 38 3At TABLE XIX TEST MATERIAL: Aroclorl242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Three-Month Sacrifice Group: Control Number of Animals Organ Examined Findings 5 Males Trachea Lung Urinary Bladder Tracheitis Chronic respiratory disease Hype rplas ia 5 Females Lung Chronic respiratory disease Ave rage Incidence Grade 1 1.0 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 = extreme . ^ DSW 035095 STLCOPCB4018922 thu^Hitnial B I 0 * T E S T Jahoia/oiicl, 9nc. 39 44, TABLE XX TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes ' Three-Month Sacrifice Group: 100 ppm Number of Animals Organ Examined Findings 5 Males Trachea Tracheitis 5 Females Lung Chronic respiratory disease Focal interstitial pneumonia Ave rage Incidence Grade 2 1.0 2 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 = extreme OSi* 035096 STLCOPCB4018923 $ndnA&Ual B l O - T E S T lalmato'lLeA, Sue. MBBaraiMiiviiwiiiTwirimi^^ 40 HSc 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 anlayses conducted on ab solute 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 1242. DSW 035097 STLCOPCB4018924 HaJuiiAial B l O * T E S T Dietary Level of Aroclor 1242 (pom) Control 1 10 100 . TABLE XXI TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Six-Month Sacrifice Summary of Mean Values Organ: Liver Organ Weight (g) Males Females 22.9 13.8** 22.3 22.0 13. 1 9.98* 13.2 11.7 Organ/Body Weight Ratio (g/100 g) Males Females 3.74 3.77 2.85** 3. 15 4.08 4.23 4.58* 3. 70 Organ/Brain Weight Ratio (g/g) Males Females 11.7 6.86** .11.0 6.71 5.76 6.95 ' 10. 8 * 5. 9 4--- \ * Statistically significant difference at the 95 percent confidence level. ** Statistically significant difference at the 99 percent confidence level. DSW 035098 fc D ndit-ikial B I 0 - T E S T la lto ia ly ik A , Unc. STLCOPCB4018926 Dietary Level of Aroclor 1242 (onm)__________ Control ' 1 10 100 TABLE XXII TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Six-Month Sacrifice Summary of Mean Values Organ: Kidneys . Organ Weight Organ/Body Weight Ratio Organ/Brain Weight Ratio (g) (g/100 g) (g/g) MalesFemalesMales_______ FemalesMalesFemales 4.04 3.51 2.79 2.44* 0.664 0.728 0.806 0.774 2.06 1.75 1.43 1.41 3.75 3.54 2.49* 2.3 3* 0. 686 ' 0.730 0. 790 0. 757 1.86 1.74 1.31 1.18 * Statistically significant difference at the 95 percent confidence level. o i/> at o o vO sO >fc. CvJ u TABLE XXIH TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Six-Month Sacrifice . Summary of Mean Values .' . Organ: Spleen Dietary Level of Organ Weight Organ/Body Weight Ratio Organ/Brain Weight Ratio Aroclor 1242 (g) (g/100 g) (g/g) (ppm)Males_______ FemalesMales FemalesMalesF emales Control 1 10 ' 100 0.752 0. 754 0.796 0.584 0.684 0.542* 0.622 0.488* 0. 122 0.154 0. 142 0.120 0. 196 0.172 0. 199 0.159 0.384 0.375 0.394 0.288 0. 350 0.313 0.327 0.248 * Statistically significant difference at the 95 percent confidence level. oin 5. O U) VJt o o P ndiisU iat 0B l - T E S T r <y V-v Lo %> Jm  Dietary Level of Aroclor 1242 (ppm) Control 1 10 100 TABLE XXIV TEST MATERIAL: Aroclor 1242 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. 3.44 0.0810 3.55 0. 106 3.35 0.0772 Organ/Body Weight Ratio (g/100 g) Males Females 0.593 0. 0279 0.716 0.0253 0. 652 0.0335 _ 0.697 0.0251 Organ/Brain Weight Ratio (g/g) Males Females. 1.81 0.0492 1.71 0.0468 , 1.76 1.65 0.0558 * 0.0392 - CP O m Ln & S' SV-' STLCOPCB4018928 tOoo sc o .to. U) U1 I-- o U D n d u ltiia l B I O - T E S T J?a/ityia{aiici, !)nc. STLCOPCB4018929 . ' Dietary Level of Aroclor 1242 (pom) Control ' 1 10 100 TABLE XXV TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Six-Month Sacrifice Summary of Mean Values Organ: Heart . Organ Weight (g) Males F emales 1.70 1.05 1.49 1.03 1.46 1.06 1.42 0.970 Organ/Body Weight Ratio (g/100 g) Males Females 0.282 0.302 0.309 0. 325 0.267 0. 335 ' 0.293 0.314 Organ/Brain Weight Ratio (g/g) Males F emales 0. 867 0. 538 0.741 0.595 , 0.722 0. 558 ' 0.700 0.492 D 3C Ou> Ul c fv & t D ttduiU icil B l O - T E S T la lio -ia ia iia i, Unc, STLCOPCB4018930 > . .' Dietary Level of Aroclor 1242 (Dom) Control l ' 10 100 . TABLE XXVI . TEST MATERIAL: Aroclor 1242 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 F emales 1.96 1.95 2.01 1.73 2.02 1.90 2.03 1.97 Organ/Body Weight Ratio (g/100 g) Males F emales 0.320 0.560 0.415 0.546 0.369 ' 0.416 0. 597 0.635 Final Body Weights of Sacrificed Rats (g) Males Females 613 348 484 317 548 488 318 310 o <aSti o u U1 Io-- UJ 4o*. X. U SrtduAkial B I 0 - T E S T lakyiaityiicA, Dnc. 47 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 1242. , DSw 035104 STLCOPCB4018931 B 1 O - T E S T la-bo'iaixy'ucA, 9*ic. 48 XJJ TABLE XXVII TEST MATERIAL: Aroclor 1242 /. Two-Year Chronic Oral Toxicity Study - Albino Rats / Histopathologic Changes Six-Month Sacrifice Group: Control Number of Animals Organ Examined Findings Ave rag Incidence Grade 5 Males Trachea Lung Liver Skeletal Muscle Tracheitis Focal tracheitis Focal pneumonitis Hype rem ia Focal pericholangitis Focal inflammation \2 '2 1 2 1 1 ' 1.5 1.0 0.5 1.0 1.0 1.0 5 Females Trachea Lung Liver Kidney Focal tracheitis Hyperemia Hype remia Pericholangitis Focal pneumonitis ' 1 2 1 1 1 1.0 2.5 1.0 0.5 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 = extreme DSW 035105 STLCOPCB4018932 9ddu4lual B I 0-T E S T Xabyia&yiiot, $nc. 49 TABLE XXVIII TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Six-Month Sacrifice Group: 100 ppm Number of Animals Organ Examined Findings Ave r age Incidence Grade 5 Males Trachea Lung Tracheitis Focal tracheitis Focal pneumonitis Hype remia 2 1.0 2 0.5 3 1.5 2 1.0 5 Females Trachea Lung Focal tracheitis Focal pneumonitis Hype remia 1 1.0 1 0.5 1 2.0 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 ' 035106 STLCOPCB4018933 DnduiiAiai B l O * T E S T jtahyiahyiled, Jhc. 50 3, Twelve-Month Sacrifice a. Gross Pathologic Findings l Gross pathologic findings among test animals were not significantly different from those noted in control animals. b. Organ Weight and Ratio Data ^ 'i The mean organ weight and ratio data collected at the i twelve-month sacrifice are presented in Tables XXIX through XXXIV. i 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 1242. DSy 035107 STLCOPCB4018934 frtd tilfo ia l B I O - T E S T la h o ia lo iw l, %ic. TABLE XXIX TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Twelve-Month Sacrifice Organ Weight and Ratio Data Summary of Mean Values Organ: Liver Organ Weight Dietary Level (g) ' (ppm)MalesFemalesMales Control - 22. 1 15.5 . 1 22. 7 13.7 10 22.4 14.4 . 100 26.3 14.4 Organ/Body Weight Ratio Organ/Brain Weight Ratio (g/100 g) (g/g) FemalesMalesFemales 3. 79 3. 52 10. 8 7. 72 3.45 3. 33 10.4 7. 05 ' 3.48 3.44 10.6 7. 39 . 3.78 3. 59 12.4 7. 16 51 o in otu t--' o03 Diuluit'iial B I 0 - T E S T . Dietary Level (onm) Control l 10 100 TABLE XXX TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats . Twelve-Month Sacrifice Organ Weight and Ratio Data Summary of Mean Values Organ: Kidneys . Organ Weight Males (g) Females 4. 04 4. 31 4. 27 4. 98* 3.19 2. 93 3.24 3. 01 Organ/Body Weight Ratio (g/100 g) Males F emales Organ/Brain Weight Ratio (g/g) Males F emales 0. 692 0. 656 0. 662 0. 716 0. 738 0. 735 0. 779 0. 745 1.97 1. 97 ' 2. 02 2. 33 1. 58 1. 51 1.66 1. 50 9<tc. * Statistically significant difference at the 95 percent confidence level. 52 $ V, D Co s: o vjn ovO onr `w y w / n f J. S 3 1 " I fl0 V 'W 'T 'G ' Dietary Level (t>pm) Control 1 10 100 TABLE XXXI TEST MATERIAL: Aroclor 1242 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 F emales Organ/Body Weight Ratio (g/100 g) Males F emales Organ/Brain Weight Ratio (g/g) Males F emales 0. 788 1.000* 0. 868 0. 968 0. 796 0.600 0. 664 0. 570 0. 133 0. 152 0. 136 , 0. 138 0. 183 0. 153 0. 160 0.145 0. 380 0. 396 0. 458 0. 307 0.412 0. 341 ' 0. 454 - -0*285 * Statistically significant difference at the 95 percent confidence level. D</) s: oUJ o  Dietary Level (pom) Control 1 10 100 TABLE XXXII TEST MATERIAL: Aroclor 1242 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 3.46 0.116 . 3.47 0. 0938 3. 00 3.67* 0. 141 0. 122 Organ/Body Weight Ratio (g/100 g) Males F emales Organ/Brain Weight Ratio (g/g) Males F emales 0. 596 0. 529 0. 457 0. 531 0.0275 0.0239 0.0332 0.0305 1.70 1. 59 ' 1.40 1.72 0.0574 0.0483 0.0719 0.0608 * Statistically significant difference at the 95 percent confidence level. o Lr> s: o bbno cn O rn to v. s p Su * U ndulfnial D I O * T E 5 T J.alo'iato'uc-i, TABLE XXXI TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Twelve-Month Sacrifice Organ "Weight and Ratio Data ' Summary of Mean Values ' Organ: Spleen Dietary Level (t>nm) Organ Weight (g) Males F emales Organ/Body Weight Ratio (g/100 g) Males F emales Organ/Brain Weight Ratio (g/g) Males F emale s Control 0. 788 0.796 0. 133 0. 183 0. 380 0. 396 1 1.000* 0.600 0. 152 0. 153 0. 458 0. 307 10 0. 868 0. 664 0. 136 0. 160 0.412 0. 341 100 0. 968 0. 570 , 0. 138 0. 145 ' 0.454 " U^285 * Statistically significant difference at the 95 percent confidence level. . ' - ' D to ui Ls) O uU>1 N> X> s fy id ttifiitil 0B I - T E S T 9nc. Dietary Level (ppm) Control 1 10 100 TABLE XXXII TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Twelve-Month Sacrifice Organ Weight and Ratio Data Summary of Mean Values Organ: Gonads ' Organ Weight Males (g) F emales - 3.46 0.116 . 3.47 0. 0938 3. 00 0. 141 3.67* 0. 122 Organ/Body Weight Ratio (g/100 g) Males F emales Organ/Brain Weight Ratio (g/g) Males F emales 0. 596 0. 529 0.457 # 0.531 0.0275 0.0239 0.0332 0.0305 1. 70 1. 59 1.40 1. 72 0.0574 0.0483 0.0719 0.0608 # Statistically significant difference at the 95 percent confidence level. Vl ooso: *** 1 o U1 %* w* STLCOPCB4018941 ' Dietary Level (com) Control 1 10 100 D In s: o OUJl TABLE XXXIII TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rat3 Twelve-Month Sacrifice Organ Weight and Ratio Data ' Summary of Mean Values ' Organ: Heart Organ Weight (g) Males Females Organ/Body Weight Ratio (g/lOOg) Males Females Organ/Brain Weight Ratio (g/g) Males F emales 1.71 1. 69 1.68 1. 87 1.23 1. 18 1. 29 1. 19 0. 293 0. 258 0. 263 , 0.268 0. 286 0. 298 0.312 0.298 0. 835 0. 776 ' 0.799 0. 878 0. 609 0. 610 0. 663 0. 591 55 <4 !)nc. B i O T* S T v itf `i.>nvjrw ynj- J. S 3 1 * O l ' Dietary Level (own) Control 1 10 100 TABLE XXXIV TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Twelve-Month Sacrifice Organ Weight and Ratio Data . Summary of Mean Values Organ: Brain Organ Weight (g) Males F emales 2.04 2.02 . 2.19 1. 95 2.11 1. 95 2.14 2. 00 Organ/Body Weight Ratio (g/100 g) Males F emales Final Body Weight of Sacrificed Animals (grams) Male s F emales 0. 351 0. 334 0. 474 0. 516 584 439 660 431 0. 329 0. 310 0.473 0.508 642 425 ' 698* -- -__^409 )/V (f 95 * Statistically significant difference at the 95 percent confidence level. oco sc ou> Ui U1 (LtiOtial B I O - T E S T Xalnyuiioniei, $nc. 57 *97 c. Histopathologic Findings Histopathologic examination of tissues taken from each rat sacrificed from the control and 100 ppm groups after twelve months of testing was conducted. Tables XXXV and XXXVI list all histopathologic changes noted. All of the lesions noted in the microscopic examination were those of spontaneous disease and cannot be related to the ingestion of Aroclor 1242. . DSW 035116 STLCOPCB4018943 ^ndnUtial B I O - T E S T Xahy-'iai&'uei, Hue. Sli/l 58 / TABLE XXXV TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Twelve-Month Sacrifice Group: Control . Humber of Animals Organ Examined Findings Incidence Avc rage Grade 5 Males Trachea Lung Urinary Bladder Tracheitis Chronic respiratory disease Calculus 1 2 1 1.0 1.0 1.0 5 Females Trachea Lung Colon Tracheitis Chronic respiratory disease Parasites 1 1 1 1.0 1.0 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 = extreme DSW 035117 STLCOPCB4018944 UtiduiUlal B l O T E S T XaliMabnicJ., 9kc. 59 TABLE XXXVI TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Twelve-Month Sacrifice Group: 100 ppm Number of Organ Animals Examined Findings Average Incidence Grade 5 Males Trachea Lung Liver Pancreas Kidney Pituitary Adrenal Tracheitis Chronic respiratory disease Congestion Focal atrophy Focal lymphoid infiltration Chromophobe hyperplasia Nodular hyperplasia Hematocyst 5 Females Trachea Lung Tracheitis Chronic respiratory disease 1 4 1 1 1 1 1 1 1 1 1.0 1. 0 1.0 1. 0 1.0 1.0 1.0 1.0 1. 0 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 = extreme DSW 035118 STLCOPCB4018945 Utid-uAhial B I O - T E 5 T Xalnyiafa'ueA, 9nc. 60 An 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. The absolute liver weight and liver to body or brain weight ratios were significantly evaluated in female rats fed 100 ppm Aroclor 1242. Statistical evaluations of other organ weights, organ to body weight and organ to brain weight ratios disclosed several randomly occurring intergroup dif ferences. The lack of any consistent dose related response indicates that these differences were not related to the ingestion of Aroclor 1242. DSW 035119 STLCOPCB4018946 ry Level 30m) antrol 1 10 100 TABLE XXXVII TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Summary of Mean Values Final Sacrifice Organ Weight Males ief Females Organ: Liver Organ /Body Weight Ratio (g/100 g) Males Females 22.0 21.9 22. 3 16.3 15.7 17. 1 3.47 2. 93 3. 18 3.05 3.00 3. 19 25.6 22.4** 3.95 4.82** tatistically significant difference at the 99 percent confidence level. r Organ/Brain Weight Ratio Males (g/g) Females 10. 10 9.97 8.42 8.03 10. 20 11.90 8.50 . N 11.60** B IO -TE S T B 1O * T E S T qIk\% ;tary Level (com) Control 1 10 100 TABLE XXXVIII TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Summary of Mean Values Final Sacrifice ' Organ Weight Males (g)' Females 5. 57 3.48 6. 13 3.45 Organ: Kidneys Organ/Body Weight Ratio (g/100 g) Males Females 0. 877 0. 646 0. 820 0. 670 ' 5.63 5.44 3.43 3.43 0. 816 . 0.835 0. 644 0. 725 5s ' Organ/Brain Weight Ratio Males (g/g) Females 2. 57 1. 79 2. 78 1. 76 2. 56 2. 52 1. 71 1. 79 ooo c o ro Ui hho u htfaitm al B IO -T E S T JoJioi STLCOPCB4018949 etary Level (com) Control 1. 10 100 TABLE XXXIX TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Summary of Mean Values Final Sacrifice '' S' . Organ: Spleen '^ _______________________________;_________________________________ ________________________________________________ | Organ Weight Organ/Body Weight Ratio Organ/Brain Weight Ratio Males (g)' Females Males (g/100 g) Females Males (g/g) F emales 1. 15 1. 26 0.96 0. 81 0. 182 0. 169 0. 181 0. 158 0. 520 0. 572 0. 492 0. 145 1.08 1. 07 0. 82 0. 65 0. 158 , 0. 165 0. 153 ' 0. 140 0.495 0.499 0. 409 0. 339 D 00 o OJ O U1 t-- K) X> h O s 3 1 * o 19 Tm v"p'(ii ;ary Level (cum) Control 1 10 100 TABLE XL TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Summary of Mean Values Final Sacrifice Organ Weight (gV Males Females 2. 52 0.123 ' 3. 20 0. 102 Organ: Gonads Organ/Body Weight Ratio (g/100 g) Males Females 0. 397 0.0222 0.424 0.0205 3.00 3.31 0. 126 0. 129 0.437 ' 0.514 0. 0237 0.0278 C! ua>t o uj Ui . K) UJ Organ/Brain Weight Ratio (gig) ' Males Females 1. 15 1.46 0. 0628 0. 0523 1.40 0. 0625 1.55 ^ 0. 0671 o > %> s Mr `**c STLCOPCB4018950  :ary Level (oom) Control 1 10 100 TABLE XL! TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Summary of Mean Values Final Sacrifice ' Organ Weight (g)' Males Females Organ: Heart Organ/Body Weight Ratio {g/100 g) Males Females 1.87 2.30* ' 2.08* 2. 19* 1. 54 1. 51 .2.59 1. 41 ' 0. 294 0.307 0.303 . 0.335 0. 288 0.292 0. 298 0. 303 . Statistically significant difference at the 95 percent confidence level. Statistically significant difference at the 99 percent confidence level. o Caot o Ui U1 t***1 IV Organ/Brain Weight Ratio (g/g) - Males F emales 0.860 1.040** 0.959* 1.010** 0. 795 0. 770 0. 788 0. 741 f5 4 J S | 0DHfLt-lbual B I * T E S T J.aboAalo-'iiel, 9nc.\ 0DttdniUial B I " T E S T lahyiatoAiai, Stic. STLCOPCB4018952 Dietary Level ______(ppm)______ Control 1 ' 10 100 TABLE XLII TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Organ Weight and Ratio Data Summary of Mean Values Final Sacrifice ' Organ Weight Males (g) Females . 2. 18 2. 20 . 1.95 1.96 2. 18 ' 2.01 2. 14 1.91 Organ: Brain Organ/Body Weight Ratio (g/100 g) Males Female 0. 342 0. 362 0. 294 0. 388 0. 313 0. 379 0. 330 0. 415 Final Body Weight of Sacrificed Animals (grams) Males Females 642 551 759 532 . 734 547 652 485 o to o u> Ul o o t-1 hJ * Vs Uniuiinial B I O - T E 5 T lalpyiahn-U, 9nc. 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 XLVH contains the results of the histopathologic examination of the urinary bladders. \ Significant liver injury was found in animals fed 100 ppm Aroclor 1242 (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 degeneration in this group which, although seen in the controls and lower test groups, were more severe and frequent in the T-III group. The vacuolar change was not seen in the control animals but was observed occasionally in liver from T-I (1 ppm) and T-H (10 ppm) animals. The vacuolar change was observed frequently 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 O to reveal the presence of fat. The vacuolar lesion in the cytoplasm of these cells was positively identified as fat. The hypertrophic change 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 cytoplasm. DSW 035126 STLCOPCB4018953 jj^dudfoial B l O * T E S T Jafoytafoiled; 9hc. 68 The hyperplasia was associated with the same cells and appeared 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 1242. This level of liver disease is not unusual in old animals. Hyperplasia of the transitional epithelium was present in the urinary bladder of animals from the control group and from each of the test groups. This lesion was usually associated with cystitis. All of the other lesions in the other tissues found in these animals are related to spontaneous disease and they are not unusual for rats of this age. . Donovan E. Gordon, D. V. M. , Ph. D. Diplomate, American College of Veterinary Pathologists DSW 035127 STLCOPCB4018954 Humber of Animals 1 Males o to o OJ TABLE XL III TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: Control Organ Examined Heart Trachea Lung . Liver .. Stomach Spleen Kidney Testes Prostate Adrenal Gland Brain Eye Findings Chronic focal myocarditis Tracheitis Chronic respiratory disease Focal degeneration Ductile hyperplasia Chronic gastritis Hemosiderosis Chronic nephritis Testicular degeneration Periarteritis Inflammation Telangiectasis Nodular hyperplasia Focal fatty change Focal encephalitis Inflammation Incidence 3 3 9 1' 2 1 3 8 2 2 1 1 1 1 1 2 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 O' J la lto 'ia to iu'A, 9nc. ' B IO -TE S T QtJ ilu a l STLCOPCB4018956 TABLE XLIII continued TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: Control Number of AnimalsOrgan ExaminedFindings_______ _IncidenceGrade 4 Females Heart Trachea Lung Liver Stomach Colon Spleen o s(/>; Uterus Kidney o u> U1 Ovary to vO 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 7 9 13 3 2 1 2 3 5 I 4 3 6 1 1 Average 2. 0 1.0 1.0 1.0 1.0 1.0 0. 5 1.0 1.0 1. 0 2. 0 1.0 1. 0 1. 0 o-j 5L s 'w 6 S 3 1 O 19 r - W 'T 'ti STLCOPCB4018957 \*umber of Animals 4 Females TABLE XLIII continued TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: Control' Organ Examined Adrenal Gland Salivary Gland Findings . Telangiectasis Nodular hyperplasia Chronic fibrosis and atrophy Incidence 9 4 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 </> s: o u> u> o Ci' U3 m v> Average Grade 1.0 1.0 1. 0 Cl Sr s 3 ! aOIi Number of Animals 13 Males 9 TABLE XLrv TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 1 ppm ' Organ Examined Heart Trachea Lung Liver . Stoma ch Spleen Kidney ' Testes Prostate Adrenal Gland Findings Chronic focal myocarditis Tracheitis Chronic respiratory disease Focal lymphoid infiltration Cirrhosis Congestion Chronic gastritis and acanthosis Hemosiderosis Chronic nephritis Calcification Periarteritis Testicular degeneration Inflamma tion Telangiectasis Nodular hyperplasia Incidence 5 9 12 1 1 1 2 .4 9 1 2 1 1 2 1 Average Grade 1.0 2. 0 1.0 1.0 1.0 1:0 1.0 2. 0 2. 0 1. 0 2. 0 1.0 4, 0 1. 0 2. 0 STLCOPCB4018958 DSW 035131 ??? si ai - O1Q TABLE XLIV continued TEST MATERIAL: Aroclor 1Z42 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 1 ppm - Number of Average AnimalsOrgan ExaminedFindingsIncidenceGrade 14 Females o </) S' o VJ1 *-* (V Heart Trachea Lung Liver Pancreas Stomach Spleen Kidney Uterus Adrenal Gland Chronci focal myocarditis Tracheitis Chronic respiratory disease Ductile hyperplasia Chronic focal pancreatitis Chronic gastritis Ulcerative gastritis Acanthosis Hemosiderosis Chronic nephritis Metritis Telangiectasis ' 6 7 13 3 2 2 1 2 8 6 1 10 1. 0 1. 0 1. 0 1. 0 1. 0 1. 0 1. 0 1. 0 2. 0 1. 0 1. 0 1. 0 i fr a 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 STLCOPCB4018960 Number of Animals 13 Males TABLE XLY TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 10 ppm ' Organ Examined Heart Trachea Lung Liver Pancreas Stomach Spleen Kidney Testes Findings Chronic focal myocarditis Tracheitis Chronic respiratory disease Focal hypertrophy and hyperplasia Hypertrophy Vacuolar change (fatty) Ductile hyperplasia Chronic focal pancreatits Acanthosis Inflammation, ulceration and ne'erosis Hemosiderosis ' Chronic nephritis Testicular degeneration Periarteritis Incidence 6 7 9 1. 1 2 1 3 6 1 7 10 2 3 DSW 035133 Average Grade 1. 0 1. 0 2. 0 1.0 1. 0 1 DO 2. 0 1. 0 1. o 1. 0 1. o 2. 0 3. 0 3. 0 -o ou `fvn vjD io yn p J. $ 3 J. - Q I 9 TABLE XLV continued TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 10 ppm' Number of Animals___________Organ Examined________________________ Findings Incidence 13 Males Prosta te Adrenal Gland Inflamma ti on Telangiectasis Medullary hyperplasia Nodular hyperplasia 2 4 1 2 13 Females O (SI 3~ O h-1 U> 4s (/) Heart Trachea Lung Tongue Stomach Spleen Lymph Node Kidney Uterus Adrenal Gland Chronic focal myocarditis Tracheitis 1 5 Chronic respiratory disease Periarteritis .9 1 Chronic gastritis and acanthosis Ulceration Hemosiderosis 5 1 5 Edema Chronic nephritis Metritis 1 6 2 Telangiectasis Nodular hyperplasia '8 1 O O -oo All other tissues and organs were normal histologically. 00 Ao otoo 0> 0. 5 = minimal 1.0 - *= 1; r 1'* Grading System 2. 0 = mild 3. 0 r moderate 4. 0 = severe 5.0 - rcmc Average Grade 3. 0 1. 0 1. 0 1.0 1. 0 1.0 1. o 2.0 1. 0 1. 0 2.0 1.0 1. 0 1.0 1. 0 1.0 Cn S yzfixymxynj- 1 S 3 1 * O I tl 1v>viprpC H tuhiihial B I O - T E $ T lalfonatyiiM , 9nc. Number of Animals 6 Males TABLE XLVI TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 100 ppm' Organ Examined Heart Trachea Lung Liver ' Pancreas Testes Stomach ' Spleen Lymph Node Kidney Findings Incidence Chronic focal myocarditis Tracheitis Chronic respiratory disease Focal degeneration Focal hypertrophy Hypertrophy Vacuolar change (fatty) Periarteritis Periarteritis Chronic gastritis and acanthosis Periarteritis Hemosiderosis Periarteritis . ---- ~ ' Chronic nephritis 3 3 6 1 1 1 3 1 3 1 1 1 ------------- 1 4 ' Average Grade 1.0 2. 0 1.0 1.0 1.0 1.-0 1.0 3. 0 2. 0 1.0 2. 0 s 1.0 _ 3. 0 2. 0 . STLCOPCB4018962 DSW 035135 tC C 4} TABLE XLVI continued TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 100 ppm' Number of . Average AnimalsOrgan ExaminedFindingsIncidenceGrade 6 Males Prostate Adrenal Gland Salivary Gland Eye Inflammati on Focal fatty change Focal chronic inflammation Inflammation 1 1 1 1 3. 0 1.0 1. 0 1.0 I S> 6CO O m cr> <v 14 Females a V) z o Ul U) cr Heart Trachea Lung Liver Chronic focal myocarditis Tracheitis Chronic respiratory disease Focal degeneration Focal hyperplasia Focal hypertrophy Hypertrophy - Nodular hyperplasia Focal cholangiohepatitis 4 .8 6 3 2 2 3 1 1 1.0 1.0 1. 0 1. 0 1.0 1.0 2. 0 1.0 1. 0 -o X* Vs Vi mmmmmmmmsmrn** TABLE XLVI continued TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes Final Sacrifice Group: 100 ppm Number of Animals Organ Examined Findings 14 Females o Co S' o UJ Ul Liver (continued) Pancreas Stomach . Spleen Lymph Node Kidney Uterus Adrenal Gland Focal hepatitis Hyperplasia Vacuolar change (fatty) Chronic focal pancreatitis Chronic gastritis Acanthosis Ulcerative gastritis Ulcer Hemosiderosis Congestion Chronic- nephritis Metritis Telangiectasis _ Nodular hyperplasia Acanthosis All other tissues and organs were normal histologically. Incidence 1 1 11 1 2 2 1 .1 4 1 7 2 8 4 1 0.5= minimal 1.0 = slight Grading System 2. 0 = mild 3.0 = moderate 4. 0 = severe 5.0= extreme Average Grade 1.0 3. 0 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 STLCOPCB4018965 TABLE XLVH TEST MATERIAL: Aroclox 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Histopathologic Changes of the Urinary Bladder Final Sacrifice Group C Sex M F Number Examined 11 14 Findings* Proteinaceous plug (34) Focal epithelial hyperplasia (62) T-I (1 ppm) M 12 F 13 Proteinaceous plug (5 82) Diffuse epithelial hyperplasia associated with diffuse cystitis (566) Diffuse epithelial hyperplasia associated with diffuse cystitis (580) None T-H (10 ppm) T-m (100 ppm) M F M F 11 13 6 13 Diffuse epithelial hyperplasia associated . with diffuse cystitis (651) Diffuse epithelial hyperplasia associated with diffuse cystitis and a proteinaceous plug (655) None Proteinaceous plug (744) Focal epithelial hyperplasia (767) * Individual animal numbers are shown in parentheses. Grading System 1.0 = minimal or trace 4. 0 = severe 2. 0 = mild 5.0 = extreme 3.0= moderate DSW 035138 Incidence 1 1 1 1 1 1 1 1 1 Average Grade 1 _ 2 1 - 3 1 - _ 2 Xjs, W f 'jwwypwys/- S3 1 * O I ai SndtUt'uai B I O - T E S T Jalx^iaU'ilcS, Snc. 80 X 7 c 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 1242 and are considered normal for a random population of rats this age. .\ 1 i i \ OSW 035139 STLCOPCB4018966 Animal lumber ind Sex 1-M 2-M * ' 16-F Location Abdomen Pancreas Abdomen 47-F 48-F 50-F 52-F 59-F 64-F 66-F Lymph node o(/) Abdomen E Abdomen u> Ui Abdomen 1-- o Abdomen Adrenal gland Abdomen Abdomen TABLE XLVH2 TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Description of Tumor Findings Group: Control Weight (grams) Size (cm) -- 11.76 - 64.98 35.09 - . 8x1x2 5x2x2 - - 2x2x1 - 2x2x3 -- - - 88.92 230.00 13 x 11 x 4 13 x 11 x 4 Classification Mammary fibroadenoma Adenocarcinoma Mammary fibroadenoma Mammary fibroadenoma ' R.eticulum 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 `w y v w tp j- s 3 1 o I ai STLCOPCB4018968 Animal Number and Sex 566 -M 569-M 604-F 609-F 611-F Location Abdomen Spleen Abdomen Abdomen Abdomen 613-F 615-F o t0 Ovary se Abdomen o U1 Abdomen TABLE XLIX TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Description of Tumor Findings Group: 1 ppm Weight (grams) 15. 00 53. 50 35. 00 335.00 Size ' (cm) 5x3x1 5x3x1 lxlxl 3x2x1 13 x 10 x 5 Classification Adenocarcinoma Lymphosarcoma Mammary fibroadenoma Fibroadenoma Fibroadenoma Fibroadenoma Granulosa cell tumor Fibroadenoma Mammary fibroadenoma oo O m cr> Months on Test 24 22 24 24 24 24 i: 23 0tv3 vt 'm w p w ffv jr l s 3 i - 0 19 Animal Number and Sex 621 -F 627-F 628-F 630-M 631-F 634-F 635-F Location Abdomen Pituitary Abdomen Abdomen Uterus Abdomen Abdomen Abdomen Pituitary TABLE XLIX continued TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Description of Tumor Findings Group: 1 ppm Weight (grams) 18. 00 - 157.20 117.90 44. 00 13.41 39. 36 Size (cm) 1x3x3 6x3x3 9x6x4 7x6x2 3x2x1 6x5x3 6x5x4 Classification Fib ro adenoma Chromophobe adenoma Fibroadenoma . Mammary fibroadenoma Mammary fibroadenoma Fibroma Fib roadenoma Fibroadenoma __ Fib roadenoma Chromophobe adenoma Months on Test 24 24 24 23 24 24 24 $1 x e8 STLCOPCB4018969 DSW 035142 Animal Number and Sex 640-M 646-M . 662-M 687-F 689-F 690-F 695-F 697-F 703- F TABLE L TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Description of Tumor Findings Group: 10 ppm Location Weight (grams) Abdomen 129. 0 Pancreas Adrenal gland - Pituitary Abdomen - 280. 0 Pituitary .- Abdomen - Pituitary - Abdomen Abdomen 3. 90 23. 15 Abdomen 175. 0 Parathyroid gland - Size (cm) 9x7x 3 -- - - - - - - 3x3x2 7x 6x3 8 x7x 5 - Classification Fibroadenoma Islet cell adenoma Medullary tumor Chromophobe adenoma Mammary fibroadenoma Chromophobe adenoma Mammary adenocarcinoma Chromophobe adenoma Mammary fibroadenoma Mammary fibroadenoma Mammary fibroadenoma Adenoma Months on Test 24 24 24 22 . 24 24 24 24 24 24 STLCOPCB4018971 vhimal umber nd Sex 07-F 08-F 11-F 12-F Location Abdomen Abdomen Abdomen Subcutaneous, abdominal TABLE L continued TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Description of Tumor Findings Group: 10 ppm Weight (grams) 74. 6 189.0 6.96 155.0 Size (cm) 7x6x3 5x4x1 3x2x1 11x8x3 Classification Mammary fibroadenoma Mammary fibroadenoma Mammary fibroadenoma Fatty tissue fibroma D (/> ST O UJ Vt -- 4> Months on Test 24 24 24 24 CD O to CLn 3U s 3 1 190i 'VC Animal Number and Sex 744-M 775-F 785-F 789-F 794-F Location Pancreas Ovary Pituitary Adrenal gland Abdomen TABLE LI TEST MATERIAL: Aroclor 1242 Two-Year Chronic Oral Toxicity Study - Albino Rats Description of Tumor Findings Group: 100 ppm Weight (grams) .260. 0 Size (cm)___________ 10 x 10 x 5 Clas sification Islet cell adenoma Granulosa cell tumor Chromophobe adenoma Medullary tumor Mammary fibroadenoma o t/> sc o OJ U1 Months on Test 24 24 24 24 23 STLCOPCB4018972 M XT'.