Document mqJJ5gzQKXdx9Q8r05z3zyYVk

9nduAbUal B I O - T E S T JalmatyUeS, Uno. REPORT TO MONSANTO COMPANY TOXICITY, REPRODUCTION AND RESIDUE STUDY WITH AROCLOR 1221 IN WHITE LEGHORN CHICKENS JUNE 20, 1972 IBT NO. J900 I. Introduction At the request of Monsanto Company, a toxicity, reproduction and residue study with Aroclor 1221 in White Leghorn chickens was initiated. This report presents the results of the investigation conducted at Wedge's Creek Research Farm, Industrial BIO-TEST Laboratories, Inc. ' DSW 034928 STLCOPCB4018755 !)nduibUal B I O - T E S T lalvVialvUei, 9*c. 2 II. Summary A toxicity, reproduction and residue study was conducted in White Leghorn chickens with Aroclor 1221. The levels were 1 {T-I), 3 (T-II) and 10 (T-III) ppm in the diet. The results of the study are as follows: The body weights and food consumption of adult birds were normal. Three females died; one in the control group, one in the T-II group and one in the T-III group. There were no significant gross pathologic changes in any of the birds. No abnormalities or systemic signs of toxicity attributable to the in gestion of Aroclor 1221 were observed during the investigation. Egg production for control birds during the test period was lower than for the birds in the three test groups. In addition, the percentage of defec tive eggs was greater in the control group than in any of the three test groups. The hatchability of eggs in the T-III group (75. 1%) was slightly lower than the hatchability in the control group (85.0%), the T-I group (85.4%) or the T-II group (83.3%). Specific gravity and shell thickness of eggs revealed no significant differences between the control and three test groups. OSW 034929 STLCOPCB4018756 Dnd^i'Ual B I O - T E S T laboKzlyUe*' Dnc, 3 The body weight and viability data for chicks revealed no significant intergroup differences. No gross pathologic alterations were noted at the time of sacrifice. Respectfully submitted, INDUSTRIAL BIO-TEST LABORATORIES, INC. Report prepared by: 'L L Dale Fletcher, B.S. Group Leader Wedge's Creek Research Farm Report approved by: /.c u a- V </t.i Donald H. Jenkirr^, D. V. M. Manager and Technical Director Wedge's Creek Research Farm M. L. Kepling^,^^^^^^^ Manager, Toxicology lk: slg:bb:psh OSW 034930 STLCOPCB4018757 jJndndlwil B l O - T $ T Jakviah-lieS, 9nc. 4 III. Procedure A. Experimental Animals The animals employed in the study were White Leghorn chickens. A total of 80 hens and 16 roosters was used. B. Organization of Groups The 96 chickens were divided into one control group (C) and three test groups (T-I, T-II and T-III). A structural outline of the experiment is presented in Table I. TABLE I TEST MATERIAL: Aroclorl221 Toxicity, Reproduction and Residue Study - White Leghorn Chickens Outline of Experiment Group Control Number of Animals Male Female 4 20 Dose Level _ . - (PPm) None T-I T-II 4 20 4 20 1.0 3.0 T-III 4 20 10.0 DSW 034931 STLCOPCB4018758 j,tduit-u4l b I U * f fc S T XaluytahyUei, 9nc, 5 C. Dosage and Feeding All groups received the same basal feed*. Test diets were prepared weekly. The test materials were diluted with acetone before addition to the feed to assure even distribution throughout the ration. An equal amount of acetone, without test material, was added to the control feed and the feed was then blended in the same manner as the test feeds. All animals were allowed water and their respective control or test feed ad libitum. Dosing began when the birds were 24 weeks of age and was continued for 13 weeks when hatching results were available. D. Observations Observations were made daily to ascertain the presence or absence of clinical signs of toxicity indicative of test material effect. All chickens were individually weighed and the group food consumption was determined weekly. As each group began laying, the eggs were collected daily and the egg weights recorded. When the egg weights were consistently between 50 and 60 grams and at least 50 percent of the hens in the group were laying, egg collection for that group was started. The time required to meet these criteria was recorded for each group. * Purina Flock Chow, Ralston Purina Co. , St. Louis, Mo. DSW 034932 STLCOPCB4018759 Dud^ihial B 1 O * T E S T 2cUnyuiiiyUei; 9nc, 6 The eggs were collected for the following parameters: 1. Egg Production and Quality Eggs were collected, weighed and candled for a number of seven-day periods. The total number, the individual weights of eggs collected and the total number of uncracked and unblemished eggs were recorded. 2. Hatchability Three-fourths of all non-defective eggs were randomly selected for the seven-day collection period, then placed in an incubator maintained at 99 to 100'F, with a wet bulb reading of 85. This pro cedure was followed until a minimum of 100 eggs from the control group and each test group had been set for hatching. The following were re corded. a. Number hatched. b. Number unhatched. c. Viability of chicks over a 30-day period, during which pe riod feed and wate r we re pe emitted ad libitum. d. Examination of unhatched eggs for fertility and stage of development. e. Weight of chicks after Day 1 and Day 30. 3. Physical Characteristics of Eggs One-fourth of the non-defective eggs and all of the defective eggs were examined to determine the following: a. Specific gravity. b. Thickness of shells at equatorial circumference (three measurements/egg). DSW 034933 STLCOPCB4018760 B 1 O - T E S T ^aJ&uii&UeA; 9hc. 7 4. Residue Studies The non-defective eggs examined for physical character istics were quick-frozen and shipped to Monsanto Company for residue analysis (shells and frozen contents separated). After hatching results were available, one-half of the chickens in each group were sacrificed, defeathered and subjected to a gross pathological examination. Individual samples of muscle, liver, fat and kidney from each group were collected and shipped to Monsanto Company for analysis. The remaining chickens were fed the base diet without test material for 30 days. The eggs were collected, weighed and candled during the recovery period. Ten eggs (minimum) per group per week were quick-frozen and shipped to Monsanto Company for analysis. At the end of the recovery regimen, the remaining chickens were sacri ficed and handled in the same manner as at the end of the test feeding pe riod. DSW 034934 STLCOPCB4018761 Jndudnial B l O - T E S T J.al*vuihvUe4-, 9*ic. 8 IV. Results A. Parental Generation 1. Body Weight Data The average male and female body weights during the test period are shown in Table II. The average male and female body weights during the recovery period are shown in Table III. These data are summarized in Table IV. The average body weight data for all test groups were considered normal when compared to the control group. DSW 034935 STLCOPCB4018762 BIO -TEST A ( (( TABLE II TEST MATERIAL: Aroclor 1221 Toxicity, Reproduction and Residue Study - White Leghorn Chickens Test Diet Period Body Weight Data Group Sex Mean Body Weight in kilograms Week: 012345678910______________ H______ 12 c M 2.05 2.06 2.09 2. 12 2. 14 2. 16 2. 16 2. 18 2. 20 2. 22 2. 22 2. 25 2. 26 F 1.71 1.71 1.73 1.76 1.76 1. 79 1. 84 1. 84 1. 84 1. 84 1.90 1.93 1.93 T-I M 1.92 1.97 2. 00 2. 06 2. 04 2. 07 2. 06 2. 09 2.09 2. 13 2. 15 2. 15 2. 1 8 F 1.66 1.67 1. 71 1.75 1.74 1.75 1. 77 1.79 1.78 1.81 1.83 1.81 1. 84 T-II M 1.91 1.91 1.95 1.97 1.99 2.01 2.04 2.08 2. 12 2. 12 2. 14 2. 16 2. 16 F 1.61 1.61 1. 64 1.66 1.66 1.70 1. 72 1. 75 1. 76 1. 76 1. 79 1.80 1. 79 t-iii M 2.03 2.04 2.09 2. 10 2. 12 2. 15 2. 16 2. 17 2. 19 2. 22 2.24 2. 22 2. 21 F 1.65 1.66 1. 70 1.70 1. 70 1. 74 1. 74 1.76 1. 79 1.79 1. 80 1. 80 1. 83 DSW 034936 sO STLCOPCB4018763 Pndnibktl B J O - T E S T 2alViai<yu&i, 2nc, 10 TABLE UI TEST MATERIAL; Aroclor 1221 Toxicity, Reproduction and Residue Study - White Leghorn Chickens Recovery Period Body Weight Data Group C T-I Sex M F M F Mean Body W eight in Kilograms Week: 1 23 4 2. 26 1. 86 2.23 1. 89 2. 24 1.91 2. 25 1.92 2. 32 1. 78 2.35 1. 78 2. 38 1. 79 2. 38 1.79 T-II T-III M 1.94 1.98 2.01 2.04 F 1. 66 1.69 1. 71 1. 70 M 2. 10 2.07 2.07 1. 99 F 1.83 1. 82 1. 83 1. 79 DSW 034937 STLCOPCB4018764 B 1O - T EST 9nc. Group C T-I T-II T-III TABLE IV TEST MATERIAL: Aroclorl221 Toxicity, Reproduction and Residue Study - White Leghorn Chickens Summary of Mean Body Weight Data (kilograms) Pretest Male Female 2. 05 1. 71 1.92 1.66 1.91 1.61 2.03 1.65 Test Period Male F emale 2. 16 1. 81 2.07 1.76 2.04 1. 71 2. 15 1.74 Sacrifice Male Female 2. 26 1.93 2. 38 2. 04 1. 79 1. 70 1.99 1. 79 DSW 034938 STLCOPCB4018765 9nduAlual B 1 O - T E S T JahMaio'U&lr Unc. 12 2. Food Consumption The food consumption data are presented in Table V. Food consumption data were considered normal for all test groups when com pared to the control group. DSW 034939 STLCOPCB4018766 !)ndud^iai B10*TEST JabyiafaUed, 9nc. 13 TABLE V TEST MATERIAL: Aroclorl221 Toxicity, Reproduction and Residue Study - White Leghorn Chickens Average Food Consumption (grams/bird/day) Week C T-I Group T-II T-IU Test Period 1 148.0 182.0 174.0 142.0 2 141.0 210.0 202.0 160.0 3 173.0 208.0 215.0 168.0 4 166.0 160.0 159.0 190.0 5 183. 0 219.0 208. 0 195.0 6 166.0 261.0 227.0 206.0 7 156.0 238.0 213.0 193.0 8 166.0 250.0 242.0 215.0 9 166.0 253.0 217.0 196.0 10 218.0 267. 0 221.0 242.0 11 211.0 244.0 224.0 204. 0 12 213.0 246.0 243.0 229.0 Recovery Period 1 110.0 200.0 225.0 227. 0 2 142.0* 180.0* 190.0* 201.0* 3 128.0 140.0 202.0 210. 0 4 135.0 T35. 0 152.0 139.0 * Incorporation of new feeding equipment. DSW 034940 STLCOPCB4018767 Dndnihial B I O * T E S T JaUta&U&i, Unc. 14 3 . Mortality and Reactions No abnormalities attributable to feeding Aroclor 1221 or systematic signs of toxicity were observed in any of the test groups when compared to the control group. Mortality, chronology and diagnoses are presented in Tables VI and VII. DSW 034941 STLCOPCB4018768 yndwdtial B I O - T E S T Ja&y&iyu&i; J^no, 15 TABLE VI TEST MATERIAL: Aroclor 1221 Toxicity, Reproduction and Residue Study - White Leghorn Chickens Mortality, Chronology and Diagnoses Group Animal Numbe r Sex W eek Died Clinical Diagnoses C 440 F 9 Lymphomatosis T-II 386 F 4 Prolapsed Rectum T-III 392 F 1 Prolapsed Rectum DSW 034942 STLCOPCB4018769 Dududtial BI O T E 5 T labyiaiiyUet., 16 TABLE VII TEST MATERIAL: Aroclor 1221 Toxicity, Reproduction and Residue Study - White Leghorn Chickens Mortality Data Group C T-I T-II T-m Number Tested MF 4 20 4 20 4 20 4 20 Numbe r Dead MF 01 00 01 01 Total Dead Total Tested 1/24 0/24 1/24 1/24 Percent Dead 4.2 0 4.2 4.2 M = Male F = Female DSW 034943 STLCOPCB4018770 yndtiilual B I O T E S T JaJxvuztvU&i, 9*vx 17 4. Gross Pathology Postmortem examination of the majority of birds revealed no abnormal tissue alterations. DSW 034944 STLCOPCB4018771 UnduAiMal B1 0 T E S T Jakmfcitei, 9m. 18 B- ESg-81. Egg Production and Quality The weekly egg production data are presented in Table VIII. The age of the hens in all groups when collection was started was 27 weeks and 31 weeks when hatching collection ended. The egg quality data are presented in Table IX. The percent age of defective eggs is greater in the control group than in any of the test groups. DSW 034945 STLCOPCB4018772 DmiuiUial B IO -T E S T f (( TABLE VIII TEST MATERIAL: Aroclor 1221 Toxicity, Reproduction and Residue Study - White Leghorn Chickens Egg Production Data.. Veek Control Average Weight Percent Jjjramej^ Production/Day Average W eight (grams) 1 52.8 2 53.9 3 54.6 4 55.8 S 56.7 6 57.0 7 57.4 8 58.3 9 58.6 10 59.2 11 60.5 12 59.4 62.8 75.0 69.2 70.0 75.7 66.4 62.8 63.5 72.8 66.9 68.9 56.5 49.4 51.7 50.3 53.1 54.1 55.1 55.3 55.6 56.4 56.8 56.8 56.6 T-I Percent Production/Day Average Weight (grams) Test Period 72.8 49.4 84.2 50.9 87.1 50.1 79.0 52.2 79.0 53.0 80.0 53.9 80.0 55.1 78.0 55.7 65.0 55.6 73.0 55.9 72.0 55.6 69.3 56.4 T-II Percent Production/Dav Average W eight (grams) 77.8 85.7 80.0 82.0 85.0 84.0 78.0 78.0 70.6 75.1 76.0 75.0 51.4 51.5 53.3 53.2 50.4 55.3 55.6 55.8 57.0 57.7 56.7 57.2 T-III Percent Production/Dav 77.4 81.9 73 .1 80.0 75.0 83.0 75.0 76.0 69.0 80.0 72.0 76.9 1 58.6 2 58.5 3 58.5 4 59.6 5* 58.9 65.4 68.2 68.2 69.8 74.0 57.0 56.0 56.3 56.3 56.5 Recove ry Period 84.2 56.4 58.5 54.0 64.2 54.7 60.0 55.5 66,6 55.3 84.7 55.5 71.4 77.7 77.7 56.2 55.7 55.5 56.9 55.6 68.0 60.3 73.0 63.0 70.0 * 3 Day a only. DSW 034946 STLCOPCB4018773 B I O - T E S T Jai&Ui&yU&i, 9tux 20 TABLE IX - TEST MATERIAL: Aroclorl221 Toxicity, Reproduction and Residue Study - White Leghorn Chickens Egg Quality Data Group C T-I T-II T-m Detective Eggs Number Percent 869 53.4 668 43.7 460 30. 1 439 30. 5 Normal Eggs Number Percent 760 46.6 860 56.3 1070 69.9 1002 69. 5 Total Number 1629 1528 1530 1441 OSW 034947 STLCOPCB4018774 Snduiltial B S O TEST lai&icUtyUel, Una. 2I 2. Hatchability The hatchability data are presented in Table X. The percent of eggs hatched was slightly lower in group T-III when compared to the control group and the other two test groups. DSW 034948 STLCOPCB4018775 3~LaUU B IO -T E S T ( (( Oroup C T-l T-1I T-1II Eggs Set 114 110 136 129 TABLE X TEST MATERIAL! Aroclor 1221 Toxicity, Reproduction and Residue Study - White Leghorn Chickens Eggs Hatched 97 94 Percent Hatched 85.0 85.4 Hatchabllity Data Eggs Unhatched Stages of Incubation Full Mid- One Term Term Week 17 10 1 2 16 63 2 Infertile 4 5 114 83. 3 22 48 5 '5 97 75. 1 32 9 10 6 7 Percent* Infertile 3. 5 4, 5 3.7 5. 4 * Percent o total set, DSW 034949 STLCOPCB4018776 UndHAhial B 1 O T li S T lalmabvUM, Ona. 23 3. Specific Gravity The specific gravity data of the eggs collected and candled are presented in Table XI. Test group data were considered normal when compared to the control data. DSW 03^950 STLCOPCB4018777 BIO-TEST h (( TABLE XI TEST MATERIAL: Aroclorl221 Toxicity, Reproduction and Residue Study - White Leghorn Chickens Specific Gravity Data Group Normal Eggs Average Number Specific Gravity C 221 1.078 T-I 220 ' 1,081 T-II 271 1.077 T-IU 24S 1, 081 Defective Eggs Average Number Specific Gravity 869 1.074 668 1.078 460 1.071 439 1.072 Number Total Eggs Average Specific Gravity 1090 1.074 888 1. 080 731 1.074 687 1. 076 DSW 034951 NA STLCOPCB4018778 9nduiUud B I O - T E S T .ta&o*ai*>'U4&, 9*ux 25 4. Err Shell Thickness The shell thickness data are presented in Table XII. The shell thickness was considered normal for all test groups when compared to the control group. DSW 034952 STLCOPCB4018779 BIO -TEST A ( (< TABLE XII TEST MATERIAL: Aroclor 1221 Toxicity, Reproduction and Residue Study - White Leghorn Chickens Egg Shell Thickness (inches) Group Normal Eggs Average Number Thickness (10`3) C 221 0. 013 T-I 220 0. 013 T-U 271 0. 012 T-IU 248 0. 013 Detective Eggs Average Number Thickness (10"^) 869 0. 012 668 0. 013 460 0. 012 439 0. 013 Total Eggs Average Number Thickness (10*3) 1090 0. 012 888 0. 013 731 0. 012 687 0.013 DSW 0349&3 CV O' STLCOPCB4018780 Stuhtibiial B I O * T E S T laitKtiiwM. Hmc. 27 C. FI Generation 1. Mean Body Weights and Viability The mean body weights and viability data are presented in Table XIII. A slight decrease in mean body weight was noted in all test groups on Day 1 when compared to the control group. 2. Gross Pathology Postmortem examination of all chicks revealed no abnormal tissue alterations. DSW 034954 STLCOPCB4018781 is s i-o ia ( (( Group C T-I T-II T-UI TABLE XIH TEST MATERIAL: Aroclor 1221 Toxicity, Reproduction and Residue Study - White Leghorn Chickens Mean Body Weight and Viability Data Number of Chicks Day 1 Mean Body Weight Day 1 (grams) Number of Chicks Day 30 Mean Body Weight Day 30 (grams) Percent Viability 97 41.6 93 279. 3 95. 8 94 38. 0 93 274. 0 98. 9 114 37. 2 101 257. 8 88. 6 97 38. 2 92 267. 8 94. 8 DS 030955 00 STLCOPCB4018782