Document KJpporpD116o7Jgzrew7KOK7o

O DEPARTMENT OF HEALTH, EDUCATION. AND WELFARE FOOD AND DRUG ADMINISTRATION WASHINGTON. D C. 20204 January 9, 1967 Dr, William H. Hunt: Monsanto Company 800 N. Lindbergh Boulevard St. Louis, Missouri 6316$ Re: Food Additive Petition Ho. 7B2117 Dear Dr. Hunt: This replies to your letter of December 28, 1966, requesting a copy of any data we may have available regarding past toxicity studies conducted by this Administration concerning 60 percent chlorinated terphenyl (Arochlor 5460) which is the subject of the above referenced petition. In response to your request we have prepared the following summary of some results obtained in our testing of various Arochlors using the A0AC bloassay method for chick; edema factor (Official Methods of Analysis, 10th Ed., Association of Official Agricultural Chemists, 26.087--26.091): Sample No. of Chicks Level In Diet ppm Heart fluid, ml (or incidence of Early hydropericardics) Deaths Remarks /.rochlor 1268 Arochlor 1268 Arochlor 5460 Arochlor 5460 Arochlor 5460 Arochlor 1242 Arochlor 1242 12 12 12 12 12 10 6 200 0.25 (1/12) 400 0.21 (3/12) 50 (0/12) 200 (0/12) 400 0,26 (1/12) 100 (2/9) 349 (1/12) 5 Hemorrhages(4/L 3 Hemorrhages(6/1- 0 None 4 Hemorrhage s (5 /1: 4 Hemorrhage s(3/1 i Enlarged heart Group Score 2+ 4 Group Score 3+ (toxic) NJ M J M STLCOPCB4072430 Q 2. Arochlor 1242 vas distilled in a spinning band column; 28 fractions and a small amount of residue were obtained. The higher boiling fractions were more toxic than the early fractions. Some of the results of chick bioassay are as follows: .. Sample No. of Level In Hydropericardium Chicks Diet ppm Incidence Group Score Remarks Fraction 1 6 100 0 0 l early death; no edema Fraction 21 Fraction 25 Fraction 28 Residue 6 6 6 6 100 100 100 100 0 2 3 5 0 no edema 2+ toxic 5+ 6 early deaths; toxic 5+ 6 early deaths; toxic Fraction 25 10 50 0 0 2 early deaths; no edema \ Fraction 28 7 10 0 0 no edema Fraction 28 10 50 . 7/7 15+ 3 early deaths 5 hemorrhages Fraction 28, molecular weight 324, represents 4.2X by weight of Arochlor 1242. Microcoulometric gas chromatograms (6 ft. column, instrument pro grammed at 4 C/minute beginning at 150 C) show the presence of 3 major and 2 minor peaks. Sincerely yours, William F. Randolph ' Petitions Control Branch ^Bureau of Science DSW 312445 "! STLCOPCB4072431