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DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE
FOOD AND DRUG ADMINISTRATION WASHINGTON, D C. HW
Dr, William H. Hunt Monsanto Company 600 N. Lindbergh Boulevard Sc. Louie, Missouri 63166
Re:
January 9, 1967
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Food Additive Petition No. 7C2117
Deer Dr. Hunt:
This replies to your letter of December 28, 1966, requesting a copy of any data we cay have available regarding past toxicity studies conducted by this Administration concerning 60 percent chlorinated terphcnyl (Arochlor 5460) which is the subject of the above referenced petition.
In respoosa to your request ve have prepared the following summary of some results obtained in our testing of various Arochlors using the AOAC bloassay method for chick edema factor (Official Methods of Analysis, 10th Ed, Association of Official Agricultural Chemists, 26.087-26.091):
Sample
Ho. of Chicks
Level In Diet nnm
Heart fluid, al ' (or incidence of Early hydropcrleardlua) Deaths
Remarks
Arochlor 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 0/12)
5 Hemorrhages(4/! 3 Hemorrhages(6/1 0 None 4 Hemorrhages(5/l 4 Hemorrhages(3/1 1 Enlarged heart
Croup Score 2+ 4 Croup Score 3-i-
(toxic)
DSW 018439
STLCOPCB4004983
>
9
2.
Arochlor 1242 vac distilled in a spinning band column; 28 fractions and a small amount of residue were obtained. The higher belling fractions vere more toxic than the early fractions. Some of the reaulte of chick bloassay are as follows:
Sample
No. of .Level In
Hydropericardium
Chicks Diet ppm Incidence Group Score
Remarks
Fraction 1
6
100
0
0 1 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
Fraction 28 Fraction 28
10
7 10
50 0
10 0 50 . 7/7
0 2 early deaths; no edema
0 no edema 15+ 3 early deaths
5 hemorrhages
Fraction 28, molecular weight 324, represents 4.2Z by veight of Arochlor 1242. Hicrocouloaetric gas chromatograms (6 ft* column, instrument pro-
and 2 minor peaks*
Sincerely yours,
,9
_____ VtVv^S, Q-
William F. Randolph Petitions Control Branch Bureau of Science
DSW 018440
STLCOPCB4004984