122 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS 9. Para-aminodiphenylamine. 10. Sulfo-para-aminodiphenylamine and its sulfate. 11. 1,4-Diaminodiphenylmethane. 12. Sulfo-diaminodiphenylamine. The United States Food and Drug Administration recommends the fol- lowing directions for making skin tests for hair dyes containing para: Directions for Making Skin Test 1. The hair dye in this package must never be used for dyeing the hair unless a preliminary skin test has been made. The skin test must be made each and every time before the hair is to be dyed, regardless of whether or not a skin test has been made at sometime previously. 2. The dye used for the preliminary test must be a portion of the article intended to be used for dyeing the hair. 3. The sample of dye to be used for the preliminary skin test should be mixed and prepared in exactly the same manner and according to the directions applicable to the actual use of the hair dye itself. 4. By means of a suitable applicator (clean camel's hair brush, cotton- tipped applicator, or other applicator) a streak of dye not less than a quarter of an inch wide and at least one-half inch long is made on the skin and scalp behind one ear. It is important that the streak of d•e extend into the hairy portions of the scalp as well as that portion of the skin that is hairless. 5. The streak of dye should be permitted to remain for at least 24 hours. The test should be read between 24 and 48 hours after applica- tion. Preferably the test area should not be covered with combs, hats, spectacles, or any other object. 6. Warning: If redness or burning, or itching, or small blisters, or any other type of eruption appear in the general area used for the skin test during the first 24 hours the individual is sensitive to the dye, and under no circumstances should it be used for dyeing the hair. Hair dyes should not be used when there is any disease or eruption present any- where on the skin or on the scalp. It has been my experience as well as that of others that too often the test is done just once by the average beauty parlor operator. Certainly, in questioning home users, there is often no attention paid to the test at all by most of the people I have interrogated. In 1952 the House of Representatives selected a committee to investigate the use of chemicals in foods and cosmetics with the thought in mind of a possible change in the Food, Drug and Cosmetics Act. A great many experts from all over the country were heard by this Com- mittee, which consisted of the following: James J. Delaney, New York, Chairman Thomas G. Abernethy, Mississippi E. H. Hedrick, West Vir- ginia Paul C. Jones, Missouri A. L. Miller, Nebraska Gordon L. Mc- Donough,, California Walt Horan, Washington Vincent A. Kleinfeld, Chief Counsel Alvin L. Gottlieb, Associate Counsel Franklin C. Bing, Ph.D., Consultant and Camille O'Reilly Agnew, Clerk.
TOXIC AND ALLERGIC COMPLICATIONS OF HAIR DYES 123 TABLE 1--HEARINGS BEYORE THE HOUSE SoeLECT COMMITTEE TO INVESTIGATE THE Usv. o¾ CHEMICALS IN FOODS AND COSMETICS House of Representatives, Eighty-Second Congress, Second Session Pursuant to H.Res. 74 and H.Res. 447 Authority Reference Remarks H. V. Ailington, M.D., Part 2, p. 746 Para dyes have a high sensitizing potential. Dermatologist M. B. Sulzburger, M.D., Part 3, p. 1067 Hair dyes can cause skin eruptions, pruritus, Dermatologist and falling out of hair.. M. Walzer, M.D., Allergist Part 3, p. 1250 Tests recommended for prevention of allergic reactions from coal tar hair dyes by pre- liminary skin sensitivity tests have proved totally inadequate. H. Sharlit, M.D., Part 3, p. 1281 Para dyes are dangerous. Dermatologist I. I. Lubowe, M,D., Part 3, p. 1315 Hair dyes cause dermatitis of scalp, falling, Dermatologist drying and brittleness of hair. The reac- tions may be precipitated by cold permanent waving. Para compounds are frequent sen- sitizers. M. Grolnick, M.D., Part 3, p. 1324 Hair dyes may cause local or general allergic Allergist reactions in the skin and in the nasal and bronchial mucous membranes. These may vary from mild to severe, from local to generalized. May rarely lead to fatality from direct or indirect causes. A pre-use patch test self applied by user or cosmetic operator is inadequate. There are hazards in the use of para among workers and fur dyers and may cause asthma. R. L. Mayer, M.D., Part 3, p. 1338 Aromatic amines are particularly strong sensi- Dermatologist, Biologist tizers. Most powerful poisons and allergens are anilines, para-aminophenol, paraphenyl- enediamine, certain nitro compounds, and certain azo dyes. Sensitivity to para may cause cross-sensitivity to other aromatic amines. L. Schwartz, M.D., Part 3, p. 1798 Incidence of reported cases of dermatitis from Dermatologist para containing hffir dyes is about 1:80,000, and in 1930's of the order of 1:10,000. This great reduction is due to purity of the para now used, greater care in making oxidizing solutions and lower content of ammonia. Pre-•dyeing test helpful. A. Rostenberg, M.D., Part 3, p. 1801 Paraphenylenediamine, paratoluylenediamine, Dermatologist and minor modifications are the most danger- ous of all cosmetics. S. M. Peck, M.D., Part 3, p. 1242 There is apparently no real statistical proof Dermatologist that the pre-use patch test with a hair dye by the beauty parlor operator has had practical preventive value. Para dyes may cause dermatitis which may be slight or general- ized. Some of my cases had such a severe eruption that they had to be hospitalized. Neither the beauty parlor operator nor the average home user in most instances is com- petent to pick up the one plus reaction of sensitivity following a self-administered skin test. This slight reaction may be the first evidence of sensitivity. C. W. Crawford, Commis- Part 3, p. 1719 There were a few deaths that were traced to ioner of Food and Drug the use of hair dyes and eyelash dyes. Administration
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