COLD WAVE LOTIONS CUTANEOUS AND SYSTEMIC EFFECTS 229 should not be as stringent as those governing the manufacture and sale of pharmaceuticals for internal consumption. Physiologically speaking, the skin and hair on the exterior of the body are organs of the body, just as much as the liver, lungs, or kidneys. These cutaneous organs must be kept healthy because they have im- portant functions to perform. And when considering any product for application to the skin or hair, it is most important to subject it to an intensive investigation in order to make certain that such a product will not in any way impair not only the health of the skin or hair, but the health of the body as well. The obvious reason for this is that we are not only concerned with the skin, but with the absorption of ex- ternal applications through the skin and their possible systemic effects. Only too often, products of a cosmetic nature are placed on the market after only a cursory investi- gation-an investigation made merely to meet the requirements of administrative bodies such as the Food and Drug Administration. These investigations are not neces- sarily made to protect the user, but rather to protect the manufacturer. I have taken tl•e time to point out the necessity for the careful evaluation of any products de- signed for use on the skin because I believe it is incumbent upon a manufacturer of any product to think in terms of the safety of the product to the user. To illustrate this point I intend to describe the manner in which my colleagues and I attacked a problem dealing with the cutaneous and systemic effects of a cold permanent wave lotion. Prior to our study, numerous papers had been published reporting alleged manifestations of skin sensi- tivity and even of systemic effects from these lotions. Various in- dividuals and groups had obtained copies of these reports and subse- quently attempted to distort the conclusions for their own benefit. In order to clarify this situation, we made an exhaustive and care- fully controlled study, which is being presented as an example of the type of study designed not only for the benefit of the manufacturer, but for the protection of the users as well. Published literature reports the use of solutions of thioglycolic acid or of its salts--not actual waving lotions--yielding results which are primarily of academic interest. A large amount of work has been done reporting the toxicity of thiogly- colares. Because this study is limited primarily to clinical con- siderations, the review of the litera- ture will be limited to the clinical and systemic considerations, as well as to some of the theory involved. There is ample evidence that the sulfhydryl group is of great physio- logicalimportance. It may act as a detoxifying agent. The metabolism of certain drugs and toxic substances involves a combination with sulf- hydryl groups, present in the pro- teins of the tissues available as glutathione, cystine, methionine,

230 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS and homocystine. It is not sur- prising, therefore, by virtue of their sulfhydryl group content, that salts of thioglycolic acid should prove to be of low systemic toxicity. In- deed, the toxic actions of heavy metals, including arsenic, may be due larg61y to their combination with the sulfhydryl groups of the proteins of the tissues with the for- mation of mercaptides. In this connection, one may point to the success of dimercaprol, usually re- ferred to as BAL, a dimercaptopro- panol, in the treatment of heavy metal poisoning. Conversely, the capacity for metal mercaptide for- mation of sulfhydryl groups, when present in large excess, may result in unfavorable toxic effects by com- bination with the metal ions of the metallo-protein enzyme systems. Dermatologic reactions attributed to cold wave lotions were first re- ported in 1944. Since that time, additional reports of both cutaneous and systemic effects of waving lo- tions, as well as the ingredients thereof, have appeared. It is quite evident that there exists a great diversity of opinion concerning the effects of waving lotions and their ingredients. This is due primarily to the use of a variety of materials, comprising in some instances the waving lotions themselves, and in others, the use of isolated ingredi- ents to the use of various concen- trations and pH of the waving mate- rials to the employment of a variety of methods of testing to a variation in the selection of test subjects, and to the inadequate testing of subjects who are sus- pected of showing systemic .toxic manifestations. It is axiomatic that differences in results reported by various observers should stem from some difference in the experi- mental approach, yet careful analy- sis of some of the published data fails to disclose adequate reasons for such divergence. For example, Beek (2), using a 6 per cent solu- tion of thioglycolic acid neutralized with ammonium hydroxide to a pH of 9.0, reported an incidence of skin reaction far in excess of that which we have found in an extensive and closely controlled investigation. From a study conducted on five female patients who had in common a history of occupational or cosmetic contact with cold wave lotions, Cot- ter (3) came to the conclusions that the cold wave lotions were respon- sible for the dermatologic and clini- cal findings,"... because, it had been possible to demonstrate their lesions in the laboratory." On pe- rusal of the case histories which were published in detail, it becomes evident that despite the common denominator of contact with cold wave lotions, there are many other and compelling reasons why the author was not justified in draw- ing the inference of causal rela- tionship between contact and clini- cal findings. Editorial and advis- ory notes appearing in medical and lay periodicals show a diver- sity of opinion on the effects of cold wave preparations, some warn- ing quixotically against the use of these agents, others taking the op-