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• W2010355418 abstract "This is the third and final portion of a report of a project designed for the purpose of improving standard methods of detecting contact allergens.The first dealt with the theoretical and technical insufficiencies of the conventional “predictive” tests (1).The second presented a compendium of experimental information on the various agencies which conduce to the establishment and measurement of human contact sensitization (2).It is the purpose of this paper to present a new method of bioassay, hereafter called the “Maximization Test/' and to record the performance of this test with a score of well known substances.Principles of Test DesignArbitrary decisions enter into the formulation of any kind of bioassay; the objectives can be fulfilled only within stated limits. It will be well to review the concepts on which the maximization test is based and to present the empirical strategies which shaped the specifications.This task has to be visualized in terms of the assumption that practically all substances are capable of being contact sensitizers for some persons under some conditions. Even the blandest substances such as lanolin, a vehicle for countless preparations, may occasionallysensitize, though diagnosis is often missed because of a very low order of suspicion (3). The sensitizing capabilities of the overwhelming preponderance of substances are very feeble; one may almost always fine-comb out of the literature a case or two of sensitization to practically anything which contacts the skin. No feasible procedure can hope to identify these allergens.There is however a class of moderate sensitizers which, though not necessarily dangerous, have sufficient allergenic potential to warrant an alertness for their sensitizing possibilities. Medical examples include neomycin, benzocaine, procaine, penicillin, and ammoniated mercury. Any procedure which purports to detect contact allergens must be capable of identifying substances in this class. The “maximization” test was empirically fashioned to meet this operational standard. Earlier, so-called predictive procedures failed to achieve this degree of sensitivity (1).The objective of the maximization test is to establish whether specified substances have allergenic potentialities and to what degree. The test is primarily designed to yield al-lergenicity ratings for individual substances, not complex mixtures, finished products or formulations. It must be thoroughly understood that the maximization procedure does not directly assess safety in use (except when negative). It does not predict the incidence of sensitization in a population of users. Fundamentally it classifies substances according to the sensitization capabilities these exhibit under an arbitrarily defined set of experimental circumstances. When it has been established that a substance is a weak, moderate or strong sensitizer, the primary business of the test is finished. Estimates of hazard, the degree of harm which will occur if the substance is incorporated in various strengths in various products and used in specified ways, involves additional considerations which are difficult to establish. In393394THE JOURNAL OF INVESTIGATIVE DERMATOLOGYTABLE IMaximization gradingSensitization Rates Grade Classification 0-2/25 3-7/25 8-13/25 14-20/25 21-25/25 1 2 3 4 5 Weak Mild Moderate Strong Extreme any case, such estimates are not an inherent part of the bioassay. We will return to this question again.The general principle is somewhat analogous to the way in which pharmacologists approach the problem of assaying tosxicity. Substances are not divided into toxic and non-toxic categories. This is unsound because all substances are toxic depending on the kind and amount of exposure. Some method of measuring 'how toxic' is required. One means of doing this is the L.D. 50, the mean dose which kills 50% of the animals. Despite limitations, this is a precise measurement which at least offers a standard means of comparing toxicities. In one recently published scheme, common substances have been classified into six toxicity grades based on L.D. 50 values as an aid to prognosis in cases of poisoning (4).The conventional attitude toward contact sensitizers is often naive: the chemical universe is didactically divided into sensitizers and non-sensitizers as if these were absolute polarities. The more appropriate question is “how sensitizing?” With the paradigm of the L.D. 50 in mind, I sought first to determine an S.D. 50 dose which would sensitize 50% of the subjects. This aim was completely frustrated by the exceedingly great difficulty, indeed impossibility, of inducing sufficiently high sensitization rates with weak allergens. It was necessary to be satisfied with a more conservative, less precise, screening technic. This was a matter of integrating all the previously acquired experimental information into a scheme which would most magnify the opportunity for sensitization. The score attained by a substance under these maximizing circumstances might then afford a quantitative means of comparison. Some indulgences had to be tolerated for the sake of practicality. For instance, although the sensitization rate is, with qualifications, proportionateto the number of exposures, five were sufficient to identify the moderate sensitizers with regularity. Similarly, while accuracy and reproducibility would be better served by using a large number of subjects, we found it possible to meet the operational standard with a test panel of 25 subjects.A procedure finally emerged whose usefulness and limitations were empirically established by testing a large number of substances about which information was available from many years of actual use. The closeness of fit of maximization scores and the verdicts of usage constituted the cardinal test of merit of the maximization procedure.From the range of results obtained, a quite arbitrary scheme of ratings was devised to afford a simple measure for quantitative comparisons. Substances were divided into five classes, numbered one to five, according to their allergenic potentialities. (Table I). To each class was assigned a simple English equivalent, 'weak' to 'extreme', denoting comparative potency. It is emphasized that these ratings are relative and not absolute.# # * Specifications of the Maximization TestThe Patch.-The patch material is a non-woven, highly absorbent, cloth, prepared by Curity under the trade name of Webril. It proved the most serviceable of many tried including various paper discs, and woven cloths of cotton, flannel and wool. Webril is sufficiently bulky to maintain a steady force against the skin, somewhat akin to the sponge pressure patch test of Fernstrom (5).Absolute occlusion is essential. Complete sealing prevents loss of the test agent and favors penetration by providing maximum hydration.Squares of Webril, 1.5” along the sides, are used for the induction exposures. These are fastened to an extremity (forearm or calf) as follows: Two 3” lengths of 1.5” wide impermeable plastic tape are overlapped i/£” lengthwise to form a 3.0” x 2.5” rectangle. The tape is 3 M Blenderm, made by the Minnesota Mining Company. It has good sticking powers and is completely impermeable to water, though it does possess limitations in that it predisposes more than conventional tapes to anhidrosis, a forerunner of miliaria in hot weather. Moreover unlike white cloth-backed tapes, bacterial multiplication is not restrained. The Blenderm is centered over the Webril patch. (Fig. 1). The surrounding area may be sprayedFig. 1. Stage I. Construction of inductive patch on forearm. Two overlapping strips of impermeable plastic tape (3 M Blenderm) have been fastened over the Webril (Curity) patch.Fig. 2. Stage II. Perforated plastic tape has been wrapped around the forearm several times to form an occlusive, thoroughly secured seal.Fig. 3. Appearance of induction site after five exposures to 5% SLS just prior to last application of the test material. The lesion is a moderately inflammatory placque covered with a clean exudate. Tape marks are also evident.395396THE JOURNAL OF INVESTIGATIVE DERMATOLOGYwith tincture of benzoin to enhance adhesion and reduce irritation. The patch is held in place by encircling the extremity several times with Johnson and Johnson Perforated Band-Aid Clear Tape, 1.5” wide (Fig. 2). This tape is somewhat more elastic than Blenderm, is porous and molds better to the variable diameter of the extremity.The challenge patches, generally on the lower back, are also of Webril except that the size is reduced to 1” squares. These are covered as above by the Blenderm rectangle. Placed over this is an identically sized, 2.5” x 3, single piece of ordinary white adhesive. The back skin is more, mobile than the lower forearm and greater reinforcement is necessary to maintain complete occlusion for 48 hours. Bending and turning tend to deform the skin and to disrupt the Blenderm strips unless these are reinforced as above. The area surrounding the patch may be sprayed with tincture of benzoin from an aerosol can. Finally the patch is held in place by overlapping strips of Johnson and Johnson Perforated Clear Plastic tape arranged to form about a 4.5” square. It is permissible to use the forearm for challenge testing in which case the patch is fastened as for induction by wrap-around taping. No commercially available patch guarantees the occlusion provided by the above arrangement which is admittedly more tedious.During induction, tape reactions of some degree are common, and sometimes extremely troublesome, especially in hot weather. Some comfort is afforded if, at the time of changing the patches, pieces of cotton cloth are placed over the more irritated areas before being bound down by the perforated tape.For induction, a volume of 1.0 ml of the test material is delivered to the Webril patch via a plastic syringe, minus the needle. For challenge 0.4 ml is used" @default.
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• W2010355418 date "1966-11-01" @default.
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• W2010355418 title "The Identification of Contact Allergens by Human Assay" @default.
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