324 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS usable due to their adverse effect on the fragrance. However, the reasons for testing these particular agents for anti-irritant activity may be of interest. The polypropylene glycol (P2000, Dow Chemical Co.) was tested because of previous successes with "block polymer" surfactant polyols. Glycol P2000 reduced irritation scores by approximately one-half when added to the formula at 0.5% and by three-quarters when used at 2.0% in this cologne. It also eliminated all traces of corneal opacity. The Azulene (guaia-azulene, Dragoco, Inc.) was tried because of claims for effectiveness against various types of primary skin irritations, such as those caused by razor burn during shaving and underarm chafing connected with antiperspirants. Azulene is a component of camphor. It was distinctly useful as an anti-irritant in this particular cologne TABLE II Draize Eye Scores--Mentholated Alcoholic Product (No wash after instillation into eye) Corneal Scores, Total Scores, hours hours Code Product Description 24 48 72 24 48 72 A Control--no menthol 0 0 0 10.0 6.2 5.0 B Control q- 0.7% menthol 5.4 5.0 2.5 14.7 12.4 6.5 C Control q- 0.7% menthol q- 0.3% PVP 0 1.7 1.7 16.0 16.0 12.7 D Control q- 0.7% menthol q- 0.14% Miranol C2M 0 0 0 0 0 0 formula, reducing total "Draize" eye scores to one-quarter and eliminat- ing all corneal opacity when used at 0.1% concentration in the cologne. The use of small amounts of PVP (polyvinyl pyrollidone, General Aniline Film Corp.) is now fairly common in shampoo formulations, for two reasons it leaves the hair more manageable and reduces eye irritation. Table I shows that 0.3% PVP-K30 eliminated all corneal opacity produced by this cologne and reduced total irritation scores considerably. The Miranol C2M Concentrated (Miranol Chemical Co., Inc.) was tried because it had previously been found to eliminate completely eye irritation caused by menthol in an alcoholic medium (cf. Table II). The current principal commercial use for this amphoteric surfactant is in shampoos which do not sting the eyes. As can be seen (Table I),
USE OF ANTI-IRRITANTS IN COSMETIC FORMULATING 325 it was an effective anti-irritant for this cologne formula, eliminating all corneal opacity and reducing total irritation scores to about one-third. An interesting insight into the mechanism by which this anti-irritant operates is provided by Formula "H" which contains Miranol 2MCA modified, the equi-molar reaction product of Miranol C2M with sul- fated lauryl alcohol, which quite obviously is not an anti-irritant. One is led to believe that the anti-irritant activity of Miranol C2M derives from its ability to combine chemically with an irritant and that combination with one irritant leaves no activity against others. Finally, thiodiglycolic acid was tried because of claims in a British patent (3) indicating that this material was valuable as an anti-irritant for certain scalp preparations. It was only partially successful against eye irritation in this aerosol cologne formula. In other tests it actually increased the eye irritation caused by an antiperspirant formula, but lowered the primary skin irritation produced by a topical proteolytic enzyme preparation (Table III). This pattern, of a material acting sometimes as an irritant and sometimes as an anti-irritant, will be observed again in the case of other additives. As a matter of interest, four of the above anti-irritants were also tested in a "Cologne Ice" type of preparation containing 2.5% perfume in a hydroalcoholic system gelled with an amine-neutralized "Car- bopol" polymer (B. F. Goodrich Chemical Co.). This preparation was judged "mildly irritating" after producing primary skin irritation TABLE III Patch Test of Proteolytic Enzyme Preparations Reactions to 24-Hr. Nonocclusive Patch 0 1+ 2+ Controls Oil gel placebo 10 0 0 Oil gel q- 2 % protease 10 0 0 O/W emulsion placebo 0 9 1 O/W emulsion q- 2% protease 0 9 1 Anti-irritant study-- O/W Emulsion q- 2% protease (a) Plus 6% Na lactate 1 3 6 (b) Plus 1% glycogen 2 3 5 (c) Plus 0.5% dithioglycolic acid 3 7 0 Note: Severity of reactions: Scoring was performed immediately after removal of patch, 24 hr after application of 0.05 g. of test material, as follows: O--no visible reaction 1 mild erythema, no edema and 2q---moderate erythema, moderate edema and induration.
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