316 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS dency to permeate unless high concentrations are employed. 3. Formulators should not reject the use of quaternaries in hair or skin care products because of earlier and probably unjustified generalizations about irritancy. 4. It must be recognized that the proof of non-irritancy and safety of every surfactant- containing product must be assessed before marketing. APPENDIX "MR. LATVEN: We have investigated between 45 and 50 surface-active agents fol- lowing instillation in the eye and found essentially the same result. However, we have got to add one thing, namely, that the nonionics can be just as irritating as the cationics in specific instances, as you have already pointed out. The incidence, however, is less. We find around 25 per cent of all nonionics are irritating in consideration of corneal opacity and around 62 per cent of anionics fall into the opaci- fication class, where it is 100 per cent with the cationics. As you have also pointed out, the important question is whether or not the final formulas produce corneal opacity. That raises a very important question, namely: When one investigates a final formulation and obtains results such as that, only one out of nine or ten animals shows opacification. How can one interpret it? I must admit complete ignorance. DR. DRAIZE: Occasionally one serious reaction only is obtained in a group of test subjects. Such a single reaction is deemed significant, since in the general population an occasional sensitive individual may be encountered, and from a standpoint of overall safety such an individual may not be overlooked. MR. LATVEN: I wonder if I could ask another question on your interpretation, namely, the insidious character of a number of these surface-active agents is the fact that they don't produce pain on instillation .... " REFERENCES (1) J. H. Draize, in Appraisal of the Saj•ty of Chemicals in Foods, Drags, and Cosmetics (Assoc. Food Drug Officials, U.S., Topeka, Kansas, 1959). (2) H. P. Drobeck, "Current Topics on the Toxicity of Cationic Surfactants," in Cationic S•factants, J. Cross and E.J. Singer, Eds. (Marcel Dekker, New York, 1994). (3) R.A. Cutler and H.P. Drobeck, "Toxicology of Cationic Surfactants," in Cationic S•rfactants, E. Jungermann, Ed. (Marcel Dekker, New York, 1970). (4) J. H. Draize and E. A. Kelley, Toxicity to eye mucosa of certain cosmetic preparations containing surface-active agents, Proc. Sci. Sect. Toilet Goods Assoc., 17, 1-4 (1952). (5) L. W. Hazelton, Relation of surface active properties to irritation of the rabbit eye, Proc. Sci. Sec. Toilet Goods Assoc., 17, 5-9 (1952). (6) P. C. M. Van der Valk, J.P. Nater, and E. Bleumink, Skin irritancy of surfactants as assessed by water vapor loss measurement,J. Invest. Dermatol., 82, 291-293 (1984). (7) E. Berardesca, D. Fideli, P. Gabba, G. Rabbiosi, and H.I. Maibach, Ranking of surfactant skin * Discussion after the Draize and Kelley presentation (4). From page 4 of the Proceedings of the Sdentific Section of the Toilet Goods Association, 17, May 1952.
SKIN IRRITATION POTENTIAL OF QUATERNARIES 317 (8) (9) (10) (11) (12) (13) (14) (15) (16) (17) (18) (19) (20) (21) irritancy in vivo in man, using the plastic occlusion stress test (POST), Contact Dermatitis, 23, 1-5 (1990). C. R. Robbins and K. Fernee, Some observations on the swelling of human epidermal membrane, J. Soc. Cosmet. Chem., 34, 21-34 (1983). C. M. Willis, C. J. M. Stephens, and J. D. Wilkinson, Experimentally-induced irritant contact der- matiris, Contact Dermatitis, 18, 20-24 (1988). R. A. Tupker, C. Willis, E. Berardesca, C. H. Lee, M. Fartasch, T. Agner, and J. Serup, Guidelines on sodium lauryl sulfate (SLS) exposure tests, Contact Dermatitis, 37, 53-69, 1997. D.A., Basketter, H.A. Griffith, X.M. Wang, K.-P. Wilhelm, and J. M. McFadden, Individual, ethnic, and seasonal variability in irritant susceptibility of skin: The implications for a predictive human patch test, Contact Dermatitis, 35, 208-211 (1996). D. A. Basketter, L. Blaikie, and F. Reynolds, The impact of atopic status on a predictive human test of skin irritation potential, Contact Dermatitis, 35, 33-39 (1996). D. A. Basketter, M. Chamberlain, H. A. Griffith, M. Rowson, E. Whittle, and M. York, The classi- fication of skin irritants by human patch test, Food Chem. Toxicol., 35,845-852 (1997). M. York, E. Griffith, and D. A. Basketter, Evaluation of a human patch test for the identification and classification of skin irritation potential, Contact Dermatitis, 34, 204-212 (1996). H. A. Griffith, K.-P. Wilhelm, M. K. Robinson, X.M. Wang, J. McFadden, M. York, and D. A. Basketter, Interlaboratory evaluation of a human patch test for the identification of skin irritation potential/hazard, Food Chem. Toxicol., 35, 255-260 (1997). J. E. Wahlberg, K. WrangsjiS, and A. Hietasalo, Skin irritancy from nonanoic acid, Contact Dermatitis, 13, 266-269 (1985). L. D. Rhein, "In Vitro Interactions: Biochemical and Biophysical Effects of Surfactants on Skin," in Surfactants in Cosmetics, M. Rieger and L. D. Rhein, Eds. (Marcel Dekker, New York, 1997). G. Irnokawa, "Surfactant Mildness," in Surfactants in Cosmetics, M. Rieger and L.D. Rhein, Eds. (Marcel Dekker, New York, 1997). W. Abraham, "Surfactant Effects on Skin Barrier," in Surfactants in Cosmetics, M. Rieger and L. D. Rhein, Eds. (Marcel Dekker, New York, 1997). A. Rawlings, C. Harding, A. Watkinson, J. Banks, C. Ackerman, and R. Sabin, The effect of glycerol and humidity on desmosome degradation in stratum corneum, Arch. DermatoL Res., 287, 457•464 (1995). M. Bergh, K. Magnusen, J. L. G. Nilsson, and A.-T. Karlberg, Contact allergenic activity of Tween 80 before and after air exposure, Contact Dermatitis, 37, 9-18 (1997).
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