392 J. P. Gulllot, M. C. Martini and J. Y. Giauffret On the contrary, eight products were harmful: The four samples of oleyl alcohol/22/to/25/ The four samples of isopropyl myristate/7/to/10/ Of the remaining seven products, two give uncertain results (capric/caprylic triglyceride /5/and octyl palmitate/17/) and for the others the irritation level was moderate (syn- thetic triglyceride/6/, decyl oleate/15/, isodecyl oleate/16/, octyl stearate/18/and ceto- stearyl octoate/19/). On the whole, the products were well tolerated when diluted to 10-15•, a figure which corresponds to the concentration found generally. In particular, the histological examina- tion was negative. It should be noted, however, that the four samples of I.P.M. provoke the appearance of numerous vesicles. This oil, used for many years and even at high levels in many cosmetic preparations, gave a high irritation potential. It can induce an acan- thosis and an oedematous degeneration of collagen fibres when applied under an occlusive patch to the rabbit for 24 h (25). Nevertheless, experiments conducted on miniature pigs do not show adverse results. The macroscopic observations are characteristic of primary irritant reactions with a degree of erythema and sometimes thickening or drying of the skin. The mean results of the weekly average show a maximum for I.P.M. n ø /7/ (1.67) and oleyl alcohols n ø /23/,/24/,/25/(1.50). These counts are relatively low (maximum rate=8) but this is due to the fact that they are calculated taking into account the measurements of erythema and oedema. However, oedema, rarely evident in histology, was never observed macro- scopically. On the other hand, secondary reactions such as vesicles, papules, maculae and/or erythematous zones were frequently noted. Furthermore, when intense aggravation occurs, 'fissures' can form and give rise to eschars which can be infectious. The microscopic findings confirm generally the macroscopic scores. Unfortunately, in cases of too severe intolerance, histology cannot serve to distinguish the irritant reactions from the allergies. It should be noted that the challenge assay, carried out after a rest period, revealed no real allergen (this was predictible considering the nature of the products studied). The analytical investigations cannot explain, for the time being, the origin of the phenomena observed. There is, however, a possible relation between tolerance and purity for I.P.M. It is hoped these experimental results can be of use to the cosmetic investigator, in spite of the fact that extrapolation to the human response is delicate. ACKNOWLEDGMENTS All the histologica1 examinations were performed and interpreted by Dr J. Guilaine, Dermatologist. The authors also gratefully acknowledge the assistance of: J. Y. Guyot, J.P. Petit, G. Blanc, J. Charroy, B. Audenaerde, J. Evans, F. Gaubert, D. Thiry and L. Ferrero. REFERENCES 1 Baer, R. L., Ramsey, D. L. and Biondi, E. The most contact a11ergens 1968-1970. Arch. Dermatol. 108 74-78 (1973).
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