INTERLABORATORY STUDY FOR THE ASSESSMENT OF POTENTIAL IRRITATIVE PROPERTIES OF HYGIENE PRODUCTS ON THE HAMSTER-CHEEK POUCH

An interlaboratory study was carried out to determine the feasibility and reliability of a method using the hamster cheek pouch as a model f or assessing the potential irritative properties of substances intende d to be applied to the lips or other mucous membranes. The test substa nces were applied once daily to both pouches for 14 consecutive days. Local and general tolerances were appraised throughout the study. At t he end of the study, histologic examination of the pouches and the mai n organs was performed. Results of the feasibility study, conducted on various types of commercial products, indicated that this model is su itable for preparations of various consistence and composition. Result s of the reliability study, carried out on gel-type preparations conta ining various concentrations of a known irritant, sodium lauryl sulfat e, indicated that the method elicits a dose-dependent reaction for thi s compound. This hamster cheek pouch method was reproducible for the v arious parameters under consideration: local tolerance, general tolera nce, histologic examination. For all products, results were in good ag reement among the various laboratories participating in the study. The French regulatory authorities of the Fraud Repression Department have accepted it as an official method for the evaluation of the potential irritative properties of cosmetics and hygiene products intended to b e applied to the lips or other mucous membranes.