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Etude de la toxicité cutanée et respiratoire des alcools dans les produits hydro-alcooliques d’hygiène des mains

Abstract : Hand hygiene (HH) is a key factor in preventing healthcare-associated infections. Current practices favor the use of alcohol-based hand rubs (AbHR), generally formulated with ethanol, propan-2-ol and/or propan-1-ol, in the presence of co-formulants for a better skin acceptability. The antimicrobial efficiency within a short time, essential because of the frequent situations of HH practice, is achieved by high levels of alcohols which can exceed 80% w/w. This raises the question of dermal and respiratory toxicity associated with the use of AbHR. The assessment of dermal toxicity based on published data and in vitro skin irritation (OECD 439) and phototoxicity tests (OECD 432) conclude to non acute dermal irritation and phototoxicity risk linked to dermal exposure to these alcohols, even in the presence of co-formulants, as provided in the AbHR. We encountered in our trials the possible lack of specificity, already described in the literature, of the reconstructed human epidermis (RhE) models for some substances, which should be kept in mind in the context of the evaluation of skin irritation in vitro. Additional investigations and an assessment using the Weight of Evidence approach may be useful before concluding the irritant properties of a test item. In terms of genotoxicity, a difference between the alcohols emerges from the bibliographic review, with genotoxic properties described only for ethanol. To a certain extent, our tests confirmed a difference in profile. Propan-2-ol and propan-1-ol tested in a battery of in vitro tests to explore the various genotoxic mechanisms (Ames test and micronucleus test (MN) on p53 competent human cells: lymphoblastoid cells TK6 and pulmonary cells NCI H292) gave negative results, even in the presence of co-formulants, or administered as vapors on air-liquid interface (ALI) NCI H292 cells. For ethanol, the same battery of tests gave equivocal results only in the MN test on TK6 cells with ethanol alone. An additional MN test on TK6 cells co-cultured with a RhE mimicking the existing skin barrier gave negative results. In addition, no significant systemic exposure to alcohols induced by HH practices is apparent from published studies in humans, with indiscernible levels of existing endogenous values for ethanol and isopropanol. All of these data support the absence of an increased systemic genotoxic risk resulting from the use of AbHR and the absence of local pulmonary genotoxicity due to exposure to alcohol vapors. In conclusion, during AbHR use for HH, no risk to human health in terms of acute skin irritation, phototoxicity and genotoxicity is apparent from this research.
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Submitted on : Wednesday, August 22, 2018 - 11:50:05 AM
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Monique Manche. Etude de la toxicité cutanée et respiratoire des alcools dans les produits hydro-alcooliques d’hygiène des mains. Médecine humaine et pathologie. Université du Droit et de la Santé - Lille II, 2017. Français. ⟨NNT : 2017LIL2S038⟩. ⟨tel-01859563⟩

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