Besides the evaluation of their potential toxicological risk for skin contact, cosmetic products such as sprays and/or products formulated with volatile solvents (i.e. parfumes, hair sprays, aftershaves, nail polishes, nail polish removers etc.) require an assessment of their potential inhalation risk. No official guideline in the cosmetic field giving precise indication how to perform this inhalation risk analysis is currently in force. People working in this field have elaborated some models based on data which have not been published and which have not formally been harmonised in the cosmetic industry. In 2010 the SCCS (Scientific Committee for Consumer Safety) published an opinion taking into account for the first time the inhalation exposure of a raw material, i.e. evaluating the risk of dihydroxyacetone for self tanning products applied in spray cabines (SCCS/1347/10, 2010). An important contribution comes from RIVM (RIVM Dutch National Institute for Public Health and the Environment) that has elaborated exposure models, has collected experimental data and has developed the ConsExp software which allows the calculation of all the possible exposures, including the inhalation exposure. Other important contributions are the work by the HERA project (Human and Environmental Risk Assessments on Ingredients of Household Cleaning Products) and the indications contained in “Consumer Exposure Estimation” (Chapter R.15) of the Guidance on Information Requirements and Chemical Safety Assessment (REACH). ASSESSMENT OF THE INHALATION RISK OF AEROSOL AND NATURAL SPRAY PRODUCTS The inhalation risk assessment of aerosol products (with propellant, with volatile solvents, i.e. deodorants, hair sprays, body sprays…) and natural sprays (without propellant, without volatile solvents but with pumps that can create small droplets, i.e. eau de toilette, eau de parfum, aftershaves..) must consider the following aspects: 1) exposure level with exposure models (aerodynamic diameter of inhalable particles 10-100 μm and of respirable particles < 10 μm (due to anatomic characteristics the respiratory track is bigger in the upper track and much smaller in the alveolar area), percentage of expulsion of the respirated particles, volume of the room where the product is sprayed, room ventilation, exposure duration). 2) toxicological profile of all the ingredients used in the product 3) evaluation of the local and/or systemic exposure of the respiratory tract 4) presence of propellants 5) calculation of MoS /MoE (Margin of Safety/Margin of Exposure) ASSESSMENT OF THE INHALATION RISK OF PRODUCTS FOR NAIL HYGIENE AND NAIL POLISHES The inhalation risk assessment of products for nail hygiene and nail polishes (i.e. nail polishes, nail polish removers, nail strengtheners and nail hardeners) must consider the following aspects: 1. exposure level with exposure models (volume of the room where the product is used, quantity of volatile solvent in the room, room ventilation, exposure duration, vapour tension, evaporation speed) 2. toxicological profile of all the ingredients used in the product 3. evaluation of the inhalation exposure 4. calculation of MoS /MoE (Margin of Safety/Margin of Exposure) After a thorough study of the literature available all over the world about this topic, Bio Basic Europe Toxicology and Regulatory Department is pleased to inform its customers that it can perform the inhalation risk assessment, which is very important, together with the skin risk assessment, for a complete toxicological assessment of a cosmetic product as a spray and/or as a product formulated with volatile substances. This inhalation risk assessment is written in English, Italian and Spanish. Bibliography: • RIVM (Dutch National Institute for Public Health and the Environment): RIVM report 320104001/2006, authors H.J. Bremmer, L.C.H. Prud’homme de Lodder, J.G.M. van Engelen • COLIPA (now COSMETICS EUROPE ASSOCIATION OF PERSONAL CARE) • SCCS (Scientific Committee for Consumer Safety, 2010) • Specials Aspects of Cosmetic Spray Safety Evaluations: Principles on Inhalation Risk Assessment, authors: H.Rothe, R.Fauts, E.Geberg K. Rettinger, W.Shuh, C.Gronewold Toxicology Letters 205 (2011) 97-104. BIO BASIC EUROPE S.r.l. Technical Department Manager Claudio Angelinetta research@biobasiceurope.it Toxicology and Regulatory Department Francesca Vallotto lab@biobasiceurope.it Toxicology and Regulatory Department Domenico Marchesini labtox@biobasiceurope.it