Principle considerations for the risk assessment of sprayed consumer products

• Published in: Toxicology letters Vol. 227; no. 1; pp. 41 - 49
• Main Authors: Steiling, W., Bascompta, M., Carthew, P., Catalano, G., Corea, N., D’Haese, A., Jackson, P., Kromidas, L., Meurice, P., Rothe, H., Singal, M.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ireland Ltd 16.05.2014
• Subjects: Administration, Inhalation; Administration, Intranasal; Aerosols - administration & dosage; Aerosols - adverse effects; Aerosols - standards; Animals; Consumer Product Safety - legislation & jurisprudence; European Union; Exposure; Germany; Guidelines as Topic; Humans; Inhalation; Legislation, Drug; Models, Biological; Nebulizers and Vaporizers; No-Observed-Adverse-Effect Level; Risk assessment; Risk Assessment - legislation & jurisprudence; Risk Assessment - methods; Spray; Toxicity Tests - standards; Germany; Exposure; Spray; Risk assessment; Inhalation
• ISSN: 0378-4274; 1879-3169
• DOI: 10.1016/j.toxlet.2014.03.005

In recent years, the official regulation of chemicals and chemical products has been intensified. Explicitly for spray products enhanced requirements to assess the consumers’/professionals’ exposure to such product type have been introduced. In this regard the Aerosol-Dispensers-Directive (75/324/EEC) with obligation for marketing aerosol dispensers, and the Cosmetic-Products-Regulation (1223/2009/EC) which obliges the insurance of a safety assessment, have to be mentioned. Both enactments, similar to the REACH regulation (1907/2006/EC), require a robust chemical safety assessment. From such assessment, appropriate risk management measures may be identified to adequately control the risk of these chemicals/products to human health and the environment when used. Currently, the above-mentioned regulations lack the guidance on which data are needed for preparing a proper hazard analysis and safety assessment of spray products. Mandatory in the process of inhalation risk and safety assessment is the determination and quantification of the actual exposure to the spray product and more specifically, its ingredients. In this respect the current article, prepared by the European Aerosol Federation (FEA, Brussels) task force “Inhalation Toxicology”, intends to introduce toxicological principles and the state of the art in currently available exposure models adapted for typical application scenarios. This review on current methodologies is intended to guide safety assessors to better estimate inhalation exposure by using the most relevant data.