title: Principle considerations for the risk assessment of sprayed consumer products.
abstract: 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.
authors.affiliation: Henkel AG & Co KGaA, Henkelstr. 67, D-40191 Düsseldorf, Germany. Electronic address: winfried.steiling@henkel.com.
authors.forename: W
authors.initials: W
authors.lastname: Steiling
authors.affiliation: Montana Air SL, Pollig. Ind. Clot del Tufau 4, SP-08295 St Vicens de Castellet, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Bascompta
authors.affiliation: Unilever UK LTD, Colworth Park, MK44 1LQ Bedforshire, Sharnbrook, UK.
authors.forename: P
authors.initials: P
authors.lastname: Carthew
authors.affiliation: Ardagh Group, Via Enrico Fermi 2, I-27023 Cassolnovo, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Catalano
authors.affiliation: SC Johnson LTD, Frimley Green, Camberley, GU16 7AJ Surrey, UK.
authors.forename: N
authors.initials: N
authors.lastname: Corea
authors.affiliation: FEA European Aerosol Federation, Avenue Herrmann-Debroux 15a, B-1160 Brussels, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: D'Haese
authors.affiliation: British Aerosol Manufactures Association, Kings Builings, Smith Square, SW1 P 3JJ London, UK.
authors.forename: P
authors.initials: P
authors.lastname: Jackson
authors.affiliation: Research Institute for Fragrance Materials Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, USA.
authors.forename: L
authors.initials: L
authors.lastname: Kromidas
authors.affiliation: L'Oreal, River Plaza, 25-29, Quai Aulagnier, F-92600 Asniéres sur Seine, France.
authors.forename: P
authors.initials: P
authors.lastname: Meurice
authors.affiliation: Procter & Gamble Service GmbH, Berliner Allee 65, D-64274 Darmstadt, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Rothe
authors.affiliation: Research Institute for Fragrance Materials Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, USA.
authors.forename: M
authors.initials: M
authors.lastname: Singal
mesh_terms: D000280:Administration, Inhalation; D000281:Administration, Intranasal; D000336:Aerosols / Q000008:administration & dosage / Q000009:adverse effects* / Q000592:standards; D000818:Animals; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D005062:European Union; D005858:Germany; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug; D008954:Models, Biological; D009330:Nebulizers and Vaporizers; D019055:No-Observed-Adverse-Effect Level; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000379:methods*; D018675:Toxicity Tests / Q000592:standards
chemical_list: D000336:Aerosols
keywords: Exposure; Inhalation; Risk assessment; Spray