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Updating exposure assessment for skin sensitization quantitative risk assessment for fragrance materials.
Api, Anne Marie; Basketter, David; Bridges, James; Cadby, Peter; Ellis, Graham; Gilmour, Nicola; Greim, Helmut; Griem, Peter; Kern, Petra; Khaiat, Alain; O'Brien, John; Rustemeyer, Thomas; Ryan, Cindy; Safford, Bob; Smith, Benjamin; Vey, Matthias; White, Ian R.
Afiliación
  • Api AM; Research Institute for Fragrance Materials, Inc., Woodcliff Lake, NJ, USA. Electronic address: amapi@rifm.org.
  • Basketter D; Consultant, DABMEB Consultancy Ltd., Sharnbrook, UK.
  • Bridges J; Member IDEA Supervisory Group, University of Surrey, Guildford, UK.
  • Cadby P; Consultant, Geneva, Switzerland.
  • Ellis G; Firmenich SA, 1 Route des Jeunes, Geneva, Switzerland.
  • Gilmour N; Unilever Safety & Environmental Assurance Centre, Sharnbrook, UK.
  • Greim H; Member IDEA Supervisory Group, Technical University of Munich, Germany.
  • Griem P; Symrise AG, Holzminden, Germany.
  • Kern P; NV Procter & Gamble Services Company SA, Strombeek-Bever, Belgium.
  • Khaiat A; Member IDEA Supervisory Group, Cosmetics Consultant, Singapore.
  • O'Brien J; Creme Global, Dublin, Ireland.
  • Rustemeyer T; Member IDEA Supervisory Group, VU Amsterdam, Netherlands.
  • Ryan C; The Procter & Gamble Company, Mason, OH, USA.
  • Safford B; Consultant, B-Safe Toxicology Consulting, Rushden, UK.
  • Smith B; Innovations in Food and Chemical Safety Programme, Singapore Institute of Food & Biotechnology Innovation, Agency for Science, Technology & Research, Singapore; School of Chemical & Biomedical Engineering, Nanyang Technological University, Singapore.
  • Vey M; International Fragrance Association, Brussels, Belgium.
  • White IR; Member IDEA Supervisory Group, St. John's Institute of Dermatology, London, UK.
Regul Toxicol Pharmacol ; 118: 104805, 2020 Dec.
Article en En | MEDLINE | ID: mdl-33075411
In 2008, a proposal for assessing the risk of induction of skin sensitization to fragrance materials Quantitative Risk Assessment 1 (QRA1) was published. This was implemented for setting maximum limits for fragrance materials in consumer products. However, there was no formal validation or empirical verification after implementation. Additionally, concerns remained that QRA1 did not incorporate aggregate exposure from multiple product use and included assumptions, e.g. safety assessment factors (SAFs), that had not been critically reviewed. Accordingly, a review was undertaken, including detailed re-evaluation of each SAF together with development of an approach for estimating aggregate exposure of the skin to a potential fragrance allergen. This revision of QRA1, termed QRA2, provides an improved method for establishing safe levels for sensitizing fragrance materials in multiple products to limit the risk of induction of contact allergy. The use of alternative non-animal methods is not within the scope of this paper. Ultimately, only longitudinal clinical studies can verify the utility of QRA2 as a tool for the prevention of contact allergy to fragrance materials.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piel / Alérgenos / Dermatitis Alérgica por Contacto / Pruebas de Irritación de la Piel / Odorantes Tipo de estudio: Etiology_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Regul Toxicol Pharmacol Año: 2020 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piel / Alérgenos / Dermatitis Alérgica por Contacto / Pruebas de Irritación de la Piel / Odorantes Tipo de estudio: Etiology_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Regul Toxicol Pharmacol Año: 2020 Tipo del documento: Article Pais de publicación: Países Bajos