- About this Journal ·
- Abstracting and Indexing ·
- Advance Access ·
- Aims and Scope ·
- Annual Issues ·
- Article Processing Charges ·
- Articles in Press ·
- Author Guidelines ·
- Bibliographic Information ·
- Citations to this Journal ·
- Contact Information ·
- Editorial Board ·
- Editorial Workflow ·
- Free eTOC Alerts ·
- Publication Ethics ·
- Reviewers Acknowledgment ·
- Submit a Manuscript ·
- Subscription Information ·
- Table of Contents
BioMed Research International
Volume 2013 (2013), Article ID 181634, 10 pages
Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose
1Research Institute for Medicines and Pharmaceutical Sciences (iMed.UL), Faculty of Pharmacy, University of Lisbon, Avenida Prof. Gama Pinto, 1649-003 Lisbon, Portugal
2Laboratório Edol Produtos Farmacêuticos S.A., Estrada Casal Canas Lote 6, 2790-007 Carnaxide, Portugal
Received 22 April 2013; Revised 19 August 2013; Accepted 29 August 2013
Academic Editor: Ronald E. Baynes
Copyright © 2013 Sara Raposo et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
- S. Raposo, S. Simões, A. J. Almeida, and H. M. Ribeiro, “Advanced systems for glucocorticoids' dermal delivery,” Expert Opinion on Drug Delivery, vol. 10, no. 6, pp. 857–877, 2013.
- G. M. Eccleston, “Functions of mixed emulsifiers and emulsifying waxes in dermatological lotions and creams,” Colloids and Surfaces A, vol. 123-124, pp. 169–182, 1997.
- S. Raposo, A. Salgado, G. Eccleston, M. Urbano, and H. M. Ribeiro, “Cold processed oil-in-water emulsions for dermatological purpose: formulation design and structure analysis,” Pharmaceutical Development and Technology, 2013.
- EU, “Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products,” OJ L262, September 1976.
- European Parliament and Council, “Regulation (EC) No. 1223/2009 of the European. Parliament and of the Council of 30 November 2009 on cosmetic products (recast)—text of importance for the EEA (Official Journal of the European Union L 342/59, 22 December 2009),” 2009, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:EN:PDF.
- H. Rothe, R. Fautz, E. Gerber et al., “Special aspects of cosmetic spray safety evaluations: principles on inhalation risk assessment,” Toxicology Letters, vol. 205, no. 2, pp. 97–104, 2011.
- M. Pauwels and V. Rogiers, “Human health safety evaluation of cosmetics in the EU: a legally imposed challenge to science,” Toxicology and Applied Pharmacology, vol. 243, no. 2, pp. 260–274, 2010.
- E. Bárány, M. Lindberg, and M. Lodén, “Unexpected skin barrier influence from nonionic emulsifiers,” International Journal of Pharmaceutics, vol. 195, no. 1-2, pp. 189–195, 2000.
- G. J. Nohynek, E. Antignac, T. Re, and H. Toutain, “Safety assessment of personal care products/cosmetics and their ingredients,” Toxicology and Applied Pharmacology, vol. 243, no. 2, pp. 239–259, 2010.
- Evonik, 2008, “Emulsifiers for skin care application,” no. 22-08, 2008, http://www.finecon.sk/userfiles/file/broschuere_pc_3.pdf.
- “VCCLAB, Virtual Computational Chemistry Laboratory,” 2005, http://www.vcclab.org/.
- G. A. Burdock, “Safety assessment of hydroxypropyl methylcellulose as a food ingredient,” Food and Chemical Toxicology, vol. 45, no. 12, pp. 2341–2351, 2007.
- National industrial chemicals notification and assessment scheme, “Full public report on poly (maleic anhydridemethyl vinyl ether) by 1,9-decadiene,” no. NA/116, 1993, http://www.docin.com/p-393512288.html.
- P. Wagner, “Inert Reassessment—2-methyl-2,4-pentanediol,” United states environmental protection agency. Washington, DC, USA, 2005.
- Tagat L2, MSDS, 2009, http://corporate.evonik.com/en/Pages/default.aspx.
- Tegosoft M, MSDS, 2011, http://corporate.evonik.com/en/Pages/default.aspx.
- Cosmetic ingredient review (CIR), “Final Report on the Safety Assessment of Myristyl Myristate and Isopropyl Myristate,” International Journal of Toxicology, vol. 1, pp. 55–80, 1982.
- Tegosoft TN MSDS, 2012, http://msds.consumer-specialties.evonik.com/msds/site6/e/result/report.jsp.
- Cosmetic ingredient review (CIR), “Expert Panel Meeting,” in Green Book, vol. 4, pp. 1–94, Alkyl Benzoates, 2010.
- Stabileze QM, MSDS, 2011, http://www.ashland.com/.
- SCCS, Scientific Committee on Consumer Safety, “Opinion on alkyl (C16, C18, C22) trimethylammonium chloride,” no. 1246, 2009.
- 1,5-pentanediol MSDS, 2012, http://www.sigmaaldrich.com/MSDS/MSDS/DisplayMSDSPage.do?country=PT&language=pt&productNumber=68336&brand=FLUKA&PageToGoToURL=http%3A%2F%2Fhttp://www.sigmaaldrich.com%2Fcatalog%2Fproduct%2Ffluka%2F68336%3Flang%3Dpt.
- CPMP/QWP/122/02, rev 1, “Guideline on stability testing: stability testing of existing active substances and related finished products,” Committee for Proprietary Medicinal Products, London, UK, 2003.
- Farmacopeia Portuguesa, Imprensa Nacional-Casa da Moeda, 9th ed. Lisboa, Portugal, 2008.
- SCCS, European Commission, “Health and Consumer Protection, Directorate-General for Health and Consumers. Scientific Committee on Consumer Safety “The SCCS's Notes of Guidance For Testing of Cosmetic Ingredients and their Safety Evaluation”,” 7th Revision. Adopted by the SCCS during the 9th plenary meeting of 14 December 2010. SCCS/1416/11, 2011, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_004.pdf.
- OECD Guideline for the testing of chemicals In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, TG439, 2010.
- F. N. Marzulli and H. I. Maibach, “Contact allergy: predictive testing in man,” Contact Dermatitis, vol. 2, no. 1, pp. 1–17, 1976.
- S. Fregert and H. Bandmann, International Contact Dermatitis Research Group Patch Testing, Springer, New York, NY, USA, 1975.
- M. Lodén, “Role of topical emollients and moisturizers in the treatment of dry skin barrier disorders,” American Journal of Clinical Dermatology, vol. 4, no. 11, pp. 771–788, 2003.
- X. W. Teng, D. C. Cutler, and N. M. Davies, “Degradation kinetics of mometasone furoate in aqueous systems,” International Journal of Pharmaceutics, vol. 259, no. 1-2, pp. 129–141, 2003.
- R. O. Potts and R. H. Guy, “Predicting skin permeability,” Pharmaceutical Research, vol. 9, no. 5, pp. 663–669, 1992.
- J. D. Bos and M. M. H. M. Meinardi, “The 500 Dalton rule for the skin penetration of chemical compounds and drugs,” Experimental Dermatology, vol. 9, no. 3, pp. 165–169, 2000.
- K. R. Brain and R. P. Chilcott, “Physicochemical factors affecting skin absorption,” in Principles and Practice of Skin Toxicology, R. P. Chilcott and S. Price, Eds., pp. 83–92, John Wiley & Sons, Chichester, UK, 2008.
- M. Pauwels and V. Rogiers, “Database search for safety information on cosmetic ingredients,” Regulatory Toxicology and Pharmacology, vol. 49, no. 3, pp. 208–216, 2007.
- L. Djekic and M. Primorac, “The influence of cosurfactants and oils on the formation of pharmaceutical microemulsions based on PEG-8 caprylic/capric glycerides,” International Journal of Pharmaceutics, vol. 352, no. 1-2, pp. 231–239, 2008.
- C. F. Zanatta, V. Ugartondo, M. Mitjans, P. A. Rocha-Filho, and M. P. Vinardell, “Low cytotoxicity of creams and lotions formulated with Buriti oil (Mauritia flexuosa) assessed by the neutral red release test,” Food and Chemical Toxicology, vol. 46, no. 8, pp. 2776–2781, 2008.
- (CIR) Cosmetic ingredient review, “Final report of the amended safety assessment of Glyceryl Laurate, Glyceryl Laurate SE, Glyceryl Laurate/Oleate, Glyceryl Adipate, Glyceryl Alginate, Glyceryl Arachidate, Glyceryl Arachidonate, Glyceryl Behenate, Glyceryl Caprate, Glyceryl Caprylate, Glyceryl Caprylate/Caprate, Glyceryl Citrate/Lactate/Linoleate/Oleate, Glyceryl Cocoate, Glyceryl Collagenate, Glyceryl Erucate, Glyceryl Hydrogenated Rosinate, Glyceryl Hydrogenated Soyate, Glyceryl Hydroxystearate, Glyceryl Isopalmitate, Glyceryl Isostearate, Glyceryl Isostearate/Myristate, Glyceryl Isostearates, Glyceryl Lanolate, Glyceryl Linoleate, Glyceryl Linolenate, Glyceryl Montanate, Glyceryl Myristate, Glyceryl Isotridecanoate/Stearate/Adipate, Glyceryl Oleate SE, Glyceryl Oleate/Elaidate, Glyceryl Palmitate, Glyceryl Palmitate/Stearate, Glyceryl Palmitoleate, Glyceryl Pentadecanoate, Glyceryl Polyacrylate, Glyceryl Rosinate, Glyceryl Sesquioleate, Glyceryl/Sorbitol Oleate/Hydroxystearate, Glyceryl Stearate/Acetate, Glyceryl Stearate/Maleate, Glyceryl Tallowate, Glyceryl Thiopropionate, and Glyceryl Undecylenate,” International Journal of Toxicology, vol. 23, no. 2, pp. 55–94, 2004.
- C. Fruijtier-Pölloth, “Safety assessment on polyethylene glycols (PEGs) and their derivatives as used in cosmetic products,” Toxicology, vol. 214, no. 1-2, pp. 1–38, 2005.
- F. A. Andersen, “Final report on the safety assessment of stearoxy dimethicone, dimethicone, methicone, amino bispropyl dimethicone, aminopropyl dimethicone, amodimethicone, amodimethicone hydroxystearate, behenoxy dimethicone, C24-28 alkyl methicone, C30-45 alkyl methicone, C30-45 alkyl dimethicone, cetearyl methicone, cetyl dimethicone, dimethoxysilyl ethylenediaminopropyl dimethicone, hexyl methicone, hydroxypropyldimethicone, stearamidopropyl dimethicone, stearyl dimethicone, stearyl methicone, and vinyldimethicone,” International Journal of Toxicology, vol. 22, no. 2, pp. 11–35, 2003.
- K. A. Traul, A. Driedger, D. L. Ingle, and D. Nakhasi, “Review of the toxicologic properties of medium-chain triglycerides,” Food and Chemical Toxicology, vol. 38, no. 1, pp. 79–98, 2000.
- K. Blackburn, J. A. Stickney, H. L. Carlson-Lynch, P. M. McGinnis, L. Chappell, and S. P. Felter, “Application of the threshold of toxicological concern approach to ingredients in personal and household care products,” Regulatory Toxicology and Pharmacology, vol. 43, no. 3, pp. 249–259, 2005.
- B. Diaz-Reinosoa, A. Mourea, H. Dominguez, and J. C. Parajo, “Membrane concentration of antioxidants from Castanea sativa leaves aqueous Extracts,” Chemical Engineering Journal, vol. 175, pp. 95–102, 2011.
- E. Bárány, M. Lindberg, and M. Lodén, “Biophysical characterization of skin damage and recovery after exposure to different surfactants,” Contact Dermatitis, vol. 40, pp. 98–103, 1999.
- K.-P. Wilhelm, G. Freitag, and H. H. Wolff, “Surfactant-induced skin irritation and skin repair: evaluation of the acute human irritation model by noninvasive techniques,” Journal of the American Academy of Dermatology, vol. 30, no. 6, pp. 944–949, 1994.
- P. G. M. Van Der Valk, M. C. Crijns, J. P. Nater, and E. Bleumink, “Skin irritancy of commercially available soap and detergent bars as measured by water vapour loss,” Dermatosen in Beruf und Umwelt, vol. 32, no. 3, pp. 87–90, 1984.
- J. L. Lévêque, “Measurement of transepidermal water loss,” in Cutaneous Investigation in Health and Disease. Noninvasive Methods and Instrumentation, J. L. Lévêque, Ed., pp. 135–152, Marcel Dekker, New York, NY, USA, 1989.
- J. N. Kraft and C. W. Lynde, “Moisturizers: what they are and a practical approach to product selection,” Skin Therapy Letter, vol. 10, no. 5, pp. 1–8, 2005.
- R. Rudolph and E. Kownatzki, “Corneometric, sebumetric and TEWL measurements following the cleaning of atopic skin with a urea emulsion versus a detergent cleanser,” Contact Dermatitis, vol. 50, no. 6, pp. 354–358, 2004.
- M. Mao-Qiang, B. E. Brown, S. Wu-Pong, K. R. Feingold, and P. M. Elias, “Exogenous nonphysiologic vs physiologic lipids: divergent mechanisms for correction of permeability barrier dysfunction,” Archives of Dermatology, vol. 131, no. 7, pp. 809–816, 1995.