Can We Make Cosmetic Contact Allergy History?
Abstract
:1. Introduction
2. Allergic Contact Dermatitis to Cosmetic Ingredients
3. Hazard Identification and Characterization
4. Risk Assessment/Management
5. Summary
Acknowledgments
Author Contributions
Conflicts of Interest
References
- Paracelsus: Die dritte Defension wegen des Schreibens der neuen Rezepte. Available online: http://www.zeno.org/Philosophie/M/Paracelsus/Septem+Defensiones/Die+dritte+Defension+wegen+des+Schreibens+der+neuen+Rezepte (accessed on 7 November 2015). (In German)
- Kimber, I.; Gerberick, G.F.; Basketter, D.A. Thresholds in contact sensitization: Theoretical considerations and practical applications. Food Chem. Toxicol. 1999, 37, 553–560. [Google Scholar] [CrossRef]
- Basketter, D.A.; Evans, P.E.; Gerberick, G.F.; Kimber, I. Factors affecting thresholds in allergic contact dermatitis: Safety and regulatory considerations. Contact Dermat. 2002, 47, 1–6. [Google Scholar] [CrossRef]
- Kimber, I.; Dearman, R.J.; Basketter, D.A.; Ryan, C.A.; Gerberick, G.F.; Lalko, J.; Api, A.M. Dose metrics in the acquisition of skin sensitization: Thresholds and importance of dose per unit area. Regul. Toxicol. Pharmacol. 2008, 52, 39–45. [Google Scholar] [CrossRef] [PubMed]
- Botham, P.A.; Basketter, D.A.; Maurer, T.H.; Mueller, D.; Potokar, M.; Bontinck, W.J. Skin sensitization—A critical review of predictive test methods in animal and man. Food Chem. Toxicol. 1991, 29, 275–286. [Google Scholar] [CrossRef]
- Cockshott, A.; Evans, P.; Ryan, C.A.; Gerberick, G.F.; Betts, C.J.; Dearman, R.J.; Kimber, I.; Basketter, D.A. The local lymph node assay in practice: A current regulatory perspective. Hum. Exp. Toxicol. 2006, 25, 387–394. [Google Scholar] [CrossRef] [PubMed]
- Basketter, D.A.; Kimber, I. Predictive tests for irritants and allergens and their use in quantitative risk assessment. In Contact Dermatitis, 5th ed.; Johansen, J.D., Frosch, P.F., Lepoittevin, J.-P., Eds.; Springer: Berlin, Germany, 2011; Chapter 13; pp. 229–240. [Google Scholar]
- Thyssen, J.P.; Giménez-Arnau, E.; Lepoittevin, J.P.; Menné, T.; Boman, A.; Schnuch, A. The critical review of methodologies and approaches to assess the inherent skin sensitization potential (skin allergies) of chemicals. Contact Dermat. 2012, 66 (Suppl. S1), 11–70. [Google Scholar] [CrossRef] [PubMed]
- Kimber, I.; Basketter, D.A. Contact sensitization: A new approach to risk assessment. Hum. Ecol. Risk Assess. 1997, 3, 385–395. [Google Scholar] [CrossRef]
- Basketter, D.A.; Lea, L.; Cooper, K.; Dickens, A.; Briggs, D.; Pate, I.; Dearman, R.J.; Kimber, I. A comparison of statistical approaches to derivation of EC3 values from local lymph node assay dose responses. J. Appl. Toxicol. 1999, 19, 261–266. [Google Scholar] [CrossRef]
- Basketter, D.A.; Gerberick, G.F.; Kimber, I. The local lymph node assay EC3 value: Status of validation. Contact Dermat. 2007, 57, 70–75. [Google Scholar] [CrossRef] [PubMed]
- Kimber, I.; Basketter, D.A.; Berthold, K.; Butler, M.; Garrigue, J.L.; Lea, L.J.; Newsome, C.; Roggeband, R.; Steiling, W.; Stropp, G.; et al. Skin sensitisation testing in potency and risk assessment. Toxicol. Sci. 2001, 59, 198–208. [Google Scholar] [CrossRef] [PubMed]
- Api, A.M.; Basketter, D.A.; Lalko, J. Correlation between experimental human and murine skin sensitization induction thresholds. Cutan. Ocul. Toxicol. 2015, 34, 298–302. [Google Scholar] [CrossRef] [PubMed]
- Gerberick, G.F.; Robinson, M.K.; Felter, S.; White, I.; Basketter, D.A. Understanding fragrance allergy using an exposure-based risk assessment approach. Contact Dermat. 2001, 45, 333–340. [Google Scholar] [CrossRef]
- Felter, S.P.; Robinson, M.K.; Basketter, D.A.; Gerberick, G.F. A review of the scientific basis for default uncertainty factors for use in quantitative risk assessment of the induction of allergic contact dermatitis. Contact Dermat. 2002, 47, 257–266. [Google Scholar] [CrossRef]
- Felter, S.P.; Ryan, C.A.; Basketter, D.A.; Gerberick, G.F. Application of the risk assessment paradigm to the induction of allergic contact dermatitis. Regul. Toxicol. Pharmacol. 2003, 37, 1–10. [Google Scholar] [CrossRef]
- Api, A.M.; Basketter, D.A.; Cadby, P.A.; Cano, M.F.; Ellis, G.; Gerberick, G.F.; Griem, P.; McNamee, P.M.; Ryan, C.A.; Safford, R. Dermal sensitization quantitative risk assessment (QRA) for fragrance ingredients. Regul. Toxicol. Pharmacol. 2008, 52, 3–23. [Google Scholar] [CrossRef] [PubMed]
- Basketter, D.A.; White, I.R. Diagnostic patch testing—Does it have a wider relevance? Contact Dermat. 2012, 67, 1–2. [Google Scholar] [CrossRef] [PubMed]
- White, J.M.L.; de Groot, A.C.; White, I.R. Cosmetics and skin care products. In Contact Dermatitis, 5th ed.; Johansen, J.D., Frosch, P.J., Lepoittevin, J.-P., Eds.; Springer: Heidelberg, Germany, 2011; pp. 591–606. [Google Scholar]
- Marks, J.G.; Belsito, D.V.; DeLeo, V.A.; Fowler, J.F., Jr.; Fransway, A.F.; Maibach, H.I.; Mathias, C.G.; Nethercott, J.R.; Rietschel, R.L.; Sherertz, E.F.; et al. North American Contact Dermatitis Group patch test results for the detection of delayed-type hypersensitivity to topical allergens. J. Am. Acad. Dermatol. 1998, 38, 911–918. [Google Scholar] [CrossRef]
- Pratt, M.D.; Belsito, D.V.; DeLeo, V.A.; Fowler, J.F., Jr.; Fransway, A.F.; Maibach, H.I.; Marks, J.G.; Mathias, C.G.; Rietschel, R.L.; Sasseville, D.; et al. North American Contact Dermatitis Group patch-test results, 2001–2002 study period. Dermatitis 2004, 15, 176–183. [Google Scholar] [PubMed]
- Zug, K.A.; Kornik, R.; Belsito, D.V.; DeLeo, V.A.; Fowler, J.F., Jr.; Maibach, H.I.; Marks, J.G., Jr.; Mathias, C.G.; Pratt, M.D.; Rietschel, R.L.; et al. North American Contact Dermatitis Group. Patch-testing North American lip dermatitis patients: Data from the North American Contact Dermatitis Group, 2001 to 2004. Dermatitis 2008, 19, 202–208. [Google Scholar] [PubMed]
- Zug, K.A.; Warshaw, E.M.; Fowler, J.F., Jr.; Maibach, H.I.; Belsito, D.L.; Pratt, M.D.; Sasseville, D.; Storrs, F.J.; Taylor, J.S.; Mathias, C.G.; et al. Patch-test results of the North American Contact Dermatitis Group 2005–2006. Dermatitis 2009, 20, 149–160. [Google Scholar] [PubMed]
- Fransway, A.F.; Zug, K.A.; Belsito, D.V.; Deleo, V.A.; Fowler, J.F., Jr.; Maibach, H.I.; Marks, J.G.; Mathias, C.G.; Pratt, M.D.; Rietschel, R.L.; et al. North American Contact Dermatitis Group patch test results for 2007–2008. Dermatitis 2013, 24, 10–21. [Google Scholar] [CrossRef] [PubMed]
- Warshaw, E.M.; Belsito, D.V.; Taylor, J.S.; Sasseville, D.; DeKoven, J.G.; Zirwas, M.J.; Fransway, A.F.; Mathias, C.G.; Zug, K.A.; DeLeo, V.A.; et al. North American Contact Dermatitis Group patch test results: 2009 to 2010. Dermatitis 2013, 24, 50–59. [Google Scholar] [CrossRef] [PubMed]
- Buckley, D.A.; Wakelin, S.H.; Seed, P.T.; Holloway, D.; Rycroft, R.J.; White, I.R.; McFadden, J.P. The frequency of fragrance allergy in a patch-test population over a 17-year period. Br. J. Dermatol. 2000, 142, 279–283. [Google Scholar] [CrossRef] [PubMed]
- Nardelli, A.; Carbonez, A.; Drieghe, J.; Goossens, A. Results of patch testing with fragrance mix 1, fragrance mix 2, and their ingredients, and Myroxylon pereirae and colophonium, over a 21-year period. Contact Dermat. 2013, 68, 307–313. [Google Scholar] [CrossRef] [PubMed]
- Mahler, V.; Geier, J.; Schnuch, A. Current trends in patch testing—New data from the German Contact Dermatitis Research Group (DKG) and the Information Network of Departments of Dermatology (IVDK). J. Dtsch. Dermatol. Ges. 2014, 12, 583–592. [Google Scholar] [CrossRef] [PubMed]
- Boonchai, W.; Desomchoke, R.; Iamtharachai, P. Trend of contact allergy to cosmetic ingredients in Thais over a period of 10 years. Contact Dermat. 2011, 65, 311–316. [Google Scholar] [CrossRef] [PubMed]
- Cronin, M.T.D.; Basketter, D.A. Multivariate QSAR analysis of a skin sensitization database. SAR and QSAR. Environ. Res. 1994, 2, 159–179. [Google Scholar]
- Basketter, D.A.; Gerberick, G.F. Interlaboratory evaluation of the Buehler test. Contact Dermat. 1996, 5, 146–151. [Google Scholar] [CrossRef]
- Gerberick, G.F.; Ryan, C.A.; Kern, P.S.; Schlatter, H.; Dearman, R.J.; Kimber, I.; Patlewicz, G.; Basketter, D.A. Compilation of historical local lymph node assay data for the evaluation of skin sensitization alternatives. Dermatitis 2005, 16, 157–202. [Google Scholar] [PubMed]
- Kern, P.S.; Gerberick, G.F.; Ryan, C.A.; Kimber, I.; Aptula, A.; Basketter, D.A. Historical local lymph node data for the evaluation of skin sensitization alternatives: A second compilation. Dermatitis 2010, 21, 8–32. [Google Scholar] [PubMed]
- Basketter, D.A.; Clapp, C.; Jefferies, D.; Safford, R.J.; Ryan, C.A.; Gerberick, G.F.; Dearman, R.J.; Kimber, I. Predictive identification of human skin sensitisation thresholds. Contact Dermat. 2005, 53, 260–267. [Google Scholar] [CrossRef] [PubMed]
- Griem, P.; Goebel, C.; Scheffler, H. Proposal for a risk assessment methodology for skin sensitization based on sensitization potency data. Regul. Toxicol. Pharmacol. 2003, 38, 269–290. [Google Scholar] [CrossRef] [PubMed]
- Schneider, K.; Akkan, Z. Quantitative relationship between the local lymph node assay and human skin sensitization assays. Regul. Toxicol. Pharmacol. 2004, 39, 245–255. [Google Scholar] [CrossRef] [PubMed]
- Basketter, D.A.; McFadden, J.P. Cutaneous allergies. In Immunotoxicity, Immune Dysfunction and Chronic Disease; Dietert, R.R., Luebke, R.W., Eds.; Humana Press: New York, NY, USA, 2012; pp. 103–126. [Google Scholar]
- Basketter, D.A.; Alepee, N.; Ashikaga, T.; Barroso, J.; Gilmour, N.; Goebel, C.; Hibatallah, J.; Hoffmann, S.; Kern, P.; Martinozzi-Teissier, S.; et al. Categorisation of chemicals according to their relative human skin sensitizing potency. Dermatitis 2014, 25, 11–21. [Google Scholar] [CrossRef] [PubMed]
- Corsini, E.; Papale, A.; Galbiati, V.; Roggen, E. Safety evaluation of cosmetic ingredients: In vitro opportunities for the identification of contact allergens. Cosmetics 2014, 1, 61–74. [Google Scholar] [CrossRef]
- Jowsey, I.R.; Basketter, D.A.; Westmoreland, C.; Kimber, I. A future approach to measuring relative skin sensitising potency: A proposal. J. Appl. Toxicol. 2006, 26, 341–350. [Google Scholar] [CrossRef] [PubMed]
- Basketter, D.A.; Kimber, I. Updating the skin sensitization in vitro data assessment paradigm in 2009. J. Appl. Toxicol. 2009, 29, 545–550. [Google Scholar] [CrossRef] [PubMed]
- Van der Veen, J.W.; Soeteman-Hernández, L.G.; Ezendam, J.; Stierum, R.; Kuper, F.C.; van Loveren, H. Anchoring molecular mechanisms to the adverse outcome pathway for skin sensitization: Analysis of existing data. Crit. Rev. Toxicol. 2014, 44, 590–599. [Google Scholar] [CrossRef] [PubMed]
- Urbisch, D.; Mehling, A.; Guth, K.; Ramirez, T.; Honarvar, N.; Kolle, S.; Landsiedel, R.; Jaworska, J.; Kern, P.S.; Gerberick, F.; et al. Assessing skin sensitization hazard in mice and men using non-animal test methods. Regul. Toxicol. Pharmacol. 2015, 71, 337–351. [Google Scholar] [CrossRef] [PubMed]
- Jaworska, J.; Dancik, Y.; Kern, P.; Gerberick, F.; Natsch, A. Bayesian integrated testing strategy to assess skin sensitization potency: From theory to practice. J. Appl. Toxicol. 2013, 33, 1353–1364. [Google Scholar] [CrossRef] [PubMed]
- Nukada, Y.; Miyazawa, M.; Kazutoshi, S.; Sakaguchi, H.; Nishiyama, N. Data integration of non-animal tests for the development of a test battery to predict the skin sensitizing potential and potency of chemicals. Toxicol. Vitr. 2013, 27, 609–618. [Google Scholar] [CrossRef] [PubMed]
- Jaworska, J.S.; Natsch, A.; Ryan, C.; Strickland, J.; Ashikaga, T.; Miyazawa, M. Bayesian integrated testing strategy (ITS) for skin sensitization potency assessment: A decision support system for quantitative weight of evidence and adaptive testing strategy. Arch. Toxicol. 2015, 89, 2355–2383. [Google Scholar] [CrossRef] [PubMed]
- Natsch, A.; Emter, R. Reporter cell lines for skin sensitization testing. Arch. Toxicol. 2015, 89, 1645–1668. [Google Scholar] [CrossRef] [PubMed]
- Basketter, D.A.; Clewell, H.; Kimber, I.; Rossi, A.; Blaauboer, B.; Burrier, R.; Daneshian, M.; Eskes, C.; Goldberg, A.; Hasiwa, N.; et al. A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing-t4 report. ALTEX 2012, 29, 3–91. [Google Scholar] [CrossRef] [PubMed]
- Api, A.M.; Belsito, D.; Bickers, D.; Bruze, M.; Calow, P.; Greim, H.; Hanifin, J.M.; McNamee, P.M.; Rogers, A.E.; Saurat, J.H.; et al. Quantitative risk assessment of contact sensitization: Clinical data to assess utility of the model. Dermatitis 2010, 21, 207–213. [Google Scholar]
- Basketter, D.A.; Angelini, G.; Ingber, A.; Kern, P.; Menné, T. Nickel, chromium and cobalt in consumer products: Revisiting safe levels in the new millennium. Contact Dermat. 2003, 49, 1–7. [Google Scholar] [CrossRef]
- Basketter, D.A.; Clapp, C.J.; Safford, B.J.; Jowsey, I.R.; McNamee, P.M.; Ryan, C.A.; Gerberick, G.F. Preservatives and skin sensitisation quantitative risk assessment: Risk benefit considerations. Dermatitis 2008, 19, 20–27. [Google Scholar] [PubMed]
- Basketter, D.A. Methyldibromo glutaronitrile, skin sensitisation and quantitative risk assessment. Cutan. Ocul. Toxicol. 2010, 29, 4–9. [Google Scholar] [CrossRef] [PubMed]
- Farage, M.A.; Bjerke, D.L.; Mahony, C.; Blackburn, K.L.; Gerberick, G.F. Quantitative risk assessment for the induction of allergic contact dermatitis: Uncertainty factors for mucosal exposures. Contact Dermat. 2003, 49, 140–147. [Google Scholar] [CrossRef]
- Dillarstone, A. Cosmetic preservatives. Contact Dermat. 1997, 37, 190. [Google Scholar] [CrossRef]
- Schwensen, J.F.; White, I.R.; Thyssen, J.P.; Menné, T.; Johansen, J.D. Failures in risk assessment and risk management for cosmetic preservatives in Europe and the impact on public health. Contact Dermat. 2015, 73, 133–141. [Google Scholar] [CrossRef] [PubMed]
- Lundov, M.D.; Opstrup, M.S.; Johansen, J.D. Methylisothiazolinone contact allergy: A growing epidemic. Contact Dermat. 2013, 69, 271–275. [Google Scholar] [CrossRef] [PubMed]
- Basketter, D.A.; Safford, R.J. Skin sensitisation quantitative risk assessment: A review of underlying assumptions. Regul. Toxicol. Pharmacol. 2016, 74, 105–116. [Google Scholar] [CrossRef] [PubMed]
- Safford, B.; Api, A.M.; Barratt, C.; Comiskey, D.; Daly, E.J.; Ellis, G.; McNamara, C.; O’Mahony, C.; Robison, S.; Smith, B.; et al. Use of an aggregate exposure model to estimate consumer exposure to fragrance ingredients in personal care and cosmetic products. Regul. Toxicol. Pharmacol. 2015, 72, 673–682. [Google Scholar] [CrossRef] [PubMed]
- EU Nickel Directive. European Parliament and Council Directive 94/27/EC of 30 June 1994: Amending for the 12th time Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations. Off. J. Eur. Commun. 1994, 188, 1–2. [Google Scholar]
- Svedman, C.; Engfeldt, M.; Api, A.M.; Politano, V.T.; Belsito, D.V.; Gruvberger, B.; Bruze, M. Does the new standard for eugenol designed to protect against contact sensitization protect those sensitized from elicitation of the reaction? Dermatitis 2012, 23, 32–38. [Google Scholar] [CrossRef] [PubMed]
- Basketter, D.A.; White, I.R.; McFadden, J.P.; Kimber, I. Skin sensitization: Integration of clinical data into hazard identification and risk assessment. Hum. Exp. Toxicol. 2015, 34, 1222–1230. [Google Scholar] [CrossRef] [PubMed]
No. | ICDRG 1974 1 | European Baseline Series 2015 |
---|---|---|
1 | Potassium dichromate | Potassium dichromate |
2 | p-Phenylenediamine | p-Phenylenediamine |
3 | Thiuram mix | Thiuram mix |
4 | Neomycin sulphate | Neomycin sulphate |
5 | Cobalt chloride | Cobalt chloride |
6 | None | Benzocaine |
7 | Nickel sulphate | Nickel sulphate |
8 | Clioquinol | Clioquinol |
9 | Colophony | Colophony |
10 | Paraben mix | Paraben mix |
11 | Black rubber mix | N-Isopropyl-N’-phenyl-p-phenylenediamine |
12 | Wool alcohols (lanolin) | Wool alcohols (lanolin) |
13 | Mercapto mix | Mercapto mix |
14 | Epoxy resin | Epoxy resin |
15 | Balsam of Peru (Myroxylon pereirae) | Balsam of Peru (Myroxylon pereirae) |
16 | Carba mix | Butyl phenolformaldehyde resin |
17 | Ethylenediamine HCl | Mercaptobenzothiazole |
18 | Formaldehyde | Formaldehyde |
19 | Fragrance mix 1 | Fragrance mix I |
20 | Wood tars | Sesquiterpene lactone mix |
21 | Naphthyl mix | Quaternium-15 |
22 | None | 2-Methoxy-6-n-pentyl-4-benzoquinone |
23 | None | Methylchloroisothiazolinone/methylisothiazolinone (MCI/MI) |
24 | None | Budesonide |
25 | None | Tixocortol pivalate |
26 | None | Methyldibromo glutaronitrile (MDGN) |
27 | None | Fragrance mix II |
28 | None | Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC) |
29 | None | Methylisothiazolinone |
30 | None | Textile dye mix |
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Basketter, D.; Corsini, E. Can We Make Cosmetic Contact Allergy History? Cosmetics 2016, 3, 11. https://doi.org/10.3390/cosmetics3010011
Basketter D, Corsini E. Can We Make Cosmetic Contact Allergy History? Cosmetics. 2016; 3(1):11. https://doi.org/10.3390/cosmetics3010011
Chicago/Turabian StyleBasketter, David, and Emanuela Corsini. 2016. "Can We Make Cosmetic Contact Allergy History?" Cosmetics 3, no. 1: 11. https://doi.org/10.3390/cosmetics3010011