3.2. Skin Irritation and Corrosion

OECD (2002). OECD Guidelines for the Testing of Chemicals No. 404: Acute Dermal Irritation/Corrosion, 13 pp. Paris, France: Organisation for Economic Cooperation and Development.

Botham P.A. , Earl L.K. , Fentem J.H. , Roguet R. , & van de Sandt J.J.M. (1998). Alternative methods for skin irritation testing: the current status. ECVAM Skin Irritation Task Force Report 1. ATLA 26, 195–211.

Zuang V. , Balls M. , Botham P.A. , Coquette A. , Corsini E. , Curren R.D. , Elliott G.R. , Fentem J.H. , Heylings J.R. , Liebsch M. , Medina J. , Roguet R. , van de Sandt H. , Wiemann C. , & Worth A.P. (2002). Follow-up to the ECVAM Prevalidation Study on In vitro Tests for Acute Skin Irritation. ECVAM Skin Irritation Task Force Report 2. ATLA 30, 109–129.

van de Sandt J. , Roguet R. , Cohen C. , Esdaile D. , Ponec M. , Corsini E. , Barker C. , Fusenig N. , Liebsch M. , Benford D. , de Brugerolle de Fraissinette A. , & Fortasch M. (1999). The use of keratinocytes and human skin models for predicting skin irritation. ATLA 27, 723–743.

Fentem J.H. , Briggs D. , Chesné C. , Elliott G.R. , Harbell J.W. , Heylings J.R. , Portes P. , Roguet R. , van de Sandt J.J.M. , & Botham P.A. (2001). A prevalidation study on in vitro tests for acute skin irritation: results and evaluation by the Management Team. Toxicology in Vitro 15, 57–93.

Fentem J.H. , & Botham P.A. (2002). ECVAMs activities in validating alternative tests for skin corrosion and irritation. ATLA 30, Suppl. 2, 61–67.

ECD (2001). Harmonised Integrated Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures. OECD series on testing and assessment, 249 pp. Paris. France: Organisation for Economic Cooperation and Development.

Robinson M.K. , Osborne R. , & Perkins M.A. (2000). In vitro and human testing strategies for skin irritation. Annals of the New York Academy of Sciences 919, 192–04.

Basketter D.A. , Chamberlain M. , Griffiths H.A. , Rowson M. , Whittle E. , & York M. (1997). The classification of skin irritants by human patch test. Food and Chemical Toxicology 35, 845–52.

COLIPA (1995). Cosmetic Product Test Guidelines for the Assessment of Human Skin Compatibility, 22 pp. Brussels, Belgium: COLIPA.

COLPIA (1997). Test Guidelines for the Assessment of Human Skin Tolerance of Potentially Irritant Cosmetic Ingredients, 17 pp. Brussels, Belgium: COLIPA.

Portes P. , Grandidier M-H. , Cohen C. , & Roguet R. (2002). Refinement of the EPISKIN™ protocol for the assessment of acute skin irritation of chemicals: follow-up to the ECVAM prevalidation study. Toxicology in Vitro 16, 765–770.

Heylings J.R. , Diot S. , Esdaile D.J. , Fasano W.J. , Manning L.A. , & Owen H.M. (2003). A prevalidation study on the in vitro skin irritation function test (SIFT) for prediction of acute skin irritation in vivo: results and evaluation of ECVAM Phase III. Toxicology in Vitro 17, 123–138.

Faller C. , Bracher M. , Dami N. , & Roguet R. (2002). Predictive ability of reconstructed human epidermis equivalents for the assessment of skin irritation of cosmetics. Toxicology in Vitro 16, 557–572.

Ponec M. , & Kempenaar J. (1995). Use of human skin recombinants as an in vitro model for testing the irritation potential of cutaneous irritants. Skin Pharmacology 8, 49–59.

Tinois E. , Tillier J. , Gaucherand M. , Dumas H. , Tardy M. , & Thivolet J. (1991). In vitro and post-transplantation differentiation of human keratinocytes grown on the human type IV collagen film of a bilayered dermal substitute. Experimental Cell Research 193, 310–319.

Roguet R. , Cohen C. , Dossou K.G. , & Rougier A. (1994). EPISKIN, a reconstituted epidermis for assessing in vitro the irritancy of topically applied compounds. Toxicology in Vitro 8, 49–59.

Roguet R. , Cohen C. , Robles C. , Courtellemont P. , Tolle M. , Guillot J.P. , & Duteil X. (1998). An interlaboratory study of the reproducibility and relevance of EPISKIN™, a reconstructed human epidermis, in the assessment of cosmetics irritancy. Toxicology in Vitro 12, 295–304.

Cannon C.L. , Neal P.J. , Southee J.A. , Kubilus J. , & Klausner M. (1994). New epidermal model for dermal irritancy testing. Toxicology in Vitro 8, 889–891.

Earl L.K. , Hall-Manning T.J. , & Holland G.H. (1999). The determination of acute chemically induced skin irritation using a human skin model. In Alternatives to Animal Testing II. Proceedings of the Second International Scientific Conference Organised by the European Cosmetic Industry (ed. Clark D.G. , Lisansky S.G. , & Macmillan R. ), 227 pp. Newbury, UK: CPL Press.

Rosdy M. , & Clauss L.C. (1990). Complete human epidermal cell differentiation in chemical defined medium at the air–liquid interface on inert filter substrates. Journal of Investigative Dermatology 95, 409–414.

de Brugerolle de Fraissinette A. , Picarles V. , Chibout S. , Kolopp M. , Medina J. , Burtin P. , Ebelin M.E. , Osborne S. , Mayer F.K. , Spake A. , Rosdy M. , De Wever B. , Ettlin R.A. , & Cordier A. (1999). Predictivity of an in vitro model for acute and chronic skin irritation (SkinEthic) applied to the testing of topical vehicles. Cell Biology and Toxicology 15, 121–135.

Robinson M.K. , Cohen C. , de Brugerolle de Fraissinette A. , Ponec M. , Whittle E. , & Fentem J.H. (2000). Non-animal testing strategies for assessment of the skin corrosion and skin irritation potential of ingredients and finished products. Food and Chemical Toxicology 40, 573–592.

Boelsma E. , Tanojo H. , Boddé H. , & Ponec M. (1996). Assessment of the potential irritancy of oleic acid on human skin: evaluation in vitro and in vivo. Toxicology in Vitro 10, 729–742.

Boelsma E. , Gibbs S. , Faller C. , & Ponec M. (2000). Characterization and comparison of reconstructed skin models: morphological and immunohistochemical evaluation. Acta Dermato-Venerologica 80, 82–88.

Medina J. , de Brugerolle de Fraissinette A. , Chibout S.D. , Kolopp M. , Kammermann R. , Burtin P. , Ebelin M.E. , & Cordier A. (2000). Use of human skin equivalent Apligraf for in vitro assessment of cumulative skin irritation potential of topical products. Toxicology and Applied Pharmacology 164, 38–45.

Heylings J.R. , Clowes H.M. , & Hughes L. (2001). Comparison of tissue sources for the skin integrity function test (SIFT). Toxicology in Vitro 13, 597–600.

Cronin M.T.D. , Dearden J.C. , Walker J.D. , & Worth A.P. (2003). Quantitative structure-activity relationships for human health effects: commonalities with other endpoints. Environmental and Toxicological Chemistry 22, 1829–1843.

Hulzebos E.M. , Maslankiewicz L. , & Walker J.D. (2003). Verification of literature-derived SARs for skin irritation and corrosion. QSAR and Combinatorial Science 22, 351–363.

Patlewicz G. , Rodford R. , & Walker J.D. (2003). QSARs for predicting skin and eye irritation. Environmental & Toxicological Chemistry 22, 1862–1869.

Barratt M.D. (1996). Quantitative structure-activity relationships for skin irritation and corrosivity of neutral and electrophilic organic chemicals. Toxicology in Vitro 10, 247–256.

Hayashi H. , Nakamura Y. , Higashi K. , Kato H. , Kishida F. , & Kaneko H. (1999). A quantitative structure-activity relationship study of the skin irritation potential of phenols. Toxicology in Vitro 13, 915–922.

Smith J.S. , Macina O.T. , Sussman N.B. , Luster M.I. , & Karol M.H. (2000). A robust structure-activity relationship (SAR) model for esters that cause skin irritation in humans. Toxicological Sciences 55, 215–222.

Cronin M.T.D. , Jaworska J.S. , Walker J.D. , Comber M.H.I. , Watts C.D. , & Worth A.P. (2003). Use of QSARs in international decision-making frameworks to predict health effects of chemical substances. Environmental Health Perspectives 10, 1391–1402.

Gerner I. , Graetschel G. , Kahl J. , & Schlede E. (2000). Development of a decision support system for the introduction of alternative methods into local irritancy/corrositivity testing strategies. Development of a relational database. ATLA 28, 11–28.

Gerner I. , Zinke S. , Graetschel G. , & Schlede E. (2000). Development of a decision support system for the introduction of alternative methods into local irritancy/corrosivity testing strategies. Creation of fundamental rules for a decision support system. ATLA 28, 665–698.

Zinke S. , Gerner I. , & Schlede E. (2000). Local irritation/corrosion testing strategies: development of a decision support system for the introduction of alternative methods. ATLA 28, 29–40.

Fentem J.H. , Archer G.E.B. , Balls M. , Botham P.A. , Curren R.D. , Earl L.K. , Esdaile D.J. , Holzhütter H.G. , & Liebsch M. (1998). The ECVAM international validation study on in vitro tests for skin corrosivity. 2. Results and evaluation by the Management Team. Toxicology in Vitro 12, 483–524.

Liebsch M. , Traue D. , Barrabas C. , Spielmann H. , Uphill P. , Wilkins S. , Wiemann C. , Kaufmann T. , Remmele M. , & Holzhütter H.G. (2000). The ECVAM prevalidation study on the use of EpiDerm for skin corrosivity testing. ATLA 28, 371–401.

ECVAM (1998). Statement on the scientific validity of the EPISKIN™ test (an in vitro test for skin corrosivity). ATLA 26, 277–280.

ECVAM (1998). Statement on the scientific validity of the rat skin transcutaneous electrical resistance (TER) test (an in vitro test for skin corrosivity). ATLA 26, 275–277.

ECVAM (2000). Statement on the application of the Epiderm™ human skin model for skin corrosivity testing. ATLA 28, 365–366.

EU (2000). Annex I to Commission Directive 2000/33/EC adapting to technical progress for the 27th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal of the European Union L136, 91–97.

ECVAM (2001). Statement on the application of the CORROSITEX® assay for skin corrosivity testing. ATLA 29, 96–97.

NIH (1999). Corrositex®: an in vitro test method for assessing dermal corrosivity potential of chemicals. NIH Publication No. 99-4495, 236 pp. Research Triangle Park, NC, USA: NIEHS.

Barratt M.D. (1996). Quantitative structure-activity relationships (QSARs) for skin corrosivity of organic acids, bases and phenols: principal components and neural network analysis of extended datasets. Toxicology in Vitro 10, 85–94.

Whittle E.G. , Barratt M.D. , Carter J.A. , Basketter D.A. , & Chamberlain M. (1996). The skin corrosivity potential of fatty acids: in vitro rat and human skin testing and QSAR studies. Toxicology in Vitro 10, 95–100.

Barratt M.D. , Brantom P.G. , Fentem J.H. , Gerner I. , Walker A.P. , & Worth A.P. (1998). The ECVAM international validation study on in vitro tests for skin corrosivity. 1. Selection and distribution of the test chemicals. Toxicology in Vitro 12, 471–482.

Barratt M.D. , Dixit M.B. , & Jones P.A. (1996). The use of in vitro cytotoxicity measurements in QSAR methods for the prediction of the skin corrosivity potential of acids. Toxicology in Vitro 10, 283–290.

Worth A.P. (2000). The Integrated Use of Physico-chemical and In Vitro Data for Predicting Chemical Toxicity. PhD Thesis, 369 pp. Liverpool John Moores University, UK.

Worth A.P. , & Cronin M.T.D. (2001). The use of bootstrap resampling to assess the uncertainty of Cooper statistics. ATLA 29, 447–459.

Worth A.P. , Fentem J.H. , Balls M. , Botham P.A. , Curren R.D. , Earl L.K. , Esdaile D.J. , & Liebsch M. (1998). An evaluation of the proposed OECD testing strategy for skin corrosion. ATLA 26, 709–720.

Worth A.P. , & Cronin M.T.D. (2001). The use of pH measurements to predict the potential of chemicals to cause acute dermal and ocular toxicity. Toxicology 169, 119–131.

EU (2004). Annex 2D to Commission Directive 2004/73/EC adapting to technical progress for the 29th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.

NIH (2002). ICCVAM evaluation of EPISKIN™, EpiDerm™ (EPI-200), and the rat skin transcutaneous electrical resistance (TER) assay: in vitro test methods for assessing dermal corrosivity potential of chemicals. NIH Publication No. 02-4502, 196 pp. Research Triangle Park, NC, USA: NIEHS.

OECD (2002). OECD Guidelines for the Testing of Chemicals No. 430. In vitro Skin Corrosion: Trans-cutaneous Electrical Resistance Test (TER), 12 pp. Paris, France: Organisation for Economic Cooperation and Development.

OECD (2002). OECD Guidelines for the Testing of Chemicals No. 431. In vitro Skin Corrosion: Human Skin Model Test, 8 pp. Paris, France: Organisation for Economic Cooperation and Development.

ICCVAM (2002). OECD Guidelines for the Testing of Chemicals. Proposal for a new guideline. In vitro membrane barrier test system for skin corrosion, 16 pp. NC, USA: ICCVAM, NIEHS.