Regulatory assessment of in vitro skin corrosion and irritation data within the European framework: Workshop recommendations

Eskes, Chantra; Detappe, Véronique; Koëter, H.B.W.M.; Joachim, Kreysa; Liebsch, Manfred; Zuang, Valérie; Amcoff, Patric; Barroso, José G.; Cotovio, José; Guest, Robert; Hermann, Martina; Hoffmann, Sebastian; Masson, Philippe; Alépée, Nathalie; Arce, Luis Alfonso; Brüschweiler, Beat Johannes; Catone, Tiziana; Čihák, Rostislav; Clouzeau, Jack; d’Abrosca, Federica; Delveaux, Cédric; Derouette, Jean Paul; Engelking, Oliver; Facchini, Davide; Fröhlicher, Mirjam; Hofmann, Markus; Hopf, Nancy B.; Molinari, Robert; Oberli, Aurelia; Ott, Matthieu; Peter, Ronald; Sá-Rocha, Vanessa de Moura; Schenk, Denis; Tomicic, Catherine; Vanparys, Philippe; Verdon, Bernadette; Wallenhorst, Thomas; Winkler, Gian Christian; Depallens, Olivier

doi:10.1016/j.yrtph.2011.10.015

Cited by 35 publications

(21 citation statements)

References 5 publications

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“…The sensitivity and specificity are comparable for agrochemical formulations (40-63% and 64-88%) when considered alone. This is in contrast to findings with 20 agrochemical formulations (cited in Eskes et al, 2012), which found more overpredictions than underpredictions. As formulations are multicomponent systems with differing ingredients and actives, the differences in predictivity may be attributable to differences in the composition of the formulations.…”

Section: Table 4bcontrasting

confidence: 99%

Applicability of in vitro tests for skin irritation and corrosion to regulatory classification schemes: Substantiating test strategies with data from routine studies

Kolle

Sullivan

Mehling

et al. 2012

Regulatory Toxicology and Pharmacology

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Section: Table 4bcontrasting

confidence: 99%

Applicability of in vitro tests for skin irritation and corrosion to regulatory classification schemes: Substantiating test strategies with data from routine studies

Kolle

Sullivan

Mehling

et al. 2012

Regulatory Toxicology and Pharmacology

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“…However, they are transitioning to in vitro data from alternative methods using human skin models [19]. For the regulatory use of in vitro data using skin models, the skin models should be validated before test [20,21]. …”

Section: Introductionmentioning

confidence: 99%

Skin corrosion and irritation test of sunscreen nanoparticles using reconstructed 3D human skin model

Choi

Kim

Choi

et al. 2014

Environ Health Toxicol

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ObjectivesEffects of nanoparticles including zinc oxide nanoparticles, titanium oxide nanoparticles, and their mixtures on skin corrosion and irritation were investigated by using in vitro 3D human skin models (KeraSkinTM) and the results were compared to those of an in vivo animal test.MethodsSkin models were incubated with nanoparticles for a definite time period and cell viability was measured by the 3-(4, 5-dimethylthiazol-2-yl)-2.5-diphenyltetrazolium bromide method. Skin corrosion and irritation were identified by the decreased viability based on the pre-determined threshold.ResultsCell viability after exposure to nanomaterial was not decreased to the pre-determined threshold level, which was 15% after 60 minutes exposure in corrosion test and 50% after 45 minutes exposure in the irritation test. IL-1α release and histopathological findings support the results of cell viability test. In vivo test using rabbits also showed non-corrosive and non-irritant results.ConclusionsThe findings provide the evidence that zinc oxide nanoparticles, titanium oxide nanoparticles and their mixture are ‘non corrosive’ and ‘non-irritant’ to the human skin by a globally harmonized classification system. In vivo test using animals can be replaced by an alternative in vitro test.

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“…Applicable to both substances and mixtures, although only limited information on the testing of mixtures is available. In particular, further investigations would be beneficial on agrochemicals due to the contradictory limited information reported and difficulty to interpret the data as the composition of the mixtures has not been identified (Eskes et al, 2012;Kolle et al, 2013). OECD TG 439 is applicable to solids, liquids, semi-solids and waxes.…”

Section: Applicability Domainmentioning

confidence: 99%

“…Moreover, only limited information is available in the public domain on the testing of mixtures with test methods falling under OECD TGs 430, 431 or 439 (Eskes et al, 2012;Kolle et al, 2013). The applicability of the test methods within OECD TGs 430, 431 and 439 for the assessment of mixtures may depend on: i) the types and categories of products tested, ii) the endpoint(s) assessed (corrosion versus irritation), and iii) the adopted in vitro test method protocol used.…”

mentioning

confidence: 99%

Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation

2017

OECD Series on Testing and Assessment

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This Guidance Document on Integrated Approach to Testing and Assessment for Skin Irritation and Corrosion has two aims:  It proposes an integrated approach on testing and assessment (IATA) for skin corrosion and irritation, in view of replacing the "testing and evaluation strategy" which is currently provided in the supplement to OECD TG 404 and which requires adaptation to scientific and technical progress.  It provides consistent information on key performance characteristics of each of the individual information sources comprising the IATA, provides guidance on how to integrate information for decision making within the approach (including decisions on the need for further testing) and on integrating all existing and generated information on the corrosive and irritant hazard potential of test chemicals for final decisions for classification and labelling. The Guidance Document was approved by the Working Group of the National Coordinators of the Test Guidelines Programme (WNT) at its 26 th meeting in April 2014. The Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology agreed to its declassification on 7 th July, 2014.

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Regulatory assessment of in vitro skin corrosion and irritation data within the European framework: Workshop recommendations

Cited by 35 publications

References 5 publications

Applicability of in vitro tests for skin irritation and corrosion to regulatory classification schemes: Substantiating test strategies with data from routine studies

Applicability of in vitro tests for skin irritation and corrosion to regulatory classification schemes: Substantiating test strategies with data from routine studies

Skin corrosion and irritation test of sunscreen nanoparticles using reconstructed 3D human skin model

Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation

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