The ECVAM International Validation Study on In Vitro Tests for Skin Corrosivity. 2. Results and Evaluation by the Management Team

Fentem, Julia H.; Archer, G.E.B.; Balls, Michael; Botham, Philip A.; Curren, Rodger; Earl, L.K.; Esdaile, David J.; Holzhütter, Hermann‐Georg; Liebsch, Manfred

doi:10.1016/s0887-2333(98)00019-8

Cited by 183 publications

(136 citation statements)

References 10 publications

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“…For example, if the model is intended to serve as a stand-alone test, that is, a complete replacement of an animal test, then, as a minimum requirement, the Cooper statistics should be significantly greater than 50% (for a two-group model) to ensure that the model is producing predictions that are significantly better than chance (Worth and Cronin 2001b). An example is provided by an ECVAM validation study in which classification models based on in vitro data were assessed for their capacity to predict skin corrosion potential (Fentem et al 1998). In this study, one of the acceptability criteria was that the sensitivity of each test be greater than 70%.…”

Section: Acceptability Criteriamentioning

confidence: 99%

Methods for reliability and uncertainty assessment and for applicability evaluations of classification- and regression-based QSARs.

Eriksson

Jaworska

Worth

et al. 2003

Environ Health Perspect

1,184

847

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This article provides an overview of methods for reliability assessment of quantitative structure-activity relationship (QSAR) models in the context of regulatory acceptance of human health and environmental QSARs. Useful diagnostic tools and data analytical approaches are highlighted and exemplified. Particular emphasis is given to the question of how to define the applicability borders of a QSAR and how to estimate parameter and prediction uncertainty. The article ends with a discussion regarding QSAR acceptability criteria. This discussion contains a list of recommended acceptability criteria, and we give reference values for important QSAR performance statistics. Finally, we emphasize that rigorous and independent validation of QSARs is an essential step toward their regulatory acceptance and implementation.

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Section: Acceptability Criteriamentioning

confidence: 99%

Methods for reliability and uncertainty assessment and for applicability evaluations of classification- and regression-based QSARs.

Eriksson

Jaworska

Worth

et al. 2003

Environ Health Perspect

1,184

847

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show abstract

“…The aim of the 1st stage study was to evaluate whether the commonly used Epiderm skin corrosion test protocols and the prediction model described in TG431 was applicable to the LabCyte EPI-MODEL. According to the test protocol, we tested 20 test chemicals selected from the ECVAM skin corrosion validation studies (Fentem et al, 1998;Liebsch et al, 2000). The results obtained with the LabCyte EPI-MODEL were perfectly correlated with the in vivo classification.…”

Section: Discussionmentioning

confidence: 99%

“…The nineteen test chemicals used in the 1st stage were selected referring to the ECVAM skin corrosion validation studies (Fentem et al, 1998;Liebsch et al, 2000) and SkinEthic RHE (SkinEthic, France) "catch up validation study" (Kandárová et al, 2006) (Table 1).…”

Section: Test Chemicalsmentioning

confidence: 99%

“…Several alternative methods were evaluated from 1996-1998 in the European Centre for the Validation of Alternative Methods (ECVAM) international validation study on in vitro tests for skin corrosion, and two assays were accepted as a full replacement of the in vivo procedure; the rat skin Transcutaneous Electrical Resistance (TER) assay based on measuring the electrical resistance in ex vivo rat skin and the EPISKIN assay using the reconstructed human epidermal model, EPISKIN (SkinEthics, Nice, France) (Fentem et al, 1998). In 2000, the EpiDerm (MatTek, MA, USA) assay was successfully validated in an ECVAM "catch-up" validation study (Liebsch et al, 2000).…”

Section: Introductionmentioning

confidence: 99%

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Assessment of the human epidermal model LabCyte EPI-MODEL for In vitro skin corrosion testing according to the OECD test guideline 431

Katoh¹,

Hamajima²,

Ogasawara³

et al. 2010

J. Toxicol. Sci.

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-A new OECD test guideline 431 (TG431) for in vitro skin corrosion tests using human reconstructed skin models was adopted by OECD in 2004. TG431 defines the criteria for the general function and performance of applicable skin models. In order to confirm that the new reconstructed human epidermal model, LabCyte EPI-MODEL is applicable for the skin corrosion test according to TG431, the predictability and repeatability of the model for the skin corrosion test was evaluated. The test was performed according to the test protocol described in TG431. Based on the knowledge that LabCyte EPI-MODEL is an epidermal model as well as EpiDerm, we decided to adopt the the Epiderm prediction model of skin corrosion for the LabCyte EPI-MODEL, using twenty test chemicals (10 corrosive chemicals and 10 non-corrosive chemicals) in the 1 st stage. The prediction model results showed that the distinction of non-corrosion to corrosion corresponded perfectly. Therefore, it was judged that the prediction model of EpiDerm could be applied to the LabCyte EPI-MODEL. In the 2 nd stage, the repeatability of this test protocol with the LabCyte EPI-MODEL was examined using twelve chemicals (6 corrosive chemicals and 6 non-corrosive chemicals) that are described in TG431, and these results recognized a high repeatability and accurate predictability. It was concluded that LabCyte EPI-MODEL is applicable for the skin corrosive test protocol according to TG431.

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“…Although the skin models were found to be more permeable compared to human skin in vivo, their permeability and toxicity response is less variable. As a result, a number of reconstituted skin models have been successfully validated for the prediction of human skin corrosion and irritancy (Alepee et al, 2010;Kandarova et al, 2006;Fentem et al, 1998). Currently, a reconstituted human skin micronucleus assay is under development for in vitro genotoxicity testing (Mun et al, 2009;Curren et al, 2006).…”

Section: Primary Cell Models Reproducing the Skinmentioning

confidence: 99%

Current standing and future prospects for the technologies proposed to transform toxicity testing in the 21st century

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2011

ALTEX

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The ECVAM International Validation Study on In Vitro Tests for Skin Corrosivity. 2. Results and Evaluation by the Management Team

Cited by 183 publications

References 10 publications

Methods for reliability and uncertainty assessment and for applicability evaluations of classification- and regression-based QSARs.

Methods for reliability and uncertainty assessment and for applicability evaluations of classification- and regression-based QSARs.

Assessment of the human epidermal model LabCyte EPI-MODEL for In vitro skin corrosion testing according to the OECD test guideline 431

Current standing and future prospects for the technologies proposed to transform toxicity testing in the 21st century

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