The Performance of the Tissue Equivalent Assay using the Skin2TM ZK1200 Model in the COLIPA International Validation Study on Alternatives to the Draize Eye Irritation Test

Southee, J. A.; McPherson, Jean; Osborne, Rosemarie; Carr, G.J.; Rasmussen, Eva

doi:10.1016/s0887-2333(98)00083-6

Cited by 15 publications

(17 citation statements)

References 7 publications

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“…The selection of chemicals was based on the availability of in vivo rabbit eye irritation data and the goal of including a broad variety of chemical types, classes, molecular weights, and structures, spanning a wide range of irritating potential. Eye irritation data sources included the ECETOC (European Center for Ecotoxicology and Toxicology of Chemicals), ZEBET BfR, and TSCA (Toxic Substances Control Act) databases, BCOP (Bovine Corneal Opacity and Permeability) validation, and the published literature (7,(25)(26)(27)(28)(29)(30)(31). When comparing in vivo and in vitro testing results, GHS classifications were used (Table 2).…”

Section: Test Chemicalsmentioning

confidence: 99%

The EpiOcular Eye Irritation Test (EIT) for Hazard Identification and Labelling of Eye Irritating Chemicals: Protocol Optimisation for Solid Materials and the Results after Extended Shipment

Kaluzhny

Kanďárová

Handa³

et al. 2015

Altern Lab Anim

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The 7th Amendment to the EU Cosmetics Directive and the EU REACH Regulation have reinforced the need for in vitro ocular test methods. Validated in vitro ocular toxicity tests that can predict the human response to chemicals, cosmetics and other consumer products are required for the safety assessment of materials that intentionally, or inadvertently, come into contact with the eye. The EpiOcular Eye Irritation Test (EIT), which uses the normal human cell-based EpiOcular™ tissue model, was developed to address this need. The EpiOcular-EIT is able to discriminate, with high sensitivity and accuracy, between ocular irritant/corrosive materials and those that require no labelling. Although the original EpiOcular-EIT protocol was successfully pre-validated in an international, multicentre study sponsored by COLIPA (the predecessor to Cosmetics Europe), data from two larger studies (the EURL ECVAM–COLIPA validation study and an independent in-house validation at BASF SE) resulted in a sensitivity for the protocol for solids that was below the acceptance criteria set by the Validation Management Group (VMG) for eye irritation, and indicated the need for improvement of the assay's sensitivity for solids. By increasing the exposure time for solid materials from 90 minutes to 6 hours, the optimised EpiOcular-EIT protocol achieved 100% sensitivity, 68.4% specificity and 84.6% accuracy, thereby meeting all the acceptance criteria set by the VMG. In addition, to satisfy the needs of Japan and the Pacific region, the EpiOcular-EIT method was evaluated for its performance after extended shipment and storage of the tissues (4–5 days), and it was confirmed that the assay performs with similar levels of sensitivity, specificity and reproducibility in these circumstances.

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Section: Test Chemicalsmentioning

confidence: 99%

The EpiOcular Eye Irritation Test (EIT) for Hazard Identification and Labelling of Eye Irritating Chemicals: Protocol Optimisation for Solid Materials and the Results after Extended Shipment

Kaluzhny

Kanďárová

Handa³

et al. 2015

Altern Lab Anim

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“…The selection of chemicals was based on the availability of in vivo rabbit eye irritation data. Data sources included the ECETOC, ZEBET and TSCA databases, BCOP validation, and the published literature (9,(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35). In addition, test materials were chosen with the aim of covering a broad range of chemical classes.…”

Section: Test Substancesmentioning

confidence: 99%

Development of the EpiOcular™ Eye Irritation Test for Hazard Identification and Labelling of Eye Irritating Chemicals in Response to the Requirements of the EU Cosmetics Directive and REACH Legislation

et al. 2011

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The recently implemented 7th Amendment to the EU Cosmetics Directive and the EU REACH legislation have heightened the need for in vitro ocular test methods. To address this need, the EpiOcular™ eye irritation test (EpiOcular-EIT), which utilises the normal (non-transformed) human cell-based EpiOcular tissue model, has been developed. The EpiOcular-EIT prediction model is based on an initial training set of 39 liquid and 21 solid test substances and uses a single exposure period and a single cut-off in tissue viability, as determined by the MTT assay. A chemical is classified as an irritant (GHS Category 1 or 2), if the tissue viability is ≤ 60%, and as a non-irritant (GHS unclassified), if the viability is > 60%. EpiOcular-EIT results for the training set, along with results for an additional 52 substances, which included a range of alcohols, hydrocarbons, amines, esters, and ketones, discriminated between ocular irritants and non-irritants with 98.1% sensitivity, 72.9% specificity, and 84.8% accuracy. To ensure the long-term commercial viability of the assay, EpiOcular tissues produced by using three alternative cell culture inserts were evaluated in the EpiOcular-EIT with 94 chemicals. The assay results obtained with the initial insert and the three alternative inserts were very similar, as judged by correlation coefficients (r2) that ranged from 0.82 to 0.96. The EpiOcular-EIT was pre-validated in 2007/2008, and is currently involved in a formal, multi-laboratory validation study sponsored by the European Cosmetics Association (COLIPA) under the auspices of the European Centre for the Validation of Alternative Methods (ECVAM). The EpiOcular-EIT, together with EpiOcular's long history of reproducibility and proven utility for ultra-mildness testing, make EpiOcular a useful model for addressing current legislation related to animal use in the testing of potential ocular irritants.

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“…Both the Testskin TM models (Organogenesis) and the Skin 2TM models (Advanced Tissue Sciences) were available for several years in the early 1990s, but their production was discontinued despite multiple encouraging validation study results obtained in both the United States and Europe. [11][12][13][14] Several other commercial tissue models are currently available, 15 but either they are protected by patents or their methods of production are kept secret by the producers. In addition, today's skin model market can be considered oligopolistic: only a handful companies dominate the entire field, and as a consequence the continued availability of tissue-engineered skin models is dependent on the economic health of these companies as well as on corporate strategies of the producers.…”

Section: The Open Source Concept For Tissue Engineering Technologiesmentioning

confidence: 99%

“Open Source”–Based Engineered Human Tissue Models: A New Gold Standard for Nonanimal Testing Through Openness, Transparency, and Collaboration, Promoted by the ALEXANDRA Association

WeverBart¹,

GoldbergAlan

EskesChantra³

et al. 2015

Applied In Vitro Toxicology

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Today, engineered three-dimensional tissue models from human cells of the skin, cornea, mucosa, and respiratory tract are widely used in pharmaceutical, chemical, consumer, and cosmetic industries as alternatives to animal testing. The currently available scientifically valid 3D tissue-engineered models, however, are protected by patents and/or are being commercialized using proprietary tissue culture procedures owned by only a few private companies. As a consequence, their continued commercial availability might not be guaranteed in the long-term. In collaboration with its partners, the ALEXANDRA Association strives to ensure a long-term, sustainable, and global implementation of alternative methods based on nonprofit, patent-free, and proprietary-free development of ''open source'' (OS) human tissue engineering technologies. By doing so, the association proposes a new standard in 3D tissue reconstruction as a basis for animal-free testing method implementation by supporting the development, production, validation, and technology transfer based on a global OS concept.

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The Performance of the Tissue Equivalent Assay using the Skin2TM ZK1200 Model in the COLIPA International Validation Study on Alternatives to the Draize Eye Irritation Test

Cited by 15 publications

References 7 publications

The EpiOcular Eye Irritation Test (EIT) for Hazard Identification and Labelling of Eye Irritating Chemicals: Protocol Optimisation for Solid Materials and the Results after Extended Shipment

The EpiOcular Eye Irritation Test (EIT) for Hazard Identification and Labelling of Eye Irritating Chemicals: Protocol Optimisation for Solid Materials and the Results after Extended Shipment

Development of the EpiOcular™ Eye Irritation Test for Hazard Identification and Labelling of Eye Irritating Chemicals in Response to the Requirements of the EU Cosmetics Directive and REACH Legislation

“Open Source”–Based Engineered Human Tissue Models: A New Gold Standard for Nonanimal Testing Through Openness, Transparency, and Collaboration, Promoted by the ALEXANDRA Association

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