The cytosensor microphysiometer toxicity test

Topic: Serious eye damage/Eye irritation

Test Method Number:

TM2004-01 (EU)

Short Name of TM:

Cytosensor

Year received:

2004

Responsible Organisation:

EURL ECVAM - European Union

Protocol(s)/SOP(s):

130

Method Description

The cytosensor microphysiometer toxicity test method is a cell-based in vitro assay that was developed as a partial replacement of the Draize rabbit eye irritation test. The method consists of a monolayer of adherent mouse L929 fibroblast cells that are cultured on a polycarbonate cell culture insert. Within the system there is also a light-sensitive pH sensor. The ocular toxicity of test substances is evaluated according to reductions in metabolic rate of the cells following exposure (as assessed by changes in the rate of reduction of pH in the cell culture medium). The cells have a natural rate of metabolism that results in the production of extra-cellular acids. This rate is expected to vary following exposure to potentially toxic substances.

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

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Date	Stage	Comment	Documents/Links
Oct 2005	Not applicable	See validation step.

Validation

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Date	Stage	Comment
Oct 2005	Ongoing	Launch of the ECVAM retrospective validation study on cytotoxicity/cell-function based assays for eye irritation, including the cytosensor microphysiometer toxicity test.
May 2006	Ongoing	First meeting of the Validation Management Group (VMG).
Oct 2008	Finalised	Completion of the ECVAM retrospective study and preparation of documentation for peer review.

Peer-review

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Date	Stage	Comment	Documents/Links
Mar 2009	Ongoing	Meeting of the ESAC Peer Review Panel to finalise the panel consensus report and draft the ESAC statement.	ESAC peer review panel report
Jul 2009	Finalised	Endorsement of the ESAC statement on the scientific validity of cytotoxicity/cell-function based in vitro assays for eye irritation testing at 31st ESAC plenary meeting.	ESAC statement

Recommendation

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Date	Stage	Comment	Documents/Links
Jul 2010	Not applicable

Regulatory acceptance/Standards

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Date	Stage	Comment	Documents/Links
Apr 2010	Drafting of new regulatory standard/guideline	Project approved and included in the OECD Test Guidelines programme. It will be published as a new TG. Project led by EU (EURL ECVAM).
Jan 2016	Stopped	Development of Test Guideline stopped because of lack commercial availability of the validated technology. Similar technologies are available on the market and therefore this method may be reconsidered in the future.