Red Blood Cell haemolysis | EURL ECVAM

Topic: Serious eye damage/Eye irritation

Test Method Number:

TM2004-04 (EU)

Short Name of TM:

RBC

Year received:

2004

Responsible Organisation:

EURL ECVAM - European Union

Protocol(s)/SOP(s):

General Comments:

Method Description

The Red Blood Cell (RBC) test is used to examine ocular irritants by measuring lysis of erythrocytes (haemolysis) and denaturation of released oxyhaemoglobin. The RBC test is a cell-based cytotoxicity assay, which allows assessing membrane damage of erythrocytes (haemolysis) and changes of the oxyhaemoglobin configuration (protein denaturation). To determine haemolysis, the haemoglobin leakage is measured spectrophotometrically.

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 Red Blood Cell test method.
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.	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. No sufficient available evidence to support the recommendation of Red blood Cell test method for regulatory use.	ESAC statement

Recommendation

Regulatory acceptance/Standards