Embryonic Stem Cell Test | EURL ECVAM

Topic: Reproductive toxicity, Embryotoxicity

Test Method Number:

TM1999-01 (EU)

Short Name of TM:

EST

Year received:

1999

Responsible Organisation:

EURL ECVAM - European Union

Protocol(s)/SOP(s):

113

General Comments:

Method Description

The embryonic stem cell system has been developed as a screening test for potentially embryotoxic substances. Disturbances of embryonic stem cell differentiation following treatment of xenobiotics indicate a potential of embryotoxicity for early pre-implantation stages of mammalian development.

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

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Date	Stage	Comment	Documents/Links
Dec 1997	Not applicable	See validation step.

Validation

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Date	Stage	Comment	Documents/Links
Jan 1998	Ongoing	Start of the ECVAM International Validation Study on In Vitro Embryotoxicity Tests (see also TM1999-02 and TM1999-03). This study followed a prevalidation phase conducted in 1997.
May 2000	Finalised	Completion of the validation study with validation report.	Validation study paper

Peer-review

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Date	Stage	Comment	Documents/Links
Oct 2001	Finalised	Endorsement of the ESAC statement on three in vitro methods for embryotoxicity at the 17th ESAC plenary meeting (see also TM1999-02 and TM1999-03).	ESAC opinion

Recommendation

Regulatory acceptance/Standards