[ascct] DB-ALM Newsletter-OECD Guidance 211 for describing non guideline in vitro test methods No. 211

  • From: Kristie Sullivan <KSullivan@xxxxxxxx>
  • To: "ascct@xxxxxxxxxxxxx" <ascct@xxxxxxxxxxxxx>
  • Date: Tue, 25 Aug 2015 00:31:42 -0400

Please see the following message. Describing in vitro methods in a harmonized
format is an important step towards harmonizing descriptions of methods which
are not official test guidelines and making it possible for data from them to
be used in a regulatory context.

From: DBALM [mailto:ecvam.dbalm@xxxxxxxxxxxxxxxx]
Sent: Thursday, August 20, 2015 12:11 PM
To: annett.j.roi@xxxxxxxxxxxxxxxx<mailto:annett.j.roi@xxxxxxxxxxxxxxxx>
Subject: DB-ALM Newsletter


DB-ALM now provides non-guideline in vitro test methods in OECD compliant
format, August 2015
The JRC's European Union Reference Laboratory for Alternative Methods to Animal
Testing (EURL ECVAM) has adapted the format of DB-ALM, its unique public
database on alternative methods, to fully comply with the OECD guidance for
describing non-guideline in vitro test methods.
JRC/EURL ECVAM scientists were important contributors to the formulation of
Guidance Document No.211 which was released by the OECD last December 2014. The
guidance was motivated by a growing awareness within the scientific and
regulatory communities that data derived from in vitro methods (e.g.
mechanistic information) can have considerable value in supporting chemical
safety assessment, even in cases where the in vitro method is not included
within an OECD Test Guideline or has not been formally validated, provided the
method is properly described in terms of its scientific/technical basis and its
reliability and relevance.
Making such method descriptions readily available via the widely accessed
DB-ALM (over 4400 registered users from 82 countries) will encourage their
uptake and use in a variety of sectors for multiple applications, such as
chemical toxicity screening or within integrated approaches to chemical safety
assessment. The data generated by end-users may also aid the retrospective
validation of methods intended for more routine regulatory use which may
eventually be incorporated into future OECD Test Guidelines. DB-ALM already
contains over 300 entries for alternative methods, at all stages of development
and with various levels of detail (summary descriptions or detailed protocols).
It covers mainly in vitro methods, but also includes non-experimental


* OECD Guidance
document<http://www.oecd.org/general/official-unclassied-documents.htm> for
describing non guideline in vitro test methods No. 211


European Commission - Joint Research Centre
Institute for Health & Consumer Protection
European Union Reference Laboratory for Alternatives to Animal Testing (EURL
EURL ECVAM DataBase service on ALternative Methods to animal experimentation

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  • » [ascct] DB-ALM Newsletter-OECD Guidance 211 for describing non guideline in vitro test methods No. 211 - Kristie Sullivan