FRAME assists with testing protocols

Following changes in the official guidelines, FRAME Trustee Dr Richard Clothier is helping to update in vitro protocols for toxicity tests, that have been validated, and which FRAME and the FRAME Alternatives Laboratory were involved with developing.

ECVAM (European Centre for the Validation of Alternative Methods) has a database of in vitro tests that have been tested in a number of laboratories or have been used in international validation trials.  This database was built on the InVittox database originally compiled by FRAME, and contains detailed protocols on how to perform and analyse the in vitro non-animal tests, along with a named experimenter who can be consulted if further guidance is required.

 
ECVAM has promoted these tests and a number of them have been fully independently reviewed and all the published data considered such that internationally acceptable guidelines could be drawn up.

Dr Clothier is the former Director of the FRAME Alternatives Laboratory (FAL) at the University of Nottingham. During his tenure, the FAL helped to develop and modify in vitro test models for human eye irritation based on damage to the  tissue's barrier function.  Due to his past experience he has been asked to assist with drawing up the protocols that are now being accepted by the OECD.

The Organisation for Economic Co-operation and Development (OECD) issues guidelines on how and when certain tests should be carried out on potentially harmful substances.

He has already assisted with updating other protocols, including one for the Neutral Red Uptake assay, which was originally modified by the FRAME Laboratory and has been used to assess ingredients and formulations of hundreds of cosmetics and in numerous international validation trials, the FAL being one of the laboratories included in European and US/EU trials.

Although it is not, in itself, a total replacement for the notorious rabbit eye test, the fluorescein leakage assay  forms part of a tiered testing strategy used for regulatory classification and labelling. The OECD has ascribed the protocol number TG 460 to the accepted Fluorescein Leakage Method as an in vitro test to assess chemicals as eye irritants and corrosives.  

Being an OECD guideline, it now has international authority and thus must be used as an accepted alternative within the EU for relevant testing.

Archived MArch 11 2013