Providing expert support to a large precious metals consortium on all mammalian toxicological issues for their REACH registration

Client

Consortium of metal industry companies

Background

Manufacturers or importers of chemicals into the European Union are required under REACH to submit a dossier of information on the substances to ECHA by tonnage-dependent deadlines. The substantial package includes relevant toxicological data, with minimum data endpoint requirements dependent on e.g. tonnage and potential exposure.

Project goals

To support a large consortium with all the mammalian toxicology aspects of their REACH registration obligations for a group of more than 80 related metal compounds.

Approach

Working alongside trusted partners to provide technical support to the consortium, bibra has responsibility for ensuring that the mammalian toxicology aspects of the submission are addressed in a timely and cost-efficient manner. We have been involved in all aspects of the consortium’s REACH registration programme including identification of relevant information and extensive data-gap analyses, preparation of endpoint study records in IUCLID 5, and advising on appropriate Integrated Testing Strategies using waiving, read-across and weight-of-evidence approaches where considered scientifically justifiable. A primary aim is to minimise the need for additional testing, particularly any studies involving vertebrate animals. Bibra will be closely involved with commissioning and monitoring of the testing programme, and advising on the impact of generated results on the testing strategy going forwards and implications for the overall regulatory submission.

Project outcome

Bibra scientists are providing ongoing support on the mammalian toxicology aspects of REACH registration requirements for the 2013 and 2018 submission deadlines.

Bibra project leader

Philip Copestake

REACH regulations and compliance

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