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 an expert, timely and cost-efficient manner.

We have been involved in all aspects of the consortium’s REACH registration programme, including exemption advice (e.g. Annex VIII derogations), identification of relevant existing information following comprehensive literature searches (including in our in-house data base TRACE), extensive data-gap analyses (DGAs), preparation of endpoint study records (ESRs) and associated endpoint summaries (ESs) in IUCLID, advising on appropriate Integrated Testing Strategies (ITS) using data waiving, read-across and weight-of-evidence (WoE) approaches where considered scientifically justifiable. A primary aim is to minimise the need for additional testing, particularly any studies involving vertebrate animals. Bibra has also been 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.

We have also prepared toxicokinetic (TK) assessments for all Annex VII-X substances, based on existing ADME studies and TK predictions from the structure, molecular weight, and physical-chemical parameters (for example vapour pressure, solubility) and also respiratory tract modelling (e.g. mass median aerodynamic diameter (MMAD) values). These enable expert predictions, notably absorption % by different exposure routes and have informed the calculation of DNELs for these metal compounds. Where the data are not sufficient to derive a DNEL or DMEL, then a qualitative assessment has been conducted (for example for some of the respiratory sensitisers). Bibra has also assisted with the human health classification and labelling of these metal compounds according to EU CLP criteria (1272/2008), the PBT/vPvB assessments, the production and edit of the Chemical Safety Reports (CSRs), and in proposing suitable and appropriate Risk Management Measures (RMMs) and Operational Conditions (OCs), where appropriate.

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 leaders

Pete Watts

Richard Young

 

REACH regulations and compliance

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