Responding to ECHA Evaluation draft decision for a UVCB

Background

The client was sent a Draft Compliance Check Decision by ECHA, following an Evaluation, on one of their UVCB (Unknown or Variable Composition, Complex Reaction Products and Biological Materials) substances REACH registered at Annex X (in 2010). The REACH Standard Information Requirements (SIRs) identified by ECHA as lacking/deficient included the need for an in vitro skin irritation/corrosion assay, a sub-chronic oral toxicity study, pre-natal developmental toxicity (PNDT) studies (in two species), and an extended one-generation reproductive toxicity (EOGRT) study. In addition, issues were identified in the read-across approach and its justification, and in the derived no-effect levels (DNELs) for workers and the general population, and consequent Risk Characterisation (RC).

Client

A global company manufacturing and supplying a large portfolio of specialty chemicals and innovative new technologies.

Project goals

To provide the client with preliminary advice on what steps could be taken in order to improve their dossier and ultimately meet the REACH SIRs highlighted by ECHA as currently being deficient.

Approach

Bibra compiled a preliminary report addressing the issues ECHA had raised and several potential solutions in order to reach a satisfactory conclusion and REACH-compliant dossier, whilst attempting to minimise the resources and use of invertebrate animals required. This included further searches for, and assessment of, data on the target and source compounds, revised/updated data-gap analyses (DGA), improvements to the current read-across justification document in order to meet ECHA’s most recent framework (RAAF) – which may include the need to commission addition phys-chem and toxicokinetic studies on the target and source compounds to support the read-across approach. Also a recommendation to commission a new in vitro skin irritation study. Ultimately, where such alternative approaches are not suitable, the possibility of submitting test proposals for the higher tier studies (sub-chronic, PNDT and EOGRTs) was suggested. The revision of DNELs and the RC step will inevitably be subsequent to the reassessment of the key data included in the revised dossier.

Bibra project team

Richard Young

Chris Waine

Charlie Johnson

 

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