ECHA scientists publish analysis supporting new guidance to reduce acute oral toxicity tests
Sonja von Aulock, ALTEX
Scientists from the European Chemicals Agency (ECHA) around Andrea Gissi and Kimmo Louekari have published an analysis of data in the REACH registration database that supports the use of sub-acute toxicity results, together with other relevant information, to cover the acute toxicity standard requirements for REACH registration in a weight of evidence approach. The analysis was performed in the context of the update of ECHA’s REACH Guidance on Acute Toxicity, which is currently in the final stage of the consultation phase and is expected to be published shortly. The authors estimate that the implementation of the new approach will obviate the need to perform animal tests for acute toxicity for about 550 substances that are expected to be registered for the REACH 2018 deadline.
The manuscript entitled “Alternative acute oral toxicity assessment under REACH based on sub-acute toxicity values” is published ahead of print in ALTEX. It details the methods and results of the performed analysis, which is based on data submitted by REACH registrants. It comes to the conclusion that low sub-acute toxicity is highly predictive of low acute toxicity. The approach is complementary to a previous paper published in ALTEX this year by Tom Luechtefeld and colleagues at CAAT and Rutgers University entitled “Analysis of public oral toxicity data from REACH registrations 2008-2014“. Before this, other articles already had suggested that low sub-acute toxicity was predictive of low acute toxicity on the basis of other, smaller datasets.
The European Commission has this year made non-animal testing the default requirement for skin corrosion/irritation, serious eye damage/eye irritation, and skin sensitization. Following a complaint that ECHA was not ensuring that animal tests for REACH registrations were only performed as a last resort and a respective decision of the EU Ombudsman, ECHA currently requires that any dossier with a proposal to test on vertebrate animals needs to have documented considerations of alternative methods for each proposed study to be considered complete.
The new publication by Gissi et al. is of special interest because it has both scientific and regulatory relevance, transparently documenting the basis for the development of the new guidance.