Non-Animal Methods For Compiling REACH Data On The Rise – ECHA
This article was originally published in The Rose Sheet
Firms subject to REACH reporting in Europe increasingly are using in vitro tests, read-across and other non-animal methods to satisfy safety-data requirements, according to the latest tri-annual report from the European Chemicals Agency.
Analysis of 38,000 registration dossiers submitted against 2010 and 2013 deadlines under the EU’s Registration, Evaluation, Authorization and Restriction of Chemicals program reveals that companies are sharing data as directed to avoid duplicative animal testing, as well as leveraging alternative strategies to generate required safety data, ECHA says in the report, announced June 2.
Animal testing under REACH is intended as a last resort to address information gaps, and firms must submit testing proposals to ECHA before conducting animal research. ECHA then consults with member-state competent authorities in its decision-making process prior to green-lighting use of animals.
Use of in vitro studies to fulfill REACH data requirements has tripled since 2011 – from 442 tests to 1,410 – and almost 20% of analyzed dossiers contained studies of this sort, ECHA says.
According to ECHA’s report, which updates findings from 2011, the most common alternative strategy – used for at least one hazard endpoint in around 75% of analyzed dossiers – is use of read-across and category building, in which registrants extrapolate safety information from known chemicals to fill data gaps for related substances.
The tactic is being employed largely for “higher-tier” endpoints for which approved non-animal test methods currently are unavailable, such as sub-chronic toxicity, pre-natal developmental toxicity or reproductive toxicity, ECHA says.
A weight-of-evidence approach that combines information from different sources is the next most-common strategy for fulfilling REACH requirements to date, followed by computer modeling, or qualitative/quantitative structural-activity relationship ((Q)SAR), according to the agency.
Registrants also are adopting new or revised in vitro methods, using biological cells, tissues or organs to evaluate for skin and eye irritation, ECHA says. According to its report, use of in vitro studies has tripled since 2011 – from 442 tests to 1,410 – and almost 20% of analyzed dossiers contained studies of this sort for the cited endpoints.
ECHA notes that registrants also are using alternative test methods to assess substances’ potential to cause skin sensitization, “even though these are still in the early stages of development.”
Overall, the REACH program has given rise to 7,939 new experimental studies – 4,887 testing vertebrate animals and 3,052 performed in vitro – aimed at producing safety data to support chemical use.
ECHA says it has encountered 293 tests conducted on vertebrate animals that were not approved via the pathway in place under REACH. The agency is investigating further to determine reasons for the deviations – if for example they were undertaken to satisfy requirements imposed by other regulations – and will report its findings to member-state authorities, it says.
According to the report, ECHA will finish evaluating all 701 animal-testing proposals submitted against the 2013 REACH deadline, covering substances produced or imported in volumes of 100 tons to 1,000 tons annually, by June 1, 2016. Most proposals relate to developmental toxicity and repeated dose toxicity studies, the agency notes.
From REACH’s inception, ECHA has encouraged companies to band together, share data and file joint submissions to promote efficiency and minimize animal testing. For the 2013 REACH deadline, ECHA received more than 8,000 registrations that were part of joint submissions, according to the report.
ECHA says it will use the report, titled “The Use of Alternatives to Testing on Animals for the REACH Regulation,” to promote non-animal test methods and alternative data-collection strategies among registrants submitting dossiers under the next REACH deadline. Firms must submit dossiers by May 31, 2018 for chemicals manufactured or imported at 1 ton to 100 tons per year.
The agency issues other reports periodically to address quality issues in REACH dossiers. In late February, ECHA published an Evaluation Progress Report advising future registrants on chemical safety reports and adaptations to standard testing approaches, among other dossier components that have proven problematic (Also see "ECHA’s 2013 Report Targets Advice To Low-Tonnage REACH Registrants" - HBW Insight, 3 Apr, 2014.).