ECHA has announced in its most recent report that registrants are now widely accepting and utilizing alternative methods to minimize animal testing. Although REACH is still requiring the same information for submissions, registrants have explored alternative methods such as in vitro and read-across studies to fill data requirements. These two methods have been extensively promoted by ECHA in order to reduce the number of animal tests completed. The in vitro method involves studies using cells, tissues or organs, while the read-across method focuses on bridging data gaps by utilizing data from other synonymous substances through either a categorical or analytical approach. Both of these methods prevent using animals as test subjects which is viewed as great step in the right direction by ECHA.
As described in the report, which is based on about 38,000 dossiers that were submitted for the 2010 and 2013 registration deadlines, registrants used read-across in as many as 75% of the studied dossiers for at least one endpoint. It has been found that the read across approach is especially useful for higher-tier endpoints which currently are lacking non-animal test strategies. In order to study skin and eye irritation of substances, many registrants have turned to in- vitro study options. In fact, since 2011, the number of in-vitro studies has tripled for eye and skin related studies. Currently, ECHA’s database maintains information on approximately 8,000 new experimental studies for endpoints. Of these, about 5,000 are tests conducted on vertebrate animals and the other 3,000 in -vitro tests.
However, during their research, ECHA also discovered that about 300 tests were conducted on vertebrate animals without approval by REACH. It is a registrant’s duty to include higher- tier studies even if they are conducted for other reasons besides REACH. ECHA is currently deliberating over this topic and will wait to hear from the Member State Authorities before taking any further action. Vertebrate testing is only to be used as an absolute last resort as stated by REACH and ECHA’S goal to promote non-animal testing methods.
In addition it is important that registrants continue to look at alternative non-animal testing methods to fill data gaps for the 2018 dossiers. With the significant number of substances requiring registration in 2018, registrants may find it difficult to even complete animal testing as demands may surpass capacity as 2018 approaches. Therefore, consider contacting H2 Compliance to explore non-animal testing approaches for your next dossier. H2 Compliance has the knowledge and expertise you need as a recent presentation on “Alternative Testing under REACH” at a toxicology association webinar makes clear.