In our meetings with international corporations we are finding a lot of confusion on this issue and a number of companies are conducting in vivo skin irritation testing for REACH, especially because certain REACH Annexes state that negative in vitro results should be followed up in vivo. Please help us get the word out on this to reduce animal suffering under REACH:
We have confirmed that, since 2010, in vitro results for skin irritation should always be accepted by ECHA – whether positive or negative. There are two fully validated methods that are included into Regulation 440/2008:
(1) OECD 435 (Method B.40): In vitro study for Skin Corrosion - In vitro membrane barrier test method (CORROSITEX) and
(2) OECD 439 (Method B.46): In vitro study for Skin Irritation - Human Skin Model Test
Annex XI of REACH states that negative results from non-validated in vitro methods must be confirmed in vivo, but since these in vitro methods are validated, this exception does not apply in this case. Annex XI also accepts non-validated in vitro methods in a weight-of- evidence approach. The concept is further explained in the ECHA 2010 Progress Report. (See page 32: “A negative result in the B.46 test does not need to be confirmed by additional testing.”)
Additionally, in some cases, even though there is no full replacement yet in the Test Methods Regulation for eye irritation, it is possible to avoid doing an in vivo eye irritation test. The Progress Report states: "Data generated by in vitro test methods (validated and pre-validated) can be used under REACH, provided that the information for the hazard endpoint is sufficient for the purpose of classification and labeling and/or risk assessment." Updated versions of OECD Test Guideline 437 and 438 (the Bovine Corneal Opacity and Permeability assay and the Isolated Chicken Eye assay) were published in July of 2013 and allow for a negative classification under the GHS (i.e., No Category). New versions of these test guidelines can be found here.
Costanza Rovida (REACH regulatory specialist, REACH Mastery, firstname.lastname@example.org
) can be contacted with any questions or please feel free to contact me.
Jessica Sandler, MHS
Director, PETA International Science Consortium, Ltd.
People for the Ethical Treatment of Animals
tel: 757-622-7382, ext. 8001