The European Chemicals Agency has launched an initiative for which it requests feedback by April 7, 2022. The initiative is an amendment to Regulation (EC) No 440/2008, which lays down test methods pursuant to Regulation (EC) no 1907/2006 (The REACH Regulation).
The proposed amendment recognizes that there have been delays in adapting the Regulation to scientific progress with regard to aligning the accepted methods with up-to-date versions and adding new international test methods. It further recognizes that such delays could hinder the replacement of animal experiments with methods that do not entail the use of a live animal, which is a legal obligation under Directive 2010/63/EU once such methods are adopted at international level.
The initiative includes a table of updated test methods and proposes to delete six animal methods no longer considered appropriate from the Annex. The methods to be deleted are:
B.22. Rodent dominant lethal test;
B.25. Mouse heritable translocation;
B.34. One-generation reproductive toxicity study;
B.35. Two-generation reproductive toxicity study;
B.39. Unscheduled DNA synthesis (UDS) test with mammalian liver cells in vivo;
C.15. Fish, Short term toxicity test on Embryo and Sac Fry Stages.
The table of updated test methods includes test methods for physicochemical, toxicological and ecotoxicological properties adopted up to 2021. The test methods for toxicological and ecotoxicological properties include in vitro and in vivo OECD test guidelines. Current in vitro OECD test guidelines adopted in 2021, which are included in the table, are:
OECD TG 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method (2021),
OECD TG 494: Vitrigel Eye Irritancy Test (2021),
OECD TG 442C: In chemico skin sensitisation: Direct peptide reactivity assay (DPRA) (2021),
OECD TG 497: Defined Approaches on Skin Sensitization (2021),
OECD TG 406: Skin sensitisation (2021),
OECD TG 498: In vitro phototoxicity test method using the Reconstructed human Epidermis (RhE) (2021)
OECD TG 249: Fish cell line acute toxicity - the RTgill-W1 cell line assay (2021)