ECHA has published advice on using new or revised OECD test guidelines related to serious eye damage/eye irritation and skin corrosion/irritation. Non-animal testing is now the default approach to gather information.
The OECD test guidelines are relevant for many registrants preparing for the 2018 REACH registration deadline. The advice on using the guidelines has been updated taking into account the recent amendments of the REACH annexes, making non-animal test methods the default requirement.
For most substances, the use of the adopted OECD in vitro test guidelines for skin and eye irritation testing will provide results which are accepted under REACH.
Regarding skin corrosion/irritation, four adopted in vitro test guidelines are available:
- OECD 439 – in vitro skin irritation (revised in 2013)
- OECD 431 – in vitro skin corrosion (revised in 2013)
- OECD 430 – Transcutaneous electrical resistance test (TER) (revised in 2013)
- OECD 435 – in vitro membrane barrier test method (2006)
Regarding serious eye damage/eye irritation, five adopted in vitro test guidelines and one draft test guideline are available:
- OECD TG 437 – The Bovine Corneal Opacity and Permeability test method (BCOP) (revised in 2013)
- OECD TG 438 – Isolated Chicken Eye Test (ICE) (revised in 2013)
- OECD TG 460 – Fluorescein leakage (FL) method (2012)
- OECD TG 491 – Short Time Exposure (STE) (2015)
- OECD TG 492 – Reconstructed human Cornea-like Epithelium (RhCE) (2015)
- Test Method Cytosensor Microphysiometer (CM) (draft under discussion)
In some cases, animal testing may still be necessary, as a last resort. For this, one revised test guideline is available:
- OECD TG 405 – in vivo Acute Eye Irritation/Corrosion (revised in 2012)
Registrants must consider and use alternative methods where possible. Due to the sequential nature of the REACH standard information requirements, and irrespective of the annual tonnage of the substance, new data for skin and eye irritation needs to be generated with in vitro testing. If the in vitro results are adequate for classification and labelling or risk assessment, no further in vivo testing is needed. Registrants need to make sure that the chosen test method is suitable for the substance to obtain adequate information from the in vitro studies.
In vitro: studies using cells, tissues or organs by using glass or plastic vessels in the laboratory
In vivo: test conducted in a living organism