CLP health hazard tests
CLP health hazard tests are the same for both substances and mixtures. Some health hazards are only based on human experience, and very few are covered by Transport. Nearly all health hazard tests are covered by REACH, see 440-2008 Test Method Regulation – 04-03-2016 , and/or by the OECD animal tests, see http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals_chem_guide_pkg-en .
Most substance testing should be carried out under REACH by the Lead Registrant, or their representative. If your substance is going to be registered for REACH by the 2018 deadline, we recommend you classify it for CLP once it has gone through registration and the test results are published.
You should only need to carry out health hazard tests on substances which are not registered for REACH, e.g. a novel substance; or which is never going to be registered for REACH, that is a substance which is only ever going to be made or imported at less than 1 tonne per annum.
You should only carry out health hazard tests on animals for mixtures where the algorithm method of classification is believed to give an incorrect answer (e.g. due to suspected synergistic effects where components interact to give a greater hazard than the algorithm method predicts), and all other classification routes (QSAR, read-across) have been ruled out.
In-vitro tests, where acceptable for CLP classification, should be used in preference to live animal testing.
CLP states “Tests on animals within the meaning of Directive 86/609/EEC shall be undertaken only where no other alternatives, which provide adequate reliability and quality of data, are possible“.
In the UK, you need permission before conducting animal tests, see https://www.gov.uk/guidance/research-and-testing-using-animals .
If you are a Lead Registrant, you may also need ECHA’s permission before being allowed to carry out animal tests. See https://echa.europa.eu/chemicals-in-our-life/animal-testing-under-reach for more details. As part of this, you will be obliged to make an Inquiry to ECHA before carrying out any new animal tests, see https://echa.europa.eu/support/dossier-submission-tools/reach-it/registration?panel=preparing-submitting-inquiry#preparing-submitting-inquiry .
So for most substances, and all mixtures, you should try to avoid animal testing.
Health hazard test methods
A list of acceptable test methods is given in CLP for each health hazard, and is summarised here for reference: Summary of Health hazard tests CLP and Transport v1.1 31-05-2017 . This document also includes appropriate REACH methods and OECD test guidelines, where they exist.
Note on skin sensitisation tests – the REACH and OECD tests are either animal tests (lymph node response tests), or in vitro tests (on human or animal skin); however dermatologists use patch testing on humans to assess individual response to skin sensitisers. Dermatologists recognise many more chemicals as skin sensitisers beyond those which currently attract the H317 classification under CLP. There is a text book by de Groot which summarises this dermatological information, available to purchase at http://www.patchtesting.info/ . If this issue affects any of your chemicals, it may be sensible to talk to a specialist dermatologist, e.g. Chris Packham of EnviroDerm Services, http://www.enviroderm.co.uk/ .
Who can carry out CLP health hazard tests
Health hazard tests must be carried out by a fully certified test house which is accredited to GLP and subscribes to any local laws on animal testing. A test house in the UK must also be registered with the UK authorities.
There is no requirement for the laboratory to be based in the EU, although this guarantees that animal welfare is of a very high standard, and that only animal tests approved within the EU are used. Using a non-EU lab (especially in India or China) may mean that a non-EU approved animal test might be used accidentally.
Reputable EU labs include Envigo (formerly Harlan, formerly Safepharm); Charles River (formerly WIL Research); and Covance (formerly Hazleton), and other laboratories are available.