About tests for CLP classification
Tests on substances or mixtures are only required where there is no other reliable source of information to enable a classification to be made. The tests are the same for both substances or mixtures.
The tests are split by hazard type into:
- physical hazard tests, see: https://ttenvironmenta.wpengine.com/clp-knowledgebase/clp-physical-hazard-tests/
- health hazard tests, see: https://ttenvironmenta.wpengine.com/clp-knowledgebase/clp-health-hazard-tests/
- environmental hazard tests, see: https://ttenvironmenta.wpengine.com/clp-knowledgebase/clp-environmental-hazard-tests/
There are two main types of test:
- physico-chemical tests to provide information on physical hazards (in CLP, these are mainly based on the Transport physical hazard tests, which are published in: Manual of Tests and Criteria Rev 6 2015,)
- animal tests to provide information on health and environmental hazards (in CLP, these are mainly based on REACH tests (published in 440-2008 Test Method Regulation – 04-03-2016 ) and the OECD tests (published online at http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals_chem_guide_pkg-en ) )
Tests on physical hazards are based on the chemistry of the substance or mixture. Some physical hazards can be modelled, although most must be tested for, and generally test data is considered more reliable than modelled data. There is no limit to the number or type of physical hazard tests which can be carried out. The physical hazard tests required can be assessed based on the substance chemistry, see: Screening questions for substance physical hazards v1.2 and Screening questions for physical hazards of mixtures v1.3 03-02-2018.
Health and environmental effects are not as easy to predict based on the chemistry of the substance or mixture, and there are usually screening tests for health effects. These tests are usually based on animal testing, either in vitro (literally “in glass”, that is in a test-tube, or other non-live animal test), or on live animals. Under EU and UK law, tests on live animals must only be carried out where no other method of testing provides reliable information; and permission must be sought from the HSE in the UK (and ECHA for REACH) before such tests can be carried out.
Health and environmental tests are mainly carried out during REACH registration of a substance, and should only be considered for a substance where it is not going to be registered for REACH, e.g. only ever going to be made or imported at less than 1 tonne per annum, but where the health or environmental risks are considered significant enough to require animal testing.
Health and environmental tests should not be carried out on mixtures, instead the algorithm methods should be used. However, they may occasionally be required where the effects may be more severe or less severe than the calculation methods of classification suggest.
If you are considering commissioning chemical tests on live animals, it is strongly recommended that you discuss this with the HSE (or other Competent Authority outside the UK), to check whether any other alternatives exist, and to ensure that you are not inadvertently breaking the law.