The 26th September 2014 saw the OECD updating 6 existing health effect guidelines (5 genotoxicity and 1 in vitro skin corrosion) for the testing of chemicals, Section 4.
Of the 5 genotoxicity guidelines updated these included:
- OECD 473 – in vitro mammalian chromosomal aberration test:
- OECD 474 – mammalian erythrocyte micronucleus test:
- OECD 475 – Mammalian bone marrow chromosomal aberration test
- OECD 487 – in vitro mammalian cell micronucleus test
- OECD 473 – in vitro mammalian chromosomal aberration test
In general these updates include the requirement to provide defined historical control ranges and distributions for both negative and positive controls. Across all 5 test guidelines greater statistical power has been achieved by increasing the number of cells scored for the desired endpoint. For the in vitro tests more emphasis is placed on considering the p53 status, genetic stability, DNA repair capacity and origin of cell lines used, with the maximum recommended dose not exceeding 10 mM or 2 mg/mL.
The remaining test guideline update is for OECD 431 (in vitro skin corrosion: reconstructed human epidermis (RHE) test method). The test procedures in the guideline have not changed, however the test guideline has revised the list of twelve chemicals that laboratories should test to demonstrate technical proficiency by correctly classifying them. The UN GHS classification for the epiCS® model has been modified and the Annex to the test guideline has been updated following a more extensive inter-laboratory collaboration of the EpiSkinTM and EpiDermTM models.
The revised test guidelines can be viewed on the OECD website (http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-4-health-effects_20745788).
For information on how this may impact on your business, or further information on the registration of plant protection products, biocides or general chemicals, contact JSC on +44 (0)1423 520245, enquiries@jsci.co.uk