…ECHA discusses non-animal tests for skin sensitisation

ECHA has provided advice on new test guidelines (TGs) from the Organisation for Economic Co-operation and Development on the use of non-animal test methods – specifically the direct peptide reactivity assay (OECD TG 442C), the ARE-Nrf2 luciferase (Keratinosens™) test method (OECD TG 442D) and the in vitro human cell line activation test (h-CLAT) (as a draft TG) – to assess skin sensitisation. These methods can be used in combination, as part of an integrated approach, to replace the need for in vivo animal testing.

European Chemicals Agency (2015). Advice for registrants on skin sensitisation testing helps reduce animal tests. ECHA/NA/15/12. http://echa.europa.eu/view-article/-/journal_content/title/advice-for-registrants-on-skin-sensitisation-testing-helps-reduce-animal-tests


…Updated ECHA advice drafted on local toxicity testing

A draft update to Chapter R.7a of ECHA’s guidance on information requirements and chemical safety assessment (IR&CSA) addresses sections relating to skin, eye and respiratory tract irritation and corrosion. Updated information is provided on new and revised EU test methods and OECD test guidelines, on non-testing methods such as quantitative structure-activity relationships (QSARs) and read-across, and on classification and labelling.

European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Chapter R.7a: Endpoint specific guidance. Draft version 4.0. April 2015. http://echa.europa.eu/documents/10162/13564/ir_csa_r7a_r7-2_caracal_draft_201504_en.pdf


…Illustrative example available on consumer exposure to substances in articles

ECHA has demonstrated the use of exposure tools to estimate consumer exposures and risks from substances that become part of an article (an object composed of one or more substances or mixtures given a specific shape, surface or design).

European Chemicals Agency (2015). New consumer exposure example helps companies to comply with REACH. ECHA/NI/15/15. http://echa.europa.eu/view-article/-/journal_content/title/new-consumer-exposure-example-helps-companies-to-comply-with-reach


…Other items of interest

Draft update to the guidance on information requirements and chemical safety assessment (IR&CSA) – Chapter R.7b (parts related to the sediment compartment only) subject to consultation by ECHA’s Partner Expert Group. http://echa.europa.eu/documents/10162/13643/ir_csa_r7b_draft_v3.0_en.pdf


ECHA calls for data relevant to the preparation of an Annex XV restriction dossier on bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP), and for evidence on reports proposing not to initiate restrictions under Article 69 on musk xylene and 4,4’-diaminodiphenylmethane (MDA). http://echa.europa.eu/addressing-chemicals-of-concern/restriction/calls-for-comments-and-evidence


Seminar on applications for authorisation to be held in June. http://echa.europa.eu/view-article/-/journal_content/title/seminar-on-applications-for-authorisation-in-june


Testing proposals involving vertebrate animals: request for information from third parties on 2-methylbut-3-yn-2-ol and sodium p-cumenesulphonate (deadline 8 or 12 June). http://echa.europa.eu/information-on-chemicals/testing-proposals/current


The above items were taken from the June 2015 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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