Normas de examen de la OCDE y la UE

Los estudios de los requisitos de información en virtud de REACH en materia de ecotoxicidad, toxicidad y propiedades físicoquímicas suelen efectuarse con arreglo a directrices de ensayo. Estas directrices oficiales han sido aprobadas por la OCDE y la UE.

Debido a la evolución tanto científica como de la normativa, las directrices de ensayo se actualizan y se completan. En esta página web, la ECHA orienta a los solicitantes sobre cómo utilizar dichas directrices para cumplir con los requisitos de informacón en virtud de REACH. Por ejemplo, se describe la función de las nuevas directrices de ensayo para las estrategias de ensayo, cuando corresponde. Dicha información se facilita antes de que se actualicen formalmente los documentos de orientación de la ECHA.

El «Documento de orientación sobre los requisitos de información y sobre la valoración de la seguridad química» puede abarcar alguna de las directrices. En estos casos, deberá consultarse el documento de orientación además de la información recogida en esta página.

En los siguientes apartados, se indica la referencia concreta a las Directrices de ensayo de la OCDE y a los métodos de ensayo de la UE, si están disponibles.

Guidance on information requirements and chemical safety assessment

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Physical-Chemical

At present, there are no prioritised test guidelines for Physical-Chemical properties to be published at this site.

Human health

Serious eye damage/eye irritation

Title and year of approval:: - Bovine Corneal Opacity and Permeability Test Method (BCOP), EU B.47, OECD 437 (adopted in 2009, revised in 2013 and 2017 by OECD)
: - Isolated Chicken Eye Test Method (ICE), EU B.48, OECD 438 (adopted in 2009 and revised in 2013 and 2017 by OECD)
: - Fluorescein Leakage Test Method (FL), OECD 460 (adopted in 2012 and revised in 2017 by OECD)
: - Short Time Exposure Test Method (STE), OECD 491 (adopted in 2015 and revised in 2017 by OECD)
: - Reconstructed Human Cornea-like Epithelium Test Method (RhCE), OECD 492 (adopted in 2015 and revised in 2017 by OECD)
: - Cytosensor Microphysiometer Test Method (CM) (Draft OECD TG under discussion)
Download:: download full PDF document
Document last updates:: 08/03/2018

Skin corrosion/irritation

Title and year of approval:: Corrosion
- Transcutaneous Electrical Resistance Test Method (TER), EU B.40, OECD 430, (2000, revised in 2013 and 2015 by OECD)
: - Reconstructed Human Epidermis Test Method (RHE) (includes more than one protocol), EU B.40 bis, OECD 431, (2000, revised in 2013, 2015 and 2016 by OECD)
: - Corrositex - In Vitro Membrane Barrier Test Method, OECD 435 (2006, revised in 2015)
: Irritation
- Reconstructed Human Epidermis Test Method (RHE) (includes more than one protocol), EU B.46, OECD 439(in EU 2009 and in OECD 2010, revised in 2013 and 2015 by OECD)

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Document last updates:: 8/03/2018

Skin sensitisation

Title and year of approval:: - In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA), OECD 442C (adopted 2015)
: - In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method (Keratinosens), OECD 442D (adopted 2015) - In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method (LuSens), draft OECD 442E available)
: - In Vitro Skin Sensitisation assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome pathway for Skin Sensitisation, OECD 442E (adopted 2017)

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Document last updates:: 8/03/2018

Genotoxicity

Title and year of approval:: - In Vitro Mammalian Cell Micronucleus Test, EU: B.49*, OECD: 487 (adopted 2010, revised 2014, 2016)
*The EU method is outdated and does not reflect the latest update of the corresponding OECD method. Any new test should be performed following the updated OECD TG.
: - In vitro mammalian cell gene mutation tests using the thymidine kinase Gene, OECD: 490 (adopted 2015, updated 2016), EU: none at present;
: - Transgenic rodent (TGR) somatic and germ cell gene mutation assays, EU: B.58, OECD: 488 (adopted 2011, revised 2013)
: - In vivo mammalian alkaline comet assay, EU: none at present, OECD: 489 (adopted 2014, updated 2016)

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Document last updates:: 8/03/2018

Environmental fate

Degradation

Title and year of approval:: OECD 314: Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater, 2008

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Document last updates:: 19/03/2014

Bioaccumulation

Title and year of approval:: - OECD 315: Bioaccumulation in Sediment-dwelling Benthic Oligochaetes, 2008
: - OECD 317: Bioaccumulation in Terrestrial Oligochaetes, 2010
: - OECD 305: Bioaccumulation in Fish: Aqueous and Dietary Exposure, 2012

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Document last updates:: 19/03/2014

Ecotoxicity

Aquatic

Title and year of approval:: - OECD 236: Fish Embryo Acute Toxicity (FET) Test, July 2013
: - OECD 209: Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation), 23 July 2010
: - OECD 210: Fish, Early-life Stage Toxicity Test, 26 July 2013 (replaces OECD 210: Fish, Early-life Stage Toxicity Test, 17 July 1992)
: - OECD 211: Daphnia magna Reproduction Test, 2 Oct 2012 (replaces OECD 211: Daphnia magna Reproduction Test, 16 Oct 2008)

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Document last updates:: 19/09/2016

Terrestrial

Title and year of approval:: - OECD 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil, 2008
: - OECD 232: Collembolan Reproduction Test in Soil, 2009

Download:: download full PDF document
Document last updates:: 19/03/2014

Sediment

Title and year of approval:: OECD 233: Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment, 2010

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Document last updates:: 19/03/2014

Physical-Chemical

Human health

Environmental fate

Ecotoxicity

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