Tavallisesti REACH-tietovaatimusten edellyttämät aineiden ekotoksisuutta, myrkyllisyyttä ja fysikaalis-kemiallisia ominaisuuksia koskevat tutkimukset suoritetaan käyttäen testausohjeita. Nämä viralliset ohjeet ovat OECD:n ja EU:n hyväksymiä.

Tieteen kehityksen ja lainsäädännön muutosten myötä testausohjeita päivitetään ja uusia otetaan käyttöön. Tällä verkkosivustolla kemikaalivirasto tukee rekisteröijiä kertomalla, miten niitä voidaan käyttää REACH-tietovaatimusten täyttämiseksi. Esimerkiksi uusien testausohjeiden roolia testausstrategioissa kuvaillaan tarvittaessa. Tällaiset tiedot annetaan ennen kuin kemikaaliviraston toimintaohjeet on virallisesti päivitetty.

"Tietovaatimuksia ja kemikaaliturvallisuusarviointia koskevat toimintaohjeet" saattavat sisältää joitakin näistä ohjeista. Niissä tapauksissa tällä sivulla olevien tietojen lisäksi on tutustuttava kyseisiin toimintaohjeisiin.

Seuraavissa osioissa viitataan erityisesti OECD:n testausohjeisiin ja EU:n testausmenetelmiin, jos niitä on saatavissa.

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:: - Defined Approaches (DA) method, OECD TG 497 (2024)
: - Reconstructed Human Cornea-like Epithelium Time-To-Toxicity (RhCE-TTT) test, OECD TG 492B (2024)
: - Bovine Corneal Opacity and Permeability (BCOP) test, EU B.47, OECD TG 437 (2023)
: - Isolated Chicken Eye (ICE) test, EU B.48, OECD TG 438 (2023)
: - Fluorescein leakage (FL) test, OECD TG 460 (2023)
: - Short Time Exposure (STE) test, OECD TG 491 (2023)
: - Reconstructed human Cornea-like Epithelium (RhCE) test, OECD TG 492 (2024)
: - Eye Irritancy Test (EIT) test, OECD TG 494 (2021)
: - In vitro macromolecular test method, OECD TG 496 (2024)
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Document last updates:: 02/06/2024

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:: Test method OECD 442C – Key Event-Based Test Guideline for in chemico skin sensitisation assays addressing the Adverse Outcome Pathway Key Event on Covalent Binding to Proteins (adopted 2015, updated 2021)
: Test method OECD 442D – Key Event-Based Test Guideline: in vitro skin sensitisation assays addressing the AOP key event on keratinocyte activation (adopted 2015, updated 2018)
: The test method – OECD 442E – Key Event-Based Test Guideline: in vitro Skin Sensitisation assays addressing Key Event on activation of dendritic cells on the adverse outcome pathway for skin sensitisation (adopted 2017, updated 2018)

: Guideline - OECD 497 – Guideline on Defined Approaches for Skin Sensitisation (adopted 2021).

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Document last updates:: 13/10/2021

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

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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