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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