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New Approach Methodology / non-animal alternative methods (NAMs) have become of enormous relevance over the last decades. They found their way into legislation commonly referred to as the 3R principle– the Replacement, Reduction and Refinement of animal experiments.

The REACH regulation (EC No. 1907/2006) from 2006 requires that “testing on vertebrate animals for the purpose of REACH shall be undertaken only as a last resort”. In 2003 the 7th amendment of the Cosmetics Directive (DIRECTIVE 2003/15/EC) stipulated a ban on animal testing for cosmetics which came into force in 2013.

The European Union Reference Laboratory for Alternatives to Animal Testing / European Centre for the Validation of Alternative Methods (EURL ECVAM) has been established and a number of OECD test guidelines have been developed in order to provide reliable and scientifically satisfactory standards for in vitro assays. Examples are tests on skin models or bovine cornea to assess skin/eye corrosion and irritation hazard.

For a complex process like skin sensitisation a single assay is not sufficient. The combination of two in vitro studies and an in chemico test leads to hazard potential classification using an DA (defined approach). These studies target three different key events in an Adverse Outcome Pathway (AOP), and two concordant results lead to the classification as sensitiser/non-sensitiser (UN GHS 1 or NC). In addition to this the new OECD 497 provides an Integrated Test Strategy (ITS) based on these studies plus in silico prediction (e. g. QSAR or DEREK Nexus database) and allows GHS Classification into Potency subcategories 1A and 1B.

in vitro Skin Tests
Guideline Description

 OECD 431

Skin Corrosion: "In Vitro Skin Corrosion: Reconstructed Human Epidermis Test Method"

 OECD 435

Skin Corrosion : "In Vitro Membrane Barrier Test Method for Skin Corrosion" (Corrositex)

 OECD 439

Skin Irritation: "In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method"


in vitro Eye Tests
Guideline Description

OECD 437

Serious Eye Damage: "Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage" (BCOP)

OECD 492

Eye Irritation: EpiOcularTM Irritation


Eye irritation/serious eye damage:

“Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Eye Hazard Identification” (SkinEthic™)


in vitro Skin Sensitisation
Guideline Description

In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA)


In Vitro Skin Sensitisation: KeratinoSens - ARE-Nrf2 Luciferase Test Method


In Vitro Skin Sensitisation: h-CLAT (human Cell Line Activation Test)

OECD 497

Defined Approaches on Skin Sensitisation


Endocrine Properties
Guideline Description
  Estrogen- and Androgen Receptor Binding Affinity - YES/YAS Assay

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