A Defined Approach (DA) consists of a selection of information sources (e.g in silico predictions, in chemico, in vitro data) used in a specific combination, and resulting data are interpreted using a fixed data interpretation procedure (DIP) (e.g. a...

The Vitrigel-Eye Irritancy Test (EIT) method is an in vitro test method that allows the identification of test chemicals not requiring classification and labelling for eye irritation or serious eye damage. This test measures the eye irritation...

This Performance-Based Test Guideline (PBTG) describes in vitro assays, which provide the methodology of Stably Transfected Transactivation to detect Estrogen Receptor Agonists and Antagonists (ER TA assays).

This Test Guideline describes an in vitro procedure that may be used for the hazard identification of irritant chemicals (substances and mixtures) in accordance with the UN Globally Harmonized System of Classification and Labelling (GHS) Category 2.

This Test Guideline addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. It provides an in chemico procedure (Direct Peptide Reactivity Assay – DPRA) used for supporting the discrimination between skin...

This method provides information on health hazard likely to arise from exposure to test substance (liquids, solids and aerosols) by application on the eye. This Test Guideline is intended preferably for use with albino rabbit. The test substance is ...

This method provides information on health hazard likely to arise from exposure to test substance via intradermical injection and/or epidermical application. In this Test Guideline, the methods preferred over other are: the Guinea Pig Maximisation ...

Skin phototoxicity (photoirritation) is defined as an acute toxic response elicited by topically or systemically administered photoreactive chemicals after the exposure of the skin to environmental light. The in vitro reconstructed human epidermis...

This Test Guideline describes in vitro assays, which use Androgen Receptor TransActivation (ARTA) to detect Androgen Receptor Agonists and Antagonists. The ARTA assay methods are mechanistically and functionally similar test methods that provide...

This Test Guideline describes a cytotoxicity-based in vitro assay that is performed on a confluent monolayer of Statens Seruminstitut Rabbit Cornea (SIRC) cells, cultured on a 96-well polycarbonate microplate.

This Test Guideline describes an in vivo assay that detects chemicals that may induce gene mutations in somatic and germ cells. In this assay, transgenic rats or mice that contain multiple copies of chromosomally integrated plasmid or phage shuttle...

The Bovine Corneal Opacity and Permeability test method (BCOP) is an in vitro test method that can be used to identify chemicals (substances or mixtures) as either 1) causing “serious eye damage” (category 1 of the Globally Harmonised System for the...

The bacterial reverse mutation test uses amino-acid requiring at least five strains of Salmonella typhimurium and Escherichia coli to detect point mutations by base substitutions or frameshifts. The principle of this bacterial reverse mutation test ...

The in vitro macromolecular test method is a biochemical in vitro test method that can be used to identify chemicals (substances and mixtures) that have the potential to induce serious eye damage as well as chemicals not requiring classification for...

Phototoxicity is defined as a toxic response is elicited by topically or systemically administered photoreactive chemicals after the exposure of the body to environmental light. Several classes of photoreactive chemicals could cause phototoxic...

The test described in this Test Guideline allows the identification of corrosive chemical substances and mixtures and it enables the identification of non-corrosive substances and mixtures when supported by a weight of evidence determination using...

This Test Guideline describes an in vitro procedure allowing the identification of chemicals (substances and mixtures) not requiring classification and labelling for eye irritation or serious eye damage in accordance with UN GHS.

This Test Guideline describes a method to evaluate photo-cytotoxicity by the relative reduction in viability of cells exposed to the chemical in the presence versus absence of light. Balb/c 3T3 cells are maintained in culture for 24 h for formation ...

This method provides information on health hazard likely to arise from short-term exposure to a test chemical by inhalation. It is a principle of the method that only moderately toxic concentrations are used so that ‘evident toxicity’, rather than...

The present Test Guideline addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical.