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 mathematical, rule-based model). DAs use...

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 phototoxicity test (RhE PT) is used to identify...

This Test Guideline proposes defined approaches (DA) combining data generated in vitro methods, with information sources such as physicochemical properties. The prediction from a DA may be used alone to determine eye hazard potential according to the hazard classes of the UN GHS (Categories 1,...

This Test Guideline describes an in vitro procedure the identification on its own of chemicals (substances and mixtures) not requiring classification (No Cat), requiring classification for eye irritation (Cat 2) and requiring classification for serious eye damage (Cat 1) according to the UN GHS...

This Test Guideline describes an in vivo erythrocyte Pig-a gene mutation assay (hereafter called the Pig-a assay) which uses an endogenous mammalian gene, the phosphatidylinositol glycan class A gene (Pig-a), as a reporter of somatic-cell gene mutation. In vivo gene mutation tests, such as the...

The basic principle underlying the Local Lymph Node Assay (LLNA) in mouse is that sensitizers induce a primary proliferation of lymphocytes in the auricular lymph nodes draining the site of chemical application. This proliferation is proportional to the dose applied and provides a measurement of...

This method provides information on health hazard likely to arise from short-term exposure to a test article (gas, vapour or aerosol/particulate test article) by inhalation. The revised Test Guideline describes two studies: a traditional LC50 protocol and a Concentration x Time (C x t) protocol....

The method described by this Test Guideline provides information that allows hazard assessment for short-term exposure to a test article by inhalation, and allows the substance to be classified according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The...

This method provides information on health hazard likely to arise from exposure to liquid or solid test substance by dermal application. This Test Guideline recommends sequential testing strategies, which include the performance of validated and accepted in vitro or ex vivo tests for...

The method permits estimation of an LD50 with a confidence interval and the results allow a substance to be classified for acute toxicity according to the Globally Harmonised System of classification and labelling of chemicals. It is easiest to apply to materials that produce death within couple...