top of page

Skin Toxicity Assays

Providing Everything You Need

OECD Test No. 428: Skin Absorption: in vitro Method

Test No. 428 is a guideline that outlines an in vitro method for evaluating the skin absorption potential of chemicals or substances. The guideline provides instructions for conducting experiments using artificial skin membranes or skin tissue samples, exposing them to the test substance, and measuring the permeation or absorption of the substance through the skin barrier. This test helps assess the potential for dermal absorption of chemicals, providing important information for evaluating their safety and potential risks to human health.

OECD Test No. 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method

Test No. 431 is a guideline that describes the in vitro Skin Corrosion Test using Reconstructed Human Epidermis (RHE). This test method is used to assess the corrosive potential of chemicals or substances on the skin. The guideline provides instructions for applying the test substance to the RHE model and evaluating its corrosive effects based on various endpoints such as tissue viability, histopathological analysis, or protein denaturation. This test helps identify substances that can cause skin corrosion, providing valuable information for evaluating their potential hazards and guiding safety measures.

OECD Test No. 435: In Vitro Membrane Barrier Test Method for Skin Corrosion

Test No. 435 is a guideline that outlines the In Vitro Membrane Barrier Test Method for assessing skin corrosion potential of chemicals or substances. The guideline provides instructions for using a membrane barrier model to simulate the skin barrier, exposing it to the test substance, and evaluating the corrosive effects. This test helps determine the ability of substances to cause damage to the skin barrier, providing important information for assessing their potential corrosive properties and guiding safety measures.

OECD Test No. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

Test No. 439 is a guideline that outlines the In Vitro Skin Irritation Test Method using Reconstructed Human Epidermis (RHE). This test is used to assess the potential skin irritation caused by chemicals or substances. The guideline provides instructions for applying the test substance to the RHE model and evaluating its effects on various endpoints such as tissue viability, cytokine release, or histopathological changes. This test helps identify substances that can cause skin irritation, providing valuable information for evaluating their potential hazards and guiding safety measures.

OECD Test No. 442A: Skin Sensitization

Test No. 442A is a guideline that describes the In Vitro Skin Sensitization Test, which is used to evaluate the potential of chemicals or substances to cause allergic skin reactions, known as sensitization. The guideline provides instructions for using reconstructed human epidermis (RHE) models or other suitable in vitro models, exposing them to the test substance, and assessing various endpoints such as cellular and cytokine responses. This test helps identify substances that have the potential to cause skin sensitization, providing important information for assessing their potential allergenicity and guiding safety measures.

OECD Test No. 442B: Skin Sensitization

The Local Lymph Node Assay: BrdU-ELISA (LLNA:BrdU-ELISA) is a non-radioactive modification to the LLNA method for identifying potential skin sensitizing test substances and measuring the proliferation of lymphocytes they induce in the auricular lymph nodes. The method described in mouse  is based on the use of measuring 5-bromo-2-deoxyuridine (BrdU) content, an analogue of thymidine, as an indicator of this proliferation. A minimum of four animals is used per dose group, with a minimum of three concentrations of the test substance, plus a concurrent negative control group and a positive control group.

OECD Test No. 442C: In Chemico Skin Sensitisation

The present Test Guideline addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. Skin sensitisation refers to an allergic response following skin contact with the tested chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS).

This Test Guideline provides an in chemico procedure (Direct Peptide Reactivity Assay – DPRA) used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS

OECD Test No. 442D: In Vitro Skin Sensitisation

The present Test Guideline addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. Skin sensitisation refers to an allergic response following skin contact with the tested chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). This Test Guideline (TG) provides an in vitro procedure (the ARE-Nrf2 luciferase test method) used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. The second key event on the adverse outcome pathway leading to skin sensitisation takes place in the keratinocytes and includes inflammatory responses as well as gene expression associated with specific cell signalling pathways such as the antioxidant/electrophile response element (ARE)-dependent pathways. The test method described in this Test Guideline (ARE-Nrf2 luciferase test method) is proposed to address this second key event.

OECD Test No. 442E: In Vitro Skin Sensitisation

The present Key Event based Test Guideline (TG) addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. More specifically, it addresses the activation of dendritic cells, which is one Key Event on the Adverse Outcome Pathway (AOP) for Skin Sensitisation. Skin sensitisation refers to an allergic response following skin contact with the tested chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). This TG provides three in vitro test methods addressing the same Key Event on the AOP: (i) the human cell Line Activation Test or h-CLAT method, (ii) the U937 Cell Line Activation Test or U-SENS and (iii) the Interleukin-8 Reporter Gene Assay or IL-8 Luc assay. All of them are used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS

bottom of page