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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 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 ...
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 sensitisers and non-sensitisers.
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 Local Lymph Node Assay: DA (LLNA: DA) 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 ...
The present Key Event based Test Guideline (TG) 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 TG is proposed to address the activation of dendritic cells, which is one Key Event on the Adverse Outcome Pathway (AOP) for Skin Sensitisation. It provides four 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, (iii) the Interleukin-8 Reporter Gene Assay or IL-8 Luc assay and (iv) the Genomic Allergen Rapid Detection for assessment of skin sensitisers (GARDTMskin). All of them are used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. The test methods described in this TG either quantify the change in the expression of cell surface marker(s) CD54 and CD86, the cytokine IL-8, or a series of genes (genomic biomarker signature) that are associated with the process of activation of monocytes and DC following exposure to sensitisers.
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 methods in combination and are intended to overcome some limitations of the individual, stand-alone methods.
With a view to assisting the evaluation of integrated approaches to testing and assessment (IATA) in regulatory decision-making within OECD Member Countries, this guidance document provides guidance on the reporting of defined approaches to testing and assessment in the area of skin ...
This document describes the state of knowledge of the adverse outcome pathway (AOP) for skin sensitisation initiated by covalent binding to proteins, assesses the weight-of-evidence supporting the AOP, identifies the key events, and identifies databases containing test results related to key events.