Oecd Guidelines For The Testing Of Chemicals Section 4 Test No 442d In Vitro Skin Sensitisation Assays Addressing The Adverse Outcome Pathway Key Event On Keratinocyte Activation
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OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 442D: In Vitro Skin Sensitisation Assays addressing the Adverse Outcome Pathway Key Event on Keratinocyte activation
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.
OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 442C: In Chemico Skin Sensitisation Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins
The present Key Event based 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 is proposed to address the Molecular Initiating Event leading to skin sensitisation, namely protein reactivity, by quantifying the reactivity of test chemicals towards model synthetic peptides or amino acid derivatives containing either lysine or cysteine. This Test Guideline provides three in chemico test methods addressing the same Key Event on the Adverse Outcome Pathway for Skin Sensitisation: (i) the Direct Peptide Reactivity Assay – DPRA, (ii) the Amino Acid Derivative Reactivity Assay – ADRA and (iii) the kinetic Direct Peptide Reactivity Assay – kDPRA. The DPRA and ADRA are used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. In contrast, the kDPRA allows discrimination of UN GHS subcategory 1A skin sensitisers from those not categorised as subcategory 1A, i.e. subcategory 1B or no category but does not allow to distinguish sensitisers from non-sensitisers.
OECD Guidelines for the Testing of Chemicals, Section 4 Guideline No. 497: Defined Approaches on Skin Sensitisation
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.