OECD 442E in vitro sensitization test
| Regulatory reference: | OECD 442E |
| Claim: | No skin sensitizing and Hypoallergenic |
| Application field: | Substances or mixtures. |
| Description of the test: | H-CLAT cytometry method to evaluate possible changes in the expression of cell surface markers (CD86 e CD54) in cultures of THP-1 human monocytes to exclude the related sensitization pathway. |
Ames test
| Regulatory reference: | OECD 471 |
| Claim: | Non mutagenic |
| Application field: | Raw ingredients for medical devices or cosmetics. |
| Description of the test: | Analysis of genotoxicity of a substance according to OECD 471. |
DPRA: Direct Peptide Reactivity Assay test
| Regulatory reference: | OECD 442C |
| Claim: | No skin sensitizing and Hypoallergenic |
| Application field: | Substances or mixtures without metal compounds. |
| Description of the test: | The DPRA is proposed to address the molecular initiating event of the skin sensitisation AOP (Adverse Outcome Pathway), namely protein reactivity, by quantifying the reactivity of test chemicals towards model synthetic peptides containing either lysine or cysteine. Cysteine and Lysine percent peptide depletion values are then used to categorise a substance in one of four classes of reactivity for supporting the discrimination between skin sensitisers and non-sensitisers. |
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