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EC number: 241-698-9 | CAS number: 17696-62-7
The skin sensitisation potential of the target substance phenylparaben was evaluated in a weight-of-evidence approach. Based on the results from an in vitro skin sensitisation assay, namely the loose-fit coculture-based sensitisation assay (LCSA), the test item phenylparaben must be considered as moderate skin-sensitiser based on the expression of the surface marker CD86.
Further evidence of the positive skin sensitisation potential of the target substance was predicted by QSAR, using the Skin Sensitization model CAESAR 2.1.6, which is implemented in the QSAR tool VEGA (version 1.2.4.). Phenylparaben is predicted to be a skin sensitizer. As a conclusion based on an assessment of the available data in a weight-of-evidence approach, the target substance must be considered as a skin-sensitiser. The classification of the target substance as skin sensitizer is also further supported by the QSAR Toolbox (Version 4.0), which revealed a positive structural alert for protein binding: Acylation (Protein Binding by OASIS v1.4 and Protein Binding by OECD).
The test item was predicted to be a senitiser in the VEGA QSAR model. Strongly similar compounds with known experimental value were found in the training set (Similarity index = 0.903), and similar molecules found in the training set had experimental values that agree with the predicted value. The descriptors for the compound had values inside the descriptor range of the compounds of the training set and the accuracy of prediction for similar molecules found in the training set was considered good. Overall, the QSAR prediction is considered supporting evidence for a sensitising potential of the test item.
In a loose-fit coculture-based sensitisation assay (LCSA), keratinocytes were isolated from skin which was received as residual material from plastic surgery. PBMCs were enriched from buffy coats by density centrifugation. Cells were cocultured in serum-free KGM-2 (PromoCell, Heidelberg, Germany) on 12-well cell culture plates. Each substance was tested with three different DC-rc/KC-donor pairs to account for interindividual variability. TNBS at a concentration of 100 µmol/L served as positive control. Dose-effect relationships for relative CD86-expression and viability as well as EC50 values were determined using GraphPadPrism software. Based on a EC50sens value of 69.23 µmol/L, can the test substance be considered as moderate skin sensitising. The EC50vit was 416.17 µmol/L, indicating that the substance is weakly irritative.
Based on the available data, classification as H317, Skin Sens 1 is warranted for the target substance.
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