Expansion of the Cosmetics Europe skin sensitisation database with new substances and PPRA data
| العنوان: | Expansion of the Cosmetics Europe skin sensitisation database with new substances and PPRA data |
|---|---|
| المؤلفون: | Sebastian Hoffmann, Nathalie Alépée, Nicola Gilmour, Petra S. Kern, Erwin van Vliet, Fanny Boislève, Dagmar Bury, Elodie Cloudet, Martina Klaric, Jochen Kühnl, Jon F. Lalko, Karsten Mewes, Masaaki Miyazawa, Hayato Nishida, Mai Thanh Tam Brami, Mustafa Varçin, Anne Marie Api, Cosmetics Europe |
| المصدر: | Regulatory toxicology and pharmacology : RTP. 131 |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Databases, Factual, Dermatitis, Allergic Contact, Animals, Humans, General Medicine, Cosmetics, Local Lymph Node Assay, Toxicology, Animal Testing Alternatives, Skin |
| الوصف: | The assessment of skin sensitisation is a key requirement in all regulated sectors, with the European Union's regulation of cosmetic ingredients being most challenging, since it requires quantitative skin sensitisation assessment based on new approach methodologies (NAMs). To address this challenge, an in-depth and harmonised understanding of NAMs is fundamental to inform the assessment. Therefore, we compiled a database of NAMs, and in vivo (human and local lymph node assay) reference data. Here, we expanded this database with 41 substances highly relevant for cosmetic industry. These structurally different substances were tested in six NAMs (Direct Peptide Reactivity Assay, KeratinoSens™, human Cell Line Activation Test, U-SENS™, SENS-IS, Peroxidase Peptide Reactivity Assay). Our analysis revealed that the substances could be tested without technical limitations, but were generally overpredicted when compared to reference results. Reasons for this reduced predictivity were explored through pairwise NAM comparisons and association of overprediction with hydrophobicity. We conclude that more detailed understanding of how NAMs apply to a wider range of substances is needed. This would support a flexible and informed choice of NAMs to be optimally applied in the context of a next generation risk assessment framework, ultimately contributing to the characterisation and reduction of uncertainty. |
| تدمد: | 1096-0295 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::67436f07a0169ef82f6ae0d2319ed98a https://pubmed.ncbi.nlm.nih.gov/35447229 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....67436f07a0169ef82f6ae0d2319ed98a |
| قاعدة البيانات: | OpenAIRE |
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