Pellevoisin, Christian published the artcileISO 10993-23 In vitro irritation testing for medical devices: Substantiating applicability to mild irritants and non-extractables, COA of Formula: C13H18O3, the main research area is irritation medical device nonextractable; Applicability domain; In vitro; Medical device safety; Mild irritants; Reconstructed human epidermis; Skin irritation.
Irritation testing is an integral part of the biocompatibility assessment of medical devices and has historically been conducted on animals, either by direct contact or with polar and non-polar solvent extracts In 2018 an ISO-sponsored interlaboratory validation study demonstrated that two reconstituted human epidermis (RhE) based assays, which were adapted from validated methods used for industrial chems., produced results essentially equivalent to those obtained with in vivo tests. This led to the publication of the ISO 10993-23:2021 standard on irritation testing, which states that RhE-based assays are now the preferred method. The 2018 validation study evaluated strong irritants, so we tested nine mild irritants (GHS Category 3), neat and spiked at different concentrations into medical device extracts, per ISO 10993-23:2021. The results substantiated the applicability of RhE-based assays for evaluating mild irritants in medical device extracts Moreover, the 2018 validation study tested solid extractable medical device materials but did not consider non-extractable medical device materials (e.g., creams, gels, or sprays). By testing nine marketed non-extractable materials, either neat or spiked with irritants, we also confirmed that RhE-based assays are readily applicable to such medical device materials.
Toxicology In Vitro published new progress about Gels. 6259-76-3 belongs to class esters-buliding-blocks, name is Hexyl 2-hydroxybenzoate, and the molecular formula is C13H18O3, COA of Formula: C13H18O3.
Referemce:
Ester – Wikipedia,
Ester – an overview | ScienceDirect Topics