title: Hydrophilic polymers--biocompatibility testing in vitro.
abstract: Biocompatibility is one of the main prerequisites for safe use of medical devices. Estimation of cytotoxicity is a part of the initial evaluation laid down in ISO standards on biological evaluation of medical devices. Hydrophilic polymers (based on 2-hydroxyethyl methacrylate HEMA) doped by addition of selected additives with antioxidant and/or free radical scavenging potential (vitamin C and hindered amine stabilizer N-(2,2,6,6-tetramethylpiperidin-4-yl)methacrylamide) were tested in different in vitro systems (3T3 Balb/c cell culture and a 3D human skin model) for biocompatibility and suitability for use as wound dressings. The results of the 3T3 NRU cytotoxicity test using both the direct and indirect contact approaches and a 3D skin model modified irritation test (EpiDerm) confirmed high biocompatibility and good skin tolerance of both the basic polymers and those enriched with specific additives up to a balanced level. HEMA polymer showed a beneficial effect against cytotoxicity of an irritant (sodium dodecyl sulfate). The in vitro biocompatibility test results were confirmed by human local skin tolerance testing.
authors.affiliation: National Reference Center for Cosmetics, National Institute of Public Health, Srobárova 48, 100 42 Prague 10, Czech Republic. kejlova@szu.cz
authors.forename: K
authors.initials: K
authors.lastname: Kejlová
authors.forename: J
authors.initials: J
authors.lastname: Labský
authors.forename: D
authors.initials: D
authors.lastname: Jírová
authors.forename: H
authors.initials: H
authors.lastname: Bendová
mesh_terms: D000328:Adult; D000818:Animals; D000975:Antioxidants / Q000008:administration & dosage / Q000633:toxicity; D041702:BALB 3T3 Cells; D047070:Bandages, Hydrocolloid; D001672:Biocompatible Materials / Q000633:toxicity*; D002470:Cell Survival / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D005347:Fibroblasts / Q000187:drug effects; D006801:Humans; D020100:Hydrogels / Q000008:administration & dosage / Q000633:toxicity*; D008297:Male; D008422:Materials Testing; D008689:Methacrylates / Q000008:administration & dosage / Q000633:toxicity*; D051379:Mice; D008875:Middle Aged; D010328:Patch Tests; D011108:Polymers / Q000008:administration & dosage / Q000633:toxicity*; D012867:Skin / Q000187:drug effects; D023422:Skin Irritancy Tests; D046509:Tissue Culture Techniques
chemical_list: D000975:Antioxidants; D001672:Biocompatible Materials; D020100:Hydrogels; D008689:Methacrylates; D011108:Polymers; C005044:hydroxyethyl methacrylate