title: Effect of sample preparation on the in vitro genotoxicity of a light curable glass ionomer cement.
abstract: The glass ionomer cement Vitrebond showed a clear genotoxic effect in the in vitro Mammalian Cell Gene Mutation Test (HPRT Test) with CHO cells as well as in the bacterial umu-test with Salmonella typhimurium TA1535/pSK1002. Both DMSO and Ham's F12 cell culture medium extracts according to ISO 10993-12 (Biological evaluation of medical devices-Part 12: sample preparation and reference materials, Geneva, Switzerland) exhibit a clear genotoxic effect in the umu-test. The effect is independent of the extraction volume in a range from 0.5 to 4 ml Ham's F12 cell culture medium. Subsequent extractions of Vitrebond showed no significant difference in the genotoxic response although weight loss and content of 2-hydroxyethyl-methacrylate dropped significantly. In vivo conditions of Vitrebond were simulated by extractions with artificial and collected human saliva. These extracts showed a clear genotoxic effect in the umu-test, even if only a few seconds of extraction time were applied. In conclusion, sample preparations for genotoxicity testing according to ISO 10993-12 reflect the in vivo conditions of Vitrebond applications. This seems to be mostly due to the hydrophilic nature of the genotoxic ingredients.
authors.affiliation: Institute of Hygiene and Environmental Health, University Hospital, RWTH Aachen, Pauwelsstrasse 30, 52074 Aachen, Germany. boris.mueller@post.rwth-aachen.de
authors.forename: B P
authors.initials: BP
authors.lastname: Müller
authors.forename: A
authors.initials: A
authors.lastname: Eisenträger
authors.forename: W
authors.initials: W
authors.lastname: Jahnen-Dechent
authors.forename: W
authors.initials: W
authors.lastname: Dott
authors.forename: J
authors.initials: J
authors.lastname: Hollender
mesh_terms: D000818:Animals; D001672:Biocompatible Materials / Q000633:toxicity; D016466:CHO Cells; D006224:Cricetinae; D017220:Dentin-Bonding Agents / Q000633:toxicity*; D005899:Glass Ionomer Cements / Q000633:toxicity*; D006801:Humans; D066298:In Vitro Techniques; D008027:Light; D008422:Materials Testing; D009152:Mutagenicity Tests; D051381:Rats; D012387:Root Canal Filling Materials / Q000633:toxicity
chemical_list: D001672:Biocompatible Materials; D017220:Dentin-Bonding Agents; D005899:Glass Ionomer Cements; D012387:Root Canal Filling Materials; C067790:Vitrabond