title: Mutagenic and clastogenic characterization of poststerilized poly(3-hydroxybutyrate-co-4-hydroxybutyrate) copolymer biosynthesized by Delftia acidovorans.
abstract: Polyhydroxyalkanoates (PHA) are naturally occurring biopolyesters that have great potential in the medical field. However, the leachables resulting from sterilization process of the biomaterials may exert toxic effect including genetic damage. Here, we demonstrate that although gamma-irradiation of poly(3-hydroxybutyrate-co-50 mol % 4-hydroxybutyrate) [P(3HB-co-4HB)] did not cause any change in the morphology by scanning electron microscopy, there was a significant degradation of this copolymer where the molecular weight was reduced by 37% after sterilization indicating the generation of leachables. Therefore, further investigation on the ability of the extract of this poststerilized copolymer to induce mutagenic effect was performed using Ames test (S. typhimurium strains TA1535 and TA1537) and umu test (S. typhimurium strain TA1535/pSK1002). Additionally, the capability of the extract to induce clastogenic effect was determined using Chinese hamster lung V79 fibroblast cells. Our results showed that with and without the presence of S9 metabolic activation, no mutagenic effects were observed in both Ames and umu tests when treated with P(3HB-co-4HB) extract. Similarly, treatment of P(3HB-co-4HB) extract in V79 fibroblast cells showed no significant production of micronuclei when compared with the positive control (Mitomycin C). Together, these results indicate that leachables of poststerilized P(3HB-co-4HB) cause no mutagenic and clastogenic effects.
authors.affiliation: Biomedical Science Department, Faculty of Allied Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur 50300, Malaysia.
authors.forename: Ee Ling
authors.initials: EL
authors.lastname: Siew
authors.forename: Nor Fadilah
authors.initials: NF
authors.lastname: Rajab
authors.forename: Annuar Bin
authors.initials: AB
authors.lastname: Osman
authors.forename: Kumar
authors.initials: K
authors.lastname: Sudesh
authors.forename: Salmaan Hussain
authors.initials: SH
authors.lastname: Inayat-Hussain
mesh_terms: D000818:Animals; D001672:Biocompatible Materials / Q000737:chemistry*; D002460:Cell Line; D006224:Cricetinae; D020605:Delftia acidovorans / Q000378:metabolism*; D005347:Fibroblasts / Q000378:metabolism; D006885:Hydroxybutyrates / Q000737:chemistry*; D015162:Micronucleus Tests; D008855:Microscopy, Electron, Scanning / Q000379:methods; D016685:Mitomycin / Q000494:pharmacology; D008970:Molecular Weight; D009152:Mutagenicity Tests; D009153:Mutagens / Q000494:pharmacology; D009154:Mutation; D011091:Polyesters / Q000737:chemistry*; D011108:Polymers / Q000737:chemistry*; D000094122:Polyhydroxybutyrates
chemical_list: D001672:Biocompatible Materials; D006885:Hydroxybutyrates; D016685:Mitomycin; D009153:Mutagens; D011091:Polyesters; D011108:Polymers; C068056:poly(3-hydroxybutyrate-co-4-hydroxybutyrate); D000094122:Polyhydroxybutyrates