In vitro genotoxicity evaluation and metabolic study of residual glutaraldehyde in animal-derived biomaterials

Abstract

Glutaraldehyde (GA) is an important additive that is mainly used in animal-derived biomaterials to improve their mechanical and antimicrobial capacities. However, GA chemical toxicity and the metabolic mechanism remain relatively unknown. Therefore, residual GA has always been a major health risk consideration for animal-derived medical devices. In this study, extracts of three bio-patches were tested via the GA determination test and mouse lymphoma assay (MLA). The results showed that dissolved GA was a potential mutagen, which could induce significant cytotoxic and mutagenic effects in mouse lymphoma cells. These toxic reactions were relieved by the S9 metabolic activation (MA) system. Furthermore, we confirmed that GA concentration decreased and glutaric acid was generated during the catalytic process. We revealed GA could be oxidized via cytochrome P450 which was the main metabolic factor of S9. We found that even though GA was possibly responsible for positive reactions of animal-derived biomaterials’ biocompatibility evaluation, it may not represent the real situation occurring in human bodies, owing to the presence of various detoxification mechanisms including the S9 system. Overall, in order to achieve a general balance between risk management and practical application, rational decisions based on comprehensive analyses must be considered.

Response of intra canal medicaments on viability and survival of SHEDs

“…The number of live cells and ALP activity of SHEDs cultured in glutaraldehyde was significantly less when compared to control. These facts were further confirmed by the study conducted by Bhandi and co-workers 28 .Shi J observed that the presence of glutaraldehyde in mouse lymphoma cells could cause considerable cytotoxic and mutagenic consequences 36 .…”

Mechanical Properties of Bioengineered Corneal Stroma

“…Collagen cross-linking increases stiffness and tensile stress, however, it comes with a reduced biocompatibility and possible toxicity of remnant cross-linking agents. [100][101][102] For these types of solutions, the main challenge is finding a reasonable balance between mechanostability and biocompatibility during the first months after implantation, so that residing keratocytes are able to effectively re-establish a healthy ECM.…”

“…Hence, it is not ideal for the production of engineered corneal implants. [100,101] An alternative is genipin, a chemical cross-linker of natural origin that can form both inter-and intramolecular cross-links in collagen fibrils. in vitro, genipin has shown to be a successful cross-linker in collagen type I hydrogels, increasing storage and loss moduli by a factor of 15 and 4.5, respectively.…”

Biocompatible and antibacterial soy protein isolate/quaternized chitosan composite sponges for acute upper gastrointestinal hemostasis

“…In the USA, the biosafety of medical devices is strictly supervised by the Food and Drug Administration [ 16 ]. Currently, biocompatibility evaluations play an important role in the preclinical research stage of hemostatic sponges [ 17 , 18 ].…”