Abstract
Background: Non-targeted screening of food contact materials (FCM) for non-intentionally added substances (NIAS) reveals a great number of unknown and unidentified substances present at low concentrations. In the absence of toxicological data, the application of the threshold of toxicological concern (TTC) or of EU Regulation 10/2011 requires methods able to fulfill safety threshold criteria. In this review, mammalian in vitro genotoxicity assays are analyzed for their ability to detect DNA-damaging substances at limits of biological detection (LOBD) corresponding to the appropriate safety thresholds. Results: The ability of the assays to detect genotoxic effects varies greatly between substance classes. Especially for direct-acting mutagens, the assays lacked the ability to detect most DNA reactive substances below the threshold of 10 ppb, making them unsuitable to pick up potential genotoxicants present in FCM migrates. However, suitability for the detection of chromosomal damage or investigation of other modes of action makes them a complementary tool as part of a standard test battery aimed at giving additional information to ensure safety. Conclusion: improvements are necessary to comply with regulatory thresholds to consider mammalian genotoxicity in vitro assays to assess FCM safety.
Highlights
Food contact materials (FCMs) are complex mixtures made up of a wide variety of substances with different chemical and toxicological properties
The application of biological assays to detect substances with genotoxic potential would enable the application of the threshold of toxicological concern (TTC) for FCM migrates to exclude cohorts of concern
When looking at DNA reactive substances, the bacterial mutation test demonstrated to be superior compared to its mammalian counterpart, the mouse lymphoma assay (MLA)
Summary
Food contact materials (FCMs) are complex mixtures made up of a wide variety of substances with different chemical and toxicological properties. Manufacturing of FCM involves the use of intentionally added substances (IAS) with functional and technical reasons in the manufacturing process or the final product Some of these substances are regulated and their toxicological properties have been assessed. Unknown substances such as breakdown products, degradation products, reaction by-products and side reaction products of IAS, or other contaminants are present, generating the so-called non-intentionally added substances (NIAS) [1]. These are present at low quantities and can be found in great numbers. Conclusion: improvements are necessary to comply with regulatory thresholds to consider mammalian genotoxicity in vitro assays to assess FCM safety
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