In recent years, the drive towards more sustainable sustainable materials has led to the developments has led to the development of compounds obtained from renewable sources such as starches, agricultural by-products and biotechnological processes. These bio-based materials seek to replace petroleum-derived alternatives, especially in areas such as packaging, cosmetics and automotive. However, their complex composition presents new challenges in terms of toxicological evaluation.
Limitations of conventional chemical analysis for UVCB substances
Many of these compounds are considered UVCB substances, i.e. mixtures with unknown or variable composition. Due to the techniques used in their processing – such as fermentation, functionalization or extraction – by-products can arise that are difficult to characterize. This limits the effectiveness of conventional chemical analysis, making it difficult to identify potential health hazards.
Against this backdrop, in vitro in vitro bioassays bioassays emerge as an effective solution. These methods make it possible to detect effects such as cytotoxicity, mutagenicity or oxidative stress even when the exact composition of the material is uncertain. Moreover, by aligning with the 3R principles, they offer an ethical and reproducible route to traditional in vivo assays.
AIMPLASthe Technological Institute of Plastics, has integrated a set of OECD-validated bioassays to address this issue. These include the Ames test for mutagenicity, the micronucleus test and the comet test for DNA damage, as well as specific cellular evaluations. This battery of tests is tailored to the type of material and its final application, allowing an assessment proportional to the level of exposure.
Biobased materials and safe design from the lab
This approach is complemented by the concept of Safe and Sustainable Design (SSbD), which combines bioassays with non-targeted chemical analysis. Thus, it is possible to identify bioactive fractions and prioritize risks from the early stages of material development. This not only increases the safety of the final product, but also anticipates potential regulatory barriers.
In materials intended for food contact, AIMPLAS applies a strategy based on EFSA criteria. If a significant migration of compounds into food is detected, an evaluation protocol including specific bioassays is activated. This stepwise model allows the requirements to be adjusted according to the actual risk of exposure.
Source and photo: AIMPLAS
