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ICCVAM Biennial Report 2020-2021

Biennial Progress Report 2020-2021 Interagency Coordinating Committee on the Validation of Alternative Methods
https://ntp.niehs.nih.gov/go/928340

U.S. Federal Agency Interests and Key Considerations for New Approach Methodologies for Nanomaterials

Engineered nanomaterials (ENMs) come in a wide array of shapes, sizes, surface coatings, and compositions, and often possess novel or enhanced properties compared to larger‑sized particles of the same elemental composition. To ensure the safe commercialization of products containing ENMs, it is important to thoroughly understand their potential risks. Given that ENMs can be created in an almost infinite number of variations, it is not feasible to conduct in vivo testing on each type of ENM. Instead, NAMs such as in vitro or in chemico test methods may be needed, given their capacity for high-throughput testing, lower cost, and ability to provide information on toxicological mechanisms. However, the different behaviors of ENMs compared to dissolved chemicals may challenge safety testing of these substances using NAMs. The ICCVAM Nanomaterials Workgroup queried ICCVAM member agencies about what types of ENMs are of agency interest and whether there is agency-specific guidance for ENMs toxicity testing (Petersen et al. 2021). To support the ability of NAMs to provide robust results in ENM testing, two key issues in the usage of NAMs, namely dosimetry and interference/bias controls, are thoroughly discussed.

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