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Current Nanomaterials Toxicity Testing Needs and Use of New Approach Methodologies Among Selected U.S. Federal Agencies



Elijah Petersen, Patricia Ceger, Jayme Coyle, David Allen, Raymond Derk, Natalia Garcia-Reyero, John Gordon, Nicole Kleinstreuer, Joanna Matheson, Danielle McShan, Bryant C. Nelson, Anil Patri, Liying Rojanasakul, Abhilash Sasidharan, Louis Scarano, Xiaoqing Chan


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, new approach methodologies (NAMs) such as in vitro or in chemico test methods may be needed given their capacity for higher throughput testing, lower cost, and ability to provide information about toxicological mechanisms. However, the different behaviors of ENMs compared to dissolved chemicals may challenge safety testing of ENMs using NAMs. In this study, member agencies within the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) were queried about what types of ENMs are of agency interest and whether there was agency-specific guidance for ENMs toxicity testing. 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 and recommendations are provided.
Altex-Alternativen Zu Tier Experimenten


Petersen, E. , Ceger, P. , Coyle, J. , Allen, D. , Derk, R. , Garcia-Reyero, N. , Gordon, J. , Kleinstreuer, N. , Matheson, J. , McShan, D. , Nelson, B. , Patri, A. , Rojanasakul, L. , Sasidharan, A. , Scarano, L. and Chan, X. (2022), Current Nanomaterials Toxicity Testing Needs and Use of New Approach Methodologies Among Selected U.S. Federal Agencies, Altex-Alternativen Zu Tier Experimenten (Accessed May 21, 2024)


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Created April 11, 2022, Updated October 19, 2022