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Volume XII, Number 183

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June 30, 2022

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ISO Publishes Standard on Characterization of CNT and CNF Aerosols for Inhalation Toxicity Tests

The International Organization for Standardization (ISO) recently published ISO/TR 23463:2022, “Nanotechnologies — Characterization of carbon nanotube and carbon nanofibre aerosols to be used in inhalation toxicity tests.” The standard reviews characterization of carbon nanotube (CNT) and carbon nanofiber (CNF) aerosols for inhalation exposure studies. According to the standard, the framework for material characterization for inhalation studies consists of:

  • Characterization of as-produced (pristine) or supplied material;

  • Characterization of administered material;

  • Characterization of material following administration; and

  • Human exposure characterization.

The standard focuses on the first two characterization needs, which include physicochemical properties (e.g., size, size distribution, aggregation/agglomeration, and shape) and measurement of concentration (e.g., mass, number, surface area, and volume). The standard states that these parameters can be measured by direct (on-line) or indirect (off-line) methods and each technique needs specific sampling procedures. The standard notes that the limited technologies in the generation and characterization of nanofibers make it difficult to perform inhalation toxicity studies, however, “although the inhalation exposure to CNT and CNF is highly likely in the workplace, and research facilities, where they are in use.” The standard provides the current status of CNT and CNF aerosol characterization used in the inhalation toxicity tests, as well as the physicochemical properties of CNTs and CNFs and their relationship with toxicity end points. ISO notes that the standard neither provides guidance on aerosol characterization for other carbon nanomaterials, nor provides guidance for characterization of CNT and CNF aerosols in the workplace or ambient air.

©2022 Bergeson & Campbell, P.C.National Law Review, Volume XII, Number 146
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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

202-557-3801
Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...

202-557-3809
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