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Germany Publishes Comparison of Inhalation and Intratracheal Instillation as Testing Methods for Characterization of Granular Biopersistent Particles

Germany’s Federal Institute for Occupational Safety and Health (BAuA) has published a report entitled Comparison of Inhalation and Intratracheal Instillation as Testing Methods for Characterisation of Granular Biopersistent Particles (GBP).  In Project F 2364, researchers conducted an in vivo validation study to evaluate the consistency of data with results obtained in the preceding intratracheal instillation study in Project F 2336.  The abstract states that the same test items were used, and similar lung loads were achieved by calculating the target values after inhalation with the Multi-Path Particle Dosimetry (MPPD) model.  This approach served as proof of whether the instillation can be a reliable surrogate instead of the physiological inhalation route while assessing the GBP status of dust samples.  According to the conclusion in the abstract, considering the percentual polymorphonuclear neutrophil (PMN), as well as the absolute PMN concentrations, “the predominant observation is that inhalation induced a smaller PMN influx (with exception of biosoluble μ-BaSO4 and nano-SiO2) at similar doses.  This can be expected because of the physiological dust uptake and deposition by inhalation that is more gentle than intratracheal instillation (bolus effect!).”  The conclusion notes that effects detected after instillation will not always allow a “non inert” statement.  The final setting of maximum tolerable clearance t1/2 and PMN levels to define the GBP category should include inhalation.  The conclusion states that “[d]oses at instillation testing of nanoparticles should not exceed volumetric values of 0.3 μl (using the correct agglomerate density).”

©2018 Bergeson & Campbell, P.C.

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

Owner of Bergeson & Campbell, P.C. (B&C®), 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...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
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 initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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