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Table 4 Overview of the data availability for the MWCNT panel from the data set extracted from the NRCWE studies for each IATA decision node and Tier of the tiered testing strategy

From: Grouping MWCNTs based on their similar potential to cause pulmonary hazard after inhalation: a case-study

 

Can HARN deposit in the distal lung?

Does the HARN dissolve very slowly in lung lining and/or lysosomal fluid?

Is HARN length > 5 µm?

Is the HARN rigid and maintain a fibrous, needle-like morphology?

Does the HARN cause frustrated phagocytosis?

Tier 1

Estimated Dae based on mean diameter and assumed density of not appropriate for heterogenous HARN

No data from in vitro dissolution studies. MWCNT predicted to be durability based on graphene structure

Size distribution profiles not available. Mean length reported

Diameter of primary particle reported plus supporting SEM images where available

Frustrated phagocytosis not specifically addressed

Tier 2

Measured MMAD not reported

No data from intracellular dissolution studies

Size distribution of aerosolized MWCNT not reported

Size distribution of aerosolized MWCNT not reported

No data from 3D granuloma model

Tier 3

Deposition after inhalation exposure not reported

Qualitative evidence of biopersistence in lung was available

 

Qualitative evidence of fibre rigidity for NM-401 and NRCWE006 in BAL macrophages and lung and liver tissue was available

Qualitative evidence of frustrated phagocytosis of NM-401 and NRCWE006 in BAL macrophages was available

  1. Please note that this is not a summary of all data for all HARN publications available to date, only those relevant to this case study