Transepithelial permeability assessment using an in vitro cell model of the human airway epithelium

Topic: Respiratory permeability/penetration, toxicokinetics, Toxicokinetics

Test Method Number:
TM2014-03 (EU)
Short Name of TM:
MucilAir
Year received:
2014
Responsible Organisation:
General Comments:
Considered to be followed up in the wider context of ADME methods

Method Description

MucilAir is an in vitro 3D reconstructed human tissue that includes a bronchial and a nasal epithelial model, which phenotypically and functionally are representative of in vivo human bronchial and nasal epithelium (ciliated cells, basal cells, goblet cells, presence of cilia and cilia-beating, and functional muco-ciliary clearance). It is cultured at an air -liquid interface and it is designed to measure how fast a specific part of the human upper airways absorbs the test substance.

This method provides Papp (apparent permeability) values for the upper airways. Therefore, it appears to be relevant from the perspective of assessing systemic or internal exposure to a test substance via the respiratory route. The test method has potential for deriving relevant absorption parameters for the respiratory tract important for human toxicokinetic evaluation of test substances. However, the exact method to be used for this purpose and the data analysis model is...

MucilAir is an in vitro 3D reconstructed human tissue that includes a bronchial and a nasal epithelial model, which phenotypically and functionally are representative of in vivo human bronchial and nasal epithelium (ciliated cells, basal cells, goblet cells, presence of cilia and cilia-beating, and functional muco-ciliary clearance). It is cultured at an air -liquid interface and it is designed to measure how fast a specific part of the human upper airways absorbs the test substance.

This method provides Papp (apparent permeability) values for the upper airways. Therefore, it appears to be relevant from the perspective of assessing systemic or internal exposure to a test substance via the respiratory route. The test method has potential for deriving relevant absorption parameters for the respiratory tract important for human toxicokinetic evaluation of test substances. However, the exact method to be used for this purpose and the data analysis model is not clearly indicated.

Track Approval Status

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    Submission
  •  
    Validation
  •  
    Peer-review
  •  
    Recommendation
  •  
    Regulatory acceptance/Standards
Step
Submission Show status
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards