In vitro model for the prediction of respiratory sensitization of inhalable substances

Topic: Sensitisation

Test Method Number:

TM2019-01 (EU)

Short Name of TM:

ALIsens

Year received:

2019

Responsible Organisation:

EURL ECVAM - European Union

General Comments:

Method Description

The test method is an in vitro assay intended for the prediction of respiratory sensitisation potential of airborne chemicals (including particulate matter and nano-materials).
The method consists of a 3D in vitro system based on human cells cultured at the air-liquid interface (ALI). This system mimics the alveolar-capillary barrier and allows to assess substances with both low and high molecular weight (e.g. pollen or house dust mites).

Track Approval Status

Submission
Validation
Peer-review
Recommendation
Regulatory acceptance/Standards

Submission

Show status

Date	Stage	Comment
Aug 2019	Receipt of presubmission	Test Presubmission Form (TPF) received by EURL ECVAM.
Mar 2020	Assessment of presubmission	Submitter notified of the preliminary presubmission evaluation and informed that a consultation with EURL ECVAM advisory PARERE (Preliminary Assessment of Regulatory Relevance) will follow.
Apr 2020	Assessment of presubmission	Consultation with EURL ECVAM advisory body PARERE.
Nov 2020	Assessment of presubmission	Submitter notified of the presubmission outcome following PARERE consultation and invited to submit a revised presubmission.

Validation

Peer-review

Recommendation

Regulatory acceptance/Standards