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Bioaccessibility testing (Bioelution) of metals, inorganic metals compounds and metals-containing materials: simulated gastric fluid

Topic : Bioaccessibility

Test Method Number: TM2016-02 (EU)
Short Name of TM: Bioelution
Year received: 2016
Responsible Organisation: EURL ECVAM - European Union
Stage of Submission: Assessment of Pre-submission
General Comments:

Test submitter invited to send full submission

Method Description

The bioelution test measures the fraction of a substance that dissolves under surrogate physiological conditions (i.e. simulated gastric fluid) and is potentially available for absorption into systemic circulation (bioaccessible concentration). This test method is not a toxicity test.

The test submitter proposed to use the method in a compartive manner (target and reference material) to generate relative bioaccessible metal ion data for the oral route of exposure, which they consider relevant to systemic effects of metal-containing materials. The relative results obtained could be used to make predictions of how the test material will behave compared to the reference material, based on relative metal ion release. This assumes that the dissolved metal ion is the cause of toxicity.

The test method was then proposed to support read across and grouping under REACH for systemic endpoints and to assign CLP classifications. In the context of hazard...

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Track Approval Status

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    Regulatory acceptance/Standards
In progressSubmissionShow status
 Regulatory acceptance/Standards