Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011-09-23 to 2012-09-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Objective of study:
bioaccessibility (or bioavailability)
Principles of method if other than guideline:
The objective of this study was to assess the dissolution of silicic acid, zirconium salt, cadmium pigment-encapsulated (IPC-2013-001) in different artificial physiological media. The test media were selected to simulate relevant human-chemical interactions (as far as practical), i.e. contact of a test substance with skin, a substance entering the human body by inhalation or by ingestion into the gastro-intestinal tract. The dissolved amount of the test item was specified by the mass concentration of the substance in the test media under the applied test conditions. The total dissolved amount was determined by measuring the total concentrations of Cd, Se and Zr in solution. The test was performed on the basis of OECD Series on Testing and Assessment No. 29 (2001; ENV/JM/ MONO(2001)9): “Guidance Document on Transformation / Dissolution of Metals and Metal Compounds in Aqueous Media” as well as according to the bioaccessibility test protocol provided by the monitor.
The bioaccessibility protocol has been developed on the basis of relevant published methods.
For the experimental setup the test item was weighed into flasks, put to volume with the respective artificial physiological medium (loading of approx. 100 mg/L) and agitated at 100 rpm at 37°C ± 2 °C. Samples were taken after 2h and 24h. The total dissolved cadmium, selenium and zirconium concentrations were determined after filtration (0.2 µm, Supor membrane) by ICP-MS.
GLP compliance:
yes (incl. QA statement)
Remarks:
2011-02-07

Test material