Registration Dossier
Registration Dossier
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EC number: 234-679-1 | CAS number: 12023-27-7
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
- Objective of study:
- other: solubility in gastric and intestinal juices
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
Test material
- Reference substance name:
- Diiron titanium pentaoxide
- EC Number:
- 234-679-1
- EC Name:
- Diiron titanium pentaoxide
- Cas Number:
- 12023-27-7
- Molecular formula:
- Fe2O5Ti
- IUPAC Name:
- titanium(4+) diiron(3+) pentaoxidandiide
- Test material form:
- solid: particulate/powder
Constituent 1
- Radiolabelling:
- no
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- From this in vitro assay on the solubility of iron from pearlescent pigments in artificial gastric and intestinal juices, the bioavailability is expected to be very low after oral ingestion.
- Executive summary:
The test item was incubated with artificial gastric or intestinal juice at 37°C for 2 and 10 hours, respectively. Subsequently the filtrates of these incubations were analyzed for iron using flame atom absorption spectroscopy (F-AAS). The content of soluble iron after incubation with artificial intestinal juice was below the limit of quantification of < 1.5 ppm. After incubation with artificial gastric juice a maximum content of soluble iron of 0.013 % was determined. Based on this study, the bioavailability of iron and, thus, of the test item from the pigments after oral ingestion is considered to be extremely low.
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