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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: reasonably well-documented investigation, raw data and relevant methodical details reported

Data source

Reference
Reference Type:
publication
Title:
Titan-Blutspiegel vor und nach Belastungsversuchen mit Titandioxid
Author:
Böckmann, J.et al.
Year:
2000
Bibliographic source:
Pharmazie 55: 140 - 143.

Materials and methods

Principles of method if other than guideline:
Human study in which titanium dioxide was given orally incorporated in gelatine capsules (2%) to human volunteers (n=5) with subsequent blood monitoring 0-24h p.a.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: human volunteers

Administration / exposure

Route of administration:
oral: capsule
Vehicle:
other: gelantine
Details on exposure:
Human study in which titanium dioxide was given orally incorporated in gelatine capsules (2%) to human volunteers (n=5) with subsequent blood monitoring 0-24h p.a..

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
increase of titanium blood levels peaked at 4-12h p.a. to levels of approx. 40 µg/L (compared to controls at 11 µg/L) suggest that uptake from the GI tract occurred
Type:
excretion
Results:
lack of e.g. urinary excretion do not allow the assignment of an oral absorption factor

Metabolite characterisation studies

Metabolites identified:
no
Details on metabolites:
Titanium dioxide as an inorganic substance is not metabolised.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
Whereas the observed increase of titanium blood levels which peaked at 4-12h p.a. to levels of approx. 40 µg/L (compared to controls at 11 µg/L) clearly suggest that uptake from the GI tract occurred, the variability and lack of other data (such as urinary excretion or a comparative group with i.v.-injection) do not allow the assignment of an oral absorption factor