Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2011
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 417 (Toxicokinetics)
Deviations:
no

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
oral
Type:
absorption
Results:
dermal
Type:
absorption
Results:
inhalation
Type:
distribution
Type:
metabolism
Type:
excretion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Oral : possibly a minor systemic absorption of toxicologically active components based on a few systemic effects in oral studies and the molecular weight
Dermal : at least some sensitizing components are able to cross outer skin layers. Components with high molecular weight are expected not to cross the skin
Inhalation : no data, but expected fugacity is very low so that this route of exposure is negligible
Details on distribution in tissues:
The few toxicological effects did not evidence relevant target organs. Very limited distribution expected for components with high molecular weight
Details on excretion:
Expected minor excretion, in feces, of absorbed unchanged substance. Unabsorbed fraction excreted in feces after ingestion

Metabolite characterisation studies

Metabolites identified:
not measured

Any other information on results incl. tables

Metabolism : Clear in vitro ability of liver enzymes to detoxify, decrease genotoxic activity and increase solubility in hydrophilic vehicles. Biological relevance of this observation is negligible for dermal or inhalative exposures (limited absorption and absence of first-pass effect) and low to moderate for oral exposure (limited absorption but first-pass effect)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
No indication of possible bioaccumulation of toxicologically relevant components. Risk of bioaccumulation limited for components with high molecular weight