Registration Dossier
Registration Dossier
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EC number: 937-130-0 | CAS number: -
Basic toxicokinetics
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:
- 2 011
- Report date:
- 2011
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- according to guideline
- 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
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