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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Assessment of toxicokinetic behaviour
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meets basic scientific principles

Data source

Reference
Reference Type:
other:
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Objective of study:
toxicokinetics
Principles of method if other than guideline:
The toxicokinetic behaviour of diisodecyl azelate (DIA) was assessed. The OECD QSAR Application Toolbox was used to make a qualitative prediction of oral absorption and of the metabolites formed in liver, skin and gastrointestinal tract. The Danish QSAR Database was used to predict dermal and oral bioavailability of DIA. The fate of these metabolites is predicted on the basis of their chemical structure based on expert judgement.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): diisodecyl azelate
- Analytical purity: no data

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
DIA is predicted to be bioavailable via the oral route but is very poorly absorbed via skin.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
DIA is expected to undergo stepwise hydrolysis of the ester bonds yielding azelaic acid and isodecanol. Both azelaic acid and isodecanol feed into the physiological process of fatty acid oxidation and subsequent metabolic pathways, finally leading to expiration as CO2. A metabolic pathway for DIA was proposed.
Tissue accumulation can be excluded.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results