Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: expert statement
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An extended assessment of the toxicokinetic behaviour of the UVCB substance was performed, taking into account the chemical structure, the available physico-chemical-data and the available toxicity data.

Data source

Referenceopen allclose all

Reference Type:
other: Expert Statement
Title:
Unnamed
Year:
2013
Report Date:
2013
Reference Type:
other: Prediction by the OECD QSAR Toolbox
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Objective of study:
absorption
distribution
excretion
metabolism
Test guideline
Qualifier:
according to
Guideline:
other: TGD, Part I, Annex IV, 2003); ECHA guidance R7c., 2008
Deviations:
no
Principles of method if other than guideline:
An assessment of toxicological behaviour of the UVCB target substance is based on its physico-chemical properties and on the results of available toxicity data data.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
Low absorption potential via all exposure routes is due to the large molecule size (MW of > 533.82 < 784.29 g/mol), high lipophilicity (LogPow of 8.0) and low water solubility (1.64 mg/L).
Type:
distribution
Results:
Entering the body, no wide distribution is expected due to the large molecule size.
Type:
metabolism
Results:
If absorbed, hydroxylation of C atoms of the carbon chains is the primary reaction expected (Phase I) with subsequent conjugation reactions (Phase II).
Type:
excretion
Results:
Conjugated metabolites are expected to be excreted via the urine or via the faeces.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Derivatives of hydroxilation, oxidation reactions and hydrolysis (only in GI tract).

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
Low bioaccumulation potential is predicted for the target UVCB substance based on the high lipophilicity (LogPow of 8.0).
Executive summary:

An assessment of toxicokinetic behaviour of the UVCB target substance was performed, taking into account the chemical structure, the available physico-chemical-data and the available toxicity data. The substance is not expected to be absorbed from GI tract by passive diffusion. A high systemic availability via dermal and inhalation routes is unlikely. If absorbed, it is expected to be predominantly distributed into fatty tissues due to its MW of > 533.82 < 784.29 and low water solubility (1.64 mg/L). The substance can enter the cell inner (LogPow of 8.0) only to alimited extent. Low risk for accumulation is expected for the UVCB target substance (LogPow is >4.0). Possible reactions: hydroxylation, oxidation and hydrolysis (only dialkyl phosphate ester) by Phase I enzymes with subsequent conjugation reactions. Conjugates are expected to be excreted via the urine or via the faeces. Parent compound is expected to be excreted via the faeces.