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 butylethanolamine 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: expert statement according to the 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 butylethanolamine 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
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Butylethanolamine
Radiolabelling:
no

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
BEA is expected to be absorbed from GI tract by passive diffusion. A high systemic availability via dermal and inhalation routes is unlikely.
Type:
distribution
Results:
BEA is expected to be predominantly distributed into the intravascular compartment due to its MW of 117.2 g/mol and high water solubility. BEA can also enter the cell inner (LogPow of 0.64). No risk for accumulation is expected for BEA (LogPow is <3.0).
Type:
metabolism
Results:
Hydroxylation and oxidation reactions by Phase I enzymes; conjugation reactions.
Type:
excretion
Results:
BEA is expected to be excreted primarily via the urine due to its MW (117.2 g/mol), vapour pressure (13.94 Pa) and high water solubility (1000 g/L).

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Derivatives of hydroxilation and oxidation reactions.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: no bioaccumulation potential based on study results
No bioaccumulation potential for BEA.
Executive summary:

An assessment of the toxicokinetic behaviour of butylethanolamine was performed, taking into account the chemical structure, the available physico-chemical-data and the available toxicity data. BEA is expected to be absorbed from GI tract by passive diffusion. A high systemic availability via dermal and inhalation routes is unlikely. BEA is expected to be predominantly distributed into the intravascular compartment due to its MW of 117.2 g/mol and high water solubility (1000 g/L). BEA can also enter the cell inner (LogPow of 0.62). No risk for accumulation is expected for BEA (LogPow is < 3.0). Possible reactions: hydroxylation and oxidation by Phase I enzymes with subsequent conjugation reactions. BEA is expected to be excreted primarily via the urine due to it MW (117.2 g/mol), vapour pressure (13.94 Pa) and the high water solubility (1000 g/L).