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:
2015
Report Date:
2015
Reference Type:
other: prediction by the OECD QSAR Toolbox
Title:
Unnamed
Year:
2015
Report Date:
2015

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., 2014
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

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
BDEA is expected to be well absorbed orally, based on the systemic effects in the acute oral toxicity study in rats, its molecular weight of 161.24 g/mol, water solubility of > 10,000 mg/L and LogPow of 0.58.
Type:
absorption
Results:
Absorption by inhalation is negligible due to the low vapour pressure (1.2 Pa).
Type:
absorption
Results:
Absorption through the skin is expected to be low due to very high water solubility (> 10,000 mg/L).
Type:
distribution
Results:
Butyldiethanolamine is expected to distribute into the inner of cells and into the intravascular compartment. The substance does not indicate a significant potential for accumulation.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Predicted metablites:
- hydroxyl derivatives 4-[bis(2-hydroxyethyl)amino]butan-2-ol);
- diethanolamine;
- butylethanolamine (BEA);
- ethanolamine;
- butylamine;
- product of N-oxidation (2-[butyl(2-hydroxyethyl)nitroryl]ethanol);
- butanal;
- hydroxyacetaldehyde;
- butanoic acid;
- hydroxyacetic acid;
- oxoacetic acid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
Butyldiethanolamine is not expected to bioaccumulate.
Executive summary:

Butyldiethanolamine is expected to be well absorbed orally, based on the systemic effects in the acute oral toxicity study in rats, its low molecular weight (161.24 g/mol), high water solubility (> 10,000 mg/L) and LogPow of 0.58. Concerning the absorption after exposure via inhalation, as the chemical has vapour pressure of 1.2 Pa (a value not indicative for absorption by inhalation), it is clear, that the substance is marginally available for inhalation. Given its lipophilicity (LogPow 0.58) - if absorbed - it is expected to be absorbed directly across the respiratory tract epithelium or through aqueous pores and/or be metabolized by the alveolar and bronchial tissue. Butyldiethanolamine is not expected to be absorbed following dermal exposure into the stratum corneum and into the epidermis, due to its high hydrophilicity. Moreover, the absence of irritating properties of Butyldiethanolamine cannot enhance absorption through the skin. Butyldiethanolamine is expected to distribute into the inner of cells and into the intravascular compartment. The substance does not indicate a significant potential for accumulation. Butyldiethanolamine is expected to be metabolised via Phase I reactions leading to hydroxylated derivatives and/or derivatives of oxidative deamination. Further, they can either be involved into intermediary metabolism for further oxidative reactions or be excreted. Butyldiethanolamine and its metabolites are expected to be eliminated mainly via the urine.