Registration Dossier

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
review article or handbook
Title:
Betaine in human nutrition
Author:
Stuart AS Graig
Year:
2004
Bibliographic source:
American Journal of Clinical Nutrition 80:539-49

Materials and methods

Objective of study:
metabolism
Principles of method if other than guideline:
Review article of a well-established metabolism route for betaine, oxidation product of choline within the human body.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
human
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified

Results and discussion

Main ADME results
Type:
metabolism
Results:
Completely metabolized by liver and kidney cells by methylation to dimethylglycine and ultimately to serine.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Dimethylglycine

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
Betaine is completely metabolized by liver and kidney cells, a very small amount is passed in urine.

This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Executive summary:

Completely metabolized by liver and kidney cells by methylation to dimethylglycine and ultimately to serine; a very small amount is passed in urine.