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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
basic toxicokinetics in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
In the assessment of betaine hydrochloride (C5H12NO2.Cl, CAS 590-46-5), a read-across approach is followed based on the information available for betaine (C5H11NO2, CAS 107-43-7). This read-across strategy is based on the hypothesis that the betaine moiety is the driver for the ecotoxicological and toxicological effects of both substances.
The read-across hypothesis is justified by the immediate dissociation of betaine hydrochloride to betaine and hydrogen and chloride ions upon dissolution in aqueous media. Both betaine and betaine hydrochloride are highly soluble (>400 g/L). Exposure to the non-common cations (H+ and Cl-) does not influence the prediction of the (eco)-toxicity at relevant concentrations because both elements are abundantly present in natural environments and the human body and emissions from this substance do not significantly increase their overall exposure concentration.

Further information is included as attachment in section 13 of IUCLID.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Objective of study:
metabolism
Type:
metabolism
Results:
Completely metabolized by liver and kidney cells by methylation to dimethylglycine and ultimately to serine.
Metabolites identified:
yes
Details on metabolites:
Dimethylglycine
Conclusions:
Betaine is completely metabolized by liver and kidney cells, a very small amount is passed in urine.
According to a read-across approach based on the rapid dissociation of betaine hydrochloride to betaine and hydrogen and chloride ions upon dissolution in aqueous media, it is concluded that the results for betaine are also applicable to betaine hydrochloride. After passage through the stomache, betaine hydrochloride will be completely dissociated and betaine will be further completely metabolized by liver and kidney cells.
There is no bioaccumulation potential based on these study results.

Description of key information

No bioaccumulation potential

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Based on several pharmacokinetic and metabolism studies on betaine and the fact that betaine hydrochloride is complete dissociated into betaine, protons and chloride ions after passage through the stomach, it can be concluded that betaine hydrochloride is mainly metabolized by liver hepatocytes and kidney cortex cells, and only a fraction is secreted in urea. Betaine has not shown any adverse effects on human health or any effects that might raise concern regarding the safety of this substance. The longer half-lifes and lower elimination times with lower doses reflect the balance between the body's own betaine synthesis, exogenous betaine and elimination. Betaine, as well as its main metabolite dimethylglycine, are homeostatically controlled by the body.