Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

basic toxicokinetics
Type of information:
calculation (if not (Q)SAR)
Migrated phrase: estimated by calculation
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assessment based on public literature

Data source

Reference Type:
other company data
Report date:

Materials and methods

Test guideline
no guideline followed
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts
EC Number:
EC Name:
β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts
Cas Number:
β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts

Results and discussion

Metabolite characterisation studies

Metabolites identified:

Any other information on results incl. tables

The decarboxylation and dealkylation processes utilising enzymes and co-factors found in eukaryotic cells point to a common metabolic process for all alkoxylated amine fatty acid derivatives, leading to ultimate formation of carbon dioxide and urea, with excretion of the carbon dioxide by respiration and through urea (in vertebrates).


This process is demonstrated to be rapid, but with fatty derivatives, the slower dealkylation processes may result in formation of tertiary or secondary amines. The final steps will be the volatile and corrosive trimethylamine or dimethylamine, but as these are metabolites of protein metabolism, living cells have mechanisms to either directly excrete the amines or more commonly convert to urea.


There is no justification to perform further vertebrate tests on the substance when there is adequate information on the class of substance and associated metabolites and when considering that these substance types are found in foods.

Applicant's summary and conclusion

Interpretation of results (migrated information): no bioaccumulation potential based on study results
The absence of raw data from testing performed to meet base-set requirements means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism or excretion. However, there is sufficient evidence that some oral absorption takes place and there is likely to be adaptive changes to the animals following transportation and possible metabolism.
Executive summary:


There was evidence of effects in organs (kidney) following repeated oral exposure, suggesting absorption by this route. There was no evidence of absorption through the skin, although surface active substances will typically undergo some skin absorption. This class of substance is used widely in cosmetics and there no evidence was found relating to adverse effects from dermal exposure


Work on cosmetic ingredients suggests no more than 20% absorption from dermal exposure to humans.



System effects were observed in the 28 day oral toxicity study with kidney effects. It is therefore possible to conclude that the substance, or the metabolites, are transported. With the high water solubility, the substance is considered to have a relatively low risk of accumulation in fat or in other tissues.



Despite relative stability in water, the high level of biodegradation during testing suggests that metabolism is likely. In the mutagenicity studies, there was marginally higher toxicity in the absence of S-9, but this is not a conclusive indicator that metabolic activity is taking place. 


There is no other evidence of metabolism mechanisms.



Kidney effects were noted in the 28 day oral toxicity study and although this may be a direct effect of the parent substance, it is possible that this is part of an adaptive change resulting from excretion of the substance or its metabolites.