β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Assessment based on public literature

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2020

Report date:

2012

Materials and methods

Test guideline

Qualifier:

no guideline followed

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts

EC Number:

290-476-8

EC Name:

β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts

Cas Number:

90170-43-7

IUPAC Name:

β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts

Radiolabelling:

no

Results and discussion

Metabolite characterisation studies

Metabolites identified:

no

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

Conclusions:

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:

Absorption

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.

 

Distribution

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.

 

Metabolism

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.

 

Excretion

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.