Dodecenylsuccinic acid, compound with 2,2',2''-nitrilotriethanol (1:1)

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Remarks:

Assessment

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Justification for type of information:

Review of toxicological and chemical data, including products of dissociation

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Objective of study:

absorption

distribution

excretion

metabolism

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Review of toxicological and chemical data, including products of dissociation

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dodecenylsuccinic acid, compound with 2,2',2''-nitrilotriethanol (1:1)

EC Number:

264-867-9

EC Name:

Dodecenylsuccinic acid, compound with 2,2',2''-nitrilotriethanol (1:1)

Cas Number:

64396-12-9

Molecular formula:

C16H28O4.C6H15NO3

IUPAC Name:

Succinic acid, dodecenyl-, triethanolamine salt (1:1)

Test material form:

liquid

Details on test material:

Commercial grade containing approximately 45% actives

Radiolabelling:

no

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

In view of the absence of apparent toxic effects, there is no direct evidence that the dissociation products will absorb if ingested.

In an in-vivo study, triethanolamine was rapidly absorbed in the gastrointestinal tract and
excreted mostly unchanged in urine.
Work on the smaller and more polar of the starting materials (triethanolamine) has demonstrated very low rates of absorption through skin and both succinic acid and triethanolamine products are widely accepted for use in cosmetics.

Details on distribution in tissues:

If absorbed, it is likely that there is distribution, although no target organ was identified.

Transfer into organs

Test no.:

#1

Observation:

not determined

Details on excretion:

In view of the potential to metabolise, perhaps leading to mineralisation (water, urea and carbon dioxide).

In an in-vivo study, triethanolamine was rapidly absorbed in the gastrointestinal tract and
excreted mostly unchanged in urine.

Metabolite characterisation studies

Metabolites identified:

no

Details on metabolites:

Succinic acid and ethanolamine derivatives are rapidly metabolised or excreted. These types of chemical substances occur in nature and are themselves products of metabolic processes and will in turn metabolise further.

The potential to metabolise is confirmed by the high levels of biodegradation.

None of the starting materials or potential metabolites are considered to have any accumulation potential.

Applicant's summary and conclusion

Conclusions:

The substance will dissociate and the alkly succinate and triethanolamine derivatives wil rapidly metabolise or be extreted.
The substance is not considered accumualtive.