Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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.