Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies)
Justification for type of information:
The substance dissociates under biological conditions when dilute forming alkyl succinic acid and triethanolamine
A toxicity assessment has been made on the dissociation products and these are not classified as hazardous.
Dermal penetration on triethanolamine suggests very low rate or dermal penetration (< 2%) and review of metabolic profile demonstrates rapid metabolic breakdown and elimination
No further animal testign can be justifed.
Cross-referenceopen allclose all
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Taken from international safety assessment report for cosmetic use of triethanolamine
Triethanolamine is one of the products of dissociation
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Principles of method if other than guideline:
Use of human skin in-vitro.
Triethanolamine emulsions used in the presence of stearic acid.
GLP compliance:
no
Radiolabelling:
no
Species:
other: Human
Sex:
not specified
Type of coverage:
other: Direct contact. In-vitro (ex-vivo)
Vehicle:
other: Emulsion of stearic acid in water
Duration of exposure:
Up to 72 hours
Doses:
Up to 5% in emulsion
Absorption in different matrices:
Absorption into skin of up to 20.9 % at pH8
Absorption into media (through skin) up to 1.2% at pH 8
(Note absorption into skin and through skin was reduced at pH 7)
Key result
Time point:
72 h
Dose:
5 % emulsion
Parameter:
percentage
Absorption:
ca. 20 %
Remarks on result:
other: pH8
Remarks:
Into skin
Key result
Time point:
72 h
Dose:
5% emulsion
Parameter:
percentage
Absorption:
ca. 1.2 %
Remarks on result:
other: pH8
Remarks:
Through skin
Conclusions:
Triethanolamine is present in the substance and is a product of dissociation.
This has been well evaluated for safety in cosmetics including dermal penetration testing.
Only a small fraction of the substance appears to penetrate the skin.
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reason / purpose:
data waiving: supporting information
Reference
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
Objective of study:
absorption
distribution
excretion
metabolism
Qualifier:
no guideline followed
Principles of method if other than guideline:
Review of toxicological and chemical data, including products of dissociation
GLP compliance:
no
Radiolabelling:
no
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.
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.
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.

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

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion