Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
publication
Title:
Triethanolamine (TEA) and TEA-Containing Ingredients as Used in Cosmetics
Author:
Cosmetic Ingredient Review Expert Panel
Year:
2011
Bibliographic source:
CIR Panel Book Page 29
Report Date:
2011

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
no

Test animals

Species:
other: Human
Sex:
not specified

Administration / exposure

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

Results and discussion

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)
Percutaneous absorptionopen allclose all
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

Applicant's summary and conclusion

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.