Registration Dossier
Registration Dossier
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EC number: 264-867-9 | CAS number: 64396-12-9
Dermal absorption
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:
- 2 011
- Bibliographic source:
- CIR Panel Book Page 29
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- 2,2',2''-nitrilotriethanol
- EC Number:
- 203-049-8
- EC Name:
- 2,2',2''-nitrilotriethanol
- Cas Number:
- 102-71-6
- Molecular formula:
- C6H15NO3
- IUPAC Name:
- 2,2',2''-nitrilotriethanol
Constituent 1
- 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.
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