Registration Dossier
Registration Dossier
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EC number: 264-867-9 | CAS number: 64396-12-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Single dose exposure
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Review document by Cosmetics Ingredient Review
Primary data sources not found, but conclusion as non-hazardous considered valid
Performing new animal testing is not justified
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 401 (Acute Oral Toxicity)
- Version / remarks:
- Different studies cited, including rats and guinea pigs
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- 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
- Specific details on test material used for the study:
- Not specified.
Test animals
- Species:
- rat
- Details on test animals or test system and environmental conditions:
- Work on other specied also cited
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- A key rat study was performed on undiluted material
Other tests used vehicles, such as guar gum - Doses:
- Up to 11.26 g/kg
- Control animals:
- not specified
- Details on study design:
- Very limited detail of methods in the review document.
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 4 190 - < 11 260 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The fact that the results are expressed as LD50 implied mortality was seen at the exceptionally high doses used for these studies
- Clinical signs:
- other: other: Not reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Although only limited details are provided in the expert review for cosmetic use, the key dissociation product and starting material, triethanolamine, is considered to be of low toxicity and is not classified as harmful.
When also considering the low toxicity of the succinic acid and succinates, no further animal testing on the salt can be justified.
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