Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Although only sparce details on methods, conclusions have been made that there is no apparent potential for skin sensitisation.
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Non-maximised repeat application
Principles of method if other than guideline:
Guinea pigs treated at concentrations of 5% to 100% solutions once a week for 3 weeks.
Repeated challenges at 25% to 100% at 1 - 3 weeks.
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
Historical data, but accepted as valid for US NTP.
Test material information:
Composition 1
Specific details on test material used for the study:
Purity and source not specified
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not specified
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
5% - 100%
Day(s)/duration:
21
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
Up to 100%
Day(s)/duration:
21
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Not specified
Positive control substance(s):
not specified
Key result
Reading:
other: Not specified
Group:
test group
Dose level:
100%
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Although methods and details of results not specified, the information is considered acceptable for the US NTP.
Note that triethanolamine is widely used in cosmestics and is not listed as a potential allergen.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The substance is based on the natural amino acid Taurine (that is approaved for use as a direct food additive), but with tertiary amine (diethanolamine).

There is no evidence that Taurine or the tertiary ethanolamine (eg triethanolamine) has any senstising potential and new testing is not considered necessary.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification