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Toxicological information

Skin sensitisation

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Administrative data

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.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
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

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Purity and source not specified

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
5% - 100%
Day(s)/duration:
21
Adequacy of induction:
highest technically applicable concentration used
Challenge
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

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
other: Not specified
Group:
test group
Dose level:
100%
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

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.