Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Concentration / amount:
0.25%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Concentration / amount:
0.25%
No. of animals per dose:
10 + 5 control

Results and discussion

Any other information on results incl. tables

Information provided in full study report

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Executive summary:

In order to assess the allergenic potential of Tetrahydrocurcuminoids, the Maximization Test was performed in 10 treated (male) and 5 control (male) Albino guinea Pigs, in accordance with OECD Guideline No. 406.

The intradermal induction of sesitization in the test group was performed in thedorsal skin from the scapular regation witn a 0.25% dilution of the test item in popylen glycol and in an emulsion of Freund's Complete Adjuvant (FCA)/Physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 100% one week after the intradermal induction. The animals of the controle group were intradermally induced with propylene glycol and FCA/physiological saline and epidermally induced with 80% ethanol under occlusion.

Two weeks after epidermal nduction the test and the control animals were challenged by epidermal application of the test item at 50% in acetone alone under occlusion. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.