Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 14th to October 18th 2011
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Certificate on April 7th 2011
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
50%
No. of animals per dose:
Preliminary test : 2 females per dose
Main test : 4 females per dose

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Group 3 (vehicle) : / Group 4 (test item 5%) : 2.22 Group 5 (test item 10%) : 2.71 Group 6 (test item 25%) : 2.43 Group 7 (test item 50%) : 2.61 Group 8 (test item 100%) : 3.92 Group 9 (HCA 25%) : 7.61
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Group 3 (vehicle) : 1042 Group 4 (test item 5%) : 2313 Group 5 (test item 10%) : 2826 Group 6 (test item 25%) : 2533 Group 7 (test item 50%) : 2715 Group 8 (test item 100%) : 4080 Group 9 (HCA 25%) : 7931

Applicant's summary and conclusion

Interpretation of results:
ambiguous
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions of the study, the test item, Epoxy Resin T1600, induced delayed contact hypersensitivity in the murine Local Lymph Node Assay.
According to the EC3 value obtained, the test item should be considered as a weak sensitizer.