Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch Number LDP200015
Purity 99.1%

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
other: ethanol:water, 7:3 (v/v)
Concentration:
0.1%, 1%, 10%, (w/v) in ethanol:water 7:3 (v/v) and 100% Undiluted
No. of animals per dose:
4 females per group
4 groups of animal
Topical application to the dorsal suface of each ear lobe (left and right)

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: Group 2 (0.1%) - SI=0.5 Group 3 (1%) - SI=1.1 Group 4 (10%) - SI = 2.8 Group 5 (100% undiluted) - SI =5.5%

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An EC3 value of 16.7% (w/v) was derived.