Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP. Guideline study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. certificate)
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 (non-LLNA)

Induction
Vehicle:
DMSO
Challenge
Vehicle:
DMSO
No. of animals per dose:
4 females for the preliminary test and 28 females for the main test

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide

Results and discussion

Any other information on results incl. tables

No clinical signs and no mortality were observed during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
Under the experimental conditions, Veralactame does not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay