Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
Concerning: Expiry date of Freund’s complete adjuvant (FCA) According to the Study Plan: 30 April 2009 Deviation: 30 April 2008 Reason for the Deviation: miswritten Presumed Effect on the Study: None
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymphnode assay (LLNA)
Justification for non-LLNA method:
The LLNA method does not need to be conducted since there is a in vivo skin sensitization study available according to previous legislation.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
50 microl

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
ca. 0.72
Test group / Remarks:
10%
Key result
Parameter:
SI
Value:
ca. 0.71
Test group / Remarks:
25%
Key result
Parameter:
SI
Value:
ca. 0.65
Test group / Remarks:
50%

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
the test item was classified as a non-sensitiser.