Registration Dossier

Toxicological information

Skin sensitisation

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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:
2014
Report Date:
2014

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
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

In vivo test system

Test animals

Species:
mouse
Strain:
CBA

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
No. of animals per dose:
5

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
Each of the three tested concentrations of the test item exceeded the stimulation index of3. The stimulation index at a concentration of 6.25% was 3.3 The stimulation index at a concentration of 12.5% was 3.8 The stimulation index at a concentration of 25% was 3.6 The mean ear thickness on day 1 day 3 day 6 for the 6.25% test group was 0.18 mm 0.18 mm 0.18 mm for the 12.5% test group was 0.18 mm 0.19 mm 0.19 mm for the 25% test group was 0.18 mm 0.18 mm 0.19 mm for the negative control group was 0.18 mm 0.18 mm 0.18 mm

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU