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:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Test material form:
liquid

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
not specified

Study design: in vivo (LLNA)

Vehicle:
other: acetone
Concentration:
0, 5, 10, 25%(v/v)
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
1.14
Test group / Remarks:
5%(v/v)
Remarks on result:
other:
Remarks:
negative
Key result
Parameter:
SI
Value:
1.43
Test group / Remarks:
10%(v/v)
Remarks on result:
other:
Remarks:
negative
Key result
Parameter:
SI
Value:
1.93
Test group / Remarks:
25%(v/v)
Remarks on result:
other:
Remarks:
negative

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was considered to be a non-sensitizer under the conditions of the test.