Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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)
Species:
mouse
Strain:
CBA/Ca
Sex:
not specified
Vehicle:
other: acetone
Concentration:
0, 5, 10, 25%(v/v)
No. of animals per dose:
4
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
Interpretation of results:
GHS criteria not met
Conclusions:
The test item was considered to be a non-sensitizer under the conditions of the test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification