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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2 (reliable with restrictions)
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25 microliter 0% (vehicle control), 1%, 10%, 25%, 50%
No. of animals per dose:
5
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Parameter:
EC3
Value:
50
Remarks on result:
other: see any other information on results including tables
Parameter:
SI
Value:
0.7
Test group / Remarks:
5
Remarks on result:
other: concentration 1%
Parameter:
SI
Value:
0.6
Test group / Remarks:
5
Remarks on result:
other: concentration 10%
Parameter:
SI
Value:
1.1
Test group / Remarks:
5
Remarks on result:
other: concentration 25%
Parameter:
SI
Value:
3
Test group / Remarks:
5
Remarks on result:
other: concentration 50%

The individual findings are summarized in the following table:

Test Item Concentration S.I.

1% (w/v) 0.7

10% (w/v) 0.6

25% (w/v) 1.1

50% (w/v) 3.0

The EC 3 value was determined to be 50%.

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance was found to be a sensitizer in an LLNA test (OECD 429) when tested at 50% (w/v) in acetone:olive oil (4:1) in mice. The EC 3 value was determined to be 50%. The substance must be classified for skin sensitisation category 1 with H317 (may cause an allergic skin reaction).