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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Vehicle:
acetone/olive oil (4:1 v/v)
No. of animals per dose:
5
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
Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Justification for classification or non-classification