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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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, other
Remarks:
In vivo study conducted in 2012 before the mandatory requirement for in vitro skin sensitisation test data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
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 (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
100, 50 and 25% v/v
No. of animals per dose:
4 females
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Positive control results:
SI = 5.76, Positive
Parameter:
SI
Remarks on result:
other: 25% = 1.48 50% = 1.92 100% = 0.94
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 25% = 23114.85 50% = 29906.12 100% = 14639.73

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not a skin sensitiser
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The substance gave a negative response in a reliable LLNA.


Migrated from Short description of key information:
The substance is not a skin sensitiser.

Justification for selection of skin sensitisation endpoint:
Only one study available. The study is Klimisch 1.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance gave a negative response in a LLNA and is therefore not classified.