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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test item was not sensitising in the local lymph node assay.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according EU/OECD guideline.
according to guideline
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
equivalent or similar to 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)
acetone/olive oil (4:1 v/v)
0 (vehicle control), 3, 10 and 30%.
No. of animals per dose:
6 mice per group
Remarks on result:
other: The NMRI mice did not show an increase in the stimulation indices for cell counts or for weights of the draining lymph nodes after application of the test substance.
Interpretation of results:
other: irritant but not sensitising
Executive summary:

This study does point to a non-specific (irritant) immunostimulating potential of the test item.


This applies to NMRI mice, for weight and cell counts of the draining lymph nodes as well as ear swelling and ear weight indices evaluated after application of the test substance. The "positive level" of ear swelling which is 2x10-2mm increase, i.e. more than 10% increase in index, has been exceeded in the high dose group. This increase is statistically significant compared to vehicle treated animals. An increase of the ear weights could also be determined in the animals of the high dose group compared to control animals. Therefore, it must be concluded that the test item has an irritant potential at the highest concentration tested, i.e. 30%.

Taken together, no antigen specific activation of the cells of the immune system via dermal route was determined after application of up to and including 30% test substance by the method used. Therefore, the concentration of 30% turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization.

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

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes. As a result the substance does not need to be classified and labelled under Regulation (EC) No 1272/2008.