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Description of key information

There are no data available on the registered substance. However, the test item was not sensitising in the local lymphnode assay (read across, CAS 752984-24-0).

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:
other: GLP study according EU/OECD guideline.
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
equivalent or similar 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:
NMRI
Sex:
female
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0 (vehicle control), 3, 10 and 30%.
No. of animals per dose:
6 mice per group
Parameter:
SI
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.