Registration Dossier

Administrative data

Description of key information

Not sensitising to skin as assessed in a local lymph node assay (OECD 429).

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The potential skin sensitisation of the test item was investigated by a local lymph node assay according to OECD guideline 429 (Synthesia, 2008). In this study the contact allergenic potential of the test item was evaluated with non radioactive measuring of cell proliferation after topical application to female BALB/c mice. Six mice per group were exposed by test and control substances on the dorsum of both ears once a day during 3 consecutive days. Draining lymph nodes were taken off at 24 hours after the last application. Concentrations: positive control DNCB (dinitrochlorobenzene): 0.5% (w/v) and test item: 10%, 1%, 0.1% (w/v) in DAE 433. Endpoints: ear weight, auricular (ear-draining) lymph node weights and cell counts = lymph node (LN) hyperplasia.The animals exposed to the test substance at the highest concentration showed skin reactions (congestion of vessels) throughout the experiment. There were no clinical observations attributable to the treatment with test substance at the middle and lower dose level. There was no difference in body weight increment of all groups in comparison to the vehicle control. The positive control substance DNCB elicited a reaction pattern with statistically significant increase in ear weight and LN hyperplasia, which was in congruence with his expected mode of action as a contact allergen. The test substance showed a tendency to increase of ear weight in the highest dose level but without lymph node hyperplasia. Residues of the test substance on the ears caused this increased weight. Comparison of values between treated groups and control group revealed that the test substance did not cause statistically significant increase in LN cell count or in LN weight. Also index of LN weight and LN cell count was not exceeded in any dose level. In conclusion, at the given experimental conditions the test substance elicited negative result in LLNA test and is therefore not considered to be sensitising to the skin.

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 under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP),
as amended for the thirteenth time in Regulation (EC) No. 2018/1480.