Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

One GLP compliant dermal sensitsation study has been conductedc according to OECD Guideline 429 and EU B.42. It is considered to be reliable (1 on the Klimisch scale) and conducted according to GLP, with a minor exception. The substance has given a clear negative result in the local lymph node assay (LLNA) in mice. This study showed that the substance does not warrant classification as a skin sensitiser according to EU DSD and CLP schemes.


Migrated from Short description of key information:
A GLP-compliant local lymph node assay (LLNA) in the mouse has been conducted according to OECD guideline 429 and EU Method B.42. Three groups of four animals were treated with 50 µL (25 µl per ear) of the test material as a suspension in propylene glycol at concentrations of 25%, 10%, and 5% w/w. The test material was considered a non-sensitiser.

Respiratory sensitisation

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

No specific test data is available on respiratory sensitisation but experience in use suggests the substance in not a respiratory sensitiser.


Migrated from Short description of key information:
No specific test data is available on respiratory sensitisation but the substance has been used in industry for many years without any incidences of respiratory sensitisation.

Justification for classification or non-classification

The substance has given a clear negative result in the in vivo LLNA study. On this basis the substance is not classified as a skin sensitiser. No specific test data is available on respiratory sensitisation but experience in use suggests the substance is not a respiratory sensitiser and hence no classification is required. The available study data show that the substance is not a skin sensitiser and therefore does not trigger labelling as a skin sensitiser according to the criteria of the EU DSD and CLP schemes.