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:

Skin sensitization

Skin sensitizing potential was assessed in a GLP-Study according to the protocols of the OECD TG 429 for local lymph node assay (reliability = val.1). A volume of 25 µl was topically applied to each ear of 10 weeks old female mice (CBA strain, inbred, SPF-quality) (5 animals/dose). Applied concentrations were 25, 50% in dimetyl formamide and 100% (undiluted). The application was performed once daily for 3 consecutive days with a 24 hour interval. 3 days after the last application, the animals were injected with tritrium labelled 3-methyl thymidine (0.25 ml, 20µCi) and sacrificed 5 hours afterwards by via tail injection of phenobarbital. The auricular lymph nodes were excised, prepared, pooled and radioactivity (disintergrations per minute) measured.

Migrated from Short description of key information:
- skin: not sensitizing (OECD 429)

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
no data available concerning respiratotry sensitisation.

Justification for classification or non-classification

The test substance does not meet the classification and labelling criteria as laid down in 67/548/EEC and 1272/2008/EEC (EU-GHS) for sensitisation.