Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
Sensitization
- 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.