Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Sensitisation was assessed using the Magnusson and Kligmann sensitisation assay. During the challenge phase of the study, mild irritation reactions were noted therefore a second challenge application was performed. After the challenge exposure 5% of the animals were judged to have been sensitised by the test compound, this leads to the conclusion that the reactions observed in the first application were not specific. 

 

On the basis of the results, the substance cannot be considered to be a skin sensitiser.


Migrated from Short description of key information:
Summary of sensitisation.

Respiratory sensitisation

Endpoint conclusion
Additional information:

No evidence of respiratory sensitisation was noted in any of the studies conducted, and it is proposed that the substance is not a respiratory sensitiser.

Justification for classification or non-classification

The above studies have all been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were all conducted to GLP in compliance with recognised guidelines. The majority of the information has been provided from a migrated nons file referring to studies which are more than 12 years old, with the permission of ECHA.

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for acute effects is therefore required.