Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

This substance was tested in according to mouse local lymph node assay (OECD 429) at concentrations of 10%, 25% or 50% w/w, and the stimulation scores were positive at all concentrations. In accordance to Directive 67/548/EEC and EU CLP (Regulation (EC) No. 1272/2008), this substance was classified as a skin sensitizer.

 

This substance did not show any sensitizing potential using the Buehler method modified to use only females largely in accordance with 1992 OECD 406. Concentrations tested in the induction, challenge, and rechallenge phases were 50%, 1%, and 1%, respectively. Due to the low challenge concentration level, this study was ranked as a supporting study and was not used for classification and labeling purpose.

EC3 value was determined to be 9.39%. Per the CLP guidance, substances are to be classified as skin sensitization 1A when the EC3 value is less than 2% and are to be classified as skin sensitization 1B when the EC3 value is greater than 2%.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Migrated from Short description of key information:
No data available for respiratory sensitization.

Justification for classification or non-classification