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:

The skin sensitizing potential of y-Butyrolactone (GBL) was assessed using the radioactive Murine Local Lymph Node Assay and was determined not to be a skin sensitizer (BASF SE, 2010).

Migrated from Short description of key information:

Not a sensitiser

Respiratory sensitisation

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

y-Butyrolactone (GBL) has not been specifically tested for respiratory sensitization but the many years of human experience handling this substance, along with information on metabolism and the absence of a skin sensitisation potential, provides sufficient evidence that it is not a respiratory sensitiser.

Migrated from Short description of key information:

Not expected to be a sensitiser

Justification for classification or non-classification

Based on the results of a Local Lymph node assay gamma-butyrolactone is judged not to be a skin sensitizer under the EU DSD criteria (EU Directive 67/548/EEC) or the EU CLP criteria (EU Regulation 1272/2008).