Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Three GLP experimental studies have been performed to cover the mutagenicity potential in bacteria and mammalian cells (Ames; mouse lymphoma cells; CA V70 cells). All studies were performed both with metabolic activation and without metabolic activation in order to check if any metabolic process can activate or enhance the mutagenic effects, if any. All mentioned studies did not show any mutagenic effects in the treated systems. Negative response was given in the presence of metabolic active and in the absence of it. Therefore the substance did not showed any mutagenic activity in both situations. The substance is therefore not classified for mutagenic potential. It’s not deemed necessary to perform an additional “in vivo” study (i.e. Micronucleus test) or any other “in vitro” testing.

Justification for classification or non-classification

Based on the in vitro tests results, the substance is not classified as mutagenic according to CLP criteria.