Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The mutagenic/genotoxic potential of 1 -isopropyl-2,2 -dimethyltrimethylene diisobutyrate has been characterized in a series of well conducted bacterial and mammalian in vitro mutagenicity tests. In a bacterial reverse mutation assay conducted according to EU Method B.13/14, there was no increase in mutation frequency in any strain of Salmonella typhimurium or Escherichia coli at concentrations up to 5000 μg/plate in the presence or absence of metabolic activation. In an in vitro chromosome aberration assay conducted by a method similar to that prescribed in OECD 473, OPPTS 870.5375 and EU B.10, there was no evidence of an increase in the number of CHO cells with chromosomal aberrations or polyploidy in the presence or absence of metabolic activation, even at dose levels that showed clear cytotoxicity. In an in vitro forward mutation assay conducted according to OECD Guideline 476, there was no increase in mutation frequency at the HGPRT locus in CHO cells at concentrations up to 40 μg/mL in the absence of metabolic activation or up to 2000 μg/mL in the presence of activation. Under nonactivation conditions, the test material was excessively cytotoxic at concentrations 62.2 μg/mL. For all studies, vehicle and positive controls induced the appropriate responses.


Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Although no in vitro or in vivo germ cell mutagenicity/genotoxicity studies were available for review, the total weight of evidence available indicates that 1 -isopropyl-2,2 -dimethyltrimethylene diisobutyrate is not expected to induce heritable mutations in the germ cells of humans and is not classified for genotoxicity according to EU CLP.