3-methylbutanone

Endpoint summary

Additional information

The mutagenic/genotoxic potential of methyl isopropyl ketone has been characterized in a well conducted bacterial in vitro mutagenicity test, an in vitro chromosomal aberration assay, and an in vitro mammalian cell mutation assay conducted in mouse lymphoma cells. All studies were conducted according to current guidelines and are considered to be key studies. In a bacterial reverse mutation assay conducted according to OECD Guideline 471, there was no increase in cytotoxicity or mutation frequency in E. coli or any strain of Salmonella typhimurium at concentrations up to 5000 μg/plate in the presence or absence of metabolic activation. In a mammalian in vitro chromosome aberration assay conducted according to OECD Guideline 473, there was no increase in chromosome aberrations or polyploidy in Chinese hamster ovary cells tested at concentrations up to 901 μg/mL methyl isopropyl ketone in the presence and absence of metabolic activation. In a mammalian in vitro gene mutation assay conducted according to OECD Guideline 475, there was no increase in mutation frequency in mouse lymphoma L5178Y cells tested with methyl isopropyl ketone at concentrations up to 880 μg/mL in the presence and absence of activation. In all three studies, the vehicle and positive controls induced the appropriate responses.   

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Although no in vivo heritable germ cell mutagenicity tests were available for review, the total weight-of-the-evidence available indicates that methyl isopropyl ketone is not expected to induce heritable mutations in the germ cells of humans and is not classified for “Germ Cell Mutagenicity” according to GHS.