Registration Dossier
Registration Dossier
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EC number: 209-264-3 | CAS number: 563-80-4
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
No hyperplasia or necrosis was observed at necropsy in male or female rats repeatedly exposed to high airborne concentrations of methyl isopropyl ketone and all genotoxicity studies were negative both in the presence and absence of metabolic activation. Based on a weight-of-the-evidence evaluation, methyl isopropyl ketone is unlikely to pose a significant risk for the development of any tumor type in humans exposed to this chemical and is not considered to be classified for “Carcinogenicity” according to GHS.
Additional information
There were no chronic repeat-exposure studies conducted with methyl isopropyl ketone available for review. However, results for a key guideline repeat-exposure study in which male and female rats were exposed to up to 3000 ppm of the test material via inhalation for 6 hr/day, 5 days/wk for a total of 22 exposures and a developmental and reproductive toxicity screening study in which the parental generation was exposed via inhalation to up to 5.0 mg/L methyl isopropyl ketone for 6 hr/day, 7 days/wk for up to 51 days suggest that the test material is unlikely to pose a significant risk for the development of a carcinogenic effect. In both studies, no necrosis or hyperplasia was observed in any organ evaluated at necropsy. In addition, no mutagenicity/genotoxicity was observed in a bacterial gene mutation assay, an in vitro mammalian chromosome aberration assay, or an in vitro mammalian gene mutation assay.
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