Swedish Chemicals Agency Evaluates the Solvent Butanone
A substance evaluation conclusion and evaluation report for the solvent butanone was recently prepared by the Swedish Chemicals Agency as part of the substance evaluation process under REACH, the European Union’s regulation on Registration, Evaluation, Authorization and Restriction of Chemicals. Butanone is also known as 2-butanone or methyl ethyl ketone (MEK). The substance evaluation report portion of the document explains why the Swedish Chemicals Agency, which carried out this task as an evaluating Member State Competent Authority (MSCA) for REACH, “considers that there is sufficient evidence that [butanone] poses an exposure-based concern for consumers and workers” and how it came to characterize the substance as posing “a potential risk to human health.” MSCAs cooperate with the European Commission, the European Chemicals Agency (ECHA), and other MSCAs to implement the REACH regulation.
The recently published report describes butanone as having “widespread uses by industrial and professional workers” with occupational exposure potentially occurring via both the inhalation and dermal routes. According to the Swedish Products Register, which includes information about chemical products manufactured or brought into Sweden, butanone is primarily used in the manufacture of cleaning agents or detergents, in gluing agents, and in solvents. The report notes that workers may also be exposed to butanone in coatings, water treatment agents, and fuel. Other uses that may expose workers include the substance’s uses in metalworking fluids, polymer processing, and in laboratories.
“Based on the information available in the open literature, the [Swedish Chemicals Agency] considers that butanone may also potentiate the neurotoxicity of other solvents,” the report continues. “Workers are most often exposed to butanone in a mixture of solvents.”
The information available when the agency carried out its evaluation “supports that [butanone] acts as a reproductive toxicant, more specifically a developmental neurotoxicant,” the report states. For this reason, the Swedish Chemicals Agency, in its MSCA role, believes that a harmonized classification for developmental toxicity according to the EU regulation on the classification, labelling, and packaging of substances and mixtures, or CLP, “may be warranted.” The report explains that such a classification “would further support the implementation of appropriate risk management measures.”
The full report is available as a PDF from ECHA’s website.