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Description of key information

The genotoxicity of the Ethyl Maltol has been assessed in vitro for two genotoxicity endpoints: mutagenicity in bacteria (Ames test) and genemutation in mammalian cells using read across from Kojic Acid. This results in a positive result in bacteria and a negative result in mammalian cells. An in vivo mammalian somatic cell study in mice with Ethyl Maltol was negative for cytogenicity.

Based on this the substance is not considered genotoxic in vitro or in vivo.

The carcinogenicity of Ethyl Maltol has been assessed in vivo in rats and dogs (Gralla et al. 1969; similar to OECD TG 453). No histopathological changes and no increases in neoplasms were seen after two years treatment with the test substance. Ethyl Maltol was evaluated by the EFSA Panel (FGE.213) which concluded that the substance is not carcinogenic based on the 24 month repeated dose toxicity study.

EFSA, 2015, http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4244/epdf

Key value for chemical safety assessment

Justification for classification or non-classification

Based on all genotoxicity information the substance is not genotoxic in vitro and in vivo and it is not carcinogenic based on a carcinogenicity study. Therefore the substance does not need to be classified for carcinogenicity according to EU CLP (EC no. 1272/2008 and its amendments).

Additional information

Chronic rat (Gralla et al. 1969; similar to OECD TG 453)

Groups of 25 male and female rats were fed for two years on diets containing Ethyl Maltol [FL-no: 07.047] calculated to deliver 0, 50, 100 and 200 mg Ethyl Maltol/kg bw/day. No abnormalities were seen as regards survival, clinical appearance, growth rate or food consumption, clinical chemistry, haematology and urinalysis. No histopathological changes and no increases in neoplasms were seen after the treatment with Ethyl Maltol.

Chronic dog (Gralla et al. 1969; similar to OECD TG 453)

Groups of 8 male and female dogs were given Ethyl Maltol, in capsules, at dose levels of 200, 250 or 125 mg/kg bw/day, 5 days per week for 2 years. All levels of Ethyl Maltol were tolerated without adverse effects. No treatment-related pathologic changes were found. No histopathological changes and no increases in neoplasms were seen after the treatment with Ethyl Maltol.