Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 225-582-5 | CAS number: 4940-11-8
Carcinogenicity
Administrative data
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
