Skip to content

Ethanol as a Developmental Toxicant

Do the Available Data Meet the Formal Requirements for the Hazard Classification under EU Law?

Walter Reinhard Aulmann


A review of the existing information for ethanol on developmental toxicity concludes a classification as a developmen­tal toxicant in the European Union (EU) is not justified. This review followed the provisions of relevant EU regulations for the hazard assessment of chemical substances. Pertinent rodent data for ethanol is based on studies that used dosing schemes that did not align with current Organization for Economic Co-operation and Development (OECD) test guidelines and EU regulations. Human data, on the other hand, suffer from methodological issues such as the insufficient exposure characterization. To close the current knowledge data gap on the potential developmental toxicity of ethanol, further toxicity studies are recommended. Developmental neurotoxicity should be the primary area of interest. In the suggested studies dosing must conform with applicable test guidelines to properly address exposures relevant for human non-food use of ethanol.

Dr. Walter Reinhard Aulmann, European Registered Toxicologist (ERT), Düsseldorf. For correspondence: The author would like to thank Nathan Pechacek, DABT for his diligent review of the manuscript.


Lx-Number Search

(e.g. A | 000123 | 01)

Export Citation