Assessment of the toxicity of citrinin

Citrinin is a mycotoxin and usually formed by fungi during storage of food. It is mainly found in grain but it can also be found in other products of plant origin like beans, fruits, vegetables and fruit juices, herbs and spices an tainted dairy products. In a recent biomonitoring study of multiple mycotoxins in the Belgian population low concentrations of citrinin were frequently detected. The Netherlands Food and Consumer Product Safety Authority (NVWA) monitors the occurrence of mycotoxins in the Netherlands and advises the Dutch government on the food safety risks related to mycotoxins. In 2012 the European Food Safety Authority (EFSA) has published an opinion where it was reported that due to limitations and uncertainties in the toxicity database (especially genotoxicity and carcinogenicity), the derivation of a health-based guidance value that would cover all possible adverse outcomes of citrinin was not considered appropriate. Nonetheless, a health-based guidance value was set on the highest dosage of a 90-day general toxicity study (not covering specific endpoints, for example carcinogenicity, developmental effects) because no effects were reported. In this report a new literature search was performed to find out whether new toxicity studies have been published (2011 to 2015). And secondly, if new toxicity studies could be used to derive a benchmark dose or a health-based guidance value. The literature search produced 38 new toxicity articles on citrinin, where seven of these studies contained in vivo animal tests. Two of the seven studies were suitable for BMD analysis. The lowest BMDL of 48 µg/kg bw/day obtained from the endpoint ‘decreased crown rump length’ from the Singh study is considered as the appropriate point of departure for risk assessment. This BMDL is 2.4 times higher than the (conservative estimate of the) NOAEL determined by EFSA in 2012. There are no new scientific articles available on the in vivo genotoxicity or carcinogenicity of citrinin. A re-evaluation of an article published in 1983 on the tumorigenicity of citrinin in rats revealed that the study was not suitable for BMD analysis. Therefore, we agree with EFSA’s concern regarding the genotoxicity and/or carcinogenicity of citrinin and EFSA’s request for a well-designed toxicological study in laboratory animals to further explore the carcinogenic potential of citrinin.