ECHA adds new pharmaceutical data to IUCLID

ECHA has published a IUCLID dataset for 528 approved pharmaceuticals, including results from animal studies and human data. The availability of this new data supports the development of alternatives to animal testing.

Helsinki, 07 November 2023 – Data for 180 new substances were added to the dataset, which already had information on 348 substances published earlier this year. The expanded dataset offers toxicological information on animals and humans in a structured format and can be used by industry and the research community. The data helps in assessing the toxicity of structurally similar chemicals, aiming to reduce animal testing. It can also be used to develop predictive models and to assess similarity between animal and human data.

ECHA has also published a customised ontology, a dictionary of toxicological terms, to help users to classify and organise the effects of chemicals in a standardised way. It combines the Ontology Lookup Service’s human and mammalian ontologies, which underwent substantial revisions, updates, and integration with novel terms. Over 20 000 new and distinct standardised terms have been added.

Earlier this year, ECHA published a scientific paper explaining the development of the database and ontology. A second paper will follow, explaining in more detail the scope and content of the datasets and possible use cases.

The IUCLID dossiers were built by extracting animal and human data from documents provided by the United States’ Food and Drug Administration. These included studies related to carcinogenicity as well as repeat-dose, developmental and reproductive toxicity. They also have information on the effects medicines have on humans, extracted from standard product labels of approved drugs. 

Press contact: Tiiu Bräutigam, press@echa.europa.eu, +358 40 506 9006