New IUCLID pharmaceutical datasets support alternatives to animal testing

ECHA/NR/23/03

ECHA has published IUCLID structured datasets for 348 approved pharmaceuticals, with results from non-clinical animal studies and human information.  

Helsinki, 24 January 2023 – The new datasets offer robust pharmaceutical information for industry and research in a structured format. They support toxicity assessment of structurally similar chemicals with the goal of reducing the need for animal testing.

They can also be used to develop predictive models and to analyse correlations based on animal and human data. Users can assess the relevance of animal models to humans by comparing results of animal tests with effects in humans. 

Ofelia Bercaru, ECHA’s Director of Prioritisation and Integration says: 

“We welcome the datasets as one further step to combine and assess available data on chemicals. The data will be useful for developing read-across or weight of evidence approaches and supports our reinforced priority to reduce the need for animal testing.” 

The datasets were built by extracting animal and human data from files 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. 

Later in 2023, a total of 530 datasets for pharmaceuticals will be available. A scientific paper will also be published later this year to explain their development and architecture.