Animal testing in toxicity testing may be avoided by using the category and analogy concept. It is based on using the structural similarity of an output substance to assume the same toxicological property in a target substance, thus fulfilling the information requirements under the Chemicals Regulation. To use this approach, high-quality studies for the endpoint or property under consideration are deposited in databases that registrants can use to access for comparison.
The approach is also appropriate for pharmaceuticals: Just this January, for example, the U.S. Food and Drug Administration (FDA) made available data in the IUCLID database containing results from preclinical animal studies and human data on approved drugs. The data are from repeated-dose toxicity studies, and carcinogenicity, developmental and reproductive toxicology studies.
More information:
https://iuclid6.echa.europa.eu/de/view-article/-/journal_content/title/us_fda_toxicity_data_19-01-2023
https://iuclid6.echa.europa.eu/de/project-iuclid-6
https://iuclid6.echa.europa.eu/de/