Studies on tissue specific carcinogenicity and on metabolism of N-nitrosamines (SC05 to FWC EMA/2020/46/TDA/L1.02 – ROC38))

Study identification

• EU PAS number:
  EUPAS1000000819
• Study ID:
  1000000819
• Official title and acronym:
  Studies on tissue specific carcinogenicity and on metabolism of N-nitrosamines (SC05 to FWC EMA/2020/46/TDA/L1.02 – ROC38))
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The MUTAMIND SC05 project investigates the major metabolic sites of the NDSRIs, which are presumed to impact the metabolic activations of these compounds. For this purpose, the MUTAMIND SC05 project will explore the (de)activation of NDSRIs using the in vitro human liver models. This aim to identify the major sites of the metabolic activation to study e.g. the hydroxylation sites. ; Furthermore, the impact of the potential conjugation reactions, which may influence the reactivity of the NDSRIs and the general detoxification process will be addressed in in vitro studies. Additionally, in silico tools will be employed to predict the metabolites generated during this process. This will facilitate the evaluation of their applicability and predictivity for the upcoming projects related to NDSRIs.; This deliverable provides an overview of the approaches that will be employed throughout the course of the project. The project is categorized into two main objectives: ; • Objective 1: Review of quantitative organ-specific carcinogenicity for N-nitrosamines.; • Objective 2: Mechanistic study on the metabolism of N-nitrosamines.;
• Study status:
  Planned

Research institutions and networks

Institutions

Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM)

Study timelines

Date when funding contract was signed

Planned:05/08/2025

Actual:05/08/2025

Study start date

Planned:05/08/2025

Data analysis start date

Planned:01/01/2026

Date of interim report, if expected

Planned:06/08/2026

Date of final study report

Planned:06/09/2026

Sources of funding

EMA

More details on funding

SC05 to FWC EMA/2020/46/TDA/L1.02 – ROC38

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable