EMA/2020/46/TDA, Lot 1 – ROC25 Refinement of enhanced Ames test conditions for N-nitrosamines MUTAMIND2

Study identification

• EU PAS number:
  EUPAS1000000684
• Study ID:
  1000000684
• Official title and acronym:
  EMA/2020/46/TDA, Lot 1 – ROC25 Refinement of enhanced Ames test conditions for N-nitrosamines MUTAMIND2
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Study protocols for the bacterial mutagenicity assay based on the current version of the EAT protocol for testing N-nitrosamines, including phenotyping the activation methodology of commonly used positive controls and selected NDSRIs.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM)

Federal Institute for Drugs and Medical Devices (BfArM)

Germany

ICCR-Roßdorf GmbH

Study timelines

Date when funding contract was signed

Planned:28/11/2024

Actual:28/11/2024

Study start date

Actual:05/12/2024

Data analysis start date

Actual:05/12/2024

Date of interim report, if expected

Actual:05/04/2025

Date of final study report

Planned:07/04/2026

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable