Quantitative structure Activity Relationships (QSAR) for nitrosamine risk assessment. EMA/2020/46/TDA/01(Lot 1) SC01 under FWC EMA/2020/46/TDA/L1.02 (QSAR for Nitrosamines)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48784
• EU PAS number:
  EUPAS46057
• Study ID:
  48784
• Official title and acronym:
  Quantitative structure Activity Relationships (QSAR) for nitrosamine risk assessment. EMA/2020/46/TDA/01(Lot 1) SC01 under FWC EMA/2020/46/TDA/L1.02 (QSAR for Nitrosamines)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Netherlands

  United Kingdom

  United States
• Study description:
  Development of a structure activity relationship for N-Nitrosamines. A special focus will be given to the evaluation of DNA adduct formation and DNA repair processes by experimental testing. With these data, groups of highly potent carcinogens will be distinguished form less potent Nitrosamines. This knowledge will allow to set different thresholds for Nitrosamines.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Fraunhofer-Gesellschaft

Study timelines

Date when funding contract was signed

Planned: 08/12/2021

Actual: 08/12/2021

Study start date

Planned: 01/01/2022

Actual: 03/01/2022

Date of interim report, if expected

Planned: 28/02/2022

Actual: 28/02/2022

Date of final study report

Planned: 31/12/2023

Sources of funding

Other

More details on funding

EMA

Study protocol

Initial protocol

01_QSAR_Study_Design_Protocols

Regulatory

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