Status: Ongoing First registered on: 02/03/2022
Last updated on: 29/08/2022
1. Study identification
EU PAS Register NumberEUPAS46057
Official titleQuantitative structure Activity Relationships (QSAR) for nitrosamine risk assessment. EMA/2020/46/TDA/01(Lot 1) SC01 under FWC EMA/2020/46/TDA/L1.02
Study title acronymQSAR for Nitrosamines
Study typeOther: research project
Brief description of the studyDevelopment 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameFraunhofer Gesellschaft
Centre locationFraunhofer Institute for Toxicology and Experimental Medicine
Details of (Primary) lead investigator
Title Dr
Last name Escher
First name Sylvia
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Germany
Netherlands
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed08/12/202108/12/2021
Start date of data collection01/01/202203/01/2022
Start date of data analysis
Date of interim report, if expected28/02/202228/02/2022
Date of final study report31/12/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyEMA100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Escher
First name Sylvia
Address line 1Nikolai-Fuchs str. 1
Address line 2 
Address line 3 
CityHannover 
Postcode30161 
CountryGermany
Phone number (incl. country code)49-162-2916659 
Alternative phone number 
Fax number (incl. country code) 
Email address sylvia.escher@item.fraunhofer.de
Public Enquiries
Title Dr 
Last name Escher 
First name Sylvia 
Address line 1Nikolai-Fuchs str. 1 
Address line 2 
Address line 3 
CityHannover 
Postcode30161 
CountryGermany 
Phone number (incl. country code)49-162-2916659 
Alternative phone number 
Fax number (incl. country code) 
Email address sylvia.escher@item.fraunhofer.de 
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