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 type

• Study type:
  Not applicable
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• If ‘Not applicable’, further details on the study type:
  Research study testing in vitro assays

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  Distinguish classes of Nitrosamines, which differ with regard to their carcinogenic potential.
• Outcomes:
  Structural rules which defines properties that lead to high or low carcinogenic potency.
• Data analysis plan:
  Derivation of acceptable daily intake values for classes of Nitrosamines