This notice is for prior information only
Legal Basis:
Regulation (EU, Euratom) No 2018/1046
Section I: Contracting authority
I.3)CommunicationAdditional information can be obtained from the abovementioned address
I.4)Type of the contracting authorityEuropean institution/agency or international organisation
I.5)Main activityGeneral public services
Section II: Object
II.1)Scope of the procurement
II.1.1)Title:
Characterisation of Human Variability in Toxicodynamics: Towards the Development of Quantitative Adverse Outcome Pathways (qAOPs)
II.1.2)Main CPV code73000000 Research and development services and related consultancy services
II.1.3)Type of contractServices
II.1.4)Short description:
The setting of health-based guidance values in chemical risk assessment involves the application of uncertainty factors (UFs) to extrapolate animal data to humans and to consider inter-human variability. Inter-human variability consists of the variability in toxicokinetics (TK) and toxicodynamics (TD). While human variability in TK is relatively well characterised, little information is known about TD variability. Attempts to gain insight into the human variability in TD processes have been hampered by the lack of adequate data and the use of transformed or dedifferentiated human cell models.
II.1.5)Estimated total value
II.1.6)Information about lotsThis contract is divided into lots: no
II.2)Description
II.2.3)Place of performanceNUTS code: ITH52 Parma
II.2.4)Description of the procurement:
The setting of health-based guidance values in chemical risk assessment involves the application of uncertainty factors (UFs) to extrapolate animal data to humans and to consider inter-human variability. Inter-human variability consists of the variability in toxicokinetics (TK) and toxicodynamics (TD). While human variability in TK is relatively well characterised, little information is known about TD variability. Attempts to gain insight into the human variability in TD processes have been hampered by the lack of adequate data and the use of transformed or dedifferentiated human cell models.
The project to be launched by EFSA proposes to use peripheral blood lymphocytes (PBLs) freshly isolated from a cohort of human volunteers. Human variability will assessed through quantitative assessments of the dose-responses to key stress responses known do induce the key pathological reactions and cell death responses observed at the cellular level in chemical-induced toxicity through high-content screening of functional and transcriptomic readouts.
II.2.14)Additional information
II.3)Estimated date of publication of contract notice:30/04/2021
Section IV: Procedure
IV.1)Description
IV.1.8)Information about the Government Procurement Agreement (GPA)The procurement is covered by the Government Procurement Agreement: no
Section VI: Complementary information
VI.3)Additional information:
Information included in this notice is to be considered as indicative and subject to changes at procurement procedure stage.
VI.5)Date of dispatch of this notice:15/03/2021
